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Quality control method of 'xuhanting' preparation

A quality control method, the technology of stopping sweating due to sweating, is applied in the quality control field of treating spontaneous sweating and night sweats, and it can solve the problems of lack of content measurement items, failure to reflect the content of Astragalus membranaceus, and failure to fully control the quality of medicines. The effect of ensuring safety and efficacy

Active Publication Date: 2008-04-30
GUANGZHOU BAIYUNSHAN QIXING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The product standard is included in the fourteenth volume of "Ministry of Health Drug Standards for Traditional Chinese Medicine Prescriptions", standard number WS3-B-2776-97. In the current standard, there are only TLC qualitative identification items for Astragalus membranaceus, and there is no content determination item. , cannot reflect the content of astragalus in the product, and fails to fully control the quality of the drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Embodiment 1: Take the Xuhanstop granules with batch number 6016 produced by the applicant.

[0018] Observation of properties, identification and inspection should comply with the relevant provisions of granules, and content determination should be carried out.

[0019] 【Properties】This product is brownish-yellow to brown granules; sweet and slightly astringent.

[0020] [Identification] Take 3g of Astragalus reference medicinal material, add 100ml of water, decoct for 1 hour, filter, concentrate the filtrate to about 30ml, move it to a separatory funnel, extract 2 times with water-saturated n-butanol, 15ml each time, combine normal For the butanol solution, wash once with 15ml of ammonia test solution, then wash twice with n-butanol-saturated water, 15ml each time, discard the washing solution, evaporate the n-butanol solution to dryness, add 1ml of methanol to the residue to dissolve, as a control Medicinal solution. Then take astragaloside IV reference substance, ...

Embodiment 2

[0028] Embodiment 2: Take the Xuhanting Capsules with batch number 3001 produced by the applicant.

[0029] Observation of properties, identification and inspection should comply with the relevant regulations under capsules, and content determination should be carried out.

[0030] 【Properties】This product is capsules, the contents are brownish-yellow to brown granules; the smell is slightly astringent.

[0031] [Identification] Take 3g of Astragalus reference medicinal material, add 100ml of water, decoct for 1 hour, filter, concentrate the filtrate to about 30ml, move it to a separatory funnel, extract 2 times with water-saturated n-butanol, 15ml each time, combine normal For the butanol solution, wash once with 15ml of ammonia test solution, then wash twice with n-butanol-saturated water, 15ml each time, discard the washing solution, evaporate the n-butanol solution to dryness, add 1ml of methanol to the residue to dissolve, as a control Medicinal solution. Then take astr...

Embodiment 3

[0039] Embodiment 3: Take the oral liquid for stopping sweating caused by coldness with the batch number 7003 produced by the applicant.

[0040] Observation of properties, identification and inspection should comply with the relevant regulations under the item of oral liquid preparations, and content determination should be carried out.

[0041] 【Properties】This product is brown-red to brown-black liquid; sweet, slightly astringent.

[0042][Identification] Take 3g of Astragalus reference medicinal material, add 100ml of water, decoct for 1 hour, filter, concentrate the filtrate to about 30ml, move it to a separatory funnel, extract 2 times with water-saturated n-butanol, 15ml each time, combine normal For the butanol solution, wash once with 15ml of ammonia test solution, then wash twice with n-butanol-saturated water, 15ml each time, discard the washing solution, evaporate the n-butanol solution to dryness, add 1ml of methanol to the residue to dissolve, as a control Medic...

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PUM

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Abstract

The invention discloses a quality control method of Xuhanting medicament, which emends the quality control standard of the original Xuhanting granule and increases the content determination of astragaloside IV. The quality control method of Xuhanting preparation of the invention doesn't have disturbance in the negative comparison, has stronger exclusivity and better repeatability, is advantageous to realize effective controlling of the quality of Xuhanting preparation finished product, and insures the security and the efficiency of human body. The invention can be applicable to not only the quality control of Xuhanting granule but also the quality control of other prescriptions such as Xuhanting capsule, oral liquid, and the like.

Description

technical field [0001] The invention relates to a quality control method of a traditional Chinese medicine compound preparation, in particular to a quality control method of a drug for treating spontaneous sweating and night sweats due to dehydration. Background technique [0002] Xuhanting granule is a drug with positive clinical efficacy in treating night sweats, night sweats, and children's night sweats. It has been on the market for many years. It is prepared from astragalus, floating wheat, jujube, glutinous rice root, and oyster (calcined) according to the conventional process of traditional Chinese medicine granules. The product standard is included in the fourteenth volume of "Ministry of Health Drug Standards for Traditional Chinese Medicine Prescriptions", standard number WS3-B-2776-97. In the current standard, there are only TLC qualitative identification items for Astragalus membranaceus, and there is no content determination item. , cannot reflect the content of...

Claims

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Application Information

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IPC IPC(8): A61K36/899A61K9/16G01N30/90G01N30/02A61P43/00A61K35/56A61K35/618
Inventor 黄夏敏邓祝玲刘声波顾利红林彤
Owner GUANGZHOU BAIYUNSHAN QIXING PHARMA
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