Quality standard testing method for Bingzhishangtong aerosol
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A technology of quality standards and detection methods, applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of improper pretreatment of drugs, ensure product quality, and inability to achieve accurate drug test results, improve safety, and improve control. Effect
Active Publication Date: 2015-11-25
GUIZHOU JINGCHENG PHARMA
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Problems solved by technology
Improper pre-treatment of drugs will lead to inaccurate drug test results, resulting in uncontrollable drug quality
Simultaneously the existing quality standard (WS-10325 (ZD-0325)-2002-2011Z) only includes the qualitative detection and the quantitative detection of rhubarb, gardenia, nuxychnium, borneol, but no drug solvent content Check and reflect the measurement items of the gardenia content of the internal quality index of the drug, which cannot guarantee the quality of the product in production
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preparation example Construction
[0035] Preparation of the test solution Take this product, remove the cap, and place it in an environment of 5°C for 30 minutes, drill a small hole in the aluminum cover, and after the gas is released, collect the liquid into a corked conical flask, Ultrasound for 1-2 hours, let stand for 5 hours, accurately measure 20ml of this product, put it in a 100ml measuring bottle, add ethanol to the mark, shake well, then accurately measure 20ml, add 3g of diatomaceous earth, mix well, evaporate to dryness, Add 40ml of water to the residue, sonicate for 20 minutes (power 250W, frequency 33KHz), filter, wash the residue with about 10ml of water, combine the filtrate and washing solution, and put it in a separatory funnel. Add 20ml of diethyl ether, shake and extract, release the water layer, add about 10ml of water to wash the ether layer, discard the diethyl ether solution, combine the aqueous solution and evaporate to dryness, add an appropriate amount of methanol to the residue to di...
Embodiment 1
[0039] Batch number 20131003
[0040] Detected according to the above detection process, the measured ethanol content is 70%, the injection rate is 0.80g / s, and the geniposide content is 0.53mg / ml.
Embodiment 2
[0042] Batch number 20131006
[0043] Detected according to the above detection process, the measured ethanol content is 75%, the injection rate is 0.85g / s, and the geniposide content is 0.50mg / ml.
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Abstract
The invention discloses a quality standard testing method for a borneol and fructus gardeniae pain-relieving aerosol with a changed propellant. The quality standard testing method is improved on the basis of an existing quality standard, a pretreatment method for performing qualitative identification on drugs is modified, an item of checking the content of ethanol and an item of checking the content of fructus gardeniae by HPLC (High Performance Liquid Chromatography) are added, the content of ethanol in the pain-relieving aerosol is not lower than 60%, one milliliter of pain-relieving aerosol contains fructus gardeniae of not lower than 0.40mg metered by geniposide C17H24010, and the spraying rate of the pain-relieving aerosol is not lower than 0.80g / s. According to the quality standard testing method, a drug detection result is accurate, the control on drug quality is intensified, and the drug safety is further improved.
Description
technical field [0001] The invention relates to a detection method of traditional Chinese medicine, in particular to a detection method of the quality standard of Bingzhi pain aerosol after changing the propellant. Background technique [0002] Bingzhi pain aerosol is a kind of aerosol for treating burns and bruises. It is used for clearing heat, detoxifying and cooling blood, promoting blood circulation and removing blood stasis to relieve pain. It can also be used for superficial second-degree burns. Container and valve composition. Most of the propellants adopted in the existing Bingzhi pain aerosol are Freon (F 12 ), but Freon has a destructive effect on the atmospheric ozone layer. Therefore, it is necessary to replace the existing Freon propellant with other environmentally friendly propellants. The patent number is 201210071687.9, and the Chinese patent application named Bingzhi pain aerosol solves the above problems, that is, other environmentally friendly propella...
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