CN102038637A - Method for preparing hydrochloric acid ramosetron injection - Google Patents
Method for preparing hydrochloric acid ramosetron injection Download PDFInfo
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- CN102038637A CN102038637A CN2009100757735A CN200910075773A CN102038637A CN 102038637 A CN102038637 A CN 102038637A CN 2009100757735 A CN2009100757735 A CN 2009100757735A CN 200910075773 A CN200910075773 A CN 200910075773A CN 102038637 A CN102038637 A CN 102038637A
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- injection
- ramosetron
- hydrochloric acid
- stabilizing agent
- dissolving
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Abstract
The invention provides a method for preparing hydrochloric acid ramosetron injection, comprising the following steps of: (a) taking water for injection as a solvent, effective dose of hydrochloric acid ramosetron as drug active component and lactic acid or sodium acetate as a stabilizing agent; (b) in a clean and dark environment, dissolving the stabilizing agent in specified amount of water for injection, then adding an osmotic pressure regulator to regulate isotonisch and adding the drug active component after the osmotic pressure regulator is dissolved; stirring and dissolving the drug active component and then complementing volume; and (c) adding 0.05-0.25 percent of active carbon and stirring for 20-30 min; removing the active carbon; controlling pH to be 4.0-5.0, filtering, filling and sealing. The invention has simple method, is easy to operate, can effectively reduce the number of related substances in the hydrochloric acid ramosetron injection and improves the stability of the hydrochloric acid ramosetron injection.
Description
Technical field
The present invention relates to the preparation method of pharmaceutical preparation, specifically the preparation method of Ramosetron HCl injection.
Technical background
Ramosetron HCl (ramosetron hydrochloride) belongs to the 5-HT3 receptor antagonist, also is to act on the strongest antiemetic so far.Because this medicine is to feeling sick of causing of chemotherapy, the effectively significant therapeutical effect of vomiting, and compare little, the long action time of consumption with the similar medicine of listing in the past.Therefore be subjected to clinicist and patient's favor deeply.But because Ramosetron HCl is oxidized easily to light, thermally labile.And in process of production, even conventional antioxidant such as adding sodium sulfite also can not effectively be controlled the related substance quantity in the finished product.
As everyone knows, along with the increase of related substance, the risk of medicine generation untoward reaction increases.Along with pharmaceuticals industry requires more and more highlyer to drug quality, therefore how to improve the stability of Ramosetron HCl injection, effectively reduce the quantity of related substance in the injection, the occurrence probability that reduces adverse effect, the safety that increases medicine and become the most important thing in the medical research.
Summary of the invention
Purpose of the present invention is exactly the new preparation process that a kind of Ramosetron HCl injection will be provided, with the related substance in effective control Ramosetron HCl injection.
The object of the present invention is achieved like this:
The preparation method of Ramosetron HCl injection provided by the present invention may further comprise the steps:
(a) with water for injection be solvent, the Ramosetron HCl of effective dose is an active constituents of medicine, and lactic acid or sodium acetate are stabilizing agent;
(b) in clean, lucifuge environment, stabilizing agent is dissolved in the water for injection of ormal weight, adds osmotic pressure regulator adjusting etc. then and ooze, after the dissolving, add active constituents of medicine; After the stirring and dissolving, supply volume;
(c) active carbon of adding 0.05～0.25% stirred 20～30 minutes, sloughed active carbon, and pH is controlled at 4.0～5.0, filtered, and fill is sealed.
The consumption proportion of active constituents of medicine of the present invention, stabilizing agent is preferred in the mass ratio of solvent: Ramosetron HCl is 0.0165%～0.03%, lactic acid 0.05%～0.3% or sodium acetate 0.3%～0.6%.
The inventive method is simple, easy to operate, can effectively reduce the quantity of the related substance in the Ramosetron HCl injection, improves the stability of Ramosetron HCl injection.
Below by instantiation the present invention is done further in detail, but it is not construed as limiting the present invention.
The specific embodiment
Embodiment 1
Preparation method: in the air purity rank is under 10000 grades, the 100 grades conditions, adopts omnidistance lucifuge operation, at first lactic acid is dissolved in the 800ml water for injection, add the sodium chloride stirring and dissolving then, after adding the Ramosetron HCl stirring and dissolving again, supply volume to 1000ml, the active carbon of adding 0.1% stirred 30 minutes, take off charcoal, pH is controlled at 4.0-5.0, crosses 0.22 μ m filter cartridge and filters fill, seal, promptly get the Ramosetron HCl injection.
Embodiment 2
The air purity rank is under 10000 grades, the 100 grades conditions, adopts omnidistance lucifuge operation, at first effective dose stabilizing agent sodium acetate is dissolved in the water for injection of 80% volume, and acetic acid regulates pH 4.5, adds the sodium chloride stirring and dissolving then, add the Ramosetron HCl stirring and dissolving again after, supply volume, the active carbon of adding 0.25% stirred 20 minutes, removed active carbon, and pH is controlled at 4.0-5.0, crossing 0.22 μ m filter cartridge filters, fill is sealed, and promptly gets the Ramosetron HCl injection.
Embodiment 3 produces the Ramosetron HCl injection according to conventional preparation method.
The air purity rank is under 10000 grades, the 100 grades conditions, at first sodium sulfite is dissolved in the water for injection of 80% volume, and hydrochloric acid is regulated pH 4.5, add the sodium chloride stirring and dissolving then, after adding the Ramosetron HCl stirring and dissolving again, supply volume, the active carbon of adding 0.25% stirred 20 minutes, remove active carbon, pH is controlled at 4.0-5.0, crosses 0.22 μ m filter cartridge and filters fill, seal, promptly get the Ramosetron HCl injection.
Embodiment 4
Under the following conditions, the stability of embodiment 1,2,3 made Ramosetron HCl injection is investigated.Investigate the result and see table 1 for details.
Table 1:
Annotate: related substance detects according to the state-promulgated pharmacopoeia relevant criterion.According to the standard code of the YBH11522005 of State Food and Drug Administration, Ramosetron HCl injection related substance must not be above 1%.
Above-mentioned test shows, investigates the result by keeping sample for a long time and shows that making product with the present invention can the fine growth that must control related substance.And according to the prolongation along with the resting period of the Ramosetron HCl injection of conventional method preparation, related substance is significant positive growth.
Claims (2)
1. the preparation method of a Ramosetron HCl injection is characterized in that it may further comprise the steps:
(a) with water for injection be solvent, the Ramosetron HCl of effective dose is an active constituents of medicine, and lactic acid or sodium acetate are stabilizing agent;
(b) in clean, lucifuge environment, stabilizing agent is dissolved in the water for injection of about ormal weight, adds osmotic pressure regulator adjusting etc. then and ooze, after the dissolving, the adding active constituents of medicine; After the stirring and dissolving, supply volume;
(c) active carbon of adding 0.05～0.25% stirred 20～30 minutes, sloughed active carbon, and pH is controlled at 4.0～5.0, crossed and filtered, and fill is sealed.
2. the preparation method of Ramosetron HCl injection according to claim 1, it is characterized in that the mass ratio of the consumption proportion of described active constituents of medicine, stabilizing agent in solvent: Ramosetron HCl is 0.0165%～0.03%, lactic acid 0.05%～0.3% or sodium acetate 0.3%～0.6%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009100757735A CN102038637B (en) | 2009-10-23 | 2009-10-23 | Method for preparing hydrochloric acid ramosetron injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009100757735A CN102038637B (en) | 2009-10-23 | 2009-10-23 | Method for preparing hydrochloric acid ramosetron injection |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102038637A true CN102038637A (en) | 2011-05-04 |
| CN102038637B CN102038637B (en) | 2012-02-15 |
Family
ID=43905406
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2009100757735A Expired - Fee Related CN102038637B (en) | 2009-10-23 | 2009-10-23 | Method for preparing hydrochloric acid ramosetron injection |
Country Status (1)
| Country | Link |
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| CN (1) | CN102038637B (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103211771A (en) * | 2012-01-18 | 2013-07-24 | 浙江亚太药业股份有限公司 | Ramosetron hydrochloride freeze-dried powder injection and preparation method thereof |
| CN106265490A (en) * | 2015-05-13 | 2017-01-04 | 上海禾丰制药有限公司 | Hydrochloric acid ramosetron injection and preparation process thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1315823C (en) * | 2004-11-02 | 2007-05-16 | 天津康鸿医药科技发展有限公司 | New method for synthesizing Ramosetron Hydrochloride |
-
2009
- 2009-10-23 CN CN2009100757735A patent/CN102038637B/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103211771A (en) * | 2012-01-18 | 2013-07-24 | 浙江亚太药业股份有限公司 | Ramosetron hydrochloride freeze-dried powder injection and preparation method thereof |
| CN103211771B (en) * | 2012-01-18 | 2015-07-29 | 浙江亚太药业股份有限公司 | Lyophilized injectable powder of a kind of Ramosetron HCl and preparation method thereof |
| CN106265490A (en) * | 2015-05-13 | 2017-01-04 | 上海禾丰制药有限公司 | Hydrochloric acid ramosetron injection and preparation process thereof |
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| Publication number | Publication date |
|---|---|
| CN102038637B (en) | 2012-02-15 |
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Owner name: HUABEI PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: NORTH CHINA PHARMACEUTICAL GROUP PREPARATION CO., LTD. Effective date: 20111207 |
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Effective date of registration: 20111207 Address after: 050015 Heping East Road, Hebei, Shijiazhuang, No. 388 Applicant after: NORTH CHINA PHARMACEUTICAL Co.,Ltd. Address before: 050015 No. 135 North sports street, Hebei, Shijiazhuang Applicant before: NORTH CHINA PHARMACEUTICAL GROUP PREPARATION Co.,Ltd. |
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Granted publication date: 20120215 Termination date: 20211023 |