CN103405654A - Traditional Chinese medicine pharmaceutical composition for treating diabetes and preparation method thereof - Google Patents
Traditional Chinese medicine pharmaceutical composition for treating diabetes and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine pharmaceutical composition for treating diabetes and a preparation method thereof. The traditional Chinese medicine pharmaceutical composition is prepared from rhizoma anemarrhenae, ginseng, golden cypress, radices trichosanthis, radix rehmanniae recen, radix scrophulariae and the like to granules, hard capsules and pills. The traditional Chinese medicine pharmaceutical composition provided by the invention has the characteristics of scientific and reasonable component matching, simple and feasible preparation process, safety and effectiveness and remarkable clinical curative effect.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition for the treatment of diabetes and preparation method thereof, belong to the pharmaceutical preparations technology field.
Background technology
In recent years, along with the quickening of modernization and the raising of people's living standard, the number of diabetics is all increasing with surprising rapidity year by year both at home and abroad, and diabetes have been classified the third-largest disease after cardiovascular, tumor as.Diabetes be a kind of due to insulin in body definitely or the carbohydrate metabolism disturbance of take that causes of relative deficiency be main systemic disease, pathogenic factor is mainly the relative of insulin or definitely not enough, its clinical manifestation is principal character mainly with polydipsia, polyphagia, polyuria, emaciated physique, and have sickness rate high and issue licence many, the characteristics that can not effect a radical cure.China's diabetics surpasses 4,000 ten thousand at present, due to the parenchymatous organs' such as the easy secondary hypertension of diabetes, atherosclerosis, kidney and retinal microvascular pathological changes complication, so it has become a kind of popular non-infective disease of serious harm society and family.But due to patient's long-term taking Western medicine antidiabetic drug, can produce larger untoward reaction and drug resistance, and Western medicine there is the not enough shortcoming of control to chronic complicating diseases.Given this, both at home and abroad medical circle more and more turns to Chinese medicine to attention, thus from research motherland's medicine treasure-house, find efficient, low toxicity, safe, inexpensive hypoglycemic medicine, have very great clinical meaning.
Diabetes spp Chinese medicine " diabetes " category, its cause of disease multi-source are in the plain body deficiency of YIN, and eating and drinking without temperance, how because of disorder of emotion.Due to labor was wanted excessively, the moon of consumption impairing the lung, stomach, kidney, caused the deficiency of YIN scorching and occur quenching one's thirst.Its pathogenesis is that the deficiency of YIN is this, scorchingly is mark, and resembling of gas and deficiency of both QI and YIN can occur consuming, sickly to later stage deficiency of YIN affecting YANG, deficiency in both YIN and YANG occurs, and even the moon exhausts that sun is died, yang-energy is got over outward, and the danger disease such as Kidney-Yin kidney-Yang decline occurs.Scorching for the primary disease deficiency of YIN, the pathogenic characteristic of deficiency of both QI and YIN, according to the principle of " the Plain Questions the most pure virginity will be discussed greatly " " deficiency syndrome should be treated by tonifying method ", " damage benefit ", " heat is trembled with fear it ", " treating dryness syndrome by moistening ", " treating dryness syndrome by moistening ", thirty years of age clearing heat and moistening dryness, supplementing QI and nourishing YIN, the method for promoting the production of body fluid to quench thirst.Clearing heat and moistening dryness to be to control its mark, and supplementing QI and nourishing YIN is with Zhi Qiben, and treating both the principal and secondary aspects of a disease makes scorching clearly, and gas is cloudy multiple, and body fluid is given birth to, and quenches one's thirst flat.
The Chinese medicine composition of the treatment diabetes of the present invention development, it be take the Rhizoma Anemarrhenae, Radix Ginseng and is monarch drug, clearing heat and moistening dryness, supplementing QI for promoting the production of body fluid; Take Cortex Phellodendri, Radix Trichosanthis, Radix Rehmanniae, Radix Scrophulariae, Radix Ophiopogonis, Radix Astragali Six-element is ministerial drug, and can increase the clearing heat and moistening dryness of monarch drug, and the merit of supplementing QI for promoting the production of body fluid has benefit, treating both the principal and the secondary aspects of a disease at the same time in clear; Cortex Lycii, Radix Glehniae, Herba Dendrobii, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis, Fructus Ligustri Lucidi, Fructus Lycii, Rhizoma Dioscoreae, Endothelium Corneum Gigeriae Galli etc. nine flavor of take is adjuvant drug, the power of association's monarch drug, and tonify without causing stagnation, grow and oiliness; Make with Radix Puerariae, the gas of the clear sun of elevate a turnable ladder taste, compress body fluid, to fill with the five internal organs; All medicines share, and jointly form supplementing QI and nourishing YIN, clearing heat and moistening dryness, and the thirsty prescription promoted the production of body fluid, and aspect the treatment diabetes, the clinical efficacy of highly significant is arranged.
Between this, for this Chinese medicine composition application a patent of invention, its publication number is CN1857618A, open day is on November 8th, 2006, this patent of invention file is from different amounts of components prescription, the aspects such as preparation technology disclose, protection, but in actual application, we find that the effect of the Chinese patent medicine of being made by above-mentioned component proportion and preparation method is desirable not enough, and the application's patent is to grope by great many of experiments, further optimize prescription proportioning and process of preparing, better prescription parameter and preparation technology have been found, and more remarkable by clinical pharmacodynamic experiment proving effect, therefore, we take and improve preparation stability and bioavailability is purpose, and creationary a kind of Chinese medicine composition for the treatment of diabetes of succeeding in developing.
Summary of the invention
The object of the invention is to provide a kind of taking convenience, steady quality, quality controllable, curative effect to treat reliably Chinese medicine composition of diabetes and preparation method thereof.
This Chinese medicine composition is a kind of compound preparation that is used for the treatment of diabetes, by weight proportion, be: 36～55 parts of the Rhizoma Anemarrhenaes, 15～27 parts of Radix Ginsengs, 23～32 parts of Cortex Phellodendris, 27～45 parts of Radix Trichosanthis, 11～19 parts of Radix Rehmanniae, 16～27 parts of Radix Scrophulariaes, 8～15 parts of Radix Ophiopogonis, 46～57 parts of the Radixs Astragali, 43～52 parts of Cortex Lycii, 12～19 parts of Radix Glehniaes, 10～18 parts of Herba Dendrobiis, 6～19 parts of Rhizoma Polygonati Odorati, 5～11 parts of Fructus Schisandrae Chinensis, 6～13 parts of Fructus Ligustri Lucidi, 7～16 parts of Fructus Lycii, 48～57 parts of Rhizoma Dioscoreaes, 34～45 parts of Endothelium Corneum Gigeriae Galli, the raw material compositing formula that Radix Puerariae is 7～15 parts, and the Chinese medicine preparation be prepared into through a series for the treatment of process,
Wherein, preferred raw material prescription proportioning is: 47.3 parts of the Rhizoma Anemarrhenaes, 21.5 parts of Radix Ginsengs, 27.6 parts of Cortex Phellodendris, 36.8 parts of Radix Trichosanthis, 15.7 parts of Radix Rehmanniae, 21.7 parts of Radix Scrophulariaes, 12.3 parts of Radix Ophiopogonis, 51.2 parts of the Radixs Astragali, 48.7 parts of Cortex Lycii, 15.8 parts of Radix Glehniaes, 14.6 parts of Herba Dendrobiis, 12.8 parts of Rhizoma Polygonati Odorati, 7.5 parts of Fructus Schisandrae Chinensis, 9.1 parts of Fructus Ligustri Lucidi, 10.8 parts of Fructus Lycii, 53.6 parts of Rhizoma Dioscoreaes, 39.2 parts of Endothelium Corneum Gigeriae Galli, 10.6 parts of Radix Puerariaes.
Above-mentioned prescription ratio range and optimum can be prepared from by following processing step:
(1) by the Rhizoma Anemarrhenae, Radix Ginseng, Cortex Phellodendri, Radix Trichosanthis, Radix Scrophulariae, Milkvetch Root, in 65～80 ℃ of oven dry 15～20h, be ground into 80～150 order fine powders, then superfine powder is broken into the medicated powder that mean diameter is less than 30 μ m;
(2) by Radix Rehmanniae, Cortex Lycii, Radix Glehniae, Herba Dendrobii, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis, Fructus Ligustri Lucidi, Fructus Lycii, Rhizoma Dioscoreae, Radix Ophiopogonis, Endothelium Corneum Gigeriae Galli, Radix Puerariae medical material, in 65～80 ℃ dry to the medical material water content be 6%～9%, be ground into 60～100 purpose coarse powder, add tween 80 to be ground into the medicated powder that mean diameter is less than 75 μ m;
By after (1) above-mentioned and (2) medicated powder mix homogeneously, add pharmaceutic adjuvant commonly used on pharmaceutics to make different Chinese medicine preparation, obtain;
Wherein preferred preparation method is:
(1) by the Rhizoma Anemarrhenae, Radix Ginseng, Cortex Phellodendri, Radix Trichosanthis, Radix Scrophulariae, Milkvetch Root, in 75 ℃ of oven dry 17h, be ground into 120 order fine powders, then superfine powder is broken into the medicated powder that mean diameter is less than 30 μ m;
(2) by Radix Rehmanniae, Cortex Lycii, Radix Glehniae, Herba Dendrobii, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis, Fructus Ligustri Lucidi, Fructus Lycii, Rhizoma Dioscoreae, Radix Ophiopogonis, Endothelium Corneum Gigeriae Galli, Radix Puerariae medical material, in 70 ℃ dry to the medical material water content be 7%, be ground into 80 order coarse powder, add tween 80 to be ground into the medicated powder that mean diameter is less than 75 μ m;
By above-mentioned (1) with above-mentioned medicated powder mix homogeneously (2) after, add on pharmaceutics pharmaceutic adjuvant commonly used to make different Chinese medicine preparation, obtain.
Medicine of the present invention is in the middle of the practical study process, and in the first to file patent of invention, comparing, its main creation point is prescription proportioning and the process of preparing of medicine, has brought thus significant technological progress, and main beneficial effect is as follows.
1. the technological merit of the proportioning of writing out a prescription:
Medicament composing prescription proportioning of the present invention is the improvement on publication number CN1857618A application basis, in process of clinical application, obtained unexpected effect, this prescription proportioning is that we accidentally obtain in long-term clinical practice, the marrow of its consumption proportion is to promote monarch, the ratio share of ministerial drug, strengthened the therapeutic effect of primary symptom, suitably reduce simultaneously most of assistant, make the ratio share of medicine, can be so that curative effect of medication relaxes lastingly more, suitably weaken the therapeutical effect of deuteropathy, by the efficacy of drugs high concentration in the treatment of primary symptom, the clinical treatment purposes that more meets thus medicine.Through large quantity research, grope, the prescription proportioning of medicine has obtained preferably effect on curative effect of medication.
2. preparation technology's technological merit:
During drug prescription of the present invention forms, take the Rhizoma Anemarrhenae, Radix Ginseng and be monarch drug, have clearing heat and moistening dryness, the supplementing QI for promoting the production of body fluid effect; Take Cortex Phellodendri, Radix Trichosanthis, Radix Scrophulariae, the Radix Astragali is ministerial drug, can increase the clearing heat and moistening dryness of monarch drug, the merit of supplementing QI for promoting the production of body fluid.Both match in playing clearly has benefit, the effect for the treatment of both the principal and the secondary aspects of a disease at the same time.We are in actual research, for above 6 flavor medical materials, from aspect analyses such as medical material quality, Crushing Behavior, effective ingredient, then adopt modern " superfine communication technique " to study, by performing creative labour and scientific and reasonable technology exploration, obtain following beneficial effect:
We combine above 6 flavor medical materials by the weight proportion in prescription after, be ground into the medicated powder of mean diameter 100 μ m, 75 μ m, 30 μ m, 10 μ m, all according to version in 2000 " in one one of Chinese pharmacopoeia in the rhizoma ane marrhenae of record the Sarsasapogenin content assaying method detect, its assay result is: 1.31%, 1.37%, 1.41%, 1.43%; As can be known from interpretation of result, medical material is after micronizing, and along with reducing of medical material mean diameter, the Sarsasapogenin content recorded increases, and wherein mean diameter is that in the medicated powder of 10 μ m and 30 μ m, the Sarsasapogenin extraction ratio is higher.
In addition, we carry out hygroscopicity and fluidity test by the medicated powder of four kinds of different-grain diameters of above-mentioned preparation, found that, the mean diameter that medicine is pulverized is less, powder flowbility is less and hygroscopicity is larger, consider the needs of actual production process, we can select to write out a prescription in the Rhizoma Anemarrhenae, Radix Ginseng, Cortex Phellodendri, Radix Trichosanthis, Radix Scrophulariae, the Milkvetch Root superfine powder is broken into into the medicated powder that mean diameter is less than 30 μ m and gets final product, because, under this particle diameter, this Chinese medicine composition is after micronization, its specific surface area increases, the dissolubility of medicine in gastrointestinal tract obviously increases, thereby increase the bioavailability of medicine, and accelerate the drug effect time, be conducive to increase curative effect, through test, the medicated powder of its curative effect and 10 μ m is suitable, therefore, consider the production cost factor, select the medicated powder of 30 μ m suitable.
Trace it to its cause, the kind relation with contents of the selection of crude drug breaking method and the physicochemical property of medical material and effective ingredient is close.During Chinese medicine composition prescription of the present invention forms, in Fructus Lycii, Radix Ophiopogonis, Rhizoma Polygonati Odorati, Radix Rehmanniae medical material, contain the compositions such as polysaccharide, saponin, phlegmatic temperament, in reality, pulverize in production process, there will be drug powder adhesion or viscous medicaments to be subjected to the phenomenon of thermal softening, can not reach required degree of grinding, the effect that impact is pulverized.We adopt the flushing breaking method, and in writing out a prescription, part non-sticky medical material, after the medicinal material dryings such as Cortex Lycii, Radix Glehniae, Herba Dendrobii, Fructus Schisandrae Chinensis, Fructus Ligustri Lucidi, Rhizoma Dioscoreae, Endothelium Corneum Gigeriae Galli, Radix Puerariae, be ground into fine powder; Again with Radix Ophiopogonis, Fructus Lycii, Rhizoma Polygonati Odorati, Radix Rehmanniae medicinal material drying after, be ground into coarse powder; After both mix homogeneously, add tween 80 to be ground into the medicated powder that mean diameter is less than 75 μ m.In the mode of this superfine grinding, add a small amount of tween 80, can play the effect of homogenizing, dispersion, and can improve the dispersion in digestive tract of drug-eluting rate and effective ingredient, dissolve and absorption, make the Chinese medicine onset slowly shortcoming overcome.
3. preparation technology's whole beneficial effect
For the whole beneficial effect of explanation technical solution of the present invention directly perceived, we have carried out a series of pharmaceutics comparative study, and detailed content is:
(1) medicine group selection best prescription proportioning of the present invention and preparation technology, be that a. is by the Rhizoma Anemarrhenae 47.3 g, Radix Ginseng 21.5g, Cortex Phellodendri 27.6g, Radix Trichosanthis 36.8g, Radix Scrophulariae 21.7g, Radix Astragali 51.2g, in 75 ℃, dry 17h, be ground into 120 order fine powders, then superfine powder is broken into the medicated powder that mean diameter is less than 30 μ m; B. by Radix Rehmanniae 15.7g, Cortex Lycii 48.7g, Radix Glehniae 15.8g, Herba Dendrobii 14.6g, Rhizoma Polygonati Odorati 12.8g, Fructus Schisandrae Chinensis 7.5g, Fructus Ligustri Lucidi 9.1g, Fructus Lycii 10.8g, Rhizoma Dioscoreae 53.6g, Radix Ophiopogonis 12.3g, Endothelium Corneum Gigeriae Galli 39.2g, Radix Puerariae 10.6g, in 70 ℃ dry to the medical material water content be 7%, be ground into 80 purpose coarse powder, add tween 80 to be ground into the medicated powder that mean diameter is less than 75 μ m; C. by after the medicated powder mix homogeneously in above-mentioned a and b, add appropriate amylum pregelatinisatum, granulate, encapsulated, obtain.
(2) preparation of CN1857618A medicine group, be about to Rhizoma Anemarrhenae 38.1g, Radix Ginseng 12.7g, Cortex Phellodendri 31.8g, Radix Trichosanthis 25.4g, Radix Rehmanniae 19.1g, Radix Scrophulariae 15.2g, Radix Ophiopogonis 15.2g, Radix Astragali 25.4g, Cortex Lycii 38.1g, Radix Glehniae 15.2g, Herba Dendrobii 19.1g, Rhizoma Polygonati Odorati 25.4g, Fructus Schisandrae Chinensis 12.7g, Fructus Ligustri Lucidi 19.1g, Fructus Lycii 15.2g, Rhizoma Dioscoreae 25.4g, Endothelium Corneum Gigeriae Galli 31.8g, the 18 flavor medical materials such as Radix Puerariae 15.2g, oven drying at low temperature (60～70 ℃), be ground into coarse powder, add poly-Pyrusussuriensis fat-80 2ml, be ground into micropowder (crossing 200 mesh sieves), after mix homogeneously, add suitable adjuvant and get final product.
We adopt the hot dipping in the water-soluble extractives assay method of stipulating in " Chinese Pharmacopoeia 2010 editions " appendix XA, and CN1857618A medicine group and medicine group of the present invention are tested, and the results are shown in Table 1.
The water-soluble extractives result (%) of table 1 liang group medicated powder
With the CN1857618A group, compare,
* *P<0.001.
By external water-soluble extractives test, shown, medical material is carried out to micronization processes, can make all kinds of chemical composition strippings in medical material more, faster, with CN1857618A medicine group, compare, the medicine made by preparation method of the present invention, the dissolution rate of its water-soluble extractives and dissolution rate all obviously improve, can be so that the curative effect of medicine is fully played.
In addition, we also adopt fixed funnel method (Zhang Zhaowang edits " pharmacy of Chinese materia medica " front page in 2003) to two groups of medicines, carry out the powder flowbility test, the measuring result is as can be known: be 39.45 ° the angle of repose of of the present invention group of medicine, and be 42.97 ° the angle of repose of CN1857618A medicine group, this explanation, of the present invention group of medicine has better mobility, can meet the requirement in suitability for industrialized production.
Simultaneously, in order to verify the stability of two groups of medicines, we also carry out long-term stable experiment to this, 25 ± 2 ° of temperature, under RH65% ± 5% condition, place after 12 months, experimental result is found, in medicine of the present invention, index composition Chinaroot Greenbier Rhizome sapogenin content does not occur obviously to reduce, and the phenomenon of the moisture absorption does not occur Chinese medicine composition, and obvious moisture absorption phenomenon has appearred in matched group CN1857618A medicine group.The medicine that this explanation technical solution of the present invention is made has the advantages that quality stability is good.
After the discussion of above-mentioned pharmaceutics comparative study, we illustrate beneficial effect with direct clinical experiment.Due to core innovative point of the present invention, be on the preparation technology of the prescription proportioning of medical material and medical material, we take the technical scheme of publication number CN1857618A and are immediate correlation technique, 4 kinds of trial drugs with prescription proportioning and preparation technology's various combination mode have been prepared, in order to simplify experimental implementation, save research expenditure, follow the experiment principle of parallel control, the Different therapeutical effect that each medicine group of forgoing is brought because of dosage form itself, adopt capsule common in pharmaceutical preparation as the experimental study carrier, thereby the creativeness of the outstanding technical solution of the present invention of science more, so this can derive for those skilled in the art fully thus, understand the beneficial effect of other parameter point technical scheme in the application, therefore the technology of the present invention content and drug effect result never are limited to this scope.
The concrete grammar of the preparation of trial drug is as follows:
1. the preparation of medicine group of the present invention:
Referring to describing about " (1) medicine group selection of the present invention best prescription proportioning and preparation technology " in above-mentioned " preparation technology's whole beneficial effect ", finally make 1000 hard capsules, standby.
2. the preparation of trial drug A group:
(1) by Rhizoma Anemarrhenae 38.1g, Radix Ginseng 12.7g, Cortex Phellodendri 31.8g, Radix Trichosanthis 25.4g, Radix Scrophulariae 15.2g, Radix Astragali 25.4g, in 75 ℃ of oven dry 17h, be ground into 120 order fine powders, then superfine powder is broken into the medicated powder that mean diameter is less than 30 μ m;
(2) by Radix Rehmanniae 19.1g, Cortex Lycii 38.1g, Radix Glehniae 15.2g, Herba Dendrobii 19.1g, Rhizoma Polygonati Odorati 25.4g, Fructus Schisandrae Chinensis 12.7g, Fructus Ligustri Lucidi 19.1g, Fructus Lycii 15.2g, Rhizoma Dioscoreae 25.4g, Radix Ophiopogonis 15.2g, Endothelium Corneum Gigeriae Galli 39.2g, Radix Puerariae 10.6g, in 70 ℃ dry to the medical material water content be 7%, be ground into 80 purpose coarse powder, add tween 80 to be ground into the medicated powder that mean diameter is less than 75 μ m;
By after (1) above-mentioned and (2) medicated powder mix homogeneously, add appropriate amylum pregelatinisatum, granulate, encapsulated, make 1000 hard capsules, standby.
3. the preparation of trial drug B group:
Get 47.3 parts of the Rhizoma Anemarrhenaes, 21.5 parts of Radix Ginsengs, 27.6 parts of Cortex Phellodendris, 36.8 parts of Radix Trichosanthis, 15.7 parts of Radix Rehmanniae, 21.7 parts of Radix Scrophulariaes, 12.3 parts of Radix Ophiopogonis, 51.2 parts of the Radixs Astragali, 48.7 parts of Cortex Lycii, 15.8 parts of Radix Glehniaes, 14.6 parts of Herba Dendrobiis, 12.8 parts of Rhizoma Polygonati Odorati, 7.5 parts of Fructus Schisandrae Chinensis, 9.1 parts of Fructus Ligustri Lucidi, 10.8 parts of Fructus Lycii, 53.6 parts of Rhizoma Dioscoreaes, 39.2 parts of Endothelium Corneum Gigeriae Galli, 10.6 parts of Radix Puerariaes, above 18 flavor medical materials, oven drying at low temperature (60～70 ℃), be ground into coarse powder, add poly-Pyrusussuriensis fat-80 2ml, be ground into micropowder (crossing 200 mesh sieves), after mix homogeneously, add appropriate amylum pregelatinisatum, granulate, encapsulated, make 1000 hard capsules.
4. the preparation of CN1857618A medicine group:
Referring to describing about " preparation of (2) CN1857618A medicine group " in above-mentioned " preparation technology's whole beneficial effect ", after granulation, the fill capsule, finally make 1000 hard capsules.
In order to verify the curative effect of finished product preparation of the present invention, the medicine group of the present invention that we will prepare, trial drug A group, trial drug B group, CN1857618A medicine group, carried out corresponding clinical trial, existing that report the test is as follows.
Clinical trial one:
1. object of study
Choose in May, 2009～2011 year JIUYUE tested case 250 examples in Hospital Attached to Shandong Chinese Medical Univ., age was at 40～65 years old, adopt parallel control, random method for designing, be divided at random 5 groups, medicine group 49 examples of the present invention wherein, male's 26 examples wherein, women's 23 examples, year mean age (55.4 ± 1.2), the course of disease 7～26 months; Test group A organizes 51 examples, male's 27 examples wherein, women's 24 examples, year mean age (53.4 ± 1.7), the course of disease 6～27 months; Experiment group B group 48 examples, male's 26 examples wherein, women's 22 examples, year mean age (56.5 ± 1.1), the course of disease 8～28 months; CN1857618A medicine group 52 examples, male's 27 examples wherein, women's 25 examples, year mean age (53.7 ± 1.3), the course of disease 7～25 months; JIANGTANGSHU JIAONANG group 50 examples, male's 26 examples wherein, women's 24 examples, average (54.1 ± 1.3) year, the course of disease 8～26 months.Analyze according to statistics, each organizes case there are no significant at aspects such as age, the courses of disease difference, has comparability.
2. case is selected
Diagnostic criteria was drafted according to Ministry of Public Health " new Chinese medicine guideline of clinical investigations " in 1993.
1. traditional Chinese medical science diabetes diagnostic criteria: all to have thirsty polydipsia, a rapid digestion of food easily hungry, and frequent micturition and sweet, body are shown in that gradually the disease such as become thin can make a definite diagnosis; 2. Western medicine diagnose standard: diabetic symptom is arranged, after the meal 2 hours blood glucoses >=11.1mmol/L or fasting glucose >=7.8m mol/L.
3. Therapeutic Method
All cases, during treating, all require diet control, and participate in suitable physical training.Treatment group is oral medicine group of the present invention, trial drug A group, trial drug B group, CN1857618A medicine group respectively, every day 3 times, each 5, takes continuously one month.Take the matched group JIANGTANGSHU JIAONANG, every day 3 times, each oral 5, took continuously one month.The patient regularly follows up a case by regular visits at special outpatient clinic weekly, carries out clinical observation.Before and after treatment, detect respectively fasting glucose, 2 h blood glucose after the meal, glycolated hemoglobin and blood fat (TC, TG), treatment is checked 1 time after finishing.
4. criterion of therapeutical effect
Efficacy assessment standard: 1. produce effects: after treatment, symptom disappears substantially, and fasting glucose<7.0mmol/L, 2 hours blood glucoses<8.3mmol/L, or blood glucose after the meal treat front decline more than 30%.Glycolated hemoglobin and the full recovery of blood fat (TC, TG) laboratory indexes are normal; 2. effective: after treatment, symptom is obviously improved, and fasting glucose<8.0mmol/L, 2 hours blood glucoses<10mmol/L, or blood glucose after the meal treat front decline more than 10%.Glycolated hemoglobin and blood fat (TC, TG) laboratory indexes make moderate progress before treating, but do not recover normal; 3. invalid: after treatment, symptom is not improved, and blood glucose, glycolated hemoglobin and blood fat (TC, TG) descend and do not reach above-mentioned standard.
5. results and analysis
The comparison of blood glucose before and after each experimental group treatment of table 2 (
)
Annotate: with the treatment front and back, self compare,
▲P<0.05,
▲ ▲P<0.01; It is relatively rear with the treatment of CN1857618A group,
P<0.05.
Experimental result by table 2 is as can be known, and medicine group of the present invention is to diabetics fasting glucose (FPG), 2 hours blood glucoses (2h PG), glycolated hemoglobin value after the meal, with before medication relatively, obvious reduction is arranged and significant difference (P<0.01) is arranged; After trial drug A group, trial drug B group, CN1857618A medicine group and JIANGTANGSHU JIAONANG group, fasting glucose (FPG), 2 hours blood glucoses (2h PG), glycolated hemoglobin value all have reduction that statistical significance (P<0.05) is also arranged after the meal; With effect after the treatment of CN1857618A medicine group relatively, medicine group of the present invention to fasting glucose (FPG), after the meal 2 hours blood glucoses (2h PG), that the glycolated hemoglobin value reduces degree is more obvious, all reaches statistical significance; Trial drug A group, trial drug B group to fasting glucose (FPG), after the meal 2 hours blood glucoses (2h PG) though, the curative effect of glycolated hemoglobin do not reach significant difference, all is better than CN1857618A medicine group and JIANGTANGSHU JIAONANG group.As can be seen here, curative effect the best of medicine group of the present invention.
The variation of blood fat before and after each experimental group treatment of table 3 (
)
Annotate: with the treatment front and back, self compare,
▲P<0.05,
▲ ▲P<0.01.
As shown in Table 3, after the patient took medicine group of the present invention, the numerical value of T-CHOL (TC) and triglyceride (TG), and compared before medication, obvious reduction arranged and significant difference is arranged; After taking trial drug A group, trial drug B group, JIANGTANGSHU JIAONANG group and CN1857618A medicine group, with before medication, compare, the numerical value of T-CHOL (TC) decreases and statistical significance is arranged, and triglyceride (TG) reduces and not obvious (P>0.05); And with the treatment of CN1857618A medicine group after effect relatively, medicine group of the present invention, trial drug A group, trial drug B group decrease to T-CHOL in serum and triglyceride numerical value, though do not reach statistical significance (P>0.05), but have significantly good effect trend, wherein take the curative effect of medicine group of the present invention as best.This experimental result explanation medicine group of the present invention can effectively be improved the hemorheological property of diabetics, and the morbidity of diabetics complication is had to certain inhibitory action, also may play preventive effect to the morbidity of diabetes simultaneously.
After each experimental group treatment of table 4, curative effect relatively
Experimental result by table 4 is as can be known, after 1 month clinical treatment, the clinical symptoms such as most of glycosuria patients' excessive thirst, polyuria, xerostomia improve significantly, medicine group of the present invention, trial drug A group, trial drug B group total effective rate all reach more than 75%, and CN1857618A medicine group and JIANGTANGSHU JIAONANG group only are respectively 67.3%, 68.0%.
Above clinical efficacy result shows: medicine group of the present invention is to patient's fasting glucose, 2 hours blood glucoses, glycolated hemoglobin, T-CHOL numerical value have very significantly reducing effect (P<0.01) after the meal, and trial drug A group, trial drug B group reducing effect is weak (P<0.05) slightly; In addition, medicine group of the present invention also reaches significant difference (P<0.05) to the reducing effect of triglyceride, but the medicine of other four groups reduces triglyceride levels there was no significant difference (P>0.05); Aspect the total effective rate index, medicine group of the present invention, trial drug A group, trial drug B group curative effect all is better than JIANGTANGSHU JIAONANG group and CN1857618A medicine group.In sum, after various experimental index overall merit, with curative effect the best of medicine group of the present invention.It can be said that bright: the technical scheme of prescribed dose proportioning of the present invention and preparation process amelioration is all to improve the powerful guarantee of the curative effect of pharmaceutical preparation treatment diabetes, not only can directly reduce the blood glucose value of diabetics, but also can alleviate the high T-CHOL of diabetics and the caused various complication of triglyceride, simultaneously the patient of high T-CHOL and triglyceride is suffered to diabetes and play certain preventive effect.Therefore, medicine of the present invention has the curative effect of good treatment diabetes.
The specific embodiment
Be below the specific embodiment of content of the present invention, for setting forth present specification, want the technical scheme of technical solution problem, help those skilled in the art to understand content of the present invention, but the realization of technical solution of the present invention is not limited to these embodiment.
Embodiment 1
(1) by Rhizoma Anemarrhenae 47.3g, Radix Ginseng 21.5g, Cortex Phellodendri 27.6g, Radix Trichosanthis 36.8g, Radix Scrophulariae 21.7g, Radix Astragali 51.2g, in 75 ℃ of oven dry 17h, be ground into 120 order fine powders, then superfine powder is broken into the medicated powder that mean diameter is less than 30 μ m;
(2) by Radix Rehmanniae 15.7g, Cortex Lycii 48.7g, Radix Glehniae 15.8g, Herba Dendrobii 14.6g, Rhizoma Polygonati Odorati 12.8g, Fructus Schisandrae Chinensis 7.5g, Fructus Ligustri Lucidi 9.1g, Fructus Lycii 10.8g, Rhizoma Dioscoreae 53.6g, Radix Ophiopogonis 12.3g, Endothelium Corneum Gigeriae Galli 39.2g, Radix Puerariae 10.6g, in 70 ℃ dry to the medical material water content be 7%, be ground into 80 purpose coarse powder, add tween 80 to be ground into the medicated powder that mean diameter is less than 75 μ m; By after (1) above-mentioned and (2) medicated powder mix homogeneously with appropriate dextrin, sucrose, mix, granulate, drying, make the 1000g granule.
Embodiment 2
(1) by Rhizoma Anemarrhenae 47.3g, Radix Ginseng 21.5g, Cortex Phellodendri 27.6g, Radix Trichosanthis 36.8g, Radix Scrophulariae 21.7g, Radix Astragali 51.2g, in 65 ℃ of oven dry 20h, be ground into 80 order fine powders, then superfine powder is broken into the medicated powder that mean diameter is less than 30 μ m;
(2) by Radix Rehmanniae 15.7g, Cortex Lycii 48.7g, Radix Glehniae 15.8g, Herba Dendrobii 14.6g, Rhizoma Polygonati Odorati 12.8g, Fructus Schisandrae Chinensis 7.5g, Fructus Ligustri Lucidi 9.1g, Fructus Lycii 10.8g, Rhizoma Dioscoreae 53.6g, Radix Ophiopogonis 12.3g, Endothelium Corneum Gigeriae Galli 39.2g, Radix Puerariae 10.6g, in 65 ℃ dry to the medical material water content be 6%, be ground into 60 purpose coarse powder, add tween 80 to be ground into the medicated powder that mean diameter is less than 75 μ m; By after (1) above-mentioned and (2) medicated powder mix homogeneously, add appropriate amylum pregelatinisatum, granulate, encapsulated, make the 1000g hard capsule.
Embodiment 3
(1) by Rhizoma Anemarrhenae 47.3g, Radix Ginseng 21.5g, Cortex Phellodendri 27.6g, Radix Trichosanthis 36.8g, Radix Scrophulariae 21.7g, Radix Astragali 51.2g, in 80 ℃ of oven dry 15 h, be ground into 150 order fine powders, then superfine powder is broken into the medicated powder that mean diameter is less than 30 μ m;
(2) by Radix Rehmanniae 15.7g, Cortex Lycii 48.7g, Radix Glehniae 15.8g, Herba Dendrobii 14.6g, Rhizoma Polygonati Odorati 12.8g, Fructus Schisandrae Chinensis 7.5g, Fructus Ligustri Lucidi 9.1g, Fructus Lycii 10.8g, Rhizoma Dioscoreae 53.6g, Radix Ophiopogonis 12.3g, Endothelium Corneum Gigeriae Galli 39.2g, Radix Puerariae 10.6g, in 80 ℃ dry to the medical material water content be 9%, be ground into 100 purpose coarse powder, add tween 80 to be ground into the medicated powder that mean diameter is less than 75 μ m; By after (1) above-mentioned and (2) medicated powder mix homogeneously with suitable substrate hot melt, stir, and carry out dripping, make the 1000g drop pill.
Embodiment 4
(1) by Rhizoma Anemarrhenae 36g, Radix Ginseng 27g, Cortex Phellodendri 23g, Radix Trichosanthis 45g, Radix Scrophulariae 27g, Radix Astragali 46g, in 80 ℃ of oven dry 15 h, be ground into 150 order fine powders, then superfine powder is broken into the medicated powder that mean diameter is less than 30 μ m;
(2) by Radix Rehmanniae 11g, Cortex Lycii 52g, Radix Glehniae 12g, Herba Dendrobii 18g, Rhizoma Polygonati Odorati 19g, Fructus Schisandrae Chinensis 5g, Fructus Ligustri Lucidi 6g, Fructus Lycii 16g, Rhizoma Dioscoreae 57g, Radix Ophiopogonis 15g, Endothelium Corneum Gigeriae Galli 34g, Radix Puerariae 15g, in 80 ℃ dry to the medical material water content be 9%, be ground into 100 purpose coarse powder, add tween 80 to be ground into the medicated powder that mean diameter is less than 75 μ m; By after (1) above-mentioned and (2) medicated powder mix homogeneously with suitable substrate hot melt, stir, and carry out dripping, make the 1000g drop pill.
Embodiment 5
(1) by Rhizoma Anemarrhenae 55g, Radix Ginseng 15g, Cortex Phellodendri 32g, Radix Trichosanthis 27g, Radix Scrophulariae 16g, Radix Astragali 57g, in 75 ℃ of oven dry 17h, be ground into 120 order fine powders, then superfine powder is broken into the medicated powder that mean diameter is less than 30 μ m;
(2) by Radix Rehmanniae 19g, Cortex Lycii 43g, Radix Glehniae 19g, Herba Dendrobii 10g, Rhizoma Polygonati Odorati 6g, Fructus Schisandrae Chinensis 11g, Fructus Ligustri Lucidi 13g, Fructus Lycii 7g, Rhizoma Dioscoreae 48g, Radix Ophiopogonis 8g, Endothelium Corneum Gigeriae Galli 45g, Radix Puerariae 7g, in 70 ℃ dry to the medical material water content be 7%, be ground into 80 purpose coarse powder, add tween 80 to be ground into the medicated powder that mean diameter is less than 75 μ m; By after (1) above-mentioned and (2) medicated powder mix homogeneously with appropriate dextrin, sucrose, mix, granulate, drying, make the 1000g granule.
Embodiment 6
(1) by Rhizoma Anemarrhenae 55g, Radix Ginseng 27g, Cortex Phellodendri 32g, Radix Trichosanthis 45g, Radix Scrophulariae 16g, Radix Astragali 46g, in 65 ℃ of oven dry 20h, be ground into 80 order fine powders, then superfine powder is broken into the medicated powder that mean diameter is less than 30 μ m;
(2) by Radix Rehmanniae 11g, Cortex Lycii 43g, Radix Glehniae 12g, Herba Dendrobii 18g, Rhizoma Polygonati Odorati 6g, Fructus Schisandrae Chinensis 11g, Fructus Ligustri Lucidi 6g, Fructus Lycii 7g, Rhizoma Dioscoreae 57g, Radix Ophiopogonis 8g, Endothelium Corneum Gigeriae Galli 45g, Radix Puerariae 7g, in 65 ℃ dry to the medical material water content be 8%, be ground into 60 purpose coarse powder, add tween 80 to be ground into the medicated powder that mean diameter is less than 75 μ m; By after (1) above-mentioned and (2) medicated powder mix homogeneously, add appropriate amylum pregelatinisatum, granulate, encapsulated, make the 1000g hard capsule.
Get medicine prepared by above-mentioned specific embodiment 1-6 and carry out clinical trial, to verify its curative effect.The object of study that this time test is taked, case selection, Therapeutic Method, curative effect index etc. are all identical with above-mentioned " clinical trial one ".Be specially: choose tested case 348 examples, be divided into 7 groups, wherein 1 group of 53 example of embodiment, 2 group of 51 example of embodiment, 3 group of 47 example of embodiment, 4 group of 49 example of embodiment, 5 group of 46 example of embodiment, 6 group of 50 example of embodiment, CN1857618A medicine group 52 examples, each organizes case there are no significant at aspects such as age, the courses of disease difference, has comparability.
Clinical test results shows, take 1 group of the embodiment of the present invention, 2 groups, 3 groups, 4 groups, 5 groups, after 6 groups and CN1857618A medicine group, we have detected patient's fasting glucose, 2 hours blood glucoses and glycolated hemoglobin index after the meal, concrete data are as follows: patient's fasting glucose (FPG) value is respectively: 7.63 ± 1.13 m mol/L, 7.77 ± 1.08 m mol/L, 7.83 ± 1.12 m mol/L, 8.25 ± 1.05m mol/L, 8.37 ± 1.10 m mol/L, 8.07 ± 1.06 m mol/L, 8.51 ± 1.10m mol/L, before and after with self, treating, compare, 1 group-6 groups of the embodiment of the present invention all show preferably therapeutic effect and highly significant statistical significance (P<0.01) are arranged, and CN1857618A medicine group reaches significant difference (P<0.05), 2 hours blood glucoses (2h PG) value is respectively after the meal: 10.56 ± 1.13 m mol/L, 10.76 ± 1.17m mol/L, 10.83 ± 1.08 m mol/L, 11.23 ± 1.10m mol/L, 11.08 ± 1.15 m mol/L, 11.16 ± 1.14m mol/L, 11.58 ± 1.13 m mol/L, before with self, treating, compare, 2 hours blood glucoses after the meal that the patient takes 1-6 group of the embodiment of the present invention have obvious reduction (P<0.01), and CN1857618A medicine group also reaches significant difference (P<0.05), glycolated hemoglobin value in patient body is respectively: 7.63 ± 1.05 m mol/L, 7.85 ± 1.08m mol/L, 7.74 ± 1.11m mol/L, 7.98 ± 1.07m mol/L, 8.25 ± 1.09 m mol/L, 8.16 ± 1.13 m mol/L, 8.37 ± 1.12m mol/L, with before self medication relatively, 1 group-4 groups of the embodiment of the present invention reduce apparent in view (P<0.01) to the glycolated hemoglobin value, and other group reduces DeGrain (P>0.05).Through above-mentioned clinical trial checking, 1 group of the embodiment of the present invention is reducing patient's fasting glucose and the best results aspect 2 hours blood glucoses and glycolated hemoglobin value after the meal, other 5 groups of embodiment therapeutic equivalences, but the comprehensive blood sugar decreasing effect of 6 groups of embodiment all is better than CN1857618A medicine group.
In addition, take 1 group of the embodiment of the present invention, 2 groups, 3 groups, 4 groups, 5 groups, after 6 groups and CN1857618A medicine group, T-CHOL in its patients serum (TC) value is respectively: 5.03 ± 1.12m mol/L, 5.21 ± 1.05 m mol/L, 5.09 ± 1.09 m mol/L, 5.16 ± 1.16m mol/L, 5.11 ± 1.13 m mol/L, 5.29 ± 1.08m mol/L, 5.37 ± 1.09m mol/L, with before self medication relatively, 1 group of the embodiment of the present invention, 3 groups, the numerical value of the T-CHOL of 5 groups (TC) has the highly significant diversity to reduce (P<0.01), 2 groups of other embodiment, 4 groups, 6 groups and CN1857618A medicine group can reach the numerical value (P<0.05) that significance reduces T-CHOL (TC), aspect the numerical value of the triglyceride in the patients serum, be respectively: 1.63 ± 1.02m mol/L, 1.86 ± 1.05 m mol/L, 1.75 ± 0.98 m mol/L, 1.93 ± 0.96m mol/L, 1.96 ± 1.03 m mol/L, 2.06 ± 0.93m mol/L, 2.26 ± 1.07 m mol/L, with before self medication relatively, each group all can to a certain degree reduce Triglycerides in Serum numerical value, but do not reach significant difference (P>0.05), and embodiment 1-6 group and CN1857618A medicine group more also not statistically significant (P>0.05), the therapeutic equivalence of each group is described.Therefore, this experiment shows, embodiment of the present invention 1-6 group medicine can suitably improve the diabetics hemorheological property, alleviates its complication, and in reducing serum aspect T-CHOL (TC) numerical value curative effect all be better than CN1857618A medicine group.
In addition, after the patient takes 1 group～6 groups of the embodiment of the present invention and CN1857618A medicine group, total effective rate is respectively 83.7%, 78.3%, 75.6%, 70.6%, 72.8%, 74.3%, 64.3%, and the clinical symptoms such as excessive thirst of Most patients, polyuria, xerostomia improves significantly.These clinical efficacy presentation of results: with CN1857618A medicine group, compare, Chinese medicine composition prepared by technical solution of the present invention is having more outstanding curative effect aspect the treatment diabetes.
In sum, Chinese medicine composition prepared by technical solution of the present invention, aspect the treatment diabetes, especially has obvious curative effect to the diabetes of deficiency of both QI and YIN, the scorching disease of the deficiency of YIN, and each embodiment medicine group all has better therapeutical effect.Hence one can see that, the advantages such as the prescription proportioning of Chinese medicine composition of the present invention is scientific and reasonable, preparation technology is efficiently feasible, drug effect is clear and definite, stable curative effect is reliable, its beneficial effect is further proved from above-mentioned series of experiments conclusion, therefore, Chinese medicine composition of the present invention is a kind of determined curative effect, prevent and treat safely and effectively diabetes medicament, have huge market potential, be worth further promoting.
Claims (9)
1. a Chinese medicine composition that is used for the treatment of diabetes, is characterized in that it is comprised of the raw material of following weight proportion: 36～55 parts of the Rhizoma Anemarrhenaes, 15～27 parts of Radix Ginsengs, 23～32 parts of Cortex Phellodendris, 27～45 parts of Radix Trichosanthis, 11～19 parts of Radix Rehmanniae, 16～27 parts of Radix Scrophulariaes, 8～15 parts of Radix Ophiopogonis, 46～57 parts of the Radixs Astragali, 43～52 parts of Cortex Lycii, 12～19 parts of Radix Glehniaes, 10～18 parts of Herba Dendrobiis, 6～19 parts of Rhizoma Polygonati Odorati, 5～11 parts of Fructus Schisandrae Chinensis, 6～13 parts of Fructus Ligustri Lucidi, 7～16 parts of Fructus Lycii, 48～57 parts of Rhizoma Dioscoreaes, 34～45 parts of Endothelium Corneum Gigeriae Galli, 7～15 parts of Radix Puerariaes.
2. the Chinese medicine composition that is used for the treatment of diabetes as claimed in claim 1, is characterized in that it is comprised of the raw material of following weight proportion: 47.3 parts of the Rhizoma Anemarrhenaes, 21.5 parts of Radix Ginsengs, 27.6 parts of Cortex Phellodendris, 36.8 parts of Radix Trichosanthis, 15.7 parts of Radix Rehmanniae, 21.7 parts of Radix Scrophulariaes, 12.3 parts of Radix Ophiopogonis, 51.2 parts of the Radixs Astragali, 48.7 parts of Cortex Lycii, 15.8 parts of Radix Glehniaes, 14.6 parts of Herba Dendrobiis, 12.8 parts of Rhizoma Polygonati Odorati, 7.5 parts of Fructus Schisandrae Chinensis, 9.1 parts of Fructus Ligustri Lucidi, 10.8 parts of Fructus Lycii, 53.6 parts of Rhizoma Dioscoreaes, 39.2 parts of Endothelium Corneum Gigeriae Galli, 10.6 parts of Radix Puerariaes.
3. the Chinese medicine composition for the treatment of diabetes as claimed in claim 1 or 2, is characterized in that, said composition adds the agent of pharmaceutic adjuvant granulation, hard capsule, drop pill commonly used on pharmaceutics.
4. the application of Chinese medicine composition as claimed in claim 1 or 2 in preparation treatment diabetes medicament.
5. the preparation method of Chinese medicine composition as claimed in claim 1 or 2, is characterized in that it is to be made according to following preparation technology by the raw material of following weight proportion: 47.3 parts of the Rhizoma Anemarrhenaes, 21.5 parts of Radix Ginsengs, 27.6 parts of Cortex Phellodendris, 36.8 parts of Radix Trichosanthis, 15.7 parts of Radix Rehmanniae, 21.7 parts of Radix Scrophulariaes, 12.3 parts of Radix Ophiopogonis, 51.2 parts of the Radixs Astragali, 48.7 parts of Cortex Lycii, 15.8 parts of Radix Glehniaes, 14.6 parts of Herba Dendrobiis, 12.8 parts of Rhizoma Polygonati Odorati, 7.5 parts of Fructus Schisandrae Chinensis, 9.1 parts of Fructus Ligustri Lucidi, 10.8 parts of Fructus Lycii, 53.6 parts of Rhizoma Dioscoreaes, 39.2 parts of Endothelium Corneum Gigeriae Galli, 10.6 parts of Radix Puerariaes;
(1) by the Rhizoma Anemarrhenae, Radix Ginseng, Cortex Phellodendri, Radix Trichosanthis, Radix Scrophulariae, Milkvetch Root, in 65～80 ℃ of oven dry 15～20h, be ground into 80～150 order fine powders, then superfine powder is broken into the medicated powder that mean diameter is less than 30 μ m;
(2) by Radix Rehmanniae, Cortex Lycii, Radix Glehniae, Herba Dendrobii, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis, Fructus Ligustri Lucidi, Fructus Lycii, Rhizoma Dioscoreae, Radix Ophiopogonis, Endothelium Corneum Gigeriae Galli, Radix Puerariae, in 65～80 ℃ dry to the medical material water content be 6%～9%, be ground into 60～100 purpose coarse powder, add tween 80 to be ground into the medicated powder that mean diameter is less than 75 μ m;
By after (1) above-mentioned and (2) medicated powder mix homogeneously, add pharmaceutic adjuvant commonly used on pharmaceutics to make different Chinese medicine preparation, obtain.
6. the preparation method of Chinese medicine composition as claimed in claim 5, is characterized in that it is to be made according to following preparation technology by the raw material of following weight proportion: 47.3 parts of the Rhizoma Anemarrhenaes, 21.5 parts of Radix Ginsengs, 27.6 parts of Cortex Phellodendris, 36.8 parts of Radix Trichosanthis, 15.7 parts of Radix Rehmanniae, 21.7 parts of Radix Scrophulariaes, 12.3 parts of Radix Ophiopogonis, 51.2 parts of the Radixs Astragali, 48.7 parts of Cortex Lycii, 15.8 parts of Radix Glehniaes, 14.6 parts of Herba Dendrobiis, 12.8 parts of Rhizoma Polygonati Odorati, 7.5 parts of Fructus Schisandrae Chinensis, 9.1 parts of Fructus Ligustri Lucidi, 10.8 parts of Fructus Lycii, 53.6 parts of Rhizoma Dioscoreaes, 39.2 parts of Endothelium Corneum Gigeriae Galli, 10.6 parts of Radix Puerariaes;
(1) by the Rhizoma Anemarrhenae, Radix Ginseng, Cortex Phellodendri, Radix Trichosanthis, Radix Scrophulariae, Milkvetch Root, in 75 ℃ of oven dry 17h, be ground into 120 order fine powders, then superfine powder is broken into the medicated powder that mean diameter is less than 30 μ m;
(2) by Radix Rehmanniae, Cortex Lycii, Radix Glehniae, Herba Dendrobii, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis, Fructus Ligustri Lucidi, Fructus Lycii, Rhizoma Dioscoreae, Radix Ophiopogonis, Endothelium Corneum Gigeriae Galli, Radix Puerariae, in 70 ℃ dry to the medical material water content be 7%, be ground into 80 purpose coarse powder, add tween 80 to be ground into the medicated powder that mean diameter is less than 75 μ m;
By after (1) above-mentioned and (2) medicated powder mix homogeneously, add pharmaceutic adjuvant commonly used on pharmaceutics to make different Chinese medicine preparation, obtain.
7. as the preparation method of Chinese medicine composition as described in claim 5 or 6, it is characterized in that:
(1) by 47.3 parts of the Rhizoma Anemarrhenaes, 21.5 parts of Radix Ginsengs, 27.6 parts of Cortex Phellodendris, 36.8 parts of Radix Trichosanthis, 21.7 parts of Radix Scrophulariaes, 51.2 parts of the Radixs Astragali, in 75 ℃ of oven dry 17h, be ground into 120 order fine powders, then superfine powder is broken into the medicated powder that mean diameter is less than 30 μ m;
(2) by 15.7 parts of Radix Rehmanniae, 48.7 parts of Cortex Lycii, 15.8 parts of Radix Glehniaes, 14.6 parts of Herba Dendrobiis, 12.8 parts of Rhizoma Polygonati Odorati, 7.5 parts of Fructus Schisandrae Chinensis, 9.1 parts of Fructus Ligustri Lucidi, 10.8 parts of Fructus Lycii, 53.6 parts of Rhizoma Dioscoreaes, 12.3 parts of Radix Ophiopogonis, 39.2 parts of Endothelium Corneum Gigeriae Galli, 10.6 parts of Radix Puerariaes, in 70 ℃ dry to the medical material water content be 7%, be ground into 80 purpose coarse powder, add tween 80 to be ground into the medicated powder that mean diameter is less than 75 μ m;
To after (1) above-mentioned and (2) medicated powder mix homogeneously, add appropriate dextrin, sucrose, then mix, granulate, drying, the granulation agent, obtain.
8. as the preparation method of Chinese medicine composition as described in claim 5 or 6, it is characterized in that:
(1) by 47.3 parts of the Rhizoma Anemarrhenaes, 21.5 parts of Radix Ginsengs, 27.6 parts of Cortex Phellodendris, 36.8 parts of Radix Trichosanthis, 21.7 parts of Radix Scrophulariaes, 51.2 parts of the Radixs Astragali, in 65 ℃ of oven dry 20h, be ground into 80 order fine powders, then superfine powder is broken into the medicated powder that mean diameter is less than 30 μ m;
(2) by 15.7 parts of Radix Rehmanniae, 48.7 parts of Cortex Lycii, 15.8 parts of Radix Glehniaes, 14.6 parts of Herba Dendrobiis, 12.8 parts of Rhizoma Polygonati Odorati, 7.5 parts of Fructus Schisandrae Chinensis, 9.1 parts of Fructus Ligustri Lucidi, 10.8 parts of Fructus Lycii, 53.6 parts of Rhizoma Dioscoreaes, 12.3 parts of Radix Ophiopogonis, 39.2 parts of Endothelium Corneum Gigeriae Galli, 10.6 parts of Radix Puerariaes, in 65 ℃ dry to the medical material water content be 6%, be ground into 60 purpose coarse powder, add tween 80 to be ground into the medicated powder that mean diameter is less than 75 μ m;
By after (1) above-mentioned and (2) medicated powder mix homogeneously, add appropriate amylum pregelatinisatum, granulate, encapsulated, make hard capsule, obtain.
9. as the preparation method of Chinese medicine composition as described in claim 5 or 6, it is characterized in that:
(1) by 47.3 parts of the Rhizoma Anemarrhenaes, 21.5 parts of Radix Ginsengs, 27.6 parts of Cortex Phellodendris, 36.8 parts of Radix Trichosanthis, 21.7 parts of Radix Scrophulariaes, 51.2 parts of the Radixs Astragali, in 80 ℃ of oven dry 15 h, be ground into 150 order fine powders, then superfine powder is broken into the medicated powder that mean diameter is less than 30 μ m;
(2) by 15.7 parts of Radix Rehmanniae, 48.7 parts of Cortex Lycii, 15.8 parts of Radix Glehniaes, 14.6 parts of Herba Dendrobiis, 12.8 parts of Rhizoma Polygonati Odorati, 7.5 parts of Fructus Schisandrae Chinensis, 9.1 parts of Fructus Ligustri Lucidi, 10.8 parts of Fructus Lycii, 53.6 parts of Rhizoma Dioscoreaes, 12.3 parts of Radix Ophiopogonis, 39.2 parts of Endothelium Corneum Gigeriae Galli, 10.6 parts of Radix Puerariaes, in 80 ℃ dry to the medical material water content be 9%, be ground into 100 purpose coarse powder, add tween 80 to be ground into the medicated powder that mean diameter is less than 75 μ m;
By after (1) above-mentioned and (2) medicated powder mix homogeneously with suitable substrate hot melt, stir, and carry out dripping, make drop pill, obtain.
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| CN105685863A (en) * | 2015-12-31 | 2016-06-22 | 苗娥 | Fructus swietenia macrophylla nutrition powder capable of lowering blood glucose and preparation method thereof |
| CN108671159A (en) * | 2018-06-27 | 2018-10-19 | 桐城市泰安中药材种植专业合作社 | A kind of composition and preparation method thereof of health treatment diabetes |
| CN108968068A (en) * | 2018-08-09 | 2018-12-11 | 魏鹏 | A kind of Halth-care composition and preparation method thereof for alleviating diabetes complications |
| CN109010621A (en) * | 2018-10-31 | 2018-12-18 | 河南中医药大学 | A kind of Chinese medicine composition that treating diabetes, preparation method and applications |
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