CN106693003A - Glucose-containing lipid emulsion sterilizing method - Google Patents
Glucose-containing lipid emulsion sterilizing method Download PDFInfo
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- CN106693003A CN106693003A CN201510463993.0A CN201510463993A CN106693003A CN 106693003 A CN106693003 A CN 106693003A CN 201510463993 A CN201510463993 A CN 201510463993A CN 106693003 A CN106693003 A CN 106693003A
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Abstract
The invention aims to provide a glucose-containing lipid emulsion sterilizing method. A rotary sterilizing method is applied to a preparation process for a glucose-containing lipid emulsion for the first time. A sterilizing process adopts the rotary sterilizing method to sterilize a soft package bag which is filled with the glucose-containing lipid emulsion, wherein the temperature is maintained at 121 DEG C during a sterilizing process, the pressure is maintained at 0.2 MPa, and the time is maintained for 15 minutes. After sterilizing is completed, the sterilized emulsion is cooled quickly by adopting a spraying device, and the glucose decomposing speed is slowed. According to the glucose-containing lipid emulsion sterilizing method, glucose decomposition of the glucose-containing lipid emulsion caused by the conventional process and post-heat layering of the emulsion can be effectively avoided, and a sterile requirement of a product is met.
Description
Technical field
The present invention relates to a kind of sterilizing methods containing glucose lipid fat emulsion, belong to pharmaceutical production technical field.
Background technology
At present with the emulsion products that list generally using the method for whole sterile working, i.e., hundred grades of cleaning shops, produced in the case of supplementary material is sterilized.Or using with traditional min of pressure sterilizing 115 DEG C × 30, or 121 DEG C × 15min and 100 DEG C flowing steam 30 minutes, although these fiery bacterium methods can reach complete sterilizing state.But it is directed to glucose lipid fat emulsion, because containing glucose, influenceed by many sterilizing factors, especially glucose, it is thermo-labile, easily decompose in the case of a high temperature, cause that 5- hydroxymethylfurfural limits are exceeded while the pH value of preparation changes therewith, emulsion physical stability is set to be deteriorated, while being easy to have the generation of the phenomenons such as oil spill, layering.And the production for containing glucose lipid fat emulsion must just can guarantee that drug safety by terminal sterilization process, so it is essential process that fat emulsion containing glucose lipid is carried out into terminal sterilization.Preparation method it is therefore desirable to provide the sterilization preparation containing glucose lipid fat emulsion, to overcome the problem that cannot be sterilized in existing preparation, there are no application document or patent report on this preparation method in terms of the sterilizing of fat emulsion containing glucose lipid so far.
The content of the invention
The present invention is to solve current traditional steam sterilization or degerming method it cannot be guaranteed that the product quality of fat emulsion containing glucose lipid (Sterility Assurance and content ensure).The present invention provides a kind of preparation method of the sterilization preparation containing glucose lipid fat emulsion by experimental study, fundamentally solves above-mentioned technical problem.
The preparation method of sterilization preparation of the present invention containing glucose lipid fat emulsion is as follows：
Fat emulsion containing glucose lipid is prepared using high pressure homogenizer, average grain diameter is controlled in the range of 100 nm-400 nm, medicine liquid irrigation is filled in aseptic soft packaging bag；The fat emulsion containing glucose lipid of embedding is sterilized using rotation sterilization, temperature maintains 121 DEG C in sterilization process, and pressure maintains 0.2 MPa, and the time maintains 15 min.Rotating speed is in the range of 5 rpms.The emulsion after sterilizing is quickly cooled down using spray equipment after the completion of sterilizing, temperature is down to normal temperature.
The method for verifying above-mentioned sterilization preparation bacteria-eliminating efficacy is as follows：In using thermophilic bacillus bud robe inoculation fat emulsion containing glucose lipid, the checking of aseptic filtration is carried out by above-mentioned degerming method, after taking-up, checked according to 2010 editions annex Sterility Tests of Chinese Pharmacopoeia.
Advantages of the present invention is as follows：
Using preparation method of the present invention will Fat Emulsion average grain diameter in the range of 100 nm-400 nm, as far as possible ensure the steady quality of fat emulsion containing glucose lipid.Then rotation sterilizing is carried out to the soft packaging bag after filling, the advantage for rotating sterilization process is as follows：
1st, the stability and uniformity of supensoid agent or emulsion are maintained, can otherwise causes supensoid agent or emulsion to produce layering；
2nd, the vacuum leak hunting for rapidly being sterilized, because defective tube somewhere, in the comprehensive motion of rotary course, can not be ideally achieved this effect；
3 thus forced convertion forms the uniform chemotactic temperature field of strength disturbance, so as to more shorten cabinet indoor temperature, the time gives the sterilizing of temperature-sensitive sex pill in a short period of time in a balanced way.
4th, due to gyration, in-cabinet temperature is more aligned compared with static type, and faster, without dead angle, thus sterilization effect is more preferably for the transmission of heat.
5th, the fat emulsion containing glucose lipid for preparing quickly is cooled down using spray equipment after rotation sterilizing is carried out to emulsion, temperature is down to normal temperature.
The fat emulsion containing glucose lipid for according to said method preparing fully achieves the requirement after product sterilizing.Without substantially change, 5- hydroxymethylfurfurals and pH value do not have any change to the particle diameter of fat emulsion containing glucose lipid after testing.
Specific embodiment
By the following examples, experimental example describes present disclosure in detail, but these embodiments are not construed as limiting the invention.
Embodiment 1：
The preparation method of sterilization preparation of the present invention containing glucose lipid fat emulsion is as follows：Be filled into liquid in flexible package and obtained final product by the fat emulsion containing glucose lipid that will be prepared using high pressure homogenizer, the nm of average grain diameter 290.Flexible package is put into rotation sterilizing cabinet, high-temperature vapour is fed, sterilizing in-cabinet temperature is rapidly increased to 115 DEG C in 3 minutes, pressure maintains 0.15 MPa, and the time was maintained in the range of 45 minutes, and rotating speed is 5 rpms.After the completion of sterilizing, automatic Water spray is carried out, 50 DEG C are reduced to by 60 min or so temperature, pressure is zero, open sterilizing cabinet door.
Embodiment 2：
The preparation method of sterilization preparation of the present invention containing glucose lipid fat emulsion is as follows：Be filled into liquid in flexible package and obtained final product by the fat emulsion containing glucose lipid that will be prepared using high pressure homogenizer, average grain diameter 305nm.Flexible package is put into rotation sterilizing cabinet, high-temperature vapour is fed, sterilizing in-cabinet temperature is rapidly increased to 121 DEG C in 3 minutes, pressure maintains 0.2MPa, and the time was maintained in the range of 30 minutes, and rotating speed is 3 rpms.After the completion of sterilizing, automatic Water spray is carried out, 50 DEG C are reduced to by 60 min or so temperature, pressure is zero, opens sterilizing cabinet door.
Embodiment 3：
The preparation method of sterilization preparation of the present invention containing glucose lipid fat emulsion is as follows：Be filled into liquid in flexible package and obtained final product by the fat emulsion containing glucose lipid that will be prepared using high pressure homogenizer, the nm of average grain diameter 298.Flexible package is put into rotation sterilizing cabinet, high-temperature vapour is fed, sterilizing in-cabinet temperature is rapidly increased to 121 DEG C in 3 minutes, pressure maintains 0.2 MPa, and the time was maintained in the range of 30 minutes, and rotating speed is 5 rpms.After the completion of sterilizing, automatic Water spray is carried out, 50 DEG C are reduced to by 60 min or so temperature, pressure is zero, open sterilizing cabinet door.
Embodiment 1-3 drug contents and other indices are as follows：
The fat emulsion containing glucose lipid that data above explanation is prepared by embodiment 1-3 methods, for steam fire bacterium, its drug content, pH value, change of size are smaller, and 5- hydroxymethylfurfurals, endotoxin and sterility test meet regulation, and the decline of conventional steam sterilization process content is more, pH value, 5- hydroxymethylfurfurals, change of size are larger.Illustrate that this rotation sterilization process is more suitable for the preparation containing glucose lipid fat emulsion, product quality is more stablized, is produced on a large scale.
Claims (6)
1. a kind of preparation method of the fat emulsion sterilization preparation containing glucose, it is characterized in that using rotation sterilization, the sterilizing of the soft packaging bag containing glucose lipid fat emulsion to embedding, temperature maintains 100 DEG C -121 DEG C in sterilization process in sterilization process, pressure maintains 0-0.2MPa, time maintains 15 min-45 min, rotating speed：1-20 r/min；The emulsion after sterilizing is quickly cooled down using spray equipment after the completion of sterilizing.
2. it is as claimed in claim 1 to rotate sterilization, it is characterised in that sterilizing in-cabinet temperature can be rapidly increased to 100 DEG C -121 DEG C in a short period of time, pressure maintains 0-0.2 MPa, and the time maintains 15 min-45 min.
3. the preparation method containing glucose lipid fat emulsion sterilization preparation as claimed in claim 2, it is characterised in that sterilising temp is preferably 121 DEG C in sterilization process.
4. the preparation method containing glucose lipid fat emulsion sterilization preparation as claimed in claim 2, it is characterised in that sterilization time is preferably 15 min in sterilization process.
5. the preparation method containing glucose lipid fat emulsion sterilization preparation as claimed in claim 2, it is characterised in that the r/min of speed 5 of autoclave rotation in sterilization process.
6. it is as claimed in claim 1 to rotate sterilization, it is characterised in that the emulsion after sterilizing quickly to be cooled down using spray equipment after the completion of sterilizing, temperature is down to normal temperature.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510463993.0A CN106693003A (en) | 2015-08-03 | 2015-08-03 | Glucose-containing lipid emulsion sterilizing method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510463993.0A CN106693003A (en) | 2015-08-03 | 2015-08-03 | Glucose-containing lipid emulsion sterilizing method |
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| CN106693003A true CN106693003A (en) | 2017-05-24 |
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| CN201510463993.0A Pending CN106693003A (en) | 2015-08-03 | 2015-08-03 | Glucose-containing lipid emulsion sterilizing method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108404179A (en) * | 2018-05-30 | 2018-08-17 | 苏州艾特森制药设备有限公司 | A kind of rotation disinfection system |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2392546Y (en) * | 1999-08-06 | 2000-08-23 | 关骏良 | Hot-press flexible-package sterilizer |
| US20080050274A1 (en) * | 2006-06-07 | 2008-02-28 | Brian Ozier | Process for treating medical waste |
| CN101926763A (en) * | 2009-06-22 | 2010-12-29 | 哈药集团生物工程有限公司 | Method for preparing lipoalprostadil sterile preparation |
| CN202105206U (en) * | 2011-05-30 | 2012-01-11 | 张家港市欧思瑞科技有限公司 | Sterilizing cabinet with lengthened steam buffer plate |
-
2015
- 2015-08-03 CN CN201510463993.0A patent/CN106693003A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN2392546Y (en) * | 1999-08-06 | 2000-08-23 | 关骏良 | Hot-press flexible-package sterilizer |
| US20080050274A1 (en) * | 2006-06-07 | 2008-02-28 | Brian Ozier | Process for treating medical waste |
| CN101926763A (en) * | 2009-06-22 | 2010-12-29 | 哈药集团生物工程有限公司 | Method for preparing lipoalprostadil sterile preparation |
| CN202105206U (en) * | 2011-05-30 | 2012-01-11 | 张家港市欧思瑞科技有限公司 | Sterilizing cabinet with lengthened steam buffer plate |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108404179A (en) * | 2018-05-30 | 2018-08-17 | 苏州艾特森制药设备有限公司 | A kind of rotation disinfection system |
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Application publication date: 20170524 |