Preparation method and quality detection method for medicine composition drop-pills

A quality detection method and composition technology, which is applied in the direction of drug combination, pharmaceutical formula, polymer compound non-active ingredients, etc., can solve the problems of ginkgolide products that have not been launched yet, and achieve rapid onset of action, difficult hydrolysis and oxidation, easy to use and easy to use. Portable effect

Active Publication Date: 2011-05-04
JIANGSU KANION PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, many researches on Ginkgo biloba products have been carried out at home and abroad, and there are clinical applications. The Chinese Pharmacopoeia 2005 Edition also includes Ginkgo biloba, Ginkgo extract and Ginkgo leaves, etc., but there is no pure ginkgolide product on the market.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Embodiment 1: pharmaceutical composition drop pill of the present invention

[0062] Take 1 kg of ginkgolide, crush the ginkgolide through a 120-mesh sieve to obtain fine ginkgolide powder, and set aside; take 2.5kg of polyethylene glycol 6000, heat it to melt, and add the fine ginkgolide in a state of 80°C heat preservation. powder, stirred to suspend; using a mechanical device to drop the medicinal material into simethicone oil 100 at 10-2°C through a dropper, cooling in a gradient, and molding to obtain 100,000 dropping pills (35mg / pill); the present invention The pharmaceutical composition drop pill contains ginkgolide and ginkgolide A (C 20 h 24 o 9 ), ginkgolide B (C 20 h 24 o 10 ) should be 7.0~11.5mg, of which ginkgolide A (C 20 h 24 o 9 ) should be 2.0 ~ 4.0mg, ginkgolide B (C 20 h 24 o 10 ) should be 5.0-7.5 mg; orally, 35 mg per pill, 10 pills each time, 3 times a day.

Embodiment 2

[0063] Embodiment 2: pharmaceutical composition drop pill of the present invention

[0064] Take 1 kg of ginkgolide, crush the ginkgolide through a 150-mesh sieve to obtain fine ginkgolide powder, and set aside; take 1.5kg of polyethylene glycol 4000, heat to melt, add fine ginkgolide at 85°C powder, stirred to suspend; use a mechanical device to drop the medicinal material into liquid paraffin at 14-2°C through a dropper for gradient cooling, and shape it to obtain 100,000 dropping pills (25mg / pill); the pharmaceutical composition of the present invention drops Each pill contains ginkgolide and ginkgolide A (C 20 h 24 o 9 ), ginkgolide B (C 20 h 24 o 10 ) should be 7.0~11.5mg, of which ginkgolide A (C 20 h 24 o 9 ) should be 2.0 ~ 4.0mg, ginkgolide B (C 20 h 24 o 10 ) should be 5.0-7.5 mg; orally, 25 mg per pill, 10 pills each time, 3 times a day.

Embodiment 3

[0065] Embodiment 3: pharmaceutical composition drop pill of the present invention

[0066] Take 1 kg of ginkgolide, crush the ginkgolide through a 110-mesh sieve to obtain a fine ginkgolide powder, and set aside; take 6 kg of stearic acid, heat it to melt, add the fine ginkgolide powder at 70°C, and stir Suspension; adopt mechanical device to drop medicinal material into the vegetable oil of 16-2 ℃ through the dropper, gradient cooling, molding, get 100,000 drop pills (70mg / pill); each pill of the pharmaceutical composition drop pill of the present invention Contains ginkgolides and ginkgolide A (C 20 h 24 o 9 ), ginkgolide B (C 20 h 24 o 10 ) should be 7.0~11.5mg, of which ginkgolide A (C 20 h 24 o 9 ) should be 2.0 ~ 4.0mg, ginkgolide B (C 20 h 24 o 10 ) should be 5.0-7.5 mg; orally, 70 mg per pill, 10 pills each time, 3 times a day.

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Abstract

The invention discloses a ginkgolides dripping pill and a preparation method and a quality detection method thereof. During the preparation process, the ginkgolides and various substrates are evenly mixed and heated according to proportion, stirred and suspended and finally prepared into the dripping pill in a gradient way; one or a plurality of distinguishing or content detecting methods are adopted to carry out quality detection. The preparation formulation of the dripping pill selected by the ginkgolides dripping pill is the typical preparation formulation of the oral administration in themodern traditional Chinese medicines, and is characterized by high medicament stability, hard hydration and oxidation, quick effect, high bioavailability as well as convenient use and carrying. The ginkgolides is a medicament which is hardly dissolved in water, is dispersed into the substrates and prepared into the dripping pill; moreover, the solubility, the stripping speed and the bioavailability thereof are improved.

Description

technical field [0001] The invention relates to a preparation method and a quality detection method of a pharmaceutical composition drop pill, in particular to a ginkgolide drop pill and a preparation method and a quality detection method thereof. Background technique [0002] Modern research has found that ginkgo biloba can regulate the tension and elasticity of blood vessels and protect blood vessels from damage; ginkgo biloba can also reduce the adhesion of platelets, thereby affecting blood circulation, protecting red blood cells from destruction, and allowing red blood cells to evenly distribute in blood vessels. This helps the transport and supply of oxygen in red blood cells. With the development of Ginkgo biloba research, it has been proved that the active ingredients of Ginkgo biloba are mainly flavonoids and lactones. Ginkgolides are a class of traditional Chinese medicine ingredients with special structure and significant pharmacological activity found only in Gi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/365A61K36/16A61K9/20A61K47/34A61K47/42G01N30/02A61P7/02A61P9/10A61P11/06A61P29/00A61P37/06A61P37/08A61K127/00A61K47/10A61K47/26
Inventor 萧伟戴翔翎凌娅王振中吴云章晨峰
Owner JIANGSU KANION PHARMA CO LTD
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