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Chaihuang preparation and its quality control method

A preparation, Chaihuang technology, applied in the field of Chaihuang preparation and its quality control, can solve the problems of not being able to control the quality very well, affecting patient compliance, low bioavailability, etc., so as to improve bioavailability and increase aesthetics , the effect of water solubility enhancement

Inactive Publication Date: 2008-01-09
SICHUAN BAILI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The main component of Scutellaria baicalensis extract is baicalin. Since baicalin has relatively low solubility in water and is difficult to dissolve in inorganic acids, the water solubility of Chaihuang preparations containing Scutellaria baicalensis extract is relatively poor, especially granules. Before taking it, it is brewed with boiling water. Because of its poor water solubility, there is often a layer of floating matter on the surface of the prepared medicinal solution, which is not beautiful and has a bitter taste, which affects the patient's compliance; and it is not easy to absorb after taking. low bioavailability
Although other dosage forms such as tablets can change the appearance, mask the taste, and improve patient compliance, they cannot solve the problems of poor water solubility, poor absorption, and low bioavailability
[0005] There are also certain defects in the current Chaihuang preparations in terms of quality control. Except for qualitative identification, the current determination of content only uses spectrophotometry to limit the content of baicalin in the preparations ("Ministry of Public Health issued drug standards for traditional Chinese medicine prescriptions") "Records under the item "Chaihuang Granules" in Volume 10 of "Preparation", but there is no corresponding determination method for the other component Bupleuri in the preparation, so its quality cannot be well controlled.

Method used

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  • Chaihuang preparation and its quality control method

Examples

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Effect test

Embodiment 1

[0021] Present embodiment is the chaihuang granule that adopts following method to make:

[0022] (1) Preparation of Bupleurum clear paste: take 125 parts by weight of Bupleurum raw medicinal materials, add 10 times and 8 times of water respectively, decoct 2 times, each time for 2 hours, combine the decoction, filter, and concentrate the filtrate to 1ml The medicinal liquid contains about 5g of raw medicinal materials, and ethanol is added to make the alcohol content reach about 70%, and it is left to stand for more than 12 hours, filtered, and the filtrate is concentrated to a relative density of about 1.30-1.35 after recovering ethanol, to obtain Bupleurum Qing Ointment, which is used for later use;

[0023] (2) Preparation of Scutellaria baicalensis paste: take 9 parts by weight of Scutellaria baicalensis extract, add about 3 times the amount of water, stir evenly, then add an appropriate amount of 40% sodium hydroxide solution, adjust the pH of the liquid to 5-5.5, Scutel...

Embodiment 2

[0026] Present embodiment is the chaihuang tablet that adopts following method to make:

[0027] (1) Preparation of Bupleurum clear paste: take 125 parts by weight of Bupleurum raw medicinal materials, add 8 times, 6 times, and 6 times of water respectively, decoct 3 times, each time for 1 hour, combine the decoction, filter, and Concentrate the filtrate until 1ml of the medicinal liquid contains about 2g of the original medicinal material, add ethanol to make the alcohol content reach about 50%, let it stand for more than 12 hours, filter, recover the ethanol from the filtrate and concentrate to a relative density of about 1.10-1.15 to obtain Bupleurum Qing Ointment. spare;

[0028] (2) Preparation of Scutellaria baicalensis paste: take 9 parts by weight of Scutellaria baicalensis extract, add about 0.5 times the amount of water, stir evenly, then add an appropriate amount of 5% sodium hydroxide solution, adjust the pH of the liquid to 5.5-6, Scutellaria baicalensis ointment...

Embodiment 3

[0031] Present embodiment is the chaihuang capsule that adopts following method to make:

[0032] (1) Preparation of Bupleurum clear paste: take 130 parts by weight of Bupleurum raw medicinal materials, add 8 times and 6 times of water respectively, decoct twice for 1.5 hours each time, combine the decoction, filter, and concentrate the filtrate to 1ml The medicinal solution contains about 8g of raw medicinal materials, adding ethanol to make the alcohol content reach about 90%, standing for more than 12 hours, filtering, recovering the ethanol from the filtrate, concentrating to a relative density of about 1.15-1.20, and obtaining Bupleurum Qing Ointment, which is used for later use;

[0033] (2) Preparation of Scutellaria baicalensis paste: take 8 parts by weight of Scutellaria baicalensis extract, add about 2 times the amount of water, stir evenly, then add an appropriate amount of 10% sodium bicarbonate solution, adjust the pH of the liquid to 6-6.5, Scutellaria baicalensi...

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Abstract

The present invention discloses a Chinese medicine Chaihuang preparation. It is made up by using (by weight portion) 100-150 portions of bupleurum root, 6-12 portions of scutellaria root and proper quantity of auxiliary material through a certain preparation process. Besides, said invention also provides a quality control method of said Chailhuang preparation.

Description

technical field [0001] The invention relates to a chaihuang preparation and a quality control method thereof. Background technique [0002] Chaihuang granules (granules) are Chinese patent medicines approved for marketing in the early 1990s to treat colds and fevers. In addition, Chaihuang Tablets, Chaihuang Capsules, Chaihuang Soft Capsules, Chaihuang Oral Liquid and other modified varieties are on the market or submitted for approval. [0003] The current Bupleurum preparation is prepared by the raw material Bupleurum: Scutellaria baicalensis extract (in terms of baicalin) with a weight ratio of 125:9 by the following method ("Ministry of Public Health Departmental Drug Standard Traditional Chinese Medicine Prescription" The method recorded in the 10th volume "Chaihuang Granules"): Take Bupleurum and add water to decoct twice, 2 hours each time, combine the decoction, filter, and concentrate the filtrate until 1ml of the liquid contains about 5g of the original medicinal m...

Claims

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Application Information

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IPC IPC(8): A61K36/539A61K9/16A61K9/20A61K9/48A61P31/04G01N33/15
Inventor 朱义
Owner SICHUAN BAILI PHARM CO LTD
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