CN103191222B - Application of hedan preparation in preparation of diabetes medicine - Google Patents

Application of hedan preparation in preparation of diabetes medicine Download PDF

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CN103191222B
CN103191222B CN201310130674.9A CN201310130674A CN103191222B CN 103191222 B CN103191222 B CN 103191222B CN 201310130674 A CN201310130674 A CN 201310130674A CN 103191222 B CN103191222 B CN 103191222B
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diabetes
hedan
glucose
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CN103191222A (en
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何凯南
曾英姿
周万辉
安少凯
赵磊
陈武
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Jiangxi Wohua Jishun Pharmaceutical Co ltd
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NANCHANG JISHUN PHARMACEUTICAL CO Ltd
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Abstract

The invention relates to application of a hedan preparation in preparation of a diabetes medicine. The hedan preparation adopts lotus leaves as the main medicine and adopts lotus leaves, red-rooted salvia roots, hawthorns, folium sennae and fructus psoraleae as the prescription medicines; the hedan preparation has the functions of reducing phlegm and descending the turbid and promoting blood circulation to remove blood stasis, and is clinically used for a patient with hyperlipemia phlegm stagnation symptoms. According to the research and the accidental discoveries, the hedan preparation has the effect of treating diabetes mellitus.

Description

Lotus pellet preparation is in the application of preparing in diabetes medicament
Technical field
The present invention relates to the application of Chinese medicinal formulae, particularly lotus pellet preparation is in the application of preparing in diabetes medicament.
Technical background
Diabetes (diabetes mellilus, DM) are that a kind of common glucose metabolism with genetic predisposition and dyshormonia cause general metabolism disorder then, and with just there being chronic progressive external persistence rising " hyperglycemia " before not treating.Due to absoluteness and relative property hypoinsulinism, or body to insulin requirements amount greatly increase and endogenous and exogenous combined effect cause characteristic pathology and clinical change, as thirsty, polydipsia, polyphagia, polyuria, lose weight, weak, the clinical syndrome such as become thin.Although the cause of disease of diabetes is not yet illustrated, think at present insulin definitely or relative deficiency or insulin resistant are the main pathophysiological basis of diabetes.The Main Function of insulin is to promote glucose in the Cell uptake blood main energy source as cellular metabolism, also promotes hepatocyte by glucose glycogen biosynthesis or is converted into fat simultaneously.This effect of insulin is obstructed, and hypoinsulinism or both exist defect simultaneously, can cause blood glucose to increase.
Along with social progress and development, the sickness rate of diabetes increases increasingly, and diabetes and complication thereof have become the popular non-infective disease of one of serious harm society and family.The control of actively developing diabetes and complication thereof has become the focus of current medical circle research.At present, be Western medicine for the medicine major part for the treatment of diabetes.The blood sugar reducing function of Western medicine is sure, but its bad reflection is also obvious to all.
Hedan tablet is taking Folium Nelumbinis as principal agent, and circulation of qi promoting damp eliminating coordinates Fructus Crataegi to regulate the flow of vital energy to help digestion, Folium Sennae loosening bowel to relieve constipation and resolving phlegm lowering turbidity, with Fructus Psoraleae temperature compensation Liver and kidney, and Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling.For the dyslipidemia due to the turbid blood stasis of expectorant.Through clinical verification Hedan tablet, cholesterol, triglyceride, the improvement of high density lipoprotein level Pseudobulbus Bletillae (Rhizoma Bletillae) atherogenic index are had to clear meaning.And safety, on hepatic and renal function without impact, can long-term taking.
Hedan tablet is to be produced by Nanchang Jishun Pharmaceutical Co., Ltd., writes out a prescription as Folium Nelumbinis, Radix Salviae Miltiorrhizae, Fructus Crataegi, Folium Sennae, Fructus Psoraleae.Function cures mainly as resolving phlegm lowering turbidity, blood circulation promoting and blood stasis dispelling.Clinically belong to and hold phlegm-turbidity and blood stasis card marquis person under the arm for hyperlipemia.The research of the present invention's process, finds, lotus pellet preparation has therapeutical effect to diabetes unexpectedly.
Summary of the invention
The object of the present invention is to provide a kind of lotus pellet preparation in the application of preparing in diabetes medicament.
Lotus pellet preparation of the present invention is to make (consumption is weight portion) by the raw material of Chinese medicine medicine of following proportioning:
Folium Nelumbinis: 30-90 part Radix Salviae Miltiorrhizae: 5-20 part Fructus Crataegi: 15-60 part Folium Sennae: 2-4 part Fructus Psoraleae: 5-20 part.
Preferred proportioning (consumption is weight portion) is as follows:
Folium Nelumbinis: 60 parts of Radix Salviae Miltiorrhizaes: 10 portions of Fructus Crataegis: 30 portions of Folium Sennae: 3 parts of Fructus Psoraleaes: 10 parts.
More than composition is by weight as proportioning, in the time producing, can increase or reduce according to corresponding proportion, as large-scale production can be taking kilogram as unit, or taking ton as unit, small-scale production also can be taking milligram as unit, weight can increase or reduce, but the constant rate of raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, for especial patient, and as serious symptom or light disease, fat or modest patient, the proportioning of amount that can corresponding adjustment composition, increases or reduces being no more than 100%, and drug effect is constant.
More than single medicinal material, especially ministerial drug and the adjuvant drug in composition, also can be replaced by the suitable Chinese medicine with the identical property of medicine, and its drug effect of the Chinese medicine preparation after replacement is constant.
Chinese medicine preparation of the present invention is by the raw material of Chinese medicine of above-mentioned formula composition being processed through extraction or other modes, being made pharmaceutically active substance, subsequently, taking this material as raw material, while needs, add medicine acceptable carrier, make according to the routine techniques of galenic pharmacy.Described active substance can obtain by extracting respectively raw material of Chinese medicine, also can obtain by common extraction raw material of Chinese medicine, also can obtain by other means, as: by pulverizing, squeeze, calcine, grind, sieve, percolation, extraction, water extraction, alcohol extraction, ester carry, the method such as ketone is carried, chromatography obtains, these active substances can be the material of extractum form, can be that dry extract can be also fluid extract, need to determine to make different concentration according to the difference of preparation.
Pharmaceutically active substance in Chinese medicine preparation of the present invention, its shared percentage by weight in preparation can be 0.1-99.9%, all the other are medicine acceptable carrier.Pharmaceutical preparation of the present invention, exists with unit dosage form, and described unit dosage form refers to the unit of preparation, as every of tablet, and every capsules of capsule, every bottle of oral liquid, every bag of granule etc.
Chinese medicine preparation of the present invention can be to appoint the pharmaceutically useful dosage form of lotus, and these dosage forms comprise: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, powder, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.Preparation of the present invention, preferably peroral dosage form, as: capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum etc.Most preferably tablet, capsule.
Chinese medicine preparation of the present invention, the preparation of its oral administration can contain conventional excipient, such as binding agent, filler, diluent, tablet agent, lubricant, disintegrating agent, coloring agent, flavoring agent and wetting agent, can carry out coating to tablet if desired.
Below data declaration beneficial effect of the present invention by experiment:
Experiment one: this experiment is with KKAy diabetes mice model, and research lotus pellet preparation is to particularly therapeutical effect and the mechanism of type Ⅱdiabetes mellitus of diabetes, for the clinical practice of expanding lotus pellet preparation provides experimental basis.
1. experiment material
1.1 laboratory animal
KKAy mice (SPF level), age in 7-8 week, 72, ♀, ♂ half and half; C57BL/6J mice (SPF level), age in 7-8 week, 10 ♀, ♂ half and half.Provide the quality certification number by Chinese Academy of Medical Sciences's laboratory animal: SCXK (capital) 2009-0004.
1.2 raising conditions
At SPF level animal feeding room sub-cage rearing, temperature 19-26 DEG C, relative humidity 40~70%, 1, every cage, lighting hours 12 hours, enough feedstuffs are added in timing, and enough drinking-water is added in timing.KKAy mouse feed is the special high lipid food of sterilizing, is produced by Institute of Experimental Animals, Chinese Academy of Medical Sciences; C 57bL/6J mouse feed is sterilizing normal diet, by Beijing Australia of section pull together feed corporation,Ltd produce.Change bedding and padding every day.
1.3 main agents and medicine
Hedan tablet, Nanchang Ji Shun Pharma Inc., lot number 20110219; Rosiglitazone Maleate Tablets, GlaxoSmithKline PLC (Tianjin) company limited, lot number: 12060114; Rat/mouse Insulin ELISA Kit is purchased from MILLIPORE company of the U.S. (lot number: ST2347EN00); Blood sugar test reagent (BIOSEN5030 type blood glucose/lactic acid analyser matched reagent).
1.4 experimental apparatus
BIOSEN5030 type blood glucose/lactic acid analyser, German EKF company manufactures.
2. experimental technique
2.1 fasting plasma glucose methods:
The equal fasting of all animals (freely drinking water) 5h, cuts tail and gets peripheral blood 10 μ l, by BIOSEN5030 type blood glucose/lactic acid analysis-e/or determining fasting glucose.
2.2 grouping and administrations:
Animal adaptability is fed after one week and is measured fasting glucose according to fasting plasma glucose method, by the grouping of actual measurement fasting blood sugar stratified random.
In 102 KKAy, choose the group that enters of fasting glucose >14.9mmol/L, be divided at random 8 groups: diabetic model group (n=11) group; Positive drug group (1.33mgkg -1d -1, n=11); Red low dose group (the 0.375gkg of lotus -1d -1, n=11); Dosage group (0.75gkg in lotus pellet -1d -1, n=11); Red high dose group (the 1.5gkg of lotus -1d -1, n=11); Normal C57BL/6J mice (n=10) is cooked matched group.
Each group of He Dan, positive drug group gavage every day 1 time, matched group gives equivalent normal saline gavage.
2.3 observation index:
2.3.1 daily observation index
Experimental session is observed animal spirit, activity, hair color and urine amount feces situation of change; Quantitative assay amount of drinking water, food-intake and body weight weekly.
2.3.2 fasting plasma glucose method
Before grouping and after administration 7d, 14d, 21d, 28d respectively tail venous blood sampling survey fasting blood sugar.After the equal fasting of all animals (freely drinking water) 5h, get blood, 1h administration before getting blood, while getting blood, peripheral blood 10 μ l are got in docking, with BIOSEN5030 type blood glucose/lactic acid analysis-e/or determining fasting glucose, more each treated animal blood glucose value.2.3.3 carbohydrate tolerance laboratory observation index and detection method
After administration, animal fasting last day 5h(freely drinks water), 1h administration before getting blood, when fasting finishes, per os gives glucose 2.0gkg -1, measure to the blood glucose value of 0h, 0.5h, 1h, 2h after glucose, observe each group of variation that gives each time point blood glucose value after glucose.
2.3.4 date processing and result are judged
Measurement data is with mean ± standard deviation represent.Application SPSS11.0 statistical software analyzes, multisample mean relatively adopt between two one factor analysis of variance (one-way ANOVA).The relatedness of two variablees adopts Linear correlative analysis.
3. experimental result
3.1 ordinary circumstance
The experimental session Normal group C57BL/6J mice mental status is good, is quick on the draw, and moves freely, and fur is glossy, and food-intake, amount of drinking water are stablized, and body weight continues to increase.Model group KKAy mice along with week age growth engender lethargy, bradykinesia, slow movement, fur tarnishes.Each administration group mouse hair light, spirit is good.
3.1.1 the weight of animals result of variations
Experimental session model group body weight is with the prolongation steady-state growth in administration cycle.Along with the prolongation in administration cycle, there is decline in various degree in each administration treated animal body weight.After administration 4 weeks, positive drug is significant difference (p < 0.01) compared with model group, and the each dosage group of He Dan body weight obviously declines, extremely significantly (p < 0.001) of difference compared with model group.In table 1.
The impact that table 1 changes KKAy Mouse Weight :
3.1.2 animal food-intake result of variations
Model group animal food-intake is apparently higher than Normal group, and experimental session model group animal food-intake changes little, and decline in various degree all appears in each administration treated animal food-intake.The results are shown in Table 2.
The impact of table 2 on KKAy mice food-intake
3.1.3 drinking water for animals amount result of variations
Model group drinking water for animals amount is apparently higher than Normal group, and experimental session model group drinking water for animals quantitative changeization is little, and decline in various degree all appears in each administration treated animal amount of drinking water.The results are shown in Table 3.
The impact of table 3 on KKAy mice amount of drinking water
3.2 impacts on fasting glucose
In the administration cycle of 4 weeks, model group animal blood glucose value is the trend progressively raising.Positive drug group is from first week fasting blood sugar of administration lower than model group (p < 0.01).Red basic, normal, high three the dosage groups of lotus start fasting blood sugar for first week from administration and are starkly lower than model group (p < 0.001).Experimental result table 4.
The fasting glucose impact (mmol/L) of table 4 on KKAy mice
Note:compared?with?the?model?group, p<0.05, **p<0.01, ***p<0.001;compared?with?the?Control?group △△△p<0.001
3.3 impacts on carbohydrate tolerance
0.5h, 1h blood sugar increasing degree are obviously compared with model group low (p < 0.01, p < 0.001) after gavage exogenous glucose for the each dosage group of He Dan, and AUC and model group relatively have obvious statistical significance (p < 0.05, p < 0.001).The results are shown in Table 5.
The impact (mmol/L) of table 5 on KKAy mice different time points blood glucose and glucose tolerance
Note:compared?with?the?model?group, p<0.05, **p<0.01, ***p<0.001;
Conclusion
KKAy mice is a kind of polygenic inheritance type 2 diabetes mellitus animal model Mus, is on the basis of inheritance susceptible, to add environmental factors and bring out, and has the feature of type Ⅱdiabetes mellitus, very similar to the performance of mankind's type Ⅱdiabetes mellitus, is type Ⅱdiabetes mellitus ideal animals model; And C57BL/6J mice is identical with KK mice genotype, under full diet, non-diabetic occurs, its matched group of Chang Zuowei.The demonstration of this experimental result, high fat is fed 12 weeks KKAy mices can there is typical insulin opposing symptom (hyperglycemia, hyperinsulinism, carbohydrate tolerance decline, and HOMAIR is high).
Finding by the observation to experimental session animal food-intake, amount of drinking water and body weight change, generally there is the situations such as polydipsia, polyphagia, polyuria in diabetic mice.Lotus pellet preparation can reduce diabetic mice food-intake, suppresses the fat trend of KKAy mice, reduces diabetic mice amount of drinking water.This experimentation shows that lotus pellet preparation is from 0.375gkg -1d -1to 1.5gkg -1d -1dosage range all can produce the effect of obvious reduction fasting glucose, and takes the later stage and present gradually obvious dose-effect relationship.
Experiment two:
1 experiment purpose: this experiment is the effect to streptozotocin (Streptozotocin, STZ), alloxan (alloxan, ALX) induced mice diabetes model by research lotus pellet preparation, observes the therapeutic effect of lotus pellet preparation to diabetes.
2 experimental sections
2.1 experiment material
2.1.1 zoopery animal adopts experiment to use Kunming rat, body weight is 190~230g.
2.1.2 medicine and reagent Hedan tablet, Nanchang Ji Shun Pharma Inc.; Alloxan and streptozotocin are HONG KONG FARCOChemical Supplies company product; Mice Chinese People's Anti-Japanese Military and Political College Mus insulin serum is Wuhan Boster Biological Technology Co., Ltd.'s product; Blood sugar kit provides for Beijing North Hua Kang clinical reagent company limited; Triglyceride Reagent box provides for Zhejiang Dong Ou biological engineering company limited; T-CHOL test kit provides for Shanghai Rongsheng Bioisystech Co., Ltd; Other reagent is domestic analytical pure.
2.2 test method
2.2.1 modeling:
2.2.1.1 the preparation of alloxan (ALX) property diabetes rat model
Adopt 2 times dose regimen, alloxan is made into 2% injection (alloxan is now with the current) with normal saline.The 1st the fasting 12h pneumoretroperitoneum injection alloxan 120mg/kg of not intaking, 15min pneumoretroperitoneum insulin injection 0.1ml, and respectively at giving after alloxan 2.5h and 5h gavage to 25% glucose 1ml/100g.Water 12h pneumoretroperitoneum injection alloxan 100mg/kg.15min pneumoretroperitoneum insulin injection 0.1ml is can't help in the 2nd fasting, and respectively at adopting glucose oxidase method to get the fasting blood sugar that eye socket rear vein beard blood is surveyed after last administration 72 hours to 25% glucose 1ml/100g. experiment to 2.5h and 5h gavage, be greater than 11.1mmol/L as diabetes rat using fasting glucose.
2.2.1.2 the preparation of streptozotocin (STZ) property diabetes rat model
30 mice adaptabilities are raised one week, give mixed fodder (high-sugar-fat-diet+normal feedstuff), continue 3 weeks.Finish posterior orbit rear vein beard and get blood and survey after animal fasting glucose (0 hours blood glucose) and gavage 25% glucose 1ml/100g the blood glucose of 1 hour and 2 hours.Lumbar injection STZ100mg/kg, and continue to give mixed fodder (the high sugared material+normal feedstuff of high fat), continue 4 weeks.After injection, adopt respectively eye socket rear vein beard to get the moving fasting glucose of hematometry and oral glucose tolerance (ditto) at the 2nd, 4 weeks, when 4th week finishes, add the fasting insulin level of surveying.Blood glucose adopts determination of glucose oxidase with blood sugar kit, and insulin is measured with insulin radioimmunoassay kit.
2.2.2 laboratory animal grouping and medication
80 of normal rats are divided into Normal group, diabetes matched group, test alloxan (ALX) property rat (large, medium and small 3 dosage) group, experiment streptozotocin (STZ) property rat (large, medium and small 3 dosage) group by table of random number.Experimental session is respectively organized rat all to feeding and freely drink water with normal diet, the experimental group every day of gavage Hedan tablet 3g/kg, 1.5g/kg, 0.75g/kg respectively; The distilled water of diabetes matched group and Normal group gavage every day respective volume, be surrounding experimental period.
2.2.3 laboratory animal fasting 12h before and after biochemical test experiment, gets respectively eye socket rear vein beard blood, and separation of serum, surveys respectively fasting glucose, T-CHOL, triglyceride.Blood sugar detection adopts glucose oxidase method, T-CHOL and triglyceride determination respectively adopt CHOD ?PAP method and enzyme Rhizoma Nelumbinis join colorimetry.
2.2.4 immunohistochemistry observation experiment de-neck execution of rat after 4 weeks, cuts open rapidly and gets tail of pancreas, and application immunohistochemistrySABC SABC method shows B cell.
2.2.5 SPSS10.0 systems soft ware processing for statistical procedures, carries out paired t-test and variance analysis before and after experiment.
3 experimental results
3.1 immunohistochemistry observed result Normal group insulins mostly are circle, ellipse, polygon or irregular type, not of uniform size.After the dyeing of SABC method, B cell is the tan immunoreation positive, and multidigit, in islets of langerhans central authorities, occupies the overwhelming majority of islets of langerhans, arrange closely, cell boundary is clearer, most circular or oval, in the distribution of immunoreation positive material and Cytoplasm, insulin secretion granule is graininess, and Cytoplasm endocrine granules is abundant, and boundary is clearer, color depth, the core of no dyeing is cavity shape, rounded or oval, in office.The a small amount of clear area existing in B cell mass is other four precious positions of islets of langerhans.Single immunoreation positive cell between the acinous cell of pars exocrina pancreatis.How irregular diabetes matched group islets of langerhans shape is, and edge part is neat.In islets of langerhans, immunoreation positive cell quantity obviously reduces, rarely seen several immunoreation sun cells that are dispersed in each islets of langerhans, there is larger irregular white space in iuntercellular, Cytoplasm endocrine granules obviously reduces even disappearance, granule is painted shallow, boundary is fuzzy, inhomogeneous respectively, the unclear even pyknosis of core boundary of cavity shape.Between exocrine portion acinous cell, be difficult to see single immunoreation positive cell.The heavy dose of group of experiment B cell immunohistochemistry changes compared with Normal group, islets of langerhans out-of-shape, in islets of langerhans, the immunoreation positive is compared also obviously minimizing of quantity, boundary is unclear, but part cell cytoplasm endocrine granules quantity compared with diabetes matched group is more, color depth, boundary is clearer, distribution uniform.A few cell core boundary clear, it is quite more that in experiment, dosage group is compared in islets of langerhans immunoreation positive cell quantity with diabetes matched group with medicine matched group, but iuntercellular still has more white space, cell outline is clearer, kytoplasm endocrine granules is more, color depth, boundary is clearer, distribution uniform.A few cell core boundary clear.Experimental group small dose group and diabetes cellular control unit immunohistochemistry change close.Between experimental group (large, medium and small dosage group) and medicine matched group exocrine portion acinous cell, also can see single immunoreation positive cell.
Before and after 3.2 biochemical indicator testing result experiments, the content of blood glucose, cholesterol and triglyceride is in table 1~table 3.
The comparison of blood sugar level before and after table 1 experiment
Note: ALX rat, STZ rat compared with before experiment, * P<0.05, compared with diabetes matched group, #P<0.05, compared with normal group, ※ P<005.
The comparison of serum cholesterol content before and after table 2 experiment
Note: ALX rat, STZ rat compared with before experiment, * P<0.05, compared with diabetes matched group, #P<0.05, compared with normal group, ※ P<005.
The comparison of serum triglycerides content before and after table 3 experiment
Note: ALX rat, STZ rat compared with before experiment, * P<0.05, compared with diabetes matched group, #P<0.05, compared with normal group, ※ P<005.
4 conclusions:
This experiment biochemistry detection result shows: experimental group is treated after 4 weeks through He Dan diabetes rat (big or middle dosage group) due to diabetes rat due to alloxan (ALX) and streptozotocin (STZ), and each group of fasting glucose all significantly reduces (P<0.05) compared with before experiment; Large, medium and small dosage group fasting glucose also significantly reduces (P<0.05) compared with diabetes matched group.At He Dan, diabetes rat due to ALX and 6 dosage groups to diabetes rat due to STZ and diabetes matched group P<0.05 are had to significant blood sugar reducing function; Relatively He Dan, to ALX, STZ hypoglycemic effect, wherein tests big or middle dosage group respectively, and after experiment, P<0.05 has obvious difference compared with before experiment, approaches Normal group blood sugar level.Respectively relatively He Dan to diabetes rat due to ALX with to the hypoglycemic effect between corresponding large, medium and small three groups of dosage groups of diabetes rat due to STZ, two kinds of diabetes type small dose group fasting glucose compared with Normal group has significant difference (P<0.05), at hypoglycemic effect fasting glucose no significant difference (P>0.05) compared with normal dose group of bigr or middle dosage group.Show that He Dan is all effective in cure and high dose group is little with middle dosage group hypoglycemic effect difference to the treatment of I type, type ii diabetes, in the time selecting He Dan treatment diabetes, can consider with in dosage group replacement high dose group, can reduce dosage.
Brief description of the drawings
Fig. 1 Normal group B cells of pancreas SABC immunohistochemical staining 10*10
Fig. 2 diabetes matched group B cells of pancreas SABC immunohistochemical staining 10*10
Fig. 3 He Dan is to the heavy dose of group of ALX rat B cell SABC immunohistochemical staining 10*10
Fig. 4 He Dan is to agent group B cell SABC immunohistochemical staining 10*10 in ALX rat
Fig. 5 He Dan is to ALX rat small dose group B cell SABC immunohistochemical staining 10*10
Fig. 6 He Dan is to the heavy dose of group of STZ rat B cell SABC immunohistochemical staining 10 × 10
Fig. 7 He Dan is to dosage group B cell SABC immunohistochemical staining 10 × 10 in STZ rat
Fig. 8 He Dan is to STZ rat small dose group B cell SABC immunohistochemical staining 10 × 10
Detailed description of the invention
Below in conjunction with embodiment, the present invention is described in detail.
Embodiment 1:
Medicine of the present invention is to be made up of following component
Folium Nelumbinis: 7500g Radix Salviae Miltiorrhizae: 1250g Fructus Crataegi: 3750g Folium Sennae: 375g Fructus Psoraleae: 1250g
The above five tastes, 90 DEG C of hot-water soaks three times for Folium Sennae, each 30 minutes, merge soak, filter, filtrate is for subsequent use; Radix Salviae Miltiorrhizae powder is broken into coarse powder, with alcohol heating reflux extraction 1.5 hours, filters, and filtrate recycling ethanol, for subsequent use; Folium Nelumbinis, Fructus Psoraleae, Fructus Crataegi and Radix Salviae Miltiorrhizae decoction dregs decoct with water secondary, and each 2 hours, decocting liquid filtered, and filtrate merges, being evaporated to relative density is 1.20(60 DEG C), place, in the time that fluid temperature is down to approximately 40 DEG C, add the ethanol of 2 times of amounts, stir evenly, leave standstill 48 hours, get supernatant, filter, filtrate recycling ethanol, merges with above-mentioned Radix Salviae Miltiorrhizae ethanol extract, is concentrated in right amount, and spraying is dry, add appropriate adjuvant, mix, granulation, be pressed into 1000, film coating, to obtain final product.
Embodiment 2:
Medicine of the present invention is to be made up of following component
Folium Nelumbinis: 3750g Radix Salviae Miltiorrhizae: 625g Fructus Crataegi: 1875g Folium Sennae: 187.5g Fructus Psoraleae: 625g
The above five tastes, Folium Sennae is cleaned, with 90 DEG C of hot-water soaks of 10 times of amounts three times, each 30 minutes, merge three times medicinal liquid, filter, filtrate is for subsequent use, Radix Salviae Miltiorrhizae powder is broken into coarse powder, with 3 times of amount 95% alcohol heating reflux 1.5 hours (65 DEG C), filters, and filtrate recycling ethanol, obtains Radix Salviae Miltiorrhizae ethanol extract, for subsequent use, Folium Nelumbinis, Fructus Psoraleae, Fructus Crataegi and Radix Salviae Miltiorrhizae decoction dregs add 10 times of water gagings and decoct 2 times, each 2 hours, decocting liquid filters, filtrate and Folium Sennae filtrate merge, being evaporated to relative density is 1.20(60 DEG C), place, treat that fluid temperature is down to approximately 40 DEG C, add 2 times of amount 95% ethanol, stir evenly, leave standstill 48 hours, get supernatant, filter, reclaim ethanol, merge with above-mentioned Radix Salviae Miltiorrhizae ethanol extract, being evaporated to relative density is 1.30(60 DEG C) thick paste, drying under reduced pressure (60-70 DEG C), pulverize, add starch 48g, magnesium stearate 1.6g, mix, incapsulate, make 1000, obtain.

Claims (3)

1. the application of lotus pellet preparation in preparation treatment type Ⅰ diabetes mellitus medicine, is characterized in that, described lotus pellet preparation is to be made up of the raw material of Chinese medicine medicine of following proportioning:
Folium Nelumbinis: 30-90 part, Radix Salviae Miltiorrhizae: 5-20 part, Fructus Crataegi: 15-60 part, Folium Sennae: 2-4 part, Fructus Psoraleae: 5-20 part.
2. according to the application of claim 1, it is characterized in that, described lotus pellet preparation is to be made up of the raw material of Chinese medicine medicine of following proportioning:
Folium Nelumbinis: 60 parts, Radix Salviae Miltiorrhizae: 10 parts, Fructus Crataegi: 30 parts, Folium Sennae: 3 parts, Fructus Psoraleae: 10 parts.
3. according to the application of claim 1, it is characterized in that, described lotus pellet preparation is tablet, capsule.
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CN101708236B (en) * 2009-12-14 2012-09-19 南昌济顺制药有限公司 Application of Hedan tablet in treating fatty liver

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