CN100348251C - Medicine for treating diabetes and its preparation method - Google Patents
Medicine for treating diabetes and its preparation method Download PDFInfo
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- CN100348251C CN100348251C CNB2003101103331A CN200310110333A CN100348251C CN 100348251 C CN100348251 C CN 100348251C CN B2003101103331 A CNB2003101103331 A CN B2003101103331A CN 200310110333 A CN200310110333 A CN 200310110333A CN 100348251 C CN100348251 C CN 100348251C
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Abstract
The present invention relates to a medicine for treating diabetes and a preparation method thereof, which comprises the following steps: Chinese yams, ginsengs, trichosanthes roots, cornel, safflower, red sage roots, semen litchi and corium stomachichum galli are respectively crushed into fine powder and blended uniformly; astragalus roots, fragrant solomonseal rhizomes, fresh rehmannia roots, glehnia, anemarrhena, lilyturf roots, mango leaves and guava leaves are chopped, boiled with water for 3 times, then the boiled liquid is combined, filtered and concentrated into pure paste; the fine powder is joined into the boiled liquid, and the mixture is blended, dried, crushed into fine powder which is sprayed in menthol dissolved by ethanol, blended, made into pills with water, dried and polished. The pills of the present invention have the functions of supplying qi and nourishing yin, promoting fluid production to quench thirst, treating the second type diabetes, and the pills have mature and stable preparation and the pills are suitable for mechanization production.
Description
Technical field
The present invention relates to the medicine that natural plants is produced, specifically, is the pill that 10 pleasant impression Chinese medicines such as a kind of Rhizoma Dioscoreae, Radix Panacis Quinquefolii, the Radix Astragali, Rhizoma Polygonati Odorati, Radix Glehniae, the Rhizoma Anemarrhenae are made.
Background technology
Pill is a kind of in the Chinese medicine conventional dosage forms, it is slow to have disintegrate, discharges medicine gradually, and effect is lasting, reduce characteristics such as toxicity and untoward reaction, generally be used for effects such as the treatment of chronic disease, kidney disease and QI and blood regulating.But the combination of different Chinese medicine preparations, the disease of its treatment is significantly different with effect.
Summary of the invention
The purpose of this invention is to provide a kind of Chinese medicine pill that is mainly used in the treatment type ii diabetes and preparation method thereof.
Raw material that pill of the present invention is used and weight proportion thereof:
Rhizoma Dioscoreae 15-19 Radix Panacis Quinquefolii 4-8 Radix Astragali 4-8
Radix Trichosanthis 4-6 Rhizoma Polygonati Odorati 4-6 Radix Rehmanniae 4-8
Radix Glehniae 4-6 Rhizoma Anemarrhenae 4-6 Fructus Corni 4-6
Radix Ophiopogonis 4-6 Folium mangiferae 4-6 Flos Carthami 4-6
Radix Salviae Miltiorrhizae 4-6 Semen Litchi 4-6 Folium Psidii Guajavae 1-3.5
Endothelium Corneum Gigeriae Galli 4-6 Mentholum 4-6.
The raw material optimum weight proportioning that pill of the present invention is used:
Rhizoma Dioscoreae 18.2, Radix Panacis Quinquefolii 7.8, the Radix Astragali 7.8, Radix Trichosanthis 5.2, Rhizoma Polygonati Odorati 5.2, Radix Rehmanniae 7.8, Radix Glehniae 5.2, the Rhizoma Anemarrhenae 5.2, Fructus Corni 5.2, Radix Ophiopogonis 5.2, Folium mangiferae 5.2, Flos Carthami 5.2, Radix Salviae Miltiorrhizae 5.2, Semen Litchi 5.2, Folium Psidii Guajavae 3.1, Endothelium Corneum Gigeriae Galli 5.2, Mentholum 5.2.
The concrete preparation method of pill of the present invention may further comprise the steps:
(1) raw material pre-treatment: medical material is up to the standards, clean, Rhizoma Dioscoreae, Radix Panacis Quinquefolii, Radix Trichosanthis, Flos Carthami, Fructus Corni, Radix Salviae Miltiorrhizae, Semen Litchi, Endothelium Corneum Gigeriae Galli eight flavor medical material pulverize separately are become fine powder, cross 80 mesh sieves, sterilized 0.5 hour down in 100Kpa with high compressed steam, drying, standby;
(2) Radix Astragali, Rhizoma Polygonati Odorati, Radix Rehmanniae, Radix Glehniae, the Rhizoma Anemarrhenae, Radix Ophiopogonis, Folium mangiferae, Folium Psidii Guajavae eight flavor medical materials shred respectively, decoct with water 3 times, each amount of water is 10 times of amounts of medical material, decocted 2 hours, collecting decoction, filter, it is 1.21～1.25 clear paste that filtrate decompression is concentrated into 80 ℃ relative density;
(3) with the medical material fine powder mix homogeneously of gained clear paste and step (1), 80 ℃ of dryings are ground into fine powder, cross 80 mesh sieves, and Mentholum adds dissolve with ethanol, spray in the above-mentioned fine powder, and mix homogeneously, 60 ℃ of dryings, standby;
(4) molding: take by weighing a small amount of medicated powder that step (3) mixes, put in the coating pan, machine, spray into distilled water, make it to become gradually tiny granule, cross 10 mesh sieves, this granule is put into coating pan, rotate coating pan, add a little medicated powder of step (3), change while stirring, to the even spheroidal granule of diameter 0.5～1mm, sieve removes the excessive fraction of crossing, the ball mould;
(5) general ball molding: take out step (4) and screened uniform spherical ball mould, the fine powder that adds step (3) while spraying water is to dry layer by layer, and volume constantly increases, and weighs 0.09 to ball and restrains, and takes out, and 60 ℃ dry down;
(6) polishing: the pill that step (5) makes worm white wax polishing, 80 ℃ of dryings;
(7) packing: every bottle 300 ball.
All can buy on the used raw materials market of the present invention, concrete prescription is as follows:
Radix Panacis Quinquefolii is the Araliaceae Radix Panacis Quinquefolii, the dry root of Panax quinquefolium L.Mostly be the U.S., Canadian import, domestic also have a cultivation.
Rhizoma Dioscoreae is the dry tuber of potato section plant Dioscarea persimilis Prain et Burkill, is distributed in ground such as Guangxi, Guangdong, Hunan, Hainan, and this product should meet the pertinent regulations under " Guangxi Chinese crude drug standard " second 26 pages of Rhizoma Dioscoreae item.
The Radix Astragali is the leguminous plant Radix Astagali, or the dry root of the film Radix Astragali.The main place of production: ground such as Shanxi, Gansu, Heilungkiang, the Inner Mongol.This product should meet " the pertinent regulations under 249 pages of Radix Astragali items of Chinese pharmacopoeia version portion in 2000.
Radix Trichosanthis is the dry root of cucurbitaceous plant building or trichosanthes rosthornii Harms.The main place of production: ground such as Henan, Guangxi, Shandong, Jiangsu, Guizhou, Anhui, this product should meet " the pertinent regulations under 42 pages of Radix Trichosanthis items of Chinese pharmacopoeia version in 2000.
Rhizoma Polygonati Odorati is the dry rhizome of liliaceous plant Rhizoma Polygonati Odorati.The main place of production: Henan, Jiangsu, Liaoning, Hunan, zhejiang and other places.This product should meet " the pertinent regulations under 64 pages of Rhizoma Polygonati Odorati items of Chinese pharmacopoeia version in 2000.
Radix Rehmanniae is the fresh or dry tuber of scrophulariaceae rehmannia glutinosa plant, the main place of production: ground such as Henan, Zhejiang, Jiangsu, Hebei, Shaanxi.This product should meet " the pertinent regulations under 94 pages of Radix Rehmanniae items of Chinese pharmacopoeia version in 2000.
Radix Glehniae is the dry root of samphire glehnia littoralis.The main place of production: ground such as Liaoning, Hebei, Shandong, Jiangsu.This product should meet " the pertinent regulations under 75 pages of Radix Glehniae items of Chinese pharmacopoeia version in 2000.
The Rhizoma Anemarrhenae is the dry rhizome of the liliaceous plant Rhizoma Anemarrhenae.The main place of production: ground such as Hebei, Shanxi, this product should meet " the pertinent regulations under 171 pages of Rhizoma Anemarrhenae items of Chinese pharmacopoeia version in 2000.
Fructus Corni is the drying and ripening sarcocarp of Cornaceae plant Fructus Corni.The main place of production: ground such as Zhejiang, Henan, Anhui, Shaanxi, Shanxi, Sichuan.This product should meet " the pertinent regulations under 22 pages of Fructus Corni items of Chinese pharmacopoeia version in 2000.
Be the liliaceous plant dried root of Radix Ophiopogonis Radix Ophiopogonis.The main place of production: ground such as Zhejiang, Sichuan.This product should meet " the pertinent regulations under Chinese pharmacopoeia version in 2000 item one one 122 pages Radix Ophiopogonis.
Folium mangiferae is the dried leaves of Anacardiaceae plant Fructus Mangifera Indicae.Be generally cultivation, be distributed in south China and Taiwan, Fujian, south of Yunnan, the Yulin in Guangxi, drink state, three areas, Wuzhou are at most.This product should meet the pertinent regulations under 54 pages of Folium mangiferae items of " Guangxi Chinese crude drug standard " nineteen ninety version.
Flos Carthami is the dried floral of feverfew Flos Carthami.The main place of production: ground such as Henan, Zhejiang, Sichuan.This product should meet " the pertinent regulations under 119 pages of Flos Carthami items of Chinese pharmacopoeia version in 2000.
Radix Salviae Miltiorrhizae is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae.The main place of production: ground such as Anhui, Shanxi, Hebei, Sichuan, Jiangsu.This product should meet " the pertinent regulations under 57 pages of Radix Salviae Miltiorrhizae items of Chinese pharmacopoeia version in 2000.
Semen Litchi is the dry mature seed of sapindaceous plant Fructus Litchi.The main place of production: Guangdong, Guangxi.This product should meet " the pertinent regulations under 196 pages of Semen Litchi items of Chinese pharmacopoeia version in 2000.
Folium Psidii Guajavae is dried leaves and a band leaf tender stem of choosing golden ma section plant Fructus psidii guajavae immaturus.Be distributed in Fujian, Guangdong, Guangxi, Hainan and south of Yunnan.There is cultivation in areas such as the Wuzhou in Guangxi, Yulin, Liuzhou, Nanning, Baise.This product should meet the pertinent regulations under 88 pages of Folium Psidii Guajavae items of " Guangxi Chinese crude drug standard " nineteen ninety version.
Endothelium Corneum Gigeriae Galli is the dry inner wall of sandbag of Phasianidae animal man chicken.This product should meet " the pertinent regulations under 151 pages of Endothelium Corneum Gigeriae Galli items of Chinese pharmacopoeia version in 2000.
Mentholum is a kind of saturated cyclic alcohol that obtains in the Oleum menthae.This product should meet " the pertinent regulations under 311 pages of Mentholum items of Chinese pharmacopoeia version in 2000.
Ethanol should meet " the pertinent regulations under two ethanol items of Chinese pharmacopoeia version in 2000.
Cera Chinensis is that the male worm of Coccidae insecticide wax insect is gregariousness in the last excretory wax of his kind of plant branch of Oleaceae plant Chinese ash, Fructus Ligustri Lucidi or Ligustrum, forms through refining.This product should meet " the pertinent regulations under two insect wax items of Chinese pharmacopoeia version in 2000.
Advantage of the present invention and effect:
Most of medical material of the present invention is through pharmacological research and clinical practice, the effective ingredient of its blood sugar reducing function is polysaccharide or water extract, as Rhizoma Dioscoreae, the Radix Astragali, Radix Trichosanthis, Rhizoma Polygonati Odorati, Radix Rehmanniae, the Rhizoma Anemarrhenae, Radix Ophiopogonis etc., but part medical material such as Rhizoma Dioscoreae, Radix Trichosanthis etc., starch-containing more, meet that heat easily becomes pasty state and to influence its composition fried, so the selected part medical material such as the Radix Astragali, Rhizoma Polygonati Odorati, the Radix Rehmanniae, eight flavor medical material decoctings such as Huang extract, be condensed into clear paste, remaining Rhizoma Dioscoreae, Radix Panacis Quinquefolii, eight flavor pulverizing medicinal materials such as Radix Trichosanthis become fine powder to spray into Mentholum again, and water is made concentrated watered pill.The pill that above-mentioned technology is made has that volume is little, and dose is few, takes, carries and store more convenient, easily absorbs, and helps characteristics such as drug effect performance, and suitable mechanization production.
Medicine of the present invention is to alloxan hyperglycemia model rat, the effect that blood sugar lowering content is arranged and increase its carbohydrate tolerance; Blood glucose rat models such as epinephrine there is the effect of blood sugar lowering content; But the carbohydrate tolerance to normal rat and mice does not have obvious influence, therefore medicine major function of the present invention: supplementing QI and nourishing YIN, promoting the production of body fluid to quench thirst, treatment type ii diabetes (syndrome of deficiency of both qi and yin).Detailed directions: oral, one time 30 ball (the heavy 0.09g of every ball), three times on the one.Storage: airtight, protection against the tide, 2 years effect duration.
The specific embodiment:
Further specify characteristics of the present invention with instantiation below.
Example 1～3
This example raw material consumption sees Table 1.
Concrete preparation method is as follows:
Rhizoma Dioscoreae, Radix Panacis Quinquefolii, Radix Trichosanthis, the mountain Zhu mass viewpoint, Flos Carthami, Radix Salviae Miltiorrhizae, Semen Litchi, Endothelium Corneum Gigeriae Galli pulverize separately are become fine powder, mixing; Except that Mentholum, eight flavors such as all the other Radixs Astragali are given cut-out respectively as one thinks fit, decoct with water 3 times, each water yield is 10 times of medical material amount, each 2 hours, collecting decoction filtered, filtrate is concentrated into the clear paste that relative density is 1.21～1.25 (80 ℃), add above-mentioned medical material fine powder, mixing, drying, be ground into fine powder, mixing; Mentholum adds dissolve with ethanol, and spray adds in the above-mentioned fine powder, and mixing is used water pill, drying, and polishing, that is, end product quality is put in storage after the assay was approved.
The discriminating of product of the present invention and assay:
Differentiate: 1) get this product, put microscopically and observe: pollen grain similar round, ellipse or olive shape, diameter 35～65um, three germinal aperatures of tool, aperture similar round, outer wall tool dentation; It is in blocks to plant skin coral shape cell, yellowish-brown or rufous, section is seen the cell string, long (radially) 35～50um, wide (cutting auspicious) 10～12um, thickens, outward by horny layer warp-wise wall microbend, the surface is seen and is polygon, and anticlinal wall is inhomogeneous to be thickened.
2) get this product.Press thin layer color popularize law (appendix VIB of Chinese Pharmacopoeia version in 2000) test, do the discriminating of medicines such as Radix Panacis Quinquefolii, Fructus Corni, Radix Salviae Miltiorrhizae, Mentholum.
Check: determination of water, get this product 20 grams, grind, accurate title is fixed, measures according to aquametry (appendix IXII second method of Chinese Pharmacopoeia version in 2000), must not surpass 9.0%.
Assay: press high-efficient liquid phase color popularize law (appendix VID of Chinese Pharmacopoeia version in 2000) and measure.Radix Panacis Quinquefolii content: per 1 gram of this product contains Radix Panacis Quinquefolii with the Ginsenoside Rb
1(C
54H
92O
23) meter, must not be less than 6um.
Other inspection: should meet every regulation relevant under the pill item (appendix IA of Chinese Pharmacopoeia version in 2000).
Example 4
This example is the clinical and zoopery of Rhizoma Dioscoreae ginseng astragalus pill of the present invention.
Zoopery:
1. pharmacodynamic experiment: gavage rat with the Rhizoma Dioscoreae ginseng astragalus pill, to raising pyrimidine hyperglycemia model rat, the blood sugar lowering content and the effect of increasing its carbohydrate tolerance to epinephrine hyperglycemia model rat, have the effect of blood sugar lowering content again; But the carbohydrate tolerance to normal rat and normal mouse does not have obvious influence.
2. acute toxicity test and safety testing: Rhizoma Dioscoreae ginseng astragalus pill crude drug dried cream powder gavages mice, and dosage is crude drug 27.9g/kg, 31.7g/kg (being respectively clinical plan 173 times, 198 times with daily dose); Rhizoma Dioscoreae ginseng astragalus pill crude drug dried cream powder gavages, and maximum dosage-feeding is a crude drug dried cream powder 27.9g/kg (clinical plan is with 173 times of daily dose); There is no abnormal response.The clinical application by the amount of drafting of prompting Rhizoma Dioscoreae ginseng astragalus pill is safe.
3. long term toxicity test: the Rhizoma Dioscoreae ginseng astragalus pill is pressed the dosage of crude drug 9.64g/kg 4.82g/kg 2.41g/kg and is given rats gavaged Rhizoma Dioscoreae ginseng astragalus pill crude drug dried cream powder (once a day) respectively, (daily dose is respectively 60 times, 30 times, 15 times of the clinical plan consumption) drug withdrawal of 12 weeks of successive administration observed for 2 weeks, there is no the overt toxicity reaction to occur.
(1) observing the outward appearance respectively organize rat, behavior, breathing, extremity activity, feed, drainage etc. shows no obvious abnormalities; No edema; Do not have the phenomenon of being poisoned to death, do not have significant difference with matched group.
(2) hematological examination project: content of hemoglobin (HGB), RBC number (RBC), leukocyte count (WBC), lymphocyte number (LYMPH), mononuclear cell number (Mid), granulocyte number (Gran), platelet count (PLT), clotting time (CT, capillary tube method).After 12 weeks of administration, 2 weeks of drug withdrawal, check above-mentioned every index, all in normal range,, the life-time service avirulence is described with the matched group no significant difference.
(3) blood biochemical is learned inspection item: total serum protein (TP), albumin (ALB), total bilirubin (Bil), T-CHOL (TCH), blood urea nitrogen (Urea), creatinine (Cr), blood glucose (Glu) content and glutamate pyruvate transaminase (ALT), glutamic oxaloacetic transaminase, GOT (AST), alkali phosphatase (ALP) activity.12 weeks of administration, 2 weeks of drug withdrawal, check that above-mentioned every index all in normal range, does not have the toxicology meaning, with the matched group no significant difference.
(4) the exponential measurement results of organ weights such as the heart, lung, liver,spleen,kidney, Zi Gong, testis: 12 weeks of administration, 2 weeks of drug withdrawal, above-mentioned organ index changes all in normal range, does not have the toxicology meaning.
Clinical observation:
1. diagnostic criteria:
(1) Western medicine diagnose standard: adopt WHO tentative standard (the very sugared method of venous plasma) in 1980, all eligible persons are all diagnosable to be diabetes.
(2) tcm diagnosis standard: allly have that thirsty polydipsia, rapid digestion of food are easily starved, a frequent micturition and card marquis persons such as sweet, body sale can make a definite diagnosis.
2. observational technique: adopt district's group at random, contrast, non-blind method observe.
(1) grouping: for observing 300 examples, look into the random alignment table, treatment group (200 example) is divided into groups with matched group (100 example).
(2) treatment group: use the Rhizoma Dioscoreae ginseng astragalus pill, oral, each 30 balls, every day 3 times:
(3) matched group: each 1 bag of edible TANGMAIKANG KELI (banknotes-system medicine company produces in the China Academy of TCM), every day 3 times
3. observed result:
(1) treatment group obvious effective rate: effective percentage is respectively 34%, 55%, and total effective rate is 89%.
The matched group obvious effective rate: effective percentage is respectively 27%, 56%, and total effective rate is 83%.Treatment group curative effect obviously is better than matched group, but the there was no significant difference meaning.
(2) clinical symptoms curative effect: each is organized symptoms such as fatigue and weakness after the patient, dizziness and tinnitus, dryness of the mouth and throat, dysphoria with feverish sensation in the chest palms and soles, palpitation and insomnia, the red constipation of urinating and all has clear improvement, but the treatment group obviously is better than matched group.
(3) biochemical curative effect: fasting glucose after treatment group and the treatment of control group, 2 hours after the meal blood glucose, glucose in urine all had obvious minimizing in 24 hours.Treatment group and matched group are relatively treated the back fasting glucose, 2 hours after the meal blood glucose, and the minimizing of twenty-four-hour urine sugar obviously is better than matched group.
(4) this research has been carried out blood, just routine examination to 200 routine patients of treatment group, and the heart, liver, kidney function test are not all found obvious adverse reaction and toxic and side effects, and prompting this product is clinical safe and reliable.
Table 1
| Project | Example 1 | Example 2 | Example 3 |
| Rhizoma Dioscoreae | 150g | ?180g | ?190g |
| Radix Panacis Quinquefolii | 40g | ?78g | ?80g |
| The Radix Astragali | 40g | ?78g | ?80g |
| Radix Trichosanthis | 40g | ?52g | ?60g |
| Rhizoma Polygonati Odorati | 40g | ?52g | ?60g |
| Radix Rehmanniae | 40g | ?78g | ?80g |
| Radix Glehniae | 40g | ?52g | ?60g |
| The Rhizoma Anemarrhenae | 40g | ?52g | ?60g |
| Fructus Corni | 40g | ?52g | ?60g |
| Radix Ophiopogonis | 40g | ?52g | ?60g |
| Folium mangiferae | 40g | ?52g | ?60g |
| Flos Carthami | 40g | ?52g | ?60g |
| Radix Salviae Miltiorrhizae | 40g | ?52g | ?60g |
| Semen Litchi | 40g | ?52g | ?60g |
| Folium Psidii Guajavae | 10g | ?31g | ?35g |
| Endothelium Corneum Gigeriae Galli | 40g | ?52g | ?60g |
| Mentholum | 40g | ?52g | ?60g |
Claims (2)
1. medicine Rhizoma Dioscoreae ginseng astragalus pill for the treatment of diabetes is characterized in that used crude drug and weight proportion thereof:
Rhizoma Dioscoreae 15-19 Radix Panacis Quinquefolii 4-8 Radix Astragali 4-8
Radix Trichosanthis 4-6 Rhizoma Polygonati Odorati 4-6 Radix Rehmanniae 4-8
Radix Glehniae 4-6 Rhizoma Anemarrhenae 4-6 Fructus Corni 4-6
Radix Ophiopogonis 4-6 Folium mangiferae 4-6 Flos Carthami 4-6
Radix Salviae Miltiorrhizae 4-6 Semen Litchi 4-6 Folium Psidii Guajavae 1-3.5
Endothelium Corneum Gigeriae Galli 4-6 Mentholum 4-6.
2. Rhizoma Dioscoreae ginseng astragalus pill according to claim 1 is characterized in that used crude drug weight proportion: Rhizoma Dioscoreae 18.2, Radix Panacis Quinquefolii 7.8, the Radix Astragali 7.8, Radix Trichosanthis 5.2, Rhizoma Polygonati Odorati 5.2, Radix Rehmanniae 7.8, Radix Glehniae 5.2, the Rhizoma Anemarrhenae 5.2, Fructus Corni 5.2, Radix Ophiopogonis 5.2, Folium mangiferae 5.2, Flos Carthami 5.2, Radix Salviae Miltiorrhizae 5.2, Semen Litchi 5.2, Folium Psidii Guajavae 3.1, Endothelium Corneum Gigeriae Galli 5.2, Mentholum 5.2.
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| CN1814123B (en) * | 2005-12-05 | 2010-12-08 | 杨雄志 | Chinese medicine composition for treating diabetes and its preparation method |
| CN101357218B (en) * | 2008-08-22 | 2011-06-01 | 张洪蛟 | Externally used medicine for treating diabetes and preparation method thereof |
| CN106806644A (en) * | 2017-02-23 | 2017-06-09 | 王胜霞 | A kind of pharmaceutical composition and preparation method with reduction blood sugar recovery pancreas function |
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| CN1127344C (en) * | 2000-03-17 | 2003-11-12 | 王申 | Oral pill for curing diabetes and its complication |
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| CN1127344C (en) * | 2000-03-17 | 2003-11-12 | 王申 | Oral pill for curing diabetes and its complication |
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