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Quality detection method of desepidine

A quality inspection method, Disheping's technology, is applied in the direction of measuring devices, material inspection products, and testing pharmaceutical preparations. It can solve the problems of poor quality control of finished products, insufficient inspection items, and poor reproducibility of results. Easy to operate, good reproducibility, and the effect of ensuring product quality

Active Publication Date: 2007-09-26
CHANGCHUN MAILING BIOLOGICAL ENG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The detection items in the existing diserping quality standards are not comprehensive enough, and the reproducibility of the results is poor when performing diserping quality standards, and the quality of finished products cannot be well controlled. The present invention improves the diserping quality standards, Make the quality control of Deshepin more stringent and the detection method more accurate

Method used

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  • Quality detection method of desepidine
  • Quality detection method of desepidine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Take this product containing diserpine (C 32 h 38 N 2 o 8 ) calculated on dry basis, not less than 98.5%

[0020] 【Properties】This product is white or off-white powder, odorless.

[0021] This product is soluble in chloroform, slightly soluble in methanol, ethanol, acetone, insoluble in water.

[0022] Melting point The melting point of this product (Chinese Pharmacopoeia 2005 edition two appendix VI C) is 217.0 ~ 222.0 ℃, and decomposes at the same time when melting.

[0023] Take this product for specific rotation, accurately weigh it, add methanol to dissolve and quantitatively dilute to make a solution containing about 4mg per 1ml, and measure according to the law (Chinese Pharmacopoeia 2005 edition two appendix VI E), the specific rotation is -130°~ -140°.

[0024] [Identification] (1) Take about 0.5mg of this product, add 5mg of p-dimethylaminobenzaldehyde, 0.2ml of glacial acetic acid and 0.2ml of sulfuric acid, mix well, and it will appear reddish brown. ...

Embodiment 2

[0040] 1. Appearance traits

[0041] Method: visual inspection

[0042] Check the appearance properties of the Deshepin sample, and the result sample is all off-white powder; Odorless.

[0043] 2. Specific rotation Take this product, accurately weigh it, add methanol to dissolve and quantitatively dilute to make a solution containing about 4mg per 1ml, and measure it with a polarimeter. As a result, the specific rotation ranges from -130° to 140° between.

[0044] 3. Solubility Take appropriate amount of Disheping raw material and conduct solubility test with different solvents. The results are shown in Table 1.

[0045]

solvent

Methanol

ethanol

Chloroform

acetone

water

0.1mol / L

Hydrochloric acid solution

0.1mol / L

sodium hydroxide solution

Sample weight

(mg)

20.90

21.71

22.12

21.14

23.65

22.84

...

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Abstract

This invention discloses one Disheping quality test method, which can control its product quality effectively and tests the relative subject, mapping abnormal part content by use of effective liquid phase spectrum, wherein, the relative subject and abnormal structure provides test sample liquid spectrum peak area less than comparison main peak area and the content measuring is no less than 98.5 percent and the weight metal test is not more than ten of million and the dry loss is no more than 0.5 percent and the burst resides no more than 0.3 percent.

Description

technical field [0001] The invention provides a quality detection method of diserpine, which is used for the quality control of diserpine products and belongs to the technical field of chemical drug synthesis. Background technique [0002] The diserpine involved in the present invention is the main component of preparing antihypertensive drugs, and its chemical name is 11-desmethoxy-18-O-(3,4,5 trimethoxybenzoyl) reserpine methyl ester , molecular formula: C 32 h 38 N 2 o 8 ;Molecular weight: 578.7. [0003] The detection items in the existing diserping quality standards are not comprehensive enough, and the reproducibility of the results is poor when performing diserping quality standards, and the quality of finished products cannot be well controlled. The present invention improves the diserping quality standards, Make the quality control of diserpin more stringent and the detection method more accurate. Contents of the invention [0004] The invention discloses a ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N33/15
Inventor 武杰杜宏明高强孙秀娥苏中
Owner CHANGCHUN MAILING BIOLOGICAL ENG CO LTD
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