WO2022057498A1 - Composition with function of relieving physical fatigue and preparation method therefor - Google Patents
Composition with function of relieving physical fatigue and preparation method therefor Download PDFInfo
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- WO2022057498A1 WO2022057498A1 PCT/CN2021/110929 CN2021110929W WO2022057498A1 WO 2022057498 A1 WO2022057498 A1 WO 2022057498A1 CN 2021110929 W CN2021110929 W CN 2021110929W WO 2022057498 A1 WO2022057498 A1 WO 2022057498A1
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- american ginseng
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Definitions
- the invention relates to the technical field of health food preparation, in particular to a composition with the function of relieving physical fatigue and a preparation method thereof.
- Physical fatigue refers to the decline of activity ability after a certain period of time and to a certain extent in the process of engaging in physical and mental work, manifested as fatigue or muscle soreness or general weakness.
- the primary physiological nature of fatigue is the effect on energy metabolism due to muscle activity.
- TCM The theory of TCM believes that the kidney stores essence, controls the bones and generates marrow, is the innate foundation, and is the motive force and source of physical strength, while the spleen is the acquired foundation, qi and blood, and the spleen controls the muscles of the limbs. , the muscle weakness.
- the liver is in charge of dredging and excreting, and it is in charge of storing blood. If the liver blood is sufficient, the muscles and bones will be strong, the movement is flexible, the fatigue can be tolerated, and the fatigue can be relieved quickly. Insufficient liver blood, lack of nourishment of the muscles and veins, slack and fatigue, or easy fatigue after activity, and the fatigue relief speed is slow.
- the present invention aims to provide a composition with the function of relieving physical fatigue.
- the composition comprises 1-27 parts of Acanthopanax senticosus, 1-10 parts of Cistanche deserticola, 1-6 parts of American ginseng, and 1-15 parts of Salvia miltiorrhiza. .
- composition comprises 2-25 parts of Acanthopanax senticosus, 2-8 parts of Cistanche deserticola, 1-4 parts of American ginseng, and 1-13 parts of Salvia miltiorrhiza.
- composition comprises 3-10 parts of Acanthopanax senticosus, 2-5 parts of Cistanche deserticola, 2-3 parts of American ginseng, and 2-5 parts of Salvia miltiorrhiza.
- the composition comprises 5 parts of Acanthopanax senticosus, 3 parts of Cistanche deserticola, 2 parts of American ginseng, and 2 parts of Salvia miltiorrhiza.
- the present invention also provides the application of any of the above compositions in the preparation of medicines, health products or foods with the function of relieving physical fatigue.
- the present invention provides a medicine, health product or food containing the composition described in any of the preceding.
- the medicine, health product or food is selected from tablets.
- the medicine, health product or food also includes auxiliary materials; the auxiliary materials include fillers, disintegrants, and lubricants.
- the auxiliary materials include but are not limited to: corn starch, calcium hydrogen phosphate, calcium carbonate, dry starch, pre-interleaved starch, dextrin, maltodextrin, microcrystalline cellulose, croscarmellose sodium, Sodium carboxymethyl starch, crospovidone, low-substituted hydroxypropyl cellulose, povidone K30, starch syrup, hydroxypropyl cellulose, magnesium stearate, talc or silicon dioxide.
- the filler includes one or more of corn starch, calcium hydrogen phosphate, maltodextrin, and microcrystalline cellulose;
- the disintegrant includes croscarmellose sodium, carboxymethyl starch One or more of sodium and low-substituted hydroxypropyl cellulose;
- the lubricant includes one or more of magnesium stearate, silicon dioxide, and talc.
- the filler is preferably microcrystalline cellulose; the disintegrant is preferably croscarmellose sodium; and the lubricant is preferably magnesium stearate.
- the present invention also proposes a method for preparing the composition as described in any preceding item, comprising:
- preparation method of described composition comprises:
- the present invention also proposes a preparation method of the aforementioned medicine, health-care product or food, wherein the medicine, health-care product or food is selected from tablets, and the preparation method comprises:
- Granulation adding 90% ethanol to the mixed powder to prepare soft material, granulating with a 20-mesh sieve, drying at 50-60°C, and granulating with a 20-mesh sieve to obtain granules;
- Tablet compression the granules are mixed with croscarmellose sodium and magnesium stearate, and compressed to obtain plain tablets;
- Coating the plain tablet is film-coated to obtain a coated tablet.
- the granulation process includes wet granulation, dry granulation or one-step granulation.
- the film coating includes one or more of hypromellose, polyvinyl alcohol, triacetin, talc, carmine aluminum lake, brilliant blue aluminum lake, and titanium dioxide.
- Acanthopanax senticosus is the dried root and rhizome or stem of Acanthopanax seuticosus (Rupr.et Maxim.) Harms of the Araliaceae plant, acrid, slightly bitter, warm, returns to the spleen, kidney and heart meridians, used for spleen and lung qi deficiency, body Deficiency, loss of appetite, deficiency of both lungs and kidneys, chronic cough and asthma, soreness of waist and knees due to kidney deficiency, insufficiency of heart and spleen, insomnia and dreaminess.
- Cistanche Cistanche is the dry, scaly stem of Cistanche deserticoLa YCMa or Cistanche tubuLosa (Schenk) Wight. It is sweet, salty and warm in nature. , Runchang laxative, used for deficiency of kidney yang, deficiency of essence and blood, impotence and infertility, soreness and weakness of waist and knees, weakness of muscles and bones, dry intestines and constipation. Cistanche is a well-known tonic Chinese medicine, and has the reputation of "desert ginseng". "Xinjiang Dayun" records that Cistanche Cistanche can invigorate the deficiency of the kidney essence.
- the deficiency of the kidney is caused by deficiency of essence and qi, or anxiety and depression, damage to the heart and spleen, or damage to the kidney due to fear. It is due to deficiency of kidney yang and atrophy. "Compendium of Materia Medica” records that this material is tonic but not severe, so it has a calm name.
- American ginseng is the dry root of Panax quinquefolium L. of the Araliaceae plant, sweet, slightly bitter, cool, and returns to the heart, lung and kidney meridians.
- American ginseng tonifies qi and nourishes yin, clears heat and promotes body fluid. It is used for qi deficiency and yin deficiency, irritability due to deficiency heat, cough and asthma, phlegm and blood, internal heat and thirst, dry mouth and throat.
- Salvia miltiorrhiza is the dry root and rhizome of the Lamiaceae plant Salvia miltiorrhiza Bge., bitter in nature, slightly cold, returning to the heart and liver meridians, promoting blood circulation and removing blood stasis, clearing the meridian and relieving pain, clearing the heart and eliminating vexation, cooling blood and eliminating carbuncle, used for chest pain and heart pain, Abdominal and hypochondriac pain, accumulation of Zhengjia, heat arthralgia pain, upset and insomnia, irregular menstruation, dysmenorrhea, amenorrhea, sore swelling and pain.
- the present invention uses Acanthopanax senticosus as the monarch medicine, Acanthopanax senticosus for invigorating the spleen and invigorating the spleen, invigorating the kidney and assisting the yang, and taking Cistanche deserticola and American ginseng as the ministerial medicines, the Cistanche deserticola invigorating the kidney and consolidating the root, the American ginseng invigorating the qi and nourishing the yin, and at the same time supplemented by the salvia miltiorrhiza to promote blood circulation, remove blood stasis, dispel Stasis and new generation to enhance Qi and blood circulation.
- the four herbs are used together to invigorate the kidney and essence, invigorate the spleen, and invigorate qi and activate blood.
- the kidney is the innate foundation and the motive force and source of physical strength; the spleen is the acquired foundation and the source of qi and blood biochemistry.
- One is the foundation of the innate, the other is the foundation of the acquired, the innate relies on the nourishment of the day after tomorrow, and the day after tomorrow relies on the innate nourishment and warmth.
- the invention is based on traditional Chinese medicine theory, combined with modern scientific research, starting from the mechanism of relieving physical fatigue and scientific compatibility, and proposes a safe and effective composition for relieving physical fatigue.
- Animal function experiments show that the composition of the invention can improve the The weight-bearing swimming time of the mice, the weight-bearing swimming test results were positive, and any two of the three biochemical indicators of blood lactate, serum urea, and liver glycogen-muscle glycogen were positive, which had the function of relieving physical fatigue.
- the R value of the influence range of each index and factor on the extraction process is C>A>B
- the range of the extraction times of medicinal materials (factor C) is the largest, and the C factor in each index component is significant, and the optimal value is C 2 , so it is determined that the number of extractions in the optimal process is 2 times.
- the extreme difference of the amount of water added (factor A) is second, and the A factor in each index component is not significant, and the optimal value is A 2 , so it is determined that the amount of water added in the optimal process (factor A) is A 2 , namely Add 10 times the amount of water each time.
- the range of extraction time (factor B) has the smallest influence, and the B factor in each index component is not significant.
- the intuitive analysis under each index shows that B 3 , because the B factor in each index component is not significant, considering the principle of energy saving, it is determined
- the extraction time (factor B) in the optimum process is B 1 , ie 1.0 hours each time.
- the optimal extraction process is as follows: adding 10 times the amount of water each time, and refluxing for 2 extractions for 1.0 hours each time.
- the verification test results showed that the total saponin content, echinacoside, verbascoside, and syringin transfer rate in the extract were all less than 3 when the extraction time was 1.0h, 1.5h, and 2.0h, indicating that the extraction time had an important effect on each index component. There was no significant effect, so the extraction time was determined to be 1.0h. Therefore, it is determined that the final extraction process is: adding 10 times the amount of water each time, and refluxing extraction for 2 times, each time for 1.0 hours.
- the concentration temperature conditions of the composition were investigated, and the transfer rate of total saponins, echinacoside, verbasin, and syringin was used as the investigation index, taking the same amount of extract, using The rotary evaporator was concentrated under reduced pressure to the same weight of concentrated solution, and the concentration temperature was set to 60, 70, and 80° C.
- the experimental results are shown in Table 11.
- Spray drying has the advantages of continuous production process and high production efficiency, so spray drying is selected for the composition of the present invention.
- the total saponin transfer rate in the spray-dried powder is used as an index to investigate.
- the influence of various factors on the drying process is very poor.
- the R value is A>B>C, and the specific gravity of the concentrate (factor A) is very poor.
- the transfer rate of echinacoside and verbascoside in the spray-dried powder is used as an index to investigate, the influence of each factor on the drying process is very poor, and the R value is A>C>B, and the specific gravity of the concentrate (factor A ) has the largest range.
- the factors A 2 >A 1 >A 3 , B 1 >B 2 >B 3 , C 2 >C 1 >C 3 , so the intuitive analysis of the optimal spray drying process is A 2 B 1 C 2 .
- the range of the specific gravity of the concentrate (factor A) is the largest, and the A factor in the index components of echinacoside and verbascoside in the spray-dried powder is significant, and the optimal value is A 2 , other
- the A factor in the index components is not significant, so the specific gravity of the concentrate (factor A) in the optimal drying process is determined to be 1.10.
- the feeding speed (factor B) in the optimal drying process is determined as B 1 , that is, the feeding Speed 40r/min.
- the inlet air temperature (factor C) in the optimal drying process is determined to be C 1 , that is, the inlet air temperature is 160°C.
- the optimal spray drying process is as follows: the specific gravity of the concentrate is 1.10, the inlet air temperature is 160°C, and the feeding speed is 40r/min.
- the preparation process of the composition of the present invention is preferably as follows: 10 times the amount of water, reflux extraction twice, 1 hour each time, the extract is concentrated under reduced pressure, the concentration temperature is 65 ⁇ 5 ° C, concentrated to a specific gravity of 1.10 (60 °C thermal measurement), spray drying, feeding speed 40r/min, inlet air temperature 160 °C, to obtain dry paste, pulverize the dry paste, pass through an 80-mesh sieve, and then obtain.
- microcrystalline cellulose, starch and dextrin with less hygroscopicity were selected as fillers for the test, and 95% ethanol was used as a wetting agent for granulation and tableting, and the disintegration time of the plain tablet was determined. , the results are shown in Table 21.
- the composition is a traditional Chinese medicine extract, and the disintegration time limit of the plain tablet is 45min, and the disintegration time limit is relatively long. Considering subsequent coating and storage factors, it is necessary to add a disintegrating agent to improve the disintegration of the tablet.
- Sodium carboxymethyl starch and croscarmellose sodium were used as disintegrants, and the addition method was adopted, adding 2% to 5% of the conventional dosage, and the disintegration time limit of the plain tablet was measured. The results are shown in Table 23.
- lubricant In order to reduce the wear of the punching die during tableting, make the tablet surface smooth and beautiful, and at the same time to ensure that the coating is carried out smoothly and the difference in tablet weight meets the regulations, a certain amount of lubricant needs to be added to the granules.
- Commonly used lubricants are magnesium stearate, talc, and micropowder silica gel, and the general dosage is about 1-2%.
- Other factors in the fixed formula were granulated according to the above-mentioned preferred formula, and 1% and 2% of magnesium stearate, talc, and micropowder silica were added respectively, and the angle of repose and tablet smoothness were used as evaluation indicators. The results are shown in Table 24.
- the preferred process of the composition is as follows: the extracts of Acanthopanax senticosus, Cistanche deserticola, American ginseng and Salvia miltiorrhiza are mixed in proportion, 20% microcrystalline cellulose is added and mixed evenly, granulated with 90% ethanol, and the granules are dried and reconstituted. After granulation, 5% of croscarmellose sodium and 2% of magnesium stearate are added, mixed evenly, compressed into tablets, and coated to obtain the finished product.
- the dry paste powder and microcrystalline cellulose are mixed uniformly, granulated with 90% ethanol, the granules are dried and granulated, and then croscarmellose sodium and magnesium stearate are added, mixed uniformly, compressed into tablets, and coated to obtain Coated tablet.
- the dry paste powder and microcrystalline cellulose are mixed uniformly, granulated with 90% ethanol, the granules are dried and granulated, and then croscarmellose sodium and magnesium stearate are added, mixed uniformly, compressed into tablets, and coated to obtain Coated tablet.
- the dry paste powder and microcrystalline cellulose are mixed uniformly, granulated with 90% ethanol, the granules are dried and granulated, and then croscarmellose sodium and magnesium stearate are added, mixed uniformly, compressed into tablets, and coated to obtain Coated tablet.
- mice used in the swimming experiment and various biochemical indicators were randomly divided into 4 groups according to their body weight, with 10 animals in each group. /kg ⁇ BW) to determine the middle dose of mice, that is, the daily consumption of mice is 460 mg/kg ⁇ BW.
- the solvent control group was given purified water, and the test solution in each group was orally administered at a daily dose of 20 mL/kg BW for 30 consecutive days. sky.
- Weight-bearing swimming experiment 30 minutes after the last oral gavage administration of the test substance, the mice with a lead skin of 5% body weight were placed in the swimming box, the water depth was greater than 30 cm, and the water temperature was 25 °C ⁇ 1.0 °C, and the mice were recorded. The time from swimming to death was taken as the weight-bearing swimming time of mice.
- liver glycogen content The animals were sacrificed 30 minutes after the last administration of the test substance, 100 mg of liver was accurately weighed, homogenized according to the procedure, centrifuged, 95% ethanol precipitated glycogen, and the content of liver glycogen was determined by anthrone method.
- lactic acid 30 minutes after the last administration of the test substance, firstly collect blood from the intraocular canthus to determine the basic value of blood lactate in a quiet state: swim in water at 30°C for 10 minutes, pick it up and wipe it dry, and immediately collect blood from the intraocular canthus for the second time.
- the third intraocular canthal blood was collected after a 20-min rest period, and the lactic acid content was measured with a glucose lactate analyzer.
- the experimental data were statistically analyzed with SPSS software.
- the composition of the present invention in the weight-bearing swimming test, the determination of serum urea nitrogen and the blood lactic acid test are all positive. Therefore, according to the functional evaluation standard of health food, the composition of the present invention has the function of relieving physical fatigue.
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Abstract
A composition with the function of relieving physical fatigue and a preparation method therefor. The composition comprises the following components in parts by weight: 1-27 parts of Acanthopanacis senticosi radix et rhizoma seu caulis, 1-10 parts of Cistanches herba, 1-6 parts of Panacis quinquefolii radix, and 1-15 parts of Salviae miltiorrhizae radix et rhizoma. Animal experiments have shown that the composition can prolong the loaded swimming time of mice; the loaded swimming experiment results were positive; and any two of the three biochemical indexes of blood lactic acid, serum urea and liver glycogen-muscle glycogen were positive, indicating that the composition has the effect of relieving physical fatigue.
Description
本发明涉及保健食品制备的技术领域，具体涉及一种具有缓解体力疲劳功能的组合物及其制备方法。The invention relates to the technical field of health food preparation, in particular to a composition with the function of relieving physical fatigue and a preparation method thereof.
体力疲劳是指在从事体力劳动和脑力劳动过程中，经过一定的时间和达到一定的程度会出现活动能力的下降，表现为疲倦或肌肉酸痛或全身无力。疲劳的最主要生理本质是由于肌肉活动而对能量代谢功能的影响。Physical fatigue refers to the decline of activity ability after a certain period of time and to a certain extent in the process of engaging in physical and mental work, manifested as fatigue or muscle soreness or general weakness. The primary physiological nature of fatigue is the effect on energy metabolism due to muscle activity.
中医理论认为，肾藏精，主骨生髓，为先天之本，是体力产生的原动力和源泉，而脾为后天之本，生气血，脾主四肢肌肉，脾盛，则肌强健，脾虚，则肌无力。肝主疏泄主，主藏血。肝血充足，则筋骨强健，运动灵活，能耐受疲劳，并能较快地缓解疲劳。肝血不足，筋脉失于濡养出现懈怠乏力，或活动后容易疲劳，且疲劳缓解速度慢。The theory of TCM believes that the kidney stores essence, controls the bones and generates marrow, is the innate foundation, and is the motive force and source of physical strength, while the spleen is the acquired foundation, qi and blood, and the spleen controls the muscles of the limbs. , the muscle weakness. The liver is in charge of dredging and excreting, and it is in charge of storing blood. If the liver blood is sufficient, the muscles and bones will be strong, the movement is flexible, the fatigue can be tolerated, and the fatigue can be relieved quickly. Insufficient liver blood, lack of nourishment of the muscles and veins, slack and fatigue, or easy fatigue after activity, and the fatigue relief speed is slow.
发明内容SUMMARY OF THE INVENTION
本发明旨在提供一种具有缓解体力疲劳功能的组合物，以重量计，所述组合物包括刺五加1～27份、肉苁蓉1～10份、西洋参1～6份、丹参1～15份。The present invention aims to provide a composition with the function of relieving physical fatigue. The composition comprises 1-27 parts of Acanthopanax senticosus, 1-10 parts of Cistanche deserticola, 1-6 parts of American ginseng, and 1-15 parts of Salvia miltiorrhiza. .
进一步地，所述组合物包括刺五加2～25份、肉苁蓉2～8份、西洋参1～4份、丹参1～13份。Further, the composition comprises 2-25 parts of Acanthopanax senticosus, 2-8 parts of Cistanche deserticola, 1-4 parts of American ginseng, and 1-13 parts of Salvia miltiorrhiza.
进一步地，所述组合物包括刺五加3～10份、肉苁蓉2～5份、西洋参2～3份、丹参2～5份。Further, the composition comprises 3-10 parts of Acanthopanax senticosus, 2-5 parts of Cistanche deserticola, 2-3 parts of American ginseng, and 2-5 parts of Salvia miltiorrhiza.
优选地，所述组合物包括刺五加5份、肉苁蓉3份、西洋参2份、丹参2份。Preferably, the composition comprises 5 parts of Acanthopanax senticosus, 3 parts of Cistanche deserticola, 2 parts of American ginseng, and 2 parts of Salvia miltiorrhiza.
本发明还提供了如上任一所述的组合物在制备具有缓解体力疲劳功能的药物、保健品或食品中的应用。The present invention also provides the application of any of the above compositions in the preparation of medicines, health products or foods with the function of relieving physical fatigue.
本发明提出了一种含有如前任一所述的组合物的药物、保健品或食品。The present invention provides a medicine, health product or food containing the composition described in any of the preceding.
具体地，所述药物、保健品或食品选自片剂。Specifically, the medicine, health product or food is selected from tablets.
进一步地，所述药物、保健品或食品还包括辅料；所述辅料包括填充剂、崩解剂、润滑剂。Further, the medicine, health product or food also includes auxiliary materials; the auxiliary materials include fillers, disintegrants, and lubricants.
优选地，所述辅料包括但不限于：玉米淀粉、磷酸氢钙、碳酸钙、干淀粉、预交化淀粉、糊精、麦芽糊精、微晶纤维素、交联羧甲基纤维素钠、羧甲基淀粉钠、交联 聚维酮、低取代羟丙纤维素、聚维酮K30、淀粉浆、羟丙基纤维素、硬脂酸镁、滑石粉或二氧化硅。Preferably, the auxiliary materials include but are not limited to: corn starch, calcium hydrogen phosphate, calcium carbonate, dry starch, pre-interleaved starch, dextrin, maltodextrin, microcrystalline cellulose, croscarmellose sodium, Sodium carboxymethyl starch, crospovidone, low-substituted hydroxypropyl cellulose, povidone K30, starch syrup, hydroxypropyl cellulose, magnesium stearate, talc or silicon dioxide.
优选地，所述填充剂包括玉米淀粉、磷酸氢钙、麦芽糊精、微晶纤维素中的一种或几种；所述崩解剂包括交联羧甲基纤维素钠、羧甲基淀粉钠、低取代羟丙纤维素中的一种或几种；所述润滑剂包括硬脂酸镁、二氧化硅、滑石粉中的一种或几种。Preferably, the filler includes one or more of corn starch, calcium hydrogen phosphate, maltodextrin, and microcrystalline cellulose; the disintegrant includes croscarmellose sodium, carboxymethyl starch One or more of sodium and low-substituted hydroxypropyl cellulose; the lubricant includes one or more of magnesium stearate, silicon dioxide, and talc.
具体地，所述填充剂优选为微晶纤维素；所述崩解剂优选为交联羧甲基纤维素钠；所述润滑剂优选为硬脂酸镁。Specifically, the filler is preferably microcrystalline cellulose; the disintegrant is preferably croscarmellose sodium; and the lubricant is preferably magnesium stearate.
本发明还提出了如前任意一项所述的组合物的制备方法，包括：The present invention also proposes a method for preparing the composition as described in any preceding item, comprising:
(1)提取：取刺五加、肉苁蓉、西洋参、丹参加水提取，得提取液；(1) Extraction: take Acanthopanax senticosus, Cistanche deserticola, American ginseng, and Salvia to participate in water extraction to obtain an extract;
(2)浓缩：对所述提取液浓缩，得浓缩液；(2) concentration: the extract is concentrated to obtain concentrated solution;
(3)干燥：对所述浓缩液进行干燥，得干浸膏。(3) Drying: drying the concentrated solution to obtain a dry extract.
进一步地，所述的组合物的制备方法包括：Further, the preparation method of described composition comprises:
(1)提取：取刺五加、肉苁蓉、西洋参、丹参加8～12倍量水提取1～3次，每次提取时间为1.0～2.0h，得提取液；(1) Extraction: take Acanthopanax senticosus, Cistanche deserticola, American ginseng, and Salvia miltiorrhiza for 1 to 3 times with 8 to 12 times the amount of water, and each extraction time is 1.0 to 2.0 hours to obtain an extract;
(2)浓缩：所述提取液减压浓缩至60～70℃下相对密度为1.05～1.15，过滤，得浓缩液；(2) Concentration: the extract is concentrated under reduced pressure to a relative density of 1.05 to 1.15 at 60 to 70°C, and filtered to obtain a concentrated solution;
(3)干燥：将所述浓缩液喷雾干燥，进料速度40～60r/min，进风温度为160～180℃；(3) Drying: the concentrated solution is spray-dried, the feeding speed is 40-60 r/min, and the inlet air temperature is 160-180 °C;
(4)粉碎：粉碎，过筛。(4) Crushing: crushing and sieving.
本发明还提出了一种如前所述的药物、保健品或食品的制备方法，所述药物、保健品或食品选自片剂，所述制备方法包括：The present invention also proposes a preparation method of the aforementioned medicine, health-care product or food, wherein the medicine, health-care product or food is selected from tablets, and the preparation method comprises:
(1)提取：刺五加5份、肉苁蓉3份、西洋参2份、丹参2份，加水提取2次，加水倍量为10倍，每次提取时间为1.0h，合并提取液；(1) Extraction: 5 parts of Acanthopanax senticosus, 3 parts of Cistanche deserticola, 2 parts of American ginseng, 2 parts of Salvia miltiorrhiza, add water to extract 2 times, the amount of water added is 10 times, the extraction time is 1.0h each time, and the extracts are combined;
(2)浓缩：所述提取液在真空度-0.08～-0.06MPa下，减压浓缩至60℃下相对密度为1.10，过滤，得浓缩液；(2) Concentration: the extract is concentrated under reduced pressure to a relative density of 1.10 at 60°C under vacuum degree of -0.08～-0.06MPa, and filtered to obtain a concentrated solution;
(3)干燥：将所述浓缩液喷雾干燥，进料速度40r/min，进风温度为160℃，得干浸膏；(3) drying: the concentrated solution is spray-dried, the feeding speed is 40r/min, and the inlet air temperature is 160°C to obtain dry extract;
(4)粉碎：所述干浸膏粉碎，过80目筛，得干膏粉；(4) pulverization: the dry extract is pulverized, and sieved with 80 meshes to obtain dry extract powder;
(5)混合：将所述干膏粉、微晶纤维素混合均匀，得混合粉；(5) Mixing: mixing the dry paste powder and microcrystalline cellulose uniformly to obtain mixed powder;
(6)制粒：所述混合粉中加入90％乙醇制备软材，20目筛制粒，50～60℃干燥，20目筛整粒，得颗粒；(6) Granulation: adding 90% ethanol to the mixed powder to prepare soft material, granulating with a 20-mesh sieve, drying at 50-60°C, and granulating with a 20-mesh sieve to obtain granules;
(7)压片：所述颗粒加入交联羧甲基纤维素钠、硬脂酸镁混匀，压片，得素片；(7) Tablet compression: the granules are mixed with croscarmellose sodium and magnesium stearate, and compressed to obtain plain tablets;
(8)包衣：所述素片包薄膜衣，得包衣片。(8) Coating: the plain tablet is film-coated to obtain a coated tablet.
进一步地，所述制粒工艺包括湿法制粒、干法制粒或一步制粒。Further, the granulation process includes wet granulation, dry granulation or one-step granulation.
进一步地，所述薄膜包衣包括羟丙甲纤维素、聚乙烯醇、三乙酸甘油酯、滑石粉、胭脂红铝色淀、亮蓝铝色淀、钛白粉的一种或几种。Further, the film coating includes one or more of hypromellose, polyvinyl alcohol, triacetin, talc, carmine aluminum lake, brilliant blue aluminum lake, and titanium dioxide.
本发明中各组分有如下特点：Each component in the present invention has the following characteristics:
刺五加为五加科植物刺五加Acanthopanax seuticosus(Rupr.et Maxim.)Harms的干燥根和根茎或茎，辛、微苦，温，归脾、肾、心经，用于脾肺气虚，体虚乏力，食欲不振，肺肾两虚，久咳虚喘，肾虚腰膝酸痛，心脾不足，失眠多梦。中医认为刺五加有益气健脾，补肾安神的作用。《名医别录》谓：“补中，益精，坚筋骨，强意志，久服轻身耐老”。《大明本草》：“补五劳七伤”。Acanthopanax senticosus is the dried root and rhizome or stem of Acanthopanax seuticosus (Rupr.et Maxim.) Harms of the Araliaceae plant, acrid, slightly bitter, warm, returns to the spleen, kidney and heart meridians, used for spleen and lung qi deficiency, body Deficiency, loss of appetite, deficiency of both lungs and kidneys, chronic cough and asthma, soreness of waist and knees due to kidney deficiency, insufficiency of heart and spleen, insomnia and dreaminess. Chinese medicine believes that Acanthopanax senticosus can benefit Qi and invigorate the spleen, and invigorate the kidney and soothe the nerves. "Famous Doctors" says: "Replenishing the middle, nourishing the essence, strengthening the muscles and bones, strengthening the will, long-term wear, light body and anti-aging". "Da Ming Materia Medica": "replenishing five labors and seven injuries".
肉苁蓉为列当科植物肉苁蓉Cistanche deserticoLa Y.C.Ma或管花肉苁蓉Cistanche tubuLosa(Schenk)Wight的干燥带鱗叶的肉质茎，味甘、咸，性温，归肾、大肠经，补肾阳，益精血，润肠通便，用于肾阳不足，精血亏虛，阳痿***，腰膝酸软，筋骨无力，肠燥便秘。肉苁蓉为著名的补益中药，有“沙漠人参”的美誉。《新疆大芸》记载管花肉苁蓉补肾精亏损，肾亏多由精气虚寒，或思虑忧郁，损伤心脾，或因恐惧伤肾，也有因湿热下注，宗筋弛而痿的，但主要是肾阳虚衰而痿。《本草纲目》记载此物补而不峻，故有从容字号。Cistanche Cistanche is the dry, scaly stem of Cistanche deserticoLa YCMa or Cistanche tubuLosa (Schenk) Wight. It is sweet, salty and warm in nature. , Runchang laxative, used for deficiency of kidney yang, deficiency of essence and blood, impotence and infertility, soreness and weakness of waist and knees, weakness of muscles and bones, dry intestines and constipation. Cistanche is a well-known tonic Chinese medicine, and has the reputation of "desert ginseng". "Xinjiang Dayun" records that Cistanche Cistanche can invigorate the deficiency of the kidney essence. The deficiency of the kidney is caused by deficiency of essence and qi, or anxiety and depression, damage to the heart and spleen, or damage to the kidney due to fear. It is due to deficiency of kidney yang and atrophy. "Compendium of Materia Medica" records that this material is tonic but not severe, so it has a calm name.
西洋参为五加科植物西洋参Panax quinquefolium L.的干燥根，甘、微苦，凉，归心、肺、肾经。西洋参补气养阴，清热生津，用于气虚阴亏，虚热烦倦，咳喘痰血，内热消渴，口燥咽干。American ginseng is the dry root of Panax quinquefolium L. of the Araliaceae plant, sweet, slightly bitter, cool, and returns to the heart, lung and kidney meridians. American ginseng tonifies qi and nourishes yin, clears heat and promotes body fluid. It is used for qi deficiency and yin deficiency, irritability due to deficiency heat, cough and asthma, phlegm and blood, internal heat and thirst, dry mouth and throat.
丹参为唇形科植物丹参miltiorrhiza Bge.的干燥根和根茎，性苦，微寒，归心、肝经，活血祛瘀，通经止痛，清心除烦，凉血消痈，用于胸痹心痛，脘腹胁痛，癥瘕积聚，热痹疼痛，心烦不眠，***，痛经经闭，疮瘍肿痛。本发明以刺五加为君药，刺五加益气健脾，补肾助阳，以肉苁蓉、西洋参为臣药，肉苁蓉补肾固本，西洋参补气养阴，同时佐以丹参活血化瘀、祛瘀生新以增强益气活血之功。四药合用，补肾益精、健脾、益气活血。肾为先天之本，是体力产生的原动力和源泉；脾为后天之本，气血生化之源。一为先天之本，一为后天之本，先天靠后天的营养，后天靠先天的滋温，相互为用，气血充沛，完成正常的生命活动，从而达到缓解体力疲劳的作用。Salvia miltiorrhiza is the dry root and rhizome of the Lamiaceae plant Salvia miltiorrhiza Bge., bitter in nature, slightly cold, returning to the heart and liver meridians, promoting blood circulation and removing blood stasis, clearing the meridian and relieving pain, clearing the heart and eliminating vexation, cooling blood and eliminating carbuncle, used for chest pain and heart pain, Abdominal and hypochondriac pain, accumulation of Zhengjia, heat arthralgia pain, upset and insomnia, irregular menstruation, dysmenorrhea, amenorrhea, sore swelling and pain. The present invention uses Acanthopanax senticosus as the monarch medicine, Acanthopanax senticosus for invigorating the spleen and invigorating the spleen, invigorating the kidney and assisting the yang, and taking Cistanche deserticola and American ginseng as the ministerial medicines, the Cistanche deserticola invigorating the kidney and consolidating the root, the American ginseng invigorating the qi and nourishing the yin, and at the same time supplemented by the salvia miltiorrhiza to promote blood circulation, remove blood stasis, dispel Stasis and new generation to enhance Qi and blood circulation. The four herbs are used together to invigorate the kidney and essence, invigorate the spleen, and invigorate qi and activate blood. The kidney is the innate foundation and the motive force and source of physical strength; the spleen is the acquired foundation and the source of qi and blood biochemistry. One is the foundation of the innate, the other is the foundation of the acquired, the innate relies on the nourishment of the day after tomorrow, and the day after tomorrow relies on the innate nourishment and warmth.
本发明以传统中医药理论为基础，结合现代科学研究，从缓解体力疲劳机制入手，科学配伍，提出了一种安全有效的缓解体力疲劳组合物，动物功能实验表明，本发明组合物能提高小鼠的负重游泳时间，负重游泳实验结果阳性，且血乳酸、血清尿素、肝糖元-肌糖元三项生化指标中任二项指标阳性，具有缓解体力疲劳功能的作用。The invention is based on traditional Chinese medicine theory, combined with modern scientific research, starting from the mechanism of relieving physical fatigue and scientific compatibility, and proposes a safe and effective composition for relieving physical fatigue. Animal function experiments show that the composition of the invention can improve the The weight-bearing swimming time of the mice, the weight-bearing swimming test results were positive, and any two of the three biochemical indicators of blood lactate, serum urea, and liver glycogen-muscle glycogen were positive, which had the function of relieving physical fatigue.
1.提取工艺的考察1. Investigation of the extraction process
1.1药材水提取单因素实验1.1 Single factor experiment of water extraction of medicinal materials
1.1.1药材水提取时间单因素考察1.1.1 Single factor investigation of water extraction time of medicinal materials
取刺五加150份、肉苁蓉90份、西洋参60份、丹参60份，平行4份，加入10倍量水，提取2次，提取时间分别设为0.5h、1.0h、1.5h、2.0h，以水提液中总皂苷总量、松果菊苷和毛蕊花糖苷、紫丁香苷转移率为指标，采用单因素试验方案进行考察。试验结果见表1。Take 150 parts of Acanthopanax senticosus, 90 parts of Cistanche deserticola, 60 parts of American ginseng, 60 parts of Salvia miltiorrhiza, 4 parts in parallel, add 10 times the amount of water, extract twice, and set the extraction time as 0.5h, 1.0h, 1.5h, 2.0h respectively, Using the total amount of total saponins, echinacoside, verbasin, and syringin transfer rate in the water extract as indicators, a single factor experiment was used to investigate. The test results are shown in Table 1.
表1 提取时间单因素试验Table 1 Extraction time single factor test
由表1可知，总皂苷总量在提取1.0h时，总量最高，1.5h后逐渐趋于平稳。松果菊苷和毛蕊花糖苷、紫丁香苷转移率则是随着时间的增加先逐渐升高，在1.5h后再降低。因此选择提取时间范围为1.0～2.0h。It can be seen from Table 1 that the total amount of total saponins was the highest when extracted for 1.0h, and gradually stabilized after 1.5h. The transfer rate of echinacoside, verbascoside and syringin first increased gradually with the increase of time, and then decreased after 1.5h. Therefore, the extraction time range was selected to be 1.0 to 2.0 h.
1.1.2药材水提取加水倍量考察1.1.2 Investigation on the amount of water added to the water extraction of medicinal materials
取刺五加150份、肉苁蓉90份、西洋参60份、丹参60份，平行4份，提取时间设为1.0h，提取2次，加水倍量分别为8、10、12、14倍，以提取液中总皂苷总量、松果菊苷和毛蕊花糖苷、紫丁香苷转移率为指标，采用单因素试验方案进行考察。试验结果见表2。Take 150 parts of Acanthopanax senticosus, 90 parts of Cistanche deserticola, 60 parts of American ginseng and 60 parts of Salvia miltiorrhiza, parallel 4 parts. The total amount of total saponins in the solution, the transfer rate of echinacoside, verbascoside, and syringin were indicators, and the single factor experiment was used to investigate. The test results are shown in Table 2.
表2 加水倍量单因素试验Table 2 Single factor test of water addition amount
由表2可知，随着加水倍量的增加，总皂苷总量先升高后下降，10倍量时最高；松果菊苷和毛蕊花糖苷的转移率逐渐增加，10～14倍趋于平缓；紫丁香苷的转移率逐渐增加，12～14倍趋于平缓，因此选择加水倍量范围为8～12倍。It can be seen from Table 2 that with the increase of the amount of water added, the total amount of total saponins first increased and then decreased, and was the highest at 10 times the amount; the transfer rates of echinacoside and verbascoside gradually increased, and tended to be flat at 10 to 14 times; The transfer rate of syringin increased gradually, and tended to be flat at 12-14 times, so the range of water addition amount was selected to be 8-12 times.
1.2提取正交试验1.2 Extraction Orthogonal Test
选取加水倍量(A)、提取时间(B)、提取次数(C)作为三个因素，每个因素各选三个水平，以提取液中总皂苷总量、松果菊苷和毛蕊花糖苷、紫丁香苷转移率为指标，选用采用L9(3
4)正交试验进行考察，因素水平见表3。
Select the amount of water added (A), extraction time (B), and extraction times (C) as three factors, and select three levels for each factor. The transfer rate of syringin was an index, and the L9(3 4 ) orthogonal test was selected for investigation. The factor levels are shown in Table 3.
表3 因素水平表Table 3 Factor level table
取刺五加150份、肉苁蓉90份、西洋参60份、丹参60份，平行9份，按正交表相关参数要求进行提取，测定提取液中总皂苷、松果菊苷和毛蕊花糖苷、紫丁香苷含量，实验结果见表4～表9。Take 150 parts of Acanthopanax senticosus, 90 parts of Cistanche deserticola, 60 parts of American ginseng, 60 parts of Salvia miltiorrhiza, and extract 9 parts in parallel according to the requirements of the relevant parameters of the orthogonal table. The glycoside content, the experimental results are shown in Table 4 to Table 9.
表4 L9(3
4)正交试验表(总皂苷)
Table 4 L9(3 4 ) orthogonal test table (total saponins)
表5 方差分析表(总皂苷)Table 5 Analysis of variance table (total saponins)
表6 L
9(3
4)正交表(松果菊苷和毛蕊花糖苷)
Table 6 L 9 (3 4 ) Orthogonal Table (Echinacea and Verbasidin)
表7 方差分析表(松果菊苷和毛蕊花糖苷)Table 7 Analysis of variance table (echinacoside and verbascoside)
表8 L
9(3
4)正交表(紫丁香苷)
Table 8 L 9 (3 4 ) Orthogonal Table (Syringin)
表9 方差分析表(紫丁香苷)Table 9 Analysis of variance table (syringin)
从表4～表5可知，以提取液中总皂苷总量为指标进行考察，各因素对提取工艺的影响极差R值为C>A>B，药材提取次数(因素C)的极差最大，各因素中C
2>C
1>C
3、A
2>A
1>A
3、B
3>B
1>B
2，故直观分析最佳提取工艺为A
2B
3C
2。方差分析显示，C因素显 著，考虑节能原则，故最佳提取工艺为A
2B
1C
2，即每次加10倍量水，回流提取2次，每次1.0小时。
From Tables 4 to 5, it can be seen that the total amount of total saponins in the extract is used as an index to investigate, and the range of the influence of each factor on the extraction process is C>A>B. The range of extraction times (factor C) is the largest , C 2 >C 1 >C 3 , A 2 >A 1 >A 3 , B 3 >B 1 >B 2 in each factor, so the optimal extraction process is A 2 B 3 C 2 by intuitive analysis. The variance analysis showed that the factor C was significant. Considering the principle of energy saving, the optimal extraction process was A 2 B 1 C 2 , that is, adding 10 times the amount of water each time, and refluxing extraction twice, 1.0 hours each time.
从表6～表7可知，以提取液中松果菊苷和毛蕊花糖苷转移率为指标进行考察，各因素对提取工艺的影响极差R值为C>A>B，药材提取次数(因素C)的极差最大，各因素中C
2>C
1>C
3、A
2>A
3>A
1、B
3>B
2>B
1，故直观分析最佳提取工艺为A
2B
3C
2。方差分析显示，C因素显著，考虑节能原则，故最佳提取工艺为A
2B
1C
2，即每次加10倍量水，回流提取2次，每次1.0小时。
From Tables 6 to 7, it can be seen that the transfer rate of echinacoside and verbascoside in the extract is used as an index to investigate, the influence of each factor on the extraction process is very poor, the R value is C>A>B, and the extraction times of medicinal materials (factor C) The range is the largest, C 2 >C 1 >C 3 , A 2 >A 3 >A 1 , B 3 >B 2 >B 1 among the factors, so the optimal extraction process is A 2 B 3 C 2 by intuitive analysis. The variance analysis showed that the factor C was significant. Considering the principle of energy saving, the optimal extraction process was A 2 B 1 C 2 , that is, adding 10 times the amount of water each time, and refluxing extraction twice, 1.0 hours each time.
从表8～表9可知，以提取液中紫丁香苷转移率为指标进行考察，各因素对提取工艺的影响极差R值为C>A>B，药材提取次数(因素C)的极差最大，各因素中C
2>C
1>C
3、A
2>A
3>A
1、B
3>B
2>B
1，故直观分析最佳提取工艺为A
2B
3C
2。方差分析显示，C因素显著，考虑节能原则，故最佳提取工艺为A
2B
1C
2，即每次加10倍量水，回流提取2次，每次1.0小时。
From Tables 8 to 9, it can be seen that the transfer rate of syringin in the extract is used as an index to investigate, the influence of each factor on the extraction process is very poor, the R value is C>A>B, and the number of times of extraction of medicinal materials (factor C) is very poor In each factor, C 2 >C 1 >C 3 , A 2 >A 3 >A 1 , B 3 >B 2 >B 1 , so the optimal extraction process is A 2 B 3 C 2 by intuitive analysis. The variance analysis showed that the factor C was significant. Considering the principle of energy saving, the optimal extraction process was A 2 B 1 C 2 , that is, adding 10 times the amount of water each time, and refluxing extraction twice, 1.0 hours each time.
综合考虑，各指标及因素对提取工艺的影响极差R值为C>A>B，药材提取次数(因素C)的极差最大，且各指标成分中C因素显著，且最优值均为C
2，因此确定最佳工艺中提取次数为2次。加水倍量(因素A)的极差其次，且各指标成分中A因素均不显著，且最优值均为A
2，因此确定最佳工艺中加水倍量(因素A)为A
2，即每次加10倍量水。提取时间(因素B)的极差影响最小，且各指标成分中B因素均不显著，各指标下的直观分析显示B
3，由于各指标成分中B因素均不显著，考虑节能原则，因此确定最佳工艺中提取时间(因素B)为B
1，即每次1.0小时。综上所述，最佳提取工艺为：每次加10倍量水，回流提取2次，每次1.0小时。
Considering comprehensively, the R value of the influence range of each index and factor on the extraction process is C>A>B, the range of the extraction times of medicinal materials (factor C) is the largest, and the C factor in each index component is significant, and the optimal value is C 2 , so it is determined that the number of extractions in the optimal process is 2 times. The extreme difference of the amount of water added (factor A) is second, and the A factor in each index component is not significant, and the optimal value is A 2 , so it is determined that the amount of water added in the optimal process (factor A) is A 2 , namely Add 10 times the amount of water each time. The range of extraction time (factor B) has the smallest influence, and the B factor in each index component is not significant. The intuitive analysis under each index shows that B 3 , because the B factor in each index component is not significant, considering the principle of energy saving, it is determined The extraction time (factor B) in the optimum process is B 1 , ie 1.0 hours each time. To sum up, the optimal extraction process is as follows: adding 10 times the amount of water each time, and refluxing for 2 extractions for 1.0 hours each time.
1.3正交验证试验1.3 Orthogonal verification test
根据正交试验结果，取刺五加300份、肉苁蓉180份、西洋参120份、丹参120份，平行9份，分为3组，加10倍量水，回流提取2次，每组时间分别为每次1.0h、1.5h、2.0h，提取液滤过，合并滤液，测定提取液中总皂苷、松果菊苷和毛蕊花糖苷、紫丁香苷的含量，以总皂苷总量、松果菊苷和毛蕊花糖苷、紫丁香苷转移率为指标，再次筛选最佳提取时间，验证最优工艺可行性及稳定性，结果见表10。According to the results of the orthogonal test, 300 parts of Acanthopanax senticosus, 180 parts of Cistanche deserticola, 120 parts of American ginseng, and 120 parts of Salvia miltiorrhiza were taken in parallel, and divided into 3 groups, added 10 times the amount of water, and extracted twice by reflux. 1.0h, 1.5h, 2.0h each time, the extract was filtered, the filtrate was combined, and the contents of total saponins, echinacoside, vervasin, and syringin in the extract were determined. The transfer rate of glucoside and syringin was an index, and the optimal extraction time was screened again to verify the feasibility and stability of the optimal process. The results are shown in Table 10.
表10 正交验证试验表Table 10 Orthogonal verification test table
验证试验结果表明，提取液中总皂苷含量、松果菊苷和毛蕊花糖苷、紫丁香苷转移率在1.0h、1.5h、2.0h提取时间时，RSD均小于3，说明提取时间对各指标成分无显著影响，故确定提取时间为1.0h。因此确定最终提取工艺为：每次加10倍量水，回流提取2次，每次1.0小时。The verification test results showed that the total saponin content, echinacoside, verbascoside, and syringin transfer rate in the extract were all less than 3 when the extraction time was 1.0h, 1.5h, and 2.0h, indicating that the extraction time had an important effect on each index component. There was no significant effect, so the extraction time was determined to be 1.0h. Therefore, it is determined that the final extraction process is: adding 10 times the amount of water each time, and refluxing extraction for 2 times, each time for 1.0 hours.
2浓缩工艺考察2. Investigation of enrichment process
2.1浓缩温度考察2.1 Investigation of concentration temperature
在上述优选的提取工艺条件下，对该组合物的浓缩温度条件进行考察，以总皂苷、松果菊苷和毛蕊花糖苷、紫丁香苷的转移率为考察指标，取相同量的提取液，采用旋转蒸发仪减压浓缩至相同重量的浓缩液，浓缩温度分别设置为60、70、80℃，实验结果见表11。Under the above-mentioned preferred extraction process conditions, the concentration temperature conditions of the composition were investigated, and the transfer rate of total saponins, echinacoside, verbasin, and syringin was used as the investigation index, taking the same amount of extract, using The rotary evaporator was concentrated under reduced pressure to the same weight of concentrated solution, and the concentration temperature was set to 60, 70, and 80° C. The experimental results are shown in Table 11.
表11 浓缩温度考察Table 11 Investigation of concentration temperature
由表11可知，当浓缩温度为70℃时，总皂苷和紫丁香苷转移率达到最高，当浓缩温度为60℃和70℃时，浓缩液中松果菊苷和毛蕊花糖苷、紫丁香苷转移率差别不大。故综合考虑，结合生产实际，选择减压浓缩温度为60～70℃。It can be seen from Table 11 that when the concentration temperature is 70 °C, the transfer rate of total saponins and syringin reaches the highest; not much differences. Therefore, comprehensive consideration, combined with the actual production, the choice of vacuum concentration temperature is 60 ~ 70 ℃.
2.2浓缩工艺验证2.2 Concentration process validation
取相同量的提取液，按优选的浓缩工艺进行3批稍放大验证试验，在60～70℃条件下减压浓缩至相同重量的浓缩液，结果见表12。Take the same amount of extract, carry out 3 batches of slightly enlarged verification tests according to the preferred concentration process, and concentrate to the same weight of concentrated solution under reduced pressure at 60-70 ° C. The results are shown in Table 12.
表12 浓缩工艺验证Table 12 Concentration Process Validation
由表12可知，三批浓缩工艺验证中，总皂苷、松果菊苷和毛蕊花糖苷、紫丁香苷转移率与小试实验结果相近，说明浓缩工艺稳定可行。It can be seen from Table 12 that in the three batches of concentration process verification, the transfer rates of total saponins, echinacoside, verbasin, and syringin are similar to the results of the pilot experiments, indicating that the concentration process is stable and feasible.
3干燥工艺条件考察3. Investigation of drying process conditions
喷雾干燥具有生产过程连续、生产效率高等优点，故本发明组合物选用喷雾干燥。Spray drying has the advantages of continuous production process and high production efficiency, so spray drying is selected for the composition of the present invention.
3.1喷雾干燥工艺正交考察3.1 Orthogonal investigation of spray drying process
以总皂苷、松果菊苷和毛蕊花糖苷、紫丁香苷转移率为考察指标，采用L
9(3
4)正交试验方案，对浓缩液比重、进料速度、进风温度进行考察。因素水平见表13。取所述处方比例的药材，加10倍量水，提取2次，每次1.0h，提取液滤过，合并滤液，在60～70℃条件下进行减压浓缩，分别得到比重为1.05、1.10、1.15(均为60℃热测，下同)的浓缩液备用。按L
9(3
4)正交表要求进行试验，收集喷干粉，测定喷干粉中总皂苷、松果菊苷和毛蕊花糖苷、紫丁香苷的含量，实验结果见表14～19。
Taking the transfer rate of total saponins, echinacoside, verbascoside and syringin as the investigation index, the L 9 (3 4 ) orthogonal test scheme was used to investigate the specific gravity of the concentrate, the feeding speed and the inlet air temperature. The factor levels are shown in Table 13. Take the medicinal materials in the prescribed proportion, add 10 times the amount of water, extract twice, 1.0 h each time, filter the extract, combine the filtrates, and concentrate under reduced pressure at 60-70 ° C to obtain specific gravities of 1.05 and 1.10, respectively. , 1.15 (both thermally measured at 60°C, the same below) concentrate for use. Carry out the test according to the requirements of the L 9 (3 4 ) orthogonal table, collect the spray-dried powder, and determine the content of total saponins, echinacoside, verbasin, and syringin in the spray-dried powder. The experimental results are shown in Tables 14-19.
表13 因素水平Table 13 Factor Levels
表14 L
9(3
4)正交表(总皂苷)
Table 14 L 9 (3 4 ) Orthogonal Table (Total Saponins)
表15 方差分析表(总皂苷)Table 15 Analysis of variance table (total saponins)
表16 L
9(3
4)正交表(松果菊苷和毛蕊花糖苷)
Table 16 L 9 (3 4 ) Orthogonal Table (echinacoside and verbascoside)
表17 方差分析表(松果菊苷和毛蕊花糖苷)Table 17 Analysis of variance table (echinacoside and verbascoside)
表18 L
9(3
4)正交表(紫丁香苷)
Table 18 L 9 (3 4 ) Orthogonal Table (Syringin)
表19 方差分析表(紫丁香苷)Table 19 Analysis of variance table (syringin)
从表14～19可以看出，以喷干粉中总皂苷转移率为指标进行考察，各因素对干燥工艺的影响极差R值为A>B>C，浓缩液比重(因素A)的极差最大，各因素中A
3>A
2>A
1、B
3>B
1>B
2、C
1>C
3>C
2，故直观分析最佳喷干工艺为A
3B
3C
1。
As can be seen from Tables 14 to 19, the total saponin transfer rate in the spray-dried powder is used as an index to investigate. The influence of various factors on the drying process is very poor. The R value is A>B>C, and the specific gravity of the concentrate (factor A) is very poor. In each factor, A 3 >A 2 >A 1 , B 3 >B 1 >B 2 , C 1 >C 3 >C 2 , so the optimal spray-drying process is A 3 B 3 C 1 by intuitive analysis.
从表14～19可以看出，以喷干粉中松果菊苷和毛蕊花糖苷转移率为指标进行考察，各因素对干燥工艺的影响极差R值为A>C>B，浓缩液比重(因素A)的极差最大，各因素中A
2>A
1>A
3、B
1>B
2>B
3、C
2>C
1>C
3，故直观分析最佳喷干工艺为A
2B
1C
2。
As can be seen from Tables 14 to 19, the transfer rate of echinacoside and verbascoside in the spray-dried powder is used as an index to investigate, the influence of each factor on the drying process is very poor, and the R value is A>C>B, and the specific gravity of the concentrate (factor A ) has the largest range. Among the factors, A 2 >A 1 >A 3 , B 1 >B 2 >B 3 , C 2 >C 1 >C 3 , so the intuitive analysis of the optimal spray drying process is A 2 B 1 C 2 .
从表14～19可以看出，以喷干粉中紫丁香苷转移率为指标进行考察，各因素对干燥工艺的影响极差R值为A>C>B，浓缩液比重(因素A)的极差最大，各因素中A
2>A
3>A
1、B
2>B
3>B
1、C
3>C
1>C
2，故直观分析最佳干燥工艺为A
2B
2C
3。
As can be seen from Tables 14 to 19, the transfer rate of syringin in the spray-dried powder is used as an index to investigate. The influence of each factor on the drying process is very poor. The R value is A>C>B, and the specific gravity of the concentrate (factor A) is extremely The difference is the largest. Among the factors, A 2 >A 3 >A 1 , B 2 >B 3 >B 1 , C 3 >C 1 >C 2 , so the optimal drying process is A 2 B 2 C 3 by intuitive analysis.
综合考虑，干燥工艺各因素极差R值中，浓缩液比重(因素A)的极差最大，喷干粉中松果菊苷和毛蕊花糖苷指标成分中A因素显著，且最优值为A
2，其他指标成分中A因素均不显著，因此确定最佳干燥工艺中浓缩液比重(因素A)为1.10。由于各指标成分中B因素均不显著，考虑到进料速度过快，不利于液体雾化，影响干燥效果，因此确定最佳干燥工艺中进料速度(因素B)为B
1，即进料速度40r/min。由于各指标成分中C因素均不显著，考虑节能原则及指标成分的稳定性，因此确定最佳干燥工艺中进风温度(因素C)为C
1，即进风温度为160℃。综上所述，最佳喷雾干燥工艺为：浓缩液比重为1.10，进风温度为160℃，进料速度为40r/min。
Comprehensive consideration, among the range R values of various factors in the drying process, the range of the specific gravity of the concentrate (factor A) is the largest, and the A factor in the index components of echinacoside and verbascoside in the spray-dried powder is significant, and the optimal value is A 2 , other The A factor in the index components is not significant, so the specific gravity of the concentrate (factor A) in the optimal drying process is determined to be 1.10. Since the B factor in each index component is not significant, considering that the feeding speed is too fast, it is not conducive to liquid atomization and affects the drying effect, so the feeding speed (factor B) in the optimal drying process is determined as B 1 , that is, the feeding Speed 40r/min. Since the C factor in each index component is not significant, considering the energy saving principle and the stability of the index component, the inlet air temperature (factor C) in the optimal drying process is determined to be C 1 , that is, the inlet air temperature is 160°C. To sum up, the optimal spray drying process is as follows: the specific gravity of the concentrate is 1.10, the inlet air temperature is 160°C, and the feeding speed is 40r/min.
3.2喷雾干燥工艺验证试验3.2 Validation test of spray drying process
取比重为1.10的浓缩液3份，按优选的干燥工艺进行3批稍放大验证试验，收集喷干粉，测定喷干粉中总皂苷、松果菊苷和毛蕊花糖苷、紫丁香苷的含量，计算转移率，结果见表20。Take 3 parts of concentrated solution with a specific gravity of 1.10, carry out 3 batches of slightly enlarged verification tests according to the preferred drying process, collect the spray-dried powder, measure the content of total saponins, echinacoside, verbascoside and syringin in the spray-dried powder, calculate the transfer The results are shown in Table 20.
表20 喷雾干燥工艺稍放大验证结果Table 20 slightly enlarged verification results of spray drying process
由表20可以看出，验证试验中，总皂苷、松果菊苷和毛蕊花糖苷、紫丁香苷转移率与正交试验最优结果接近，说明干燥工艺稳定可行。It can be seen from Table 20 that in the verification test, the transfer rates of total saponins, echinacoside, verbasin, and syringin are close to the optimal results of the orthogonal test, indicating that the drying process is stable and feasible.
综上所述，本发明组合物的制备工艺优选为：10倍量水，回流提取2次，每次1小时，提取液减压浓缩，浓缩温度为65±5℃，浓缩至比重1.10(60℃热测)，喷雾干燥，进料速度40r/min，进风温度160℃，得干膏，干膏粉碎，过80目筛，即得。To sum up, the preparation process of the composition of the present invention is preferably as follows: 10 times the amount of water, reflux extraction twice, 1 hour each time, the extract is concentrated under reduced pressure, the concentration temperature is 65 ± 5 ° C, concentrated to a specific gravity of 1.10 (60 ℃ thermal measurement), spray drying, feeding speed 40r/min, inlet air temperature 160 ℃, to obtain dry paste, pulverize the dry paste, pass through an 80-mesh sieve, and then obtain.
4制粒工艺研究4 Research on granulation process
4.1填充剂的选择及用量考察4.1 Selection and dosage of fillers
根据中间体干膏粉的性质，选择吸湿性较小的微晶纤维素、淀粉和糊精作为填充剂进行试验，以95％乙醇为润湿剂进行制粒压片，测定素片崩解时限，结果见表21。According to the properties of the intermediate dry paste powder, microcrystalline cellulose, starch and dextrin with less hygroscopicity were selected as fillers for the test, and 95% ethanol was used as a wetting agent for granulation and tableting, and the disintegration time of the plain tablet was determined. , the results are shown in Table 21.
表21 填充剂种类及其用量筛选Table 21 Types of fillers and their dosage screening
结果表明，使用糊精制粒易结块，且素片崩解时间过长。使用玉米淀粉制粒易结块，可压性差。使用20％微晶纤维素制粒不结块，且可压性好，素片崩解时限为45min，已能够满足生产的要求。因此确定在中间体干膏粉中加入20％微晶纤维素作为填充剂。The results showed that the granules using dextrin were easy to agglomerate, and the disintegration time of the plain tablets was too long. Granulation with corn starch is easy to agglomerate and has poor compressibility. Using 20% microcrystalline cellulose to granulate does not agglomerate, and has good compressibility, and the disintegration time limit of plain tablets is 45 minutes, which can meet the requirements of production. Therefore, it is determined to add 20% microcrystalline cellulose as a filler in the intermediate dry paste powder.
4.2润湿剂的选择4.2 Selection of wetting agent
分别以体积分数70％、80％、90％、95％的乙醇为润湿剂制软材，20目筛挤压制粒，55±5℃干燥，再用20目筛整粒，收集颗粒。以制软材情况、软材过筛情况和颗粒状态为指标，考察不同体积分数乙醇的制粒效果，结果见表22。Use 70%, 80%, 90%, and 95% ethanol as a wetting agent to prepare soft material respectively, extrude and granulate through a 20-mesh sieve, dry at 55±5°C, and granulate with a 20-mesh sieve to collect the granules. The granulation effect of different volume fractions of ethanol was investigated by taking the production of soft materials, the sieving of soft materials and the state of particles as indicators. The results are shown in Table 22.
表22 润湿剂考察结果Table 22 Wetting agent investigation results
结果表明，采用90％乙醇作为润湿剂制粒最优。The results showed that 90% ethanol was the best wetting agent for granulation.
4.3崩解剂的选择4.3 Choice of disintegrant
该组合物为中药提取物，素片崩解时限为45min，崩解时限较长，考虑到后续包衣及储存因素，因此需要加入崩解剂以改善片剂崩解情况。以羧甲基淀粉钠和交联羧甲基纤维素钠为崩解剂，采用外加法，按常规使用量2％～5％加入，测定素片崩解时限，结果见表23。The composition is a traditional Chinese medicine extract, and the disintegration time limit of the plain tablet is 45min, and the disintegration time limit is relatively long. Considering subsequent coating and storage factors, it is necessary to add a disintegrating agent to improve the disintegration of the tablet. Sodium carboxymethyl starch and croscarmellose sodium were used as disintegrants, and the addition method was adopted, adding 2% to 5% of the conventional dosage, and the disintegration time limit of the plain tablet was measured. The results are shown in Table 23.
表23 崩解剂考察结果Table 23 Disintegrant investigation results
结果表明，以5％交联羧甲基纤维素钠作为崩解剂较好。The results show that 5% croscarmellose sodium is better as disintegrant.
4.4润滑剂的筛选4.4 Screening of lubricants
为了降低压片时对冲模的磨损，使片面光洁美观，同时为了保证包衣顺利进行，片重差异符合规定，需要在颗粒中加入一定量的的润滑剂。常用的润滑剂为硬脂酸镁、滑石粉、微粉硅胶，一般用量约为1～2％。固定配方中其他因素，按照上述优选的配方制粒，分别加入1％和2％硬脂酸镁、滑石粉、微粉硅胶，以颗粒休止角和片剂光洁度为评价指标，结果见表24。In order to reduce the wear of the punching die during tableting, make the tablet surface smooth and beautiful, and at the same time to ensure that the coating is carried out smoothly and the difference in tablet weight meets the regulations, a certain amount of lubricant needs to be added to the granules. Commonly used lubricants are magnesium stearate, talc, and micropowder silica gel, and the general dosage is about 1-2%. Other factors in the fixed formula were granulated according to the above-mentioned preferred formula, and 1% and 2% of magnesium stearate, talc, and micropowder silica were added respectively, and the angle of repose and tablet smoothness were used as evaluation indicators. The results are shown in Table 24.
表24 润滑剂筛选Table 24 Lubricant Screening
结果表明，以2％硬脂酸镁作为润滑剂较好。The results show that it is better to use 2% magnesium stearate as lubricant.
通过制剂工艺研究，确定该组合物的优选工艺为：刺五加、肉苁蓉、西洋参、丹参提取物按比例混合，加入20％微晶纤维素混合均匀，以90％乙醇制粒，颗粒干燥、整粒后加入5％交联羧甲基纤维素钠和2％硬脂酸镁，混匀，压片，包衣即得成品。Through the preparation process research, it is determined that the preferred process of the composition is as follows: the extracts of Acanthopanax senticosus, Cistanche deserticola, American ginseng and Salvia miltiorrhiza are mixed in proportion, 20% microcrystalline cellulose is added and mixed evenly, granulated with 90% ethanol, and the granules are dried and reconstituted. After granulation, 5% of croscarmellose sodium and 2% of magnesium stearate are added, mixed evenly, compressed into tablets, and coated to obtain the finished product.
实施例1Example 1
取刺五加500份、肉苁蓉300份、西洋参200份、丹参200份，加入10倍量水，提取2次，每次1小时，合并提取液，于65±5℃减压浓缩至比重1.10(60℃热测)，喷雾干燥，进风温度为160℃，进料速度为40r/min，得干膏。干膏粉碎，过80目筛，得干膏粉。将干膏粉和微晶纤维素混匀，以90％乙醇制粒，颗粒干燥、整粒后加入交联羧甲基纤维素钠和硬脂酸镁，混匀，压片，包衣，得包衣片。Take 500 parts of Acanthopanax senticosus, 300 parts of Cistanche, 200 parts of American ginseng, 200 parts of Salvia miltiorrhiza, add 10 times the amount of water, extract twice, 1 hour each time, combine the extracts, and concentrate under reduced pressure at 65 ± 5 ℃ to a specific gravity of 1.10 ( 60 ℃ thermal test), spray drying, the air inlet temperature is 160 ℃, the feeding speed is 40 r/min, and the dry paste is obtained. The dry paste was pulverized and passed through an 80-mesh sieve to obtain dry paste powder. The dry paste powder and microcrystalline cellulose are mixed uniformly, granulated with 90% ethanol, the granules are dried and granulated, and then croscarmellose sodium and magnesium stearate are added, mixed uniformly, compressed into tablets, and coated to obtain Coated tablet.
实施例2Example 2
取刺五加500份、肉苁蓉300份、西洋参200份、丹参200份，加入12倍量水，提取1次，每次2小时，合并提取液，于65±5℃减压浓缩至比重1.10(60℃热测)，喷雾干燥，进风温度为160℃，进料速度为40r/min，得干膏。干膏粉碎，过80目筛，得干膏粉。将干膏粉和微晶纤维素混匀，以90％乙醇制粒，颗粒干燥、整粒后加入交联羧甲基纤维素钠和硬脂酸镁，混匀，压片，包衣，得包衣片。Take 500 parts of Acanthopanax senticosus, 300 parts of Cistanche deserticola, 200 parts of American ginseng and 200 parts of Salvia miltiorrhiza, add 12 times the amount of water, extract once for 2 hours each time, combine the extracts, and concentrate under reduced pressure at 65±5°C to a specific gravity of 1.10 ( 60 ℃ thermal test), spray drying, the air inlet temperature is 160 ℃, the feeding speed is 40 r/min, and the dry paste is obtained. The dry paste was pulverized and passed through an 80-mesh sieve to obtain dry paste powder. The dry paste powder and microcrystalline cellulose are mixed uniformly, granulated with 90% ethanol, the granules are dried and granulated, and then croscarmellose sodium and magnesium stearate are added, mixed uniformly, compressed into tablets, and coated to obtain Coated tablet.
实施例3Example 3
取刺五加500份、肉苁蓉300份、西洋参200份、丹参200份，加入8倍量水，提取3次，每次1.5小时，合并提取液，于65±5℃减压浓缩至比重1.10(60℃热测)，喷雾干燥，进风温度为160℃，进料速度为40r/min，得干膏。干膏粉碎，过80目筛，得干膏粉。将干膏粉和微晶纤维素混匀，以90％乙醇制粒，颗粒干燥、整粒后加入交联羧甲基纤维素钠和硬脂酸镁，混匀，压片，包衣，得包衣片。Take 500 parts of Acanthopanax senticosus, 300 parts of Cistanche deserticola, 200 parts of American ginseng, 200 parts of Salvia miltiorrhiza, add 8 times the amount of water, extract 3 times, 1.5 hours each time, combine the extracts, and concentrate under reduced pressure at 65 ± 5 ℃ to a specific gravity of 1.10 ( 60 ℃ thermal test), spray drying, the air inlet temperature is 160 ℃, the feeding speed is 40 r/min, and the dry paste is obtained. The dry paste was pulverized and passed through an 80-mesh sieve to obtain dry paste powder. The dry paste powder and microcrystalline cellulose are mixed uniformly, granulated with 90% ethanol, the granules are dried and granulated, and then croscarmellose sodium and magnesium stearate are added, mixed uniformly, compressed into tablets, and coated to obtain Coated tablet.
二 缓解体力疲劳功能试验2. Function test for relieving physical fatigue
1.材料与方法1. Materials and methods
1.1样品1.1 Sample
样品组(按照本发明实施例1、2、3制备得到)；Sample group (prepared according to Examples 1, 2, and 3 of the present invention);
空白对照组。Blank control group.
1.2实验动物1.2 Experimental animals
雄性健康ICR小鼠，SPF级，体重18-22g。由北京维通利华实验动物技术有限公司南京分公司提供，实验动物生产许可证号：SCXK(苏)2016-0003号，合格证编号：201809889。实验动物屏障环境设施使用许可证号：SYXK(苏)2017-0031。灭菌鼠饲 料来源及合格证号：北京科澳协力饲料有限公司，SCXK(京)2014-0010。实验期间全部动物给予灭菌全价鼠颗粒饲料和灭菌水自由食用。Male healthy ICR mice, SPF grade, weighing 18-22g. Provided by Beijing Weitong Lihua Laboratory Animal Technology Co., Ltd. Nanjing Branch, the experimental animal production license number: SCXK (Su) 2016-0003, the certificate number: 201809889. Laboratory animal barrier environment facility use license number: SYXK (Su) 2017-0031. Source and certificate number of sterilized rat feed: Beijing Keao Xieli Feed Co., Ltd., SCXK (Beijing) 2014-0010. During the experiment, all animals were given sterilized full-price mouse pellet feed and sterilized water for free consumption.
1.3仪器及试剂1.3 Instruments and Reagents
仪器：游泳箱，电子天平，TU1901双光束紫外可见分光光度计，Biosen C-Line葡萄糖/乳酸自动分析仪，奥林巴斯AU640全自动生化分析仪，JY92-Ⅱ型超声波细胞粉碎机等。试剂：尿素氮测定试剂盒(脲酶法)购自宁波美康生物科技有限公司；糖原测定试剂盒购自南京建成生物工程研究所；乳酸酶膜及试剂购自德国EKF诊断公司；其余试剂均为分析纯。Instruments: swimming box, electronic balance, TU1901 dual-beam UV-Vis spectrophotometer, Biosen C-Line automatic glucose/lactic acid analyzer, Olympus AU640 automatic biochemical analyzer, JY92-Ⅱ ultrasonic cell crusher, etc. Reagents: Urea nitrogen determination kit (urease method) was purchased from Ningbo Meikang Biotechnology Co., Ltd; analytically pure.
1.4剂量选择及受试样品给予方式1.4 Dosage selection and test sample administration
游泳实验及各项生化指标(血清尿素氮、肝糖原、血乳酸)所用动物均各按体重随机分成4组，每组10只，按相当于人体每日每千克体重推荐摄入量(46mg/kg·BW)的10倍确定小鼠的中剂量，即小鼠每日食用量为460mg/kg·BW。将样品研磨成粉状后称取2300mg加纯化水至100mL配制成受试液，溶剂对照组给予纯净水，各组受试液以每日20mL/kg·BW的量经口灌胃，连续30天。The animals used in the swimming experiment and various biochemical indicators (serum urea nitrogen, liver glycogen, blood lactate) were randomly divided into 4 groups according to their body weight, with 10 animals in each group. /kg·BW) to determine the middle dose of mice, that is, the daily consumption of mice is 460 mg/kg·BW. After grinding the sample into powder, weigh 2300 mg and add purified water to 100 mL to prepare the test solution. The solvent control group was given purified water, and the test solution in each group was orally administered at a daily dose of 20 mL/kg BW for 30 consecutive days. sky.
1.5实验方法1.5 Experimental method
1.5.1负重游泳实验：末次经口灌胃给予受试物30min后，置尾根部负荷5％体重铅皮的小鼠于游泳箱中，水深大于30cm，水温25℃±1.0℃，记录小鼠从游泳开始至死亡的时间，作为小鼠负重游泳时间。1.5.1 Weight-bearing swimming experiment: 30 minutes after the last oral gavage administration of the test substance, the mice with a lead skin of 5% body weight were placed in the swimming box, the water depth was greater than 30 cm, and the water temperature was 25 °C ± 1.0 °C, and the mice were recorded. The time from swimming to death was taken as the weight-bearing swimming time of mice.
1.5.2血清尿素氮(BUN)含量的测定：末次经口灌胃给予受试物30min后，小鼠在温度为30℃的水中游泳90min，休息60min后采血，分离血清按有关试剂盒要求检测。1.5.2 Determination of serum urea nitrogen (BUN) content: 30 minutes after the last oral gavage administration of the test substance, the mice swim in water at a temperature of 30 ° C for 90 minutes, rest for 60 minutes and then collect blood, and separate serum for detection according to the requirements of the relevant kits .
1.5.3肝糖原含量测定：末次给予受试物30min后处死动物，精确称取肝脏100mg，按程序匀浆，离心，95％乙醇沉淀糖原，蒽酮法测定肝糖原含量。1.5.3 Determination of liver glycogen content: The animals were sacrificed 30 minutes after the last administration of the test substance, 100 mg of liver was accurately weighed, homogenized according to the procedure, centrifuged, 95% ethanol precipitated glycogen, and the content of liver glycogen was determined by anthrone method.
1.5.4乳酸测定：末次给予受试物30min后，首先眼内眦采血测定安静状态下的血乳酸基础值：在30℃水中游泳10min，捞起擦干，立即第二次眼内眦采血，并于休息20min后第三次眼内眦采血，均用葡萄糖乳酸分析仪测定乳酸含量。1.5.4 Determination of lactic acid: 30 minutes after the last administration of the test substance, firstly collect blood from the intraocular canthus to determine the basic value of blood lactate in a quiet state: swim in water at 30°C for 10 minutes, pick it up and wipe it dry, and immediately collect blood from the intraocular canthus for the second time. The third intraocular canthal blood was collected after a 20-min rest period, and the lactic acid content was measured with a glucose lactate analyzer.
1.6统计方法1.6 Statistical methods
实验数据用SPSS软件进行统计分析。The experimental data were statistically analyzed with SPSS software.
2.结果2. Results
2.1样品对小鼠体重的影响见表25。2.1 The effects of the samples on the body weight of mice are shown in Table 25.
表25 样品对小鼠体重的影响
Table 25 Effects of samples on body weight of mice
由此可知，小鼠的初始体重各实验组与溶剂对照组间比较，数据均无显著性差异(P﹥0.05)，即小鼠的初始体重在各组间较为均衡。经口给予小鼠受试物30d后，各组终末体重满足方差齐的要求，各组与溶剂对照组比较，数据均无显著性差异(P﹥0.05)，即各受试物对小鼠的体重增长无明显影响。It can be seen that there is no significant difference in the initial body weight of mice between each experimental group and the solvent control group (P﹥0.05), that is, the initial body weight of mice is relatively balanced among the groups. After oral administration of the test substance to mice for 30 days, the final body weight of each group met the requirement of homogeneity of variance, and there was no significant difference in the data between each group and the solvent control group (P﹥0.05), that is, each test substance had a significant effect on mice weight gain was not significantly affected.
2.2样品对小鼠负重游泳时间的影响见表26。2.2 See Table 26 for the effects of the samples on the weight-bearing swimming time of mice.
表26 样品对小鼠负重游泳时间的影响
Table 26 Effects of samples on swimming time with weight in mice
由此可知，与溶剂对照组比较，各样品组小鼠游泳时间均延长，但相对于溶剂对照组，实例1数据有显著性差异(P<0.01)，因此样品在负重游泳实验中结果为阳性。It can be seen that compared with the solvent control group, the swimming time of the mice in each sample group was prolonged, but compared with the solvent control group, the data of Example 1 had significant difference (P<0.01), so the result of the sample was positive in the weight-bearing swimming test .
2.3样品对小鼠运动后血清尿素氮水平和肝糖原储备量的影响见表27。2.3 The effects of samples on serum urea nitrogen levels and hepatic glycogen reserves after exercise in mice are shown in Table 27.
表27 样品对小鼠运动后血清尿素氮水平和肝糖原储备量的影响
Table 27 Effects of samples on serum urea nitrogen levels and hepatic glycogen reserves in mice after exercise
由此可知，游泳90min后，各样品组小鼠血清尿素氮含量均低于溶剂对照组值，相对于溶剂对照组，实例1、2组的数据有显著性差异(P<0.05，P<0.01)，因此样品在血清尿素氮实验中结果为阳性；各样品组小鼠肝糖原相对于溶剂对照组略有降低，但与溶剂对照组值比较，各样品组数据均无显著性差异(P﹥0.05)，因此样品在肝糖原测定实验中结果为阴性。It can be seen that after swimming for 90 minutes, the serum urea nitrogen content of the mice in each sample group was lower than the value of the solvent control group. ), so the sample was positive in the serum urea nitrogen test; the liver glycogen of the mice in each sample group was slightly lower than that of the solvent control group, but compared with the value of the solvent control group, there was no significant difference in the data of each sample group (P > 0.05), so the sample was negative in the liver glycogen assay.
2.4样品对小鼠运动后血乳酸含量的影响见表28。2.4 The effects of samples on blood lactate content in mice after exercise are shown in Table 28.
表28 样品对小鼠运动后血乳酸含量的影响
Table 28 Effects of samples on blood lactate content in mice after exercise
注：血乳酸曲线下面积＝5*(游泳前血乳酸值+3*游泳后0min的血乳酸值+2*游泳后休息20min的血乳酸值)Note: Area under the blood lactate curve = 5* (blood lactate value before swimming + 3* blood lactate value at 0min after swimming + 2*blood lactate value at 20min rest after swimming)
由此可知，各样品组小鼠运动前后三个时间点血乳酸曲线下面积均小于溶剂对照组，其中实例1数据具有显著性差异(P<0.01)，因此样品在血乳酸实验中结果为阳性。It can be seen that the area under the blood lactate curve of the mice in each sample group is smaller than that of the solvent control group at three time points before and after exercise, and the data of Example 1 has a significant difference (P<0.01), so the result of the sample in the blood lactate test is positive. .
综上，本发明组合物在负重游泳实验、血清尿素氮测定和血乳酸实验结果均阳性，因此根据保健食品功能学评价标准，本发明组合物具有缓解体力疲劳的功能。In conclusion, the results of the composition of the present invention in the weight-bearing swimming test, the determination of serum urea nitrogen and the blood lactic acid test are all positive. Therefore, according to the functional evaluation standard of health food, the composition of the present invention has the function of relieving physical fatigue.
以上实施例的说明只是用于帮助理解本发明的方法及其核心思想。应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以对本发明进行若干改进和修饰，这些改进和修饰也落入本发明权利要求的保护范围内。The descriptions of the above embodiments are only used to help understand the method and the core idea of the present invention. It should be pointed out that for those skilled in the art, without departing from the principle of the present invention, several improvements and modifications can also be made to the present invention, and these improvements and modifications also fall within the protection scope of the claims of the present invention.
Claims (10)
- 一种具有缓解体力疲劳功能的组合物，其特征在于，以重量计，所述组合物包括刺五加1～27份、肉苁蓉1～10份、西洋参1～6份、丹参1～15份。A composition with the function of relieving physical fatigue, characterized in that, by weight, the composition comprises 1-27 parts of Acanthopanax senticosus, 1-10 parts of Cistanche deserticola, 1-6 parts of American ginseng, and 1-15 parts of Salvia miltiorrhiza.
- 根据权利要求1所述的组合物，其特征在于，所述组合物包括刺五加2～25份、肉苁蓉2～8份、西洋参1～4份、丹参1～13份。The composition according to claim 1, wherein the composition comprises 2-25 parts of Acanthopanax senticosus, 2-8 parts of Cistanche deserticola, 1-4 parts of American ginseng, and 1-13 parts of Salvia miltiorrhiza.
- 根据权利要求1所述的组合物，其特征在于，所述组合物包括刺五加3～10份、肉苁蓉2～5份、西洋参2～3份、丹参2～5份。The composition according to claim 1, wherein the composition comprises 3-10 parts of Acanthopanax senticosus, 2-5 parts of Cistanche deserticola, 2-3 parts of American ginseng, and 2-5 parts of Salvia miltiorrhiza.
- 根据权利要求1所述的组合物，其特征在于，所述组合物包括刺五加5份、肉苁蓉3份、西洋参2份、丹参2份。The composition according to claim 1, wherein the composition comprises 5 parts of Acanthopanax senticosus, 3 parts of Cistanche deserticola, 2 parts of American ginseng, and 2 parts of Salvia miltiorrhiza.
- 根据权利要求1～4任一所述的组合物在制备具有缓解体力疲劳功能的药物、保健品或食品中的应用。The application of the composition according to any one of claims 1 to 4 in the preparation of a medicine, a health product or a food with a function of relieving physical fatigue.
- 一种含有权利要求1-4任一所述的组合物的药物、保健品或食品。A medicine, health product or food containing the composition of any one of claims 1-4.
- 根据权利要求6所述的药物、保健品或食品，其特征在于，所述药物、保健品或食品还包括辅料，所述辅料包括填充剂、崩解剂或润滑剂。The medicine, health product or food according to claim 6, characterized in that, the medicine, health product or food further comprises auxiliary materials, and the auxiliary materials comprise fillers, disintegrants or lubricants.
- 一种如权利要求1～4任一所述的组合物的制备方法，其特征在于，包括：A preparation method of the composition according to any one of claims 1 to 4, characterized in that, comprising:(1)提取：取刺五加、肉苁蓉、西洋参、丹参加水提取，得提取液；(1) Extraction: take Acanthopanax senticosus, Cistanche deserticola, American ginseng, and Salvia to participate in water extraction to obtain an extract;(2)浓缩：对所述提取液浓缩，得浓缩液；(2) concentration: the extract is concentrated to obtain concentrated solution;(3)干燥：对所述浓缩液进行干燥。(3) Drying: The concentrated solution is dried.
- 根据权利要求8所述的制备方法，其特征在于，包括：preparation method according to claim 8, is characterized in that, comprises:(1)提取：取刺五加、肉苁蓉、西洋参、丹参加8～12倍量水提取1～3次，每次提取时间为1.0～2.0h，得提取液；(1) Extraction: take Acanthopanax senticosus, Cistanche deserticola, American ginseng, and Salvia miltiorrhiza for 1 to 3 times with 8 to 12 times the amount of water, and each extraction time is 1.0 to 2.0 hours to obtain an extract;(2)浓缩：所述提取液减压浓缩至60～70℃下相对密度为1.05～1.15，过滤，得浓缩液；(2) Concentration: the extract is concentrated under reduced pressure to a relative density of 1.05 to 1.15 at 60 to 70°C, and filtered to obtain a concentrated solution;(3)干燥：将所述浓缩液喷雾干燥，进料速度40～60r/min，进风温度为160～180℃；(3) Drying: the concentrated solution is spray-dried, the feeding speed is 40-60 r/min, and the inlet air temperature is 160-180 °C;(4)粉碎：粉碎，过筛。(4) Crushing: crushing and sieving.
- 一种如权利要求6～7所述的药物、保健品或食品的制备方法，其特征在于，所述药物、保健品或食品选自片剂，所述制备方法包括：A method for preparing a medicine, health product or food according to claims 6 to 7, wherein the medicine, health product or food is selected from tablets, and the preparation method comprises:(1)提取：刺五加5份、肉苁蓉3份、西洋参2份、丹参2份，加水提取2次，加水倍量为10倍，每次提取时间为1.0h，合并提取液；(1) Extraction: 5 parts of Acanthopanax senticosus, 3 parts of Cistanche deserticola, 2 parts of American ginseng, 2 parts of Salvia miltiorrhiza, add water to extract 2 times, the amount of water added is 10 times, the extraction time is 1.0h each time, and the extracts are combined;(2)浓缩：所述提取液在真空度-0.08～-0.06MPa下，减压浓缩至60℃下相对密度为1.10，过滤，得浓缩液；(2) Concentration: the extract is concentrated under reduced pressure to a relative density of 1.10 at 60°C under vacuum degree of -0.08～-0.06MPa, and filtered to obtain a concentrated solution;(3)干燥：将所述浓缩液喷雾干燥，进料速度40r/min，进风温度为160℃，得干浸膏；(3) drying: the concentrated solution is spray-dried, the feeding speed is 40r/min, and the inlet air temperature is 160°C to obtain dry extract;(4)粉碎：所述干浸膏粉碎，过80目筛，得干膏粉；(4) pulverization: the dry extract is pulverized, and sieved with 80 meshes to obtain dry extract powder;(5)混合：将所述干膏粉、微晶纤维素混合均匀，得混合粉；(5) mixing: mixing the dry paste powder and microcrystalline cellulose uniformly to obtain mixed powder;(6)制粒：所述混合粉中加入90％乙醇制备软材，20目筛制粒，50～60℃干燥，20目筛整粒，得颗粒；(6) Granulation: adding 90% ethanol to the mixed powder to prepare soft material, granulating with a 20-mesh sieve, drying at 50-60°C, and granulating with a 20-mesh sieve to obtain granules;(7)压片：所述颗粒加入交联羧甲基纤维素钠、硬脂酸镁混匀，压片，得素片；(7) Tablet compression: the granules are mixed with croscarmellose sodium and magnesium stearate, and compressed to obtain plain tablets;(8)包衣：所述素片包薄膜衣，得包衣片。(8) Coating: the plain tablet is film-coated to obtain a coated tablet.
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