CN1280010A - Oral medicine for treating diabetes and its production method - Google Patents
Oral medicine for treating diabetes and its production method Download PDFInfo
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- CN1280010A CN1280010A CN 00106370 CN00106370A CN1280010A CN 1280010 A CN1280010 A CN 1280010A CN 00106370 CN00106370 CN 00106370 CN 00106370 A CN00106370 A CN 00106370A CN 1280010 A CN1280010 A CN 1280010A
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- Medicines Containing Plant Substances (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention belongs to the field of medicine technology. The product essentially contains pharmaceutical active ingredients of beta-ecdysone and 2-beta-ecdysone acetate, and the weight ratio of the beta-ecdysone to the 2-beta-ecdysone acetate is 50-95 percent and 5-50 percent. In addition, the extract can contain 4-12% of total weight of beta-ecdysone and 2-beta-ecdysone acetate, and trace compounds except beta-ecdysone and 2-beta-ecdysone acetate in the extract of herba Eragrostis Nigrae. The medicine can be prepared from natural herba Cymbopogonis Citrari, has no adverse side effects, and has obvious curative effect, and the provided production method is suitable for industrialized mass production, and has low cost.
Description
The invention belongs to the human technical field of pharmaceuticals, be specifically related to a kind of oral formulations and production method thereof for the treatment of diabetes.
Radix Cyanotis vagae is the blue cerastium plant Radix Cyanotis vagae (Cyanotis arachnoides C.B.C.Clarke) of Commelianaceae, records in " national Chinese herbal medicine compilation ", generally with the root treatment of arthritis of being used as medicine.Publication number is that the Chinese patent file of Chinese patent CN1246363A has been announced " a kind of medicine for the treatment of diabetes and preparation method thereof ", its product is and must is a kind of medicine made from following method: get the Radix Cyanotis vagae herb, drying and crushing, with industrial alcohol or ethanol/water or ethyl acetate or methanol or water heating and refluxing extraction 1-5 times, each 2-4 hours, filter, filtrate concentrates, placement is spent the night, refilter, filtrate is concentrated into bulk, oven dry grinds, and adding ethanol/ethyl acetate (1: 9-9: 1) heating for dissolving cold filtration, it is effective site that filtrate concentrating is ground into powder, formulation preparation method is made capsule or by weight 1: 2-1 routinely: 5 add excipient, pelletizing press sheet.The preparation method of its product just defines the said method of this product.As seen the document does not have clear and definite active constituents of medicine component and content, and the preparation method that is provided also is difficult to adapt to industrial production requirement.
The present invention aims to provide a kind of oral drugs and production method thereof for the treatment of diabetes, and this medicine has clear and definite active ingredient components and content, and curative effect is obvious, and its production method is applicable to large-scale industrialization production, and cost is low.
Product of the present invention contains active constituents of medicine β-ecdyson and 2-β-ecdyson acetas in essence, and the weight ratio of the two is: β-ecdyson 50-95%, 2-β-ecdyson acetas 5-50%.
It is its active constituents of medicine that product of the present invention can also contain other minor compound that accounts for β-ecdyson and 2-β-ecdyson acetas gross weight 4-12%, other minor compounds in the alcohol extract that said other minor compound is the Radix Cyanotis vagae herb except that β-ecdyson and 2-β-ecdyson acetas.
The active constituents of medicine and the content thereof of products perfection of the present invention are: contain β-ecdyson and 2-β-ecdyson acetas, the weight ratio of the two is: β-ecdyson 60-85%, 2-β-ecdyson acetas 15-40%, and contain other minor compound that accounts for β-ecdyson and 2-β-ecdyson acetas gross weight 6-10%, other minor compounds in the alcohol extract that said other minor compound is the Radix Cyanotis vagae herb except that β-ecdyson and 2-β-ecdyson acetas.
The preparation method of product of the present invention is: be coarse powder with Radix Cyanotis vagae herb drying and crushing earlier, add the ethanol of water or 40%-95% concentration or dehydrated alcohol heating extraction two to six times again, filter, filtrate adds natural clarifying agent or the clarifying treatment after-filtration is carried out in the chemical clarification agent, D101 type macroporous adsorptive resins or AB-8 type macroporous adsorptive resins or clear liquor concentrate and make crude product on the clear liquor, go up D101 type macroporous adsorptive resins or AB-8 type macroporous adsorbent resin behind the water dissolution, with methanol or ethanol elution, eluent reclaim under reduced pressure methanol or ethanol, dry, make effective ingredient in Chinese,, add appropriate amount of auxiliary materials and can be made into oral formulations through being ground into fine powder.The oral formulations of making can be tablet, capsule, granule, powder etc.In the said method, is coarse powder earlier preferably, adds the ethanol of water or 40%-95% concentration or dehydrated alcohol heating extraction three times again Radix Cyanotis vagae herb drying and crushing.
The present invention adopts the Radix Cyanotis vagae herb to extract, because the root of plant, stem, leaf, flower, fruit ingredient are not exclusively the same, so in the product made of the inventive method, the content of its active constituents of medicine is a scope.
The inventive method is if make tablet, capsule or granule, then 2000g-6000g Radix Cyanotis vagae can be made into 1000 or.The method of optimizing be 3500g-5000g Radix Cyanotis vagae can be made into 1000 or.
Diabetes are a kind of whole body chronic metabolic disease that genetic predisposition is arranged, and belong to the category of traditional Chinese medical science diabetes.Its main feature is hyperglycemia and glycosuria, clinical manifestation with polydipsia, polyphagia, polyuria, to become thin be feature.This disease is prone to multiple complications, is one of refractory disease of serious threat human health, can prevent the generation and the development of its complication to effective treatment of diabetes.The oral Chinese medicine preparation of being made by Cyanotis arachnoides P.E has inhibitory action to the hyperglycemia that pancreas hyperglycemia, alloxan or insulin antibody cause, can alleviate the pathophysiology symptom of the artificial diabetes that causes by alloxan, make glycogen content, it is normal that content of propylene glycol, acetone acid content and liver mitochondrial calcium channel function recover; Can make because the phospholipid spectrum that the pathologic of the hepatic mitochondria film that causes of insulin deficit changes recovers normal, can replenishing YIN and removing heat, removing damp and stopping pain, dredge channels and activating collaterals, to treatment type determined curative effect, non-evident effect.Through clinical trial certificate total effective rate 84%.
Method of the present invention adopts natural clarifying agent or chemical clarification agent that extracting solution is carried out clarifying treatment, purpose is that to remove protein in the extracting solution, tannin, natural gum, pigment etc. most of invalid or to the deleterious composition of diabetes patient, be used in combination macroporous adsorptive resins simultaneously, monosaccharide, oligosaccharide and part micromolecular water soluble compound have been removed, make the proportioning of each effective ingredient reach optimum, fully guarantee the drug safety of diabetics.The result is as follows in its clinical experiment:
Patient's situation: 100 routine patients, male's 55 examples wherein, women's 45 examples; Demonstrate,prove 34 examples according to the Chinese medical discrimination intense heat due to deficiency of YIN, deficiency of both QI and YIN disease 37 examples, deficiency of both YIN and YANG disease 10 examples, stagnation of QI and blood disease 19 examples.All case is a non-insulin-dependent diabetes mellitus.
Therapeutic scheme: the capsule of oral invention 3 times on the 1st, each 2,2 weeks were 1 course of treatment.
Criterion of therapeutical effect: produce effects: disease disappears substantially, fasting glucose＜7.2mmol/L, twenty-four-hour urine sugar quantitatively＜10.0g;
Effectively: disease is obviously improved, fasting glucose＜8.3mmol/L, twenty-four-hour urine sugar quantitatively＜25.0g;
Invalid: disease does not have obvious improvement, and fasting glucose, twenty-four-hour urine sugar quantitatively do not reach effective standard.
Therapeutic outcome: produce effects 29 examples (29%), effective 55 examples (55%), invalid 16 examples (16%), total effective rate 84%.Better to intense heat due to deficiency of YIN, deficiency of both QI and YIN, stagnation of QI and blood three disease curative effects, can effectively alleviate shortness of breath and fatigue, thirst and liking drink, disease such as that To Be Protected from Heat is vexed, cardiopalmus perspiration, numb limbs and tense tendons, the red constipation of urinating.
Compare with prior art, advantage of the present invention and good effect are: medicine has clear and definite active component and content, and curative effect is obvious, and is suitable for large-scale industrialization production, and cost is low.Product of the present invention can be prepared from the natural drug Radix Cyanotis vagae, and is evident in efficacy, have no side effect, and can make full use of plant resources.
Embodiment 1: getting 2000g Radix Cyanotis vagae herb drying and crushing is coarse powder, add water heating extraction secondary, filter, filtrate adds natural clarifying agent and carries out crossing D101 type macroporous adsorptive resins after the clarifying treatment, use methanol-eluted fractions, eluent reclaim under reduced pressure methanol, drying, be ground into fine powder, add right amount of auxiliary materials and make granule.By analysis, (weight ratio) contains β-ecdyson 50%, 2-β-ecdyson acetas 43%, other minor compound 7% in the active constituents of medicine.
Embodiment 2:, to get 3500g Radix Cyanotis vagae drying and crushing be coarse powder, the ethanol heating extraction four times that adds 95% concentration is filtered, and filtrate adds natural clarifying agent and carries out the clarifying treatment after-filtration and concentrate and make crude product, go up AB-8 type macroporous adsorbent resin behind the water dissolution, use ethanol elution, eluent decompression recycling ethanol, drying, be ground into fine powder, add right amount of auxiliary materials and make granule, the dress capsule is made 1000 capsules.By analysis, (weight ratio) contains β-ecdyson 75%, 2-β-ecdyson acetas 15%, other minor compound 10% in the active constituents of medicine.
Embodiment 3: getting 4500g Radix Cyanotis vagae drying and crushing is coarse powder, add the dehydrated alcohol heating extraction five times, filter, filtrate adding chemical clarification agent carrying out clarifying treatment after-filtration concentrates makes crude product, goes up the D101 macroporous adsorbent resin behind the water dissolution, uses ethanol elution, the eluent decompression recycling ethanol, drying is ground into fine powder, adds right amount of auxiliary materials and makes 1000 of tablettings.By analysis, (weight ratio) contains β-ecdyson 90%, 2-β-ecdyson acetas 5%, other minor compound 5% in the active constituents of medicine.
Embodiment 4: getting 6000g is coarse powder with the Radix Cyanotis vagae drying and crushing, the ethanol heating extraction six times that adds concentration 75% is filtered, and filtrate adds clarifier and carries out the clarifying treatment after-filtration and concentrate and make crude product, go up AB-8 type macroporous adsorbent resin behind the water dissolution, use methanol-eluted fractions, eluent reclaim under reduced pressure methanol, drying, be ground into fine powder, add right amount of auxiliary materials and make granule, the dress capsule is made 1000 of capsules.By analysis, (weight ratio) contains β-ecdyson 85%, 2-β-ecdyson acetas 10%, other minor compound 5% in the active constituents of medicine.
Embodiment 1-4 products obtained therefroms all contain active constituents of medicine β-ecdyson and 2-β-ecdyson acetas, and the weight ratio of the two is all in following ranges: β-ecdyson 50-95%, 2-β-ecdyson acetas 5-50%; And all containing other minor compound that accounts for β-ecdyson and 2-β-ecdyson acetas gross weight 4-12% is its active constituents of medicine.
Above embodiment is only for the present invention is further illustrated, and scope of the present invention is not subjected to the limitation of illustrated embodiment.
Claims (7)
1, a kind of oral drugs for the treatment of diabetes, it is characterized in that containing in essence active constituents of medicine β-ecdyson and 2-β-ecdyson acetas, the weight ratio of the two is: β-ecdyson 50-95%, 2-β-ecdyson acetas 5-50%.
2, as the oral drugs of the said treatment diabetes of claim 1, it is characterized in that also containing other minor compound that accounts for β-ecdyson and 2-β-ecdyson acetas gross weight 4-12% is its active constituents of medicine, other minor compounds in the ferment extract that said other minor compound is the Radix Cyanotis vagae herb except that β-ecdyson and 2-β-ecdyson acetas.
3, as the oral drugs of the said treatment diabetes of claim 2, the weight ratio that it is characterized in that β-ecdyson and 2-β-ecdyson acetas is: β-ecdyson 60-85%, 2-β-ecdyson acetas 15-40%, and contain said other minor compound that accounts for β-ecdyson and 2-β-ecdyson acetas gross weight 6-10%.
4, a kind of production method for the treatment of the oral drugs of diabetes, it is characterized in that being coarse powder with Radix Cyanotis vagae herb drying and crushing earlier, add the ethanol of water or 40%-95% concentration or dehydrated alcohol heating extraction two to six times again, filter, filtrate adds natural clarifying agent or the clarifying treatment after-filtration is carried out in the chemical clarification agent, D101 type macroporous adsorptive resins or AB-8 type macroporous adsorptive resins or clear liquor concentrate and make crude product on the clear liquor, go up D101 type macroporous adsorptive resins or AB-8 type macroporous adsorbent resin behind the water dissolution, with methanol or ethanol elution, eluent reclaim under reduced pressure methanol or ethanol, dry, make effective ingredient in Chinese, through being ground into fine powder, adding appropriate amount of auxiliary materials and can be made into oral formulations.
5, as the production method of the oral drugs of the said treatment diabetes of claim 4, it is characterized in that being coarse powder with Radix Cyanotis vagae herb drying and crushing earlier, add the ethanol of water or 40%-95% concentration or dehydrated alcohol heating extraction three times again.
6, as the production method of the oral drugs of the said treatment diabetes of claim 4, it is characterized in that 2000g-6000g Radix Cyanotis vagae is made 1000 tablets or 1000 seed lac wafers.
7, as the production method of the oral drugs of the said treatment diabetes of claim 6, it is characterized in that 3500g-5000g Radix Cyanotis vagae is made 1000 tablets or 1000 seed lac wafers.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 00106370 CN1280010A (en) | 2000-06-12 | 2000-06-12 | Oral medicine for treating diabetes and its production method |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 00106370 CN1280010A (en) | 2000-06-12 | 2000-06-12 | Oral medicine for treating diabetes and its production method |
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| CN1280010A true CN1280010A (en) | 2001-01-17 |
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| CN 00106370 Pending CN1280010A (en) | 2000-06-12 | 2000-06-12 | Oral medicine for treating diabetes and its production method |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101849680A (en) * | 2010-06-01 | 2010-10-06 | 通化兴辰生物科技制品有限公司 | Megadenia gel health food |
| WO2011137759A1 (en) | 2010-05-07 | 2011-11-10 | 重庆植恩药业有限公司 | Novel ecdysterone synthesis derivative, preparation method and use thereof |
| CN102526151A (en) * | 2012-02-19 | 2012-07-04 | 贵州师范大学 | Medicinal composition and application thereof |
| CN102766186A (en) * | 2012-08-03 | 2012-11-07 | 玉溪市维和生物技术有限责任公司 | Preparation method and application of ecdysone-rich plant standardized extract |
| CN102872167A (en) * | 2012-09-29 | 2013-01-16 | 楚雄州百草岭药业发展有限公司 | Cyanotis root extract rich in beta-ecdysone and preparation method thereof |
| AU2008332981B2 (en) * | 2007-11-30 | 2014-06-12 | Biophytis | Use of phytoecdysones in the preparation of a composition for acting on metabolic syndrome |
-
2000
- 2000-06-12 CN CN 00106370 patent/CN1280010A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2008332981B2 (en) * | 2007-11-30 | 2014-06-12 | Biophytis | Use of phytoecdysones in the preparation of a composition for acting on metabolic syndrome |
| WO2011137759A1 (en) | 2010-05-07 | 2011-11-10 | 重庆植恩药业有限公司 | Novel ecdysterone synthesis derivative, preparation method and use thereof |
| CN101849680A (en) * | 2010-06-01 | 2010-10-06 | 通化兴辰生物科技制品有限公司 | Megadenia gel health food |
| CN102526151A (en) * | 2012-02-19 | 2012-07-04 | 贵州师范大学 | Medicinal composition and application thereof |
| CN102526151B (en) * | 2012-02-19 | 2013-10-16 | 贵州师范大学 | Medicinal composition and application thereof |
| CN102766186A (en) * | 2012-08-03 | 2012-11-07 | 玉溪市维和生物技术有限责任公司 | Preparation method and application of ecdysone-rich plant standardized extract |
| CN102766186B (en) * | 2012-08-03 | 2015-07-15 | 玉溪市维和生物技术有限责任公司 | Preparation method and application of ecdysone-rich plant standardized extract |
| CN102872167A (en) * | 2012-09-29 | 2013-01-16 | 楚雄州百草岭药业发展有限公司 | Cyanotis root extract rich in beta-ecdysone and preparation method thereof |
| CN102872167B (en) * | 2012-09-29 | 2014-11-12 | 楚雄州百草岭药业发展有限公司 | Cyanotis root extract rich in beta-ecdysone and preparation method thereof |
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