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Quality control method of ginkgo oral carity disintegration tablet

A quality control method and technology of orally disintegrating tablets, applied in the direction of medical raw materials derived from Ginkgo biloba, measuring devices, testing pharmaceutical preparations, etc. can solve problems well

Inactive Publication Date: 2006-08-30
GUIZHOU YIBAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ginkgo biloba products are currently available in various formulations. Ginkgo orally disintegrating tablet is a fast-dissolving ginkgo preparation with the characteristics of fast absorption and high absorption rate. Chinese patent application 200310123852.1 describes the prescription and preparation of a ginkgo orally disintegrating tablet Method, due to the particularity of orally disintegrating preparations, its quality control method has not been well resolved for a long time. For ginkgo preparations, there is no quality control method for ginkgo orally disintegrating tablets in the prior art. The quality control methods of other dosage forms are directly used for orally disintegrating tablets, and there is a problem of inaccurate detection. Therefore, it is a problem that medical workers need to solve to study an effective quality control method with high accuracy and reasonable

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0094] 1000 orally disintegrating tablets formula:

[0095] Ginkgo Biloba Extract 150g

[0096] Ethyl cellulose 20g

[0097] Mannitol 58g

[0098] Microcrystalline Cellulose 40g

[0099] Croscarmellose Sodium (CCNz) 16g

[0100] Citric acid 5g

[0101] Sodium bicarbonate 5g

[0102] Aspartame 2g

[0103] Peppermint essence 2g

[0104] Magnesium Stearate 2g

[0105] Quality control methods are as follows:

[0106] Properties: This product is an orally disintegrating tablet, the drug is white and brown spots, and can disintegrate rapidly in the mouth without obvious bitterness and gritty feeling;

[0107] Identification includes:

[0108] (1) Take this product, approximately equivalent to 30 mg of total flavonol glycosides, grind it finely, add 20 ml of a mixed solution of 25% HCL:methanol=1:4, heat and reflux for 1 hour, filter, add 30 ml of distilled water to the filtr...

Embodiment 2

[0119] 1000 orally disintegrating tablets formula:

[0120] Ginkgo Biloba Extract 40.0g

[0121] Polyacrylic resin IV 10.0g

[0122] Ethyl cellulose 10.0g

[0123] Mannitol 100.0g

[0124] Sodium starch glycolate 2.0g

[0125] Cross-linked polyvinylpyrrolidone 20.0g

[0126] Low-substituted hydroxypropyl cellulose 25.0g

[0127] Microcrystalline Cellulose 15g

[0128] Aspartame 5.0g

[0129] Micronized silica gel 10g

[0130] Magnesium Stearate 2.5g

[0131] Quality control methods are as follows:

[0132] Properties: This product is an orally disintegrating tablet, the drug is white and brown spots, and can disintegrate rapidly in the mouth without obvious bitterness and gritty feeling;

[0133] Identification includes:

[0134] (1) Take this product, approximately equivalent to 50 mg of total flavonol glycosides, grind it finely, add 100 ml of a mixed solu...

Embodiment 3

[0145] 1000 orally disintegrating tablets formula:

[0146] Ginkgo Biloba Extract 100g

[0147] Ethylcellulose 15g

[0148] Mannitol 50g

[0149]Microcrystalline Cellulose 35g

[0150] Croscarmellose sodium (CCN z ) 10g

[0151] Citric acid 5g

[0152] Sodium bicarbonate 5g

[0153] Aspartame 5g

[0154] Peppermint essence 3g

[0155] Micronized silica gel 10g

[0156] Magnesium Stearate 3g

[0157] Quality control methods are as follows:

[0158] Properties: This product is an orally disintegrating tablet, the drug is white and brown spots, and can disintegrate rapidly in the mouth without obvious bitterness and gritty feeling;

[0159] Identification includes:

[0160] (1) Take this product, approximately equivalent to 10 mg of total flavonol glycosides, grind it finely, add 10-ml of a mixed solution of 10% HCL: methanol = 1:9, heat and reflux for 0.5 hours, filter...

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Abstract

A quality control method for the oral disintegrating tablet of gingko features high precision, sensitivity and stability, so ensuring high quality and curative effect of product.

Description

Technical field: [0001] The invention relates to a quality control method of ginkgo orally disintegrating tablets, belonging to the field of pharmaceutical technology. technical background: [0002] Cardiovascular disease is a disease with a high mortality rate. According to the report of the World Health Organization, one out of every three deaths worldwide is due to cardiovascular disease, and the mortality rate is still increasing. Cardiovascular disease has attracted extensive attention from domestic and foreign medical circles. Ginkgo biloba has the functions of antagonizing platelet activating factor, inhibiting platelet aggregation, and eliminating oxygen free radicals. It is a good medicine for treating cardiovascular and cerebrovascular diseases, especially coronary heart disease, angina pectoris, acute cerebral infarction, and cerebral arteriosclerosis or circulatory disorders. . Ginkgo biloba products are currently available in various formulations. Ginkgo oral...

Claims

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Application Information

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IPC IPC(8): A61K36/16A61K9/20A61P9/00A61P9/10G01N30/90G01N33/15
Inventor 叶湘武张梅
Owner GUIZHOU YIBAI PHARMA CO LTD
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