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Quality control method of ginkgo oral carity disintegration tablet

The technology of an orally disintegrating tablet and a detection method is applied in the quality control of ginkgo orally disintegrating tablets and the field of medicines, and can solve the problem of the quality control method of ginkgo orally disintegrating tablet, inaccurate detection, and inability to solve the quality control method well. And other issues

Inactive Publication Date: 2009-07-29
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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  • Quality control method of ginkgo oral carity disintegration tablet
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  • Quality control method of ginkgo oral carity disintegration tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0100] 1000 orally disintegrating tablets formula:

[0101] Ginkgo Biloba Extract 150g

[0102] Ethyl cellulose 20g

[0103] Mannitol 58g

[0104] Microcrystalline Cellulose 40g

[0105] Croscarmellose sodium (CCN z ) 16g

[0106] Citric acid 5g

[0107] Sodium bicarbonate 5g

[0108] Aspartame 2g

[0109] Peppermint essence 2g

[0110] Magnesium Stearate 2g

[0111] Quality control methods are as follows:

[0112] 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;

[0113] Identification includes:

[0114] (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 filtrate, and then Evaporate to 20ml, extract 3 times with ether, 15ml each time, combine the ether s...

Embodiment 2

[0125] 1000 orally disintegrating tablets formula:

[0126] Ginkgo Biloba Extract 40.0g

[0127] Polyacrylic resin IV 10.0g

[0128] Ethyl cellulose 10.0g

[0129] Mannitol 100.0g

[0130] Sodium starch glycolate 2.0g

[0131] Cross-linked polyvinylpyrrolidone 20.0g

[0132] Low-substituted hydroxypropyl cellulose 25.0g

[0133] Microcrystalline Cellulose 15g

[0134] Aspartame 5.0g

[0135] Micronized silica gel 10g

[0136] Magnesium Stearate 2.5g

[0137] Quality control methods are as follows:

[0138] 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;

[0139] Identification includes:

[0140] (1) Take this product, approximately equivalent to 50 mg of total flavonol glycosides, grind it finely, add 100 ml of a mixed solution of 50% HCL:methanol=9:1, heat and reflux for 5 hours, filter, add 50 ml of distilled water to the filtrat...

Embodiment 3

[0151]1000 orally disintegrating tablets formula:

[0152] Ginkgo Biloba Extract 100g

[0153] Ethylcellulose 15g

[0154] Mannitol 50g

[0155] Microcrystalline Cellulose 35g

[0156] Croscarmellose sodium (CCN z ) 10g

[0157] Citric acid 5g

[0158] Sodium bicarbonate 5g

[0159] Aspartame 5g

[0160] Peppermint essence 3g

[0161] Micronized silica gel 10g

[0162] Magnesium Stearate 3g

[0163] Quality control methods are as follows:

[0164] 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;

[0165] Identification includes:

[0166] (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, add 10 ml of distilled water to the filtrate , then evaporated to 5ml, extracted once with ether,...

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Abstract

The invention relates to a quality control method of ginkgo orally disintegrating tablets. The quality control method has good precision, sensitivity and stability, can ensure the safety, uniformity, stability, effectiveness and controllability of product quality, and ensure drug safety and clinical curative effect.

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