CN101403731A - Isatis smalt particle content measuring method - Google Patents
Isatis smalt particle content measuring method Download PDFInfo
- Publication number
- CN101403731A CN101403731A CNA2008101974320A CN200810197432A CN101403731A CN 101403731 A CN101403731 A CN 101403731A CN A2008101974320 A CNA2008101974320 A CN A2008101974320A CN 200810197432 A CN200810197432 A CN 200810197432A CN 101403731 A CN101403731 A CN 101403731A
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- smalt
- isatis
- preparation
- adenosine
- particle content
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Abstract
The invention relates to a method used for measuring the grain content of radix isatidis, which is characterized in that content control indexes are selected and content measurement is carried out by adopting a high-efficiency liquid chromatography. The method comprises chromatographic condition and system adaptability tests, the preparation of a reference substance solution, the preparation of a sample solution and content limitation. The method has the advantages of strong specialization, good controllability, simple and convenient operation, can control the internal quality of the radix isatidis better and ensures the controllability of the product quality.
Description
Technical field
The present invention is the content assaying method of Chinese patent drug isatis smalt particle, comprises selection, content assaying method and the content limit of index composition, belongs to medical technical field.
Background technology
Chinese patent drug isatis smalt particle proper mass standard only has one to differentiate item, do not use content that end product quality is controlled, quality control index is more single, for better controlling this product quality, ensure drug safety, we carry out assay with Radix Isatidis in the preparation and the total water soluble ingredient adenosine of folium isatidis as controlling index, and content assaying method carried out linear relationship, negative test, stability, repeatability, methodological investigation such as the recovery, the result shows that this method is feasible, favorable reproducibility, by assay to many batch samples, drafted the suitable assay limit of this product, the preparation quality standard specificity that result's proof is worked out is strong, and controllability is good, can better control the inherent quality of this product, guarantee the controlled of the stable and quality of preparation process.
Summary of the invention
The content assaying method that the purpose of this invention is to provide a kind of isatis smalt particle so that better control the quality of this product, ensures drug safety.
Another object of the present invention is to determine the content limit of isatis smalt particle.
The inventive method has been determined the content controlling index, adopts high performance liquid chromatography to carry out assay, and this method comprises chromatographic condition and system suitability test, the preparation of reference substance solution, the preparation and the content limit of need testing solution.
Described content controlling index is an adenosine.
Described chromatographic condition and system suitability test are: be filling agent with the octadecyl silane; With methanol-water (12～16: 88～84) be moving phase; Detect wavelength 260nm ± 2nm.Number of theoretical plate calculates by the adenosine peak should be not less than 3000.
The preparation method of described reference substance solution is: it is an amount of to get the adenosine reference substance, is that solvent is made a certain proportion of solution with methyl alcohol.
The preparation method of described need testing solution is: with 30% methyl alcohol is solvent, the ultrasonic method preparation.
Described content limit is: every bag of this product contains Radix Isatidis and folium isatidis with adenosine (C
10H
13N
5O
4) meter, must not be less than 0.6mg.
Embodiment
Realize further specifying by following embodiment, but should not be understood that any limitation of the invention of the present invention.
Embodiment 1
With the adenosine is the controlling index of assay, carries out assay as follows:
Chromatographic condition and system suitability test are filling agent with the octadecyl silane; With methanol-water (14: 86) is moving phase; Detect wavelength 260nm.Number of theoretical plate calculates by the adenosine peak should be not less than 3000.
It is an amount of that the preparation precision of reference substance solution takes by weighing the adenosine reference substance, adds methyl alcohol and make the solution that every 1ml contains 5 μ g, promptly.
Content 0.5g under this product content uniformity item is got in the preparation of need testing solution, and accurate the title decides, and puts in the 25ml measuring bottle, adds the about 20ml of 30% methyl alcohol, 30 minutes (120W of sonicated, 40kHz), take out, put coldly, add 30% methyl alcohol and be diluted to scale, shake up, filter, get subsequent filtrate, promptly.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of determination method inject liquid chromatograph, measure, promptly.
Every bag of this product contains Radix Isatidis and folium isatidis with adenosine (C
10H
13N
5O
4) meter, must not be less than 0.6mg.
Embodiment 2
With the adenosine is the controlling index of assay, carries out assay as follows:
Chromatographic condition and system suitability test are filling agent with the octadecyl silane; With methanol-water (12: 88) is moving phase; Detect wavelength 260nm.Number of theoretical plate calculates by the adenosine peak should be not less than 3000.
It is an amount of that the preparation precision of reference substance solution takes by weighing the adenosine reference substance, adds methyl alcohol and make the solution that every 1ml contains 5 μ g, promptly.
Content 1g under this product content uniformity item is got in the preparation of need testing solution, and accurate the title decides, and puts in the 50ml measuring bottle, adds the about 45ml of 30% methyl alcohol, 30 minutes (120W of sonicated, 40kHz), take out, put coldly, add 30% methyl alcohol and be diluted to scale, shake up, filter, get subsequent filtrate, promptly.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of determination method inject liquid chromatograph, measure, promptly.
Every bag of this product contains Radix Isatidis and folium isatidis with adenosine (C
10H
13N
5O
4) meter, must not be less than 0.6mg.
Embodiment 3
With the adenosine is the controlling index of assay, carries out assay as follows:
Chromatographic condition and system suitability test are filling agent with the octadecyl silane; With methanol-water (16: 84) is moving phase; Detect wavelength 260nm.Number of theoretical plate calculates by the adenosine peak should be not less than 3000.
It is an amount of that the preparation precision of reference substance solution takes by weighing the adenosine reference substance, adds methyl alcohol and make the solution that every 1ml contains 5 μ g, promptly.
Content 2g under this product content uniformity item is got in the preparation of need testing solution, and accurate the title decides, and puts in the 100ml measuring bottle, adds the about 95ml of 30% methyl alcohol, 30 minutes (120W of sonicated, 40kHz), take out, put coldly, add 30% methyl alcohol and be diluted to scale, shake up, filter, get subsequent filtrate, promptly.
Accurate respectively reference substance solution and each the 10 μ l of need testing solution of drawing of determination method inject liquid chromatograph, measure, promptly.
Every bag of this product contains Radix Isatidis and folium isatidis with adenosine (C
10H
13N
5O
4) meter, must not be less than 0.6mg.
Description of drawings:
Accompanying drawing is isatis smalt particle content testing process figure.
Claims (6)
1, a kind of method that is used for isatis smalt particle content measuring, it is characterized in that selecting the content controlling index, adopt high performance liquid chromatography to carry out assay, this method comprises chromatographic condition and system suitability test, the preparation of reference substance solution, the preparation and the content limit of need testing solution.
2, isatis smalt particle content measuring method as claimed in claim 1 is characterized in that described content controlling index is an adenosine.
3, isatis smalt particle content measuring method as claimed in claim 1 is characterized in that the test of described chromatographic condition and system suitability is: be filling agent with the octadecyl silane; With methanol-water (12～16: 88～84) be moving phase; Detect wavelength 260nm ± 2nm.Number of theoretical plate calculates by the adenosine peak should be not less than 3000.
4, isatis smalt particle content measuring method as claimed in claim 1, it is characterized in that the preparation method of described reference substance solution is: it is an amount of to get the adenosine reference substance, is that solvent is made a certain proportion of solution with methyl alcohol.
5, isatis smalt particle content measuring method as claimed in claim 1, it is characterized in that the preparation method of described need testing solution is: with 30% methyl alcohol is solvent, the ultrasonic method preparation.
6, isatis smalt particle content measuring method as claimed in claim 1 is characterized in that described content limit is: every bag of this product contains Radix Isatidis and folium isatidis with adenosine (C
10H
13N
5O
4) meter, must not be less than 0.6mg.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810197432.0A CN101403731B (en) | 2008-10-30 | 2008-10-30 | Isatis smalt particle content measuring method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810197432.0A CN101403731B (en) | 2008-10-30 | 2008-10-30 | Isatis smalt particle content measuring method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101403731A true CN101403731A (en) | 2009-04-08 |
| CN101403731B CN101403731B (en) | 2014-07-23 |
Family
ID=40537807
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200810197432.0A Active CN101403731B (en) | 2008-10-30 | 2008-10-30 | Isatis smalt particle content measuring method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101403731B (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106442801A (en) * | 2016-11-10 | 2017-02-22 | 陕西师范大学 | Method of simultaneously measuring content of 11 active ingredients in folium isatidis |
| CN108918734A (en) * | 2018-07-31 | 2018-11-30 | 四川新绿色药业科技发展有限公司 | A kind of efficient liquid phase method detecting folium isatidis medicinal material, medicine materical crude slice, standard decoction, granule characteristic spectrum |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1528383A (en) * | 2003-09-30 | 2004-09-15 | 广州白云山制药股份有限公司广州白云 | Isatis root preparation and quality control method thereof |
| CN1539454A (en) * | 2003-08-29 | 2004-10-27 | 成都三明药物研究所 | Preparaton of banlangen and method for controlling quality |
-
2008
- 2008-10-30 CN CN200810197432.0A patent/CN101403731B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1539454A (en) * | 2003-08-29 | 2004-10-27 | 成都三明药物研究所 | Preparaton of banlangen and method for controlling quality |
| CN1528383A (en) * | 2003-09-30 | 2004-09-15 | 广州白云山制药股份有限公司广州白云 | Isatis root preparation and quality control method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 安洁; 吕华冲: "高效液相色谱法测定蛹虫草子实体中腺苷的含量", 《广东药学院学报》 * |
| 赵成: "HPLC法测定感冒退热颗粒中腺苷的含量", 《现代中药研究与实践》 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106442801A (en) * | 2016-11-10 | 2017-02-22 | 陕西师范大学 | Method of simultaneously measuring content of 11 active ingredients in folium isatidis |
| CN106442801B (en) * | 2016-11-10 | 2018-12-28 | 陕西师范大学 | Method that is a kind of while measuring 11 kinds of active constituent contents in folium isatidis |
| CN108918734A (en) * | 2018-07-31 | 2018-11-30 | 四川新绿色药业科技发展有限公司 | A kind of efficient liquid phase method detecting folium isatidis medicinal material, medicine materical crude slice, standard decoction, granule characteristic spectrum |
| CN108918734B (en) * | 2018-07-31 | 2021-06-22 | 四川新绿色药业科技发展有限公司 | High performance liquid chromatography method for detecting characteristic spectrums of folium isatidis medicinal materials, decoction pieces, standard decoction and formula granules |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101403731B (en) | 2014-07-23 |
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| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CB03 | Change of inventor or designer information | ||
| CB03 | Change of inventor or designer information |
Inventor after: Xu Shiqing Inventor before: Lu Zhicheng Inventor before: Lu Jianhua Inventor before: Wu Ning Inventor before: Li Tangxiu |
|
| TR01 | Transfer of patent right | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20171213 Address after: 430030 Development Building, No. 607, Wuhan City, Hubei Province, 907 Patentee after: Wuhan Junan Pharmaceutical Co.,Ltd. Address before: 430079 Wuhan City, Hubei Province, Xiong Chu street famous garden 215 3-9A Patentee before: WUHAN KANGYU MEDICINE SCIENCE AND TECHNOLOGY Co.,Ltd. |
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Effective date of registration: 20220706 Address after: 430040 room 1, floor 6, building 9, No. 17, Qixiong Road, Cihui street, Dongxihu District, Wuhan City, Hubei Province Patentee after: Hubei Huahong Medicine Co.,Ltd. Address before: 430030 907, Jianshe building, No. 607, Jianshe Avenue, Wuhan, Hubei Patentee before: Wuhan Junan Pharmaceutical Co.,Ltd. |