CN101926761B - Production method of compound potassium dihydrogn phosphate - Google Patents
Production method of compound potassium dihydrogn phosphate Download PDFInfo
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- CN101926761B CN101926761B CN 201010208559 CN201010208559A CN101926761B CN 101926761 B CN101926761 B CN 101926761B CN 201010208559 CN201010208559 CN 201010208559 CN 201010208559 A CN201010208559 A CN 201010208559A CN 101926761 B CN101926761 B CN 101926761B
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Abstract
The invention relates to a production method of compound potassium dihydrogn phosphate injection, which comprises the following steps in turn: material preparation, decoloration, encapsulation, sterilization, leakage detection, lamp inspection, bottle boiling, lettering and packaging. The production method also comprises heating-cooling treatment for at least one time after the encapsulation step and before the packaging step, and the heating-cooling treatment is to heat the injection to 40 to 100 DEG C first and then allows the injection to cool naturally to room temperature. No crystals precipitate from the injection provided by the invention even in a shock cooling environment or in a low-temperature storage environment, so that the quality and the use performance of the product are guaranteed.
Description
Technical field
The present invention relates to a kind of production method of compound potassium dihydrogn phosphate.
Background technology
Compound potassium dihydrogn phosphate is clinical to be mainly used in the parenteral alimentation therapy as the supplement of phosphorus, and its main component is dipotassium hydrogen phosphate and potassium dihydrogen phosphate.Common compound potassium dihydrogn phosphate is the compound preparation of 2ml specification on the market, contains potassium dihydrogen phosphate 413.63～457.17mg and dipotassium hydrogen phosphate (three water of crystallization) 303.53～335.48mg in the solution of 2ml.
In the prior art, the production method of compound potassium dihydrogn phosphate in turn includes the following steps:
(1), batching: take by weighing potassium dihydrogen phosphate and the dipotassium hydrogen phosphate (three water of crystallization) of recipe quantity, add water for injection, stir and make fully dissolving;
(2), decolouring: in the solution of step (1), add active carbon, stir the rear filtration of decolouring, keep filtrate;
(3), embedding: step (2) gained filtrate is filled into sealing by fusing in the qualified ampoule bottle of cleaning;
(4), high temperature sterilize;
(5), leak detection: in the sterilizing cabinet, the suction color water the color water basin under room temperature is hunted leak under vacuum condition;
(6), lamp inspection;
(7), scald bottle: the outer surface that cleans ampoule bottle with hot water;
(8), lettering: outside ampoule bottle, write lot number, date of manufacture and effect duration;
(9), packing: product introduction outer package warehouse-in.
The stability of the injection that existing this production method is produced is not very desirable, mainly be in the put procedure before use, particularly when winter, have crystal in the injection and separate out, even make dissolution of crystals by heating this moment, yet within the very short time of placing, particularly under the environment of low temperature, just have a new crystallization very soon, so, cause very big inconvenience to use.
Summary of the invention
Technical problem to be solved by this invention is to overcome the deficiencies in the prior art, and a kind of production method of improved compound potassium dihydrogn phosphate is provided, can crystallization at storage process by its gained potassium dihydrogn phosphate.
For solving above technical problem, the present invention takes following technical scheme:
A kind of production method of compound potassium dihydrogn phosphate, comprise successively batching, decolouring, embedding, sterilization, leak detection, lamp inspection, scald bottle, lettering and packaging step, described production method also is included in after the described embedding step, before the described packaging step, described injection is heated-cooling processing at least one times, described heating-cooling processing refers at first injection is warming up to 40 ℃～100 ℃, then gives free rein to be cooled to ambient temperature.
According to an aspect of the present invention: the temperature that color water is used in the control leak detection is at 60 ℃～100 ℃, between preferred 90 ℃～100 ℃, so that realize once described heating-cooling processing when hunting leak.
According to another aspect of the invention, after described leak detection step, utilize the heating system of sterilizing cabinet that injection is heated to 40 ℃～100 ℃, then from sterilizing cabinet, take out injection, thereby make its natural cooling realize once described heating-cooling processing.
According to the present invention, described heating-cooling processing can also be carried out in described boiling hot bottle step, specifically, control is scalded the temperature of bottle water between 60 ℃～100 ℃, preferred 80 ℃～100 ℃, after scalding the bottle end, the injection natural cooling is stated in the office, thereby realizes once described heating-cooling processing.
According to the present invention, described heating-cooling processing can be carried out when carrying out described leak detection, perhaps after described leak detection step, carries out before the described lettering step, and perhaps heating-cooling processing has repeatedly.
According to the present invention, in described heating-cooling processing, preferably at first injection is heated to more than 60 ℃, most preferably be heated to more than 80 ℃.
Because the enforcement of above technical scheme, the present invention compared with prior art has following advantage:
Injection after the embedding even run into the environment of quenching, does not have crystallization through after heating-cooling processing of the present invention yet in the injection, guaranteed quality and the serviceability of product.
The specific embodiment
The present invention will be further described in detail below in conjunction with specific embodiment, but the present invention is not limited to following examples.
Embodiment 1
A kind of production method of compound potassium dihydrogn phosphate comprises the steps:
(1), batching: take by weighing potassium dihydrogen phosphate and the dipotassium hydrogen phosphate (three water of crystallization) of recipe quantity, add water for injection, stir and make fully dissolving;
(2), decolouring: in the solution of step (1), add active carbon, stir the rear filtration of decolouring, keep filtrate;
(3), embedding: step (2) gained filtrate is filled into sealing by fusing in the qualified ampoule bottle of cleaning;
(4), high temperature (under 121 ℃) sterilization;
(5), leak detection: in the sterilizing cabinet under the vacuum condition, the color water that sucks 80 ℃ is hunted leak, and after the leak detection, takes out injection, and placing at ambient temperature, (about 10 ℃) make it naturally be down to room temperature;
(6), lamp inspection;
(7), scald bottle: the outer surface that cleans ampoule bottle with 80 ℃ of hot water;
(8), lettering: outside ampoule bottle, write lot number, date of manufacture and effect duration;
(9), packing: product introduction outer package warehouse-in.
Embodiment 2
A kind of production method of compound potassium dihydrogn phosphate comprises the steps:
(1), batching: take by weighing potassium dihydrogen phosphate and the dipotassium hydrogen phosphate (three water of crystallization) of recipe quantity, add water for injection, stir and make fully dissolving;
(2), decolouring: in the solution of step (1), add active carbon, stir the rear filtration of decolouring, keep filtrate;
(3), embedding: step (2) gained filtrate is filled into sealing by fusing in the qualified ampoule bottle of cleaning;
(4), high temperature sterilize;
(5), leak detection: in the sterilizing cabinet under the vacuum condition, the color water that sucks under the room temperature (about 10 ℃) is hunted leak, and after the leak detection, in sterilizing cabinet, injection is heated to 80 ℃, then takes out injection, naturally cools to room temperature;
(6), lamp inspection;
(7), scald bottle: the outer surface that cleans ampoule bottle with 85 ℃ of hot water;
(8), lettering: outside ampoule bottle, write lot number, date of manufacture and effect duration;
(9), packing: product introduction outer package warehouse-in.
Embodiment 3
A kind of production method of compound potassium dihydrogn phosphate comprises the steps:
(1), batching: take by weighing potassium dihydrogen phosphate and the dipotassium hydrogen phosphate (three water of crystallization) of recipe quantity, add water for injection, stir and make fully dissolving;
(2), decolouring: in the solution of step (1), add active carbon, stir the rear filtration of decolouring, keep filtrate;
(3), embedding: step (2) gained filtrate is filled into sealing by fusing in the qualified ampoule bottle of cleaning;
(4), high temperature sterilize;
(5), leak detection: in the sterilizing cabinet under the vacuum condition, the color water that sucks room temperature (about 10 ℃) hunt leak (finding has crystallization in the injection);
(6), lamp inspection;
(7), scald bottle: with the outer surface of the cleaning of the hot water more than 80 ℃ ampoule bottle, guarantee that the injection temperature rises to more than 60 ℃, then naturally cools to room temperature (crystallization disappearance);
(8), lettering: outside ampoule bottle, write lot number, date of manufacture and effect duration;
(9), packing: product introduction outer package warehouse-in.
Embodiment 4
A kind of production method of compound potassium dihydrogn phosphate comprises the steps:
(1), batching: take by weighing potassium dihydrogen phosphate and the dipotassium hydrogen phosphate (three water of crystallization) of recipe quantity, add water for injection, stir and make fully dissolving;
(2), decolouring: in the solution of step (1), add active carbon, stir the rear filtration of decolouring, keep filtrate;
(3), embedding: step (2) gained filtrate is filled into sealing by fusing in the qualified ampoule bottle of cleaning;
(4), high temperature sterilize;
(5), leak detection: in the sterilizing cabinet under the vacuum condition, the color water that sucks room temperature (about 10 ℃) hunt leak (finding has crystallization in the injection);
(6), lamp inspection;
(7), scald bottle: the outer surface that cleans ampoule bottle with 88 ℃ of hot water;
(8), injection is warming up to 80 ℃, then naturally cool to room temperature;
(9), lettering: outside ampoule bottle, write lot number, date of manufacture and effect duration;
(10), packing: product introduction outer package warehouse-in.
Comparative Examples 1
A kind of production method of compound potassium dihydrogn phosphate comprises the steps:
(1), batching: take by weighing potassium dihydrogen phosphate and the dipotassium hydrogen phosphate (three water of crystallization) of recipe quantity, add water for injection, stir and make fully dissolving;
(2), decolouring: in the solution of step (1), add active carbon, stir the rear filtration of decolouring, keep filtrate;
(3), embedding: step (2) gained filtrate is filled into sealing by fusing in the qualified ampoule bottle of cleaning;
(4), high temperature sterilize;
(5), leak detection: in the sterilizing cabinet under the vacuum condition, the color water that sucks room temperature (about 10 ℃) hunt leak (finding has crystallization in the injection);
(6), lamp inspection;
(7), scald bottle: the outer surface that cleans ampoule bottle with 90 ℃ of hot water;
(8), lettering: outside ampoule bottle, write lot number, date of manufacture and effect duration;
(9), packing: product introduction outer package warehouse-in.
By the crystallization situation of compound potassium dihydrogn phosphate after having placed 24 hours under the varying environment temperature of embodiment 1 to 4 and Comparative Examples 1 preparation tested, the results are shown in Table 1.
Table 1
As seen from Table 1, even the injection that the inventive method is produced does not have crystallization yet under low temperature environment, guaranteed quality and the serviceability of product.
More than the present invention has been done detailed description; its purpose is to allow the personage that is familiar with this art can understand content of the present invention and is implemented; can not limit protection scope of the present invention with this; the equivalence that all spirit according to the present invention are done changes or modifies, and all should be encompassed in protection scope of the present invention.
Claims (4)
1. the production method of a compound potassium dihydrogn phosphate, comprise successively batching, decolouring, embedding, sterilization, leak detection, lamp inspection, scald bottle, lettering and packaging step, it is characterized in that: described production method also comprises described injection is heated-cooling processing at least one times, described heating-cooling processing refers at first injection is warming up to 60 ℃～80 ℃, then give free rein to be cooled to ambient temperature, described heating-cooling processing is carried out when carrying out described leak detection, perhaps after described leak detection step, carry out before the described lettering step.
2. production method according to claim 1 is characterized in that: control the temperature of leak detection usefulness color water at 60 ℃～100 ℃, so that realize once described heating-cooling processing when hunting leak.
3. production method according to claim 2 is characterized in that: control leak detection and use the temperature of color water between 90 ℃～100 ℃.
4. production method according to claim 1 is characterized in that: in described boiling hot bottle step, control is scalded the temperature of bottle water between 80 ℃～100 ℃, scald after bottle finishes, thereby the office is stated the injection natural cooling and realized once described heating-cooling processing.
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102813675A (en) * | 2012-09-07 | 2012-12-12 | 天津市嵩锐医药科技有限公司 | Compound potassium hydrogen phosphate medicine combination for injection |
| CN106265499A (en) * | 2016-09-18 | 2017-01-04 | 天津金耀药业有限公司 | A kind of compound potassium dihydrogn phosphate pharmaceutical composition |
| CN106963779A (en) * | 2017-04-20 | 2017-07-21 | 南京正科医药股份有限公司 | A kind of production method of compound potassium dihydrogn phosphate |
| CN108619091B (en) * | 2018-06-12 | 2020-10-16 | 南京正科医药股份有限公司 | Compound potassium hydrogen phosphate injection |
| CN115887365B (en) * | 2022-11-19 | 2023-07-25 | 华夏生生药业(北京)有限公司 | Mannitol injection and its production process |
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| CN101518512A (en) * | 2009-03-24 | 2009-09-02 | 河北天成药业有限公司 | Calcium gluconate injection and preparation method thereof |
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| CN101518512A (en) * | 2009-03-24 | 2009-09-02 | 河北天成药业有限公司 | Calcium gluconate injection and preparation method thereof |
| CN101716136A (en) * | 2009-11-27 | 2010-06-02 | 河南辅仁怀庆堂制药有限公司 | Famotidine injection and preparation method thereof |
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