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Quality control method of composite prepn. of dry mango tree leaves extract

A quality control method and technology of compound preparations, applied in the direction of testing pharmaceutical preparations, measuring devices, pharmaceutical formulations, etc., can solve the problem that the content sensitivity and accuracy of chlorpheniramine maleate are not very good, and the reproducibility and stability are not good. Very ideal and other problems, to achieve effective, stable and controllable, stable and controllable quality, and overcome the large measurement deviation

Inactive Publication Date: 2008-07-16
广西南宁允上医药科技开发有限公司
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  • Application Information

AI Technical Summary

Problems solved by technology

The reproducibility and stability of the determination conditions formulated by the above studies are not very ideal in actual use, especially the sensitivity and accuracy of using a thin-layer scanner to measure the content of chlorpheniramine maleate in mango cough tablets are not good. Very good, so these methods have not been included in the specifications for this formulation

Method used

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  • Quality control method of composite prepn. of dry mango tree leaves extract
  • Quality control method of composite prepn. of dry mango tree leaves extract
  • Quality control method of composite prepn. of dry mango tree leaves extract

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Mango Cough Drops

[0051] 1. Identify the dried mango leaf extract contained in mango cough tablets

[0052] Take 2g of this product after removing the coating, grind it finely, add 50ml of water, heat it in a water bath for 30 minutes, stir it from time to time, take it out, let it cool, filter, evaporate the filtrate to dryness, add 1ml of methanol to the residue to dissolve, filter, and use the filtrate as The test solution. Take another gallic acid reference substance, add methanol to make a solution containing 0.5mg per 1ml, as the reference substance solution. According to the test of thin-layer chromatography (Appendix VI B of the Chinese Pharmacopoeia in 2005), draw 2 μl of each of the above two solutions, and place them on the same silica gel G thin-layer plate with sodium carboxymethyl cellulose as the binder, and use three Chloromethane-ethyl acetate-formic acid (6:2:2) was used as the developer, developed, taken out, dried in the air, sprayed with 2% ferr...

Embodiment 2

[0079] Mango Cough Capsules

[0080] (1) Identification of mango cough capsules containing dried mango leaf extract

[0081] Take 2g of the content of this product, grind it finely, add 50ml of water, heat it in a water bath for 30 minutes, stir it from time to time, take it out, let it cool, filter, evaporate the filtrate to dryness, add 1ml of methanol to the residue to dissolve, filter, and use the filtrate as the test sample solution. Take another gallic acid reference substance, add methanol to make a solution containing 0.5mg per 1ml, as the reference substance solution. According to the test of thin-layer chromatography (Appendix VI B of the Chinese Pharmacopoeia in 2005), draw 2 μl of each of the above two solutions, and place them on the same silica gel G thin-layer plate with sodium carboxymethyl cellulose as the binder, and use three Chloromethane-ethyl acetate-formic acid (6:2:2) was used as the developer, developed, taken out, dried in the air, sprayed with 2% f...

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Abstract

A compound medicine in the form of tablet, capsule or softgel is prepared from the dried extract of mango leaf, sodium houttuyfonate and chlorphenamine maleate. Its quality control method features that a thin-layer chromatography is used to identify said three components and an efficient liquid-phase chromatographe is used to measure their contents.

Description

technical field [0001] The invention relates to a quality control method of a compound preparation of Chinese and Western medicines, in particular to tablets, capsules and soft capsules made from mango leaf dry extract, sodium houttuyniatin and chlorpheniramine maleate new quality control method for pharmaceuticals. Background technique [0002] The compound preparation of dried mango leaf extract is mainly composed of dried mango leaf extract, sodium houttuyfonate and chlorpheniramine maleate, and has the effects of clearing the lung and reducing phlegm, relieving cough and relieving asthma. For the treatment of cough, asthma, phlegm. [0003] At present, the medicine made from this group of prescriptions includes mango cough tablets, and its quality standard is recorded in page 50 of the fifth volume of "Prescriptions of Traditional Chinese Medicine" issued by the Ministry of Health of the People's Republic of China. Mango cough tablets have been on the market for many y...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K36/185A61P11/14A61P11/10A61P11/06G01N30/92G01N33/15
Inventor 黄冠宇韦翠吉韦宏官
Owner 广西南宁允上医药科技开发有限公司
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