CN103040889B - Ginseng-acanthopanax oral liquid and production process thereof - Google Patents
Ginseng-acanthopanax oral liquid and production process thereof Download PDFInfo
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Abstract
The invention provides a ginseng-acanthopanax oral liquid and a production process thereof. The following raw materials are adopted in parts by weight: 1 part of ginseng, 10-20 parts of acanthopanax and 15-40 parts of purified water. The following index system is adopted to strictly control product quality: the content of syringin is more than or equal to 2.0mg/100ml, the pH value is 4.0-6.0, and the soluble solid content is more than or equal to 1.0%. The production process of the ginseng-acanthopanax oral liquid, provided by the invention, omits a step of alcohol precipitation, and the loss of ginseng polysaccharides is avoided, so that good anti-fatigue effect of the oral liquid is guaranteed; and the whole technological process adopts sterile operation, high temperature sterilization and suitable packing material, so that the microbiological safety of a product is guaranteed, the product is stable, no antiseptic substance is required to be added, and a food is safe and reliable.
Description
Technical field
The invention belongs to health product technology field, be specifically related to a kind of Radix Ginseng oral liquid of acanthopanax bark and production technology thereof.
Background technology
Along with the quickening of people's rhythm of life and the aggravation of social competition, the reasons such as operating pressure, sleep quality be not good of modern erratic daily life system, height, cause the threat of facing mankind chronic fatigue syndrome, have affected the mankind's health.
Radix Ginseng, sweet in the mouth, micro-hardship, flat.Return spleen, lung, heart channel." property of medicine opinion " says it: " main five hide QI-insufficiency, and five kinds of strain and seven kinds of impairment is deficient, thin and weak tell contrary, lower food ... tonifying five ZANG-organs six internal organs, in guarantor, keep god." " medicine class on the analogy of natural things " claim: Radix Ginseng " control spleen lung YANG QI deficiency, and can tonifying the lung, tachypnea, lose heart, weak breath.Mend and in slow, pathogenic fire in purgation of spleen excess lung stomach, kind controlling losed heart." there is good strongly invigorating primordial QI, multiple arteries and veins is admittedly de-, invigorating the spleen to benefit the lung, promoting the production of body fluid to quench thirst effect.
Radix Et Caulis Acanthopanacis Senticosi, acrid in the mouth, micro-hardship, temperature.Return spleen, kidney, heart channel." Chinese medicine voluminous dictionary " sums up: " have compared with better ' adaptogen ' sample effect of Radix Ginseng, enhancing body resistance aspect, act on quite extensively Radix Et Caulis Acanthopanacis Senticosi, and the resistivity of energy enhanced machine to destructive stimulus factor, can regulate pathological process, makes it to be tending towards normalization." " national Chinese patent medicine product collection " title: its " strengthening the body resistance, kidney and spleen invigorating, intelligent promoting and the mind tranquilizing.Be applicable to spleen kidney deficiency, soreness of the waist and knees, neurasthenia, insomnia, inappetence, body nihility power." " Chinese medicine modern study and clinical practice " cloud its: " replenishing QI to invigorate the spleen, tonifying the kidney for tranquilization ".
Both share, and the gas of tonification lung, spleen, the heart, kidney rouses oneself internal organs function, jointly brings into play the effect of QI invigorating and body resistance strengthening, and effectively alleviating physical fatigue, extensively appears in the formula of current anti-fatigue health-product containing and medicine.
As CN03111170.X, name is called the patent of invention of " a kind of oral liquid for resisting fatigue ".Disclose a kind of oral liquid for resisting fatigue, its formula is (by weight): Radix Ginseng 1-7, Radix Et Caulis Acanthopanacis Senticosi 1-7, Radix Rhodiolae 0.1-0.7, Radix Ophiopogonis 0.1-0.7, white sugar 0-6, sodium benzoate 0-0.15, deionized water 15-30.Its production technology is: in raw material, add 8 times of water, heating and refluxing extraction three times, merges three times extracting solution, filter, when being concentrated into density and being the extractum of 1.18-1.2, add ethanol, sedimentation 72 hours, filters, and adds water, white sugar in filtrate, heated and boiled, filter, in filtrate, add sodium benzoate, add deionized water to required volume, mix bottling.
There is following shortcoming in the Antifatigue oral liquid of this patent:
1, in production technology, adopt the method for precipitate with ethanol to remove impurity, and the material that plays obvious antifatigue effect in Radix Ginseng is ginseng polysaccharide, with ginseng pectin for mainly representing composition, pectin is the chemical substance that a class can be water-soluble, but this class material is insoluble to ethanol, if adopt ethanol to carry out precipitate with ethanol, can cause ginseng polysaccharide to lose in a large number, cannot ensure the resisting fatigue effect of this product.
2, in oral liquid, add sodium benzoate as antiseptic, although sodium benzoate is conventional chemical preservative, but due to chemical composition of Chinese materia medica complexity, can not avoid likely there will be in Chinese medicine and the material of this product generation chemical composition, so avoid using this product can better ensure the safety of taking of this product.
Summary of the invention
The present invention is directed to above-mentioned technical problem, a kind of Radix Ginseng Radix Et Caulis Acanthopanacis Senticosi Antifatigue oral liquid and production technology thereof are provided.Oral liquid main component of the present invention is behaved and is participated in Radix Et Caulis Acanthopanacis Senticosi, formula belongs to the crowd of the deficiency of vital energy mainly for physical fatigue, in conjunction with modern medicine and pharmacology in the achievement in research aspect alleviating physical fatigue, adopt the health-care method of QI invigorating righting, choose reasonable material combination is the health food with physical-fatigue-relieving health function.
For achieving the above object, the present invention adopts following technical scheme:
A kind of Radix Ginseng oral liquid of acanthopanax bark, is characterized in that: by weight, proportioning raw materials is 1 part of Radix Ginseng, 10 ~ 20 parts of Radix Et Caulis Acanthopanacis Senticosis, 15 ~ 40 parts of purified water.
In described Radix Ginseng oral liquid of acanthopanax bark, containing syringoside >=2.0mg/100ml, pH value is 4.0 ~ 6.0, soluble solid >=1.0%.
The present invention selects syringoside as content's index composition, is to be one of effective ingredient of resisting fatigue in Radix Et Caulis Acanthopanacis Senticosi due to syringoside, adopts this index components can well weigh the effect of the resisting fatigue of this product.
It is 4.0 ~ 6.0 that the present invention limits pH value scope, is because product is within the scope of this PH, and significantly precipitation does not occur, it is stable that simultaneously main effective ingredient syringoside content keeps.
The present invention limits soluble solid >=1.0%, is the oral liquid that is Chinese medicine extraction due to product, selects total amount that soluble solid can weigh the effective ingredient extracting from Chinese medicine more than 1.0%.
The production technology of described Radix Ginseng oral liquid of acanthopanax bark, concrete steps are as follows:
A gets 1 part of 10 ~ 20 parts of Radix Et Caulis Acanthopanacis Senticosi, Radix Ginseng and adds water, and decoct and extract 2 times, each 2 hours, add water volume for the 1st time and be 14 times of medical material weight, add water volume for the 2nd time and be 12 times of medical material weight, filter, filtrate merges, and obtains filtrate A, and pH value is 4.0 ~ 6.0.
Under the condition of above-mentioned amount of water, the main composition in Radix Ginseng and Radix Et Caulis Acanthopanacis Senticosi can as much as possiblely extract.
B is not more than in temperature under the condition of 70 DEG C, and the decompression volume of filtrate A is concentrated into 6 times of raw material weight, relative density 1.01-1.02(50 DEG C of survey), for subsequent use.
The envelope-bulk to weight ratio of above-mentioned A step and B step is L/kg.
The present invention limits medicinal liquid and is concentrated to relative density 1.01-1.02(50 DEG C) scope in, medicine liquid volume is concentrated to the volume of regulation substantially.
C gets concentrated solution, leaves standstill, and cold preservation is spent the night, and filters, and obtains liquor B.
In D liquor B, add 15 ~ 40 parts of purified water to total amount, mix homogeneously, obtains mixed liquor.
The fill of E mixed liquor, obtains bottled oral liquid.
F is bottled oral liquid pressure sterilizing 15min at 120 ~ 125 DEG C, and quality inspection is qualified, and outer package to obtain final product.
The sterilising temp here and time are the characteristics for product of the present invention, have good heat stability, consider that the present invention does not add any antiseptic, therefore adopt the highest sterilizing methods of safety, can well ensure the safety of taking of product.
The Packaging Bottle of using in described technique and bottle cap are for subsequent use after being up to the standards, cleaning, drying, and touchstone is YBB 0003 " soda-lime glass control oral liquid bottle (trying) ".
Described technological operation is all carried out under 100,000 grades of clean environment.
Beneficial effect of the present invention shows:
1, the present invention chooses people and participates in the charge ratio that Radix Et Caulis Acanthopanacis Senticosi is 1:15, it is the relevant regulations for Radix Ginseng day taking dose according to " bulletin about approval Radix Ginseng (artificial growth) for new resource food " (Ministry of Public Health bulletin 2012 No. 17), Radix Ginseng day, taking dose was≤3 grams/day, consider reality take process in likely there will be more than a day situation about time taking, in order better to ensure the safety of taking of this product, determine that the Radix Ginseng dosage in this product is 1g/ bottle.Under the prerequisite of taking dose of having determined Radix Ginseng, according to the regulation of the Pharmacopoeia of the People's Republic of China () the daily dosage of Radix Et Caulis Acanthopanacis Senticosi, the optimal proportion that the people who has chosen this prescription participates in Radix Et Caulis Acanthopanacis Senticosi is 1:10 ~ 20.Under this dosage, human body there will not be Radix Ginseng to take rear common " dry property " after taking, human body without any discomfort, and resisting fatigue successful.
2, production technology of the present invention is in decoction process, taking the extraction ratio of Radix Ginseng and Radix Et Caulis Acanthopanacis Senticosi as index, the strict ratio of having controlled amount of water and medical material of calculating, has ensured that the main composition in Radix Ginseng and Radix Et Caulis Acanthopanacis Senticosi can as much as possiblely extract, thereby has ensured drug effect.
3, production technology of the present invention is saved the step of precipitate with ethanol, has avoided ginseng polysaccharide's loss, thereby has further ensured the effective of oral liquid resisting fatigue.
4, the present invention selects syringoside content as product index, syringoside is one of main anti-fatigue effect composition in Radix Et Caulis Acanthopanacis Senticosi, the present invention analyses scientifically the extraction ratio of the syringoside in Radix Et Caulis Acanthopanacis Senticosi medical material, draw syringoside content >=2.0mg/100ml, thereby ensured the quality controllability of product.
5, to limit the pH value scope of product be 4.0 ~ 6.0 in the present invention, and product is within the scope of this PH, and significantly precipitation does not occur, it is stable that simultaneously main effective ingredient syringoside content keeps; Limit soluble solid >=1.0%, for the total amount of weighing the effective ingredient that product extracts from Chinese medicine more than 1.0%.Quality stability and the drug effect of product are further ensured.
6, whole technological process of the present invention takes sterile working, high temperature sterilize and suitable packaging material to ensure the microbial safety of product, in stability study, adopt microbial limit index to detect, in the stability study process of product, do not occur underproof phenomenon.Therefore, product is stable, and without adding antiseptic, food safety is reliable.
Detailed description of the invention
Below in conjunction with detailed description of the invention, essentiality content of the present invention is described in further detail.
Embodiment 1
A kind of Radix Ginseng oral liquid of acanthopanax bark, by weight, proportioning raw materials is 1 part of Radix Ginseng, 10 parts of Radix Et Caulis Acanthopanacis Senticosis, 15 parts of purified water.
Embodiment 2
A kind of Radix Ginseng oral liquid of acanthopanax bark, by weight, proportioning raw materials is 1 part of Radix Ginseng, 15 parts of Radix Et Caulis Acanthopanacis Senticosis, 26 parts of purified water.
Embodiment 3
A kind of Radix Ginseng oral liquid of acanthopanax bark, by weight, proportioning raw materials is 1 part of Radix Ginseng, 20 parts of Radix Et Caulis Acanthopanacis Senticosis, 40 parts of purified water.
Syringoside content 2.0mg/100ml, pH value is 4.0, soluble solid 1.0%.
Embodiment 4
A kind of Radix Ginseng oral liquid of acanthopanax bark, by weight, proportioning raw materials is 1 part of Radix Ginseng, 14 parts of Radix Et Caulis Acanthopanacis Senticosis, 25 parts of purified water.
Syringoside content 5.2mg/100ml, pH value is 6.0, soluble solid 3.3%.
Embodiment 5
A kind of Radix Ginseng oral liquid of acanthopanax bark, by weight, proportioning raw materials is 1 part of Radix Ginseng, 16 parts of Radix Et Caulis Acanthopanacis Senticosis, 28 parts of purified water.
Syringoside content 4.6mg/100ml, pH value is 5.0, soluble solid 3.6%.
Embodiment 6
A kind of Radix Ginseng oral liquid of acanthopanax bark, by weight, proportioning raw materials is 1 part of Radix Ginseng, 15 parts of Radix Et Caulis Acanthopanacis Senticosis, 30 parts of purified water.
Syringoside content 6.4mg/100ml, pH value is 5.2, soluble solid 2.5%.
Embodiment 7
The production technology of Radix Ginseng oral liquid of acanthopanax bark:
A gets 1 part of 15 parts of Radix Et Caulis Acanthopanacis Senticosi, Radix Ginseng and adds water, and decoct and extract 2 times, each 2 hours, add water volume for the 1st time and be 14 times of medical material weight, add water volume for the 2nd time and be 12 times of medical material weight, filter, filtrate merges, and obtains filtrate A, and pH value is 6.0.
At room temperature, the decompression volume of filtrate A is concentrated into 6 times of raw material weight to B, relative density 1.01(50 DEG C of survey), for subsequent use.
The envelope-bulk to weight ratio of above-mentioned A step and B step is L/kg.
C gets concentrated solution, leaves standstill, and cold preservation is spent the night, and filters, and obtains liquor B.
In D liquor B, add 26 parts of purified water to total amount, mix homogeneously, obtains mixed liquor.
The fill of E mixed liquor, 100ml/ bottle, obtains bottled oral liquid.
F is bottled oral liquid pressure sterilizing 15min at 120 DEG C, and quality inspection is qualified, and outer package to obtain final product.
Embodiment 8
The production technology of Radix Ginseng oral liquid of acanthopanax bark:
A gets 1 part of 10 parts of Radix Et Caulis Acanthopanacis Senticosi, Radix Ginseng and adds water, and decoct and extract 2 times, each 2 hours, add water volume for the 1st time and be 14 times of medical material weight, add water volume for the 2nd time and be 12 times of medical material weight, filter, filtrate merges, and obtains filtrate A, and pH value is 4.0.
B is at 70 DEG C, and the decompression volume of filtrate A is concentrated into 6 times of raw material weight, relative density 1.02(50 DEG C of survey), for subsequent use.
The envelope-bulk to weight ratio of above-mentioned A step and B step is L/kg.
C gets concentrated solution, leaves standstill, and cold preservation is spent the night, and filters, and obtains liquor B.
In D liquor B, add 15 parts of purified water to total amount, mix homogeneously, obtains mixed liquor.
The fill of E mixed liquor, 100ml/ bottle, obtains bottled oral liquid.
F is bottled oral liquid pressure sterilizing 15min at 125 DEG C, and quality inspection is qualified, and outer package to obtain final product.
The Packaging Bottle of using in described technique and bottle cap are for subsequent use after being up to the standards, cleaning, drying, and touchstone is YBB 0003 " soda-lime glass control oral liquid bottle (trying) ".
Embodiment 9
The production technology of Radix Ginseng oral liquid of acanthopanax bark:
A gets 1 part of 20 parts of Radix Et Caulis Acanthopanacis Senticosi, Radix Ginseng and adds water, and decoct and extract 2 times, each 2 hours, add water volume for the 1st time and be 14 times of medical material weight, add water volume for the 2nd time and be 12 times of medical material weight, filter, filtrate merges, and obtains filtrate A, and pH value is 5.5.
B is at 50 DEG C, and the decompression volume of filtrate A is concentrated into 6 times of raw material weight, relative density 1.015(50 DEG C of survey), for subsequent use.
The envelope-bulk to weight ratio of above-mentioned A step and B step is L/kg.
C gets concentrated solution, leaves standstill, and cold preservation is spent the night, and filters, and obtains liquor B.
In D liquor B, add 40 parts of purified water to total amount, mix homogeneously, obtains mixed liquor.
The fill of E mixed liquor, obtains bottled oral liquid.
F is bottled oral liquid pressure sterilizing 15min at 122 DEG C, and quality inspection is qualified, and outer package to obtain final product.
The Packaging Bottle of using in described technique and bottle cap are for subsequent use after being up to the standards, cleaning, drying, and touchstone is YBB 0003 " soda-lime glass control oral liquid bottle (trying) ".
Craft sanitary requirement
(1) logistics separates with artificial abortion
1, logistics program
Raw material → lixiviate → concentrate → mix → fill → sterilizing → packaging → finished product (unidirectional following current, without moving back and forth)
2, the clean program of thing:
General district material → visual examination → exterior clean → (sloughing outer package) → insert extension material nameplate → general district to deposit
Clean area material → visual examination → exterior clean → (sloughing outer package) → insert (pass-through box) → clean area between extension material nameplate → buffering to deposit
3, the clean program of people
General district: post, personnel → entrance hall → more footwear () → change one's clothes (one) → general district
Clean area: personnel → entrance hall → more footwear () → change one's clothes (one) → buffering washes one's hands → more footwear (two) → purified water (two) → hands sterilization (band glove) → post, clean area of washing one's hands → change one's clothes
(2) production environment cleanliness factor requirement
1, general production area
(1) ground is clean and tidy, and door glass, metope, ceiling cleaning are intact.Equipment, pipeline, pipeline marshalling and wrap up bright and clean, still, emit, drip, leak, cleaned at regular intervals maintenance.
(2) equipment, container, instrument are placed by production management's requirement, and cleaned at regular intervals also meets clean requirement.
(3) Workplace must not smoking, must not eat food, and must not deposit and produce irrelevant article and private foreign material.
2, clean area
(1), except meeting the requirement of general production area, must accomplish that equipment, container, instrument, pipeline keep clean.Housing material must not enter one's respective area before thoroughly not cleaning.
(2) in region, cleanliness factor requirement is 100,000 grades, utilize laminar-flow type integral air conditioner to purify, temperature is controlled at 18-26 DEG C, relative humidity is controlled at 45-65%, rate of ventilation >=15 time/hour, medium effeciency filter (ten thousand grades) is non-woven fabrics filter material (changing clothes once for 3 months), wind speed >=0.3 meter per second, air pressure difference meets the requirements, and method checks clump count≤10 in accordance with regulations.
(3) in region, there is dissolving and wait post setting cleaner unit.
3, Quality Mgmt Dept will specify special messenger to make regular check on production area craft sanitary and cleanliness factor.
Embodiment 10
The stability test result of Radix Ginseng oral liquid of acanthopanax bark of the present invention is as follows:
The present invention, by adopting sterile working, high temperature sterilize and suitable packaging material to ensure the microbial safety of product, adopts microbial limit index to detect in stability study, finds that underproof phenomenon does not appear in product in stability study process.Prove that thus this product is stable, without adding antiseptic, food safety is reliable.
Embodiment 11
The stability test result of Radix Ginseng oral liquid of acanthopanax bark of the present invention is as follows:
Embodiment 12
The stability test result of Radix Ginseng oral liquid of acanthopanax bark of the present invention is as follows:
Embodiment 13
The animal experiment of Radix Ginseng oral liquid of acanthopanax bark alleviating physical fatigue function of the present invention:
1. materials and methods
1.1 samples: Radix Ginseng oral liquid of acanthopanax bark, brown liquid, human body recommended amounts every day is 100ml/60kg.BW(5 times of concentrated solution).
1.2 laboratory animals: 160 of the male mice in kunming being provided by Sichuan Provincial Academy of Traditional Chinese Medicine Experimental Animal Center, body weight 18-22g, production licence number is SCXK(river) 2008-19.SPF level, experimental animal room is barrier system, occupancy permit number is SYXK (river) 2011-043, temperature 20-25 DEG C, relative humidity 40-70%.
1.3 dosage are selected and preparation: 3.33ml/kg.BW, 6.67ml/kg.BW, tri-dosage groups of 10.0ml/kg.BW (be equivalent to respectively human body recommended amounts 10,20,30 times) are established in test, get respectively 41.6ml, 83.4ml, 125.0ml tested material, each adding distil water is settled to 250ml and mixes, refrigerator-freezer is preserved, be finished again and join, separately establish distilled water matched group.Test is divided into one, two, three, four group, every group of 40 animals.
1.4 key instruments and reagent: SBA-40C type bio-sensing analyser, electronic balance, agitator, swimming trunk, homogenizer, stopwatch, urea kit, anthrone reagent, hemolytic agent, trichloroacetic acid, glucose standard solution, the lactic acid standard solution of the UV1100 spectrophotometer that Shanghai Techcomp Instrument Ltd. produces, the CX4 automatic clinical chemistry analyzer that Beckman Coulter Inc. of the U.S. produces, Shandong Province academy sciences Biology Research Institute production.
1.5 test method
1.5.1 before test, prepare tested material with distillation water as solvent, by 20ml/kg.BW per os gavage mice, give every day once, give continuously 30 days.
1.5.2 Loaned swimming test: the animal last of one group of each dosage group of test is given after tested material 30min, by the load microfuse of 5% body weight of Mus root of the tail portion, again mice is put into 25 ± 1.0 DEG C of water temperatures, the swimming trunk went swimming of depth of water 30cm, recording mice starts, to the dead time, to calculate the swimming time of mice from swimming.
1.5.3 serum urea is measured: the animal last of two groups of each dosage groups of test is given after tested material 30min, mice is put into not swimming with a load attached to the body of the water 90min of 30 DEG C of temperature, after rest 60min, pull out eyeball and adopt whole blood 0.5ml, get serum by the operation of test kit description, the kit measurement serum urea content providing with CX4 automatic clinical chemistry analyzer and Beckman Coulter Inc. of the U.S..
1.5.4 hepatic glycogen is measured: the animal last of three groups of each dosage groups of test is given after tested material 30min, execution animal is got liver and blots with filter paper after normal saline rinsing, take about 100mg liver, measure the content of hepatic glycogen by the anthrone method in " health food inspection and assessment technique specification " (version in 2003).
1.5.5 blood Plasma lactate: the animal last of four groups of each dosage groups of test is given after tested material 30min, do not bear a heavy burden and stop after the water went swimming 10min of 30 DEG C of temperature.Plasma lactate method: the each blood sampling of rest 20min 20 μ l after 0min and swimming before swimming, after swimming, after adding respectively 50 μ l hemolytic agents vibrations to mix, then use SBA-40C type bio-sensing analysis-e/or determining.Measurement result is multiplied by extension rate 3.5 and is Serum lactic acid content.
1.6 test data statistics: test data statistics adopts SPSS 11.0 for windows software kit processing.Data are through homogeneity test of variance, and variance is neat, carry out variance analysis, as P value is less than 0.05, compare between two by Dunnett method; If heterogeneity of variance, carries out data transaction, still uneven, use rank test instead, as P value is less than 0.05, use Dunnett ' s T3 method to compare between two.
2. result
2.1 impacts on Mouse Weight:
From table 1,2,3, the initial body weight of each dosage group and control animals is learned processing by statistics, variance neat (P>0.05), and the results of analysis of variance (P>0.05) shows that the initial body weight of each treated animal is balanced.When the mid-term of three dosage treated animals, body weight was with end, body weight and matched group comparison, learn and process by statistics, difference that there are no significant (P>0.05).
2.2 impacts on the mice burden swimming time:
From table 4, the swimming with a load attached to the body time of three dosage groups and matched group comparison, learn and process by statistics, and the swimming with a load attached to the body time lengthening of three dosage groups all has significant difference (P<0.05, P<0.01, P<0.01).
2.3 Radix Ginseng oral liquid of acanthopanax bark on mouse movement after the impact of serum urea:
From table 5, serum urea and matched group comparison after three dosage group mouse movements, learn and process by statistics, and the serum urea of three dosage groups reduces all significant difference (P<0.01).
2.4 impacts of Radix Ginseng oral liquid of acanthopanax bark on Mouse Liver glycogen:
From table 6, the hepatic glycogen content of three dosage group mices and matched group comparison, learn and process by statistics, and the hepatic glycogen content of three dosage groups raises all significant difference (P<0.05).
2.5 Radix Ginseng oral liquid of acanthopanax bark on mouse movement after the impact of blood lactate level:
From table 7, the blood lactic acid area under curve of three dosage groups and matched group comparison, learn and process by statistics, the blood lactic acid area under curve of three dosage groups there are no significant difference (P>0.05).
3. brief summary
Continuous 30 days per os gavages of Radix Ginseng oral liquid of acanthopanax bark of the present invention give after male mice, and visible growth of animal is good, body weight sustainable growth.Three dosage groups can obviously extend the mice burden swimming time, and Loaned swimming test result is positive; The serum urea of three dosage groups reduces significant difference, and serum urea measurement result is positive; Three dosage groups hepatic glycogen content that can significantly raise, hepatic glycogen measurement result is positive; There was no significant difference between three dosage group blood lactic acid area under curve and matched group, measurement result is negative.By the regulation in " health food inspection and assessment technique specification " (version in 2003), Radix Ginseng oral liquid of acanthopanax bark of the present invention has obvious alleviating physical fatigue function to animal.
Embodiment 14
Radix Ginseng oral liquid of acanthopanax bark Toxicological evaluation test of the present invention:
1. materials and methods
1.1 samples: Radix Ginseng oral liquid of acanthopanax bark, content is brown liquid, human body recommended amounts every day 100ml/60kg.BW (20 times of concentrated solutions).When test, prepare tested material with distillation water as solvent.
1.2 experimental animals: Kunming mouse and SD rat are provided by Sichuan Provincial Academy of Traditional Chinese Medicine Experimental Animal Center, Da Shuo bio tech ltd, Chengdu and Chengdu Inst. of Biological Products's Experimental Animal Center, and production licence number is respectively SCXK(river) 2008-19.SPF level, SCXK(river) 2008-24.SPF level and SCXK(river) 2010-126.SPF level.Experimental animal room is barrier system, and occupancy permit number is SYXK(river) 2011-043, temperature 20-25 DEG C, relative humidity 40%-70%.
1.3 instruments and reagent:
1.3.1 key instrument: CX4 type automatic clinical chemistry analyzer, XT-2000i type Automatic Blood Cell Analyzer, METTLER electronic balance, OLYMPUS BH-2 type microscope, dissecting instrument, superclean bench.
1.3.2 main agents: biochemical reagents box, cyclophosphamide, 1,8-dihydroxyanthraquinone, Hydrazoic acid,sodium salt, 2-aminofluorene, 4-nitroquinoline-N oxide, ametycin, S-9 mixed liquor.
1.4 large and small Mus acute toxicity tests: adopt respectively each 20 of Kunming mouse and SD rat, male and female half and half, Mouse Weight
18-22g, rat body weight 180-220g, large and small Mus is divided into respectively two groups at random, and totally 4 groups, 10 animals of every group of homology same sex.Test is established dosage group of 15000mg/kg.BW by maximum tolerated dose method, and taking 90g tested material adding distil water, to be settled to 120ml for subsequent use, and large and small Mus all gives tested material by per os gavage of 20ml/kg.BW.Animal fasting 16h before gavage, does not limit drinking-water, observes poisoning symptom and the death condition of animal in a week, and off-test is put to death animal after weighing and done gross anatomy.
1.5 genetic toxicity tests:
1.5.1 Salmonella reversion test: use self-control through β-naphthoflavene and phenobarbital induction male rat liver S
9, make S by standard method
9after mixed liquor, as activation system, with indirect mutagen, (20 μ g/ ware 2-aminofluorenes are for TA
97,tA
98, TA
100, 50 μ g/ wares 1,8-dihydroxyanthraquinone is for TA
102bacterium) mensuration S
9active.Test adopts TA
97, TA
98, TA
100, TA
102four kinds of bacterial strains, tested material is established five dosage groups of 8,40,200,1000,5000 μ g/ wares and solvent control group (distilled water), spontaneous matched group and positive controls.First prepare tested material working solution: accurately take 5.0g tested material, adding distil water mixes and is high workload concentration 50mg/ml to 100ml, when test, get this working solution 100 μ l and add plate to be the highest tested material final concentration (5000 μ g/ ware), down dilute and obtain following concentration as basis with 5 times of distilled water taking maximum concentration.High pressure steam sterilization.Adding and do not adding S
9experimental condition under carry out flat board and mix method test.Make three parallel wares for every group, repeated trials once.-S
9positive control: TA
97and TA
98with 4-nitroquinoline-N-oxide of 0.5 μ g/ware; TA
100with the Hydrazoic acid,sodium salt (NaN of 1.5 μ g/wares
3); TA
102with the ametycin (MMC) of 1.0 μ g/wares; + S
9positive control TA
102with 1 of 50 μ g/wares, 8-dihydroxyanthraquinone, its excess-three bacterial strain all adopts the 2-aminofluorene (2-AF) of 20 μ g/wares.It is 0.1ml that every ware adds the volume of positive control.
1.5.2 PCEMNR micronucleus test: adopt 50 of Kunming mouses, body weight 25-30g, male and female half and half, 2500mg/kg.BW, 5000mg/kg.BW, tri-dosage groups of 10000mg/ ㎏ .BW are established in test, separately establish solvent (distilled water) matched group and cyclophosphamide positive controls (CP, 40mg/kg.BW).Take 2.5g, 5.0g, 10.0g tested material respectively adding distil water to 20ml, separately take 0.04gCP adding distil water and mix to 20ml.Gavage volume is pressed 20ml/kg.BW, test adopts twice administration by gavage of 30h, two minor tick 24h, after giving tested material for the second time, the de-cervical vertebra of 6h is put to death animal, get breastbone marrow and carry out film-making by the regulation in " health food inspection and assessment technique specification " (version in 2003), fixing, after Giemsa dyeing, under oily mirror, in every mice 1000 polychromatic erythrocytes of counting (PCE), contain micronucleus cell number, calculate the permillage of micronucleus.Observe the ratio (PCE/NCE) of polychromatic erythrocyte and mature erythrocyte in 200 erythrocyte.
1.5.3 mouse sperm deformity test: adopt 25 of male mice in kunming, body weight 28-33g, mice is divided into 5 groups at random, every group of 5 animals, 2500mg/kg.BW, 5000mg/kg.BW, tri-dosage groups of 10000mg/ ㎏ .BW are established in test, separately establish solvent (distilled water) matched group and cyclophosphamide positive controls (CP, 40mg/ ㎏ .BW).Get 10g, 20g, 40g tested material respectively adding distil water to 80ml, separately take 0.04g CP, adding distil water mixes to 20ml.Gavage volume is pressed 20ml/kg.BW per os every day gavage once, gavage 5 days continuously, in giving first after tested material the 35th day, de-cervical vertebra execution animal is got bilateral epididymis and carries out film-making, by the regulation in " health food inspection and assessment technique specification " (version in 2003), methanol is fixed, after 1% Yihong dyeing, under high power lens, 1000 complete sperms of every animal counting, record sperm deformity, lopsided type and calculate rate of teratosperm.
1.6 30 days feeding trials: select 80 of ablactation SD rats, male and female half and half, body weight is 64-78g, 2.08ml/ ㎏ .BW, 4.17ml/ ㎏ .BW, tri-dosage groups of 8.33ml/ ㎏ .BW (be equivalent to respectively human body recommended intake 25,50,100 times) are established in test, separately establish distilled water matched group, every group of 20 rats, male and female half and half.Test adopts administration by gavage, first prepares tested material solution, takes respectively 52.1ml, 104.2ml, 208.3ml tested material, and each adding distil water is settled to 250ml and mixes for subsequent usely, is finished and joins.Give tested material by per os gavage of 10ml/Kg.BW every day, continuous 30 days. and the single cage of every rat every day is fed.Observe the general performance of animal every day, calculate weekly food-intake twice, and claim body weight one time, according to food intake dose, calculate food utilization, when off-test, fasting 16h, weigh and put to death animal after femoral artery blood-letting, blood sampling is measured hematological indices with XT-2000i type Automatic Blood Cell Analyzer, the test kit that the CX4 type automatic clinical chemistry analyzer of producing with Beckman Coulter Inc. of the U.S. and Guangzhou Biao Jia Science and Technology Ltd. provide, measure blood biochemistry index, dissect animal and observe internal organs change, claim liver, kidney, spleen, testis weight, calculate its dirty body ratio, get liver, kidney, spleen, gastrointestinal, testis (ovary) is made histopathological examination.Duration of test animal ad lib, drinking-water.
1.7 test data statistics: PCEMNR micronucleus test adopts X 2 test, mouse sperm deformity test adopts
Rank test, 30 days feeding trial data are through homogeneity test of variance, and variance is neat, carries out variance analysis, compares between two by Dunnett method as P value is less than 0.05; If heterogeneity of variance, carries out data transaction, still uneven, use rank test instead, as
P value is less than 0.05, uses Dunnett ' s T3 method to compare between two, and above-mentioned statistics is all used SPSS 11.0 for Windows
Software processes.
2, result
2.1 acute toxicity tests: general performance and behavior to large and small Mus after tested material are showed no extremely, have no animal dead (table 8) in the observation period, when off-test, put to death animal gross anatomy naked eyes no abnormality seen.Radix Ginseng oral liquid of acanthopanax bark of the present invention is all greater than 15000mg/ ㎏ .BW to large and small Mus acute oral MTD value, belongs to nontoxic level by acute toxicity classification.
2.2. genetic toxicity test
2.2.1 Salmonella reversion test: by no matter adding and do not adding S as seen in table 9, table 10
9under condition, the average change clump count that returns of the each dosage group of tested material does not all exceed two times of solvent control groups, and the average change clump count that returns of positive controls all exceedes solvent control group more than two times, present obvious positive reaction, the above results show this tested material do not induce four kinds of bacterial strains return become clump count increase.
2.2.2 PCEMNR micronucleus test: the results are shown in Table 11, the micronucleus permillage of three dosage groups of tested material and negative control group comparison, through X 2 test, the micronuclear rates of male and female Mus there are no significant difference (P>0.05), cyclophosphamide positive controls highly significant higher than negative control group (P<0.01).Result has no tested material and brings out PCEMNR micronuclear rates and increase.
2.2.3 mouse sperm deformity test: the results are shown in Table 12, three dosage group rate of teratosperms of tested material and negative control group comparison, through rank test there was no significant difference (P> 0.05), cyclophosphamide positive controls highly significant higher than negative control group (P<0.01).Sperm deformity type main manifestations is taking unsetting, Wugou as main.The above results shows that tested material do not bring out mouse sperm deformity rate and increase.
2.3 rat 30 days feeding trials
Duration of test animal health condition is good, body weight sustainable growth, and every group of rat gives all not occur poisoning symptom after the tested material of various dose, also have no animal dead every day.
2.3.1 the impact on rat body weight
From table 13, the body weight of the initial body weight of three dosage group male and female rats, 1-4 week body weight and the 30th day is compared with matched group, learns by statistics processing, there was no significant difference (P>0.05).
2.3.2 on the rat impact of food-intake weekly
From table 14, the food-intake weekly of three dosage group male and female rats is compared with matched group, learns and processes by statistics, difference that there are no significant (P>0.05).
2.3.3 the impact on rat food utilization
The food utilization weekly and the total foodstuff utilization rate that the results are shown in Table 15, three dosage group male and female rats are compared with matched group, learn and process by statistics, there was no significant difference (P>0.05).
2.3.4 the impact of rat blood being learned
From table 16, the hematological indices testing result of three dosage group male and female rats is compared with matched group, learn and process by statistics, except male low dose group basophil significantly raises (P < 0.01), all the other each dosage groups there are no significant difference (P>0.05).Above institute measured value is in this chamber range of normal value.
2.3.5 the impact on rat blood in latter stage biochemistry
From table 17, the Biochemistry test result in latter stage of three dosage group male and female rats is compared with matched group, learns and processes by statistics, dosage group indices there are no significant difference (P>0.05).
2.3.6 the impact on the dirty body ratio of rat
The testis body ratio that the results are shown in Table liver body ratio, spleen body ratio, kidney body ratio and the male Mus of 18, three dosage group male and female rats is compared with matched group, learns and processes by statistics, difference that there are no significant (P>0.05).
2.3.7 pathological examination
After off-test, put to death animal, carry out gross anatomy, naked eyes no abnormality seen changes.Histopathological examination result shows: matched group has the focal mild inflammation cellular infiltration of 1 routine nephridial tissue interstitial, has the focal renal tubules mineral of 1 routine nephridial tissue calmness; Cellular infiltration, it is abnormal that all the other are showed no by inspection tissue.Tested material high dose group has the focal renal tubules mineral of 1 routine nephridial tissue calmness, has the above institute of the focal mild inflammation of 1 routine nephridial tissue interstitial to find to be the spontaneous pathological changes of animal, has no tested material high dose group and causes animal toxic injury change (in Table 19-25).
3 brief summaries
3.1 Radix Ginseng oral liquid of acanthopanax bark of the present invention are all greater than 15000mg/kg.BW to large and small Mus acute oral toxicity test result MTD value, by acute toxicity classification, belong to nontoxic level.
3.2 3 genetic toxicity tests (Salmonella reversion test, PCEMNR micronucleus test and mouse sperm deformity test) result has no Radix Ginseng oral liquid of acanthopanax bark mutagenic action of the present invention.
3.3 30 days feeding trials, visible animal growth is normal, body weight sustainable growth, and figure is active, and stool, urine no abnormality seen changes.Duration of test has no animal and occurs poisoning symptom and death.The body weight weekly of three dosage group male and female rats, food-intake, weekly food utilization and total foodstuff utilization rate, dirty body ratio are compared with matched group weekly, difference that there are no significant (P > 0.05); Hematology's conventional sense result, Biochemistry test result were compared with matched group and were significantly raise (P < 0.01) except male low dose group basophil latter stage, all the other each dosage groups there are no significant difference (P>0.05).Above institute measured value is all in this chamber range of normal value.Histopathological examination result, except the spontaneous pathological changes of animal, has no tested material high dose group and causes that animal toxic injury changes.
Claims (3)
1. a production technology for Radix Ginseng oral liquid of acanthopanax bark, is characterized in that: by weight, proportioning raw materials is 1 part of Radix Ginseng, 10 ~ 20 parts of Radix Et Caulis Acanthopanacis Senticosis, 15 ~ 40 parts of purified water;
Described Radix Ginseng oral liquid of acanthopanax bark is containing syringoside >=2.0mg/100ml, and pH value is 4.0 ~ 6.0, soluble solid >=1.0%;
Concrete steps are as follows:
A gets 1 part of 10 ~ 20 parts of Radix Et Caulis Acanthopanacis Senticosi, Radix Ginseng and adds water, and decoct and extract 2 times, each 2 hours, add water volume for the 1st time and be 14 times of medical material weight, add water volume for the 2nd time and be 12 times of medical material weight, filter, filtrate merges, and obtains filtrate A, and pH value is 4.0 ~ 6.0;
B is not more than in temperature under the condition of 70 DEG C, and the decompression volume of filtrate A is concentrated into 6 times of raw material weight, records relative density 1.01-1.02 at 50 DEG C, for subsequent use;
The envelope-bulk to weight ratio of above-mentioned A step and B step is L/kg;
C gets concentrated solution, leaves standstill, and cold preservation is spent the night, and filters, and obtains liquor B;
In D liquor B, add 15 ~ 40 parts of purified water to total amount, mix homogeneously, obtains mixed liquor;
The fill of E mixed liquor, obtains bottled oral liquid;
F is bottled oral liquid pressure sterilizing 15min at 120 ~ 125 DEG C, and quality inspection is qualified, and outer package to obtain final product.
2. the production technology of a kind of Radix Ginseng oral liquid of acanthopanax bark according to claim 1, it is characterized in that: the Packaging Bottle of using in described technique and bottle cap are for subsequent use after being up to the standards, cleaning, drying, touchstone is YBB 0003 " soda-lime glass control oral liquid bottle (trying) ".
3. the production technology of a kind of Radix Ginseng oral liquid of acanthopanax bark according to claim 1, is characterized in that: described technological operation environment is 100,000 grades of cleanings.
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| 朴奉花等.健脑灵口服液稳定性的研究.《中成药》.1996,第18卷(第2期),2-4. |
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