CN103432420A - Traditional Chinese medicine composition for treating diabetes, and preparation method and detection method thereof - Google Patents
Traditional Chinese medicine composition for treating diabetes, and preparation method and detection method thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for treating diabetes, and a preparation method and a detection method thereof. The traditional Chinese medicine composition is prepared by rhizoma anemarrhenae, ginseng, cortex phellodendri, radix trichosanthis, unprocessed rehmannia root, radix scrophulariae and the like. The detection method of the traditional Chinese medicine composition comprises the steps of thin-layer identifications of cortex phellodendri, cortex lycii radicis, fructus lycii, fructus schizandrae, glossy privet fruit and root of kudzu vine; and determination of sarsasapogenin content in the traditional Chinese medicine composition. The traditional Chinese medicine composition provided by the invention has the characteristics of simple and practical process, safety and efficiency, significant pharmacology and drug efficacy and clinical effects.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition for the treatment of diabetes and preparation method thereof and detection method, 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 relative deficiency cause take carbohydrate metabolism disturbance as 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, thereby research from motherland's medicine treasure-house, finds efficient, low toxicity, safe, inexpensive hypoglycemic medicine, has very great clinical meaning.
Diabetes spp Chinese medicine " diabetes " category, its cause of disease multi-source is in the plain body deficiency of YIN, and eating and drinking without temperance, how because of disorder of emotion.Due to labor is wanted excessively, the moon of consumption impairing the lung, stomach, kidney, cause the deficiency of YIN scorching appearance to be quenched one's thirst.Its pathogenesis be the deficiency of YIN be this, scorching be mark, and resembling of gas and deficiency of both QI and YIN can appear consuming, sick to later stage deficiency of YIN affecting YANG, deficiency in both YIN and YANG appears, 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 take the Rhizoma Anemarrhenae, Radix Ginseng 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 different amounts of components from prescription, the aspects such as preparation technology disclose, protection, but in actual application, the effect of the Chinese patent medicine that our discovery is made by above-mentioned preparation method is desirable not enough, and the application's patent is to grope by great many of experiments, further optimize process of preparing, and better preparation technology's flow process and parameter have been found, 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, Chinese medicine composition and method for making and the detection method that quality controllable, curative effect is treated diabetes reliably.
Technical solution of the present invention is: a kind of Chinese medicine composition that is used for the treatment of diabetes is characterized in that it is to be made according to following preparation technology by the raw material of following weight proportion: 38.1 parts of the Rhizoma Anemarrhenaes, 12.7 parts of Radix Ginsengs, 31.8 parts of Cortex Phellodendris, 25.4 parts of Radix Trichosanthis, 19.1 parts of Radix Rehmanniae, 15.2 parts of Radix Scrophulariaes, 15.2 parts of Radix Ophiopogonis, 25.4 parts of the Radixs Astragali, 38.1 parts of Cortex Lycii, 15.2 parts of Radix Glehniaes, 19.1 parts of Herba Dendrobiis, 25.4 parts of Rhizoma Polygonati Odorati, 12.7 parts of Fructus Schisandrae Chinensis, 19.1 parts of Fructus Ligustri Lucidi, 15.2 parts of Fructus Lycii, 25.4 parts of Rhizoma Dioscoreaes, 31.8 parts of Endothelium Corneum Gigeriae Galli, 15.2 parts of Radix Puerariaes; Become fine powder standby the Rhizoma Anemarrhenae, Radix Ginseng, Radix Trichosanthis, Radix Rehmanniae, Radix Scrophulariae, the Radix Astragali, Radix Glehniae, Herba Dendrobii, Rhizoma Polygonati Odorati, Rhizoma Dioscoreae, Endothelium Corneum Gigeriae Galli 11 flavor pulverizing medicinal materials; Then by Cortex Phellodendri, Fructus Schisandrae Chinensis, Fructus Ligustri Lucidi, Radix Puerariae 4 flavor medical materials, and adopt after ethanol extraction drying to obtain ethanol extract; By the medicinal residues after alcohol extraction and Radix Ophiopogonis, Cortex Lycii, Fructus Lycii 3 flavor medical materials, decoct with water extraction again; Water decoction is used to alcohol deposition method again, after removing impurity, obtain water extract after drying; By above-mentioned fine powder, after ethanol extract and water extract mix homogeneously, obtain total mixture, and add suitable adjuvant, mix, granulate, make hard capsule.
Concrete technical scheme is comprised of the raw material of following weight proportion: 38.1 parts of the Rhizoma Anemarrhenaes, 12.7 parts of Radix Ginsengs, 31.8 parts of Cortex Phellodendris, 25.4 parts of Radix Trichosanthis, 19.1 parts of Radix Rehmanniae, 15.2 parts of Radix Scrophulariaes, 15.2 parts of Radix Ophiopogonis, 25.4 parts of the Radixs Astragali, 38.1 parts of Cortex Lycii, 15.2 parts of Radix Glehniaes, 19.1 parts of Herba Dendrobiis, 25.4 parts of Rhizoma Polygonati Odorati, 12.7 parts of Fructus Schisandrae Chinensis, 19.1 parts of Fructus Ligustri Lucidi, 15.2 parts of Fructus Lycii, 25.4 parts of Rhizoma Dioscoreaes, 31.8 parts of Endothelium Corneum Gigeriae Galli, 15.2 parts of Radix Puerariaes;
By following steps, be prepared from:
(1) the Rhizoma Anemarrhenae, Radix Ginseng, Radix Trichosanthis, Radix Rehmanniae, Radix Scrophulariae, the Radix Astragali, Radix Glehniae, Herba Dendrobii, Rhizoma Polygonati Odorati, Rhizoma Dioscoreae, Endothelium Corneum Gigeriae Galli 11 flavor pulverizing medicinal materials are become to 60-120 order fine powder, sieve, standby;
(2) get Cortex Phellodendri, Fructus Schisandrae Chinensis, Fructus Ligustri Lucidi, Radix Puerariae medical material, add 7～10 times of amount 60%～90% alcohol reflux 1～3 time, each 1～3 h, filter, merging filtrate also reclaims ethanol to nothing alcohol flavor, and the medicinal liquid concentrate drying also is ground into dried cream powder, sieve, medicinal residues are standby;
(3) the medicinal residues in (2) are merged with Radix Ophiopogonis, Cortex Lycii, Fructus Lycii medical material again, the decocting that adds 8～12 times of amounts boils 1～3 time, each 0.5～2 h, filter, merging filtrate, concentrating under reduced pressure becomes the clear paste that relative density is 1.05～1.15, add ethanol to make to reach 60%～80% containing the alcohol amount, stir evenly, standing 12～48 h of cold preservation, filter, decompression filtrate recycling ethanol, concentrating under reduced pressure is dry and be ground into dried cream powder, sieves, standby;
(4) by dried cream powder in dried cream powder, (3) in fine powder, (2) in above-mentioned (1), after mix homogeneously, obtain total mixture, and add suitable adjuvant, mix, granulate, make hard capsule.
Wherein preferred preparation method is:
(1) the Rhizoma Anemarrhenae, Radix Ginseng, Radix Trichosanthis, Radix Rehmanniae, Radix Scrophulariae, the Radix Astragali, Radix Glehniae, Herba Dendrobii, Rhizoma Polygonati Odorati, Rhizoma Dioscoreae, Endothelium Corneum Gigeriae Galli 11 flavor pulverizing medicinal materials are become to 80 order fine powders, sieve, standby;
(2) get Cortex Phellodendri, Fructus Schisandrae Chinensis, Fructus Ligustri Lucidi, Radix Puerariae medical material, add 8 times of amount 75% alcohol reflux 2 times, each 2 h, filter, and merging filtrate also reclaims ethanol to nothing alcohol flavor, and the medicinal liquid concentrate drying also is ground into dried cream powder, sieves, and medicinal residues are standby;
(3) the medicinal residues in (2) are merged with Radix Ophiopogonis, Cortex Lycii, Fructus Lycii medical material again, the decocting that adds 10 times of amounts boils 2 times, each 1 h, filter, merging filtrate, concentrating under reduced pressure becomes the clear paste that relative density is 1.05～1.15, add ethanol to make to reach 70% containing the alcohol amount, stir evenly, standing 24 h of cold preservation, filter, decompression filtrate recycling ethanol, concentrating under reduced pressure is dry and be ground into dried cream powder, sieves, standby;
(4) by dried cream powder in dried cream powder, (3) in fine powder, (2) in above-mentioned (1), after mix homogeneously, obtain total mixture, and add suitable adjuvant, mix, granulate, make hard capsule.
The discrimination method of above Chinese medicine composition is as follows:
(1) the thin layer of Cortex Phellodendri is differentiated: get Chinese medicine composition 3g, add methanol 20ml, reflux 15 minutes, let cool, and filters, and gets filtrate as need testing solution; Separately get Cortex Phellodendri control medicinal material 0.3 g, with " preparing need testing solution " same procedure, make control medicinal material solution respectively; Get again the berberine hydrochloride reference substance, add methanol and make the solution of every 1 ml containing 0.2mg, product solution in contrast; According to thin layer chromatography test in appendix VIB of Chinese Pharmacopoeia version in 2010, draw each 2 μ l of above-mentioned three kinds of solution, put on same silica gel g thin-layer plate respectively, take ethyl acetate-butanone-formic acid-water=10:7:1:1 as developing solvent, launch, take out, dry, put under the 365nm ultraviolet light and inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, the speckle of aobvious same color;
(2) the thin layer of Cortex Lycii and Fructus Lycii is differentiated: get Chinese medicine composition 5g, add water 50ml, shake up, place 1 hour, supersound process 5 minutes, take out, centrifugal, gets supernatant, extract with ethyl acetate 25 ml joltings, divide and get acetic acid ethyl fluid, be concentrated into 1 ml, as need testing solution; Separately get Fructus Lycii reference substance medical material 1g and Cortex Lycii reference substance medical material 2g, with " preparing need testing solution " same procedure, make Fructus Lycii, Cortex Lycii control medicinal material solution respectively; According to thin layer chromatography test in appendix VIB of Chinese Pharmacopoeia version in 2010, draw above-mentioned three kinds of solution, 5 μ l, put on same silica gel g thin-layer plate respectively, take ethyl acetate-chloroform-formic acid=9:6:0.5 as developing solvent, launch, take out, dry, put under the 365nm ultraviolet light and inspect, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, the fluorescence speckle of aobvious same color;
(3) the thin layer of Fructus Schisandrae Chinensis is differentiated: get Chinese medicine composition 5g, add chloroform 40ml, reflux 30 minutes, filter, the filtrate evaporate to dryness, and residue adds chloroform 1.5ml to be made to dissolve, as need testing solution; Separately get Fructus Schisandrae Chinensis control medicinal material 2g, with " preparing need testing solution " same procedure, make control medicinal material solution, then get the deoxyschizandrin reference substance respectively, add chloroform and make the solution of every 1ml containing 1mg, product solution in contrast; According to thin layer chromatography test in appendix VIB of Chinese Pharmacopoeia version in 2010, above-mentioned absorption need testing solution 4 μ l, control medicinal material solution 1 μ l and reference substance solution 2 μ l, put in same silica gel G respectively
254on lamellae, the upper solution of petroleum ether-Ethyl formate-formic acid=15:5:1 of take is developing solvent, launches, take out, dry, put under the 254nm ultraviolet light and inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color;
(4) the thin layer of Fructus Ligustri Lucidi is differentiated: get Chinese medicine composition 3g, and the 30ml that adds diethyl ether, reflux 30 minutes, filter, and filtrate volatilizes, and residue adds dehydrated alcohol 2ml to be made to dissolve, as need testing solution; Separately even up pier fruit acid reference substance, add dehydrated alcohol and make the solution of every 1ml containing 1mg, product solution in contrast; According to thin layer chromatography test in appendix VIB of Chinese Pharmacopoeia version in 2010, draw each 2 μ l of above-mentioned two kinds of solution, put on same silica gel g thin-layer plate respectively, take chloroform-methanol=40:1 as developing solvent, launch, take out, dry, spray is with the phosphomolybdic acid test solution, 105 ℃ of heating 5 minutes, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, the speckle of aobvious same color;
(5) the thin layer of Radix Puerariae is differentiated: get this Chinese medicine composition 4g, add methanol 50ml, supersound process 30 minutes, filter, the filtrate evaporate to dryness, residue adds water 10 ml to be made to dissolve, put on processed good polyamide column, first water 100 ml washings, discard washing liquid, then use 30% ethanol 100ml eluting, collect eluent, evaporate to dryness, residue adds methanol 2ml to be made to dissolve, as need testing solution; Separately get the puerarin reference substance, add methanol and make the solution of 1ml containing 1mg, product solution in contrast; According to thin layer chromatography test in appendix VIB of Chinese Pharmacopoeia version in 2010, draw each 2 μ l of above-mentioned solution, put on same silica gel g thin-layer plate respectively, take chloroform-methanol-water=7:2.5:0.25 as developing solvent, launch, take out, dry, put under the 365nm ultraviolet light and inspect, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
The active constituent content measuring method of above Chinese medicine composition is as follows:
Get Chinese medicine composition 1g, accurately weighed, put in tool plug conical flask, precision adds ethanol 25ml, weighed weight, soaked overnight, supersound process 40 minutes, let cool, weighed weight again, supply the weight of less loss with ethanol, shake up, filter, precision measures subsequent filtrate 10 ml, put water bath method, residue adds water 10 ml, hydrochloric acid 1 ml, put in water-bath reflux 2 hours, take out, let cool, jolting limit, limit drip 40% sodium hydroxide solution to color by orange sport orange red, with the chloroform jolting, extract 2 times, each 30ml, merge chloroform extraction liquid, evaporate to dryness, residue adds dissolve with methanol, be transferred in 5 ml measuring bottles, add methanol to scale, shake up, as test sample, separately get Chinaroot Greenbier Rhizome sapogenin reference substance appropriate, add methanol and make the solution of every 1ml containing 0.17mg, product solution in contrast, precision is drawn above-mentioned reference substance solution, need testing solution respectively, and the injection liquid chromatography, take methanol: water=94:6 as mobile phase, is measured, and calculates, and contains Chinaroot Greenbier Rhizome sapogenin C in Chinese medicine composition
27h
44o
3must not be less than the 0.38mg/ grain.
Technical solution of the present invention is in the middle of the practical study process, and than immediate correlation technique, its main creation point is the extraction purification aspect of medical material, has brought thus significant technological progress, and its main beneficial effect is as follows.
Chinese medicine composition of the present invention is comprised of the 18 flavor Chinese medicines such as the Rhizoma Anemarrhenae, Radix Ginseng, Ramulus Cinnamomi, Cortex Phellodendri, Radix Trichosanthis; the dosage form that application number is 200610066989.1 protections is common oral preparation; its technique with all medical material cold drying in side after; the employing micronizing is prepared from; but, in actual use, find that its drug effect is not also desirable especially; may for the active component enrichment not enough, cause drug bioavailability lower.Modern study shows, in side, Cortex Phellodendri, Fructus Schisandrae Chinensis, Fructus Ligustri Lucidi, its main active of Radix Puerariae have: berberine, jateorhizine, schizandrin, oleanolic acid, Radix Puerariae total flavones etc., these materials all have the excellent dissolution effect in the ethanol of middle and high concentration, therefore adopt ethanol extraction, the Chinese medicine active component can be extracted; And in side in Radix Ophiopogonis, Cortex Lycii, Fructus Lycii medical material main active have: Radix Ophiopogonis total saponins, taurine, lycium barbarum polysaccharide etc. adopt the decocting method of boiling to extract; In addition, for to greatest extent that extracts active ingredients in medical material is complete, therefore the medicinal residues after ethanol extraction and Radix Ophiopogonis, Cortex Lycii, Fructus Lycii medical material are extracted with decocting, after extracting solution is concentrated, and employing water extract-alcohol precipitation method, to remove chlorophyll, the impurity components such as starch, the content of raising active substance component; According to above-mentioned preparation technology, the Chinese medicine composition obtained, we carry out accelerated stability test and 12 months long-term stable experiments of 6 months to this, experimental result is found, after placing 12 months, Chinaroot Greenbier Rhizome sapogenin content in medicine of the present invention, with 0 month, compare, content does not occur obviously to reduce, and the phenomenon of the moisture absorption does not occur Chinese medicine composition, this illustrates Chinese medicine composition of the present invention, has the characteristics of good stability.
It is below the pharmacodynamic study test to technical solution of the present invention, because core innovative point of the present invention is: the extraction and purification process aspect of medical material, we take the technical scheme of publication number CN1857618A is immediate correlation technique, therefore we to take the two technology contents in pharmacodynamic experiment be contrast, research level in conjunction with modern pharmacology, and the blood sugar lowering test to STZ and alloxan animal hyperglycemia model by research Chinese medicine composition of the present invention, impact on alloxan model mice serum insulin content and alloxan model mice anti-fatigue test, illustrated fully the pharmacodynamics curative effect of traditional Chinese medicine composition for treating diabetes of the present invention, result shows, it has very significantly therapeutic effect.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, thereby the creativeness of the outstanding technical solution of the present invention of science more, we take the middle product group of one of them the most approaching technical scheme and are studied as representative, 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, so the technology of the present invention content and drug effect result never are limited to this scope.
1 test material and result processing method:
1.1 the preparation of trial drug:
The preparation of A trial drug of the present invention:
(1) by Rhizoma Anemarrhenae 38.1g, Radix Ginseng 12.7g, Radix Trichosanthis 25.4g, Radix Rehmanniae 19.1g, Radix Scrophulariae 15.2g, Radix Astragali 25.4g, Radix Glehniae 15.2g, Herba Dendrobii 19.1g, Rhizoma Polygonati Odorati 25.4g, Rhizoma Dioscoreae 25.4g, Endothelium Corneum Gigeriae Galli 31.8g, be ground into 80 order fine powders, sieve, standby;
(2) get Cortex Phellodendri 31.8g, Fructus Schisandrae Chinensis 12.7g, Fructus Ligustri Lucidi 19.1g, Radix Puerariae 15.2g, add 8 times of amount 75% alcohol reflux 2 times, each 2 h, filter, merging filtrate also reclaims ethanol to nothing alcohol flavor, and the medicinal liquid concentrate drying also is ground into dried cream powder, sieve, medicinal residues are standby;
By the medicinal residues in (2) again with Radix Ophiopogonis 15.2g, Cortex Lycii 38.1g, Fructus Lycii 15.2g, the decocting that adds 10 times of amounts boils 2 times, each 1 h, filter, merging filtrate, concentrating under reduced pressure becomes the clear paste that relative density is 1.05～1.15, add ethanol to make to reach 70% containing the alcohol amount, stir evenly, standing 24 h of cold preservation, filter, decompression filtrate recycling ethanol, concentrating under reduced pressure is dry and be ground into dried cream powder, sieves, standby;
(4) by dried cream powder in dried cream powder, (3) in fine powder, (2) in above-mentioned (1), after mix homogeneously, standby; Before use, adding distil water is mixed with the suspendible medicinal liquid, obtains the middle product group of medicine of the present invention.
B. the preparation of product group in the middle of CN1857618A:
Get Rhizoma Anemarrhenae 38.1g, Radix Ginseng 21.5g, Cortex Phellodendri 27.6g, Radix Trichosanthis 36.8g, Radix Rehmanniae 15.7g, 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 above 18 flavor medical materials of 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), standby after mix homogeneously; Before use, the suspendible medicinal liquid that adding distil water is mixed with in the middle of the invention described above, product group concentration is identical, obtain the middle product group of CN1857618A.
1.2 experimental animal: white mice, Kunming kind ♂ 20-24 g; By Shandong University's Experimental Animal Center, provided;
1.3 statistical procedures: experimental result with
mean, adopt the t check, measure the significance of group difference.
2.1 the impact on STZ animal pattern blood glucose
Get 100 of healthy mices, divide at random 5 groups, 20 every group, be respectively Normal group, model control group, phenformin group, the middle product group of CN1857618A, the middle product group of medicine of the present invention.Before experiment, fasting is 18 hours, freely drinks water.Streptozotocin (STZ) is dissolved in to (pH=4.2-4.3) in 0.05M citric acid ice bath buffer salt solution before injection and is configured to 10mg/ml solution, through lumbar injection 0.2ml, dosage is 40mg/KG.Except normal control treated animal lumbar injection equal volume normal saline, all the other each groups are all injected STZ.Injection STZ treated animal is got blood in 72 hours after modeling, measures blood glucose value, select blood glucose >=13.8 mmol/L as diabetic mice as modeling success standard.Through above-mentioned screening process, choose 50 mices, be divided into 5 groups, wherein Normal group retains, and all the other 40 are divided into: product group in the middle of product group, medicine of the present invention in the middle of model control group, phenformin group, CN1857618A, 10 every group.Each organizes equal gastric infusion: Normal group and model control group give normal saline 2.0ml/100g, positive controls gives 0.5% phenformin hydrochloride aqueous solution 2.0ml/100g, and the dosage that gives the middle product group of of the present invention group of medicine and the middle product group of CN1857618A is 0.054g/100g, once a day, continuous 3 weeks, and fasting 3 hours before the last administration, within after administration 2 hours, get blood and survey BG(blood glucose) value, carry out statistical procedures, experimental result is in Table 1.
Table 1 on the impact of STZ model mice BG (
)
Annotate: relatively rear with the normal group treatment,
■ ■p<0.01; Relatively rear with the model group treatment, * P<0.05, * * P<0.01; It is relatively rear with product group treatment in the middle of CN1857618A,
△p<0.05.
Table 1 result shows, with normal group, compares, and the blood glucose of model control group is significantly increased and significant difference is arranged, and illustrates that this experiment modeling is successfully.With after model control group treatment relatively, in the middle of phenformin group, CN1857618A in the middle of product group, medicine of the present invention the product group diabetic mice due to streptozotocin is all had to hypoglycemic activity, and reached significance difference opposite sex curative effect; With product group in the middle of CN1857618A, compare, in the middle of medicine of the present invention, the reduction blood glucose action effect of product group and phenformin group, also reach statistical significance, has obviously better effect trend.This results suggest thus, in the middle of medicine of the present invention, the product group causes the blood sugar increasing due to Mice Islet Cells β damage that obvious inhibitory action is arranged to STZ, and curative effect is better than product group in the middle of CN1857618A, suitable according to phenformin to group with the positive.
2.2 the impact on alloxan model mice blood glucose
Get 100 of healthy male mices, divide at random 5 groups, 20 every group, be respectively: product group in the middle of product group, medicine of the present invention in the middle of Normal group, model control group, phenformin group, CN1857618A.Before experiment, fasting is 18 hours, freely drinks water, and alloxan is dissolved in normal saline, is mixed with the 10mg/ml solution for standby.Except the normal saline of Normal group lumbar injection equal volume, all the other respectively organize alloxan 0.3 ml of lumbar injection every day, and dosage is 150mg/KG, injects continuously 2 days.Except Normal group, all the other each treated animals are got blood in 72 hours after modeling, measure blood glucose value, select blood glucose >=13.8 mmol/L as diabetic mice as modeling success standard.Through above-mentioned screening, choose 50 mices, except Normal group retains, all the other 40 are divided into: product group in the middle of product group, medicine of the present invention in the middle of model control group, phenformin group, CN1857618A; Dosage is with " 2.1 ", and fasting 3 hours before the last administration, within after administration 2 hours, gets blood, measures BG(blood glucose) value, carry out statistical procedures, experimental result sees the following form 2.
Table 2 on the impact of alloxan model mice blood glucose (
)
Annotate: relatively rear with the normal group treatment,
■ ■p<0.01; Relatively rear with the model group treatment, * * P<0.01, * * * P<0.001; It is relatively rear with product group treatment in the middle of CN1857618A,
△p<0.05.
Table 2 result shows, with normal group, compares, and the model control group experimental result has significant difference, and this experiment modeling success is described; With model control group relatively, in the middle of phenformin group, CN1857618A in the middle of product group, medicine of the present invention the product group remarkable to diabetic mice hypoglycemic activity effect due to alloxan, and reached the significance difference opposite sex; With product group in the middle of CN1857618A, compare, in the middle of medicine of the present invention, product group and phenformin group reduce the blood glucose effect increases to some extent, and reached statistical significance, result confirms, in the middle of medicine of the present invention, the product group causes the blood sugar increasing due to Mice Islet Cells β damage that obvious inhibitory action is arranged to alloxan, and curative effect is better than the middle product group of CN1857618A, suitable with the positive controls phenformin.
2.3 the impact on the insulin cell function
Mice modeling method and grouping, with " 2.2 ", are got 50 of mices, are divided into 5 groups, product group in the middle of product group, medicine of the present invention in the middle of Normal group, model control group, phenformin group, CN1857618A; Each organizes equal gastric infusion, Normal group and model control group give normal saline 2.0ml/100g, and positive controls gives 0.5% phenformin hydrochloride aqueous solution 2.0ml/100g, and the dosage that gives the middle product group of of the present invention group of medicine and the middle product group of CN1857618A is 0.054g/100g, once a day, after continuous 3 weeks, get mice serum, with I-insulin radioimmunoassay, RIA medicine box, measure insulin content, the results are shown in Table 3.
Table 3 on the impact of alloxan model mice serum insulin content (
)
Annotate: with normal group, compare,
■ ■p<0.01; Compare * P<0.05, * * * P<0.001 with model group; With product group in the middle of CN1857618A, compare,
△p<0.05.
Table 3 result shows, model group and normal group compared, and the result demonstration, the diversity between the two has reached utmost point significance, shows this research modeling success; To the alloxan model mice, after treatment in three weeks, in the middle of medicine of the present invention, product group, the middle product group of CN1857618A, phenformin group all can make the mice serum insulin content increase, and compare with model control group, and have reached significant difference; With product group in the middle of CN1857618A, compare, in the middle of medicine of the present invention, product group and phenformin group increase alloxan model mice serum insulin content, and reach statistical significance, this results suggest, in the middle of medicine of the present invention, the product group recovers to have significant facilitation to alloxan model mice β cell function.
2.4 the impact on mouse anti-reflecting fatigue
Mice modeling method and grouping are identical with " 2.2 ", each organizes equal gastric infusion, except Normal group gives the normal saline of same dose and volume, all the other are respectively organized dosage and are 0.054g/100g, continuous 4 days, before the last administration, fasting is 12 hours, and in the last administration after 1 hour, each group mice is put into respectively to depth of water 25cm, in the container that water temperature is 21 ℃, record is put into water to sinking to the bottom time of not refloating as swimming continuance time from mice, respectively organizes the ability of the mice strong degree of muscle power and resisting fatigue.Experimental result is in Table 4.
Table 4 on the impact of mice swimming time (
)
Annotate: with normal group, compare,
■ ■p<0.01; Compare * P<0.05, * * P<0.01, * * * P<0.001 with model control group; With product group in the middle of CN1857618A, compare,
△ △p<0.01.
Experimental result from table 4: with normal group, compare, the test index of the mice of model group has significant diversity, points out the modeling success of this experiment; With model control group, compare, in the middle of medicine of the present invention, product group, Hypolycemic pellet group, the middle product group of CN1857618A all obviously increase the mice swimming time, and statistical difference are arranged; With product group in the middle of CN1857618A, compare, in the middle of medicine of the present invention, the product group obviously extends the mice swimming time, reached the diversity effect, results suggest: in the middle of medicine group of the present invention, the product group has potentiation to the prolongation of mice swimming time, show that it can improve the laboratory animal anti-fatigue ability, and be better than the middle product group of CN1857618A, be conducive to improve the resistance of experimental animal.
In sum, in the middle of medicine of the present invention, the middle product group of product group and CN1857618A all has the alloxan of reduction and streptozotocin model mice blood glucose, alloxan model mice serum insulin content is increased and improves to the effects such as alloxan model mice swimming time, these effects are pharmacological basis for the treatment of diabetes disease, curative effect the best of medicine of the present invention wherein, as can be seen here, medicine of the present invention with approach most correlation technique and compare and there is outstanding beneficial effect.
The specific embodiment
Be below the specific embodiment of content of the present invention, want the technical scheme of technical solution problem for setting forth present specification, contribute to 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) the Rhizoma Anemarrhenae 38.1 g, Radix Ginseng 12.7 g, Radix Trichosanthis 31.8g, Radix Rehmanniae 19.1g, Radix Scrophulariae 15.2g, Radix Astragali 25.4g, Radix Glehniae 15.2g, Herba Dendrobii 19.1g, Rhizoma Polygonati Odorati 25.4g, Rhizoma Dioscoreae 25.4g, Endothelium Corneum Gigeriae Galli 31.8g are ground into to 80 order fine powders, sieve, standby;
(2) get Cortex Phellodendri 31.8g, Fructus Schisandrae Chinensis 12.7g, Fructus Ligustri Lucidi 19.1g, Radix Puerariae 15.2g medical material, add 8 times of amount 75% alcohol reflux 2 times, each 2h, filter, merging filtrate also reclaims ethanol to nothing alcohol flavor, and the medicinal liquid concentrate drying also is ground into dried cream powder, sieve, medicinal residues are standby;
By the medicinal residues in (2) again with Radix Ophiopogonis 15.2g, Cortex Lycii 38.1g, Fructus Lycii 15.2g medical material merge, the decocting that adds 10 times of amounts boils 2 times, each 1h, filter, merging filtrate, concentrating under reduced pressure becomes the clear paste that relative density is 1.05～1.15, add ethanol to make to reach 70% containing the alcohol amount, stir evenly, the standing 36h of cold preservation, filter, decompression filtrate recycling ethanol, concentrating under reduced pressure is dry and be ground into dried cream powder, sieves, standby;
(4) by fine powder in above-mentioned (1), dried cream powder in (2), dried cream powder in above-mentioned (3), after mix homogeneously, obtain total mixture, and add suitable adjuvant, mixes, and granulates, and makes 1000 hard capsules.
Embodiment 2
(1) the Rhizoma Anemarrhenae 38.1 g, Radix Ginseng 12.7 g, Radix Trichosanthis 31.8g, Radix Rehmanniae 19.1g, Radix Scrophulariae 15.2g, Radix Astragali 25.4g, Radix Glehniae 15.2g, Herba Dendrobii 19.1g, Rhizoma Polygonati Odorati 25.4g, Rhizoma Dioscoreae 25.4g, Endothelium Corneum Gigeriae Galli 31.8g are ground into to 60 order order fine powders, sieve, standby;
(2) get Cortex Phellodendri 31.8g, Fructus Schisandrae Chinensis 12.7g, Fructus Ligustri Lucidi 19.1g, Radix Puerariae 15.2g medical material, add 7 times of amount 90% alcohol reflux 3 times, each 1h, filter, merging filtrate also reclaims ethanol to nothing alcohol flavor, and the medicinal liquid concentrate drying also is ground into dried cream powder, sieve, medicinal residues are standby;
By the medicinal residues in (2) again with Radix Ophiopogonis 15.2g, Cortex Lycii 38.1g, Fructus Lycii 15.2g medical material merge, the decocting that adds 12 times of amounts boils 1 time, each 0.5h, filter, merging filtrate, concentrating under reduced pressure becomes the clear paste that relative density is 1.05～1.15, add ethanol to make to reach 60% containing the alcohol amount, stir evenly, standing 48 h of cold preservation, filter, decompression filtrate recycling ethanol, concentrating under reduced pressure is dry and be ground into dried cream powder, sieves, standby;
(4) by fine powder in above-mentioned (1), dried cream powder in (2), dried cream powder in above-mentioned (3), after mix homogeneously, obtain total mixture, and add suitable adjuvant, mixes, and granulates, and makes 1000 hard capsules.
Embodiment 3
(1) the Rhizoma Anemarrhenae 38.1 g, Radix Ginseng 12.7 g, Radix Trichosanthis 31.8g, Radix Rehmanniae 19.1g, Radix Scrophulariae 15.2g, Radix Astragali 25.4g, Radix Glehniae 15.2g, Herba Dendrobii 19.1g, Rhizoma Polygonati Odorati 25.4g, Rhizoma Dioscoreae 25.4g, Endothelium Corneum Gigeriae Galli 31.8g are ground into to 120 order fine powders, sieve, standby;
(2) get Cortex Phellodendri 31.8g, Fructus Schisandrae Chinensis 12.7g, Fructus Ligustri Lucidi 19.1g, Radix Puerariae 15.2g medical material, add 10 times of amount 60% alcohol reflux 1 time, each 3 h, filter, merging filtrate also reclaims ethanol to nothing alcohol flavor, and the medicinal liquid concentrate drying also is ground into dried cream powder, sieve, medicinal residues are standby;
By the medicinal residues in (2) again with Radix Ophiopogonis 15.2g, Cortex Lycii 38.1g, Fructus Lycii 15.2g medical material merge, the decocting that adds 8 times of amounts boils 3 times, each 2 h, filter, merging filtrate, concentrating under reduced pressure becomes the clear paste that relative density is 1.05～1.15, add ethanol to make to reach 80% containing the alcohol amount, stir evenly, the standing 12h of cold preservation, filter, decompression filtrate recycling ethanol, concentrating under reduced pressure is dry and be ground into dried cream powder, sieves, standby;
(4) by fine powder in above-mentioned (1), dried cream powder in (2), dried cream powder in above-mentioned (3), after mix homogeneously, obtain total mixture, and add suitable adjuvant, mixes, and granulates, and makes 1000 hard capsules.
In order further to verify the curative effect of finished product preparation of the present invention, we have carried out corresponding clinical trial by the final drug prepared in above-mentioned specific embodiment 1-3, existing that report the test is as follows.
Clinical observation and curative effect
1. object of study:
Choose tested case 251 examples of in June, 2009～2011 year July 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, 1 group of 52 example of embodiment wherein, male's 28 examples wherein, women's 24 examples, year mean age (55.3 ± 1.1), the course of disease 8～25 months; 2 group of 49 example of embodiment, male's 26 examples wherein, women's 23 examples, year mean age (51.2 ± 1.5), the course of disease 7～28 months; 3 group of 46 example of embodiment, male's 27 examples wherein, women's 19 examples, year mean age (57.3 ± 0.9), the course of disease 9～26 months; CN1857618A Capsules group 53 examples, male's 29 examples wherein, women's 24 examples, year mean age (50.5 ± 1.3), the course of disease 8～24 months; Matched group (JIANGTANGSHU JIAONANG) 51 examples, male's 28 examples wherein, women's 23 examples, average (52.3 ± 1.6) year, the course of disease 6～27 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:
According to Ministry of Public Health " new Chinese medicine guideline of clinical investigations " in 1993, diagnostic criteria was drafted.
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 gradually are shown in that 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 1 group, 2 groups, 3 groups of the oral embodiment of the present invention, CN1857618A Capsules group respectively, every day 3 times, each 5, takes continuously one month.Matched group is taken JIANGTANGSHU JIAONANG, every day 3 times, each oral 5, takes continuously one month.The patient is regularly followed up a case by regular visits at special outpatient clinic weekly, carries out clinical observation.Detect respectively fasting glucose, 2 h blood glucose after the meal before and after treatment, 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, fasting glucose<7.0mmol/L, and 2 hours blood glucoses<8.3mmol/L, or blood glucose after the meal treats 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, fasting glucose<8.0mmol/L, and 2 hours blood glucoses<10mmol/L, or blood glucose after the meal treats 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 5 (
)
Annotate: with the treatment front and back, self compare,
▲p<0.05,
▲ ▲p<0.01; It is relatively rear with the treatment of CN1857618A Capsules group,
□p<0.05.
Experimental result from table 5,1 group, 2 groups, 3 groups medicines of the embodiment of the present invention are relatively front to diabetics fasting glucose (FPG), 2 hours blood glucoses (2h PG), glycolated hemoglobin value and medication after the meal, obvious reduction is arranged and significant difference (P<0.01) is arranged; After taking CN1857618A Capsules group and JIANGTANGSHU JIAONANG group, fasting glucose (FPG), 2 hours blood glucoses (2h PG), glycolated hemoglobin value have and reduce and statistical significance (P<0.05) arranged after the meal; With effect after the treatment of CN1857618A Capsules group, compare, fasting glucose (FPG) after the treatment of 1 group, 2 groups, 3 groups of the embodiment of the present invention, the reduction degree of 2 hours blood glucoses (2h PG), glycolated hemoglobin value is more obvious after the meal, all reach statistical significance, wherein curative effect the best of 1 group of the embodiment of the present invention.Its presentation of results: medicine group of the present invention has obvious therapeutical effect to diabetics, and curative effect is than CN1857618A Capsules group excellence.
The variation of blood fat before and after each experimental group treatment of table 6 (
)
Annotate: with the treatment front and back, self compare,
▲p<0.05,
▲ ▲p<0.01.
As shown in Table 6, after the patient takes 1 group of the embodiment of the present invention, the medicine of 2 groups, 3 groups, T-CHOL (TC) is compared with before medication with the numerical value of triglyceride (TG), obvious reduction is arranged and significant difference is arranged; After taking JIANGTANGSHU JIAONANG group and CN1857618A Capsules group medicine, and compare before medication, the numerical value of T-CHOL (TC) decreases and statistical significance is arranged, and triglyceride (TG) reduces and be not obvious; With effect after CN1857618A Capsules group treatment relatively, though 1 group, 2 groups, 3 groups of the embodiment of the present invention decrease and do not reach statistical significance T-CHOL value and triglyceride value, there is significantly good effect trend; This experimental result, illustrate that medicine group of the present invention can improve the diabetics hemorheological property, and good therapeutic effect is arranged.
After each experimental group treatment of table 7, curative effect relatively
Experimental result from table 7, after 1 month clinical treatment, the clinical symptoms such as most of glycosuria patients' excessive thirst, polyuria, xerostomia improve significantly, 1 group, 2 groups, 3 groups of the embodiment of the present invention and CN1857618A Capsules group total effective rate are respectively 92.3%, 89.8%, 84.8%, 79.2%, and the JIANGTANGSHU JIAONANG group is only 74.5%, above clinical efficacy presentation of results: Chinese medicine composition prepared by technical solution of the present invention is aspect the treatment diabetes, have the curing protrusion effect, curative effect all is better than JIANGTANGSHU JIAONANG group and CN1857618A Capsules group.
Above clinical efficacy result shows: Chinese medicine composition prepared by technical solution of the present invention is aspect the treatment diabetes, especially the diabetes of deficiency of both QI and YIN, the scorching disease of the deficiency of YIN had to obvious therapeutic effect, the medicine group of each embodiment all has the curing protrusion effect.Result shows, Chinese medicine composition of the present invention has the advantages such as preparation technology is efficiently feasible, drug effect is clear and definite, stable curative effect is reliable, its beneficial effect is no matter from the extraction and purification process of medical material, or on the forming technique of finished product preparation, all effectively guaranteed the excellent results of Chinese medicine composition of the present invention, this further proves, Chinese medicine composition of the present invention is a kind of determined curative effect, prevent and treat safely and effectively diabetes medicament, there is huge market potential, be worth further promoting.
Claims (6)
1. a Chinese medicine composition that is used for the treatment of diabetes, is characterized in that it is to be made according to following preparation technology by the raw material of following weight proportion: 38.1 parts of the Rhizoma Anemarrhenaes, 12.7 parts of Radix Ginsengs, 31.8 parts of Cortex Phellodendris, 25.4 parts of Radix Trichosanthis, 19.1 parts of Radix Rehmanniae, 15.2 parts of Radix Scrophulariaes, 15.2 parts of Radix Ophiopogonis, 25.4 parts of the Radixs Astragali, 38.1 parts of Cortex Lycii, 15.2 parts of Radix Glehniaes, 19.1 parts of Herba Dendrobiis, 25.4 parts of Rhizoma Polygonati Odorati, 12.7 parts of Fructus Schisandrae Chinensis, 19.1 parts of Fructus Ligustri Lucidi, 15.2 parts of Fructus Lycii, 25.4 parts of Rhizoma Dioscoreaes, 31.8 parts of Endothelium Corneum Gigeriae Galli, 15.2 parts of Radix Puerariaes; Become fine powder standby the Rhizoma Anemarrhenae, Radix Ginseng, Radix Trichosanthis, Radix Rehmanniae, Radix Scrophulariae, the Radix Astragali, Radix Glehniae, Herba Dendrobii, Rhizoma Polygonati Odorati, Rhizoma Dioscoreae, Endothelium Corneum Gigeriae Galli 11 flavor pulverizing medicinal materials; Get Cortex Phellodendri, Fructus Schisandrae Chinensis, Fructus Ligustri Lucidi, Radix Puerariae 4 flavor medical materials, obtain ethanol extract after employing ethanol extraction drying; By the medicinal residues after alcohol extraction and Radix Ophiopogonis, Cortex Lycii, Fructus Lycii 3 flavor medical materials, decoct with water extraction again; And water decoction is used to alcohol deposition method again, after removing impurity, obtain water extract after drying; By above-mentioned fine powder, after ethanol extract and water extract mix homogeneously, obtain total mixture, and add suitable adjuvant, mix, granulate, make hard capsule.
2. the Chinese medicine composition that is used for the treatment of diabetes as claimed in claim 1, is characterized in that it is to be made according to following preparation technology by the raw material of following weight proportion: 38.1 parts of the Rhizoma Anemarrhenaes, 12.7 parts of Radix Ginsengs, 31.8 parts of Cortex Phellodendris, 25.4 parts of Radix Trichosanthis, 19.1 parts of Radix Rehmanniae, 15.2 parts of Radix Scrophulariaes, 15.2 parts of Radix Ophiopogonis, 25.4 parts of the Radixs Astragali, 38.1 parts of Cortex Lycii, 15.2 parts of Radix Glehniaes, 19.1 parts of Herba Dendrobiis, 25.4 parts of Rhizoma Polygonati Odorati, 12.7 parts of Fructus Schisandrae Chinensis, 19.1 parts of Fructus Ligustri Lucidi, 15.2 parts of Fructus Lycii, 25.4 parts of Rhizoma Dioscoreaes, 31.8 parts of Endothelium Corneum Gigeriae Galli, 15.2 parts of Radix Puerariaes;
By above-mentioned 18 flavor Chinese crude drugs, operate in the steps below:
(1) the Rhizoma Anemarrhenae, Radix Ginseng, Radix Trichosanthis, Radix Rehmanniae, Radix Scrophulariae, the Radix Astragali, Radix Glehniae, Herba Dendrobii, Rhizoma Polygonati Odorati, Rhizoma Dioscoreae, Endothelium Corneum Gigeriae Galli powder are broken into to 60-120 order fine powder, sieve, standby;
(2) get Cortex Phellodendri, Fructus Schisandrae Chinensis, Fructus Ligustri Lucidi, Radix Puerariae medical material, add 7～10 times of amount 60%～90% alcohol reflux 1～3 time, each 1～3 h, filter, merging filtrate also reclaims ethanol to nothing alcohol flavor, and the medicinal liquid concentrate drying also is ground into dried cream powder, sieve, medicinal residues are standby;
(3) the medicinal residues in (2) are merged with Radix Ophiopogonis, Cortex Lycii, Fructus Lycii medical material again, the decocting that adds 8～12 times of amounts boils 1～3 time, each 0.5～2 h, filter, merging filtrate, concentrating under reduced pressure becomes the clear paste that relative density is 1.05～1.15, add ethanol to make to reach 60%～80% containing the alcohol amount, stir evenly, standing 12～48 h of cold preservation, filter, decompression filtrate recycling ethanol, concentrating under reduced pressure is dry and be ground into dried cream powder, sieves, standby;
(4) by dried cream powder in dried cream powder, (3) in fine powder, (2) in above-mentioned (1), after mix homogeneously, obtain total mixture, and add suitable adjuvant, mix, granulate, make hard capsule.
3. the Chinese medicine composition that is used for the treatment of diabetes as claimed in claim 2, is characterized in that it is to be made according to following preparation technology by the raw material of following weight proportion: 38.1 parts of the Rhizoma Anemarrhenaes, 12.7 parts of Radix Ginsengs, 31.8 parts of Cortex Phellodendris, 25.4 parts of Radix Trichosanthis, 19.1 parts of Radix Rehmanniae, 15.2 parts of Radix Scrophulariaes, 15.2 parts of Radix Ophiopogonis, 25.4 parts of the Radixs Astragali, 38.1 parts of Cortex Lycii, 15.2 parts of Radix Glehniaes, 19.1 parts of Herba Dendrobiis, 25.4 parts of Rhizoma Polygonati Odorati, 12.7 parts of Fructus Schisandrae Chinensis, 19.1 parts of Fructus Ligustri Lucidi, 15.2 parts of Fructus Lycii, 25.4 parts of Rhizoma Dioscoreaes, 31.8 parts of Endothelium Corneum Gigeriae Galli, 15.2 parts of Radix Puerariaes;
By above-mentioned 18 flavor Chinese crude drugs, operate in the steps below:
(1) the Rhizoma Anemarrhenae, Radix Ginseng, Radix Trichosanthis, Radix Rehmanniae, Radix Scrophulariae, the Radix Astragali, Radix Glehniae, Herba Dendrobii, Rhizoma Polygonati Odorati, Rhizoma Dioscoreae, Endothelium Corneum Gigeriae Galli powder are broken into to 80 order fine powders, sieve, standby;
(2) get Cortex Phellodendri, Fructus Schisandrae Chinensis, Fructus Ligustri Lucidi, Radix Puerariae medical material, add 8 times of amount 75% alcohol reflux 2 times, each 2 h, filter, and merging filtrate also reclaims ethanol to nothing alcohol flavor, and the medicinal liquid concentrate drying also is ground into dried cream powder, sieves, and medicinal residues are standby;
(3) the medicinal residues in (2) are merged with Radix Ophiopogonis, Cortex Lycii, Fructus Lycii medical material again, the decocting that adds 10 times of amounts boils 2 times, each 1 h, filter, merging filtrate, concentrating under reduced pressure becomes the clear paste that relative density is 1.05～1.15, add ethanol to make to reach 70% containing the alcohol amount, stir evenly, standing 24 h of cold preservation, filter, decompression filtrate recycling ethanol, concentrating under reduced pressure is dry and be ground into dried cream powder, sieves, standby;
(4) by dried cream powder in dried cream powder, (3) in fine powder, (2) in above-mentioned (1), after mix homogeneously, obtain total mixture, and add suitable adjuvant, mix, granulate, make hard capsule.
4. arbitrary Chinese medicine composition that is used for the treatment of diabetes as described as claim 1-3, is characterized in that, the combination of one or more during the said composition discrimination method comprises the following steps:
(1) the thin layer of Cortex Phellodendri is differentiated: get Chinese medicine composition 3g, add methanol 20ml, reflux 15 minutes, let cool, and filters, and gets filtrate as need testing solution; Separately get Cortex Phellodendri control medicinal material 0.3 g, with " preparing need testing solution " same procedure, make control medicinal material solution respectively; Get again the berberine hydrochloride reference substance, add methanol and make the solution of every 1 ml containing 0.2mg, product solution in contrast; According to thin layer chromatography test in appendix VIB of Chinese Pharmacopoeia version in 2010, draw each 2 μ l of above-mentioned three kinds of solution, put on same silica gel g thin-layer plate respectively, take ethyl acetate-butanone-formic acid-water=10:7:1:1 as developing solvent, launch, take out, dry, put under the 365nm ultraviolet light and inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, the speckle of aobvious same color;
(2) the thin layer of Cortex Lycii and Fructus Lycii is differentiated: get Chinese medicine composition 5g, add water 50ml, shake up, place 1 hour, supersound process 5 minutes, take out, centrifugal, gets supernatant, extract with ethyl acetate 25 ml joltings, divide and get acetic acid ethyl fluid, be concentrated into 1 ml, as need testing solution; Separately get Fructus Lycii reference substance medical material 1g and Cortex Lycii reference substance medical material 2g, with " preparing need testing solution " same procedure, make Fructus Lycii, Cortex Lycii control medicinal material solution respectively; According to thin layer chromatography test in appendix VIB of Chinese Pharmacopoeia version in 2010, draw above-mentioned three kinds of solution, 5 μ l, put on same silica gel g thin-layer plate respectively, take ethyl acetate-chloroform-formic acid=9:6:0.5 as developing solvent, launch, take out, dry, put under the 365nm ultraviolet light and inspect, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, the fluorescence speckle of aobvious same color;
(3) the thin layer of Fructus Schisandrae Chinensis is differentiated: get Chinese medicine composition 5g, add chloroform 40ml, reflux 30 minutes, filter, the filtrate evaporate to dryness, and residue adds chloroform 1.5ml to be made to dissolve, as need testing solution; Separately get Fructus Schisandrae Chinensis control medicinal material 2g, with " preparing need testing solution " same procedure, make control medicinal material solution respectively; Get again the deoxyschizandrin reference substance, add chloroform and make the solution of every 1ml containing 1mg, product solution in contrast; According to thin layer chromatography test in appendix VIB of Chinese Pharmacopoeia version in 2010, draw above-mentioned need testing solution 4 μ l, control medicinal material solution 1 μ l and reference substance solution 2 μ l, put in same silica gel G respectively
254on lamellae, the upper solution of petroleum ether-Ethyl formate-formic acid=15:5:1 of take is developing solvent, launches, take out, dry, put under the 254nm ultraviolet light and inspect, in the test sample chromatograph, with control medicinal material chromatograph and the corresponding position of reference substance chromatograph on, the fluorescence speckle of aobvious same color;
(4) the thin layer of Fructus Ligustri Lucidi is differentiated: get Chinese medicine composition 3g, and the 30ml that adds diethyl ether, reflux 30 minutes, filter, and filtrate volatilizes, and residue adds dehydrated alcohol 2ml to be made to dissolve, as need testing solution; Separately even up pier fruit acid reference substance, add dehydrated alcohol and make the solution of every 1ml containing 1mg, product solution in contrast; According to thin layer chromatography test in appendix VIB of Chinese Pharmacopoeia version in 2010, draw each 2 μ l of above-mentioned two kinds of solution, put on same silica gel g thin-layer plate respectively, take chloroform-methanol=40:1 as developing solvent, launch, take out, dry, spray is with the phosphomolybdic acid test solution, 105 ℃ of heating 5 minutes, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, the speckle of aobvious same color;
(5) the thin layer of Radix Puerariae is differentiated: get Chinese medicine composition 4g, add methanol 50ml, supersound process 30 minutes, filter, the filtrate evaporate to dryness, residue adds water 10 ml to be made to dissolve, put on processed good polyamide column, first water 100 ml washings, discard washing liquid, then use 30% ethanol 100ml eluting, collect eluent, evaporate to dryness, residue adds methanol 2ml to be made to dissolve, as need testing solution; Separately get the puerarin reference substance, add methanol and make the solution of 1ml containing 1mg, product solution in contrast; According to thin layer chromatography test in appendix VIB of Chinese Pharmacopoeia version in 2010, draw each 2 μ l of above-mentioned solution, put on same silica gel g thin-layer plate respectively, take chloroform-methanol-water=7:2.5:0.25 as developing solvent, launch, take out, dry, put under the outer light of purple 365nm and inspect, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, the fluorescence speckle of aobvious same color.
5. arbitrary Chinese medicine composition that is used for the treatment of diabetes as described as claim 1-3, it is characterized in that, the content assaying method of said composition is as follows: get Chinese medicine composition 1g, accurately weighed, put in tool plug conical flask, precision adds ethanol 25ml, weighed weight, soaked overnight, supersound process 40 minutes, let cool, weighed weight again, supply the weight of less loss with ethanol, shake up, filter, precision measures subsequent filtrate 10 ml, put water bath method, residue adds water 10 ml, hydrochloric acid 1 ml, put in water-bath reflux 2 hours, take out, let cool, jolting limit, limit drip 40% sodium hydroxide solution to color by orange sport orange red, with the chloroform jolting, extract 2 times, each 30ml, merge chloroform extraction liquid, evaporate to dryness, residue adds dissolve with methanol, be transferred in 5 ml measuring bottles, add methanol to scale, shake up, as test sample, separately get Chinaroot Greenbier Rhizome sapogenin reference substance appropriate, add methanol and make the solution of every 1ml containing 0.17mg, product solution in contrast, precision is drawn above-mentioned reference substance solution, need testing solution respectively, and the injection liquid chromatography, take methanol: water=94:6 as mobile phase, is measured, and calculates, and contains Chinaroot Greenbier Rhizome sapogenin C in Chinese medicine composition
27h
44o
3must not be less than the 0.38mg/ grain.
6. the application of arbitrary Chinese medicine composition as described as claim 1-3 in preparation treatment diabetes medicament.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105055851A (en) * | 2015-08-03 | 2015-11-18 | 河北科技大学 | Chinese medicinal composition for treatment of diabetes, preparation and application thereof |
| CN106075021A (en) * | 2016-07-12 | 2016-11-09 | 佛山杰致信息科技有限公司 | A kind of Chinese medicine composition treating diabetes and preparation method thereof |
| CN106692845A (en) * | 2017-03-10 | 2017-05-24 | 李耀宗 | Medicament for treating diabetes and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1857618A (en) * | 2006-04-04 | 2006-11-08 | 宁波诚年药业有限公司 | Chinese medicine preparation for reducing sugar |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1857618A (en) * | 2006-04-04 | 2006-11-08 | 宁波诚年药业有限公司 | Chinese medicine preparation for reducing sugar |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105055851A (en) * | 2015-08-03 | 2015-11-18 | 河北科技大学 | Chinese medicinal composition for treatment of diabetes, preparation and application thereof |
| CN105055851B (en) * | 2015-08-03 | 2019-07-19 | 河北科技大学 | A kind of Chinese medicine composition that treating diabetes, its preparation and its application |
| CN106075021A (en) * | 2016-07-12 | 2016-11-09 | 佛山杰致信息科技有限公司 | A kind of Chinese medicine composition treating diabetes and preparation method thereof |
| CN106692845A (en) * | 2017-03-10 | 2017-05-24 | 李耀宗 | Medicament for treating diabetes and preparation method thereof |
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