CN101403731B - Isatis smalt particle content measuring method - Google Patents
Isatis smalt particle content measuring method Download PDFInfo
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- CN101403731B CN101403731B CN200810197432.0A CN200810197432A CN101403731B CN 101403731 B CN101403731 B CN 101403731B CN 200810197432 A CN200810197432 A CN 200810197432A CN 101403731 B CN101403731 B CN 101403731B
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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 to control end product quality, quality control index is more single, for better controlling this product quality, ensure drug safety, we using Radix Isatidis and the total water soluble ingredient adenosine of folium isatidis in preparation and carry out assay as controlling index, and content assaying method is carried out to linear relationship, negative test, stability, repeatability, the methodological investigation such as the recovery, result shows that the method is feasible, favorable reproducibility, by the assay to many batch samples, drafted the suitable assay limit of this product, the preparation quality standard specificity that result proof is worked out is strong, controllability is good, can better control the inherent quality of this product, guaranteed the controlled of the stable and quality of preparation process.
Summary of the invention
The content assaying method that the object of this invention is to provide a kind of isatis smalt particle, to 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 determined that content controls index, adopts high performance liquid chromatography to carry out assay, and the method comprises that chromatographic condition and system suitability, the preparation of reference substance solution are, the preparation of need testing solution and content limit.
It is adenosine that described content is controlled index.
Described chromatographic condition and system suitability are: take octadecyl silane as filling agent; The methanol-water (12～16:88～84) of take is mobile phase; Detect wavelength 260nm ± 2nm.Number of theoretical plate calculates and should be not less than 3000 by adenosine peak.
The preparation method of described reference substance solution is: get adenosine reference substance appropriate, the methyl alcohol of take is made a certain proportion of solution as solvent.
The preparation method of described need testing solution is: take 30% methyl alcohol as solvent, ultrasonic method preparation.
Described content limit is: every bag of this product containing Radix Isatidis and folium isatidis with adenosine (C
10h
13n
5o
4) meter, must not be less than 0.6mg.
Embodiment
By following embodiment, realize and further illustrating of the present invention, but should not be understood to any limitation of the invention.
Embodiment 1
The control index that the adenosine of take is assay, carry out as follows assay:
Chromatographic condition and system suitability be take octadecyl silane as filling agent; The methanol-water (14:86) of take is mobile phase; Detect wavelength 260nm.Number of theoretical plate calculates and should be not less than 3000 by adenosine peak.
It is appropriate that the preparation precision of reference substance solution takes adenosine reference substance, adds methyl alcohol and make every 1ml containing the solution of 5 μ g, obtains.
Content 0.5g under this product content uniformity item is got in the preparation of need testing solution, accurately weighed, puts in 25ml measuring bottle, adds the about 20ml of 30% methyl alcohol, 30 minutes (120W of ultrasonic processing, 40kHz), take out, let cool, add 30% methyl alcohol and be diluted to scale, shake up, filter, get subsequent filtrate, obtain.
Determination method is accurate reference substance solution and each 10 μ l of need testing solution of drawing respectively, and injection liquid chromatography, measures, and obtains.
Every bag of this product containing Radix Isatidis and folium isatidis with adenosine (C
10h
13n
5o
4) meter, must not be less than 0.6mg.
Embodiment 2
The control index that the adenosine of take is assay, carry out as follows assay:
Chromatographic condition and system suitability be take octadecyl silane as filling agent; The methanol-water (12:88) of take is mobile phase; Detect wavelength 260nm.Number of theoretical plate calculates and should be not less than 3000 by adenosine peak.
It is appropriate that the preparation precision of reference substance solution takes adenosine reference substance, adds methyl alcohol and make every 1ml containing the solution of 5 μ g, obtains.
Content 1g under this product content uniformity item is got in the preparation of need testing solution, accurately weighed, puts in 50ml measuring bottle, adds the about 45ml of 30% methyl alcohol, 30 minutes (120W of ultrasonic processing, 40kHz), take out, let cool, add 30% methyl alcohol and be diluted to scale, shake up, filter, get subsequent filtrate, obtain.
Determination method is accurate reference substance solution and each 10 μ l of need testing solution of drawing respectively, and injection liquid chromatography, measures, and obtains.
Every bag of this product containing Radix Isatidis and folium isatidis with adenosine (C
10h
13n
5o
4) meter, must not be less than 0.6mg.
Embodiment 3
The control index that the adenosine of take is assay, carry out as follows assay:
Chromatographic condition and system suitability be take octadecyl silane as filling agent; The methanol-water (16: 84) of take is mobile phase; Detect wavelength 260nm.Number of theoretical plate calculates and should be not less than 3000 by adenosine peak.
It is appropriate that the preparation precision of reference substance solution takes adenosine reference substance, adds methyl alcohol and make every 1ml containing the solution of 5 μ g, obtains.
Content 2g under this product content uniformity item is got in the preparation of need testing solution, accurately weighed, puts in 100ml measuring bottle, adds the about 95ml of 30% methyl alcohol, 30 minutes (120W of ultrasonic processing, 40kHz), take out, let cool, add 30% methyl alcohol and be diluted to scale, shake up, filter, get subsequent filtrate, obtain.
Determination method is accurate reference substance solution and each 10 μ l of need testing solution of drawing respectively, and injection liquid chromatography, measures, and obtains.
Every bag of this product containing Radix Isatidis and folium isatidis with adenosine (C
10h
13n
5o
4) meter, must not be less than 0.6mg.
Accompanying drawing explanation:
Accompanying drawing is isatis smalt particle content overhaul flow chart.
Claims (1)
1. the method for isatis smalt particle content measuring, is characterized in that it is adenosine that content is controlled index, adopts high performance liquid chromatography to carry out assay; High performance liquid chromatography comprises that chromatographic condition and system suitability, the preparation of reference substance solution are, the preparation of need testing solution and content limit; Described chromatographic condition and system suitability are: take octadecyl silane as filling agent; Take methanol-water as mobile phase, and the volume ratio of methyl alcohol and water is 14: 86,12: 88 or 16: 84; Detect wavelength 260nm ± 2nm, number of theoretical plate calculates and should be not less than 3000 by adenosine peak; The preparation method of described reference substance solution is: get adenosine reference substance appropriate, the methyl alcohol of take is made a certain proportion of solution as solvent; The preparation method of described need testing solution is: take 30% methyl alcohol as solvent, ultrasonic method preparation.
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 |
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| Publication Number | Publication Date |
|---|---|
| CN101403731A CN101403731A (en) | 2009-04-08 |
| CN101403731B true CN101403731B (en) | 2014-07-23 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200810197432.0A Active CN101403731B (en) | 2008-10-30 | 2008-10-30 | Isatis smalt particle content measuring method |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| 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 |
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 (4)
| Title |
|---|
| HPLC法测定感冒退热颗粒中腺苷的含量;赵成;《现代中药研究与实践》;20080830;第22卷(第4期);方法与结果部分 * |
| 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》.2008,第24卷(第2期),123-125. * |
| 安洁 * |
| 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》.2008,第22卷(第4期),28-29. |
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| CN101403731A (en) | 2009-04-08 |
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Inventor after: Xu Shiqing Inventor before: Lu Zhicheng Inventor before: Lu Jianhua Inventor before: Wu Ning Inventor before: Li Tangxiu |
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| 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. |
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