Detection method of Maxing cough syrup

A detection method and technology for relieving cough of Maxing are applied in the field of component identification and component content determination of Maxing cough syrup, which can solve the problems of no quality index, no identification and detection method, and unreasonable, so as to maintain interests and ensure clinical curative effect. Effect

Active Publication Date: 2016-08-31
SICHUAN FENGCHUN PHARMA
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  • Abstract
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  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Maxing 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 pure traditional Chinese medicine, which has the effects of antitussive, expectorant, and asthma, and is clinically used for acute and chronic bronchitis and wheezing. Maxing cough syrup is currently on the market for the treatment of acute and chronic bronchitis. It is a commonly used drug for inflammation and 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 detection of any other medicinal materials or ingredients in it, and 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, wantonly reduce raw materials or even do not add 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. Some parts (ephedra root) have completely different functions. Ephedra ephedra has a sweating effect, while ephedra root has an antiperspirant effect. It is recorded in "Compendium of Materia Medica": Ephedra ephedra sweats, which cannot be controlled by driving, but the root joints are antiperspirant. "Modern Chinese Medicine Records" records: Although ephedra and ephedra roots come from the same plant, they contain different chemical components due to different medicinal parts, so their properties, flavors, efficacy, pharmacology, and clinical applications are different. "Chinese Pharmacopoeia" also indicates that ephedra Sweating, ephedra root antiperspirant, ephedrine, the main component of ephedra, increases systolic and diastolic blood pressure, and increases pulse pressure, while ephedrine, the main component of ephedra root, has a hypotensive effect and reduces pulse pressure. Upper ephedra is a medicinal material that is in short supply and is under control. People often uproot the ephedra plant when harvesting, and do not completely separate the above-ground part of the ephedra plant from its underground part, which will reduce the curative effect of the prepared medicine or even cause disease instead of curing the disease. Therefore, it is controlled Ephedra root, not allowing it to be mixed with ephedra is very necessary to ensure the curative effect of Maxing 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. 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 produced will be harmful to the human body, so it is not recommended It is easy to control. Some manufacturers may greatly reduce the amount of bitter almonds used for safety or even not use them, resulting in no curative effect of the medicine. Therefore, it is very important to strengthen the detection of bitter almonds, but the composition of bitter almonds is complex. Although "Chinese Pharmacopoeia" has bitter almonds Identification method, but the detection effect is not ideal, and only amygdalin reference substance is used for identification, and the component is single. This method is used in traditional Chinese medicine preparations with more complex components, which is easy to be affected and even more difficult to achieve. "Chinese Pharmacopoeia "It is mentioned that the extraction with petroleum ether is because bitter almonds contain a large amount of fatty oil, but Chinese patent medicines do not contain a large amount of fatty oil, so it is not very reasonable to choose petroleum ether for extraction. In addition, the processing method is too cumbersome and final. The unfolding effect is not good, and it is not accurate for identifying the bitter almond ingredients in Maxing cough syrup, so it is urgent to find another better method to detect the bitter almond ingredients

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034][Prescription] Ephedra 120g Bitter almond 80g Gypsum 240g Licorice (burnt) 60g

[0035] [Preparation method] The above four flavors, the bitter almonds are pressed to remove the oil, and the remaining three flavors are boiled with water, then the bitter almonds are added, decocted twice, the first time is 4 hours, the second time is 3 hours, the decoction is combined, filtered, and allowed to 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.

[0036] 【Properties】 This product is a brown viscous liquid; sweet.

[0037] [Identification] (1) Identification of the components of ephedrine hydrochloride:

[0038] 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...

Embodiment 2

[0061] Except that component identification and content determination methods are different, all the other methods are the same as in Example 1.

[0062] [Identification] (1) Identification of the components of ephedrine hydrochloride:

[0063] 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; Get ephedrine hydrochloride reference substance separately, make the solution that every 1ml contains 5mg with methanol, as reference substance solution, test according to thin-layer chromatography, absorb 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, take...

Embodiment 3

[0081] Except that component identification and content determination methods are different, all the other methods are the same as in Example 1.

[0082] [Identification] (1) Identification of the components of ephedrine hydrochloride:

[0083] 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; Get ephedrine hydrochloride reference substance separately, make the solution that every 1ml contains 5mg with methanol, as reference substance solution, test according to thin-layer chromatography, absorb 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, take...

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PUM

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Abstract

The invention provides a detection method of Maxing cough syrup and relates to a detection method of a traditional Chinese medicine prescription preparation, aiming at solving the problems that a present production process of Maxing cough syrup that part of manufacturers add a few of corresponding medicinal materials and do not add the corresponding medicinal materials so that the curative effect of medicines is obviously reduced, the safety and effectiveness of the medicines are influenced and the benefits of patients are seriously damaged. The detection method comprises the following steps: carrying out thin-layer identification on ephedrine and ephedrina A, carrying out thin-layer identification on bitter almonds, carrying out thin-layer identification on liquorice roots and carrying out content determination of ephedrine hydrochloride. The components and content of the Maxing cough syrup can be effectively detected and the medicine is relatively safe and relatively effective, so that the clinical curative effect of the syrup preparation is guaranteed and the benefits of patients are maintained.

Description

technical field [0001] The invention relates to a detection method of a traditional Chinese medicine prescription, in particular to a method for identifying components and determining component content of maxing cough syrup. Background technique [0002] Maxing 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 pure traditional Chinese medicine, which has the effects of antitussive, expectorant, and asthma, and is clinically used for acute and chronic bronchitis and wheezing. Maxing cough syrup is currently on the market for the treatment of acute and chronic bronchitis. It is a commonly used drug for inflammation and 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 detection of any other medici...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/90G01N30/06G01N30/02A61K36/736A61K9/00A61P11/14A61K33/06
CPCA61K9/0095A61K33/06A61K36/17A61K36/484A61K36/736G01N30/02G01N30/06G01N30/90G01N2030/027G01N2030/062A61K2300/00
Inventor 钟茂团何德中温国梁古莉任红黎黎
Owner SICHUAN FENGCHUN PHARMA
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