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Method for detecting cleanliness of Chinese patent drug production equipment

A technology for production equipment and Chinese patent medicines, applied in measuring devices, analyzing materials through chemical reactions, and analyzing materials through observation of the influence of chemical indicators, can solve the problems of expensive TOC instruments, easy chemical reactions, Problems such as blockage of instrument pipelines, to achieve the effect of fast detection speed, low cost, and low detection volume

Active Publication Date: 2012-07-18
SHINEWAY PHARMA GRP LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the TOC instrument is expensive, so its application range is quite limited
In addition, since the production equipment of Chinese patent medicine often leaves tannin, protein and other macromolecular substances, these substances are prone to chemical reactions and block the pipeline of the instrument during the detection process of the TOC instrument, making it impossible to detect

Method used

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  • Method for detecting cleanliness of Chinese patent drug production equipment
  • Method for detecting cleanliness of Chinese patent drug production equipment
  • Method for detecting cleanliness of Chinese patent drug production equipment

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1: Methodological investigation on the cleanliness testing standard of Yiqitongluo granule production equipment

[0032] Yiqi Tongluo Granule is a Chinese patent medicine for treating stroke. It is made from astragalus, salvia miltiorrhiza, chuanxiong, safflower and earthworm according to the following method:

[0033] Weigh the decoction pieces of Danshen and Chuanxiong according to the prescription, add 3 times the amount of 70% ethanol to soak three times, each time for 48 hours, combine the ethanol extract, filter, recover the ethanol until it has no alcohol smell, and set aside. Add 8 times the amount of water to the medicinal dregs, astragalus, earthworm coarse grains and safflower medicinal materials, decoct three times for 1 hour each time, combine the decoction, filter, concentrate the filtrate, combine with the alcohol extraction part, and continue to concentrate until the relative density is 1.25—1.30 (80°C) clear ointment. Take the clear paste and a...

Embodiment 2

[0066] Example 2: Cleanliness detection of Huoxiangzhengqi soft capsule production equipment pill press machine

[0067] Take 2 / 1000 of the contact area between the liquid medicine and the equipment to wipe the test substance with a cotton swab, add 30ml of 60% ethanol to ultrasonically dissolve and filter, wash, evaporate the filtrate to dryness, add 60% ethanol to dilute to a 1ml measuring bottle, and use it as the test solution. Separately take the contents of Huoxiangzhengqi Soft Capsules and make a 0.3mg / ml solution with 60% ethanol as a standard solution. According to the test of thin-layer chromatography (Appendix VIB of the Pharmacopoeia of the People's Republic of China, 2010 Edition), draw 10 μl of each of the above two solutions and spot them on the same thin-layer plate, spray 10% sulfuric acid ethanol solution, and heat at 105°C until the spots develop color. clear. The spots of the test solution shall not be darker than those of the standard solution.

Embodiment 3

[0068] The color development effect of embodiment 3 ethanol sulfate chromogen to different Chinese patent medicine varieties

[0069] Take Qingkailing Injection, Shujintongluo Granules, Xuanmai Ganju Buccal Tablets, Xuesaitong Dropping Pills and add water to make a 0.4 mg / ml solution. According to thin-layer chromatography (Appendix VIB, Chinese Pharmacopoeia 2010 Edition), precisely draw 10 μl of each of the above solutions, spot on the same thin-layer plate, control the spot diameter to be consistent and less than 8mm, spray 10% sulfuric acid ethanol solution, and heat at 105°C until the spots are clearly colored.

[0070] Result: the test solution of each variety shows clear spots (see attached Figure 4 )

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Abstract

The invention discloses a method for detecting the cleanliness of Chinese patent drug production equipment, which includes the following steps: a) preparing a intermediate of a to-be-detected variety into the standard solution with a certain concentration according to the residual limit standard; b) sampling the cleaned Chinese patent drug production equipment by adopting the conventional sampling method and performing concentration, extraction or constant volume for the sample, so as to obtain the to-be-detected solution; c) absorbing the standard solution and the to-be-detected solution to drip on the same thin-layered plate respectively; and d) spraying the developer to the thin-layered plate, comparing the color of the spot of the to-be-detected solution with that of the spot of the standard solution, or performing the thin layer chromatography scanning, so as to compare the peak area of the spot of the to-be-detected solution with that of the spot of the standard solution. The method for detecting the cleanliness of the Chinese patent drug production equipment has wide application range, low detection cost and excellent detection effect.

Description

Technical field [0001] The detection method that involves the cleanliness of the production equipment in the pharmaceutical industry is specifically a method for testing the cleanliness of patent medicine production equipment. Background technique [0002] The production of Chinese medicines often produces multiple varieties of the same equipment. Therefore, after the production equipment is produced, it must be strictly cleaned to avoid the pollution of the previous product to the latter product, so as to ensure the production of drugs production.quality.In order to ensure the cleanliness of production equipment, the cleaning equipment is often detected in actual production to check whether the device can be safely used to produce the next variety.Traditional detection methods usually use high -efficiency liquid chromatography (HPLC), gas chromatography (GC), thin -layer chromatography (TLC) method, and ultraviolet spectrophot glory (UV).These methods are detected for the charac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/78G01N30/90
Inventor 陈浩达刘军锋董倩段文静甄兰敏姜海
Owner SHINEWAY PHARMA GRP LTD
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