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Compound preparation for treating bronchitis, its preparation method and quality control method

A quality control method and bronchitis technology, which can be used in medical preparations containing active ingredients, pharmaceutical formulations, bulk delivery, etc., and can solve problems such as single dosage form

Inactive Publication Date: 2006-10-04
张友生
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But because there is only one dosage form of syrup in the current market, the dosage form is single and cannot meet the needs of different patients, so it is imperative to develop a new dosage form, and the quality standard of the original syrup only differentiates ephedrine hydrochloride and only detects drugs However, there is no quality control standard for other traditional Chinese medicine ingredients in medicines such as dried tangerine peel, Qianhu, licorice, etc., so it needs to be further improved and improved.

Method used

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  • Compound preparation for treating bronchitis, its preparation method and quality control method

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0030]Experimental Example 1. The granules of the present invention (Ansou granules) treated 30 cases of bronchitis. All the cases were from outpatient clinics.

[0031] 1. Diagnostic criteria and observation methods

[0032] The diagnostic criteria were based on the "Clinical Guidelines for the Treatment of Chronic Bronchitis with New Chinese Medicines".

[0033] Administration method: Oral Ansou Granules, 1 bag at a time, 3 times a day; 20 days as a course of treatment.

[0034] 2. General information

[0035] 1. Gender: 19 males and 11 females.

[0036] 2. Age: 10 cases were 15-30 years old, 11 cases were 31-50 years old, and 9 cases were 51-65 years old. The youngest is 16 years old, the oldest is 61 years old, and the average age is 44.1 years old.

[0037] 3. There are 12 cases of simple type and 18 cases of wheezing type with different syndrome types.

[0038] 4. Course of disease: 8 cases of ≤ 7 days, 12 cases of > 7 to 15 days, 10 cases of > 15 days.

[0039] 5....

experiment example 2

[0071] Experimental example 2: the thin-layer identification method of granule ephedrine hydrochloride of the present invention

[0072] Instruments and reagents: KQ-100 ultrasonic cleaner; 101-1-BS electric heating constant temperature blast drying oven; ephedrine hydrochloride reference substance (0090-9801 for content determination of China National Institute for the Control of Pharmaceutical and Biological Products); TLC; Hand-laid plate (thickness 0.3 mm); thin-layer chromatography silica gel (batch number: 010503, manufactured by Qingdao Ocean Chemical Co., Ltd.) methanol, etc.: all of analytical grade.

[0073] 1. Preparation of the test solution: take 5g of this product, add 30ml of methanol, ultrasonically treat it for 15 minutes, filter, evaporate the filtrate to dryness, add 3ml of methanol to the residue to dissolve, filter, and use the filtrate as the test solution.

[0074] 2. Preparation of reference substance solution: take ephedrine hydrochloride reference sub...

experiment example 3

[0078] Experimental example 3: the thin layer identification method of granules of the present invention dried tangerine peel

[0079] Instruments and reagents: KQ-100 ultrasonic cleaner; tangerine peel reference medicinal material (0969-9803 China Institute for the Control of Pharmaceutical and Biological Products); tangerine peel (raw medicinal material for feeding); neutral alumina for chromatography (batch number: 010412, Shanghai No. 5) Four Chemical Reagent Co., Ltd.); thin layer plate: hand-laid plate (thickness 0.3mm); thin layer chromatography silica gel (batch number: 010503, manufactured by Qingdao Ocean Chemical Co., Ltd.) methanol, etc.: all of analytical grade.

[0080] 1. Preparation of the test solution; take 20g of this product, add 50ml of methanol, ultrasonically treat it for 15 minutes, filter, evaporate the filtrate to dryness, add 20ml of water to the residue to dissolve, and extract twice with 30ml of water-saturated n-butanol. Combine the n-butanol extr...

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Abstract

The invention discloses a process for preparing compound granule and the quality control method, wherein the compound granule is prepared from flitilarry bulb fluid extract, liquid extract of liquorice, platycodon glaucus, roor of sessile stemona, peucedanum root, pinellia tuber, dried orange peel, ammonium chloride, ephedrine hydrochloride and menthanol. The quality control method is characterized by the thin layer chromatogram authentication to dried orange peel, peucedanum root and licorice root, as well as the content measuring method for ephedrine hydrochloride.

Description

technical field [0001] The invention relates to a compound preparation, in particular to a compound granule for treating bronchitis, a preparation method and a quality control method thereof. Background technique [0002] Bronchitis belongs to the category of "cough" and "asthma" in traditional Chinese medicine, and is a common and frequently-occurring disease in clinical practice. The Ansou Syrup currently on the market is a compound preparation composed of traditional Chinese medicine and Western medicine. Ammonium resolves phlegm, ephedrine hydrochloride for relieving cough, organic combination of Chinese and Western medicines, which are the agents for moistening the lungs and resolving phlegm, relieving cough and relieving asthma. Have better curative effect. However, since there is only one dosage form of syrup in the market at present, which cannot meet the needs of different patients, it is imperative to develop a new dosage form, and the quality standard of raw syr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/904A61K9/16A61P11/00
Inventor 张友生张思宁
Owner 张友生
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