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Method for quality control of Qianbai biyan solid prepn. for treating rhinitis

A quality control method and solid preparation technology, which is applied in the field of Qianbai rhinitis solid preparation made of 16g ​​of Angelica dahurica and 16g of Chuanxiong, notopterygium 32g, which can solve the problems of large limitations, difficulties in production and management, and difficulty in controlling the quality of Qianbai rhinitis tablets, etc. question

Inactive Publication Date: 2006-06-14
GUIZHOU YIBAI PHARMA CO LTD
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  • Abstract
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  • Claims
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Problems solved by technology

[0002] Qianbai Rhinitis Tablets for the treatment of acute and chronic rhinitis, sinusitis and pharyngitis in the fifth volume (WS3-B-0884-91) of "Drug Standards of the Ministry of Health of the People's Republic of China" (Chinese patent medicine preparations), the drug formula is prepared by Senecio 4848g, Selaginella 808g, Cassia 484g, Ephedra 162g, Notopterygium 32g, Angelica dahurica 16g and Ligusticum chuanxiong 16g, the above raw materials were made into 1000 tablets; and its quality control standards were promulgated, but the existing ones promulgated by the Ministry of Health In the quality control method of Qianbai Biyan Tablets, Senecio is only used as a qualitative identification, its specificity is not strong, and its limitations are relatively large. In addition, the lack of content determination makes it difficult to control the quality of Qianbai Biyan Tablets; while "Chinese Pharmacopoeia" 2000 edition The quality control method of Qianbai Biyan Tablets recorded in a book is almost the same as the existing quality control method of Qianbai Biyan Tablets promulgated by the Ministry of Health. There is no microscopic identification, no detection index, and it is difficult to control the quality of
[0003] For a long time, the quality of traditional Chinese medicine preparations has been difficult to effectively control. Effectively controlling the quality of traditional Chinese medicine products is a major issue. The methods used in the prior art are incomplete, and a few are not targeted. It is difficult to achieve the purpose of real quality control by using these methods
The above Qianbai Biyan tablet preparation is difficult to control the quality of the preparation due to the lack of quality control methods; it has brought difficulties to normal production and operation, and it is difficult to provide a good quality control method for the preparation product by using known technologies. The present invention aims at Due to the deficiencies of the existing technology, new methods are adopted to control the quality of Qianbai Biyan Tablets, especially the method of content determination in the preparation is added, the content of ephedrine in the drug is determined by high performance liquid chromatography, and the two ingredients of ephedra and notopterygium are added. The thin-layer chromatography identification method of flavor medicinal materials and the qualitative identification method of other drugs in solid preparations make sample processing easier and ensure a higher quality standard level of this compound preparation

Method used

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  • Method for quality control of Qianbai biyan solid prepn. for treating rhinitis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0141] The quality control of embodiment 1 capsules of the present invention

[0142] Take Chinese medicinal materials Senecio 4848g, Selaginella 808g, Cassia 484g, Ephedra 162g, Notopterygium 32g, Angelica dahurica 16g and Ligusticum chuanxiong. liquid, filtered, and the filtrate was concentrated into a thick ointment; the rest of notopterygium and other shamisen were crushed into fine powder, added to the above thick ointment, stirred, dried, pulverized into fine powder, mixed evenly, packed into capsules, and made into 1000 capsules.

[0143] 1, measure the content of ephedrine with high performance liquid chromatography (an appendix VI D of Chinese Pharmacopoeia version in 2000):

[0144] Test equipment, reagents, reagents

[0145] Shimadzu LC-10ATvp high performance liquid chromatograph, LC-10ATvp infusion pump; SPD-M10Avp secondary array detector; SCL-10Avp system controller; CTO-10ASvp constant temperature column oven; CLASS-VP6.1 workstation data processing system; M...

Embodiment 2

[0171] The quality control of embodiment 2 tablet of the present invention

[0172] Take Chinese medicinal materials Senecio 4848g, Selaginella 808g, Cassia 484g, Ephedra 162g, Notopterygium 32g, Angelica dahurica 16g and Ligusticum chuanxiong. liquid, filtered, and the filtrate was concentrated into a thick ointment; the remaining notopterygium and other shamisen were crushed into fine powder, added to the above thick ointment, stirred evenly, dried, pulverized into fine powder, mixed evenly, added appropriate amount of auxiliary materials, and pressed into tablets to make 1000 tablets. Instantly.

[0173] 1, measure the content of ephedrine with high performance liquid chromatography (an appendix VI D of Chinese Pharmacopoeia edition in 2000):

[0174] Test equipment, reagents, reagents

[0175] Shimadzu LC-10ATvp high performance liquid chromatograph, LC-10ATvp infusion pump; SPD-M10Avp secondary array detector; SCL-10Avp system controller; CTO-10ASvp constant temperature c...

Embodiment 3

[0201] The quality control of embodiment 3 granules of the present invention

[0202] Take Chinese medicinal materials Senecio 4848g, Selaginella 808g, Cassia 484g, Ephedra 162g, Notopterygium 32g, Angelica dahurica 16g and Ligusticum chuanxiong. liquid, filtered, and the filtrate was concentrated into a thick ointment; the remaining notopterygium and other shamisen were crushed into fine powder, added to the above thick ointment, stirred evenly, granulated, dried, granulated, mixed evenly, and packed separately, each bag had a capacity of 10g, and the product was obtained.

[0203] 1, measure the content of ephedrine with high performance liquid chromatography (an appendix VI D of Chinese Pharmacopoeia edition in 2000):

[0204] Test equipment, reagents, reagents

[0205] Shimadzu LC-10ATvp high performance liquid chromatograph, LC-10ATvp infusion pump; SPD-M10Avp secondary array detector; SCL-10Avp system controller; CTO-10ASvp constant temperature column oven; CLASS-VP6.1 ...

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Abstract

A quality control method for the solid medicine í‹QianbaiíŒ used to treat rhinitis features that a thin-layer chromatography is used for qualitative identification to senscio, ephedra, notopterygium root and other components, and an efficient liquid-phase chromatography is used to measure the content of ephedrin.

Description

Technical field: [0001] The present invention relates to a quality control method of Qiancypress rhinitis solid preparation made from 4848g of Senecio, 808g of Selaginella, 484g of Cassia, 162g of Ephedra, 32g of Notopterygium, 16g of Angelica dahurica and 16g of Rhizoma Chuanxiong. The quality control method of Qianbai rhinitis solid preparation for the determination of the content of ephedrine in the drug and the identification of Chinese medicinal materials Senecio, Ephedra and Notopterygium by thin-layer chromatography and the qualitative identification of other drugs in the solid preparation. Background technique: [0002] Qianbai Rhinitis Tablets for the treatment of acute and chronic rhinitis, sinusitis and pharyngitis in the fifth volume (WS3-B-0884-91) of "Drug Standards of the Ministry of Health of the People's Republic of China" (Chinese patent medicine preparations), the drug formula is prepared by Senecio 4848g, Selaginella 808g, Cassia 484g, Ephedra 162g, Notop...

Claims

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Application Information

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IPC IPC(8): A61K36/482A61P11/02G01N30/90G01N33/15
Inventor 叶湘武王泽坤
Owner GUIZHOU YIBAI PHARMA CO LTD
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