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Detection method for cough syrup

A cough syrup and detection method technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of no quality indicators, no identification and detection methods, and the decline of drug efficacy, so as to achieve the effect of maintaining interests and ensuring clinical efficacy

Active Publication Date: 2016-10-12
SICHUAN FENGCHUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

[0002] Chinese medicine cough syrup is a variety recorded in the twentieth volume of traditional Chinese medicine preparations in the "Drug Standards of the Ministry of Health". The standard number is WS3-B-4010-98. A syrup made of traditional Chinese medicine, which has the effects of antitussive, expectorant, and asthma, and is clinically used for acute and chronic bronchitis and wheezing. Chinese medicine cough syrup is currently on the market for the treatment of acute and chronic bronchitis and It is a commonly used drug for wheezing, but in the original standard, except for the qualitative identification of ephedra with ephedrine hydrochloride as a control, there is no qualitative and quantitative quality inspection for any other medicinal materials and any ingredients in it. There are neither quality indicators nor these qualities. The identification and detection methods of indicators, unscrupulous manufacturers do not strictly follow the prescription dosage ingredients when producing drugs, and wantonly reduce raw materials, resulting in a significant decline in the efficacy of drugs, affecting the safety and effectiveness of drugs, and seriously damaging the interests of patients
[0003] On the other hand, ephedra is used in the prescription, which is the monarch drug in the prescription. It is listed first, and the dosage is the largest among the medicinal materials. The effect of the underground part (ie ephedra root) is completely different, even opposite, ephedra has a sweating effect, and ephedra root has an antiperspirant effect. "Compendium of Materia Medica" records: ephedra's sweating gas cannot be controlled by driving, but the root joints are antiperspirant "Modern Traditional Chinese Medicine" records: Although ephedra and ephedra roots come from the same plant, but because of different medicinal parts, the chemical components contained are different, so the nature, flavor, efficacy, pharmacology, and clinical application are different. The component ephedrine causes the systolic and diastolic blood pressure to rise, and the pulse pressure increases, while the main component ephedrine and other substances of ephedra root have a hypotensive effect and reduce the pulse pressure, but now ephedra is a scarce and controlled medicinal material, and people are harvesting Sometimes they are uprooted, and the aboveground part of the ephedra plant, namely ephedra, is not completely separated from the underground part, i.e. ephedra root, so that the curative effect of the medicine made will be reduced or even cause disease instead of curing the disease. Therefore, control ephedra root and prevent it from being mixed into ephedra , it is very necessary to ensure the curative effect of Chinese medicine cough syrup
[0004] Bitter almonds are used in the prescription, and the amygdalin contained in it has antitussive and antiasthmatic effects. The main principle is that amygdalin can be hydrolyzed by the amygdalin contained in the bitter almond itself, or by the human intestinal microbial enzymes. Trace amounts of hydrocyanic acid and benzaldehyde are produced, which can inhibit the respiratory center and achieve the purpose of antitussive and antiasthmatic. It does not have antitussive and antiasthmatic effects. If amygdalin is not hydrolyzed in the early stage and too much is hydrolyzed by microbial enzymes in the human intestinal tract, too much hydrocyanic acid and benzaldehyde will be produced, which will be harmful to the human body, so it is difficult to control , some manufacturers may not use bitter almonds for safety, resulting in no curative effect of the medicine, so it is very important to strengthen the inspection of bitter almonds in quality monitoring
However, the composition of bitter almonds is complex. Although the "Chinese Pharmacopoeia" has an identification method for bitter almonds, the effect is not good, and only the reference substance of amygdalin is used for identification, and the ingredients are single. This method is used in traditional Chinese medicine preparations with more complex ingredients. It is even more difficult to achieve. The article "Research on the Quality Standards of Xuanfei Zhike Mixture" in "China Medical Guide" explores the identification of bitter almonds as a reference medicinal material by TLC, but some processing methods are obviously based on "Chinese Pharmacopoeia", such as "Take 20ml of the mixture, extract twice with petroleum ether, 20ml each time, and discard the petroleum ether extract" is unreasonable. In addition, the processing method is too cumbersome and the final development effect is not good. Bitter almonds don't work at all, so a lot of research has to be done to find another good way to monitor bitter almonds

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] [Prescription] Ephedra 120g Bitter almond 80g Gypsum 240g Licorice (burned) 60g

[0037] [Preparation method] For the above four flavors, press bitter almonds to remove oil; for the other three flavors, add water to boil, add bitter almonds, decoct twice, the first time for 4 hours, the second time for 3 hours, combine the decoction, filter, and let stand , take the supernatant and concentrate to 420ml, add 625g of sucrose, boil, filter, then add 1.15g of benzoic acid (dissolved with 100ml of ethanol), adjust the total amount to 1000ml, stir well, filter, and obtain.

[0038] 【Properties】 This product is a brown viscous liquid; sweet.

[0039] 【identification】

[0040] (1) TLC identification of ephedrine hydrochloride

[0041] Take 10ml of this product, add 1ml of concentrated ammonia test solution, extract twice with a mixture of ether:ethanol=8:2 by volume, 10ml each time, combine the extracts, dehydrate with anhydrous sodium sulfate, filter, and the filtrate Evapo...

Embodiment 2

[0064] (1) TLC identification of ephedrine hydrochloride

[0065] Take 10ml of this product, add 1ml of concentrated ammonia test solution, extract twice with a mixture of ether:ethanol=8:2 by volume, 10ml each time, combine the extracts, dehydrate with anhydrous sodium sulfate, filter, and the filtrate Evaporate to dryness, residue adds methanol 1ml and makes dissolving, as need testing solution, gets ephedrine hydrochloride reference substance in addition, makes the solution that every 1ml contains 5mg with methanol, as reference substance solution, according to thin-layer chromatography test, absorbs above-mentioned two 5 μl of each solution was spotted on the same silica gel G thin-layer plate, and n-butanol: glacial acetic acid: water = 8:2:1 by volume ratio was used as the developer, developed, taken out, dried in the air, and sprayed with 0.5 % ninhydrin in acetone solution, baked at 105°C for about 10 minutes;

[0066] In the chromatogram of the test product, there ar...

Embodiment 3

[0083] (1) TLC identification of ephedrine hydrochloride

[0084] Take 10ml of this product, add 1ml of concentrated ammonia test solution, extract twice with a mixture of ether:ethanol=8:2 by volume, 10ml each time, combine the extracts, dehydrate with anhydrous sodium sulfate, filter, and the filtrate Evaporate to dryness, residue adds methanol 1ml and makes dissolving, as need testing solution, gets ephedrine hydrochloride reference substance in addition, makes the solution that every 1ml contains 5mg with methanol, as reference substance solution, according to thin-layer chromatography test, absorbs above-mentioned two 5 μl of each solution was spotted on the same silica gel G thin-layer plate, and n-butanol: glacial acetic acid: water = 8:2:1 by volume ratio was used as the developer, developed, taken out, dried in the air, and sprayed with 0.5 % ninhydrin in acetone solution, baked at 105°C for about 10 minutes;

[0085] In the chromatogram of the test product, there ar...

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PUM

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Abstract

The invention provides a detection method for cough syrup and relates to a detection method for a traditional Chinese medicine preparation. The detection method is adopted for monitoring the illegal manufacturer which invests few or no corresponding medicinal materials and even mixes the forbidden medicinal materials, which causes the result that the medicine cannot achieve the proper clinical effect. The prescription of the cough syrup provided by the invention includes ephedra, semen armeniacae amarae, gypsum and liquorice (roasted). Through the thin-layer identification for ephedra, ephedra root and ephedra alkali A, thin-layer identification for semen armeniacae amarae, thin-layer identification for liquorice and content determination of ephedrine hydrochloride in the cough syrup, components and component contents of traditional Chinese medicine cough syrup can be effectively detected, necessary medicinal materials including ephedra, semen armeniacae amarae and liquorice contained in the medicine can be ensured and meanwhile, mixing of the forbidden medicine ingredient of ephedra roots is prevented; the method is scientific and reasonable as well as practicable; the medicine is more safe and effective, so that the clinical effect of the particle preparation can be ensured and the benefit of the patient is protected.

Description

technical field [0001] The invention relates to a detection method of a traditional Chinese medicine prescription preparation, in particular to a component identification and content determination method of a traditional Chinese medicine cough syrup. Background technique [0002] Chinese medicine cough syrup is a variety recorded in the twentieth volume of traditional Chinese medicine preparations in the "Drug Standards of the Ministry of Health". The standard number is WS3-B-4010-98. A syrup made of traditional Chinese medicine, which has the effects of antitussive, expectorant, and asthma, and is clinically used for acute and chronic bronchitis and wheezing. Chinese medicine cough syrup is currently on the market for the treatment of acute and chronic bronchitis and It is a commonly used drug for wheezing, but in the original standard, except for the qualitative identification of ephedra with ephedrine hydrochloride as a control, there is no qualitative and quantitative qu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/90
CPCG01N30/02G01N30/06G01N30/90G01N2030/027
Inventor 钟茂团温国梁古莉何德中林剑
Owner SICHUAN FENGCHUN PHARMA
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