CN103893540A - Traditional Chinese medicine composition capable of controlling abnormal glucose tolerance, and preparation method thereof - Google Patents
Traditional Chinese medicine composition capable of controlling abnormal glucose tolerance, and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition capable of controlling abnormal glucose tolerance, and a preparation method thereof. The traditional Chinese medicine composition comprises, by weight, 12 to 20 parts of radix puerariae, 12 to 20 parts of cortex mori, 8 to 14 parts of semen trigonellae, 8 to 14 parts of radix salviae miltiorrhizae, 8 to 14 parts of wolfberry, 16 to 28 parts of radix astragali, and 8 to 14 parts of radix polygonati officinalis. The preparation method comprises following steps: radix puerariae, cortex mori, semen trigonellae, and radix salviae miltiorrhizae are subjected to extraction via traditional ethanol extraction method, and an obtained material is subjected to condensation so as to obtain a thick extractum A; wolfberry, radix astragali, and radix polygonati officinalis are subjected to extraction via traditional water extraction method, and an obtained product is subjected to condensation so as to obtain a thick extractum B; the thick extractum A is mixed with the thick extractum B so as to obtain a thick extractum C, and the thick extractum C is dried, smashed, and sieved; traditional auxiliary materials are added; and a solid preparation used for oral administration is obtained via traditional processes. The traditional Chinese medicine composition is capable of controlling symptoms of abnormal glucose tolerance, and is mainly used for treating diseases, such as diabetes, caused by abnormal glucose tolerance.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition and preparation method thereof, particularly a kind of Chinese medicine composition of controlling impaired glucose tolerance and preparation method thereof.
Background technology
Impaired glucose tolerance belongs to a reversible stage, is the compensatory stage of human body carbohydrate metabolism disturbance, is to be that diabetes are in early days to the transition stage of diabetes by impaired glucose tolerance.Impaired glucose tolerance does not also mean that to suffer from diabetes, but it is undesired to represent that patient's islet function has occurred, than normal person, diabetes more easily occurs, and also has the cardiovascular diseases of increasing and microangiopathic danger simultaneously, and this type of patient should cause highly vigilant of.If regulate and control properly, just can enjoy health; Otherwise, just likely develop into diabetes.Therefore, the therapeutic intervention of impaired glucose tolerance is the key of prevention type 2 diabetes mellitus.
When human body carbohydrate tolerance slightly lowers, most people may there is no obvious sense of discomfort, so many people think little of, does not also take any treatment means.Expert points out, although Subjects with Impair Glucose Tolerant can't be buckled the medicated cap of diabetes, often means that islet function has occurred undesired, and the danger that diabetes occur for they exceeds 100 times than normal person, is called as the reserves of diabetes.Finally will there are three kinds of results in this part reserves: a kind of is the ranks that become a full member of diabetes patient; Another kind is that to maintain standing state constant; Also having one is to recover normal by active treatment or diet motion conditioning.And result of study shows, if not Results of Subjects with Impair Glucose Tolerant, nearly 67% patient can be changed diabetes into.
Diabetes are or relative deficiency absolute with insulin secretion, and the endocrine metabolism disease that carbohydrate metabolism disturbance is main manifestations, is commonly encountered diseases, the frequently-occurring disease of current harm humans health, has become the mankind's the 5th dead killer.Its characteristic shows as hyperglycemia and glucose in urine, also comprises the disorder of fat, protein, electrolyte etc. simultaneously, often causes severe complication.Diabetes patient blood sugar's excessive concentration, causes glucose in urine, and glycosuria increases has taken away moisture, and clinical manifestation is polyuria, thereby thirsty polydipsia; The nutrient substance of eating can not utilize and store in vivo, for the needed heat energy of maintenance metabolism, can only decompose and consume body fat and albumen, therefore shows as weight loss, fatigue and weak and easy hungry polyphagia.The course of disease of diabetes is long, cardiovascular, cerebrovascular, kidney, optical fundus retina and neural chronic disease easily occur, even blind and disable, and has a strong impact on patient's health and work, viability.In addition diabetes patient is also easy to occur cutization pyogenic infection, urinary system infection, pulmonary tuberculosis, fungal infection etc.Can also there is the acute complicationses such as ketoacidosis, hyperosmolar coma, lactic acidosis and life-threatening in serious case.The generation development of diabetes be one slowly and the process of concealment, there are some researches show from blood glucose and be increased to and occur clinical symptoms, average 7 years of this one-phase, in fact slight blood glucose increases and comprises that impaired fasting glucose (IFG) (IFG) and impaired glucose tolerance (IGT) damaged islet function stealthily, and has started generation and the development of vascular complication.Therefore early discovery blood glucose increases, and carries out prophylactic treatment in time, becomes the continuation development of controlling diabetes from source.
At present, no matter developed country or developing country, the sickness rate of diabetes increases year by year, and diabetes have become the 3rd serious main Chronic Non-Communicable Diseases after tumor, cardiovascular and cerebrovascular disease.Diabetes are called " quenching one's thirst " in the traditional Chinese medical science, to quench one's thirst be take polydipsia, polyphagia, polyuria, become thin, urinate pleasantly sweet a kind of disease as feature.The traditional Chinese medical science thinks that its cause of disease is mainly eating and drinking without temperance, disorder of emotion, labor and wants to be impairment of the kidney etc.; Its pathogenesis be by lung, stomach, the dirty the moon of kidney three thanks to scorching, consumption of body fluid by heat, disappear and burn water paddy and cause.In Chinese traditional herbs treatment diabetes action temperature and lasting, side effect is little, and the mechanism of action is often many target spots, manifold effect, multi-functional comprehensive function.By adjusting tonifying five ZANG-organs, essence, gas, blood, body fluid are given birth to active, easily reach clearing heat and moistening lung, replenishing QI to invigorate the spleen, promoting the production of body fluid to quench thirst, enriching yin and nourishing kidney, the merit of blood circulation promoting and enriching.In addition, in conjunction with the prescription such as modern medical theory and food safety, utilize modern science technique, fully guarantee that effective ingredient is absorbed by the body, to reach the generation of prevention impaired glucose tolerance, hyperglycemia and diabetes, effectively help early diabetes patient and impaired glucose tolerance person to reduce blood glucose, improve the health care of various subjective symptomss.
Summary of the invention
The object of the invention is to provide a kind of Chinese medicine composition of controlling impaired glucose tolerance and preparation method thereof.
The present invention seeks to be achieved through the following technical solutions.
The crude drug of Chinese medicine composition of the present invention consists of:
Radix Puerariae 12-20 weight portion, Cortex Mori 12-20 weight portion, Semen Trigonellae 8-14 weight portion, Radix Salviae Miltiorrhizae 8-14 weight portion, Fructus Lycii 8-14 weight portion, Radix Astragali 16-28 weight portion, Rhizoma Polygonati Odorati 8-14 weight portion.
The crude drug composition of Chinese medicine composition of the present invention is preferably:
Radix Puerariae 15-17 weight portion, Cortex Mori 15-17 weight portion, Semen Trigonellae 10-12 weight portion, Radix Salviae Miltiorrhizae 10-12 weight portion, Fructus Lycii 10-12 weight portion, Radix Astragali 21-23 weight portion, Rhizoma Polygonati Odorati 10-12 weight portion.
The crude drug composition of Chinese medicine composition of the present invention is preferably:
Radix Puerariae 16 weight portions, Cortex Mori 16 weight portions, Semen Trigonellae 11 weight portions, Radix Salviae Miltiorrhizae 11 weight portions, Fructus Lycii 11 weight portions, the Radix Astragali 22 weight portions, Rhizoma Polygonati Odorati 11 weight portions.
The crude drug composition of Chinese medicine composition of the present invention is preferably:
Radix Puerariae 14 weight portions, Cortex Mori 18 weight portions, Semen Trigonellae 9 weight portions, Radix Salviae Miltiorrhizae 13 weight portions, Fructus Lycii 9 weight portions, the Radix Astragali 26 weight portions, Rhizoma Polygonati Odorati 9 weight portions.
The crude drug composition of Chinese medicine composition of the present invention is preferably:
Radix Puerariae 19 weight portions, Cortex Mori 13 weight portions, Semen Trigonellae 13 weight portions, Radix Salviae Miltiorrhizae 9 weight portions, Fructus Lycii 13 weight portions, the Radix Astragali 20 weight portions, Rhizoma Polygonati Odorati 13 weight portions.
In Chinese medicine composition of the present invention, Radix Puerariae, Cortex Mori, Semen Trigonellae, Radix Salviae Miltiorrhizae exist with the form of alcohol extract separately; Fructus Lycii, the Radix Astragali, Rhizoma Polygonati Odorati are to exist with the form of water extract separately.
Crude drug of the present invention is Chinese medicinal material, can on market, buy.
Get traditional Chinese medicinal composition raw materials of the present invention, add conventional adjuvant, according to common process, make oral solid formulation and include but not limited to capsule, tablet, granule, electuary, chewable tablet etc.; Preferably hard capsule.
The preparation method of Chinese medicine composition of the present invention is as follows: Radix Puerariae, Cortex Mori, Semen Trigonellae, Radix Salviae Miltiorrhizae routinely ethanol extraction method extract, concentrated, obtain thick extractum A; Fructus Lycii, the Radix Astragali, Rhizoma Polygonati Odorati routinely water extracting method are extracted, concentrated, obtain thick extractum A; Thick extractum A and thick extractum B are mixed into thick extractum C, dry, pulverize and sieve, add conventional adjuvant, according to common process, make oral solid formulation.
Described ethanol extraction method is: Radix Puerariae, Cortex Mori, Semen Trigonellae, Radix Salviae Miltiorrhizae, put in reflux, extract, tank, and add 40-80% ethanol extraction, decoct 1-3 time, the 6-10 that at every turn adds water doubly measures, and decocts 1-2 hour, filter, merge extractive liquid,, for subsequent use.
Described water extracting method is: Fructus Lycii, the Radix Astragali, Rhizoma Polygonati Odorati, to put in reflux, extract, tank, and extracting in water, decocts 1-3 time, and the 6-10 that at every turn adds water doubly measures, and decocts 1-2 hour, filter, merge extractive liquid,, for subsequent use.
Described concentrated condition and degree are: temperature 70 C, pressure 0.08Mpa carry out concentrating under reduced pressure, are concentrated into 50 ℃ of heat and survey the thick extractum that relative density is 1.15～1.25.
Described dry condition is: adopt boulton process, and drying parameter: temperature is 70 ℃, vacuum is 0.08Mpa, the time is 50～60 hours.
Described pulverizing and sieving selects 80 mesh sieves to sieve.
The preparation method of Chinese medicine composition hard capsule of the present invention (called after of the present invention is with grinding the beautiful astragalus capsules of board Radix Puerariae) is:
Radix Puerariae, Cortex Mori, Semen Trigonellae, Radix Salviae Miltiorrhizae, add 80% ethanol extraction, decocts 2 times, adds water 6 times to measure to decoct 1h at every turn, filter, and merge extractive liquid,, for subsequent use; Fructus Lycii, the Radix Astragali, Rhizoma Polygonati Odorati, extracting in water, decocts 2 times, adds water 10 times to measure to decoct 1.5h at every turn, filter, merge extractive liquid,, for subsequent use; Get alcohol extraction filtrate and put in vacuum concentration pot, reclaim ethanol, and be concentrated into 50 ℃ heat survey relative densities be 1.15-1.25, obtain thick extractum A, vacuum concentration process parameter: vacuum is 0.08Mpa, temperature: 70 ℃; Water intaking is carried filtrate and is put in vacuum concentration pot, and being concentrated into 50 ℃ of heat, to survey relative densities be 1.15-1.25, obtains thick extractum B, vacuum concentration process parameter: vacuum is 0.08Mpa, temperature: 70 ℃; Thick extractum A and thick extractum B are mixed into thick extractum C, are heated to 70 ℃ with vacuum decompression drying baker and are dried, obtain dry extract C, vacuum decompression Drying Technology Parameter: vacuum is 0.08Mpa, temperature: 70 ℃; Dry extract C is ground into 80 order powder, obtains dry extract C; Dry extract C and starch are mixed 30 minutes, cross 80 mesh sieves and obtain mixed powder D; By mixed powder D, take 90% alcoholic solution as wetting agent, with wet granulation, add magnesium stearate, mix filled capsules and get final product.
Chinese medicine composition of the present invention has the function of controlling impaired glucose tolerance symptom, is mainly used in the diseases such as diabetes that treatment causes by impaired glucose tolerance, has the crowd that is suitable for more widely, and take, carry, storage etc. is more convenient, be easier to extensively be used.The present invention through scientific composition, experiment is groped repeatedly, in conjunction with the advantage of the Chinese patent medicine prescription of traditional treatment impaired glucose tolerance, conventional formulation has been carried out to bold innovation, and improved its production technology, and its steady quality, evident in efficacy, safety are had no side effect.
Following experimental example and embodiment are used for further illustrating but are not limited to the present invention.
Experimental example 1, Radix Puerariae, Cortex Mori, Semen Trigonellae, tanshinol extraction process are investigated
Radix Puerariae, Cortex Mori, Semen Trigonellae, Radix Salviae Miltiorrhizae are all conventional Chinese medicine, and wherein Radix Puerariae is with flavones ingredients such as puerarin, Semen sojae atricolor (Semen Glycines) glycoside, daidzeins.Cortex Mori is with umbelliferone, scopoletin and flavone component.Semen Trigonellae is with alkaloid, ruscogenin, flavone, fatty acid.Radix Salviae Miltiorrhizae is with TANSHINONES, tanshinol, Radix Salviae Miltiorrhizae quinone and salviol, Radix Salviae Miltiorrhizae aldehyde.Alcohol extraction, take puerarin as significant composition, adopts Diluted Alcohol to extract and can obtain better effects.
Due to alcohol extraction, to have equipment simply universal, with low cost, and production site is less demanding, and easily operation, is applicable to industrialized great production; Alcohol extracting method, at industrial general employing heat reflow method, can retain effective ingredient simultaneously, reaches the object of discarding the dross and selecting the essential.Radix Puerariae in we, Cortex Mori, Semen Trigonellae, four kinds of medical material main components of Radix Salviae Miltiorrhizae are all take liposoluble substance as main, therefore adopt Diluted Alcohol to extract as solvent, tentative extraction time is 2 times.。By selecting L9 (3
4) orthogonal table, design Three factors-levels orthogonal test, investigation 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, does to investigate index with puerarin total amount in medical material, screens best extraction process.
In the medical material ratio in formula, taking clean medical material tests, measure the content of extract puerarin, calculate medical material paste-forming rate, finally convert out puerarin total amount in medical material, puerarin assay method is shown in one of the Pharmacopoeia of the People's Republic of China (version in 2010), concrete test arrangement and the results are shown in Table 1, table 2, table 3.
Table 1 Extraction technique is investigated factor level table
| Level | Quantity of solvent (doubly) | 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 1,2,3, can find out A by intuitive analysis method
1b
3c
1for optimum extraction process, solvent load is 6 times, 80% alcohol solvent, and extraction time is 1 hour.In addition, the present invention carries out variance analysis to orthogonal experiments, analysis result is in table 3, therefrom can find out: in three factors, only have B factor (concentration of alcohol) to have significant difference, be that concentration of alcohol is that to affect puerarin total amount in this medical material be principal element, this and intuitive analysis method conclusion match.Therefore determine that the optimum extraction process parameter of Radix Puerariae, Cortex Mori, Semen Trigonellae, Radix Salviae Miltiorrhizae is: each 6 times of amounts of amount of water, extract solvent 80% ethanol, extraction time is each 1 hour.
The comparison of extraction time list factor:
On the basis of above technical study, carried out single factor comparative test and investigated the impact of the content that extracts paste-forming rate on extract of 1 time, 2 times and 3 times and puerarin the extract time.Select technique 80% ethanol, 6 times of amounts, extract 1 hour, extraction time is respectively to 1 time, 2 times and 3 times and compares, and result is as follows, in table 4.
The contrast of table 4 extraction time
| 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, in the extraction time contrast of 1,2,3 time, wherein there is no significant difference with paste-forming rate and the puerarin content contrast of 3 times 2 times.For to considering the various factors that can run in production, such as extraction efficiency height, loss in production etc. factor, with the consideration of extraction efficiency in actual production lower than the test data of laboratory, adopt final technique: measure 80% ethanol extractions 2 times with 6 times, each extraction 1 hour, gets final product to obtain good extraction effect.
Experimental example 2, Fructus Lycii, the Radix Astragali, the research of Rhizoma Polygonati Odorati extraction process by water
Fructus Lycii, the Radix Astragali, Rhizoma Polygonati Odorati are all conventional Chinese medicine, take polysaccharide composition as main, adopt water extraction can obtain better effects.Due to water extraction, to have equipment simply universal, with low cost, and production site is less demanding, and easily operation, is applicable to industrialized great production; Water extraction method, at industrial general employing heat reflow method, can retain effective ingredient simultaneously, reaches the object of discarding the dross and selecting the essential.Fructus Lycii in we, the Radix Astragali, three kinds of medical material main components of Rhizoma Polygonati Odorati, all take polysaccharide as main, adopt water to extract as solvent.By selecting L
9(3
4) orthogonal table, design Three factors-levels orthogonal test, investigation extraction solvent multiple (8 times, 10 times, 12 times), extraction time (1h, 1.5,2h) and the concrete technology parameter such as extraction time, do to investigate index with crude polysaccharides in medical material, screen best extraction process.
In the medical material ratio in formula, taking clean medical material tests, measure the content of extract crude polysaccharides, calculate medical material paste-forming rate, finally convert out crude polysaccharides total amount in medical material, crude polysaccharides assay method is shown in one of " health food technology standard " (version in 2003), concrete test arrangement and the results are shown in Table 5, table 6, table 7.
Table 5 Extraction technique is investigated factor level table
| Level | Quantity of solvent (doubly) | 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 5,6,7, can find out A by intuitive analysis method
2b
2c
2for optimum extraction process, solvent load is 10 times, extraction time 2 times, and extraction time is 1.5 hours.In addition, the present invention carries out variance analysis to orthogonal experiments, analysis result is in table 7, therefrom can find out: in three factors, C factor (extraction time) has significant difference, be to be that to affect crude polysaccharides in this medical material be principal element extraction time, this and intuitive analysis method conclusion match.Therefore determine that the optimum extraction process parameter of Fructus Lycii, the Radix Astragali, Rhizoma Polygonati Odorati is: each 10 times of amounts of amount of water, to extract 2 times, extraction time is each 1.5 hours.
Concentrated, dry, the disintegrating process of experimental example 3, alcohol-extracted extract and the water extracted immersing paste are investigated
Through laboratory lab scale research, formulate the concentrated condition of technique and concentrated degree, temperature 70 C, pressure 0.08Mpa carry out concentrating under reduced pressure, being concentrated into relative density is that 1.15～1.25(50 ℃ of heat is surveyed) thick extractum; The dry boulton process that adopts carries out, drying parameter: temperature is 70 ℃, and vacuum is 0.08Mpa, the time is 50～60 hours; Pulverize and sieve, select 80 mesh sieves to sieve.This technique is amplified and is produced correcting action through pilot scale, determines scientific and reasonable technical data.
After mixing, table 8 water extraction, alcohol-extracted extract powder and starch samples sample appearance observed result table in different time, different location
By upper table, can see: in the time of 10 minutes, mix inhomogeneous, within 20 minutes, mix inhomogeneous, 30 minutes time, mix substantially even, after 40 minutes, mix homogeneous non-variegation, mix homogeneously is described, therefore the incorporation time of the mixed powder of medicinal substances extract dried cream powder and starch is decided to be 30 minutes more suitable.
Experimental example 4, preferred dosage form
This product is to mix and be used as medicine with Chinese crude drug extract powder, is applicable to making hard capsule.Capsule preparations has stable in properties, and production technology is simple, the feature that supplementary product consumption is few, can greatly save production cost, compare than other liquid preparations, more easily be accepted by patient, such as traditional liquid dosage form is main mainly with decoction, taking dose is larger, carries inconvenience, and taste is also difficult for being accepted, and make hard capsule, can cover the smell such as bitterness, fishy smell of content, and profile is bright and clean attractive in appearance, eats and carry all very convenient; Separately compare with pill with tablet, hard capsule disintegrate in gastrointestinal tract is very fast, and it is high that effective Kuai ﹑ has absorbed ﹑ drug bioavailability, and can Fang Chao ﹑ lucifuge, and stable in properties is convenient to preserve, and extends and discharges health care material.Therefore this product is preferentially selected the dosage form of hard capsule preparation as product.
Experimental example 5, processing technology routine design considerations
Radix Puerariae, Cortex Mori, Semen Trigonellae, Radix Salviae Miltiorrhizae are all conventional Chinese medicine, and wherein Radix Puerariae is with flavones ingredients such as puerarin, Semen sojae atricolor (Semen Glycines) glycoside, daidzeins.Cortex Mori is with umbelliferone, scopoletin and flavone component.Semen Trigonellae is with alkaloid, ruscogenin, flavone, fatty acid.Radix Salviae Miltiorrhizae is with TANSHINONES, tanshinol, Radix Salviae Miltiorrhizae quinone and salviol, and Radix Salviae Miltiorrhizae aldehyde adopts concentrating under reduced pressure method concentrated to said extracted liquid.Fructus Lycii, the Radix Astragali, Rhizoma Polygonati Odorati are all conventional Chinese medicine, take polysaccharide composition as main, adopt water extraction can obtain better effects.Can reduce in product effective ingredient because concentrating under reduced pressure method is concentrated destroyed, strengthen concentrated efficiency.
The selection foundation of experimental example 6, capsule adjuvant
Conventional adjuvant has dextrin, starch and microcrystalline Cellulose.Wherein microcrystalline Cellulose price is relatively high, and dextrin and starch are relatively cheap, but the moisture resistance of dextrin is poor; Because the content of this product is mainly Chinese crude drug extract, Chinese medicine extract is very easily subject to the impact of humiture in storage, there is the moisture absorption, caking phenomenon, for avoiding extract that the moisture absorption, deliquescing, caking phenomenon occur in storage, in preparation process, need to add appropriate filler, according to the feature of above several adjuvants, the present invention selects starch as capsule-filling agent, because starch is white powder, and odorless, tasteless, be conventional capsule excipient; Its moisture resistance is strong compared with dextrin, therefore adds a certain amount of starch to improve product resistance to water soak, and the starch features such as to have character highly stable, and appearance luster is good, and cost is low, is applicable to this product.
In addition, during for enhancing filled capsules, the mobility of powder, adds appropriate magnesium stearate, to guarantee the accuracy of capsule loading amount.Magnesium stearate for white is easily without the fine powder of grittiness, is commonly used for fluidizer in food, medicine.
The formulation of experimental example 7, capsule specification
This product is studied through lab scale craft, dry cream yield after Radix Puerariae, Cortex Mori, Semen Trigonellae, Radix Salviae Miltiorrhizae extract is about 14%～25% left and right, dry cream yield after Fructus Lycii, the Radix Astragali, Rhizoma Polygonati Odorati are extracted is about 20%～40% left and right, according to day amount, add the supplementary product starch and the magnesium stearate that meet preparation process requirement, determine that capsule loading amount is 0.5g/ grain, edible 3 times of every day, each edible 4, take a number suitable, meet and take custom.
Experimental example 8, impaired glucose tolerance functional evaluation experimental study
1. experiment purpose
By rat impaired glucose tolerance functional experiment research, observe and be subject to the impact of test product on insulin resistant model rat index of correlation, evaluate be subject to test product improve impaired glucose tolerance function.
2. experiment material
2.1 tested medicines
Capsule of the present invention (with grinding the beautiful astragalus capsules of board Radix Puerariae), is prepared from by embodiment 1.
2.2 reagent
Ai Ke blood sugar test paper, lot number, 20120324, Jinake Biotechnology Hangzhou company limited.
Blood sugar detection test kit: lot number 20120627, Zhongsheng Beikong Biological Science & Technology Co., Ltd..
T-CHOL (CHO) is measured test kit: lot number 20120713, Zhongsheng Beikong Biological Science & Technology Co., Ltd..
Triglyceride (TG) is measured test kit: lot number 20120628, Zhongsheng Beikong Biological Science & Technology Co., Ltd..
Low-density lipoprotein cholesterol (LDL-C) is measured test kit: lot number 20120528, Zhongsheng Beikong Biological Science & Technology Co., Ltd..
Insulin (INS) ria-determination test kit: lot number 20120520, Zhongsheng Beikong Biological Science & Technology Co., Ltd..
Blood glucose (Glu) is measured test kit: lot number 20120625, Zhongsheng Beikong Biological Science & Technology Co., Ltd..
2.3 laboratory animals and raising situation
(1) laboratory animal
Wistar rat, SPF level, male, body weight 180g-220g, purchased from Laboratory Animal Science portion of Department Of Medicine, Peking University.Licence numbering: SCXK(capital) 2006-0008.
(2) feedstuff
No. II, common Mus full-valence pellet feed, purchased from the feed corporation,Ltd that pulls together of Beijing Australia of section.Credit number: SCXK(capital) 2009-0012.
(3) raising condition
Experimental animal feeding in SPF level animal housing, fluorescent lamp lighting, the 12h light and shade cycle, freely drink water, diet, 22 ℃ ± 2 ℃ of temperature ,-10 times/h blows 6 times.
2.4 experimental apparatus
Xh6080 is put and is exempted from instrument: Xi'an He Yi factory.
The BCD-257SL of Haier refrigerating refrigerator: Qingdao HaiEr Co., Ltd.
Sartorious BT 124S precise electronic balance: Sai Duolisi scientific instrument (Beijing) company limited.
The sub-WB388 electronic timer in Europe: Europe sub-trade (Shanghai) Co., Ltd..
3. experimental technique
3.1 arranged by test product dosage
Recommend crowd's consumption to carry out dosage setting according to description.Description stipulates that crowd's dose is 3g/ people/day.6 times of rat bioequivalence dosage behaviour clinical application amount are set in this experiment, and people's standard body weight is drafted as 60kg, and therefore the dose,equivalent of rat is 3g ÷ 60kg × 6=0.3g/kg.Rat is established two dosage groups, is respectively 0.3g/kg and 0.6g/kg.
3.3 functional experiment groupings
Laboratory animal adaptability was raised after 2 days, and rat is divided into 4 groups at random by body weight, 12 every group.Be respectively: blank group, model group, high dose group, low dose group.
3.4 are subject to test product to give method
High dose group and low dose group are subject to test product 0.3g/kg and 0.6g/kg.Blank group and model group give equal-volume solvent.Route of administration is per os pipe gastric infusion, and gastric infusion volume is 5ml/kg body weight rat.
3.5 experimental technique
Give common complete feed except blank group, its excess-three group group is all synthesized high lipid food modeling.Continuously modeling 8 weeks, modeling starts high dose group and low dose group and gives corresponding dosage and be subject to test product.
Be subject to test product after 8 weeks, water 16h is can't help in rat fasting, respectively organizes rat oral gavage and gives glucose solution (2.0g/kg), and tail point is got blood, and blood sugar test paper mensuration 0,30,120min time point blood glucose value, calculate different time points Area under the curve of blood glucose.
After experiment finishes, rat fasting be can't help after water 16h, ventral aorta blood sampling, the centrifugal serum of preparing, measure fasting glucose, insulin (INS), CHO, TG, LDL, LDL level in serum, and calculate insulin sensitivity index (ISI) and insulin resistance index (IRI).
4. statistical method
Experimental data with " mean+SD (
) " represent.Data are first carried out homogeneity test of variance.Variance selects One-Way ANOVA method to carry out comparing between each group together; Heterogeneity of variance select t ' check organize between relatively.
5. experimental result
(1) with grinding the impact of the beautiful astragalus capsules of board Radix Puerariae on Insulin Resistance of Rats model index of correlation
Result of study shows, feeds after high lipid food, and model group rat blood serum INS level significantly raises, ISI significantly reduces, and IRI significantly raises, with the comparison of blank group, there is significant difference (all p<0.001), show insulin resistant model modeling success.With model group comparison, with the ISI and the IRI that grind the beautiful astragalus capsules high and low dose of board Radix Puerariae group and can significantly reduce rat model, there is the good effect that improves rat model insulin sensitivity and insulin resistant.
Result of study shows, feeds after high lipid food, and model group rat blood serum CHO, LDL level significantly raise, and with the comparison of blank group, has significant difference (all p<0.001), shows to have formed obvious lipid metabolic disorder.With change of serum C HO, LDL and the TG level of grinding the beautiful astragalus capsules high and low dose of board Radix Puerariae group and can significantly reduce rat model, with model group comparison, there is significant difference, there is the good effect that improves the disorder of insulin resistant model lipid metabolism in rats.
(2) with grinding the impact of the beautiful astragalus capsules of board Radix Puerariae on insulin resistant model carbohydrate tolerance
Experimental studies results shows, model group rat oral gives after glucose 2.0g/kg, 0,0.5,2h Area under the curve of blood glucose significantly increases, and relatively has significant difference (p<0.05) with blank group.Can significantly reduce rat model Area under the curve of blood glucose with grinding the beautiful astragalus capsules 0.3g/kg of board Radix Puerariae, relatively have significant difference (p<0.01) with model group.
6. experiment conclusion
(1) after high lipid food is fed, rat can form insulin resistant model, produces typical insulin resistant impaired glucose tolerance and blood fat disorder and changes.
(2) can improve insulin resistant model animal insulin opposing index of correlation and lipid metabolic disorder with grinding the beautiful astragalus capsules of board Radix Puerariae, and improve impaired glucose tolerance.
Following embodiment all can realize effect described in above-mentioned experimental example.
Embodiment 1 hard capsule of the present invention
Raw material composition: Radix Puerariae 16Kg, Cortex Mori 16Kg, Semen Trigonellae 11Kg, Radix Salviae Miltiorrhizae 11Kg, Fructus Lycii 11Kg, the Radix Astragali 22 Kg, Rhizoma Polygonati Odorati 11Kg.
Preparation method:
(1) extract, filter, concentrate, be dried
1. the extraction of medical material
Radix Puerariae, Cortex Mori, Semen Trigonellae, salvia piece, put in reflux, extract, tank, adds 80% ethanol extraction, decocts 2 times, adds water 6 times to measure to decoct 1h at every turn, filter (filter material is 80 order nylon cloths), and merge extractive liquid,, for subsequent use.Fructus Lycii, the Radix Astragali, Rhizoma Polygonati Odorati are put in reflux, extract, tank, and extracting in water decocts 2 times, add water 10 times to measure to decoct 1.5h at every turn, filter (filter material is 80 order nylon cloths), and merge extractive liquid,, for subsequent use.
2. vacuum concentration
Get alcohol extraction filtrate and put in vacuum concentration pot, reclaim ethanol, and be concentrated into relative density be 1.15-1.25(50 ℃ heat survey), obtain thick extractum A.
Water intaking is carried filtrate and is put in vacuum concentration pot, and to be concentrated into relative density be that 1.15-1.25(50 ℃ of heat is surveyed), obtain thick extractum B.
Thick extractum A and thick extractum B are mixed into thick extractum C.
Vacuum concentration process parameter: vacuum is 0.08Mpa, temperature: 70 ℃.
3. dry
Get the thick extractum C of above-mentioned mixing, be heated to 70 ℃ be dried with vacuum decompression drying baker, obtain dry extract C, dry extract C is ground into 80 order powder with universal mill, crosses 80 mesh sieves, obtains dry extract C.
Vacuum decompression Drying Technology Parameter: vacuum is 0.08Mpa, temperature: 70 ℃
(2) hybrid technique of fine powder raw material
Dry extract C is placed in to three-dimensional mixer with the starch of crossing 80 mesh sieves and fully mixes, mix 30 minutes, cross 80 mesh sieves and obtain mixed powder D.
(3) granulate
By mixed powder D, take 90% alcoholic solution as wetting agent, use wet granulation.The dry granule of this product can be broken and have harsh feeling to be advisable through pointing light sth. made by twisting.
Grain made parameter: 70 ℃ of inlet temperature.
(4) total mix process
Get qualified granule, add magnesium stearate, put in three-dimensional mixer, mix 20 minutes.
(5) capsule-filling, polishing
Adopt automatic capsule filling machine that above-mentioned qualified granule is filled in No. 0 capsule by operating process, adjust loading amount to every heavy 0.5g/ grain, polishing in machine for automatically polishing.
(6) subpackage, packing, product inspection, warehouse-in
Adopt medicinal high-density polyethylene bottle subpackage, meet the prescription of " national drug packing container (material) standard " YBB00122002.Every bottled 60, after packing, be up to the standards, warehouse-in.
Embodiment 2 tablet of the present invention
Radix Puerariae 14Kg, Cortex Mori 18Kg, Semen Trigonellae 9Kg, Radix Salviae Miltiorrhizae 13Kg, Fructus Lycii 9Kg, Radix Astragali 26Kg, Rhizoma Polygonati Odorati 9Kg.
Add conventional adjuvant, according to common process, make tablet.
Embodiment 3 granule of the present invention
Radix Puerariae 19Kg, Cortex Mori 13Kg, Semen Trigonellae 13Kg, Radix Salviae Miltiorrhizae 9Kg, Fructus Lycii 13Kg, Radix Astragali 20Kg, Rhizoma Polygonati Odorati 13Kg.
Add conventional adjuvant, according to common process, granulation agent.
Claims (10)
1. control a Chinese medicine composition for impaired glucose tolerance, it is characterized in that the crude drug of said composition consists of:
Radix Puerariae 12-20 weight portion, Cortex Mori 12-20 weight portion, Semen Trigonellae 8-14 weight portion, Radix Salviae Miltiorrhizae 8-14 weight portion, Fructus Lycii 8-14 weight portion, Radix Astragali 16-28 weight portion, Rhizoma Polygonati Odorati 8-14 weight portion.
2. Chinese medicine composition as claimed in claim 1, is characterized in that the crude drug of said composition consists of:
Radix Puerariae 15-17 weight portion, Cortex Mori 15-17 weight portion, Semen Trigonellae 10-12 weight portion, Radix Salviae Miltiorrhizae 10-12 weight portion, Fructus Lycii 10-12 weight portion, Radix Astragali 21-23 weight portion, Rhizoma Polygonati Odorati 10-12 weight portion.
3. Chinese medicine composition as claimed in claim 1, is characterized in that the crude drug of said composition consists of:
Radix Puerariae 16 weight portions, Cortex Mori 16 weight portions, Semen Trigonellae 11 weight portions, Radix Salviae Miltiorrhizae 11 weight portions, Fructus Lycii 11 weight portions, the Radix Astragali 22 weight portions, Rhizoma Polygonati Odorati 11 weight portions;
Or Radix Puerariae 14 weight portions, Cortex Mori 18 weight portions, Semen Trigonellae 9 weight portions, Radix Salviae Miltiorrhizae 13 weight portions, Fructus Lycii 9 weight portions, the Radix Astragali 26 weight portions, Rhizoma Polygonati Odorati 9 weight portions;
Or Radix Puerariae 19 weight portions, Cortex Mori 13 weight portions, Semen Trigonellae 13 weight portions, Radix Salviae Miltiorrhizae 9 weight portions, Fructus Lycii 13 weight portions, the Radix Astragali 20 weight portions, Rhizoma Polygonati Odorati 13 weight portions.
4. any one Chinese medicine composition as described in claim 1-3, is characterized in that Radix Puerariae in said composition, Cortex Mori, Semen Trigonellae, Radix Salviae Miltiorrhizae exist with the form of alcohol extract separately; Fructus Lycii, the Radix Astragali, Rhizoma Polygonati Odorati are to exist with the form of water extract separately.
5. any one Chinese medicine composition as described in claim 1-3, is characterized in that getting crude drug, adds conventional adjuvant, according to common process, makes oral solid formulation: capsule, tablet, granule, electuary or chewable tablet.
6. Chinese medicine composition as claimed in claim 5, is characterized in that described dosage form is hard capsule.
7. the preparation method of oral solid formulation as claimed in claim 5, is characterized in that the method is:
Radix Puerariae, Cortex Mori, Semen Trigonellae, Radix Salviae Miltiorrhizae routinely ethanol extraction method extract, concentrated, obtain thick extractum A; Fructus Lycii, the Radix Astragali, Rhizoma Polygonati Odorati routinely water extracting method are extracted, concentrated, obtain thick extractum A; Thick extractum A and thick extractum B are mixed into thick extractum C, dry, pulverize and sieve, add conventional adjuvant, according to common process, make oral solid formulation.
8. preparation method as claimed in claim 7, is characterized in that in the method:
Described ethanol extraction method is: Radix Puerariae, Cortex Mori, Semen Trigonellae, Radix Salviae Miltiorrhizae, put in reflux, extract, tank, and add 40-80% ethanol extraction, decoct 1-3 time, the 6-10 that at every turn adds water doubly measures, and decocts 1-2 hour, filter, merge extractive liquid,, for subsequent use;
Described water extracting method is: Fructus Lycii, the Radix Astragali, Rhizoma Polygonati Odorati, to put in reflux, extract, tank, and extracting in water, decocts 1-3 time, and the 6-10 that at every turn adds water doubly measures, and decocts 1-2 hour, filter, merge extractive liquid,, for subsequent use;
Described concentrated condition and degree are: temperature 70 C, pressure 0.08Mpa carry out concentrating under reduced pressure, are concentrated into 50 ℃ of heat and survey the thick extractum that relative density is 1.15～1.25;
Described dry condition is: adopt boulton process, and drying parameter: temperature is 70 ℃, vacuum is 0.08Mpa, the time is 50～60 hours;
Described pulverizing and sieving selects 80 mesh sieves to sieve.
9. the preparation method of hard capsule as claimed in claim 6, is characterized in that the method is:
Radix Puerariae, Cortex Mori, Semen Trigonellae, Radix Salviae Miltiorrhizae, add 80% ethanol extraction, decocts 2 times, adds water 6 times to measure to decoct 1h at every turn, filter, and merge extractive liquid,, for subsequent use; Fructus Lycii, the Radix Astragali, Rhizoma Polygonati Odorati, extracting in water, decocts 2 times, adds water 10 times to measure to decoct 1.5h at every turn, filter, merge extractive liquid,, for subsequent use; Get alcohol extraction filtrate and put in vacuum concentration pot, reclaim ethanol, and be concentrated into 50 ℃ heat survey relative densities be 1.15-1.25, obtain thick extractum A, vacuum concentration process parameter: vacuum is 0.08Mpa, temperature: 70 ℃; Water intaking is carried filtrate and is put in vacuum concentration pot, and being concentrated into 50 ℃ of heat, to survey relative densities be 1.15-1.25, obtains thick extractum B, vacuum concentration process parameter: vacuum is 0.08Mpa, temperature: 70 ℃; Thick extractum A and thick extractum B are mixed into thick extractum C, are heated to 70 ℃ with vacuum decompression drying baker and are dried, obtain dry extract C, vacuum decompression Drying Technology Parameter: vacuum is 0.08Mpa, temperature: 70 ℃; Dry extract C is ground into 80 order powder, obtains dry extract C; Dry extract C and starch are mixed 30 minutes, cross 80 mesh sieves and obtain mixed powder D; By mixed powder D, take 90% alcoholic solution as wetting agent, with wet granulation, add magnesium stearate, mix filled capsules and get final product.
10. any one Chinese medicine composition as described in claim 1-3 has the application in the medicine of controlling impaired glucose tolerance symptom function in preparation.
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