CN103040889A - 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 human health.
Radix Ginseng, sweet in the mouth, little 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 ... the tonifying five ZANG-organs six internal organs, keep god among the guarantor." " 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 the purgation of spleen excess lung stomach, kind controlling losed heart." good strongly invigorating primordial QI is arranged, multiple arteries and veins takes off invigorating the spleen to benefit the lung, promoting the production of body fluid to quench thirst effect admittedly.
Radix Et Caulis Acanthopanacis Senticosi, acrid in the mouth, little hardship, temperature.Return spleen, kidney, heart channel." Chinese medicine voluminous dictionary " sums up: " have than better ' adaptogen ' sample effect of Radix Ginseng, enhancing body resistance aspect act on quite extensively Radix Et Caulis Acanthopanacis Senticosi, and the energy enhanced machine can be regulated pathological process to the resistivity of destructive stimulus factor, makes it to be tending towards normalization." " national Chinese patent medicine product collection " title: its " strengthening the body resistance, kidney and spleen invigorating, intelligence promoting and the mind tranquilizing.Be applicable to the 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 the 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 prescription of present anti-fatigue health-product containing and medicine.
Such 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 prescription 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: add 8 times of water in the raw material, 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 is filtered, and adds water, white sugar in the filtrate, heated and boiled, filter, add sodium benzoate in the filtrate, add deionized water to required volume, mix bottling.
There is following shortcoming in the Antifatigue oral liquid of this patent:
1, adopt the method for precipitate with ethanol to remove impurity in the production technology, and the material that plays obvious antifatigue effect in the Radix Ginseng is the ginseng polysaccharide, take the ginseng pectin as 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 come precipitate with ethanol, can cause the ginseng polysaccharide to lose in a large number, can't guarantee the resisting fatigue effect of this product.
2, add sodium benzoate in the oral liquid as antiseptic, although sodium benzoate is chemical preservative commonly used, but because chemical composition of Chinese materia medica is complicated, can not avoid to occur in the Chinese medicine material with this product generation chemical constituent, so avoid using this product can better guarantee 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, prescription 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 the alleviating physical fatigue, adopt the health-care method of QI invigorating righting, the 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.
Contain syringoside 〉=2.0mg/100ml in the described Radix Ginseng oral liquid of acanthopanax bark, pH value is 4.0 ~ 6.0, soluble solid 〉=1.0%.
The present invention selects syringoside as the content's index composition, is because syringoside is one of effective ingredient of resisting fatigue in the Radix Et Caulis Acanthopanacis Senticosi, 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 the pH value scope, is that it is stable that simultaneously main effective ingredient syringoside content keeps because product in this PH scope, does not significantly precipitate appearance.
The present invention limits soluble solid 〉=1.0%, is because product is the oral liquid of Chinese medicine extraction, selects soluble solid can weigh the total amount of the effective ingredient that extracts more than 1.0% from Chinese medicine.
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 gets 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 the Radix Et Caulis Acanthopanacis Senticosi can as much as possiblely extract.
B is not more than in temperature under 70 ℃ the condition, and the decompression volume of filtrate A is concentrated into 6 times of raw material weight, relative density 1.01-1.02(50 ℃ 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 ℃) 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 gets liquor B.
Add 15 ~ 40 parts of purified water in the D liquor B to total amount, mix homogeneously gets mixed liquor.
The fill of E mixed liquor gets bottled oral liquid.
F is at 120 ~ 125 ℃ of lower bottled oral liquid pressure sterilizing 15min, and quality inspection is qualified, outer package, and get final product.
The sterilising temp here and time are the characteristics for product of the present invention, have preferably heat stability, consider that the present invention does not add any antiseptic, therefore adopt the highest sterilizing methods of safety, can well guarantee the safety of taking of product.
The Packaging Bottle of using in the 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 the environment of 100,000 grades of cleanings.
Beneficial effect of the present invention shows:
1, the present invention chooses the people and participates in the charge ratio that Radix Et Caulis Acanthopanacis Senticosi is 1:15, according to the relevant regulations of " being the bulletin of new resource food about approval Radix Ginseng (artificial growth) " (Ministry of Public Health bulletin 2012 No. 17) for Radix Ginseng day taking dose, Radix Ginseng day taking dose be≤3 the gram/day, consider taking of reality and might occur more than a day inferior situation about taking in the process, in order better to guarantee the safety of taking of this product, determined that then the Radix Ginseng dosage in this product is the 1g/ bottle.Under the prerequisite of the taking dose of having determined Radix Ginseng, according to the regulation of the Pharmacopoeia of the People's Republic of China (an one) 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, can not occur Radix Ginseng after human body is taken and take rear common " dry property ", human body without any discomfort, and resisting fatigue successful.
2, production technology of the present invention is in decoction process, take 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 guaranteed that the main composition in Radix Ginseng and the Radix Et Caulis Acanthopanacis Senticosi can as much as possiblely extract, thereby has guaranteed 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 guaranteed 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 the Radix Et Caulis Acanthopanacis Senticosi, the present invention analyses scientifically the extraction ratio of the syringoside in the Radix Et Caulis Acanthopanacis Senticosi medical material, draw syringoside content 〉=2.0mg/100ml, thereby guaranteed 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 in this PH scope, and significantly precipitation does not occur, and it is stable that simultaneously main effective ingredient syringoside content keeps; Limit soluble solid 〉=1.0%, be used for weighing the total amount of the effective ingredient that product extracts from Chinese medicine more than 1.0%.Quality stability and the drug effect of product have further been guaranteed.
6, whole technological process of the present invention takes sterile working, high temperature sterilize and suitable packaging material to guarantee the microbial safety of product, in stability study, adopt the microbial limit index to detect, underproof phenomenon do not occur in the stability study process of product.Therefore, product is stable, need not to add antiseptic, and food safety is reliable.
The specific embodiment
Below in conjunction with the specific embodiment 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 are 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 are 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 are 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 are 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 gets filtrate A, and pH value is 6.0.
B at room temperature, the decompression volume of filtrate A is concentrated into 6 times of raw material weight, relative density 1.01(50 ℃ 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 gets liquor B.
Add 26 parts of purified water in the D liquor B to total amount, mix homogeneously gets mixed liquor.
The fill of E mixed liquor, the 100ml/ bottle gets bottled oral liquid.
F is at 120 ℃ of lower bottled oral liquid pressure sterilizing 15min, and quality inspection is qualified, outer package, and get 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 gets filtrate A, and pH value is 4.0.
B is under 70 ℃, and the decompression volume of filtrate A is concentrated into 6 times of raw material weight, relative density 1.02(50 ℃ 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 gets liquor B.
Add 15 parts of purified water in the D liquor B to total amount, mix homogeneously gets mixed liquor.
The fill of E mixed liquor, the 100ml/ bottle gets bottled oral liquid.
F is at 125 ℃ of lower bottled oral liquid pressure sterilizing 15min, and quality inspection is qualified, outer package, and get final product.
The Packaging Bottle of using in the 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 gets filtrate A, and pH value is 5.5.
B is under 50 ℃, and the decompression volume of filtrate A is concentrated into 6 times of raw material weight, relative density 1.015(50 ℃ 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 gets liquor B.
Add 40 parts of purified water in the D liquor B to total amount, mix homogeneously gets mixed liquor.
The fill of E mixed liquor gets bottled oral liquid.
F is at 122 ℃ of lower bottled oral liquid pressure sterilizing 15min, and quality inspection is qualified, outer package, and get final product.
The Packaging Bottle of using in the 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) ".
The craft sanitary requirement
(1) logistics separates with artificial abortion
1, logistics program
Raw material → lixiviate → concentrated → mixing → fill → sterilization → packing → finished product (unidirectional following current is 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
(pass-through box) → clean area is deposited between clean area material → visual examination → exterior clean → (sloughing outer package) → slotting extension material nameplate → buffering
3, the clean program of people
General district: personnel → entrance hall → more footwear () → change one's clothes (one) → generally distinguishes the post
Clean area: footwear () → change one's clothes (the one) → buffering of personnel → entrance hall → more washes one's hands → footwear (two) → purified water (two) → hands sterilization (band glove) → clean area post of washing one's hands → change one's clothes more
(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 the cleaning 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 thoroughly must not enter the one's respective area before the cleaning.
(2) the cleanliness factor requirement is 100,000 grades in the zone, utilize the laminar-flow type integral air conditioner to purify, temperature is controlled at 18-26 ℃, 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 in 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) have dissolving in the zone and wait the post setting cleaner unit.
3, Quality Mgmt Dept will specify the 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 adopts the microbial limit index to detect in stability study by adopting sterile working, high temperature sterilize and suitable packaging material to guarantee the microbial safety of product, finds that underproof phenomenon does not appear in product in the stability study process.Prove that thus this product is stable, need not to add 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 sample: the 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 animal: 160 of the male mice in kunming that is provided by the Sichuan Provincial Academy of Traditional Chinese Medicine Experimental Animal Center, body weight 18-22g, production licence number is the SCXK(river) the 2008-19.SPF level, experimental animal room is barrier system, occupancy permit number is SYXK (river) 2011-043, temperature 20-25 ℃, relative humidity 40-70%.
1.3 dosage is selected and preparation: 3.33ml/kg.BW, 6.67ml/kg.BW, three 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 the 250ml mixing, refrigerator-freezer is preserved, be finished and join, other establishes the distilled water matched group.Test is divided into one, two, three, four group, every group of 40 animals.
1.4 key instrument 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, lactic acid standard solution that the CX4 automatic clinical chemistry analyzer that the UV1100 spectrophotometer that Shanghai Techcomp Instrument Ltd. produces, U.S. Beckman Coulter Inc. produce, Shandong Province academy sciences Biology Research Institute produce.
1.5 test method
1.5.1 with distillation water as solvent preparation tested material, press 20ml/kg.BW per os gavage mice before the test, give every day once, give continuously 30 days.
1.5.2 Loaned swimming test: after the animal last that will test one group of each dosage group gives tested material 30min, with the load microfuse of 5% body weight of Mus root of the tail section, again mice is put into 25 ± 1.0 ℃ of water temperatures, the swimming trunk went swimming of depth of water 30cm, the record mice begins to Post-dead duration from swimming, calculates the swimming time of mice.
1.5.3 serum urea is measured: after the animal last that will test two groups of each dosage groups gives tested material 30min, mice is put into not swimming with a load attached to the body of the water 90min of 30 ℃ of temperature, after the rest 60min, pull out eyeball and adopt whole blood 0.5ml, get serum by test kit description operation, the kit measurement serum urea content that provides with CX4 automatic clinical chemistry analyzer and U.S. Beckman Coulter Inc..
1.5.4 hepatic glycogen is measured: after the animal last that will test three groups of each dosage groups gives tested material 30min, the execution animal is got liver and blots with filter paper after the normal saline rinsing, take by weighing about 100mg liver, measure the content of hepatic glycogen by the anthrone method in " health food check and assessment technique standard " (version in 2003).
1.5.5 blood Plasma lactate: after the animal last that will test four groups of each dosage groups gave tested material 30min, not bearing a heavy burden stopped behind the water went swimming 10min of 30 ℃ of temperature.The Plasma lactate method: the rest 20min 20 μ l that respectively take a blood sample after 0min and the swimming before swimming, after the swimming, add respectively 50 μ l hemolytic agents and vibrate behind the mixing, use again SBA-40C type bio-sensing analysis-e/or determining.Measurement result multiply by extension rate 3.5 and is Serum lactic acid content.
1.6 test data statistics: the test data statistics adopts SPSS 11.0 for windows software kits to process.Data are through the variance test of homogeneity, and variance is neat, carry out variance analysis,, then compare in twos with the Dunnett method less than 0.05 such as the P value; If heterogeneity of variance then carries out data transaction, and is still uneven, use rank test instead, less than 0.05, then use Dunnett ' s T3 method to compare in twos such as the P value.
2. result
2.1 the impact on Mouse Weight:
By table 1,2,3 as seen, 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) show that the initial body weight of each treated animal is balanced.Body weight and matched group were relatively learned by statistics and are processed when the mid-term of three dosage treated animals, body weight was with end, difference that there are no significant (P〉0.05).
2.2 the impact on the mice burden swimming time:
By as seen from Table 4, the swimming with a load attached to the body time of three dosage groups and matched group are relatively learned by statistics and are processed, 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 the Radix Ginseng oral liquid of acanthopanax bark on mouse movement after the impact of serum urea:
By as seen from Table 5, the serum urea behind three dosage group mouse movements and matched group are relatively learned by statistics and are processed, and the serum urea of three dosage groups reduces all significant difference (P＜0.01).
2.4 the Radix Ginseng oral liquid of acanthopanax bark is on the impact of Mouse Liver glycogen:
By as seen from Table 6, the hepatic glycogen content of three dosage group mices and matched group are relatively learned by statistics and are processed, and the hepatic glycogen content of three dosage groups raises all significant difference (P＜0.05).
2.5 the Radix Ginseng oral liquid of acanthopanax bark on mouse movement after the impact of blood lactate level:
By as seen from Table 7, the blood lactic acid area under curve of three dosage groups and matched group are relatively learned by statistics and are processed, the blood lactic acid area under curve of three dosage groups there are no significant difference (P〉0.05).
3. brief summary
After continuous 30 days per os gavages of Radix Ginseng oral liquid of acanthopanax bark of the present invention gave male mice, visible growth of animal was good, the body weight sustainable growth.Three dosage groups can obviously prolong the mice burden swimming time, and the Loaned swimming test result is positive; The serum urea of three dosage groups reduces significant difference, and the serum urea measurement result is positive; Three dosage groups hepatic glycogen content that can significantly raise, the hepatic glycogen measurement result is positive; There was no significant difference between three dosage group blood lactic acid area under curve and the matched group, measurement result is negative.By the regulation in " health food check and assessment technique standard " (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 sample: Radix Ginseng oral liquid of acanthopanax bark, content are brown liquid, human body recommended amounts every day 100ml/60kg.BW (20 times of concentrated solutions).Prepare tested material with the distillation water as solvent during test.
1.2 experimental animal: Kunming mouse and SD rat reach large bio tech ltd by Sichuan Provincial Academy of Traditional Chinese Medicine Experimental Animal Center, Chengdu and Chengdu Inst. of Biological Products's Experimental Animal Center provides, and production licence number is respectively the SCXK(river) 2008-19.SPF level, SCXK(river) 2008-24.SPF level and SCXK(river) the 2010-126.SPF level.The experimental animal room is barrier system, and occupancy permit number is the SYXK(river) 2011-043, temperature 20-25 ℃, relative humidity 40%-70%.
1.3 instrument 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 test: adopt respectively each 20 of Kunming mouse and SD rats, 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 the maximum tolerated dose method, and taking by weighing 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 the gavage does not limit drinking-water, observes poisoning symptom and the death condition of animal in the week, and the off-test rear execution animal of weighing does gross anatomy.
1.5 genetic toxicity test:
1.5.1 Salmonella reversion test: use self-control to induce male rat liver S through β-naphthoflavene and phenobarbital
9, make S by standard method
9As activation system, (20 μ g/ ware 2-aminofluorenes are used for TA with indirect mutagen after the mixed liquor
97,TA
98, TA
100, 50 μ g/ wares 1, the 8-dihydroxyanthraquinone is used for TA
102Bacterium) measures S
9Active.TA is adopted in test
97, TA
98, TA
100, TA
102Four kinds of bacterial strains, tested material are 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.At first prepare the tested material working solution: accurately take by weighing the 5.0g tested material, adding distil water to 100ml mixing is high workload concentration 50mg/ml, get this working solution 100 μ l adding plate during test and be the highest tested material final concentration (5000 μ g/ ware), namely get following concentration take maximum concentration as basic down the dilution with 5 times of distilled water.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 the 4-nitroquinoline of 0.5 μ g/ware-N-oxide; TA
100Hydrazoic acid,sodium salt (NaN with 1.5 μ g/wares
3); TA
102Ametycin (MMC) with 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.The volume that every ware adds positive control is 0.1ml.
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, three dosage groups of 10000mg/ ㎏ .BW are established in test, other establishes solvent (distilled water) matched group and cyclophosphamide positive controls (CP, 40mg/kg.BW).Take by weighing 2.5g, 5.0g, 10.0g tested material difference adding distil water to 20ml, other takes by weighing 0.04gCP adding distil water to 20ml mixing and gets final product.The gavage volume is pressed 20ml/kg.BW, twice administration by gavage of 30h adopted in test, two minor tick 24h, 6h takes off cervical vertebra execution animal after giving tested material for the second time, get the breastbone marrow and carry out film-making by the regulation in " health food check and assessment technique standard " (version in 2003), fixing, after the Giemsa dyeing, under oily mirror, contain the micronucleus cell number in every mice 1000 polychromatic erythrocytes of counting (PCE), 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, three dosage groups of 10000mg/ ㎏ .BW are established in test, other establishes solvent (distilled water) matched group and cyclophosphamide positive controls (CP, 40mg/ ㎏ .BW).Get 10g, 20g, 40g tested material difference adding distil water to 80ml, other takes by weighing 0.04g CP, and adding distil water to 20ml mixing gets final product.The gavage volume is pressed 20ml/kg.BW per os every day gavage once, gavage is 5 days continuously, after giving first tested material the 35th day, taking off cervical vertebra puts to death animal and gets the bilateral epididymis and carry out film-making, by the regulation in " health food check and assessment technique standard " (version in 2003), methanol is fixed, after the dyeing of 1% Yihong, 1000 complete sperms of every animal counting under high power lens, record sperm deformity, lopsided type and calculating 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, three dosage groups of 8.33ml/ ㎏ .BW (be equivalent to respectively human body recommended intake 25,50,100 times) are established in test, other establishes the distilled water matched group, every group of 20 rats, male and female half and half.Administration by gavage is adopted in test, at first prepares tested material solution, namely takes by weighing respectively 52.1ml, 104.2ml, 208.3ml tested material, and it is for subsequent use that each adding distil water is settled to the 250ml mixing, 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, during off-test, fasting 16h weighs and put to death animal after the femoral artery blood-letting, and blood sampling is measured hematological indices with XT-2000i type Automatic Blood Cell Analyzer, mark the test kit that good Science and Technology Ltd. provides with CX4 type automatic clinical chemistry analyzer and Guangzhou that U.S. Beckman Coulter Inc. produces, measure blood biochemistry index, dissect animal and observe the internal organs change, claim liver, kidney, spleen, testis is heavy, 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 the test data statistics: the PCEMNR micronucleus test adopts X 2 test, the mouse sperm deformity test is adopted
Rank test, 30 days feeding trial data are through the variance test of homogeneity, and variance is neat, carries out variance analysis, compares in twos with the Dunnett method less than 0.05 such as the P value; If heterogeneity of variance then carries out data transaction, and is still uneven, use rank test instead, as
The P value then uses Dunnett ' s T3 method to compare in twos less than 0.05, and above-mentioned statistics is all used SPSS 11.0 for Windows
Software processes.
2, result
2.1 acute toxicity test: general performance and behavior to large and small Mus after the tested material are showed no unusually, have no animal dead (table 8) in the observation period, during off-test, put to death animal gross anatomy naked eyes no abnormality seen.Radix Ginseng oral liquid of acanthopanax bark of the present invention all greater than 15000mg/ ㎏ .BW, belongs to nontoxic level by the acute toxicity classification to large and small Mus acute oral MTD value.
2.2. genetic toxicity test
2.2.1 Salmonella reversion test: by as seen no matter adding and do not adding S in table 9, the table 10
9Under the condition, average the returning of each dosage group of tested material becomes the bacterium colony number average above two times of solvent control groups, and the average change bacterium colony number average that returns of positive controls surpasses the solvent control group more than two times, present obvious positive reaction, the above results shows that this tested material does not induce four kinds of bacterial strains to return to become clump count to be increased.
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 are relatively, through X 2 test, the micronuclear rates of male and female Mus there are no significant difference (P〉0.05), cyclophosphamide positive controls then highly significant is higher than negative control group (P＜0.01).The result has no tested material and brings out the PCEMNR micronuclear rates and increase.
2.2.3 mouse sperm deformity test: the results are shown in Table 12, tested material three dosage groups rate of teratosperm and negative control group are relatively, through rank test there was no significant difference (P〉0.05), cyclophosphamide positive controls then highly significant is higher than negative control group (P＜0.01).Sperm deformity type main manifestations is take unsetting, Wugou as main.The above results shows that tested material do not bring out the mouse sperm deformity rate and increase.
2.3 30 days feeding trials of rat
The duration of test animal health condition is good, the body weight sustainable growth, and every group of rat gives poisoning symptom all not occur after the tested material of various dose every day, also has no animal dead.
2.3.1 the impact on rat body weight
By as seen 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 weekly impact of food-intake of rat
By as seen from Table 14, the weekly food-intake of three dosage group male and female rats is compared with matched group, and learn by statistics and process, difference that there are no significant (P〉0.05).
2.3.3 the impact on the rat food utilization
The weekly food utilization 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, and learn by statistics and process, there was no significant difference (P〉0.05).
2.3.4 the impact on rat blood
By as seen from Table 16, the hematological indices testing result of three dosage group male and female rats is compared with matched group, learn to 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
By as seen from Table 17, the Biochemistry test result in latter stage of three dosage group male and female rats compares with matched group, and learn by statistics and process, 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, and learn by statistics and process, difference that there are no significant (P〉0.05).
2.3.7 pathological examination
Put to death animal after the off-test, carry out gross anatomy, the naked eyes no abnormality seen changes.The histopathological examination result shows: matched group has the focal mild inflammation cellular infiltration of matter between 1 routine nephridial tissue, has the focal renal tubules mineral of 1 routine nephridial tissue calm; Cellular infiltration, it is unusual that all the other are showed no by the inspection tissue.The tested material high dose group has the focal renal tubules mineral of 1 routine nephridial tissue calm, has that the above institute of the focal mild inflammation of matter finds to be the spontaneous pathological changes of animal between 1 routine nephridial tissue, has no the tested material high dose group and causes animal toxic injury change (seeing Table 19-25).
3 brief summaries
3.1 Radix Ginseng oral liquid of acanthopanax bark of the present invention to large and small Mus acute oral toxicity test as a result the MTD value press the acute toxicity classification all greater than 15000mg/kg.BW, belong to nontoxic level.
3.2 three 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, the body weight sustainable growth, and the figure is active, and the stool, urine no abnormality seen changes.Duration of test has no animal and poisoning symptom and death occur.The weekly body weight of three dosage group male and female rats, weekly food-intake, food utilization and total foodstuff utilization rate, dirty body ratio are compared difference that there are no significant (P＞0.05) with matched group weekly; Hematology's conventional sense result, Biochemistry test result compared with matched group and 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.The histopathological examination result except the spontaneous pathological changes of animal, has no the tested material high dose group and causes that the animal toxic injury changes.
Claims (5)
1. Radix Ginseng oral liquid of acanthopanax bark, it 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.
2. a kind of Radix Ginseng oral liquid of acanthopanax bark according to claim 1, it is characterized in that: described Radix Ginseng oral liquid of acanthopanax bark contains syringoside 〉=2.0mg/100ml, and pH value is 4.0 ~ 6.0, soluble solid 〉=1.0%.
3. the production technology of a kind of Radix Ginseng oral liquid of acanthopanax bark according to claim 1, it is characterized in that: 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 gets filtrate A, and pH value is 4.0 ~ 6.0;
B is not more than in temperature under 70 ℃ the condition, and the decompression volume of filtrate A is concentrated into 6 times of raw material weight, records relative density 1.01-1.02 under 50 ℃, and is 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 gets liquor B;
Add 15 ~ 40 parts of purified water in the D liquor B to total amount, mix homogeneously gets mixed liquor;
The fill of E mixed liquor gets bottled oral liquid;
F is at 120 ~ 125 ℃ of lower bottled oral liquid pressure sterilizing 15min, and quality inspection is qualified, outer package, and get final product.
4. the production technology of a kind of Radix Ginseng oral liquid of acanthopanax bark according to claim 3, it is characterized in that: the Packaging Bottle of using in the 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) ".
5. according to claim 3 or the production technology of 4 described a kind of Radix Ginseng oral liquid of acanthopanax bark, it is characterized in that: described technological operation environment is 100,000 grades of cleanings.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2015101058A1 (en) * | 2013-12-31 | 2015-07-09 | 华中科技大学 | Infrared imaging detection and positioning method for underground building in plane surface environment |
| CN109985080A (en) * | 2017-12-29 | 2019-07-09 | 辽宁上药科技开发有限公司 | A kind of preparation method and application comprising ginseng and Sessileflower Acanthopanax Bark double-layer tablets |
-
2013
- 2013-01-25 CN CN201310028933.7A patent/CN103040889B/en active Active
Non-Patent Citations (1)
| Title |
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| 朴奉花等: "健脑灵口服液稳定性的研究", 《中成药》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2015101058A1 (en) * | 2013-12-31 | 2015-07-09 | 华中科技大学 | Infrared imaging detection and positioning method for underground building in plane surface environment |
| CN109985080A (en) * | 2017-12-29 | 2019-07-09 | 辽宁上药科技开发有限公司 | A kind of preparation method and application comprising ginseng and Sessileflower Acanthopanax Bark double-layer tablets |
| CN109985080B (en) * | 2017-12-29 | 2021-09-24 | 辽宁上药科技开发有限公司 | Preparation method and application of double-layer tablet containing ginseng and acanthopanax sessiliflorus |
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