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Chaihuang soft capsule and quality control method

A quality control method and soft capsule technology, applied in the directions of capsule delivery, measuring device, pharmaceutical formulation, etc., can solve the problems of unacceptable to patients, uncomfortable for diabetics and the elderly, poor taste of granules, and achieve novel dosage forms and stable methods. Reliable, easy-to-use results

Inactive Publication Date: 2008-09-24
STATE GRID CORP OF CHINA +1
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Problems solved by technology

, Prescription: Bupleurum 1250g, Scutellaria baicalin extract (calculated as baicalin) 90g, is a commonly used clinical preparation for treating upper respiratory tract infection, cold and fever, and has definite curative effect. It is suitable for diabetics and the elderly, and the taste of the granules is poor, which is not easy for patients to accept

Method used

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Embodiment Construction

[0026] Chaihuang soft capsule prescription: Bupleurum 1250g, Scutellaria baicalensis extract (calculated as baicalin) 90g, propylene glycol 40g, polyethylene glycol 400 300-500g.

[0027] Functions and Indications: Clearing away heat and reducing inflammation. For upper respiratory tract infection, cold and fever.

[0028] Usage and dosage: Take orally, 4 capsules each time, 2 times a day.

[0029] Specifications: 0.66g per capsule

[0030] Storage: sealed.

[0031] Preparation method of Chaihuang soft capsules: take Bupleurum bupleuri and add 10 times the amount of water to decoct twice, each time for 2 hours, filter, combine the filtrate, concentrate the filtrate to a relative density of 1.22-1.25 (60°C), add ethanol under stirring to contain The amount of alcohol reaches 60%, let stand for 12 hours, filter, the filtrate recovers ethanol under reduced pressure (60~70°C, -0.08MPa), and continues to concentrate under reduced pressure to a relative density of 1.32-1.35 (60°C...

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Abstract

The invention relates to a traditional Chinese medicine, that is a soft capsule of Chinese thorowax and baicalin extractive, and a method of quality control thereof. The traditional Chinese medicine consists of the following ingredients according to the weight content: 1,250 grams of Chinese thorowax, 90 grams of baicalin extractive (in terms of baicalin), 40 grams of propanediol and 300 to 500 grams of carmowax 400. The method of quality control consists of qualitative authentication and content measurement. The soft capsule of Chinese thorowax and baicalin extractive has the characteristics that the taking is convenient, the bioavailability is high and no restriction is exerted to the capsule user. A diluting agent is preferably selected to make the capsule neither too hard nor too soft and make the quality stable. Simultaneously, the Chinese thorowax in the formula is conducted an aqueous extraction and ethanol sediment and baicalin is charged as an extractive, which is fit to be made into a soft capsule with a novel preparation formulation and improved curative effect. The method of quality control can control the active ingredients of the soft capsule of Chinese thorowax and baicalin extractive effectively; moreover, the method is stable and reliable and has strong specificity, thereby enhancing the overall quality of the soft capsule of Chinese thorowax and baicalin extractive greatly and guaranteeing the curative effect.

Description

technical field [0001] The invention relates to a traditional Chinese medicine preparation, i.e. chaihuang soft capsule and a quality control method thereof. Background technique [0002] In the existing technology, "Chaihuang Granules" is recorded in the "Drug Standards of the Ministry of Health of the People's Republic of China" (Chinese Medicine Prescriptions) Volume 10, page 141, standard number: WS 3 -B-2009-95. , Prescription: Bupleurum 1250g, Scutellaria baicalin extract (calculated as baicalin) 90g, is a commonly used clinical preparation for treating upper respiratory tract infection, cold and fever, and has definite curative effect. It is taken by diabetics and the elderly, and the taste of the granules is poor, which is difficult for patients to accept. [0003] At present, the country's requirements for the safety, effectiveness, uniformity and stability of drugs are being strengthened. It is particularly important for the qualitative and quantitative analysis ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/539A61K9/48A61K47/34A61P11/00G01N30/90G01N30/02A61K47/10
Inventor 王鹏仇仁春
Owner STATE GRID CORP OF CHINA
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