CN102727433A - Preparation method of pralidoxime chloride injection - Google Patents
Preparation method of pralidoxime chloride injection Download PDFInfo
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- CN102727433A CN102727433A CN2012102426885A CN201210242688A CN102727433A CN 102727433 A CN102727433 A CN 102727433A CN 2012102426885 A CN2012102426885 A CN 2012102426885A CN 201210242688 A CN201210242688 A CN 201210242688A CN 102727433 A CN102727433 A CN 102727433A
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- chloride injection
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Abstract
The invention relates to a preparation method of pralidoxime chloride injection, belonging to the pharmaceutical field. The method comprises the steps of weighing 500g of pralidoxime chloride, then adding the pralidoxime chloride into 1600ml injection water which is less than 40 DEG C, repplenishing the injection water which is less than 40 DEG C to reach 2000ml, and then mixing well, adjusting the pH of the solution to 2.5 to 4.5, sterilizing, filtering, implementing sterile filling, inspecting the leakage, and storing the finished product under the lightproof refrigeration condition of 2 DEG C to 8 DEG C. According to the method specified in the invention, by controlling and optimizing the production process and the storage conditions of following chlorine pralidoxime injection, the products are in line with the national quality standards, and the quality stability of the products in the storage period is guaranteed at the same time.
Description
Technical field
The invention belongs to medicine field, be specifically related to the method for preparing and the storage requirement of pralidoxime chloride injection.
Background technology
1, the pralidoxime chloride injection belongs to national essential drugs, and character is colourless or yellowish clear liquid, and the cholinesterase activity that acute organophosphorus insecticide is suppressed has reactivation in various degree, is used to save the poisoning of multiple organophosphorus ester insecticides.But the poisoning effect to Malathion, metrifonate, dichlorvos, Rogor, BFPO (dimefox), bis(isopropylamino)fluorophosphine oxide (mipafox) and schradane (schradan) etc. is relatively poor; Acetylcholine esterase to carbamate pesticide suppressed does not have reactivation.
2, the original operative norm of pralidoxime chloride injection is two ones the 5th of Ministerial Standard of the People's Republic of China.
3, on JIUYUE 30th, 2012, State Food and Drug Administration issued a notice; Safe and effective, quality controllable for guaranteeing clinical practice; State Food and Drug Administration revises pralidoxime chloride injection standard; New quality standard numbering WS-10001 (HD-1031)-2002-2011, revised standard was carried out from December in 2011 on the 30th, and the kind primary standard is stopped using simultaneously.
4, new and old quality standard is contrasted; Find; The control of the content of pralidoxime chloride injection changes to 95%-105%, has increased bacterial endotoxin and related substance test item, wherein in the chromatogram of related substance project specifies need testing solution if any impurity peaks; Single impurity peak area must not be greater than contrast solution main peak area (1.0%), each impurity peak area with must not be greater than 2 times (2.0%) of contrast solution main peak area.
5, the pralidoxime chloride process for preparing injection liquid is 80 ℃ of waters for injection of measuring dosing amount 80%, with the pralidoxime chloride stirring and dissolving of recipe quantity, replenishes water for injection to full dose and stirs.Regulate medicinal liquid PH2.5-4.5, filter, embedding, 115 ℃ of 30min sterilizations, are preserved at room temperature or shady and cool place (being no more than 20 ℃) at the finished product shading.
6, the pralidoxime chloride injection for preparing according to above-mentioned original production process can not meet revised WS-10001 (HD-1031)-2002-2011 pralidoxime chloride injection quality standard.Mainly be that this product does not meet national standard in production and the related substance project in storage process.
Summary of the invention
In order to produce the pralidoxime chloride injection that meets WS-10001 (HD-1031)-2002-2011 national standard, we have carried out following test and investigation:
1, through research; We think that the sterilising conditions of pralidoxime chloride injection is bigger to the quality influence of product; For this reason, test reduces the sterilising temp and the sterilization time of pralidoxime chloride injection, and investigation is the quality situation of product under 100 ℃ of 30min and two kinds of sterilising conditions of 100 ℃ of 15min.
Conclusion: visible by above result of the test, different sterilising conditions is very big to the related substance influence of pralidoxime chloride injection finished product, and sterilising temp is high more, sterilization time is long more, and the content of product is low more, and related substance is big more.
2, just have the underproof phenomenon of related substance after the sterilization of pralidoxime chloride injection; For this reason; We have considered the aseptic technology of this product, promptly produce according to aseptic technology in the non-final sterilization injection preparation workshop that obtains national aseptic injection GMP certificate, and the product that embedding is come out is unsterilised; Product is aseptic to be controlled in the clean area production process and guarantees, has so just effectively avoided the destruction of sterilization to product stability.The sample of producing is stored under shading, normal temperature condition, and we observe this sample continuously and regularly detect 40 ℃ of accelerated tests, and test data is following:
Conclusion: through aseptic explained hereafter; Can effectively avoid the pralidoxime chloride injection the destruction of sterilization link to product; The product quality that the harsh output of aseptic technology is come is qualified; But in accelerated test, the stability of product still can change, and the related substance of product quickens just not meet in the 2nd day national standard at 40 ℃.
3, through research to pralidoxime chloride injection technology; The temperature of finding the water for injection that this product technological requirement is used when preparation is 80 ℃; Too high may the impacting of water for injection temperature that preparation is used to product; For this reason, we prepare through the water for injection of different temperature in test, and under aseptic process conditions, produce.
Conclusion: visible by above result of the test; The pralidoxime chloride injection that the water for injection of different temperatures is prepared out is big to related substance difference; The water for injection temperature that preparation is used is high more; Its related substances of product is big more, and the water for injection temperature of preparation is controlled at＜40 ℃ of product qualities the bests of producing.
4, thus, we can find out that the pralidoxime chloride injection uses＜40 ℃ of waters for injection to prepare; And according to aseptic explained hereafter, finished product is unsterilised, and the product that harsh output is come meets state quality standard; But can quality can change at lay up period; For this reason, we store sample according to different storage temperatures, and study and investigate at lay up period.
Conclusion: visible by above result of the test, the storage requirement of different finished products has a significant effect to product quality, and storage temperature is low more, and the stability of product is good more.Because the storage of finished products mode of the manufacturer of production pralidoxime chloride injection all is shading, preserves at room temperature or shady and cool place (being no more than 20 ℃) on the market; In order better to guarantee the quality stability of product at lay up period, we select shading, under the condition of cold preservation (2 ℃-8 ℃), product are stored according to the pharmacopeia regulation.
The specific embodiment
Below through preparation, storage and the investigation of constant product quality property of pralidoxime chloride injection this production technology beneficial effect of the invention is described.
1, test material
1.1 raw material
Pralidoxime chloride: Chengdu Lisite Pharmaceutical Co., Ltd.
1.2 ampoule: low borosilicate ampoule
2, produce prescription and preparation technology
2.1 pralidoxime chloride injection (2ml:0.5g) is write out a prescription and the amount of processing:
Pralidoxime chloride 500g
Water for injection adds to 2000ml
2.2 pralidoxime chloride injection preparation technology:
In Agitation Tank, measure dosing amount 80%＜40 ℃ of waters for injection, add the pralidoxime chloride stirring and dissolving of recipe quantity, add＜40 ℃ of waters for injection are to full dose, stir.Regulate medicinal liquid PH2.5-4.5, aseptic filtration, aseptic embedding, leak detection, finished product is put in 2 ℃ of-8 ℃ of cold preservations, shading is stored.
3, constant product quality property investigation
2 ℃ of-8 ℃ of cold preservations of the sample of producing, shading are stored, regularly detect and investigate product quality according to state quality standard.
Conclusion: (2 ℃-8 ℃) carry out long term store to product under the condition of cold preservation, do not have obvious variation at the product of lay up period quality, store that product quality still meets state quality standard after six months.
4, conclusion:
This experimental result shows, through control and following pralidoxime chloride process for preparing injection liquid of optimization and storage requirement, can produce the product that meets state quality standard, also can guarantee product quality of stability in storage period simultaneously.The present invention requires the pralidoxime chloride injection to use＜40 ℃ of waters for injection to prepare; Sterile filling production is carried out in workshop obtaining national aseptic injection GMP certificate; Unsterilised leak detection of the finished product of producing; Finished product is stored under the condition of shading, cold preservation (2 ℃-8 ℃), during long term store, can guarantee the stability of product quality.
Claims (4)
1. the method for preparing of a pralidoxime chloride injection is characterized in that: take by weighing 500g pralidoxime chloride raw material, join in the water for injection of 1600ml＜40 ℃; Add＜40 ℃ of waters for injection are to 2000ml, stir, and regulating medicinal liquid pH is 2.5-4.5; Aseptic filtration; Sterile filling, leak detection, finished product is stored under shading, 2 ℃ of-8 ℃ of refrigerated conditions.
2. the method for preparing of a kind of pralidoxime chloride injection according to claim 1 is characterized in that: the employed water for injection temperature of preparation pralidoxime chloride injection is＜40 ℃.
3. the method for preparing of a kind of pralidoxime chloride injection according to claim 2; It is characterized in that: the pralidoxime chloride injection adopts sterile filling production; Need produce unsterilised leak detection of finished product according to aseptic technology in the non-final sterilization injection preparation workshop that obtains national aseptic injection GMP certificate.
4. the method for preparing of a kind of pralidoxime chloride injection according to claim 3 is characterized in that: pralidoxime chloride injection storage of finished products condition is shading, 2 ℃ of-8 ℃ of cold preservations.
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| CN2012102426885A CN102727433A (en) | 2012-07-13 | 2012-07-13 | Preparation method of pralidoxime chloride injection |
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| CN2012102426885A CN102727433A (en) | 2012-07-13 | 2012-07-13 | Preparation method of pralidoxime chloride injection |
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| CN102727433A true CN102727433A (en) | 2012-10-17 |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101584693A (en) * | 2008-05-22 | 2009-11-25 | 北京嘉事联博医药科技有限公司 | Pralidoxime chloride-containing drug composition and method for preparing same |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101584693A (en) * | 2008-05-22 | 2009-11-25 | 北京嘉事联博医药科技有限公司 | Pralidoxime chloride-containing drug composition and method for preparing same |
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Application publication date: 20121017 |