CN102415949A - Novel liquid medicine filling and freezing process and liquid medicine filling and freezing device - Google Patents
Novel liquid medicine filling and freezing process and liquid medicine filling and freezing device Download PDFInfo
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- CN102415949A CN102415949A CN2011102026411A CN201110202641A CN102415949A CN 102415949 A CN102415949 A CN 102415949A CN 2011102026411 A CN2011102026411 A CN 2011102026411A CN 201110202641 A CN201110202641 A CN 201110202641A CN 102415949 A CN102415949 A CN 102415949A
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Abstract
The invention relates to a novel liquid medicine filling and freezing process and a liquid medicine filling and freezing device. The process comprises the following steps: in a liquid medicine filling flow of the production process of freeze-dried powder for injection, a cooling bath and a heat preservation device are added at the outer layer of a transmission device of a traditional linear type liquid medicine filling machine, a low-temperature circulating cooling pump is connected externally to make liquid medicine quickly frozen when the medicine liquid is filled, so various liquid medicine can be filled and frozen in different layers, then a lyophilization step is carried out, powder for injection containing various drug ingredients can be produced in one step, and the defect that the traditional process can only produce the freeze-dried powder for injection containing one drug ingredient is overcome.
Description
Technical field
The present invention relates to a kind of novel liquid medicine filling refrigerating process and liquid medicine filling freezing equipment, belong to the pharmaceutical engineering technical field.
Background technology
Injectable sterile powder is commonly called as the powder pin.Every in aqueous solution unsettled medicine, like biological preparation such as some antibiotic (benzylpenicillin, cephalosporins) and some enzyme preparations (Trypsin, coenzyme A) and blood plasma, all need process injectable sterile powder.
According to manufacturing condition, injectable sterile powder is divided into two big types: injection lyophilisation product system is mixed with aseptic aqueous solution with medicine, the product that behind the powder-tight that freeze-drying makes, obtains; The product that obtains after the sterile bulk drug direct packaging sealing that Injectable sterile packing product system adopts sterilization solvent crystallization, spray drying method to make.
The flow chart of injection lyophilisation product is seen Figure of description 2.
Freeze drying process be meant medicine after freezing under vacuum state, without liquid state, directly from the solid-state gaseous state that sublimes up into, the operating process of removing moisture thus.The operation of product before the lyophilizing, identical with aqueous solution injection basically, i.e. dosing, filtration, packing, but sample path length will approach during packing, the technology after the packing is generally following: freezing, primary drying (distillation), redrying (desorption) and seal.
The vial lyophilized formulations is a kind of common lyophilized formulations in the injection, and common method for preparing is:
Sealed container in the inner container → liquid medicine filling of the medicinal liquid → goods of the configuration of medicinal liquid → process aseptic filtration → freeze vacuum drying → freeze dryer drying box.
But above-mentioned classical technology can only be used for producing the freeze-dried powder of single preparation composition, if when the powder pin contains two kinds or multiple difference of specific gravity ingredient, and panipenem/betamipron powder pin for example, this technology just can't realize.
In order to address the above problem; The inventor of our company through improving this step of liquid medicine filling, has worked out a kind of novel liquid medicine filling refrigerating process and liquid medicine filling freezing equipment on the traditional handicraft basis; In liquid medicine filling that medicinal liquid is freezing; Can be at the two-layer or multilamellar medicinal liquid of fill in the same bottle, and then get into step of freeze drying, can realize two kinds of perhaps productions of the powder pin of multiple composition of disposable fill.
Summary of the invention
To the existing bottle medicine freeze-dry process that can only produce a kind of drug ingredient, provide a kind of and can produce two kinds of perhaps novel bottle lyophilizing medicine technologies of multiple drug ingredient.In the freeze-dried powder production process, cold-aseptic filling adds cooling bath in filling apparatus, and it is freezing rapidly to make medicinal liquid inject bottle, can add multiple medicinal liquid, multiple medicinal liquid laminated freezing, and then get into step of freeze drying.This technology is following:
A kind of novel bottle lyophilizing pharmaceutical production Technology, it comprises following flow process:
Sealed container in the inner container → liquid medicine filling of the medicinal liquid → goods of the configuration of medicinal liquid → process aseptic filtration → quick freezing → water for injection fill → quick freezing → secondary liquid medicine filling → quick freezing → freeze vacuum drying → freeze dryer drying box
Concrete process chart is seen Figure of description 3.
Liquid medicine filling device outside is provided with cooling bath, injects the liquid nitrogen alcohol mixed solution in the cooling bath, controls temperature between 0 degree-subzero 120 degree with the cold cycle coolant pump; After medicinal liquid perfusion for the first time finishes, freezing in transport process, then through the distilled water perfusion equipment; Pour into a small amount of water for injection, continue freezingly in transport process, get into medicinal liquid perfusion equipment for the second time then; So circulation can realize repeatedly layering fill of medicinal liquid, then half tamponade; Get into step of freeze drying at last, when treating that moisture is controlled at 1-3%, promptly salable.
Because the temperature of cooling bath is between 0 degree-subzero 120 degree, dabbling medicinal liquid can be freezing rapidly, and required time is extremely short; Interlayer is done with water for injection in the centre; Prevent that two-layer medicinal liquid is miscible, whole pouring process required time is shorter, and under aseptic condition, carries out; Can well guarantee that medicinal liquid can not receive antibacterial or air influence, guarantee that medicine undergoes no deterioration.
Another object of the present invention provides a kind of liquid medicine filling freezing equipment, and the liquid medicine filling refrigerating process described in the present invention is achieved, and uses the liquid medicine filling freezing equipment that this technological design comes out and includes, but are not limited to this equipment.
That is according to the present invention, another purpose of foregoing invention is by providing the liquid medicine filling freezing equipment that comprises following each parts to realize:
A kind of liquid medicine filling freezing equipment comprises into bottle rotating disk, advances a bottle screw rod, conveyer belt, at least 3 cover filling parts, buffering refrigerator tray, frame that buffering external cooling bath of refrigerator tray and heat-preserving equipment are controlled temperature with the cryogenic refrigeration circulating pump.
Concrete structure is seen Figure of description 4.
Description of drawings
Fig. 1 is a process diagram of the present invention.
Fig. 2 is the flow chart of injection lyophilisation product.
Fig. 3 is the process chart of bottle lyophilizing pharmaceutical production.
Fig. 4 is a liquid medicine filling freezing equipment structure chart of the present invention.
The specific embodiment
With panipenem/betamipron mixture is that example uses this liquid medicine filling freezing equipment to carry out medicinal liquid lyophilized formulations production technology:
At first, panipenem, solid sodium chloride raw material and water for injection are mixed with clear solution by a certain percentage, under inert gas environment, carry out contaminant filter → adjustment solution pH value → modulating liquid → aseptic filtration;
Get into the fill link then, cillin bottle comes out to inject the panipenem solution 1.6ml that modulates for the first time through advancing the conveyer belt that bottle rotating disk gets into filling machine from baking oven; By way of transporter that has the sub-cooled groove and the freezing pallet of buffering, 80 degree under the cooling bath zero temperature, solvent is freezing rapidly; Get into the water for injection filling apparatus, inject water for injection 0.8ml, continue on the transporter that has the sub-cooled groove, to transmit; Get into the freezing pallet of buffering, 80 degree under the cooling bath zero temperature get into medicinal liquid perfusion equipment for the second time; The betamipron solution 1.6ml that injection modulates, it is freezing rapidly to get into the freezing pallet of buffering from transporter;
The bottle of the intact medicinal liquid (filling nitrogen) of fill is by the transition rotating disk of the defeated bottle of screw rod to the plug that falls then, and the rotating disk of jumping a queue of 24 statures is given in switching again.Defeated bottle is to the station of jumping a queue; Half top cement plug → collection; Bottle behind the false add plug is sent bottle into the tabular conveyer belt of bottle outlet by the transition rotating disk and is got into conveying mechanism; Get into the fridge drying baker again and carry out pre-freeze → vacuum exhaust → primary drying → redrying → removing vacuum → total head plug, by way of freeze drying box → roll lid → lamp inspection → labeling → outer package.
Claims (5)
1. the liquid medicine filling freezing method in the bottle lyophilizing pharmaceutical production comprises that step is shown in Figure of description 1; The method of liquid medicine filling comprises: liquid medicine filling → quick freezing → distilled water fill → quick freezing → secondary or repeatedly liquid medicine filling → lyophilizing for the first time.
2. as above-mentioned liquid medicine filling freezing method, it is characterized in that freezing medicinal liquid canned the time.
3. as above-mentioned medicine liquid tank dress freezing method, it is characterized in that medicine bottle that fill finishes can get into buffered freezing pallet and carry out quick freezing.
4. liquid medicine filling freezing equipment that is used to realize the arbitrary method of claim 1 to 3 by at least three cover filling apparatus, conveyer device, goes out bottle member and frame is formed; Every suit filling apparatus comprises the into freezing pallet of buffering of bottle rotating disk, the conveyer belt that advances a bottle screw rod, tyre cooling bath and attemperator, fill head, tyre cooling bath and attemperator.
5. liquid medicine filling freezing equipment described in claim 4, wherein, the built-in liquid nitrogen alcoholic solution of cooling bath, 0 ℃～-120 ℃ of temperature.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011102026411A CN102415949A (en) | 2011-07-20 | 2011-07-20 | Novel liquid medicine filling and freezing process and liquid medicine filling and freezing device |
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| Application Number | Priority Date | Filing Date | Title |
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| CN2011102026411A CN102415949A (en) | 2011-07-20 | 2011-07-20 | Novel liquid medicine filling and freezing process and liquid medicine filling and freezing device |
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| CN102415949A true CN102415949A (en) | 2012-04-18 |
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| CN2011102026411A Pending CN102415949A (en) | 2011-07-20 | 2011-07-20 | Novel liquid medicine filling and freezing process and liquid medicine filling and freezing device |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102743346A (en) * | 2012-06-25 | 2012-10-24 | 瑞阳制药有限公司 | Small-size fat-soluble vitamin freeze-dried powder injection and preparation method and preparation device thereof |
| CN104340650A (en) * | 2013-08-05 | 2015-02-11 | 江苏泰尔新材料股份有限公司 | Multistage cooling production line and cooling control method |
| CN104354888A (en) * | 2014-10-30 | 2015-02-18 | 上海东富龙科技股份有限公司 | Forming and filling instant freezer for manufacturing freeze-dried tablets |
| CN106726577A (en) * | 2016-12-27 | 2017-05-31 | 楚天智能机器人（长沙）有限公司 | A kind of lyophilized production line |
| CN109153468A (en) * | 2016-04-12 | 2019-01-04 | 凡尔克斯医药***公司 | Method and apparatus for loading freeze-drying system |
| CN115463128A (en) * | 2022-09-23 | 2022-12-13 | 深圳太太药业有限公司 | Panipenem betamipron compound combination medicine for injection and preparation method thereof |
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| CN101526298A (en) * | 2008-03-03 | 2009-09-09 | 蔡强 | Freezing dryer set for preparing liposome medicament |
| CN101766597A (en) * | 2008-12-31 | 2010-07-07 | 北京利乐生制药科技有限公司 | Injection preparation with levo-oxiracetam as active component |
| CN101953805A (en) * | 2010-09-29 | 2011-01-26 | 贵州益佰制药股份有限公司 | Method for preparing antitumor medical preparation |
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| CN1047034A (en) * | 1989-04-18 | 1990-11-21 | 三共株式会社 | A kind of preparation contains the freeze-drying method of pharmaceutical compositions |
| CN101526298A (en) * | 2008-03-03 | 2009-09-09 | 蔡强 | Freezing dryer set for preparing liposome medicament |
| CN101766597A (en) * | 2008-12-31 | 2010-07-07 | 北京利乐生制药科技有限公司 | Injection preparation with levo-oxiracetam as active component |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102743346A (en) * | 2012-06-25 | 2012-10-24 | 瑞阳制药有限公司 | Small-size fat-soluble vitamin freeze-dried powder injection and preparation method and preparation device thereof |
| CN102743346B (en) * | 2012-06-25 | 2016-03-02 | 瑞阳制药有限公司 | Small size fat-soluble vitamin freeze-dried powder needle preparation method and preparation facilities thereof |
| CN104340650A (en) * | 2013-08-05 | 2015-02-11 | 江苏泰尔新材料股份有限公司 | Multistage cooling production line and cooling control method |
| CN104354888A (en) * | 2014-10-30 | 2015-02-18 | 上海东富龙科技股份有限公司 | Forming and filling instant freezer for manufacturing freeze-dried tablets |
| CN109153468A (en) * | 2016-04-12 | 2019-01-04 | 凡尔克斯医药***公司 | Method and apparatus for loading freeze-drying system |
| CN109153468B (en) * | 2016-04-12 | 2021-11-16 | 凡尔克斯医药***公司 | Method and apparatus for loading a lyophilization system |
| CN106726577A (en) * | 2016-12-27 | 2017-05-31 | 楚天智能机器人（长沙）有限公司 | A kind of lyophilized production line |
| CN115463128A (en) * | 2022-09-23 | 2022-12-13 | 深圳太太药业有限公司 | Panipenem betamipron compound combination medicine for injection and preparation method thereof |
| CN115463128B (en) * | 2022-09-23 | 2023-10-03 | 深圳太太药业有限公司 | Panipenem and betamilone compound combination drug for injection and preparation method thereof |
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| CB03 | Change of inventor or designer information |
Inventor after: Cui Dongdong Inventor after: Wu Yiyan Inventor after: Zhao Yujia Inventor after: Zhao Junchang Inventor after: Han Ruiting Inventor after: Cai Wei Inventor after: Ren Yulan Inventor after: Xu Chunlin Inventor before: Cui Dongdong |
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Free format text: CORRECT: INVENTOR; FROM: CUI DONGDONG TO: CUI DONGDONG WU YIYAN ZHAO YUJIA ZHAO JUNCHANG HAN RUITING CAI WEI REN YULAN XU CHUNLIN |
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Application publication date: 20120418 |