CN103072932A - Aseptic packaging method of clindamycin phosphate injection - Google Patents
Aseptic packaging method of clindamycin phosphate injection Download PDFInfo
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- CN103072932A CN103072932A CN2013100139749A CN201310013974A CN103072932A CN 103072932 A CN103072932 A CN 103072932A CN 2013100139749 A CN2013100139749 A CN 2013100139749A CN 201310013974 A CN201310013974 A CN 201310013974A CN 103072932 A CN103072932 A CN 103072932A
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- clindamycin phosphate
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Abstract
The invention discloses an aseptic packaging method of clindamycin phosphate injection, which comprises the following steps: (1) weighing clindamycin phosphate injection raw and auxiliary materials under a negative pressure weighing cover according to the process proportion, adding into a mixing vessel sterilized in advance in sequence, adding water for injection to dilute and uniformly mixing; (2) supplementing the water for injection under the matching of a mixing vessel weighing system according to the process proportion to total preparation quantity, adjusting the PH value of liquid medicine to 6.5-6.8 and then filtering and sterilizing the liquid medicine through a 0.22-mum sterilizing-level filter of a redundancy filtering system; and (3) injecting the filtered sterile liquid medicine into a plastic bottle blowing, filling and sealing integrated machine through an aseptic pipeline system and finishing bottle blowing, filling and sealing under the protection of a level-A laminar flow hood to obtain a finished product. The aseptic packaging method has the benefits that the production process requires no terminal sterilization; the original chemical characteristics of the clindamycin phosphate injection are ensured; and plastic ampoule is used for packing, so that no fragment is generated during the use, and a blood vessel can not be plugged. Therefore, a powerful safeguard is provided for the clinical use safety of the clindamycin phosphate injection.
Description
Technical field
The present invention relates to the pharmaceutical production field, be specifically related to the aseptic packaging method of clindamycin phosphate injection.
Background technology
Clindamycin phosphate is mainly used in the infection of gram-positive bacteria and anaerobe, clinical efficacy is good, but because the particular characteristics of product, its content declines to a great extent behind high-temperature sterilization, related substance exceeds standard, and takes the conventional terminal sterilization can't make the injection products that meets the Chinese Pharmacopoeia standard.Therefore domestic clindamycin phosphate is made capsule or powder-injection product more, but the curative effect of parenteral solution is good more than capsule or powder product, so clindamycin phosphate injection is still the development direction of pharmacy producer, only a few producer is also arranged at present in trial-production, but the equal out of reach national standard of finished product.And traditional glass ampule forms negative pressure in the ampoule in adding the hot-seal process, the operation of cutting ampoule in the use procedure, can produce a hundreds of thousands of tiny glass granules, the moment of ampoule fracture, the negative pressure in the ampoule can be inhaled glass chip into the liquid, after injecting human body, be easy to cause embolism.
Summary of the invention
The technical problem to be solved in the present invention provides a kind of aseptic packaging method of clindamycin phosphate injection, this production technology need not terminal sterilization, guaranteed original chemical nature of clindamycin phosphate injection, and be packaged as plastic ampoule, in use can not produce chip, can not cause embolism to blood vessel, strong guarantee is provided for the safety of its clinical use.
The present invention is achieved through the following technical solutions:
The aseptic packaging method of clindamycin phosphate injection may further comprise the steps:
(1) adds successively in the ingredients pot that sterilization is good in advance after under negative pressure weighing cover, the clindamycin phosphate injection supplementary material being weighed up by processing compound, inject dilute with water, mix;
(2) under the ingredients pot Weighing system cooperates by processing compound supplementary injection water to preparing total amount, regulate the pH value to 6.5 of liquid～6.8, then liquid carries out filtration sterilization by the 0.22um degerming level filter of redundant filtering system;
(3) sterile liquid medicine after the filtration blows the embedding all-in-one by aseptic pipeline system injected plastic bottle; the other end of plastic bottle blowing embedding all-in-one adds plastic pellet; passing into filtrated air after adopting hot melt that plastic pellet is melted blows parison and makes the sky plastic ampoule; simultaneously sealing after injecting sterile liquid medicine under the protection of A level laminar flow hood, finished product is examined, packed to get to last lettering, cutting, vacuum leak detection, lamp.
The further improvement of the present invention scheme is that the hot melt condition in the described step (3) is 170-230 ℃, 350bar.
Negative pressure weighing cover is a kind of Local Purification equipment for place special uses such as pharmacy, microbe research and scientific experiments, it provides a kind of vertical one-way gas flow, the part pure air circulates in the work area, part drains near zone, make the work area produce negative pressure, prevent cross pollution, be used for guaranteeing the high-cleanness, high environment of work area.
A level laminar flow hood forms laminar flow after air is passed through high efficiency particulate air filter with certain wind speed, makes pure air be vertical way flow, thereby has guaranteed to reach in the work area high-cleanness, high of technological requirement.
Plastic bottle blowing embedding all-in-one is Qianshan Pharmaceutical Machinery Co., Ltd., Hunan's ASY1/20 plastic ampoule bottle/can processed of producing/sealing all-in-one machine.
Beneficial effect of the present invention:
One, the present invention is owing to adopting 0.22um degerming level filter that liquid is carried out aseptic filtration, then enter plastic bottle blowing embedding all-in-one by aseptic pipeline system, whole process is finished at same set of sterile system, works incessantly, is not exposed in the environment, guaranteed the aseptic level of whole production process, do not need to carry out terminal sterilization, original character of product does not change, and the product related substance does not exceed standard, meet the Chinese Pharmacopoeia standard, guaranteed the safety of its clinical use.
Two, the present invention is packaged as plastic ampoule, in use can not produce chip, can not cause embolism to blood vessel, strong guarantee is provided for the safety of its clinical use.
Description of drawings
Fig. 1 is flow package figure of the present invention.
The specific embodiment
As shown in Figure 1, the aseptic packaging method of clindamycin phosphate injection of the present invention may further comprise the steps:
(1) adds successively in the ingredients pot that sterilization is good in advance after under negative pressure weighing cover, the clindamycin phosphate injection supplementary material being weighed up by processing compound, inject dilute with water, mix;
(2) under the ingredients pot Weighing system cooperates by processing compound supplementary injection water to preparing total amount, regulate the pH value to 6.5 of liquid～6.8, then liquid carries out filtration sterilization by the 0.22um degerming level filter of redundant filtering system;
(3) sterile liquid medicine after the filtration blows the embedding all-in-one by aseptic pipeline system injected plastic bottle; the other end of plastic bottle blowing embedding all-in-one adds plastic pellet; passing into filtrated air after adopting hot melt that plastic pellet is melted blows parison and makes the sky plastic ampoule; simultaneously sealing after injecting sterile liquid medicine under the protection of A level laminar flow hood, finished product is examined, packed to get to last lettering, cutting, vacuum leak detection, lamp.
Claims (2)
1. the aseptic packaging method of clindamycin phosphate injection is characterized in that may further comprise the steps:
(1) adds successively in the ingredients pot that sterilization is good in advance after under negative pressure weighing cover, the clindamycin phosphate injection supplementary material being weighed up by processing compound, inject dilute with water, mix;
(2) under the ingredients pot Weighing system cooperates by processing compound supplementary injection water to preparing total amount, regulate the pH value to 6.5 of liquid～6.8, then liquid carries out filtration sterilization by the 0.22um degerming level filter of redundant filtering system;
(3) sterile liquid medicine after the filtration blows the embedding all-in-one by aseptic pipeline system injected plastic bottle; the other end of plastic bottle blowing embedding all-in-one adds plastic pellet; passing into filtrated air after adopting hot melt that plastic pellet is melted blows parison and makes the sky plastic ampoule; simultaneously sealing after injecting sterile liquid medicine under the protection of A level laminar flow hood, finished product is examined, packed to get to last lettering, cutting, vacuum leak detection, lamp.
2. method according to claim 1, it is characterized in that: the hot melt condition in the described step (3) is 170-230 ℃, 350bar.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2013100139749A CN103072932A (en) | 2013-01-15 | 2013-01-15 | Aseptic packaging method of clindamycin phosphate injection |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2013100139749A CN103072932A (en) | 2013-01-15 | 2013-01-15 | Aseptic packaging method of clindamycin phosphate injection |
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| CN103072932A true CN103072932A (en) | 2013-05-01 |
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| CN2013100139749A Pending CN103072932A (en) | 2013-01-15 | 2013-01-15 | Aseptic packaging method of clindamycin phosphate injection |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114955031A (en) * | 2022-05-27 | 2022-08-30 | 山东希尔康泰药业有限公司 | Diclofenac sodium lidocaine hydrochloride injection aseptic preparation system |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101874770A (en) * | 2009-04-30 | 2010-11-03 | 华北制药集团制剂有限公司 | Clindamycin phosphate injection and preparation method thereof |
| CN102133178A (en) * | 2011-03-09 | 2011-07-27 | 成都普什制药有限公司 | Clindamycin phosphate injection and preparation method thereof |
| CN102144966A (en) * | 2011-04-08 | 2011-08-10 | 沈阳格林制药有限公司 | Preparation method of clindamycin phosphate injection |
-
2013
- 2013-01-15 CN CN2013100139749A patent/CN103072932A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101874770A (en) * | 2009-04-30 | 2010-11-03 | 华北制药集团制剂有限公司 | Clindamycin phosphate injection and preparation method thereof |
| CN102133178A (en) * | 2011-03-09 | 2011-07-27 | 成都普什制药有限公司 | Clindamycin phosphate injection and preparation method thereof |
| CN102144966A (en) * | 2011-04-08 | 2011-08-10 | 沈阳格林制药有限公司 | Preparation method of clindamycin phosphate injection |
Non-Patent Citations (3)
| Title |
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| 《机电信息》 20111031 张洪飞 浅谈吹灌封"三合一"工艺与工程 , 第29期 * |
| 张洪飞: "浅谈吹灌封"三合一"工艺与工程", 《机电信息》, no. 29, 31 October 2011 (2011-10-31) * |
| 柴健: "浅谈输液包装容器材料和生产工艺", 《医药工程设计杂志》, vol. 21, no. 5, 31 December 2000 (2000-12-31) * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114955031A (en) * | 2022-05-27 | 2022-08-30 | 山东希尔康泰药业有限公司 | Diclofenac sodium lidocaine hydrochloride injection aseptic preparation system |
| CN114955031B (en) * | 2022-05-27 | 2023-09-22 | 山东希尔康泰药业有限公司 | Sterile preparation system for diclofenac sodium lidocaine hydrochloride injection |
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Application publication date: 20130501 |