CN114028493B - Medicinal and edible coated red granules for varicose vein of lower limb and preparation method thereof - Google Patents

Medicinal and edible coated red granules for varicose vein of lower limb and preparation method thereof Download PDF

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CN114028493B
CN114028493B CN202111587897.9A CN202111587897A CN114028493B CN 114028493 B CN114028493 B CN 114028493B CN 202111587897 A CN202111587897 A CN 202111587897A CN 114028493 B CN114028493 B CN 114028493B
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parts
weight
red
granules
coated
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CN114028493A (en
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钭凌娟
方莉
祝泽刚
刁银军
戴雪晴
林文洁
吴纪荣
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Zhejiang Agricultural Machinery Research Institute
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Abstract

The invention provides a medicine-food homologous red-coated particle for varicose vein of lower limb and a preparation method thereof, aiming at solving the problems that the medicine for treating varicose vein of lower limb in the prior art is mainly a potion, has short storage time and is inconvenient to drink. The medicinal and edible capsanthin granules comprise the following raw materials in parts by weight: 1-5 parts of raspberry, 1-5 parts of saffron, 1-3 parts of kudzu root, 1-3 parts of mulberry fruit, 1-5 parts of radish seed, 1-3 parts of allium macrostemon and 1-3 parts of mint. The preparation method comprises the following steps: adding 2000 parts by volume of water into the raw material composition, decocting, cooling, and filtering to obtain decoction dregs; adding 1500 parts by volume of water into the dregs of a decoction, decocting, cooling and compressing to obtain brown viscous paste, and drying to obtain traditional Chinese medicine extract powder; mixing the traditional Chinese medicine extract powder and auxiliary materials according to the weight ratio of 1:1, adding 70% of wetting agent ethanol, and drying to obtain the red-coated granules. The product can be used for treating lower limb varicosis, soreness of limbs, swelling, pain, subcutaneous stagnation, induration, and edema.

Description

Medicinal and edible coated red granules for varicose vein of lower limb and preparation method thereof
Technical Field
The invention belongs to the technical field of medicines for varicose vein of lower limbs, and particularly relates to medicine-food homologous red-coated granules for varicose vein of lower limbs and a preparation method thereof.
Background
Varicose vein of lower Limb (LEVV) is a common clinical disease and frequently encountered disease. LEVV has no obvious discomfort in the early stage, the disease condition develops, and patients have the symptoms of heavy limbs, soreness, distending pain, fatigue and the like. After the patient stands for a long time, edema and leg muscle spasm can occur in the foot boot area, and lower limb eczema or ulcer and pigmentation can be caused to affect the life quality of the patient when the treatment is not timely performed.
The existing medicine for treating varicose vein of lower limb mainly is a potion, has the problems of short preservation time, inconvenient drinking and poor treatment effect, and has larger side effect.
Disclosure of Invention
The invention provides a medicine-food homologous red-coated particle for varicose vein of lower limb and a preparation method thereof, aiming at solving the problems that the medicine for treating varicose vein of lower limb in the prior art is mainly a potion, has short storage time and is inconvenient to drink.
In order to solve the technical problems, the technical scheme adopted by the invention is as follows:
in a first aspect, the invention provides a medicine-food homologous red-coated particle for varicose vein of lower limbs, which comprises the following raw materials in parts by weight: 1-5 parts of raspberry, 1-5 parts of crocus sativus, 1-3 parts of kudzu root, 1-3 parts of mulberry fruit, 1-5 parts of radish seed, 1-3 parts of allium macrostemon and 1-3 parts of mint.
Wherein, the raspberry: warm in nature, sweet in flavor and sour. Entering kidney meridian and bladder meridian; tonifying kidney, arresting spontaneous emission, and reducing urination. They belong to the group of herbs with astringents to secure essence, reduce urination and stop leukorrhagia.
Wherein, saffron: has the effects of promoting blood circulation, removing blood stasis, cooling blood, removing toxic substances, relieving depression and tranquilizing, and is mainly used for treating the clinical manifestations of amenorrhea, abdominal mass, postpartum stasis, warm toxicity, macula, melancholy, stuffiness, palpitation and mania, etc. in the body.
Wherein, mulberry fruit: expanding the blood volume of human body, and enhancing the immunity of the organism by the hematopoietic function; strengthening spleen and stomach, promoting digestion, and promoting digestion, wherein the nutrient substances such as fatty acid, malic acid, etc. can help fat, protein, and starch to digest and absorb, and enhance intestinal motility; it also can make hair black and bright.
Wherein, root of kudzu vine: has antipyretic, anticoagulant, and spasmolytic effects; lowering blood pressure, increasing coronary blood flow and cerebral blood flow, improving microcirculation, increasing nutrition supply, and reducing cholesterol and blood viscosity; promoting osteoblast proliferation and differentiation, and promoting children intelligence; accelerating the blood circulation of retina and improving the visual function; inhibiting dysentery bacillus and resisting cancer.
Wherein, the macrostem onion: the flavor is pungent, warm and bitter, and enters heart, lung, stomach and large intestine meridians, activating yang and dissipating nodulation, and moving qi and removing stagnation.
Wherein, the mint: pungent in nature and taste, cool, enter lung and liver meridians, and have effects of dispelling wind-heat, clearing head and eyes, relieving sore throat, promoting eruption, dispersing stagnated liver qi and promoting qi circulation; has effects in promoting digestion and tranquilizing.
Wherein, the radish seed: has the functions of promoting digestion, eliminating stagnation, lowering qi and eliminating phlegm.
The further improved scheme is as follows: the medicinal and edible coated red granules for varicose vein of lower limbs comprise the following raw materials in parts by weight: 3 parts of raspberry, 1 part of saffron, 3 parts of kudzuvine root, 3 parts of mulberry fruit, 1 part of radish seed, 1 part of allium macrostemon and 1 part of mint.
The further improved scheme is as follows: the medicinal and edible coated red granules for varicose vein of lower limbs comprise the following raw materials in parts by weight: 4 parts of raspberry, 1 part of saffron, 4 parts of kudzuvine root, 2 parts of mulberry fruit, 1 part of radish seed, 2 parts of allium macrostemon and 1 part of mint.
The further improved scheme is as follows: the medicinal and edible coated red granules for varicose vein of lower limbs comprise the following raw materials in parts by weight: raspberry 1 part, crocus sativus 5 parts, kudzu vine root 1 part, mulberry fruit 3 parts, radish seed 1 part, allium macrostemon 3 parts and mint 1 part.
The further improved scheme is as follows: the medicinal and edible coated red granules for varicose vein of lower limbs comprise the following raw materials in parts by weight: 5 parts of raspberry, 1 part of saffron, 3 parts of kudzuvine root, 1 part of mulberry fruit, 5 parts of radish seed, 1 part of allium macrostemon and 3 parts of mint.
In a second aspect, the invention provides a preparation method of medicinal and edible coated red granules for varicose vein of lower limbs, which comprises the following steps:
taking 1-5 parts by weight of raspberry, 1-5 parts by weight of crocus sativus, 1-3 parts by weight of kudzu root, 1-3 parts by weight of mulberry fruit, 1-5 parts by weight of radish seed, 1-3 parts by weight of allium macrostemon and 1-3 parts by weight of mint to obtain a raw material composition;
adding 1900-2100 parts by volume of water into the raw material composition, decocting for 48-52min under a boiling condition, cooling, and filtering to obtain medicine residues;
adding 1400-1600 parts by volume of water into the residues, decocting for 48-52min under boiling condition, cooling and compressing to obtain brown viscous paste, and drying to obtain Chinese medicinal extract powder;
mixing the Chinese medicinal extract powder with adjuvants at a weight ratio of 1:1, adding 70% wetting agent ethanol, and making into wet granule; drying the wet granules at the temperature of 55 ℃ and finishing granules to obtain the medicinal and edible red-coated granules.
The weight parts are as follows: 1 part by volume 20 g: 1 ml.
The further improved scheme is as follows: the preparation method of the medicinal and edible coated red granules for varicose vein of lower limb comprises the following steps:
taking 3 parts of raspberry, 1 part of saffron, 3 parts of kudzuvine root, 3 parts of mulberry fruit, 1 part of radish seed, 1 part of allium macrostemon and 1 part of mint to obtain a raw material composition;
adding 2000 parts by volume of water into the raw material composition, decocting for 50min under a boiling condition, cooling, and filtering to obtain medicine residues;
adding 1500 parts by volume of water into the residues, decocting for 50min under boiling condition, cooling and compressing to obtain brown viscous paste, and drying to obtain Chinese medicinal extract powder;
mixing the Chinese medicinal extract powder with adjuvants at a weight ratio of 1:1, adding 70% wetting agent ethanol, and making into wet granule; drying the wet granules at the temperature of 55 ℃ and finishing granules to obtain the medicinal and edible red-coated granules.
The further improved scheme is as follows: the preparation method of the medicinal and edible coated red granules for varicose vein of lower limb comprises the following steps:
taking 4 parts of raspberry, 1 part of saffron, 4 parts of kudzuvine root, 2 parts of mulberry fruit, 1 part of radish seed, 2 parts of longstamen onion bulb and 1 part of mint to obtain a raw material composition;
adding 2000 parts by volume of water into the raw material composition, decocting for 50min under a boiling condition, cooling, and filtering to obtain medicine residues;
adding 1500 parts by volume of water into the residues, decocting for 50min under boiling condition, cooling and compressing to obtain brown viscous paste, and drying to obtain Chinese medicinal extract powder;
mixing the Chinese medicinal extract powder with adjuvants at a weight ratio of 1:1, adding 70% wetting agent ethanol, and making into wet granule; drying the wet granules at the temperature of 55 ℃ and finishing granules to obtain the medicinal and edible red-coated granules.
The further improved scheme is as follows: the auxiliary materials comprise dextrin and lactose, and the weight ratio of the dextrin to the lactose is 1: 1.5. the main function of the dextrin is to shape the coated red particles and the main function of the lactose is to adjust the taste.
The invention has the beneficial effects that:
the red-coated particles are mainly prepared from seven edible homologous medicines of raspberry, saffron, mulberry fruit, kudzu vine root, allium macrostemon, mint and radish seed, and have the main effects of activating blood and dissolving stasis, blocking blood stasis, relaxing channels and activating collaterals and nourishing liver and kidney; can be used for treating lower limb venous distension, limb soreness, swelling, pain, subcutaneous stasis, induration, and edema. Can exert the advantages of less adverse reaction, good safety, obvious curative effect and the like of the traditional Chinese medicine. In addition, the medicament is prepared from seven edible homologous medicaments of the saffron, the mulberry fruit, the kudzuvine root, the allium macrostemon, the mint and the radish seed, and has no side effect basically.
In addition, under the guidance of the theory of traditional Chinese medicine, the invention optimizes the extraction process of the traditional Chinese medicine in the prescription of the red-coated granules, and determines that the optimal test scheme for preparing the red-coated granules is that the dosage ratio of the traditional Chinese medicine extract powder to the auxiliary material is 1:1 (the ratio has obvious influence on the yield of the red-coated granules), wherein the ratio of dextrin to lactose in the auxiliary material is 1: 1.5. Meanwhile, the content of rutin and gallic acid in the particles is determined by using a UPLC-MS/MS method, and the content is used as a quality detection standard of the coated red particles so as to provide a theoretical basis for industrial production of the coated red particles.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments of the invention without inventive step, are within the scope of the invention.
The first embodiment is as follows:
the embodiment provides a medicine-food homologous red-coated particle for varicose vein of lower limbs, which comprises the following raw materials in parts by weight: 1-5 parts of raspberry, 1-5 parts of crocus sativus, 1-3 parts of kudzu root, 1-3 parts of mulberry fruit, 1-5 parts of radish seed, 1-3 parts of allium macrostemon and 1-3 parts of mint.
Example two:
the medicine-food homologous Fuhong granules for varicose vein of lower limb provided by the embodiment comprise the following raw materials in parts by weight: 3 parts of raspberry, 1 part of saffron, 3 parts of kudzuvine root, 3 parts of mulberry fruit, 1 part of radish seed, 1 part of allium macrostemon and 1 part of mint.
Example three:
the medicine-food homologous Fuhong granules for varicose vein of lower limb provided by the embodiment comprise the following raw materials in parts by weight: 4 parts of raspberry, 1 part of saffron, 4 parts of kudzuvine root, 2 parts of mulberry fruit, 1 part of radish seed, 2 parts of allium macrostemon and 1 part of mint.
Example four:
the medicine-food homologous Fuhong granules for varicose vein of lower limb provided by the embodiment comprise the following raw materials in parts by weight: raspberry 1 part, crocus sativus 5 parts, kudzu vine root 1 part, mulberry fruit 3 parts, radish seed 1 part, allium macrostemon 3 parts and mint 1 part.
Example five:
the medicine-food homologous Fuhong granules for varicose vein of lower limb provided by the embodiment comprise the following raw materials in parts by weight: 5 parts of raspberry, 1 part of saffron, 3 parts of kudzuvine root, 1 part of mulberry fruit, 5 parts of radish seed, 1 part of allium macrostemon and 3 parts of mint.
Example six:
the embodiment provides a preparation method of medicinal and edible coated red granules for varicose vein of lower limbs, which comprises the following steps:
taking 1-5 parts by weight of raspberry, 1-5 parts by weight of crocus sativus, 1-3 parts by weight of kudzu root, 1-3 parts by weight of mulberry fruit, 1-5 parts by weight of radish seed, 1-3 parts by weight of allium macrostemon and 1-3 parts by weight of mint to obtain a raw material composition;
adding 1900-2100 parts by volume of water into the raw material composition, decocting for 48-52min under a boiling condition, cooling, and filtering to obtain medicine residues;
adding 1400-1600 parts by volume of water into the residues, decocting for 48-52min under boiling condition, cooling and compressing to obtain brown viscous paste, and drying to obtain Chinese medicinal extract powder;
mixing the Chinese medicinal extract powder with adjuvants at a weight ratio of 1:1, adding 70% wetting agent ethanol, and making into wet granule; drying the wet granules at the temperature of 55 ℃ and finishing granules to obtain the medicinal and edible red-coated granules.
1 part by weight: 1 part by volume 20 g: 1 ml.
Wherein the auxiliary materials comprise dextrin and lactose, and the weight ratio of the dextrin to the lactose is 1: 1.5.
Example seven:
the preparation method of the medicinal and edible coated red granules for treating varicose vein of lower limb provided by the embodiment comprises the following steps:
taking 3 parts of raspberry, 1 part of saffron, 3 parts of kudzuvine root, 3 parts of mulberry fruit, 1 part of radish seed, 1 part of allium macrostemon and 1 part of mint to obtain a raw material composition;
adding 2000 parts by volume of water into the raw material composition, decocting for 50min under a boiling condition, cooling, and filtering to obtain medicine residues;
adding 1500 parts by volume of water into the residues, decocting for 50min under boiling condition, cooling and compressing to obtain brown viscous paste, and drying to obtain Chinese medicinal extract powder;
mixing the Chinese medicinal extract powder with adjuvants at a weight ratio of 1:1, adding 70% wetting agent ethanol, and making into wet granule; drying the wet granules at the temperature of 55 ℃ and finishing granules to obtain the medicinal and edible red-coated granules.
Wherein the auxiliary materials comprise dextrin and lactose, and the weight ratio of the dextrin to the lactose is 1: 1.5.
Example eight:
the preparation method of the medicinal and edible coated red particles for varicose vein of lower limbs provided by the embodiment comprises the following steps:
taking 4 parts of raspberry, 1 part of saffron, 4 parts of kudzuvine root, 2 parts of mulberry fruit, 1 part of radish seed, 2 parts of allium macrostemon and 1 part of mint to obtain a raw material composition;
adding 2000 parts by volume of water into the raw material composition, decocting for 50min under a boiling condition, cooling, and filtering to obtain medicine residues;
adding 1500 parts by volume of water into the residues, decocting for 50min under boiling condition, cooling and compressing to obtain brown viscous paste, and drying to obtain Chinese medicinal extract powder;
mixing the Chinese medicinal extract powder with adjuvants at a weight ratio of 1:1, adding 70% wetting agent ethanol, and making into wet granule; drying the wet granules at the temperature of 55 ℃ and finishing granules to obtain the medicinal and edible red-coated granules.
Wherein the auxiliary materials comprise dextrin and lactose, and the weight ratio of the dextrin to the lactose is 1: 1.5.
The invention is further illustrated below in connection with the tests:
1 materials and reagents
1.1 materials
The experimental materials of raspberry, saffron, kudzu root, longstamen onion bulb, hawthorn, mint, mulberry and the like are provided by agriculture science research institute in Jinhua city, and all meet the regulations of the first part of the 2020 edition of Chinese pharmacopoeia and related items.
Rutin and gallic acid are derived from Tianjin Binhaoyuan scientific and technological development limited; methanol and acetonitrile are chromatographically pure; the rest reagents are analytically pure reagents.
1.2 instruments
Instrument Waters XevoTQ-S UPLC-MS/MS (FIS. Provisions.) Waters corporation, USA; tissue homogenizers (IKA, germany); Milli-Q ultra pure water purification system (Millipore, USA); BSA2202S electronic balance (sartorius, germany); 101-2 model intelligent digital display air-blast oven, Shanghai Xinyi Instrument Co., Ltd.
2 methods and results
2.1 preparation of Red-covered granules
2.1.1 preparation of Chinese medicinal extract powder
Accurately weighing 325g of Chinese medicinal powder (Rubi fructus: stigma croci Sativi: radix Puerariae: Mori fructus: Raphani semen: Bulbus Allii Macrostemi: herba Menthae) at mass ratio of 3: 1: 3: 1), adding 2000mL of water, decocting for 50min (with boiling time), cooling, filtering, adding 1500mL of water into residue, decocting for 50min, cooling, filtering, mixing filtrates, concentrating under reduced pressure to obtain brown viscous paste, and drying to obtain Chinese medicinal extract powder.
2.1.2 orthogonal optimization test design for adjuvant compounding
An L9(34) orthogonal test is designed according to three levels of a mixing auxiliary material ratio (dextrin: lactose), a dosage ratio of the traditional Chinese medicine extract powder and the auxiliary material, a wetting agent ethanol concentration and a drying temperature as influencing factors. See table 1. Taking the granule yield as a result reference index, placing the coated red granules in a 10 mesh (No. 1 sieve) and sieving for 5min, and then placing the coated red granules in an 80 mesh (No. 5 sieve) and sieving for 5 min. The results of the orthogonal tests are shown in tables 2 and 3. (yield (%) ═ weight of granules between sieve No. 1 and sieve No. 5)/total weight of granules × 100%).
TABLE 1 preparation level factor table for coated red granules
Level of Adjuvant materials ratio (dextrin: lactose) The dosage ratio of the extract powder to the auxiliary materials Wetting agent ethanol concentration/%) Drying temperature/. degree.C
1 1∶1 1∶0.5 60 55
2 1∶1.5 1∶1 70 65
3 1∶3 1∶2 80 75
2.2 screening the auxiliary materials of the red-covered granules
2.2.1 analysis of orthogonal experimental results of compounding ratio of red-coated granule adjuvants
According to the analysis of the L9(34) orthogonal test result of the red-coated particle preparation, the traditional Chinese medicine extract powder and the auxiliary materials (raw and auxiliary material ratio) have significant difference on the yield of the red-coated particle preparation. The wetting agent ethanol concentration and the particle drying temperature have little influence on the yield of the prepared red-covered particles.
Through analysis of variance and experimental analysis, the optimal test scheme for preparing the red-coated granules is determined to be that the dosage ratio of the traditional Chinese medicine extract powder to the auxiliary materials is 1:1, wherein the ratio of dextrin to lactose in the auxiliary materials is 1:1.5, the concentration of the wetting agent ethanol is 70%, and the drying temperature of the granules is 55 ℃.
2.2.2 Fuhong granule adjuvant ratio verification experiment
The dosage ratio of the traditional Chinese medicine extract powder to the auxiliary materials is 1: 1; wherein the ratio of dextrin to lactose in the auxiliary materials is 1: 1.5; the concentration of the wetting agent ethanol is 70 percent; the drying temperature of the pellets was 55 ℃ and 3 replicates were performed. The percent of pass of the red-covered granules was determined, with an average percent of pass of 94.6% and an RSD of 0.85%. The process has reliable optimization results, and the yield of the red-covered particles can be effectively predicted.
TABLE 2 results of orthogonal experiments
Serial number Ratio of the auxiliary materials Ointment auxiliary ratio Concentration of ethanol Drying temperature Yield of
1 1 1 1 1 79.34
2 1 2 2 2 83.45
3 1 3 3 3 74.45
4 2 1 2 3 89.23
5 2 2 3 1 94.21
6 2 3 1 2 83.67
7 3 1 3 2 88.45
8 3 2 1 3 85.74
9 3 3 2 1 91.34
Mean value 1 79.080 85.673 82.917 88.297
Mean value 2 89.037 87.800 88.007 85.190
Mean value 3 88.510 83.153 85.703 83.140
Extreme difference 9.957 4.647 5.090 5.517
TABLE 3 analysis of variance
Sources of variance Sum of squares of class III Degree of freedom Mean square F Significance of
Compounding ratio of auxiliary materials 521.078 2 260.539 425.666 ＜0.05
Raw material to auxiliary material ratio 81.072 2 40.536 66.227 <0.01
Alcohol concentration 103.053 2 51.526 84.183 ＞0.05
Drying temperature 107.953 2 53.977 88.186 ＞0.05
2.3 assay of rutin and Gallic acid in Red-covered granule
2.3.1 chromatographic conditions
Liquid chromatography conditions: a chromatographic column: ACQUITYBEH C18 (2.1X 100mm, 1.7 μm); column temperature: 40 ℃; temperature of the sample chamber: 20 ℃; flow rate: 0.4mL min-1; mobile phase: methanol (A) and 0.1% (v/v) formic acid solution (B); gradient elution (see table 4); the sample size was 1. mu.L.
Table 4 mobile phase gradient elution procedure
Time/min A
0～1.5 10％
1.5～4 10％～50％
4～8 50％～90％
8～10.5 90％
10.5～10.6 90％～10％
10.6～13 10％
Mass spectrum conditions: (anion mode)
An ion source: electrospray ion source (ESI); ion source temperature: 150 ℃; the monitoring mode is as follows: multiple Reaction Monitoring (MRM); capillary voltage: 3.0 kV; desolventizing gas (nitrogen) temperature: 160 ℃; desolventizing air flow rate: 800L/h; cone hole back-blowing (nitrogen) flow rate: 40L/h; collision gas (argon) flow rate: 0.15 mL/min; the mass spectrum collection parameters of rutin and gallic acid in the MRM monitoring mode are shown in Table 5.
TABLE 5 Mass Spectrometry acquisition parameters of rutin and gallic acid under MRM monitoring mode
Figure BDA0003428237200000111
2.3.2 control solutions and sample preparation
Preparing a reference substance mixed standard solution: precisely weighing rutin and gallic acid 5.0mg respectively, dissolving in methanol, and dissolving in 50mL volumetric flask for use.
Sample preparation:
preparing a reddened water-fried sample: precisely weighing 5g of the traditional Chinese medicine formula according to 2.1.1, decocting, combining the decoction, concentrating into extract powder, diluting with methanol to 100mL, and filtering with 0.22 μm organic phase filter membrane to obtain a water-decocted red sample for later use.
Preparation of a red-covered particle sample: 1.00g of the red-coated particles prepared by the method in the seventh embodiment are precisely weighed, and the volume is adjusted to 100mL by using methanol for standby.
2.3.3 Linear relationship examination
Accurately measuring 0.00, 1.00, 2.00, 3.00, 4.00 and 5.00mL of rutin and gallic acid mixed standard solution prepared in the step 2.3.2, respectively placing the mixed standard solution in a 10mL volumetric flask, and metering the volume of methanol to a scale mark. The assay was performed according to 2.3.1 chromatographic conditions. The regression equation of rutin and gallic acid standard solution and the related coefficient are shown in table 6.
TABLE 6 regression equation of standard rutin and gallic acid solution, correlation coefficient
Standard article Concentration range/. mu.g/ml Regression equation Coefficient of correlation r
Rutin 10～50 Y＝0.0087X+0.032 0.9995
Gallic acid 10～50 Y＝0.0094-0.00014 0.9986
2.3.4 precision test
And (3) taking the solution obtained by diluting the rutin and gallic acid standard sample solution by 25 times, and repeatedly measuring for 6 times, wherein the RSD of the rutin and gallic acid concentration measurement results is 0.89% and 1.04% respectively, which shows that the precision of the measuring instrument is good.
2.3.5 stability test
Taking the prepared red-covered water fried sample and the red-covered particle sample, measuring once every 1h for 6 times, wherein the RSD of the red-covered water fried sample is 1.13%, and the RSD of the red-covered particle sample is 0.94%. The stability of the red-covered water-fried sample and the red-covered particle sample is good within 6 h.
2.3.6 repeatability test
6 parts of the red-coated particle sample is precisely weighed to prepare a sample solution, the contents of rutin and gallic acid are measured under the condition of an instrument, and the RSD of the content measurement results of the rutin and the gallic acid is respectively 0.45% and 0.57%, which shows that the repeatability of the method for measuring the rutin and the gallic acid is good.
2.3.7 normalized recovery test
Precisely weighing 1.00g of the coated red particle sample, performing content measurement according to instrument conditions and a measurement method, and measuring the content of three reference substances. And precisely weighing 1.00g of the same batch of red granule sample, adding 10, 15 and 20 mu g of rutin and gallic acid reference substances, and measuring the content of the rutin and gallic acid reference substances. As a result, the average recovery rates of rutin and gallic acid were 99.5% (RSD was 1.4%) and 100.2% (RSD was 1.67%).
2.4 sample assay
Precisely weighing 3 batches of red-coated water decocted samples and 1g of red-coated particle samples, diluting the methanol to a constant volume of 100mL volumetric flask, and measuring the contents of rutin and gallic acid by a UPLCMS/MS method, wherein the results are shown in Table 7.
TABLE 7 determination results of rutin and gallic acid content in inula red
Figure BDA0003428237200000131
The following tests can be carried out:
the proportion of the red-coated particles to the auxiliary materials; the optimal preparation process of the red-coated granules comprises the following steps of taking the ratio of dextrin to lactose, the ethanol concentration of a wetting agent and the drying temperature of granules in auxiliary materials as influencing factors, and performing orthogonal test: the ratio of the traditional Chinese medicine extract powder to the auxiliary materials is 1:1, wherein the ratio of dextrin to lactose in the auxiliary materials is 1:1.5, the concentration of the wetting agent ethanol is 70%, and the drying temperature of the granules is 55 ℃.
Compared with the traditional water decoction of the capsanthin, the capsanthin particle has the advantages that the content of rutin and gallic acid is reduced to a certain extent, but the reduction amount is within 8 percent, and the treatment effect on the lower limb varicose vein is small.
Rutin and gallic acid are one of the effective components of flavonoids in the red-coated particles, and can remove free radicals, inhibit lipid peroxidation and improve hemodynamics. The test uses rutin and gallic acid as reference substances to measure the content of the rutin and the gallic acid by an UPLCMS/MS method, and the method meets the requirement of measuring the content of the red-coated particles through precision, stability, repeatability and standard-adding recovery experiments, and can provide quality basis for the quality control of the industrial production of the red-coated particles.
The invention is further illustrated below with reference to the effect of the patient taking the reddened granules prepared in example seven:
the traditional Chinese medicine coated red granules for treating varicose vein of lower limb are dried in an oven for 3 hours at 70 ℃, mixed uniformly, ground into powder and bagged, and each bag contains 30 g of the powder.
The using method comprises the following steps: the product can be taken after being mixed with boiling water, and can be taken as a main food after being taken with three meals every day.
And (4) index observation: and (3) observing and analyzing the lower limb swelling score, the blood stasis score, the subcutaneous induration score, the skin ulcer score numerical condition, the life quality score and the life self-care ability score numerical condition of the patient before and after the administration. Evaluating the lower limb swelling score according to 4 grades, wherein the score is 0-3, and when the score is 0, no lower limb swelling symptom is shown; when the score is 1, mild lower limb swelling symptoms are indicated; a score of 2 indicates moderate lower limb swelling; when the score was 3, the symptom of severe lower limb swelling was indicated. Evaluating the blood stasis score according to 4 grades, wherein the score is 0-3, and when the score is 0, the blood stasis symptom is represented; a score of 1 indicates mild blood stasis; a score of 2 indicates moderate blood stasis; a score of 3 indicates severe blood stasis. Evaluating subcutaneous induration scores according to 4 grades, and scoring for 0-3 points; when the score is 0, no subcutaneous induration symptom is indicated; a score of 1 indicates mild subcutaneous induration; a score of 2 indicates moderate subcutaneous induration symptoms; when the score was 3, severe subcutaneous induration symptoms were indicated. Evaluating the skin ulcer score according to 4 grades, wherein the score is 0-3, and when the score is 0, no skin ulcer symptom is shown; when the score is 1, mild skin ulcer symptoms are indicated; a score of 2 indicates moderate skin ulcer symptoms; when the score was 3, severe skin ulcer symptoms were indicated. Evaluating the quality of life according to a quality of life score scale, wherein the score scale is 0-100 points; the higher the score obtained by evaluation, the better the life quality performance; the lower the score obtained from the assessment, the worse the quality of life performance. Evaluating the self-care ability of life according to a self-care ability rating scale, wherein the scale is 0-100 points; the higher the score obtained by evaluation is, the higher the life self-care ability performance is; the lower the score obtained from the assessment, the lower the performance of the self-care ability of life.
The numerical conditions of the lower limb swelling score, the blood stasis score, the subcutaneous induration score and the skin ulcer score of the four weeks before and after the red-coated traditional Chinese medicine for treating varicose vein of the lower limb prepared in the seventh embodiment are used for 50 patients: after the medicine is taken, the values of the lower limb swelling score, the blood stasis score, the subcutaneous induration score and the skin ulcer score of the patient are lower than those before the medicine is taken, and the difference has statistical significance (P is less than 0.05), which is shown in Table 8.
TABLE 8 comparison of Effect before and after taking the coated Red granule prepared in EXAMPLE VII
Before and after administration Lower limb swelling scoring Blood stasis score Subcutaneous induration score Skin ulcer score
After being used (n is 50) 0.87±0.15 0.86±0.09 0.89±0.12 0.68±0.11
Before medicine (n is 50) 2.23±0.16 1.77±0.14 1.97±0.12 1.44±0.14
t 6.322 6.456 6.238 6.432
P ＜0.05 ＜0.05 ＜0.05 ＜0.05
And (4) conclusion: the red-coated traditional Chinese medicine granules for treating varicose vein of lower limb prepared by the embodiment seven can effectively relieve the symptoms of swelling of lower limb, blood stasis, subcutaneous induration and skin ulcer of patients with varicose vein of lower limb.
The numerical conditions of the lower limb swelling score, the blood stasis score, the subcutaneous induration score and the skin ulcer score before and after four weeks of the traditional Chinese medicine coated red particles for treating varicose veins of the lower limbs prepared in the example eight are used for 50 patients: after the medicine is taken, the values of the lower limb swelling score, the blood stasis score, the subcutaneous induration score and the skin ulcer score of the patient are lower than those before the medicine is taken, and the difference has statistical significance (P is less than 0.05), which is shown in table 9.
TABLE 9 comparison of the effect before and after taking the red-coated granules prepared in example eight
Before and after administration Lower limb swelling scoring Blood stasis score Subcutaneous induration score Skin ulcer score
After being used (n is 50) 0.95±0.08 0.84±0.17 0.76±0.14 0.72±0.03
Before medicine (n is 50) 2.38±0.16 1.85±0.21 2.04±0.08 1.63±0.11
t 6.423 6.357 6.664 6，348
P ＜0.05 ＜0.05 ＜0.05 ＜0.05
And (4) conclusion: the red-coated traditional Chinese medicine granules for treating varicose vein of lower limb prepared in the embodiment eight can effectively relieve the symptoms of swelling of lower limb, blood stasis, subcutaneous induration and skin ulcer of patients with varicose vein of lower limb.
The invention is not limited to the above alternative embodiments, and any other various forms of products can be obtained by anyone in the light of the present invention, but any changes in shape or structure thereof, which fall within the scope of the present invention as defined in the claims, fall within the scope of the present invention.

Claims (7)

1. The medicinal and edible coated red granules for varicose vein of lower limbs are characterized by being prepared from the following raw materials in parts by weight: 1-5 parts of raspberry, 1-5 parts of crocus sativus, 1-3 parts of kudzu root, 1-3 parts of mulberry fruit, 1-5 parts of radish seed, 1-3 parts of allium macrostemon and 1-3 parts of mint.
2. The medicine-food homologous red-coated particle for varicose vein of lower limbs of claim 1, which is prepared from the following raw materials in parts by weight: 3 parts of raspberry, 1 part of saffron, 3 parts of kudzuvine root, 3 parts of mulberry fruit, 1 part of radish seed, 1 part of allium macrostemon and 1 part of mint.
3. The medicine-food homologous red-coated particle for varicose vein of lower limbs of claim 1, which is prepared from the following raw materials in parts by weight: raspberry 1 part, saffron 5 parts, kudzu vine root 1 part, mulberry fruit 3 parts, radish seed 1 part, longstamen onion bulb 3 parts and peppermint 1 part.
4. The medicine-food homologous red-coated particle for varicose vein of lower limbs of claim 1, which is prepared from the following raw materials in parts by weight: 5 parts of raspberry, 1 part of saffron, 3 parts of kudzuvine root, 1 part of mulberry fruit, 5 parts of radish seed, 1 part of allium macrostemon and 3 parts of mint.
5. A preparation method of medicinal and edible coated red granules for varicose vein of lower limb is characterized by comprising the following steps:
taking 1-5 parts by weight of raspberry, 1-5 parts by weight of crocus sativus, 1-3 parts by weight of kudzu root, 1-3 parts by weight of mulberry fruit, 1-5 parts by weight of radish seed, 1-3 parts by weight of allium macrostemon and 1-3 parts by weight of mint to obtain a raw material composition;
adding 1900-2100 parts by volume of water into the raw material composition, decocting for 48-52min under a boiling condition, cooling, and filtering to obtain medicine residues;
adding 1400-1600 parts by volume of water into the residues, decocting for 48-52min under boiling condition, cooling and compressing to obtain brown viscous paste, and drying to obtain Chinese medicinal extract powder;
mixing the traditional Chinese medicine extract powder and auxiliary materials according to the weight ratio of 1:1, and adding 70% of wetting agent ethanol to prepare wet granules; drying the wet granules at the temperature of 55 ℃ and finishing granules to obtain medicinal and edible red-coated granules;
the weight parts are as follows: 1 part by volume =20 g: 1 ml.
6. The preparation method of the medicinal and edible coated red particle for varicose vein of lower limb according to claim 5, which is characterized by comprising the following steps:
taking 3 parts of raspberry, 1 part of saffron, 3 parts of kudzuvine root, 3 parts of mulberry fruit, 1 part of radish seed, 1 part of allium macrostemon and 1 part of mint to obtain a raw material composition;
adding 2000 parts by volume of water into the raw material composition, decocting for 50min under a boiling condition, cooling, and filtering to obtain medicine residues;
adding 1500 parts by volume of water into the residues, decocting for 50min under boiling condition, cooling and compressing to obtain brown viscous paste, and drying to obtain Chinese medicinal extract powder;
mixing the traditional Chinese medicine extract powder and auxiliary materials according to the weight ratio of 1:1, and adding 70% of wetting agent ethanol to prepare wet granules; drying the wet granules at the temperature of 55 ℃ and finishing granules to obtain the medicinal and edible red-coated granules.
7. The preparation method of the medicinal and edible red-coated granule for varicose vein of lower limbs as claimed in claim 5 or 6, wherein the auxiliary material comprises dextrin and lactose at a weight ratio of 1: 1.5.
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103751633A (en) * 2013-12-31 2014-04-30 青岛恒波仪器有限公司 Traditional Chinese medicinal composition for treating varicose vein of lower limb and preparation method thereof
CN105395779A (en) * 2015-12-26 2016-03-16 哈尔滨和谐旺科技开发有限公司 Traditional Chinese medicine for efficiently treating varicosity and preparation method thereof
CN105641051A (en) * 2014-11-12 2016-06-08 颜菲 Cold coagulation and blood stasis type lower limb varicosis treating traditional Chinese medicine formula

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103751633A (en) * 2013-12-31 2014-04-30 青岛恒波仪器有限公司 Traditional Chinese medicinal composition for treating varicose vein of lower limb and preparation method thereof
CN105641051A (en) * 2014-11-12 2016-06-08 颜菲 Cold coagulation and blood stasis type lower limb varicosis treating traditional Chinese medicine formula
CN105395779A (en) * 2015-12-26 2016-03-16 哈尔滨和谐旺科技开发有限公司 Traditional Chinese medicine for efficiently treating varicosity and preparation method thereof

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