CN1274304C - Etomidate fatty emulsion injection preparation method - Google Patents
Etomidate fatty emulsion injection preparation method Download PDFInfo
- Publication number
- CN1274304C CN1274304C CN 02112797 CN02112797A CN1274304C CN 1274304 C CN1274304 C CN 1274304C CN 02112797 CN02112797 CN 02112797 CN 02112797 A CN02112797 A CN 02112797A CN 1274304 C CN1274304 C CN 1274304C
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- CN
- China
- Prior art keywords
- etomidate
- preparation
- fatty emulsion
- emulsion injection
- colostrum
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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Abstract
The present invention relates to a method for preparing etomidate fatty emulsion injection preparation. An oil phase is manufactured by throwing soybean oil and lecithin in a container for heating and stirring uniformly; then, a mixed solution is prepared by adding etomidate to the oil phase; water for injection is arranged in the other container, and a water phase is prepared by adding glycerol, uniformly stirring and filtration; colostrum is prepared by pouring the mixed solution in the water phase under high speed stirring; the pH is adjusted to alkalescent; the mixed solution is homogenized, filtered and filled in ampoule by a high pressure homogenizing machine for supplying nitrogen, sealing and sterilization. The present invention is simple, and does not need a special device. The present invention has the advantages of short time and low cost, and is favorable to mass production.
Description
Technical field
The present invention relates to a kind of medicine fat milk ejection preparation, particularly a kind of preparation method of Etomidate fatty emulsion ejection preparation.
Background technology
Etomidate is non-barbiturates intravenous anesthesia derivant, its action intensity is respectively 4 times and 12 times of thiopentone of barbital sodium, and general anesthesia induction is fast, reviving, recovering after the administration is also fast, drowsiness, dizzy and other untoward reaction no longer appears after patient revives, and the effect of certain resisting emesis is arranged, therefore obtained using widely.Etomidate has water solublity injection and fat milk injection etc.The water solublity injection side effect such as injection site pain and muscular tremor, postoperative phlebitis, thrombophlebitis usually can occur because of injection osmotic pressure height; Fat emulsion injection is compared with it then not or has been alleviated these side effect.But the preparation method of Etomidate fatty emulsion injection but exists complex process, particularly contains medium-chain fatty acid in the prescription and makes defectives such as cost is higher, has restricted the production and the application of said preparation.
Summary of the invention
Purpose of the present invention just is to overcome above-mentioned defective, develop a kind of can be fast and the preparation method of the low Etomidate fatty emulsion injection of cost.
Technical scheme of the present invention is: the preparation method of Etomidate fatty emulsion injection, and its major technique feature is:
(1) soybean oil, Ovum Gallus domesticus Flavus lecithin are put in the container, are heated, stir,
Make oil phase;
(2) etomidate is joined in the oil phase, the weight ratio of etomidate and Ovum Gallus domesticus Flavus lecithin is 1: 6, and mix homogeneously obtains mixed liquor;
(3) an amount of water for injection is placed another container, add glycerol, stir, make water through filtering with microporous membrane;
(4) mixed liquor that step (2) is obtained is poured the aqueous phase that step (3) obtains under high-speed stirred, makes colostrum, regulates PH to alkalescence with the 1M sodium hydroxide solution;
(5) colostrum that makes is moved into high pressure homogenizer, homogenize;
(6) with the colostrum emulsion through filtering with microporous membrane, fill in the 10ml ampoule, logical nitrogen, sealing by fusing;
(7) ampoule is placed the rotation steriliser sterilize.
Advantage of the present invention and effect are that preparation method is simple, and not high and do not have specific (special) requirements to the equipment requirements used in the preparation process, the time is short, and cost is low, is beneficial to production in enormous quantities.
The specific embodiment
To prepare 1000 (20mg/10ml) injection is example:
Etomidate 20g
Chain fatty acid triglycerides 1000g
(injection soybean oil)
Ovum Gallus domesticus Flavus lecithin 120g
Glycerol 250g
Water for injection 10000ml
Soybean oil, lecithin respectively with filtering with microporous membrane, are put in the container by above-mentioned amount, again this container is placed water-bath, be heated to about 50 ℃, stir, make oil phase; Etomidate is joined in the oil phase, obtain mixed liquor behind the mix homogeneously; Water for injection is placed another container, add glycerol, stir, and make water through 0.45 μ m microporous filter membrane; The mixed liquor that will contain etomidate, soybean oil and lecithin is poured glycerinated aqueous phase under high-speed stirred, make colostrum, and regulates PH to alkalescence with the 1M sodium hydroxide solution, and pH value is between 7.5～9, and pH value is 8.5 in this example; The colostrum that makes is moved into high pressure homogenizer, till the extremely newborn grain of homogenize is qualified on inspection; Again with the colostrum emulsion through 5 μ m filtering with microporous membranes, fill in the ampoule of 10ml, logical nitrogen, sealing by fusing; Place the rotation steriliser to sterilize again, about 30 minutes, promptly make the Etomidate fatty emulsion injection formulation of 20mg/10ml.
Claims (4)
1. the preparation method of Etomidate fatty emulsion injection is characterized in that:
(1) soybean oil, Ovum Gallus domesticus Flavus lecithin are put in the container, heated, stir, make oil phase;
(2) etomidate is joined in the oil phase, the weight ratio of etomidate and Ovum Gallus domesticus Flavus lecithin is 1: 6, and mix homogeneously obtains mixed liquor;
(3) an amount of water for injection is placed another container, add glycerol, stir, make water through filtering with microporous membrane;
(4) mixed liquor that step (2) is obtained is poured the aqueous phase that step (3) obtains under high-speed stirred, makes colostrum, regulates PH to alkalescence with the 1M sodium hydroxide solution;
(5) colostrum that makes is moved into high pressure homogenizer, homogenize;
(6) with the colostrum emulsion through filtering with microporous membrane, fill in the 10ml ampoule, logical nitrogen, sealing by fusing;
(7) ampoule is placed the rotation steriliser sterilize.
2. the preparation method of Etomidate fatty emulsion injection according to claim 1 is characterized in that the microporous filter membrane in step (3) is 0.45 μ m microporous filter membrane.
3. the preparation method of Etomidate fatty emulsion injection according to claim 1 is characterized in that the microporous filter membrane in step (6) is 5 μ m microporous filter membrane.
4. the preparation method of Etomidate fatty emulsion injection according to claim 1 is characterized in that pH value in step (4) is between 7.5～9.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02112797 CN1274304C (en) | 2002-03-25 | 2002-03-25 | Etomidate fatty emulsion injection preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02112797 CN1274304C (en) | 2002-03-25 | 2002-03-25 | Etomidate fatty emulsion injection preparation method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1399959A CN1399959A (en) | 2003-03-05 |
| CN1274304C true CN1274304C (en) | 2006-09-13 |
Family
ID=4742261
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 02112797 Expired - Lifetime CN1274304C (en) | 2002-03-25 | 2002-03-25 | Etomidate fatty emulsion injection preparation method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1274304C (en) |
Families Citing this family (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100386085C (en) * | 2003-12-17 | 2008-05-07 | 昆明紫健生物技术有限公司 | Fat Emulsion transfusion liquid for preventing and curing tumour and production method thereof |
| CN100386082C (en) * | 2005-12-22 | 2008-05-07 | 济南百诺医药科技开发有限公司 | Oryzanol composition and its preparation method |
| CN101904814A (en) | 2009-06-04 | 2010-12-08 | 上海恒瑞医药有限公司 | Preparation method of drug loaded emulsion |
| CN102579433A (en) * | 2011-01-14 | 2012-07-18 | 海南际中博远实业发展有限公司 | Application of etomidate to preparation of medicament for preventing or treating posttraumatic stress disorder |
| CN103768055B (en) * | 2012-10-26 | 2015-11-25 | 上海医药工业研究院 | Injection etomidate composition and method of making the same |
| CN103961314A (en) * | 2013-01-24 | 2014-08-06 | 上海医药工业研究院 | Stable anesthetic emulsion |
| CN104706587A (en) * | 2013-12-16 | 2015-06-17 | 天津迈迪瑞康生物医药科技有限公司 | Etomidate fat emulsion concentrated solution, preparation method and application thereof |
| CN104569264B (en) * | 2014-12-30 | 2016-05-18 | 李宏 | A kind of assay method of Etomidate related substance |
| CN104644554B (en) * | 2015-03-05 | 2018-03-16 | 北京蓝丹医药科技有限公司 | A kind of Etomidate pharmaceutical composition and preparation method thereof |
| CN105055310B (en) * | 2015-08-30 | 2018-03-09 | 四川百利药业有限责任公司 | A kind of injection Etomidate composition and preparation method thereof |
| CN107049967A (en) * | 2016-12-31 | 2017-08-18 | 辰欣药业股份有限公司 | A kind of Etomidate freeze-dried emulsion and preparation method thereof |
| CN110860252A (en) * | 2019-12-19 | 2020-03-06 | 宁波和信制药设备有限公司 | Stirring device applied to fat emulsion preparation system and mixing method |
-
2002
- 2002-03-25 CN CN 02112797 patent/CN1274304C/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| CN1399959A (en) | 2003-03-05 |
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| C14 | Grant of patent or utility model | ||
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Owner name: JIANGSU ENHUA PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: XUZHOU YIHUA MEDICINE SCIENCE AND TECHNOLOGY CO., LTD. Effective date: 20070727 |
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| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20070727 Address after: 221007 No. 289, Zhongshan North Road, Jiangsu, Xuzhou Patentee after: Jiangsu Nhwa Pharmaceutical Co., Ltd. Address before: 221007 extension of Xuzhou, Jiangsu, Zhongshan North Road Patentee before: Yihua Medicinal Science and Technology Co., Ltd., Xuzhou |
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| C56 | Change in the name or address of the patentee | ||
| CP02 | Change in the address of a patent holder |
Address after: 221007 No. 18 Yang Shan Road, Xuzhou Economic Development Zone, Jiangsu, China Patentee after: Jiangsu Nhwa Pharmaceutical Co., Ltd. Address before: 221007 Zhongshan North Road, Jiangsu, No. 289, Patentee before: Jiangsu Nhwa Pharmaceutical Co., Ltd. |
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| CX01 | Expiry of patent term |
Granted publication date: 20060913 |
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