Traditional Chinese medicine preparation containing herba ephedra and quality detecting method for ephedrine hydrochloride thereof

A quality detection method and ephedrine hydrochloride technology, which are applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of difficulty in quality assurance, unsatisfactory reproducibility, technical lag, etc., and achieve accurate and reliable measurement results and convenient color rendering. , Control the effect of product quality

Inactive Publication Date: 2018-10-23
广西昌弘制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are many types of preparations with similar functions on the market, and it is difficult to guarantee their quality. Therefore, special preparation methods and quality inspection methods are needed to ensure their quality.
[0005] At present, the TLC identification method of Clematis clematis and the content determination method of ephedra have been recorded, but the content determination method adopts TLC scanning method, the technology is relatively lagging, the method is relatively rough, and the reproducibility is not ideal, and the TLC scanning method is in the It has been rarely used in the current drug detection technology. Although the prior art has reported the use of high performance liquid chromatography to detect ephedrine hydrochloride in traditional Chinese medicine preparations containing ephedra, the method is relatively cumbersome

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] Weigh 3kg of Clematis clematis and 1kg of ephedra, add water to extract twice after mixing, the amount of water added each time is equivalent to 12 times and 10 times of the total weight of medicinal materials, the two extraction times are 3 hours and 2 hours respectively, combine the extracts, filter , when the filtrate was concentrated at 70°C, the relative density was a clear paste of 1.10, adding tablet auxiliary materials dextrin, talcum powder, sodium carboxymethyl starch, cellulose derivatives, and making tablets according to conventional schemes; in every 0.4g of clear paste, Contains ephedra 1.5mg in terms of ephedrine hydrochloride;

[0066] The thin-layer identification method of ephedrine hydrochloride in the described tablet comprises the steps:

[0067] Take 1g of this product powder, add a few drops of concentrated ammonia test solution, add 5ml of chloroform, heat and reflux for 1h, filter, evaporate the filtrate to dryness, add 2ml of methanol to the re...

Embodiment 2

[0074] Weigh 3.8kg of Clematis clematis and 1kg of ephedra, mix them and extract 3 times with 40% ethanol under reflux, each time the amount of ethanol is 10 times, 8 times, 6 times of the total amount of medicinal materials, and the three extraction times are 4 hours and 2 hours respectively , 1 hour, combine the extracts, filter, and when the filtrate is concentrated to 70 ° C, the relative density is 1.05 clear paste, add tablet auxiliary materials powdered sugar, starch, polyethylene glycol, talcum powder, cellulose derivatives, and prepare according to the conventional scheme Get tablet; In every 0.4g clear paste, contain ephedra 1.7mg in terms of ephedrine hydrochloride;

[0075] The thin-layer identification method of ephedrine hydrochloride in the described tablet comprises the steps:

[0076] Take 2g of this product powder, add a few drops of concentrated ammonia test solution, add 7ml of chloroform, heat and reflux for 1h, filter, evaporate the filtrate to dryness, a...

Embodiment 3

[0083] Weigh 4.5kg of Clematis clematis and 1kg of Ephedra Ephedra, add water to extract 2 times after mixing, the amount of water added each time is equivalent to 12 times and 8 times of the total weight of medicinal materials, and the extraction time is 3 hours and 2 hours respectively, and the extracts are combined. Filtrate, concentrate the filtrate to a clear paste with a relative density of 1.10 at 70°C, add ethanol to make the alcohol content 40%, let it stand for 12 hours, filter, concentrate the filtrate to an extract with a relative density of 1.05 at 70°C, add capsules Auxiliary materials starch, ethanol, magnesium stearate, capsules are made according to conventional scheme; In every 0.4g extractum, contain ephedra in ephedrine hydrochloride 2.5mg;

[0084] The thin-layer identification method of ephedrine hydrochloride in the described capsule comprises the steps:

[0085] Take 3g of this product powder, add a few drops of concentrated ammonia test solution, add 9ml...

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Abstract

The invention discloses a traditional Chinese medicine preparation containing herba ephedra and a quality detecting method for ephedrine hydrochloride thereof. The traditional Chinese medicine preparation is prepared from radix clematidis and the herba ephedra. The method is capable of qualitatively detecting the ephedrine hydrochloride in the preparation by using a thin-film chromatographic analysis method, and has the advantages of strong separating power, high sensitivity, rapid separating speed, convenient color development, and simpleness and convenience in operation. The high performanceliquid chromatography is used for assaying the content of the ephedrine hydrochloride in the preparation, wherein a detection wavelength is 272 nm, at this moment the absorption of an ephedrine hydrochloride reference substance is maximum and blank liquid has no interference, so a detecting result is accurate and reliable, and the quality of a product can be accurately controlled; acetonitrile-methyl alcohol-0.1% glacial acetic acid of which a volume ratio is (0.5 to 2) : (3 to 5) : (93 to 96.5) is used as a mobile phase for preparing a reference substrate solution and a test example solution, and the peak shape and a separation degree of the ephedrine hydrochloride are good. The traditional Chinese medicine composition can be further prepared into multiple preparations, and the administration and carrying needs of a patient in different illness states are satisfied.

Description

technical field [0001] The invention relates to the field of compound medicinal preparations and analysis, in particular to a traditional Chinese medicine preparation containing ephedra and a quality detection method for ephedrine hydrochloride thereof. Background technique [0002] Ephedra is the dry herbaceous stem of Ephedra sinica Stapf, Ephedra intermedia Schrenk et C.A.Mey. or Ephedra equisetina Bge. Also known as Sedaoma, Jieligen, etc. Ephedra pungent, slightly bitter, warm. Return lung, urinary bladder channel. Ephedra can produce sweat and dispel cold, ventilate the lung and relieve asthma, promote diuresis and reduce swelling, and is used for anemofrigid cold, chest tightness, wheezing and coughing, feng shui edema; bronchial asthma. Honey ephedra nourishes the lungs and relieves cough. It is mostly used for symptom resolution, asthma and cough. [0003] Clematis chinensis Osbeck, Clematis hexapetala Pall. or Clematis manshurica Rupr. dry roots and rhizomes o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 阙锋
Owner 广西昌弘制药有限公司
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