CN1054053C

CN1054053C - Medicine for reducing blood sugar and its preparation method and use

Info

Publication number: CN1054053C
Application number: CN95102128A
Authority: CN
Inventors: 朱立群; 李文展
Original assignee: Individual
Current assignee: Individual
Priority date: 1995-03-11
Filing date: 1995-03-11
Publication date: 2000-07-05
Anticipated expiration: 2015-03-11
Also published as: CN1131020A

Abstract

The present invention relates to a medicine for reducing blood sugar and a preparation method thereof and application thereof. The medicine is prepared by using traditional Chinese medicine materials with the functions of supplementing qi, nourishing yin, clearing away heat, promoting blood circulation by removing blood stasis, reinforcing the kidney and reducing blood sugar and adding a proper quantity of chromium elements and a western medicine of glybenzcyclamide; thus, the medicine not only has the function of effectively reducing blood sugar, but also has the functions of preventing, curing and reducing diabetic complications. Besides, the medicine has optimum therapeutical effects on non-insulin dependent diabetes.

Description

Antidiabetic drug and preparation method thereof

The present invention relates to contain the medicinal preparation of vegetable material, relate in particular to a kind of antidiabetic drug and preparation method thereof.

Diabetes are a kind of common endocrine metabolism diseases, the prevalence of the present diabetes of China is trend of rising year by year, domestic medical market existing several traditional Chinese medicine antidiabetic preparationses are as JINQI JIANGTANG PIAN, the clinical effectiveness of antidiabetic drugs such as JIANGTANGSHU and SHENQI JIANGTANG sheet is all not really desirable, the effect of the diabetes pill antidiabetic drug of Chinese medicine and western medicine compound formulation also a little less than, Western medicine antihypelipidemic preparation glyburide and phenformin, metformin etc., certain hypoglycemic activity is arranged, effect was obvious when consumption was big, but consumption one conference produces many untoward reaction, in addition, single do not have obvious improvement effect with the blood sugar lowering Western medicine to some common complication of diabetes.

The object of the present invention is to provide a kind of antidiabetic drug and preparation method thereof, it is blood sugar lowering, blood fat reducing effectively, can also prevent the generation of diabetic complication, and side effect is little.

The objective of the invention is to realize by following technical scheme.

Antidiabetic drug of the present invention is by 3～6% Radix Codonopsis, Rhizoma Dioscoreae, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, 2～5% the Radix Rehmanniae, Radix Scrophulariae, Rhizoma Alismatis, Semen Cuscutae, Fructus Lycii, Radix Dipsaci, Radix Scutellariae, Radix Puerariae, the Radix Aucklandiae, Radix Et Rhizoma Rhei, Folium Ipomoeae, in 5～8% the Radix Astragali, Herba Epimedii, the Cortex Mori eight flavor is to 20 flavor Chinese crude drugs, allocate 0.1～0.3% glyburide again into, and 25～35% chromium yeast is made.

The preparation method of antidiabetic drug of the present invention is, Radix Et Rhizoma Rhei in this medicament composing prescription of elder generation, it is standby that Rhizoma Dioscoreae is ground into 100 order fine powders with pulverizer, with Herba Epimedii, Semen Cuscutae, Radix Dipsaci, the Radix Astragali, the Radix Rehmanniae, Radix Scrophulariae, Radix Codonopsis, Rhizoma Alismatis, Radix Angelicae Sinensis, Radix Puerariae, Rhizoma Chuanxiong, Cortex Mori, the Radix Aucklandiae, Radix Paeoniae Rubra, Fructus Lycii, the Radix Scutellariae water decocts, leach decocting liquid, Radix Salviae Miltiorrhizae, Folium Ipomoeae is with 95% and 50% ethanol extracted twice, collect extracting solution, decocting liquid and ethanol extract are carried out concentrating under reduced pressure respectively, concentrated solution after drying, be ground into the following fine powder of 100 orders, this fine powder and aforesaid standby fine powder are merged the back mixing, add glyburide, chromium yeast and an amount of auxiliary type agent, make granule (pelletize), make finished product preparation again behind granulate (screening granule), its technological process as shown in Figure 1.

Radix Et Rhizoma Rhei can be under 60～80 ℃ in its preparation, and the ethanol warm macerating with 25% extracted after 12 hours, and extracting solution and other decocting liquid and ethanol extract merge; Decocting technology is to carry out at twice in boiling flow container, for the first time Herba Epimedii, Semen Cuscutae, Radix Dipsaci, the Radix Astragali, the Radix Rehmanniae, Radix Scrophulariae, Radix Codonopsis, Rhizoma Alismatis, Radix Angelicae Sinensis, Radix Puerariae, Rhizoma Chuanxiong, Cortex Mori, the Radix Aucklandiae, Radix Paeoniae Rubra, a few flavor medical materials of Fructus Lycii are added 10 times of water, add Radix Scutellariae when soaking 20 minutes post-heating to 100 ℃, decocted 120 minutes, leach after the decocting liquid first time, add 8 times of water again, being heated to 100 ℃ decocted 60 minutes, leach decocting liquid for the second time, merge twice decocting liquid, filter with 200 mesh sieves.

Ethanol extraction technology is to carry out at twice in extraction pot, for the first time with Radix Salviae Miltiorrhizae, Folium Ipomoeae with 95% alcohol reflux 2 hours, collect extracting solution, for the second time with 50% alcohol reflux 2 hours, collection extracting solution, merging extracted twice liquid; Decocting liquid and ethanol extract are carried out concentrating under reduced pressure respectively, and the temperature of concentrating under reduced pressure is 60 ℃, is concentrated into the solution ratio and weighs 1.15～1.35; Exsiccant temperature is dried to moisture below 6% less than 80 ℃, and drying can adopt vacuum drying oven and freezer dryer, also can adopt spray drying; Auxiliary type agent can be starch, dextrin, lactose, also can be third hydroxylated cellulose; Prilling can adopt wet granulation, promptly mixes with fine powder with 65～85% ethanol, rubs granule with the hands with 14～16 eye mesh screens, also can adopt non-slurry pelletizing, and promptly fine powder mixes with lactose and then rolls grain with dried milling train; Finished dosage forms can be a tablet, also can be granule, can also be capsule.This antidiabetic drug can be used for treating non-insulin-dependent diabetes mellitus, for the generation that prevents some complication of diabetes obvious effect is arranged also, and side effect is little.

Specifically narrate embodiment below in conjunction with accompanying drawing:

Fig. 1 is a process flow diagram of the present invention

Specific embodiments of the invention are:

With Radix Et Rhizoma Rhei 2 grams, after Rhizoma Dioscoreae 2 gram is put together and is ground into fine powder with pulverizer, it is standby to cross 100 mesh sieves, with Herba Epimedii 3 grams, Semen Cuscutae 2 grams, Radix Dipsaci 2 grams, the Radix Astragali 3 grams, the Radix Rehmanniae 2 grams, Radix Scrophulariae 2 grams, Radix Codonopsis 2 grams, Rhizoma Alismatis 2 grams, Radix Angelicae Sinensis 2 grams, Radix Puerariae 2 grams, Rhizoma Chuanxiong 2 grams, Cortex Mori 3 grams, the Radix Aucklandiae 2 grams, Radix Paeoniae Rubra 2 grams, Fructus Lycii 2 grams are put into and are boiled flow container, add and put into 2 gram Radix Scutellariaes when 350 gram water are heated to 100 ℃, decocted 120 minutes, the filtrate decocting liquid, add 280 gram water again and be heated to 100 ℃ of decoctions 60 minutes, leach decocting liquid, merge decocting liquid twice, filter with 200 mesh sieves.

With Radix Salviae Miltiorrhizae 2 grams, Folium Ipomoeae 2 grams are put into extraction pot, alcohol reflux with 95% extracted once in 2 hours, after collecting extracting solution, the alcohol reflux of reuse 50% extracted for the second time in 2 hours, collect extracting solution, decocting liquid and ethanol extract merging are put into the concentrating under reduced pressure jar, at concentrating under reduced pressure below 60 ℃, to solution proportion be 1.15～1.35, concentrated solution is carrying out drying with vacuum drying oven below 80 ℃, is dried to water content below 6%, is ground into the following fine powder of 100 orders, this fine powder and aforesaid standby fine powder are merged the back mixing, add 0.1 gram glyburide, 15 gram chromium yeast and appropriate amount of starch, ethanol with 65% and fine powder are mixed to the suitable humidity of pelletize, rub the grain after drying with the hands with 14 eye mesh screens, encapsulated after screening.Content of dispersion in every capsules is 0.3 gram, wherein contains 1 milligram of glyburide, contains trivalent chromium 3 micrograms, and adult's dosage every day is 8 to 20 capsules.

This antidiabetic drug and JINQI JIANGTANG PIAN and diabetes pill are contrasted use clinically, and the curative effect of antidiabetic drug group obviously is better than other two groups, and the criterion according to the treatment diabetes curative effect is organized in following table 1 to table 3 with statistical data:

The quantitative variation of fasting glucose and twenty-four-hour urine sugar before and after table 1 non-insulin-dependent diabetes mellitus (NIDDM) patient treatment (x ± s)
				Grouping	Blood glucose (mg/dl)		Glucose in urine is (g/24h) quantitatively
The example number	After treating before the treatment	After treating before the treatment			Blood glucose (mg/dl)		Glucose in urine is (g/24h) quantitatively
The example number	After treating before the treatment	After treating before the treatment	This antidiabetic drug of diabetes pill JINQI JIANGTANG PIAN		34 37 96	193.8 164.3 ±28.6 ±24.1* 201.4 180.7 ±31.2 ±21.5* 197.2 132.6 ±29.6 ±20.5**	52.74 36.75 ±19.13 ±13.86* 54.31 43.76 ±21.45 ±10.72* 54.12 20.47 ±19.65 ±12.17**

Annotate: with compare * P＜0.05, * * P＜0.01 before the treatment

Table 2 NIDDM is with the variation of cholesterolemia before and after the patient treatment of hyperlipidemia and triglyceride (x ± s)
				Grouping	The example number	After treating before cholesterol (mg/dl) treatment	After treating before the triglyceride treatment
This antidiabetic drug of diabetes pill JINQI JIANGTANG PIAN	31 38 40	241.4 217.2 ±20.7 ±18.5* 245.2 231.4 ±24.1 ±20.8 242.7 201.6 ±19.8 ±17.4**	227.8 202.4 ±21.3 ±20.5* 231.3 219.5 ±24.1 ±21.4 230.3 187.5 ±21.8 ±16.7**	Grouping	The example number	After treating before cholesterol (mg/dl) treatment	After treating before the triglyceride treatment

Annotate: with compare before the treatment, * P＜0.05, * * P＜0.01, be 2 months the course of treatment

Table 3 is respectively organized NIDDM patient's efficacy analysis
						Grouping	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)
This antidiabetic drug of diabetes pill JINQI JIANGTANG PIAN	34 37 96	4 0 39	17 11 51	13 26 6	61.8 29.7 93.7	Grouping	The example number	Produce effects	Effectively	Invalid	Total effective rate (%)

Annotate: from the efficacy analysis of treatment front and back, this antidiabetic drug group curative effect obviously is better than other two groups

This antidiabetic drug takes benefiting QI for activating blood circulation and enriching yin and nourishing kidney method to treat to treatment of diabetes, in the prescription, the Radix Astragali, Radix Codonopsis, Rhizoma Dioscoreae, the Radix Rehmanniae, Fructus Lycii, Radix Scrophulariae and Radix Salviae Miltiorrhizae have supplementing QI and nourishing YIN heat clearing away effect, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae has function of promoting blood circulation to disperse blood clots, Herba Epimedii, Semen Cuscutae, Fructus Lycii and Radix Dipsaci have the kidney invigorating effect, the Radix Astragali, Radix Scutellariae, Radix Puerariae, Cortex Mori, Radix Et Rhizoma Rhei, Fructus Lycii, Rhizoma Alismatis and Folium Ipomoeae have hypoglycemic activity in various degree, the all medicines of this medicine share, for regulating carbohydrate metabolism, blood fat reducing and the effect that improves the blood high viscosity and high coagulant state can be significantly improved.In addition, chromium yeast (organo-chromium compound) contains trivalent chromium, the trivalent chromium element is the center active component of glucose tolerance factor (GTF), effect with tangible enhancing insulin bioactivity, it is active that chromium yeast itself has not had fermentation, except that chrome content is higher, also contain protein, vitamin B group and crude fibre etc., there is not difference with the composition of common edible yeast, but the blood glucose that can reduce diabetes that its trace element chromium had, blood fat and the effect that improves insulin bioactivity but can be used for medically treating diabetes.Diabetes are a kind of comprehensive diseases, except that the blood glucose height, also often be associated with some complication such as dyslipidemia, therefore monotherapy is often not really desirable, except that having traditional effect, share among the we, on the treatment of diabetes effect, then have collaborative and potentiation with trivalent chromium element and glyburide, therefore, adopt this antidiabetic drug can improve curative effect significantly.

Clinical practice proves that antidiabetic drug blood sugar decreasing effect of the present invention is good, and long-term use without side effects reaches design purpose.

Claims

1, a kind of antidiabetic drug, it is characterized in that, it is by 3～6% Radix Codonopsis, Rhizoma Dioscoreae, Radix Angelicae Sinensis, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, 2～5% the Radix Rehmanniae, Radix Scrophulariae, Rhizoma Alismatis, Semen Cuscutae, Fructus Lycii, Radix Dipsaci, Radix Scutellariae, Radix Puerariae, the Radix Aucklandiae, Radix Et Rhizoma Rhei, Folium Ipomoeae, 5～8% the Radix Astragali, Herba Epimedii, Cortex Mori 20 flavor Chinese crude drugs, the chromium yeast of allocating 0.1～0.3% glyburide and 25～30% again into is made.

2, a kind of preparation method of antidiabetic drug as claimed in claim 1, it is characterized in that, with the Radix Et Rhizoma Rhei in this medicament composing prescription, it is standby that Rhizoma Dioscoreae is ground into 100 order fine powders with pulverizer, with Herba Epimedii, field dobber, Radix Dipsaci, the Radix Astragali, the Radix Rehmanniae, Radix Scrophulariae, Radix Codonopsis, Rhizoma Alismatis, Radix Angelicae Sinensis, Radix Puerariae, Rhizoma Chuanxiong, Cortex Mori, the Radix Aucklandiae, Radix Paeoniae Rubra, Fructus Lycii, after the Radix Scutellariae water decocts, leach decocting liquid, filter with 200 mesh sieves then, Radix Salviae Miltiorrhizae, Folium Ipomoeae is with 95% and 50% ethanol extracted twice, collect extracting solution, decocting liquid and ethanol extract are carried out concentrating under reduced pressure respectively, concentrated solution after drying, be ground into the following fine powder of 100 orders, this fine powder and aforesaid standby fine powder are merged the back mixing, add glyburide, chromium yeast and auxiliary type agent, make granule, behind granulate, make finished product preparation again.

3, the preparation method of antidiabetic drug according to claim 2 is characterized in that, described Radix Et Rhizoma Rhei ethanol warm macerating with 25% under 80 ℃ extracted after 12 hours, and extracting solution and other decocting liquid and ethanol extract merge.

4, the preparation method of antidiabetic drug according to claim 2, it is characterized in that, described decocting technology is to carry out at twice in boiling flow container, for the first time with Herba Epimedii, Semen Cuscutae, Radix Dipsaci, the Radix Astragali, the Radix Rehmanniae, Radix Scrophulariae, Radix Codonopsis, Rhizoma Alismatis, Radix Angelicae Sinensis, Radix Puerariae, Rhizoma Chuanxiong, the Radix Aucklandiae, Cortex Mori, Radix Paeoniae Rubra, a few flavor medical materials of Fructus Lycii add Radix Scutellariae when adding 20 minutes post-heating to 100 of 10 times of water loggings bubbles ℃, decocted 120 minutes, leach decocting liquid, add 8 times of water again, being heated to 100 ℃ decocted 60 minutes, leach second batch of decocting liquid, merge after twice decocting liquid, filter with 200 mesh sieves.

5, the preparation method of antidiabetic drug according to claim 2, it is characterized in that, described ethanol extraction technology is to carry out at twice in extraction pot, for the first time Radix Salviae Miltiorrhizae, Folium Ipomoeae are extracted after 2 hours with 95% alcohol reflux, collect extracting solution, the second time, the alcohol reflux with 50% extracted after 2 hours, collected extracting solution, merged extracted twice liquid.

6, the preparation method of antidiabetic drug according to claim 2 is characterized in that, the temperature of described concentrating under reduced pressure is 60 ℃, is concentrated into the solution ratio and weighs 1.15～1.35.

7, the preparation method of antidiabetic drug according to claim 2 is characterized in that, described baking temperature is dried to moisture below 6% less than 80 ℃, dry employing vacuum drying oven, or freezer dryer, perhaps spray drying.

8, the preparation method of antidiabetic drug according to claim 2 is characterized in that, described auxiliary type agent is a starch, or dextrin, or lactose, or third hydroxylated cellulose.

9, the preparation method of antidiabetic drug according to claim 2 is characterized in that, described prilling adopts wet granulation, perhaps non-slurry pelletizing.

10, the preparation method of antidiabetic drug according to claim 2 is characterized in that, described finished dosage forms is a tablet.

11, the preparation method of antidiabetic drug according to claim 2 is characterized in that, described finished dosage forms is a granule.

12, the preparation method of antidiabetic drug according to claim 2 is characterized in that, described finished dosage forms is a capsule.