Quality control method of econazole nitrate vagina soft capsule
A quality control method, the technology of econazole nitrate, is applied in the field of quality control of econazole nitrate vaginal soft capsules, to achieve the effects of product quality control, good reproducibility, and strong specificity
Inactive Publication Date: 2016-10-05
SHENZHEN JIATAI PHARMA
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Problems solved by technology
[0004] The present invention is to provide a quality control method of econazole nitrate vaginal soft capsules, which is used to solve the problem of how to control the quality of econazole nitrate vaginal soft capsules in the prior art
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[0017] The present invention will be further elaborated below with reference to the accompanying drawings.
[0018] In the present invention, the econazole nitrate vaginal soft capsule comprises a soft capsule skin and contents filled in the soft capsule skin.
[0019] Specifically, the content includes, in parts by weight: 50 parts of econazole nitrate, 250-350 parts of white petrolatum, 25 parts of beeswax and 325-425 parts of light liquid paraffin.
[0020] The soft capsule skin comprises in parts by weight: 1 part of gelatin, 0.6 part of glycerin, 1 part of water and 0.008 part of sunscreen. The soft capsule skin also includes 0.033 parts of a pH regulator, 0.12 parts of a disintegrant and 0.0035 parts of a preservative in parts by weight.
[0021] In one embodiment, for every 1000 econazole nitrate vaginal soft capsules prepared, the contents include: 50 g of econazole nitrate, 250 g of white petrolatum, 25 g of beeswax and 425 g of light liquid paraffin.
[0022] In on...
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Abstract
The invention relates to a quality control method of econazole nitrate vagina soft capsules. The method includes the steps of: a) performing appearance identification to a proper amount of the contents in the econazole nitrate vagina soft capsules; b) with econazole nitrate as a reference substance, identifying the econazole nitrate component in the econazole nitrate vagina soft capsules through thin layer chromatography; c) with a sulfuric acid solution of diphenylamine as a color developing agent, identifying the econazole nitrate component in the econazole nitrate vagina soft capsules; d) irradiating an econazole nitrate solution prepared from the contents with ultraviolet light, and identifying the econazole nitrate component in the econazole nitrate vagina soft capsules through a spectrophotometric method; and e) measuring the content of the econazole nitrate component in the econazole nitrate vagina soft capsules. The quality control method has strong specificity and good repeatability and is sensitive and stable, and can be used for effectively controlling the quality of the econazole nitrate vagina soft capsules.
Description
technical field [0001] The invention relates to the field of quality control of gynecological external preparations, in particular to a quality control method of econazole nitrate vaginal soft capsules. Background technique [0002] Econazole nitrate vaginal soft capsules can be stored and transported at room temperature, which is convenient for patients to store the drug and ensure the quality and use of the drug, and the soft capsule skin contains sunscreen, which effectively prevents econazole nitrate from being stored during storage. And the product changes due to exposure to light during transportation, ensuring the stability of econazole nitrate. [0003] Econazole nitrate vaginal soft capsule is a new gynecological medicine for vaginitis. How to control its quality to effectively control the product quality of econazole nitrate vaginal soft capsule has become an important topic at present. Contents of the invention [0004] The invention aims to provide a quality c...
Claims
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IPC IPC(8): G01N30/90G01N30/02G01N30/06G01N21/78G01N21/33
Inventor 张小勇李冠霖农达舒李欢欢
Owner SHENZHEN JIATAI PHARMA