Quality inspection method for capsule for treating lower urinary tract infection

A quality testing method and a technique for urinary tract infection, which are applied in the field of quality testing of capsules for treating lower urinary tract infections, can solve problems such as lack of quality standards and unfavorable quality control, and achieve the requirements of ensuring curative effect, controlling product quality, and strictly and reasonably controlling process. Effect

Active Publication Date: 2013-05-01
贵州远程制药有限责任公司
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Problems solved by technology

[0005] The existing capsules for treating lower urinary tract infection have

Method used

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  • Quality inspection method for capsule for treating lower urinary tract infection
  • Quality inspection method for capsule for treating lower urinary tract infection

Examples

Experimental program
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Effect test

experiment example

[0022] (1) The qualitative identification methods of Gardenia, Astragalus, Hedyotis diffusa, Ophiopogon japonicus, and Bitterwood are as follows:

[0023](1) TLC identification of gardenia and geniposide: gardenoside mainly contains gardenoside, dehydroxygeniposide, etc. Therefore, 20ml of solubilizer (methanol, ethanol, n-butanol or ethyl acetate) was used, shaken well, ultrasonically treated or heated to reflux for 40 minutes, filtered, the filtrate was evaporated to dryness, and the residue was solubilized (50% methanol, ethanol, n-butanol or ethyl acetate) 2ml to dissolve, as the test solution. Another 2 g of the negative mock preparation lacking gardenia was taken, and the negative control solution was prepared in the same way. Then take 1g of gardenia reference medicinal material, add solvent (50% methanol, ethanol, n-butanol or ethyl acetate) 10ml, and prepare the reference medicinal material solution in the same way. Then take the geniposide reference substance, add ...

Embodiment

[0055] A quality detection method for capsules for treating lower urinary tract infection, comprising the following steps:

[0056] (1) Identification of Gardenia, Astragalus, Hedyotis diffusa, Ophiopogon japonicus, and Bitterwood:

[0057] (1) Take 2g of the content of this product, add 20ml of 50% methanol, sonicate for 40 minutes, filter, evaporate the filtrate to dryness, add 2ml of methanol to the residue to dissolve, and use it as the test solution. Take another 1 g of gardenia reference medicinal material, add 10 ml of 50% methanol, and prepare the reference medicinal material solution in the same way. Then take the geniposide reference substance, add methanol to make a solution containing 4mg per 1ml, and use it as the reference substance solution. According to the test of thin-layer chromatography (Appendix VIB of Chinese Pharmacopoeia 2005 Edition), draw 2 μl of each of the above three solutions, and spot them on the same silica gel GF respectively. 254 On a thin-l...

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Abstract

The invention discloses a quality inspection method for a capsule for treating lower urinary tract infection. The method comprises steps of: a chromatographic condition and system applicability test; preparation of a reference solution; preparation of a sample solution by taking about 2g of a product, adding 25ml of methanol precisely, heating for reflux for 30 min, cooling, weighing, supplementing lost weight with methanol, shaking evenly, filtering, precisely weighing 2ml of a subsequent filtrate, placing the subsequent filtrate in a 50ml round-bottom flask, volatilizing methanol, adding 10ml of 2.5mol / L sulfuric acid solution, conducting an ultrasonic treatment for 5 min, then adding 10ml of trichloromethane, heating to reflux for 1 h, separating out a trichloromethane solution, extracting an acid solution with trichloromethane by shaking for 2 times, emerging the trichloromethane solution, dehydrating, volatilizing trichloromethane, precisely adding 10ml of methanol into the residue, heating gently to dissolve the residue, cooling, supplementing lost weight with methanol, shaking evenly, filtering, and taking a subsequent filtrate to obtain the sample solution; and precisely drawing 20 muL of the reference solution and the sample solution respectively; and injecting the solution into a liquid chromatograph for determination. The method provided by the invention can not only ensure the efficacy of the product but also stabilize product quality.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicines, in particular to a quality detection method for capsules for treating lower urinary tract infection. [0002] Background technique [0003] Capsules for treating lower urinary tract infection, prescription weight ratio: Gardenia 18-30, Astragalus 18-30, Hedyotis diffusa 15-26, Ophiopogon japonicus 15-26, Bitterwood 8-20, Mallow 15-26, Preparation method: the above six flavors, Gardenia, Hedyotis diffusa, and Bitterwood are extracted twice with 60% ethanol under reflux, each time for 2 hours, filtered, and the filtrate is combined (medicine dregs for later use), the filtrate is recovered with ethanol and concentrated to relative density It is 1.30~1.35 (60 ℃) clear ointment, set aside; Astragalus, mallow fruit, Ophiopogon japonicus are mixed with the above-mentioned dregs, add water and decoct twice, each time for 2 hours, filter, combine the filtrate, and concentrate the fi...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/90
Inventor 程吉祥
Owner 贵州远程制药有限责任公司
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