CN1746670A - Quality inspection of Ricosi preparation - Google Patents
Quality inspection of Ricosi preparation Download PDFInfo
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- CN1746670A CN1746670A CN 200510041037 CN200510041037A CN1746670A CN 1746670 A CN1746670 A CN 1746670A CN 200510041037 CN200510041037 CN 200510041037 CN 200510041037 A CN200510041037 A CN 200510041037A CN 1746670 A CN1746670 A CN 1746670A
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- profit monarch
- monarch
- profit
- acetonitrile
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Abstract
A method for detecting quality of Likejun preparation includes preparing chromatogram conditions by using silica gel as loading agent and using water - acetonitrile - glacial acetic acid as flowing phase as well as using wavelength of 210 nm as detection wavelength, preparing test solution by putting proper amount of Likejun preparation into acetonitrile of 100 micron g / ml, preparing control solution by putting proper amount of likejun control matter into acetonitrile of 100 micron g / ml, carrying out determination as injecting 10 - 20 micron l of each prepared solution into liquid phase chromatograph, calculating and determining Likejun content in sample.
Description
Invention field;
The present invention relates to field of pharmaceutical preparations, but disclose a kind of quality determining method of profit monarch's preparation.
Background technology:
(former name: the leucogen) chemistry is by name: but 2-(α-phenyl-α-carbethoxyl group-methyl) thiazolidine-4-carboxylic acid is drug for increasing white cells to profit monarch.Structural formula is as follows:
Molecular formula: C
14H
17O
4NS
Molecular weight: 295.36
But profit monarch is used to leucocyte, the thrombopenia of preventing and treating a variety of causes to cause, clinically is mainly used in the leucocyte that tumor chemoradiotherapy, endocrinopathy medicine etc. cause, the treatment of thrombopenia.But what use clinically at present is profit monarch sheet (10mg/ sheet, two kinds of specifications of 20mg/ sheet), but but the singularity of the former medicine of monarch Yin Li, what content assaying method prolonged usefulness always in its quality determining method is the chemistry titration method, its limitation is arranged, the method complex operation, and use is the chemical reagent that operating personnel is had big harmfulness.
But the invention provides a kind of defective that has overcome content assaying method in existing profit monarch's quality of the pharmaceutical preparations detection method, and be convenient to operate, content assaying method that accuracy and sensitivity, reliability all are higher than a kind of advanced technology of former method.
Goal of the invention
But the purpose of this invention is to provide a kind of defective that has overcome content assaying method in existing profit monarch's quality of the pharmaceutical preparations detection method, and be convenient to operate, measuring method that accuracy and sensitivity, reliability all are higher than the advanced technology of former method.
Summary of the invention
But the quality determining method of profit monarch's preparation of the present invention, but but but get profit monarch or profit monarch and suitable auxiliary material mixing or profit monarch and granulate with suitable auxiliary material mixing back, but make various profit monarch's solid pharmaceutical preparations, that is, but but each profit monarch preparation unit contains profit monarch (former name: the leucogen) 5-80mg.It is characterized in that comprising following work:
(1) chromatographic condition: with octadecylsilane chemically bonded silica is filling agent; Water-acetonitrile-glacial acetic acid (56: 44: 0.3) is a moving phase; The detection wavelength is 210nm; External standard method.
(2) preparation of need testing solution: but it is an amount of to get profit monarch preparation thing, behind the porphyrize, precision takes by weighing, and makes 100 μ g/ml with acetonitrile or moving phase, filters, and getting subsequent filtrate is need testing solution.
(3) preparation of reference substance solution: but it is an amount of to get profit monarch reference substance, precision takes by weighing, and makes 100 μ g/ml with acetonitrile or moving phase, filters, and getting subsequent filtrate is reference substance solution.
(4) assay: respectively accurately draw need testing solution and each 10-20 μ l of reference substance solution injects liquid chromatograph, measure, but in the calculation sample profit monarch content to guarantee the safe and effective of product.
But the quality determining method of profit monarch's preparation of the present invention, wherein the moving phase of (1) chromatographic condition is made up of water-acetonitrile-glacial acetic acid, and its best proportioning is water-acetonitrile-glacial acetic acid (56: 44: 0.3).
But the quality determining method of profit monarch's preparation of the present invention, the wherein preparation of (3) reference substance solution: but precision takes by weighing profit monarch reference substance 10mg, puts in the 100ml volumetric flask, with acetonitrile or moving phase dissolving, be settled to 100ml then, shake up, filter, get subsequent filtrate and be reference substance solution.
But the quality determining method of profit monarch's preparation of the present invention, but but wherein each profit monarch preparation unit contain the profit monarch (former name: the leucogen) 5-80mg, its content be limited to the 90-110% of standard content.
But the quality determining method of profit monarch's preparation of the present invention, but but wherein profit monarch preparation be various profit monarch's preparations, as solid pharmaceutical preparation and their controlled release and sustained release preparations such as tablet, capsule, granules.
Method of the present invention is preferably come out by many tests:
But the quality determining method of profit monarch's preparation of the present invention carries out uv scan but get profit monarch reference substance solution, and not end absorption is arranged at the 210nm place, so select the 210nm place for detecting wavelength.
When chromatographic condition for being filling agent with octadecylsilane chemically bonded silica; Water-acetonitrile-glacial acetic acid (56: 44: 0.3) is a moving phase; When the detection wavelength is 210nm, but profit monarch's number of theoretical plate is not less than 3000, and sample is not less than 1.3 with the degree of separation at nearest peak.
But the quality determining method specificity of profit monarch's preparation of the present invention is strong, conventional production with the detection no influence of auxiliary material to product.
But the sensitivity of the quality determining method of profit monarch's preparation of the present invention is good, detects to be limited to 0.5 μ g/ml; Quantitatively be limited to 2.0 μ g/ml; In 2.22-166.5 μ g/ml scope good linear relationship is arranged all, related coefficient is 0.999.
But the quality determining method of profit monarch's preparation of the present invention shows that through 5 detections the RSD value of method precision is 0.30%; Study on the stability through seven hours shows that the RSD value that eight times are detected in seven hours of test sample solution is 0.80%; Three horizontal average recoveries of method are all more than 98%, and its RSD value is 0.31.％
Show that through the testing result to tens of batches of products method is better than former method in detection precision, sensitivity, and easy to operate, the solvent of use obviously descends to operating personnel's harmfulness, meets the quality testing requirement.
Claims (5)
- But 1, a kind of quality determining method of profit monarch's preparation, but but but get profit monarch or profit monarch and suitable auxiliary material mixing or profit monarch and granulate with suitable auxiliary material mixing back, but make various profit monarch's solid pharmaceutical preparations, that is, but but each profit monarch preparation unit contains profit monarch (former name: the leucogen) 5-80mg.It is characterized in that comprising following work:(1) chromatographic condition: with octadecylsilane chemically bonded silica is filling agent; Moving phase is made up of water-acetonitrile-glacial acetic acid; Detecting wavelength is the 210nm external standard method,(2) preparation of need testing solution: but it is an amount of to get profit monarch preparation thing, behind the porphyrize, precision takes by weighing, and makes 100 μ g/ml with acetonitrile or moving phase, filters, and getting subsequent filtrate is need testing solution,(3) preparation of reference substance solution: but it is an amount of to get profit monarch reference substance, precision takes by weighing, and makes 100 μ g/ml with acetonitrile or moving phase, filters, and getting subsequent filtrate is reference substance solution,(4) assay: respectively accurately draw need testing solution and each 10-20 μ l of reference substance solution injects liquid chromatograph, measure, but in the calculation sample profit monarch content to guarantee the safe and effective of product.
- But 2, the quality determining method of the described profit monarch's preparation of claim 1, wherein the moving phase of (1) chromatographic condition is made up of water-acetonitrile-glacial acetic acid, and its best proportioning is water-acetonitrile-glacial acetic acid (56: 44: 0.3).
- But 3, the quality determining method of the described profit monarch's preparation of claim 1, the wherein preparation of (3) reference substance solution: but precision takes by weighing profit monarch reference substance 10mg, puts in the 100ml volumetric flask, with acetonitrile or moving phase dissolving, be settled to 100ml then, shake up, filter, get subsequent filtrate and be reference substance solution.
- But 4, the quality determining method of claim 1,2,3 described profit monarch's preparations, but but wherein each profit monarch preparation unit contain the profit monarch (former name: the leucogen) 5-80mg, its content be limited to the 90-110% of standard content.
- But 5, the quality determining method of the described profit monarch's preparation of claim 4, but but wherein profit monarch preparation be various profit monarch's preparations, as solid pharmaceutical preparation and their controlled release and sustained release preparations such as tablet, capsule, granules.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200510041037XA CN1302283C (en) | 2005-07-15 | 2005-07-15 | Quality inspection of Ricosi preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB200510041037XA CN1302283C (en) | 2005-07-15 | 2005-07-15 | Quality inspection of Ricosi preparation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1746670A true CN1746670A (en) | 2006-03-15 |
| CN1302283C CN1302283C (en) | 2007-02-28 |
Family
ID=36166296
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB200510041037XA Active CN1302283C (en) | 2005-07-15 | 2005-07-15 | Quality inspection of Ricosi preparation |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1302283C (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103226142A (en) * | 2012-01-30 | 2013-07-31 | 南京长澳医药科技有限公司 | Method for detecting leucogen concentration in blood plasma |
| CN105467045A (en) * | 2016-01-06 | 2016-04-06 | 福建农林大学 | Method for quickly detecting L-thiazolidine-4-carboxylic acid in lentinula edodes |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1629128A (en) * | 2004-08-30 | 2005-06-22 | 俞锋 | Method for preparing leucogen materials and leucogen tablets |
-
2005
- 2005-07-15 CN CNB200510041037XA patent/CN1302283C/en active Active
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103226142A (en) * | 2012-01-30 | 2013-07-31 | 南京长澳医药科技有限公司 | Method for detecting leucogen concentration in blood plasma |
| CN103226142B (en) * | 2012-01-30 | 2016-08-10 | 上海动量医药科技有限公司 | The detection method of leucogen concentration in a kind of blood plasma |
| CN105467045A (en) * | 2016-01-06 | 2016-04-06 | 福建农林大学 | Method for quickly detecting L-thiazolidine-4-carboxylic acid in lentinula edodes |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1302283C (en) | 2007-02-28 |
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Owner name: JIANGSU JI BEIER MEDICINE CO.,LTD. Free format text: FORMER OWNER: ZHANG HONGYE Effective date: 20080725 |
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Effective date of registration: 20080725 Address after: Jiangsu city of Zhenjiang province high tech Industrial Development Zone South Road two Patentee after: Jiangsu Jibeier Pharm Co., Ltd. Address before: Jiangsu city of Zhenjiang province high tech Industrial Development Zone South Road two Patentee before: Zhang Hongye |
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Owner name: JIANGSU JIBEIER PHARMACEUTICAL CO., LTD. Free format text: FORMER NAME: JIANGSU JIBEIER PHARMA CO., LTD. |
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| CP01 | Change in the name or title of a patent holder |
Address after: 212009 Jiangsu city of Zhenjiang province high tech Industrial Development Zone South Road two Patentee after: Jiangsu Jibeier Pharmaceutical Co., Ltd. Address before: 212009 Jiangsu city of Zhenjiang province high tech Industrial Development Zone South Road two Patentee before: Jiangsu Jibeier Pharm Co., Ltd. |