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Quality control method of asthma tablets

A quality control method and the technology of asthma tablets, which are applied to medical preparations containing active ingredients, pharmaceutical formulas, plant raw materials, etc., can solve problems such as too simple quality control indicators, inability to control product quality, and affect product quality, so as to achieve control The effect of product quality, good guidance on production, and stable product quality

Active Publication Date: 2008-01-30
贵州省科晖制药有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Morphine in poppy shell is one of the active ingredients in the prescription, but it is also highly addictive. Codeine phosphate in poppy shell and ephedrine hydrochloride in ephedra are also active ingredients in the prescription. These three indicators The amount of content directly affects the curative effect of the product
Platycodon grandiflorum and licorice as raw materials, if not identified, will affect the quality of the product
However, the original standard for Asthma Tablets only provided qualitative identification methods for poppy shell and ephedra, without any content determination and identification indicators for bellflower and licorice. The quality control indicators were too simple to effectively control the quality of the product.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

experiment example

[0020] Experimental example: content determination of morphine, codeine phosphate, and ephedrine hydrochloride

[0021] (1) Selection of mobile phase:

[0022] Mobile phase 1: 0.05mol / 1 potassium dihydrogen phosphate-methanol-acetonitrile-triethylamine (80:10:10:0.3);

[0023] Mobile phase 2: 0.05mol / 1 potassium dihydrogen phosphate-methanol-acetonitrile-triethylamine (75:7:18:0.4);

[0024] Mobile phase 3: 0.05mol / 1 potassium dihydrogen phosphate-methanol-acetonitrile-triethylamine (78:7:15:0.2);

[0025] Mobile phase 4: water-acetonitrile-phosphoric acid (90:10:0.1);

[0026] Mobile phase 5: 0.01mol / 1 potassium dihydrogen phosphate-acetonitrile-phosphoric acid (90:10:0.1);

[0027] Mobile phase 6: 0.01mol / 1 potassium dihydrogen phosphate-acetonitrile-phosphoric acid-triethylamine (90:5:0.2:0.2);

[0028] Mobile phase 7: 0.01mol / 1 potassium dihydrogen phosphate-acetonitrile-triethylamine-phosphoric acid (95:5:0.4:0.2)

[0029] Through the analysis of the above comparativ...

Embodiment

[0067] Quality control methods for asthma tablets, including:

[0068] 1. Identification of Campanulaceae:

[0069] Weigh 0.5g of the fine powder of this product, put it in a stoppered test tube, add 2ml of 10% hydrochloric acid solution, bathe in water for 1h, take it out, centrifuge at 3500r / min for 10min, pour out the supernatant, adjust the pH to 9-10 with ammonia water, add 1ml of chloroform, Fully shake, 3000r / min centrifugal 10min, take chloroform layer as need testing solution; Another take 0.2g of bellflower contrast medicinal material, make contrast medicinal material solution with the same method; For the test, take 5 μl of each of the above two solutions, spot them on the same silica gel G thin-layer plate, use ethyl acetate: butanone: formic acid: water = 10:0.5:0.5:0.5 as the developer, develop, take out, and dry in the air , viewed under UV light (365nm). In the chromatogram of the test product, at the position corresponding to the chromatogram of the control ...

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Abstract

The present invention discloses a quality control method of asthma tablets, which includes the flowing steps: (1) chromatography conditions and system suitability experiment; (2) preparation of control solution; (3) preparation of test solution is as following: taking the product, removing the coating, porphyrizing, taking about 1g, placing into a 50ml volumetric flask, adding 1ml of ammonia test solution and 25ml of chloroform precisely, weighing the weight, carrying out the ultrasonic treatment with the power of 260w and the frequency of 40KHz for 30 minutes, cooling, weighing the weight, using the chloroform to supplement the loss weight, shaking evenly, filtering, sucking 5ml of filtrate precisely, adding 2ml of 2 percent hydrochloric ethanol anhydrous, shaking evenly, drying up by evaporation in a water bath, adding 10ml of 0.1percent hydrochloric acid in the residual slag, full dissolving by ultrasound, filtering, and taking the subsequent filtrate; (4) weigh and suck the control solution and the test solution precisely and respectively to inject to an HPLC instrument for determination. The method adopts the HPLC to carry out the content determination of morphine, codeine phosphate and ephedrine hydrochloride in the prescription under a same system, which can not only ensure the efficacy of the products, but can also enable the quality of the products to be stable.

Description

technical field [0001] The invention belongs to the field of quality control of traditional Chinese medicine preparations, in particular to a quality control method of asthma tablets. Background technique [0002] Asthma tablets are composed of poppy shell, bellflower, ephedra, and licorice four herbs, which have the effect of relieving cough and relieving asthma, and are used for cough and asthma. Poppy shell and ephedra are the main medicines in the prescription, mainly used to treat cough and asthma. Morphine in poppy shell is one of the active ingredients in the prescription, but it is also highly addictive. Codeine phosphate in poppy shell and ephedrine hydrochloride in ephedra are also active ingredients in the prescription. These three indicators The amount of the content directly affects the curative effect of the product. Platycodon grandiflorum and licorice as raw materials, if not identified, will affect the quality of the product. However, the original standar...

Claims

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Application Information

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IPC IPC(8): A61K36/66A61P11/06A61P11/14
Inventor 刘文炜高玉琼霍昕刘建华杨迺嘉
Owner 贵州省科晖制药有限公司
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