CN103893540B - A kind of Chinese medicine composition controlling IGT and preparation method thereof - Google Patents
A kind of Chinese medicine composition controlling IGT and preparation method thereof Download PDFInfo
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Abstract
The present invention relates to a kind of Chinese medicine composition controlling IGT and preparation method thereof, the bulk drug of this Chinese medicine composition consists of: the root of kudzu vine 12 20 weight portion, the root bark of white mulberry 12 20 weight portion, faenum graecum 8 14 weight portion, the red sage root 8 14 weight portion, the fruit of Chinese wolfberry 8 14 weight portion, the Radix Astragali 16 28 weight portion, radix polygonati officinalis 8 14 weight portion.Preparation method is as follows: the root of kudzu vine, the root bark of white mulberry, faenum graecum, red sage root alcohol extraction procedure routinely extracts, and concentrates, obtains thick extractum A;The fruit of Chinese wolfberry, the Radix Astragali, radix polygonati officinalis water extracting method routinely extracts, and concentrates, obtains thick extractum A;Thick extractum A and thick medicinal extract B are mixed into thick medicinal extract C, dry, pulverize and sieve, add customary adjuvant, according to common process, make oral solid formulation.Chinese medicine composition of the present invention has the function of control IGT symptom, is mainly used in treating the diseases such as the diabetes being caused by IGT.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition and preparation method thereof, particularly to a kind of Chinese medicine controlling IGT
Composition and preparation method thereof.
Background technology
IGT belongs to a reversible stage, is the compensatory stage of human body carbohydrate metabolism disturbance, is by IGT
I.e. diabetes are in early days to the transition stage of diabetes.IGT is not meant to suffer from diabetes, but represents the pancreas of patient
Island function has occurred abnormal, is easier to occur diabetes than normal person, also has increase cardiovascular disease and micro-blood simultaneously
The sick danger of pipe, this type of patient should cause highly vigilant of.If regulating and controlling proper, it is possible to enjoy health;Otherwise, it is possible to send out
Exhibition is diabetes.Therefore, the therapeutic intervention of IGT is the key of prevention diabetes B.
When human body sugar tolerance slightly lowers, most people may there is no obvious sense of discomfort, so many people think little of, also
Do not take any treatment means.Expert points out, although Subjects with Impair Glucose Tolerant can't be buckled the cap of diabetes, but often anticipates
Taste islet function and has been occurred abnormal, and they occur the danger of diabetes to exceed 100 times than normal person, are referred to as glycosuria
Sick reserves.This part reserves finally will appear from three kinds of results: a kind of ranks being to become a full member of diabetes patient;Another kind of
It is to maintain standing state constant;One is also had to be to move conditioning recovery normally by active treatment or diet.And result of study table
Bright, if Subjects with Impair Glucose Tolerant not Results, the patient of nearly 67% can be changed into diabetes.
Diabetes are absolute with insulin secretion or relative deficiency, and carbohydrate metabolism disturbance is the endocrine metabolism of main performance
Disease, is common disease, the frequently-occurring disease currently endangering human health, it has also become the dead killer of the 5th of the mankind.Its characteristic shows
For hyperglycaemia and glucose in urine, also include the disorder of fat, protein, electrolyte etc. simultaneously, often result in severe complication.Diabetes are sick
People's blood sugar excessive concentration, causes glucose in urine, and glycosuria increases has taken away moisture, and clinical manifestation is diuresis, thus thirsty many drinks;Eat
Nutriment can not utilize and store in vivo, for the heat energy required for maintenance metabolism, can only decompose and consume body fat
And albumen, therefore behave as Body weight loss, fatigue and weak and easy hungry many foods.The course of disease length of diabetes, easily cardiovascular, the brain blood of generation
Pipe, kidney, eye ground and neural chronic disease, even blind and disable, have a strong impact on the health of patient and work,
Viability.In addition diabetes patient is also easy to cutization pyogenic infection, urinary infection, pulmonary tuberculosis, fungal infection etc..
Several cases can also occur the acute complicationses such as DKA, hyperosmolar coma, lactic acidosis and life-threatening.Sugar
What urine was sick occurs development to be a process slowly hidden, and there are some researches show and is increased to clinical symptoms occur from blood sugar, this
In average 7 years of stage, in fact slight blood sugar increases and includes that IFG (IFG) and IGT (IGT) are quiet
Damage islet function quietly, and start generation and the development of vascular complication.Therefore early detection blood sugar increases, and in time
Carry out prophylactic treatment, become the continuation development controlling diabetes from source.
At present, no matter developed country or developing country, the incidence of disease of diabetes increases year by year, and diabetes become
For the after tumour, cardiovascular and cerebrovascular disease the 3rd serious major chronic NCD.Diabetes are referred to as " disappearing in the traditional Chinese medical science
Yearningly ", to quench one's thirst be with many drinks, many food, diuresis, become thin, urinate the pleasantly sweet a kind of disease being characterized.The traditional Chinese medical science thinks that its cause of disease is mainly
Eating and drinking without temperance, disorder of emotion, labor are intended to be impairment of the kidney;Its interpretation of the cause, onset and process of an illness is, consumption of body fluid by heat scorching by lung, stomach, the dirty yin deficiency of kidney three, disappear bright water paddy
And cause.In Chinese traditional herbs treatment diabetes action temperature and persistently, side effect little, and the mechanism of action often for Mutiple Targets, manifold effect,
Multi-functional comprehensive function.By adjusting tonifying five zang organs, make essence, gas, blood, body fluid raw active, easily reach clearing heat and moistening lung, replenish qi to invigorate the spleen, raw
Quench the thirst in Tianjin, enriching yin and nourishing kidney, the work(of blood circulation promoting and enriching.Additionally, combine the prescription such as modern medical theory and food security, utilize modern section
Learn technique, fully ensure that active ingredient is absorbed by the body, to reach to prevent the generation of IGT, hyperglycaemia and diabetes,
Effectively help early diabetes patient and impaired glucose tolerance person to reduce blood sugar, improve the health care of various subjective symptoms.
Content of the invention
Present invention aim at providing a kind of Chinese medicine composition controlling IGT and preparation method thereof.
The present invention seeks to be achieved through the following technical solutions.
The bulk drug of Chinese medicine composition of the present invention consists of:
Root of kudzu vine 12-20 weight portion, root bark of white mulberry 12-20 weight portion, faenum graecum 8-14 weight portion, red sage root 8-14 weight portion, Chinese holly
Matrimony vine 8-14 weight portion, Radix Astragali 16-28 weight portion, radix polygonati officinalis 8-14 weight portion.
The bulk drug composition of Chinese medicine composition of the present invention is preferably:
Root of kudzu vine 15-17 weight portion, root bark of white mulberry 15-17 weight portion, faenum graecum 10-12 weight portion, red sage root 10-12 weight portion,
Fruit of Chinese wolfberry 10-12 weight portion, Radix Astragali 21-23 weight portion, radix polygonati officinalis 10-12 weight portion.
The bulk drug composition of Chinese medicine composition of the present invention is preferably:
The root of kudzu vine 16 weight portion, the root bark of white mulberry 16 weight portion, faenum graecum 11 weight portion, the red sage root 11 weight portion, the fruit of Chinese wolfberry 11 weight
Part, the Radix Astragali 22 weight portion, radix polygonati officinalis 11 weight portion.
The bulk drug composition of Chinese medicine composition of the present invention is preferably:
The root of kudzu vine 14 weight portion, the root bark of white mulberry 18 weight portion, faenum graecum 9 weight portion, the red sage root 13 weight portion, the fruit of Chinese wolfberry 9 weight portion,
The Radix Astragali 26 weight portion, radix polygonati officinalis 9 weight portion.
The bulk drug composition of Chinese medicine composition of the present invention is preferably:
The root of kudzu vine 19 weight portion, the root bark of white mulberry 13 weight portion, faenum graecum 13 weight portion, the red sage root 9 weight portion, the fruit of Chinese wolfberry 13 weight
Part, the Radix Astragali 20 weight portion, radix polygonati officinalis 13 weight portion.
In Chinese medicine composition of the present invention, the root of kudzu vine, the root bark of white mulberry, faenum graecum, the red sage root are presented in respective alcohol extracting thing;
The fruit of Chinese wolfberry, the Radix Astragali, radix polygonati officinalis are presented in respective water extract.
The bulk drug of the present invention is Chinese medicinal material, is commercially available.
Take traditional Chinese medicinal composition raw materials of the present invention, add customary adjuvant, according to common process, make oral solid formulation bag
Include but be not limited to capsule, tablet, granule, electuary, chewable tablets etc.;Preferably hard capsule.
The preparation method of Chinese medicine composition of the present invention is as follows: the root of kudzu vine, the root bark of white mulberry, faenum graecum, red sage root alcohol extract routinely
Method is extracted, and concentrates, obtains thick extractum A;The fruit of Chinese wolfberry, the Radix Astragali, radix polygonati officinalis water extracting method routinely extracts, and concentrates, obtains thick medicinal extract B;
Thick extractum A and thick medicinal extract B are mixed into thick medicinal extract C, dry, pulverize and sieve, add customary adjuvant, according to common process, make
Oral solid formulation.
Described alcohol extraction procedure is: the root of kudzu vine, the root bark of white mulberry, fenugreek, the red sage root, puts back in stream extractor, adds 40-80% second
Alcohol extracting, decocts 1-3 time, adds 6-10 times amount every time, decocts 1-2 hour, filters, and merges extract, standby.
Described water extracting method is: the fruit of Chinese wolfberry, the Radix Astragali, radix polygonati officinalis, puts back in stream extractor, and extracting in water decocts 1-3 time,
Add water 6-10 times amount every time, decocts 1-2 hour, filters, and merges extract, standby.
The condition of described concentration and degree be: temperature 70 C, pressure 0.08Mpa carry out reduced pressure concentration, are concentrated into 50 DEG C of heat
Survey the thick medicinal extract that relative density is 1.15~1.25.
The condition of described drying is: employing boulton process, drying parameter: temperature is 70 DEG C, and vacuum is 0.08Mpa,
Time is 50~60 hours.
Described selection 80 mesh sieve that pulverize and sieve.
The preparation method of Chinese medicine composition hard capsule of the present invention (present invention is named grinds together the beautiful astragalus capsules of the board root of kudzu vine) is:
The root of kudzu vine, the root bark of white mulberry, fenugreek, the red sage root, add 80% alcohol extract, decocts 2 times, adds 6 times amount every time and decocts 1h, filter
Cross, merge extract, standby;The fruit of Chinese wolfberry, the Radix Astragali, radix polygonati officinalis, extracting in water, decoct 2 times, 10 times amount that add water every time decoct 1.5h,
Filter, merge extract, standby;Take alcohol extracting filtrate and put in vacuum concentration pot, reclaim ethanol, and it is relatively close to be concentrated into 50 DEG C of heat surveys
Degree is 1.15-1.25, obtains thick extractum A, vacuum concentration process parameter: vacuum is 0.08Mpa, temperature: 70 DEG C;Water intaking proposes filter
Liquid is put in vacuum concentration pot, and be concentrated into 50 DEG C heat survey relative densities be 1.15-1.25, obtain thick medicinal extract B, vacuum concentration process
Parameter: vacuum is 0.08Mpa, temperature: 70 DEG C;Thick extractum A and thick medicinal extract B are mixed into thick medicinal extract C, are dried with vacuum decompression
Case is heated to 70 DEG C of dryings, obtains dry extract C, vacuum decompression Drying Technology Parameter: vacuum is 0.08Mpa, temperature: 70 DEG C;Dry
Medicinal extract C is ground into 80 mesh powder, obtains dry extract C;Dry extract C and starch are mixed 30 minutes, crosses 80 mesh sieves and obtain mixed powder D;
By mixed powder D, with 90% ethanol solution as wetting agent, with wet granulation, add magnesium stearate, mixing, fill capsule and get final product.
Chinese medicine composition of the present invention has the function of control IGT symptom, is mainly used in treatment by IGT
The diseases such as the diabetes causing, have a wide applicable crowd, and take, carry, storage etc. more convenient, it is easier to by extensively
Administration.The present invention gropes through scientific composition, repeatedly experiment, in conjunction with Chinese patent drug prescription excellent of traditional treatment IGT
Point, has carried out bold innovation, and has improved its production technology to conventional formulation so that it is steady quality, evident in efficacy, safety are without pair
Effect.
Following experimental example and embodiment are used for further illustrating but are not limited to the present invention.
Experimental example the 1st, the root of kudzu vine, the root bark of white mulberry, fenugreek, tanshinol extraction process are investigated
The root of kudzu vine, the root bark of white mulberry, fenugreek, the red sage root are all conventional Chinese medicine, wherein the root of kudzu vine with Puerarin, soybean (soya bean) glucoside,
The flavones ingredients such as daidzein.The root bark of white mulberry is with umbelliferone, Scopoletin and flavone component.Fenugreek is with alkaloid, soap
Glucoside unit, flavones, aliphatic acid.The red sage root is with tanshinone, tanshinol, red sage root quinone and danshensu, red sage root aldehyde.Alcohol extracting is with Puerarin for mark
Will composition, uses Diluted Alcohol to extract and can obtain better effects.
Due to alcohol extracting, to have equipment simply universal, and with low cost, production site is less demanding, easily operates, and is suitable for industry
Change big production;Alcohol extracting method industrially typically uses heat reflow method simultaneously, can retain active ingredient, reach the mesh discarded the dross and selected the essential
's.Based on the root of kudzu vine in Ben Fang, the root bark of white mulberry, fenugreek, four kinds of medicinal material main components of the red sage root are all with liposoluble substance, therefore use dilute
Ethanol extracts as solvent, and tentative extraction time is 2 times.By selecting L9 (34) orthogonal arrage, design Three factors-levels
Orthogonal test, investigates Extraction solvent multiple (6 times, 8 times, 10 times), extraction time (1h, 1.5,2h) and concentration of alcohol (40%,
60%, 80%) the concrete technology parameter such as, makees inspection target with Puerarin total amount in medicinal material, screens optimal extraction process.
In the medicinal material ratio in formula, weigh net medicinal material and test, measure the content of extract Puerarin, calculate medicinal material
Paste-forming rate, is finally converted into Puerarin total amount in medicinal material, and Puerarin assay method is shown in the Pharmacopoeia of the People's Republic of China (2010
Version) one, concrete test arrangement and the results are shown in Table the 1st, table the 2nd, table 3.
Table 1 Extraction technique investigates factor level table
Level | Quantity of solvent (again) | Alcohol concentration (%) | Extraction time (h) |
1 | 6 | 40 | 1 |
2 | 8 | 60 | 1.5 |
3 | 10 | 80 | 2 |
Table 2 extraction process orthogonal test arranges and experimental result
Table 3 analysis of variance table
According to table the 1st, the 2nd, 3, can be seen that A with intiutive analysis method1B3C1For optimum extraction process, i.e. solvent load is 6 times,
The alcohol solvent of 80%, extraction time is 1 hour.In addition, the present invention carries out variance analysis, analysis result to orthogonal experiments
It is shown in Table 3, it can be seen that: in three factors, only B factor (concentration of alcohol) has significant difference, i.e. concentration of alcohol is to affect this
In secondary medicinal material, Puerarin total amount is principal element, and this matches with intiutive analysis method conclusion.Therefore determine the root of kudzu vine, the root bark of white mulberry, Hu Lu
Bar, the optimum extraction process parameter of the red sage root be: each dosage 6 times amount, Extraction solvent 80% ethanol, and extraction time is little for every time 1
When.
Extraction time single factor test compares:
On the basis of process above research, carry out single factor test comparative test to the extract time and investigate extraction 1 time, 2 times
Impact with 3 paste-forming rates on extract and the content of Puerarin.Select technique 80% ethanol, 6 times amount, extract 1 hour, right
Extraction time is respectively 1 time, 2 times and 3 times and compares, and result is as follows, is shown in Table 4.
Table 4 extraction time contrasts
Extraction time | Paste-forming rate (%) | Puerarin content (mg/g) |
1 | 15.68 | 0.044 |
1 | 15.12 | 0.041 |
2 | 19.56 | 0.057 |
2 | 20.44 | 0.061 |
3 | 21.69 | 0.066 |
3 | 21.83 | 0.061 |
Analyzed from upper table 4, during the 1st, the 2nd, the extraction time of 3 times contrasts, wherein 2 paste-forming rates with 3 times and Puerarin
Content balance does not has significant difference.For in view of the various factors that can run in production, such as extraction efficiency is just, raw
Loss in product etc. factor, and in actual production, extraction efficiency, less than the consideration of the test data in laboratory, uses final work
Skill: i.e. with 6 times amount 80% alcohol extract 2 times, extracts 1 hour every time, preferable extraction effect.
Experimental example the 2nd, the fruit of Chinese wolfberry, the Radix Astragali, the research of radix polygonati officinalis extraction process by water
The fruit of Chinese wolfberry, the Radix Astragali, radix polygonati officinalis are all conventional Chinese medicine, based on polysaccharide composition, use water to extract and can obtain preferably
Effect.Owing to water carries, to have equipment simply universal, and with low cost, production site is less demanding, easily operates, and is suitable for industrialization big
Produce;Water extracting method industrially typically uses heat reflow method simultaneously, can retain active ingredient, reach the purpose discarded the dross and selected the essential.
Based on the fruit of Chinese wolfberry in Ben Fang, the Radix Astragali, three kinds of medicinal material main components of radix polygonati officinalis are all with polysaccharide, adopt and use water as solvent and carry
Take.By selecting L9(34) orthogonal arrage, design Three factors-levels orthogonal test, investigation Extraction solvent multiple (8 times, 10 times, 12
Again), the concrete technology parameters such as extraction time (1h, 1.5,2h) and extraction time, make inspection target with Thick many candies in medicinal material, screening
Optimal extraction process.
In the medicinal material ratio in formula, weigh net medicinal material and test, measure the content of extract Thick many candies, calculate medicinal material
Paste-forming rate, is finally converted into Thick many candies total amount in medicinal material, and Thick many candies assay method is shown in " health food technology specification " (2003
Version) one, concrete test arrangement and the results are shown in Table the 5th, table the 6th, table 7.
Table 5 Extraction technique investigates factor level table
Level | Quantity of solvent (again) | Extraction time | Extraction time (h) |
1 | 8 | 1 | 1 |
2 | 10 | 2 | 1.5 |
3 | 12 | 3 | 2 |
Table 6 extraction process orthogonal test arranges and experimental result
Table 7 analysis of variance table
According to table the 5th, the 6th, 7, can be seen that A with intiutive analysis method2B2C2For optimum extraction process, i.e. solvent load is 10 times,
Extraction time 2 times, extraction time is 1.5 hours.In addition, the present invention carries out variance analysis, analysis result to orthogonal experiments
It is shown in Table 7, it can be seen that: in three factors, C factor (extraction time) has significant difference, i.e. extraction time is to affect this medicine
In material, Thick many candies is principal element, and this matches with intiutive analysis method conclusion.Therefore determine the fruit of Chinese wolfberry, the Radix Astragali, most preferably the carrying of radix polygonati officinalis
Taking technique parameter is: each amount of water 10 times amount, extracts 2 times, and extraction time is 1.5 hours every time.
The concentration of experimental example the 3rd, alcohol-extracted extract and the water extracted immersing paste, drying, disintegrating process are investigated
Through the research of laboratory lab scale, formulating technique and concentrating the degree of condition and concentration, temperature 70 C, pressure 0.08Mpa enter
Row reduced pressure concentration, is concentrated into the thick medicinal extract that relative density is 1.15~1.25 (50 DEG C of heat are surveyed);It is dried and use boulton process to enter
OK, drying parameter: temperature is 70 DEG C, and vacuum is 0.08Mpa, the time is 50~60 hours;Pulverize and sieve, select 80 mesh sieve mistakes
Sieve.This technique produces correcting action through enlarged experiment, determines scientific and reasonable technical data.
Table 8 water carries, alcohol-extracted extract powder and starch mixing after different time, different location sample sample appearance observed result
Table
By upper table, in figure 5 it can be seen that mixed uneven when 10 minutes, mixing in 20 minutes is uneven, mixed base when 30 minutes
This uniformly mixes homogeneous non-variegation, illustrate to mix after 40 minutes, therefore mixing medicinal substances extract dried cream powder and starch
The incorporation time closing powder is set to 30 minutes ratios conveniently.
Experimental example the 4th, preferred dosage form
This product is to be used as medicine with the mixing of Chinese medicine extract powder, is suitable for making hard shell capsules.Capsule preparations has stable in properties, raw
Production. art is simple, and the few feature of supplementary product consumption can be greatly saved production cost, compare than other liquid preparations, it is easier to be suffered from
Person accepts, and based on such as traditional liquid formulation is many with decoction, taking dose is relatively big, carries inconvenience, and taste is not easy to be connect by people
It is subject to, and makes hard shell capsules, the smell such as bitter taste, fishy smell of content can be covered, and profile is bright and clean attractive in appearance, edible and carry all
Easily;Another compared with tablet and pill, hard shell capsules is disintegrated comparatively fast in the gastrointestinal tract, effective fast good absorbing medicine biological utilisation
Degree height, and can moistureproof lucifuge, stable in properties, it is simple to preserve, extend release health care material.Therefore this product is preferentially selected
Hard capsule preparation is as the formulation of product.
Experimental example the 5th, processing technology routine design considerations
The root of kudzu vine, the root bark of white mulberry, fenugreek, the red sage root are all conventional Chinese medicine, wherein the root of kudzu vine with Puerarin, soybean (soya bean) glucoside,
The flavones ingredients such as daidzein.The root bark of white mulberry is with umbelliferone, Scopoletin and flavone component.Fenugreek is with alkaloid, soap
Glucoside unit, flavones, aliphatic acid.Said extracted liquid is used by the red sage root with tanshinone, tanshinol, red sage root quinone and danshensu, red sage root aldehyde
Reduced pressure concentration method concentrates.The fruit of Chinese wolfberry, the Radix Astragali, radix polygonati officinalis are all conventional Chinese medicine, based on polysaccharide composition, use water to extract desirable
Obtain better effects.It is destroyed because the concentration of reduced pressure concentration method can reduce active ingredient in product, increase the efficiency of concentration.
The selection gist of experimental example the 6th, capsule auxiliary material
Conventional auxiliary material has dextrin, starch and microcrystalline cellulose.Wherein microcrystalline cellulose price is of a relatively high, dextrin and shallow lake
Powder is relatively cheap, but the moisture resistance difference of dextrin;Because the content of this product is mainly Chinese medicinal material extract, Chinese medical extract is in storage
Easily affected by humiture during Tibetan, the moisture absorption, caking phenomenon are occurred, for avoiding extract to inhale in storage
Tide, deliquescing, caking phenomenon, need to add appropriate filler in preparation process, according to the feature of above several auxiliary materials, this
Bright selection starch is as capsule filler, because starch is white powder, and odorless, tasteless, it is conventional capsule excipient;It resists
Moist strong compared with dextrin, therefore add a certain amount of starch improving product resistance to water soak, and starch to have character highly stable, outward
The features such as sight color and luster is good, low cost, are relatively suitable for this product.
In addition, be the mobility strengthening powder when filling capsule, add appropriate magnesium stearate, to guarantee capsule loading amount
Accuracy.Magnesium stearate, for white easily without the fine powder of grittiness, is commonly used for glidant in food, medicine.
The formulation of experimental example the 7th, capsule specification
This product through lab scale craft study, the root of kudzu vine, the root bark of white mulberry, fenugreek, the red sage root extract after dried cream yield be about 14%
About~25%, the fruit of Chinese wolfberry, the Radix Astragali, radix polygonati officinalis extract after dried cream yield be about about 20%~40%, according to day amount, then
Plus meeting supplementary product starch and the magnesium stearate of preparation process requirement, determine that capsule loading amount is 0.5g/ grain, eat 3 every day, often
Secondary edible 4, take a number suitable, meet and take custom.
Experimental example the 8th, IGT functional evaluation experimental study
1. experiment purpose
By the research of rat IGT functional experiment, observe by test product to insulin resistant model rat index of correlation
Impact, evaluate by the improvement IGT function of test product.
2. experiment material
2.1 test medicine
Capsule of the present invention (grinds i.e. together the beautiful astragalus capsules of the board root of kudzu vine), is prepared from by embodiment 1.
2.2 reagent
Ai Ke blood sugar test paper, lot number, 20120324, Jinake Biotechnology Hangzhou Co., Ltd.
Blood sugar detection kit: lot number 20120627, Zhongsheng Beikong Biological Science & Technology Co., Ltd..
T-CHOL (CHO) mensuration kit: lot number 20120713, Zhongsheng Beikong Biological Science & Technology Co., Ltd..
Triglycerides (TG) mensuration kit: lot number 20120628, Zhongsheng Beikong Biological Science & Technology Co., Ltd..
LDL-C (LDL-C) measures kit: lot number 20120528, biotechnology share is controlled in middle raw north
Co., Ltd.
Insulin (INS) ria-determination kit: lot number 20120520, Zhongsheng Beikong Biological Science & Technology Co., Ltd..
Blood sugar (Glu) mensuration kit: lot number 20120625, Zhongsheng Beikong Biological Science & Technology Co., Ltd..
2.3 animals used as test and raising situation
(1) animal used as test
Wistar rat, SPF level, male, body weight 180g-220g, it is purchased from Laboratory Animal Science portion of Department Of Medicine, Peking University.
Licensing is numbered: SCXK (capital) 2006-0008.
(2) feed
Common mouse full-valence pellet feed II, pulls together feed corporation,Ltd purchased from Beijing Australia of section.Credit number: SCXK (capital)
2009-0012.
(3) rearing conditions
Experimental animal feeding in SPF level animal housing, fluorescent lamp lighting, in the 12h light and shade cycle, freely drink water, diet, temperature
22 DEG C ± 2 DEG C, blow 6 times-10 times/h.
2.4 laboratory apparatus
Xh6080 is put and is exempted from instrument: Xi'an He Yi factory.
Haier BCD-257SL refrigerating refrigerator: Qingdao HaiEr Co., Ltd.
Sartorious BT 124S precise electronic balance: Sai Duolisi scientific instrument (Beijing) Co., Ltd.
The sub-WB388 electronic timer in Europe: the sub-trade (Shanghai) Co., Ltd. in Europe.
3. experimental technique
3.1 are arranged by test product dosage
Crowd's consumption is recommended to carry out dosage setting according to specification.Specification regulation crowd's dose is 3g/ people/day.This
Experiment sets 6 times of rat bioequivalence dosage behaviour clinical application amount, people's SBW is drafted as 60kg, therefore rat
Dose,equivalent is 3g ÷ 60kg × 6=0.3g/kg.Rat sets two dosage groups, respectively 0.3g/kg and 0.6g/kg.
3.3 functional experiment packets
After animal used as test adaptability is raised 2 days, rat is randomly divided into 4 groups by body weight, often organizes 12.It is respectively as follows: blank group,
Model group, high dose group, low dose group.
3.4 by test product administration way
High dose group and low dose group give by test product 0.3g/kg and 0.6g/kg.Blank group and model group give equal-volume
Solvent.Method of administration is per os pipe gastric infusion, and gastric infusion volume is 5ml/kg body weight rat.
3.5 experimental technique
In addition to blank group gives common complete feed, its excess-three group group all gives to synthesize high lipid food modeling.Continuous modeling 8
In week, modeling starts high dose group and low dose group gives corresponding dosage by test product.
Giving by after test product 8 weeks, Rat Fast can't help water 16h, and each group rat oral gavage gives glucose solution (2.0g/
Kg), tail point takes blood, and the 0th, blood sugar test paper measures the 30th, 120min time point blood glucose value, calculates under different time points blood glucose curve
Area.
After experiment terminates, after Rat Fast can't help water 16h, abdominal aorta is taken a blood sample, centrifugal serum of preparing, mensuration serum hollow
Abdomen blood sugar, insulin (INS), CHO, TG, LDL, LDL level, and calculate insulin sensitivity index (ISI) and insulin resistance refers to
Number (IRI).
4. statistical method
Experimental data is with " mean+SD" represent.Data first carry out homogeneity test of variance.Variance is neat
One-Way ANOVA method is selected to carry out comparing between each group;Heterogeneity of variance selects t ' inspection to compare between organizing.
5. experimental result
(1) the beautiful impact on Insulin Resistance of Rats model index of correlation for the astragalus capsules of the board root of kudzu vine is ground together
Table 9 is same grinds the beautiful impact on rat model glycometabolism index of correlation for the astragalus capsules of the board root of kudzu vine
Note: compare with blank group,△△△P<0.001;Compare with model group,*P < 0.05,**P<0.01。
Result of study shows, after feeding high lipid food, model group rats serum I NS level significantly raises, and ISI significantly drops
Low, IRI significantly raises, and compares with blank group, has significant difference (equal p < 0.001), show that insulin resistant model modeling becomes
Work(.Compare with model group, grind together the beautiful astragalus capsules high and low dose group of the board root of kudzu vine and can significantly reduce ISI and IRI of rat model, tool
Play the role of preferably to improve rat model insulin sensitivity and insulin resistance.
Table 10 is same grinds the beautiful impact on rat model blood lipids for the astragalus capsules of the board root of kudzu vine
Note: compare with blank group,△P < 0.05,△△P < 0.01,△△△P<0.001;Compare with model group,*P < 0.05,**P<
0.01,***P<0.001。
Result of study shows, after feeding high lipid food, model group rats change of serum C HO, LDL level significantly raise, with blank
Group compares, and has significant difference (equal p < 0.001), suggests the formation of obvious disorders of lipid metabolism.Grind together the beautiful stilbene glue of the board root of kudzu vine
Capsule high and low dose group can significantly reduce change of serum C HO of rat model, LDL and TG level, compares with model group, has conspicuousness difference
Different, have and preferably improve the disorderly effect of insulin resistant model lipid metabolism in rats.
(2) the beautiful impact on insulin resistant model sugar tolerance for the astragalus capsules of the board root of kudzu vine is ground together
Table 11 is same grinds the beautiful impact on rat model Area under the curve of blood glucose for the astragalus capsules of the board root of kudzu vine
Packet | N | To the 0th, the 0.5th, 2h blood sugar AUC (h.mmol/ml) after glucose |
Blank group | 12 | 13.59±0.64 |
Model group | 12 | 14.55±0.93△ |
High dose group | 12 | 14.86±1.10△△ |
Low dose group | 12 | 13.09±1.15** |
Note: compare with blank group,△P < 0.05,△△P<0.01;Compare with model group,**P<0.01。
Experimental studies results shows, after model group rats oral administration of glucose 2.0g/kg, the 0th, the 0.5th, under 2h blood glucose curve
Area significantly increases, and comparing with blank group has significant difference (p < 0.05).Can show with grinding the beautiful astragalus capsules 0.3g/kg of the board root of kudzu vine
Write and reduce rat model Area under the curve of blood glucose, compare with model group and have significant difference (p < 0.01).
6. experiment conclusion
(1), after high lipid food is fed, rat can form insulin resistant model, produces typical insulin resistance sugar tolerance
Abnormal and blood fat disorder changes.
(2) the same beautiful astragalus capsules of the board root of kudzu vine that grinds can improve insulin resistant model animal insulin opposing index of correlation and lipid
Metabolic disorder, and improve IGT.
Following embodiment all can realize effect described in above-mentioned experimental example.
Embodiment 1 hard capsule of the present invention
Raw material form: root of kudzu vine 16Kg, root bark of white mulberry 16Kg, faenum graecum 11Kg, red sage root 11Kg, fruit of Chinese wolfberry 11Kg, Radix Astragali 22Kg,
Radix polygonati officinalis 11Kg.
Preparation method:
(1) extract, filter, concentrate, be dried
1. the extraction of medicinal material
The root of kudzu vine, the root bark of white mulberry, fenugreek, salvia piece, put back in stream extractor, add 80% alcohol extract, decoct 2 times, often
Secondary 6 times amount that add decoct 1h, filter (filter material is 80 mesh nylon cloths), merge extract, standby.The fruit of Chinese wolfberry, the Radix Astragali, radix polygonati officinalis put back into stream
In extractor, extracting in water, decoct 2 times, 10 times amount that add water every time decoct 1.5h, filter (filter material is 80 mesh nylon cloths), merge
Extract, standby.
2. it is concentrated in vacuo
Take alcohol extracting filtrate and put in vacuum concentration pot, reclaim ethanol, and to be concentrated into relative density be 1.15-1.25 (50 DEG C of heat
Survey), obtain thick extractum A.
Water intaking carries filtrate and puts in vacuum concentration pot, and to be concentrated into relative density be 1.15-1.25 (50 DEG C of heat are surveyed), obtains thick
Medicinal extract B.
Thick extractum A and thick medicinal extract B are mixed into thick medicinal extract C.
Vacuum concentration process parameter: vacuum is 0.08Mpa, temperature: 70 DEG C.
3. it is dried
Taking above-mentioned mixing thick medicinal extract C, being heated to 70 DEG C of dryings with vacuum decompression drying box, obtain dry extract C, dry extract C uses
Universal mill is ground into 80 mesh powder, crosses 80 mesh sieves, obtains dry extract C.
Vacuum decompression Drying Technology Parameter: vacuum is 0.08Mpa, temperature: 70 DEG C
(2) hybrid technique of fine powder raw material
Dry extract C is placed in three-dimensional mixer with the starch crossing 80 mesh sieves and fully mixes, mix 30 minutes, cross 80 mesh
Sieve to obtain mixed powder D.
(3) pelletize
By mixed powder D, with 90% ethanol solution as wetting agent, use wet granulation.The dry particle of this product is gently twisted with the fingers through finger can be broken
And have harsh feeling to be advisable.
Grain made parameter: EAT 70 DEG C.
(4) total mix process
Take conforming particle, add magnesium stearate, put in three-dimensional mixer, mix 20 minutes.
(5) capsule is filled, is polished
Use automatic capsule filling machine to be filled in No. 0 capsule above-mentioned conforming particle by operating process, adjust loading amount extremely
Every weight 0.5g/ grain, polishes in machine for automatically polishing.
(6) packing, packaging, product inspection, warehouse-in
Use medicinal high-density polyethylene bottle to dispense, meet " national drug packing container (material) standard "
The quality requirement of YBB00122002.Often bottled 60, after packaging, it is qualified to check, warehouse-in.
Embodiment 2 Tablets
Root of kudzu vine 14Kg, root bark of white mulberry 18Kg, faenum graecum 9Kg, red sage root 13Kg, fruit of Chinese wolfberry 9Kg, Radix Astragali 26Kg, radix polygonati officinalis 9Kg.
Add customary adjuvant, according to common process, make tablet.
Embodiment 3 granule of the present invention
Root of kudzu vine 19Kg, root bark of white mulberry 13Kg, faenum graecum 13Kg, red sage root 9Kg, fruit of Chinese wolfberry 13Kg, Radix Astragali 20Kg, radix polygonati officinalis 13Kg.
Add customary adjuvant, according to common process, make granule.
Claims (10)
1. the Chinese medicine composition controlling IGT, it is characterised in that the bulk drug of said composition consists of:
Root of kudzu vine 12-20 weight portion, root bark of white mulberry 12-20 weight portion, faenum graecum 8-14 weight portion, red sage root 8-14 weight portion, the fruit of Chinese wolfberry
8-14 weight portion, Radix Astragali 16-28 weight portion, radix polygonati officinalis 8-14 weight portion.
2. Chinese medicine composition as claimed in claim 1, it is characterised in that the bulk drug of said composition consists of:
Root of kudzu vine 15-17 weight portion, root bark of white mulberry 15-17 weight portion, faenum graecum 10-12 weight portion, red sage root 10-12 weight portion, matrimony vine
Sub-10-12 weight portion, Radix Astragali 21-23 weight portion, radix polygonati officinalis 10-12 weight portion.
3. Chinese medicine composition as claimed in claim 1, it is characterised in that the bulk drug of said composition consists of:
The root of kudzu vine 16 weight portion, the root bark of white mulberry 16 weight portion, faenum graecum 11 weight portion, the red sage root 11 weight portion, the fruit of Chinese wolfberry 11 weight portion, Huang
Stilbene 22 weight portion, radix polygonati officinalis 11 weight portion;
Or the root of kudzu vine 14 weight portion, the root bark of white mulberry 18 weight portion, faenum graecum 9 weight portion, the red sage root 13 weight portion, the fruit of Chinese wolfberry 9 weight portion, Huang
Stilbene 26 weight portion, radix polygonati officinalis 9 weight portion;
Or the root of kudzu vine 19 weight portion, the root bark of white mulberry 13 weight portion, faenum graecum 13 weight portion, the red sage root 9 weight portion, the fruit of Chinese wolfberry 13 weight portion,
The Radix Astragali 20 weight portion, radix polygonati officinalis 13 weight portion.
4. any one Chinese medicine composition as described in claim 1-3, it is characterised in that the root of kudzu vine in said composition, the root bark of white mulberry,
Faenum graecum, the red sage root are presented in respective alcohol extracting thing;The fruit of Chinese wolfberry, the Radix Astragali, radix polygonati officinalis are with the shape of respective water extract
Formula exists.
5. any one Chinese medicine composition as described in claim 1-3, it is characterised in that take bulk drug, adds customary adjuvant,
According to common process, make oral solid formulation: capsule, tablet or granule.
6. Chinese medicine composition as claimed in claim 5, it is characterised in that described oral solid formulation is hard capsule.
7. the preparation method of oral solid formulation as claimed in claim 5, it is characterised in that the method is:
The root of kudzu vine, the root bark of white mulberry, faenum graecum, red sage root alcohol extraction procedure routinely extracts, and concentrates, obtains thick extractum A;The fruit of Chinese wolfberry, the Radix Astragali,
Radix polygonati officinalis water extracting method routinely extracts, and concentrates, obtains thick medicinal extract B;Thick extractum A and thick medicinal extract B are mixed into thick medicinal extract C, are dried,
Pulverize and sieve, add customary adjuvant, according to common process, make oral solid formulation.
8. preparation method as claimed in claim 7, it is characterised in that in the method:
Described alcohol extraction procedure is: the root of kudzu vine, the root bark of white mulberry, fenugreek, the red sage root, puts back in stream extractor, adds 40-80% ethanol and carry
Take, decoct 1-3 time, add 6-10 times amount every time, decoct 1-2 hour, filter, merge extract, standby;
Described water extracting method is: the fruit of Chinese wolfberry, the Radix Astragali, radix polygonati officinalis, puts back in stream extractor, and extracting in water decocts 1-3 time, every time
Add water 6-10 times amount, decocts 1-2 hour, filters, and merges extract, standby;
The condition of described concentration and degree be: temperature 70 C, pressure 0.08Mpa carry out reduced pressure concentration, is concentrated into 50 DEG C of heat and surveys phases
It is the thick medicinal extract of 1.15~1.25 to density;
The condition of described drying is: use boulton process, drying parameter: temperature is 70 DEG C, and vacuum is 0.08Mpa, time
It is 50~60 hours;
Described selection 80 mesh sieve that pulverize and sieve.
9. the preparation method of hard capsule as claimed in claim 6, it is characterised in that the method is:
The root of kudzu vine, the root bark of white mulberry, fenugreek, the red sage root, add 80% alcohol extract, decocts 2 times, adds 6 times amount every time and decocts 1h, filter, closes
And extract, standby;The fruit of Chinese wolfberry, the Radix Astragali, radix polygonati officinalis, extracting in water, decoct 2 times, 10 times amount that add water every time decoct 1.5h, filter,
Merge extract, standby;Take alcohol extracting filtrate and put in vacuum concentration pot, reclaim ethanol, and be concentrated into 50 DEG C heat survey relative densities be
1.15-1.25, obtains thick extractum A, vacuum concentration process parameter: vacuum is 0.08Mpa, temperature: 70 DEG C;Water intaking carries filtrate and puts very
In empty concentration tank, and be concentrated into 50 DEG C of heat to survey relative densities be 1.15-1.25, obtains thick medicinal extract B, vacuum concentration process parameter: true
Reciprocal of duty cycle is 0.08Mpa, temperature: 70 DEG C;Thick extractum A and thick medicinal extract B are mixed into thick medicinal extract C, with the heating of vacuum decompression drying box
To 70 DEG C of dryings, obtain dry extract C, vacuum decompression Drying Technology Parameter: vacuum is 0.08Mpa, temperature: 70 DEG C;Dry extract C powder
It is broken into 80 mesh powder, obtain dry extract C;Dry extract C and starch are mixed 30 minutes, crosses 80 mesh sieves and obtain mixed powder D;By mixed powder
D, with 90% ethanol solution as wetting agent, with wet granulation, adds magnesium stearate, mixing, fills capsule and get final product.
10. any one Chinese medicine composition as described in claim 1-3 has control IGT symptom function in preparation
Medicine in application.
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CN102688295A (en) * | 2012-06-14 | 2012-09-26 | 上海中医药大学 | Chinese medicine composition for controlling metabolic diseases as well as preparation method and application thereof |
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