CN102488911A - Sodium hyaluronate injection sterilization method for guaranteeing aseptic packaging - Google Patents
Sodium hyaluronate injection sterilization method for guaranteeing aseptic packaging Download PDFInfo
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- CN102488911A CN102488911A CN2011103884551A CN201110388455A CN102488911A CN 102488911 A CN102488911 A CN 102488911A CN 2011103884551 A CN2011103884551 A CN 2011103884551A CN 201110388455 A CN201110388455 A CN 201110388455A CN 102488911 A CN102488911 A CN 102488911A
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- aseptic packaging
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Abstract
The invention relates to a sodium hyaluronate injection sterilization method for guaranteeing aseptic packaging, and the method comprises the following steps: firstly, determining sterilization parameters for the fewest degradation of sodium hyaluronates in different concentrations and specifications, and determining the temperature and the time when a certain sterilization effect is achieved; then, under the condition of the temperature and the acting time, obtaining expansive acting force curves of sodium hyaluronate injections (in different concentrations and specifications) in an aseptic packaging type prefillable syringe; setting the acting force value of each expansive acting force curve into a control program of sterilization equipment, thereby obtaining automatic back-pressing control programs for product sterilization in different concentrations and specifications; and in the process of sterilization, introducing a certain proportion of compressed air to carry out back pressing, so that the pressure of a sterilizing chamber is controlled so as to prevent aseptic packaging from being damaged due to the displacement of a rubber plug.
Description
Technical field:
The present invention relates to a kind of sodium hyaluronate injection sterilizing methods that ensures aseptic packaging.
Background technology:
Glass acid (Hyaluronic acid is called for short HA), by the straight chain polysaccharide that (1 → 3)-2-acetylaminohydroxyphenylarsonic acid 2-deoxidation-β-D-glucose-(1 → 4)-O-β-D-glucuronic acid disaccharidase recurring unit is formed, molecular formula is (C
14H
21NO
11) n, according to tissue-derived difference, the molecular weight excursion is 2 * 10
5～7 * 10
6, the disaccharidase units is 300～11000 pairs.
The acid of commodity glass is generally sodium-salt form, is white fiber shape or pulverulent solids, and stronger hygroscopicity is arranged, and is water-soluble, is insoluble to organic solvent.The macromolecular network structure of hyaluronic acid sodium through with H
2The a large amount of water of O formation hydrogen bonded has the multiple substrate of formation in vivo, regulates osmotic pressure, regulates and control the transhipment of macromolecular substances, forms effects such as physical barriers and adjusting cell function at cell peripheral.
The hyaluronic acid sodium preparation can be used as the auxiliary treatment of ophthalmologic operation adjuvant drug and morphotropism gonarthrosis and scapulohumeral periarthritis, is also organizing generation, wound healing, tumor invasion and adjusting cell function aspects to have the important physical function.
The hyaluronic acid sodium injection generally guarantees that through sterile working and process control product is aseptic now; But this production technology mode has very big risk; Groped to obtain the sterilizing parameter that makes the product palliating degradation degree low through experiment; Guarantee that product is aseptic, but also have many shortcomings in the sterilization process:
1. in the sterilization stroke, chamber pressure explosion bottle situation occurs less than the expansion power of medicinal liquid self in the sterilization cabinet.
2. plug and helmet are prone to produce displacement in sterilization process, have destroyed the aseptic packaging sealing, in the later stage product is stored, have the contaminated long bacterium risk of medicine.
Summary of the invention:
The purpose of this invention is to provide a kind of sodium hyaluronate injection sterilizing methods that ensures aseptic packaging; To overcome the deficiency of above-mentioned sodium hyaluronate injection sterilizing methods; This method can ensure that sodium hyaluronate injection sterilization process intermediate package is intact, prevents displacement destruction aseptic packaging sealings such as plug.
For realizing the object of the invention, technical scheme of the present invention is:
A kind of sodium hyaluronate injection sterilizing methods that ensures aseptic packaging; It is characterized in that, the sodium hyaluronate injection bottle will be housed put into steam-air sterilization cabinet, be warming up to 121 ℃～130 ℃; Sterilization time 10min; In the sterilization stroke, feed a certain proportion of compressed air and carry out back-pressure, control sterilization chamber pressure 0.16MPa～0.20MPa.
The present invention is through confirming the minimum sterilizing parameter of hyaluronic acid sodium degraded of variable concentrations and specification, and temperature is 121 ℃～130 ℃, and sterilization time 10min guarantees to reach sterilization effect F
0＞8; Under said temperature and action time condition, obtain the expansion force curve of variable concentrations sodium hyaluronate injection in aseptic packaging form pre-encapsulated injector, obtain active force scope 0.10MPa～0.15MPa.Above-mentioned force value is set in the sterilizing installation control sequence, obtains automatic back-pressure control sequence, in the sterilization stroke, especially in the temperature-fall period, feed a certain proportion of compressed air and carry out back-pressure, control sterilization chamber pressure 0.16MPa～0.20MPa.
Advantage of the present invention is:
1. reached the sterilization purpose, the hyaluronic acid sodium less degradation can satisfy the clinical intended purpose in market.
2. syringe explosion and the destructive situation of plug displacement generation aseptic packaging have been avoided producing in the sterilization stroke.
The specific embodiment:
Below in conjunction with embodiment the present invention is further described.
Embodiment 1:
Get 2.5ml: 200 of 25mg specification glass acid sodium injections; Be put on the shelf in steam-air sterilization cabinet; Setting sterilising temp is 121 ℃ of sterilization 10min; Recording hyaluronic acid sodium medicinal liquid expansion power value with this understanding is to be 0.12MPa, and the inner room pressure parameter of setting in the sterilization cabinet back-pressure program is 0.16MPa, and other gets with batch 200 sodium hyaluronate injections and controls sterilization automatically.
Embodiment 2:
Get 0.5ml: 200 of 7mg specification glass acid sodium injections; Be put on the shelf in steam-air sterilization cabinet; Setting sterilising temp is 123 ℃ of sterilization 10min; Recording hyaluronic acid sodium medicinal liquid expansion power value with this understanding is to be 0.14MPa, and the inner room pressure parameter of setting in the sterilization cabinet back-pressure program is 0.19MPa, and other gets with batch 200 sodium hyaluronate injections and controls sterilization automatically.
Embodiment 3:
Get 2.5ml: 200 of 25mg specification glass acid sodium injections; Be put on the shelf in steam-air sterilization cabinet; Setting sterilising temp is 126 ℃ of 10min sterilizations; Recording hyaluronic acid sodium medicinal liquid expansion power value with this understanding is to be 0.13MPa, and the inner room pressure parameter of setting in the sterilization cabinet back-pressure program is 0.18MPa, and other gets with batch 200 sodium hyaluronate injections and controls sterilization automatically.
Embodiment 4:
Get 0.5ml: 200 of 7mg specification glass acid sodium injections; Be put on the shelf in steam-air sterilization cabinet; Setting sterilising temp is 126 ℃ of 10min sterilizations; Recording hyaluronic acid sodium medicinal liquid expansion power value with this understanding is to be 0.15MPa, and the inner room pressure parameter of setting in the sterilization cabinet back-pressure program is 0.20MPa, and other gets with batch 200 sodium hyaluronate injections and controls sterilization automatically.
Carrying out inspections such as aseptic, physical and chemical index, sealing after the said goods sterilization, below is that each embodiment back-pressure sterilization is relatively seen table 1 with conventional sterilization physicochemical data and aseptic packaging integrity.
Table 1
Claims (2)
1. sodium hyaluronate injection sterilizing methods that ensures aseptic packaging; It is characterized in that, the sodium hyaluronate injection bottle will be housed put into steam-air sterilization cabinet, be warming up to 121 ℃～130 ℃; Sterilization time 10min; In the sterilization stroke, feed a certain proportion of compressed air and carry out back-pressure, control sterilization chamber pressure 0.16MPa～0.20MPa.
2. the sodium hyaluronate injection sterilizing methods of guarantee aseptic packaging as claimed in claim 1 is characterized in that, the temperature-fall period in the sterilization stroke feeds a certain proportion of compressed air and carries out back-pressure, control sterilization chamber pressure 0.16MPa～0.20MPa.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011103884551A CN102488911A (en) | 2011-11-29 | 2011-11-29 | Sodium hyaluronate injection sterilization method for guaranteeing aseptic packaging |
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| CN2011103884551A CN102488911A (en) | 2011-11-29 | 2011-11-29 | Sodium hyaluronate injection sterilization method for guaranteeing aseptic packaging |
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| CN102488911A true CN102488911A (en) | 2012-06-13 |
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102973495A (en) * | 2012-11-15 | 2013-03-20 | 上海景峰制药股份有限公司 | Method of slowing down degradation of sodium hyaluronate in body |
| CN104721856A (en) * | 2015-04-12 | 2015-06-24 | 连云港国鑫食用菌成套设备有限公司 | Explosion-proof bag sterilization cabinet adaptive to sealed packaging bag sterilization, method and application |
| CN105287626A (en) * | 2015-10-26 | 2016-02-03 | 张敏 | Mucosa injection |
| CN108261420A (en) * | 2017-12-07 | 2018-07-10 | 上海昊海生物科技股份有限公司 | The method of the sodium hyaluronate injection prepare with scale of mixed vapour-air sterilization |
| CN110652600A (en) * | 2019-09-27 | 2020-01-07 | 浙江都邦药业股份有限公司 | Multistage sterilization and disinfection equipment for injection and disinfection process thereof |
| CN111202855A (en) * | 2020-02-18 | 2020-05-29 | 北京四环科宝制药有限公司 | Damp-heat sterilization method for citicoline and sodium salt injection thereof |
| CN111939278A (en) * | 2020-07-31 | 2020-11-17 | 珠海润都制药股份有限公司 | Sterilization process of higenamine hydrochloride injection |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101890182A (en) * | 2009-09-16 | 2010-11-24 | 上海其胜生物制剂有限公司 | Preparation method of medical hyaluronic acid gel preparation for sterilizing high-pressure steam |
| CN102126694A (en) * | 2010-12-29 | 2011-07-20 | 昆明南疆制药有限公司 | Method for eliminating deformation of polypropylene transfusion bottle |
-
2011
- 2011-11-29 CN CN2011103884551A patent/CN102488911A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101890182A (en) * | 2009-09-16 | 2010-11-24 | 上海其胜生物制剂有限公司 | Preparation method of medical hyaluronic acid gel preparation for sterilizing high-pressure steam |
| CN102126694A (en) * | 2010-12-29 | 2011-07-20 | 昆明南疆制药有限公司 | Method for eliminating deformation of polypropylene transfusion bottle |
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102973495A (en) * | 2012-11-15 | 2013-03-20 | 上海景峰制药股份有限公司 | Method of slowing down degradation of sodium hyaluronate in body |
| CN104721856A (en) * | 2015-04-12 | 2015-06-24 | 连云港国鑫食用菌成套设备有限公司 | Explosion-proof bag sterilization cabinet adaptive to sealed packaging bag sterilization, method and application |
| CN104721856B (en) * | 2015-04-12 | 2018-04-27 | 连云港国鑫食用菌成套设备有限公司 | Suitable for the explosion-proof bag sterilizing cabinet and method and purposes of sealed packing bag sterilizing |
| CN105287626A (en) * | 2015-10-26 | 2016-02-03 | 张敏 | Mucosa injection |
| CN108261420A (en) * | 2017-12-07 | 2018-07-10 | 上海昊海生物科技股份有限公司 | The method of the sodium hyaluronate injection prepare with scale of mixed vapour-air sterilization |
| CN110652600A (en) * | 2019-09-27 | 2020-01-07 | 浙江都邦药业股份有限公司 | Multistage sterilization and disinfection equipment for injection and disinfection process thereof |
| CN110652600B (en) * | 2019-09-27 | 2020-07-28 | 浙江都邦药业股份有限公司 | Multistage sterilization and disinfection equipment for injection and disinfection process thereof |
| CN111202855A (en) * | 2020-02-18 | 2020-05-29 | 北京四环科宝制药有限公司 | Damp-heat sterilization method for citicoline and sodium salt injection thereof |
| CN111939278A (en) * | 2020-07-31 | 2020-11-17 | 珠海润都制药股份有限公司 | Sterilization process of higenamine hydrochloride injection |
| CN111939278B (en) * | 2020-07-31 | 2021-08-17 | 珠海润都制药股份有限公司 | Sterilization process of higenamine hydrochloride injection |
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Application publication date: 20120613 |