Preparation method and quality detection method of bupleurum oral solution

A technology for oral liquid and Bupleurum, applied in the field of preparation of Bupleurum oral liquid, can solve the problems of high requirements for sample processing and detection methods, easy decomposition, and large limitations, and achieves good product quality stability and high content of active ingredients. , the effect of high quality standard level

Active Publication Date: 2012-06-13
GUANGDONG ZHONGSHENG PHARMA
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Problems solved by technology

However, the content of saikosaponin in Bupleurum preparations is low, easy to decompose, and requires high sample processing and detection methods
For example, in CN 100522138C, in order to measure the content of each component in Xiaochaihutang oral liquid, it is proposed to use thin layer chromatography to scrape two dark bands at about 0.5 of the Rf value, measure the absorbance, and calculate the method of saikosaponin a (d) content method, this method is greatly affected by ambient temperature and humidity, the operation of scraping the dark band is complicated, and the data accuracy is low, the method sensitivity is poor, and the content of different components under the same absorption wavelength cannot be determined separately
In addition, in terms of quality control, the Bupleurum oral liquid recorded in the 2010 edition of "Chinese Pharmacopoeia" only has identification items, and there is no content determination of saponins and total flavonoids, which has great limitations and is still blank under the content determination items , it is difficult to accurately control the quality of Bupleurum Oral Liquid
In the literature "Determination of the Content of Saikosaponin b2 in Bupleurum Oral Liquid by HPLC", in order to make up for the blank in the content determination items of Bupleurum Oral Liquid, only the degradation product saikosaponin in Bupleurum Oral Liquid was established. The content determination method of b2 does not carry out the content determination of its main active ingredient saikosaponin a (d), therefore, this method is not perfect, and the total content of saikosaponin active ingredients has not been established test methods

Method used

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  • Preparation method and quality detection method of bupleurum oral solution
  • Preparation method and quality detection method of bupleurum oral solution
  • Preparation method and quality detection method of bupleurum oral solution

Examples

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Effect test

Embodiment 1

[0077] Example 1: Take 1000g of Bupleurum bupleuri, add four times the amount of water, soak at 80°C for half an hour, heat and reflux for 1 hour, collect 1000ml of the initial distillate by steam distillation, add sodium chloride to make the concentration reach 12% for salting out, and then Perform redistillation, collect 300ml of redistillate, add 30ml of propylene glycol, and set aside; filter the decoction of medicinal materials after collecting the first distillate, concentrate the filtrate to a concentrated solution with a relative density of 1.2, add 0.5% hydrochloric acid at 60°C 200g of 2% chitin solution, stirred at 700r / min for 5min, 150r / min for 40min, refrigerated for 24 hours and centrifuged at 1500r / min for 0.5 hour, filtered, the filtrate was combined with the double distilled liquid, filtered, added essence, mixed Evenly, adjust the pH value to 4.8 with dilute hydrochloric acid, add 100ml of distillate, filter, pot, and sterilize by flowing steam.

Embodiment 2

[0078] Example 2: Take 1000g of Bupleurum bupleuri, add four times the amount of water, soak at 80°C for half an hour, heat and reflux for 1 hour, collect 3000ml of the initial distillate by steam distillation, add sodium chloride to make the concentration reach 12%, and carry out salting out. Perform redistillation, collect 600ml of redistillate, add 30ml of propylene glycol, and set aside; filter the decoction of medicinal materials after collecting the first distillate, concentrate the filtrate to a concentrated solution with a relative density of 1.1, add 0.1% phosphoric acid at 60°C 300g of 3% ZTC1+1 solution, stirred at 350r / min for 40min, 300r / min for 5min, refrigerated for 24 hours and centrifuged at 800r / min for 3 hours, filtered, the filtrate was combined with the double distilled liquid, filtered, and the essence was added. Mix evenly, adjust the pH value to 3.5 with dilute hydrochloric acid, add 50ml of distillate, filter, pot, and sterilize with flowing steam to ...

Embodiment 3

[0080] Take 1000g of Bupleurum medicinal material, add four times the amount of water, soak at 80°C for half an hour, heat and reflux for 1 hour, collect 2000ml of the initial distillate by steam distillation, add sodium chloride to make the concentration reach 12% for salting out, and then Perform redistillation, collect 500ml of redistillate, add 30ml of propylene glycol, and set aside; filter the decoction of medicinal materials after collecting the first distillate, concentrate the filtrate to a concentrated solution with a relative density of 1.3, add 3% acetic acid and 100g of 0.5% chitosan solution of 0.2% phosphoric acid mixed solution, stirred at 700r / min for 10min, after stirring at 250r / min for 10min, refrigerated for 24 hours and centrifuged at 1200r / min for 1.5 hours at high speed, filtered, the filtrate was combined with double distilled liquid, Filter, add essence, mix well, adjust the pH value to 4.0 with dilute hydrochloric acid, add 200ml of distillate, filter...

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Abstract

The invention discloses a preparation method of a bupleurum oral solution. The components of the preparation only contain one medical material, namely bupleurum. During preparation, a flocculant is used to remove impurity particles in the liquid medicine and the clear liquid which is obtained through centrifugal filtration is used to prepare the product. The method changes the previous train of thought that the water extraction and alcohol precipitation technology is adopted to clarify the liquid medicine, thus the production cost can be saved, resources and the environment can be protected, the basic effective substance of the original prescription is kept, the problem of the traditional technology that when the water decoction is filtered and concentrated to directly prepare, the finished product is stored for a long time to generate a lot of precipitate and have low clarity degree can be improved, the production efficiency can be obviously increased, the production cost can be reduced, the production process can be simplified, the prepared bupleurum oral solution preparation has high content of the effective component and the curative effect is more remarkable. In addition, theinvention also provides a detection method for measuring the component content of the bupleurum oral solution on the existing quality standard basis of the bupleurum oral solution, thus the inherent quality of the preparation can be better controlled and the quality supervision and detection can be performed effectively.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicine pharmacy, and in particular relates to a preparation method and a quality control method of Bupleurum bupleurum oral liquid. Background technique [0002] Bupleurum Oral Liquid is a Chinese patent medicine for relieving exterior syndrome and reducing fever. It has been on the market in my country for many years. It is clinically used for fever caused by exogenous factors. Bupleurum Oral Liquid is prepared from 1000g of Chinese herbal medicine Bupleurum according to the conventional process of oral liquid preparation of Chinese patent medicine. The process adopts the traditional water extraction and concentration process, and the prepared product will generate a large amount of precipitation after long-term storage, which seriously affects the clarity and quality of the product. . In addition, the quality control of the final product is carried out in accordance with the stand...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/233A61K9/08G01N21/31G01N30/02A61P29/00
Inventor 原素何敏华杜静陈小新
Owner GUANGDONG ZHONGSHENG PHARMA
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