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Quality standard of throat smoothing dropping pills

A technology of quality standards and dropping pills, which is applied in the fields of pill delivery, measuring devices, and medical preparations containing active ingredients, etc. It can solve problems such as large sample interference, poor precipitation reaction specificity, and inability to explain problems, etc., to improve the quality level , Increase the effect of market competitiveness

Inactive Publication Date: 2008-04-02
津药达仁堂集团股份有限公司第六中药厂
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0022] 1. The physical and chemical identification item in the original standard cannot explain the problem because of the poor specificity of the precipitation reaction in the compound preparation
[0023] 2. TLC identification of indigo, indirubin, cholic acid, and deoxycholic acid: Since the sample pretreatment method in the original standard is the method of ultrasonic extraction and filtration after alcohol dissolution, it was found in the daily inspection that the matrix polyethylene glycol in the drug Diol-6000 interferes a lot with spotting, making the unfolding effect unsatisfactory
[0024] 3. Thin-layer identification of borneol and menthol: Since the sample pretreatment method in the original standard is the method of alcohol-soluble ultrasonic extraction and filtration, it is found in the daily inspection that the matrix polyethylene glycol-6000 in the drug interferes with the spotting Larger, making the unfolding effect unsatisfactory

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Embodiment 1: Qingyan Dropping Pills quality standard revision explanation and the test of precision, reproducibility, stability, recovery rate:

[0069] 【identification】

[0070] 1. The item of physical and chemical identification in the original standard has been deleted. The reason is that the specificity of the precipitation reaction in the compound preparation is poor, which cannot explain the problem.

[0071] 2. Increase the TLC identification of myrobalan:

[0072] (1) In the test, a blank test was first carried out to prove that the method has no interference. Take one-tenth of the amount of the prescription, take all the raw and auxiliary materials in the prescription except Myrobalan, and prepare negative samples according to the process preparation method. Take 1g of the negative sample, and prepare the negative control solution according to the preparation method of the test solution. After sampling, it was found that the specificity was good.

[0073]...

Embodiment 2

[0174] Embodiment 2: the revised quality standard of Qingyan Dropping Pills:

[0175] [Prescription] Qingdai 100g Licorice 100g Myrobalan 80g Menthol 80g

[0176] Borneol 20g Artificial Bezoar 12g Polyethylene Glycol 6000 500g

[0177] [Preparation method] Heat and melt polyethylene glycol 6000, add indigo naturalis and stir well, filter, then add licorice extract (note 1), myrobalan extract (note 2), artificial bezoar, borneol, menthol, fully stir, and mix well , sieved, insulated at 90-100 degrees centigrade and dropped in liquid paraffin at 15-20 degrees centigrade for cooling, made into about 30,000 pills, dried with liquid paraffin, coated, to obtain final product.

[0178] [Properties] This product is brown to dark brown dripping pills; the taste is slightly bitter and the gas is pungent and cool.

[0179] [Identification] 1. TLC identification of indigo, indirubin, cholic acid and deoxycholic acid:

[0180] Take 1g of crushed Qingyan dripping pills, add 40ml of...

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Abstract

The invention relates to the technical field of the traditional Chinese medicine and in particular to the quality standard of a pharynx-clearing dropping pill which is made from the raw materials of a natural indigo, liquorice, myrobalam, menthol, borneol, artificial cow-bezoar, polyglycol 6000. The item of physicochemical identification in the former quality standard is deleted; the thin layer identification of the borneol and the menthol, the thin layer identification of indigotin or indirubin and cholic acid or deoxycholic acid and the item of mensuration of bilirubin content are revised; the thin layer identification of the myrobalam, the layer identification of the liquorice and the item of the mensuration and detection of glycyrrhizic acid content are added, and the quantitative index of the liquorice content in each pill can not be less than 32 microgrammes, which is calculated according to the glycyrrhizic acid (C42H62O16). The invention improves the controllability of the quality standard of the pharynx-clearing dropping pill and further ensures the internal quality of the product, and the invention has great meaning for promoting the product sale and guaranteeing the medication safeness for the patient.

Description

technical field [0001] The invention relates to the technical field of traditional Chinese medicines, in particular to the quality standard of Qingyan dripping pills made from Qingdai, licorice, myrobalan, menthol, borneol, artificial bezoar and polyethylene glycol 6000. Background technique [0002] Qingyan Dropping Pills are used to dispel wind and clear heat, detoxify and sore throat. For wind-heat sore throat, sore throat, dry throat, thirst; or mild wind, fever, throat swelling, red tip of tongue, thin white or thin yellow fur, floating or slippery pulse, suitable for acute pharyngitis The medicine for the patients with the above symptoms has the characteristics of small dosage, fast absorption, convenient taking, easy to carry, safe and reliable, and has a good curative effect on patients with pharyngitis. Since it was put on the market, it has been widely recognized by patients with its definite curative effect and rapid effect. Existing ministerial standard number:...

Claims

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Application Information

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IPC IPC(8): A61K36/484A61K36/70A61K9/20A61P11/04G01N30/02G01N30/90A61K31/045A61K35/413
Inventor 韩露兰
Owner 津药达仁堂集团股份有限公司第六中药厂
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