CN104224696A - Preparation method of aminomethylbenzoic acid injection - Google Patents
Preparation method of aminomethylbenzoic acid injection Download PDFInfo
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- CN104224696A CN104224696A CN201310245802.4A CN201310245802A CN104224696A CN 104224696 A CN104224696 A CN 104224696A CN 201310245802 A CN201310245802 A CN 201310245802A CN 104224696 A CN104224696 A CN 104224696A
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- aminomethylbenzoic acid
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Abstract
The invention discloses a preparation method of an aminomethylbenzoic acid injection. The method comprises the following steps: 1, adding 50% of newly boiled injection water to a thick mixing tank, adding aminomethylbenzoic acid, stirring and dissolving; 2, adding medicinal carbon and stirring evenly; 3, adding injection water to full dose, and stirring for 15 minutes; 4, filtering by a Suzhou sand rod and a polyether sulfone folding filter of 0.33 micron; 5 sampling and detecting visible foreign particles; 6 filtering a liquid medicine in a storage tank by a polyether sulfone folding filter of 0.41 micron, sampling and detecting the visible foreign particles to be qualified, and then inputting into a base bottle for encapsulating; 7 introducing nitrogen into the base bottle for encapsulating; and 8 sterilizing at the temperature of 121 DEG C for 15 minutes. According to the preparation method, dual sterile filtration is adopted, and the sterilization effect is ensured.
Description
Technical field
The present invention relates to a kind of preparation method, particularly relate to a kind of preparation method of Aminomethylbenzoic acid Injection.
Background technology
Aminomethylbenzoic acid Injection is coagulant.The natural antagonist of various fibrinolysin (former) is there is, as antiplasmin element etc. in blood circulation.Under normal circumstances, in blood, anti-fibrinolytic species activity is higher than fibrinolytic species activity doubly a lot, so unlikely generation is fibrinolytic hemorrhage.But these antagonists can not block be adsorbed on the online activator of fibrin (as urokinase etc.) activate and form fibrinolysin.Fibrinolysin is a kind of endopeptidase, and the energy fibrinous arginine of cracking and lysine peptide chain in neutral environment, form fibrin degradation product (FDP), and it is hemorrhage to cause sludged blood to dissolve.There is antibacterial in existing Aminomethylbenzoic acid Injection.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of preparation method of Aminomethylbenzoic acid Injection, and it adopts dual aseptic filtration, ensure that bacteria-eliminating efficacy.
The present invention solves above-mentioned technical problem by following technical proposals: a kind of preparation method of Aminomethylbenzoic acid Injection, is characterized in that, it comprises the following steps:
Step one, adds the water for injection newly boiled of amount of preparation 50%, adds aminomethylbenzoic acid, stirring and dissolving in dense preparing tank;
Step 2, adds medicinal charcoal, stirs; After extremely clear and bright with the de-charcoal of Suzhou sand rod time filter, filter in dilute preparing tank;
Step 3, adds water for injection to full dose, stirs 15 minutes, makes it even;
Step 4, returns filter with Suzhou sand rod, 0.33 μm of collapsible filter of polyether sulfone;
Step 5, visible foreign matters inspection is done in sampling, samples censorship measured center simultaneously and surveys intermediates content and pH value, every all qualified after, medicinal liquid is filtered into receiver;
Step 6, the medicinal liquid in receiver is through 0.41 μm of collapsible frit of polyether sulfone, and after visible foreign matters passed examination is done in sampling, input seat bottle is for embedding;
Step 7, passes into nitrogen and carries out embedding in seat bottle;
Step 8, temperature be 121 DEG C, the time be the condition of 15 minutes under sterilize.
Positive progressive effect of the present invention is: the present invention adopts dual aseptic filtration, ensure that bacteria-eliminating efficacy.In addition, the present invention adopts 121 DEG C of sterilizings, the overkill method p-aminomethylbenzoic acid injection of 15 minutes carries out sterilizing, guarantees to obtain enough Sterility Assurance.
Detailed description of the invention
The preparation method of Aminomethylbenzoic acid Injection of the present invention comprises the following steps:
Step one, adds the water for injection newly boiled of amount of preparation 50%, adds aminomethylbenzoic acid, stirring and dissolving in dense preparing tank;
Step 2, adds medicinal charcoal, stirs; After extremely clear and bright with the de-charcoal of Suzhou sand rod time filter, filter in dilute preparing tank;
Step 3, adds water for injection to full dose, stirs 15 minutes, makes it even; PH value is regulated to use concentrated hydrochloric acid;
Step 4, returns filter with Suzhou sand rod, 0.33 μm of collapsible filter of polyether sulfone;
Step 5, visible foreign matters inspection is done in sampling, samples censorship measured center simultaneously and surveys intermediates content and pH value, every all qualified after, medicinal liquid is filtered into receiver;
Step 6, the medicinal liquid in receiver is through 0.41 μm of collapsible frit of polyether sulfone, and after visible foreign matters passed examination is done in sampling, input seat bottle is for embedding;
Step 7, passes into nitrogen and carries out embedding in seat bottle;
Step 8, temperature be 121 DEG C, the time be the condition of 15 minutes under sterilize, improve the sterility assurance level of product.
Aminomethylbenzoic acid Injection is after 121 DEG C × 15min sterilizing, and its character, content, pH value, visible foreign matters, related substance and aseptic, without significant change compared with changing the data of (121 DEG C × 15min) before sterilizing parameter, all conform to quality requirements.
Although the foregoing describe the specific embodiment of the present invention, it will be understood by those of skill in the art that these only illustrate, under the prerequisite not deviating from principle of the present invention and essence, various changes or modifications can be made to these embodiments.Therefore, protection scope of the present invention is defined by the appended claims.
Claims (1)
1. a preparation method for Aminomethylbenzoic acid Injection, is characterized in that, it comprises the following steps:
Step one, adds the water for injection newly boiled of amount of preparation 50%, adds aminomethylbenzoic acid, stirring and dissolving in dense preparing tank;
Step 2, adds medicinal charcoal, stirs; After extremely clear and bright with the de-charcoal of Suzhou sand rod time filter, filter in dilute preparing tank;
Step 3, adds water for injection to full dose, stirs 15 minutes, makes it even;
Step 4, returns filter with Suzhou sand rod, 0.33 μm of collapsible filter of polyether sulfone;
Step 5, visible foreign matters inspection is done in sampling, samples censorship measured center simultaneously and surveys intermediates content and pH value, every all qualified after, medicinal liquid is filtered into receiver;
Step 6, the medicinal liquid in receiver is through 0.41 μm of collapsible frit of polyether sulfone, and after visible foreign matters passed examination is done in sampling, input seat bottle is for embedding;
Step 7, passes into nitrogen and carries out embedding in seat bottle;
Step 8, temperature be 121 DEG C, the time be the condition of 15 minutes under sterilize.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310245802.4A CN104224696A (en) | 2013-06-20 | 2013-06-20 | Preparation method of aminomethylbenzoic acid injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310245802.4A CN104224696A (en) | 2013-06-20 | 2013-06-20 | Preparation method of aminomethylbenzoic acid injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN104224696A true CN104224696A (en) | 2014-12-24 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310245802.4A Pending CN104224696A (en) | 2013-06-20 | 2013-06-20 | Preparation method of aminomethylbenzoic acid injection |
Country Status (1)
| Country | Link |
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| CN (1) | CN104224696A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110215432A (en) * | 2019-04-08 | 2019-09-10 | 辽宁海神联盛制药有限公司 | A kind of aminomethylbenzoic acid sodium chloride injection and preparation method thereof |
| CN114028328A (en) * | 2021-12-16 | 2022-02-11 | 安徽联谊药业股份有限公司 | Aminotoluic acid injection and preparation method thereof |
-
2013
- 2013-06-20 CN CN201310245802.4A patent/CN104224696A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110215432A (en) * | 2019-04-08 | 2019-09-10 | 辽宁海神联盛制药有限公司 | A kind of aminomethylbenzoic acid sodium chloride injection and preparation method thereof |
| CN114028328A (en) * | 2021-12-16 | 2022-02-11 | 安徽联谊药业股份有限公司 | Aminotoluic acid injection and preparation method thereof |
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| Date | Code | Title | Description |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20141224 |