CN110876718A - Tranexamic acid injection and preparation method thereof - Google Patents
Tranexamic acid injection and preparation method thereof Download PDFInfo
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- CN110876718A CN110876718A CN201911256257.2A CN201911256257A CN110876718A CN 110876718 A CN110876718 A CN 110876718A CN 201911256257 A CN201911256257 A CN 201911256257A CN 110876718 A CN110876718 A CN 110876718A
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
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- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
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Abstract
The invention relates to a preparation method of tranexamic acid injection, which comprises the following steps: 1) preparing raw materials: performing quality detection on tranexamic acid and water for injection, and selecting the tranexamic acid and the water for injection which are qualified in quality detection as raw materials; 2) configuration: adding 60-80 ℃ injection water accounting for 60-80% of the prescription amount and tranexamic acid accounting for the prescription amount into a concentration preparation tank, stirring until the injection water and the tranexamic acid are dissolved, pumping the dissolved solution into a dilution preparation tank, adding the injection water to the full amount when the solution is cooled to 20-30 ℃, and controlling the pH value to be 7.0-8.0; 3) ampoule treatment: raising the temperature of a sterilization area of the tunnel type sterilization drying oven to 300 ℃ and keeping the temperature stable for later use, cleaning the ampoule, and sending the ampoule into the tunnel type sterilization drying oven for dry heat sterilization for 15-20 min after the ampoule is cleaned; 4) and (6) filling, sterilizing and packaging. The preparation method does not need activated carbon adsorption, simplifies the production process, reduces the production cost, and simultaneously, the obtained tranexamic acid injection product has stable quality and higher clinical safety.
Description
Technical Field
The invention relates to the technical field of pharmaceutical preparations, in particular to tranexamic acid injection and a preparation method thereof.
Background
Tranexamic acid (Tranexamic acid), also known as Tranexamic acid, is chemically trans-4-aminomethylcyclohexanecarboxylic acid, as a white crystalline powder; has no odor, slightly bitter taste, is easily soluble in water, is hardly soluble in ethanol, acetone, chloroform or diethyl ether, and is mainly used in clinical dosage forms such as injection. Tranexamic acid can safely and reliably reduce the death rate of patients with traumatic hemorrhage, can reduce the possibility of progressive hemorrhage of patients with craniocerebral disease, can obviously reduce the blood loss of women with excessive menstrual bleeding and obviously reduce the postpartum hemorrhage, and meanwhile, tranexamic acid is also used as a second-line scheme for the auxiliary treatment before and after the operation of hemophilia patients with factor VIII deficiency, and can also be used for hereditary angioedema, so the application is very wide.
In the prior art, the preparation process of tranexamic acid injection mostly comprises the steps of configuring, filling, sterilizing and packaging by adopting a low borosilicate glass ampoule, wherein activated carbon adsorption is adopted in the configuration process, and pyrogens and metal ions are removed by the activated carbon adsorption, for example, Chinese patent with publication number CN102973501A discloses a tranexamic acid injection and a preparation method thereof, and the activated carbon for injection added in the preparation process is pretreated: the method comprises the following steps of washing and drying needle activated carbon by using acetone, ethanol and an ethylene diamine tetraacetic acid aqueous solution to remove residual metals and other impurities in the needle activated carbon, and using the pretreated needle activated carbon for preparing the tranexamic acid injection, wherein the generation of an impurity-Z-isomer can be reduced, and the quality of the tranexamic acid injection is ensured; secondly, the use of the activated carbon can cause opalescence, which affects insoluble particles and pH of the product; thirdly, the active carbon generates dust in the using process, which causes environmental pollution and simultaneously influences the final quality of the product. In addition, in the actual production process, when having the quality risk, the active carbon adsorption complex operation is complicated, and the production degree of difficulty is great, and personnel and energy consumption are great, and manufacturing cost is higher. In addition, in the current Chinese market, the phytotoxicity of the injection occurs frequently, and most of the phytotoxicity is caused by no sterility, and as in the technical scheme of the Chinese patent, the sterilization adopts water bath sterilization, so that the clinical safety and the quality stability of the tranexamic acid injection are difficult to ensure. Therefore, the invention aims to improve the tranexamic acid injection and the preparation method thereof in the prior art so as to simplify the production process, reduce the production cost and obtain the tranexamic acid injection with stable quality and meeting the related requirements.
Disclosure of Invention
The technical problem to be solved by the invention is to provide a tranexamic acid injection and a preparation method thereof, so as to obtain the tranexamic acid injection with simpler production process, more stable product quality and ensured clinical safety.
The technical problem solved by the invention is realized by adopting the following technical scheme:
a preparation method of tranexamic acid injection comprises the following steps:
1) preparing raw materials: performing quality detection on tranexamic acid and water for injection, and selecting the tranexamic acid and the water for injection which are qualified in quality detection as raw materials;
2) configuration: adding 60-80 ℃ injection water accounting for 60-80% of the prescription amount and tranexamic acid accounting for the prescription amount into a concentration preparation tank, stirring until the injection water and the tranexamic acid are dissolved, pumping the dissolved solution into a dilution preparation tank, adding the injection water to the full amount when the solution is cooled to 20-30 ℃, and controlling the pH value to be 7.0-8.0;
3) ampoule treatment: raising the temperature of a sterilization area of the tunnel type sterilization drying oven to 300 ℃ and keeping the temperature stable for later use, cleaning the ampoule, and sending the ampoule into the tunnel type sterilization drying oven for dry heat sterilization for 15-20 min after the ampoule is cleaned;
4) and (6) filling, sterilizing and packaging.
The preparation process does not contain an activated carbon adsorption step.
Further, in step 2), pH adjustment is performed with 10% dilute hydrochloric acid or 1% sodium hydroxide solution.
Further, the sterilization process is carried out at 121 deg.C for 15 min.
Further, in the step 1), the bacterial endotoxin of qualified tranexamic acid is less than or equal to 0.2EU/mg, and the heavy metal content is lower than ten parts per million by detecting according to a heavy metal detection method of 0821 in Chinese pharmacopoeia general regulations.
Further, in the step 1), the bacterial endotoxin of the qualified water for injection is less than or equal to 0.25EU/ml, the total amount of aerobic bacteria is less than or equal to 10cfu/100ml, and the heavy metal content is lower than one millionth by detection according to 0821 heavy metal detection method in Chinese pharmacopoeia general rules.
Furthermore, the bacterial endotoxin of the prepared tranexamic acid injection finished product is less than or equal to 0.15 EU/mg.
Further, the ampoule is a medium borosilicate glass ampoule.
Furthermore, the material of the concentrated preparation tank, the diluted preparation tank and the related pipelines is 316L, the acid and alkali corrosion resistance is good, the compatibility research of the tranexamic acid injection and the pipelines shows that the element impurities are far lower than the limit, the concentrated preparation tank, the diluted preparation tank and the related pipelines are disinfected by 0.4% of sodium hydroxide solution before use and are cleaned by water for injection, and finally the pipelines are sterilized by circulating steam.
A tranexamic acid injection comprises tranexamic acid and water for injection, wherein each 1000ml of the injection contains 100g of tranexamic acid, and is prepared by adopting the method.
Has the advantages that: according to the preparation method of the tranexamic acid injection, active carbon adsorption is not needed in the preparation process, the production process is simplified, the process difficulty and the production cost are reduced, and the produced tranexamic acid injection still meets the quality requirement.
The preparation method of tranexamic acid injection avoids the risks caused by the introduction of impurities such as chloride, sulfate, metal and the like in the finished injection product and the residual of the activated carbon due to improper control of the source, model, manufacturing method, transportation and storage of the activated carbon, and has more stable quality.
According to the invention, the sterilization process is improved, so that the prepared tranexamic acid injection is stable and can endure the sterilization process of 121 ℃ for 15min, the sterilization process F0 is more than 12, and compared with water bath sterilization, the sterilization process can better ensure the aseptic level and has higher clinical safety.
In the invention, the aim of simplifying the production process and obtaining the tranexamic acid injection with qualified quality is systematically achieved by redefining the content of bacterial endotoxin and heavy metal in the raw material tranexamic acid, the content of aerobic bacteria in water for injection, the content of bacterial endotoxin and heavy metal, controlling the material and cleaning process of production equipment, improving the selection of a packaging ampoule, the pyrogen removal process and the final sterilization process.
Detailed Description
In order to make the technical means, the creation features, the achievement purposes and the effects of the invention easy to understand, the invention is further described with the specific embodiments.
Example 1
Preparation of tranexamic acid injection (Specification: 2ml:0.2g)
Prescription dose (1000 pieces)
Tranexamic acid 200g
Adding water for injection to 2000ml
The preparation process comprises the following steps:
1) preparing raw materials: performing quality detection on tranexamic acid and water for injection, and selecting the tranexamic acid and the water for injection which are qualified in quality detection as raw materials; wherein the bacterial endotoxin of qualified tranexamic acid is less than or equal to 0.2EU/mg, the detection is carried out according to the 0821 heavy metal detection method of Chinese pharmacopoeia general rules, the content of heavy metal is less than ten parts per million, the bacterial endotoxin of qualified water for injection is less than or equal to 0.25EU/ml, the total number of aerobic bacteria is less than or equal to 10cfu/100ml, the detection is carried out according to the 0821 heavy metal detection method of Chinese pharmacopoeia general rules, and the content of heavy metal is less than one;
2) configuration: adding injection water with the prescription amount of 80% and the injection water with the temperature of 60 ℃ and tranexamic acid with the prescription amount into a concentrated preparation tank, stirring until the injection water and the tranexamic acid are dissolved, wherein the stirring speed is 45Hz, starting a pump after visual clarification, pumping the dissolved solution into a diluted preparation tank, cleaning the concentrated preparation tank by 20% of the rest injection water, and pumping into the diluted preparation tank after cleaning; starting the diluting preparation tank to stir at the stirring speed of 45Hz, adding the injection water to full volume when the solution in the diluting preparation tank is cooled to 20 ℃, controlling the pH to be 7.38, and slowly adjusting the pH by adding a small amount of 10% hydrochloric acid solution or 1% sodium hydroxide solution for multiple times;
3) ampoule treatment: heating the sterilizing area of the tunnel type sterilizing and drying oven to 300 ℃ and keeping the temperature stable for later use, cleaning the ampoule, wherein the ampoule is a medium borosilicate glass ampoule, fully cleaning the ampoule with the bottle mouth facing downwards for 10min,
the speed of the bottle washer is 400 bottles/minute, the bottle washer rotates 180 degrees after cleaning is finished, the bottle mouth of the ampoule is upward, the ampoule enters a tunnel type sterilization dryer through a conveying mesh belt under the protection of A-level laminar flow to carry out dry heat sterilization and pyrogen removal, and the sterilization time lasts for 20 min;
4) filling: 2ml specification loading control: filling at a volume of not less than 2.15 ml;
sterilizing at 121 deg.C for 15min to obtain F0 value greater than 12
Packaging, namely clamping the ampoules into a plastic card, boxing and boxing.
Example 2
Preparation of tranexamic acid injection (standard: 5ml:0.5g)
Prescription dose (1000 pieces)
Tranexamic acid 500g
Adding 5000ml of water for injection
The preparation process comprises the following steps:
1) preparing raw materials: performing quality detection on tranexamic acid and water for injection, and selecting the tranexamic acid and the water for injection which are qualified in quality detection as raw materials; wherein the bacterial endotoxin of qualified tranexamic acid is less than or equal to 0.2EU/mg, the detection is carried out according to the 0821 heavy metal detection method of Chinese pharmacopoeia general rules, the content of heavy metal is less than ten parts per million, the bacterial endotoxin of qualified water for injection is less than or equal to 0.25EU/ml, the total number of aerobic bacteria is less than or equal to 10cfu/100ml, the detection is carried out according to the 0821 heavy metal detection method of Chinese pharmacopoeia general rules, and the content of heavy metal is less than one;
2) configuration: adding injection water with the prescription amount of 60%% and the temperature of 80 ℃ and tranexamic acid with the prescription amount into a concentrated preparation tank, stirring until the injection water and the tranexamic acid are dissolved, wherein the stirring speed is 45Hz, starting a pump after visual clarification, pumping the dissolved solution into a diluted preparation tank, cleaning the concentrated preparation tank by 40% of the rest injection water, and pumping into the diluted preparation tank after cleaning; starting the diluting preparation tank to stir at the stirring speed of 45Hz, adding the injection water to full volume when the solution in the diluting preparation tank is cooled to 25 ℃, controlling the pH to be 7.38, and slowly adjusting the pH by adding a small amount of 10% hydrochloric acid solution or 1% sodium hydroxide solution for multiple times;
3) ampoule treatment: raising the temperature of a sterilization area of the tunnel type sterilization drying oven to 300 ℃ and keeping the temperature stable for later use, cleaning the ampoule, wherein the ampoule is a medium borosilicate glass ampoule, and fully cleaning the ampoule with the bottle mouth facing downwards for 15 min;
the speed of the bottle washer is 300 bottles/minute, the bottle washer rotates 180 degrees after cleaning is finished, the bottle mouth of the ampoule is upward, the ampoule enters a tunnel type sterilization dryer through a conveying mesh belt under the protection of A-level laminar flow to carry out dry heat sterilization and pyrogen removal, and the sterilization time lasts for 15 min;
4) filling: 5ml specification loading control: filling with no less than 5.3 ml;
sterilizing at 121 deg.C for 15min to obtain F0 value greater than 12;
packaging, namely clamping the ampoules into a plastic card, boxing and boxing.
The quality of the liquid preparation intermediate, the filling intermediate and the finished product in the production processes of the embodiment 1 and the embodiment 2 is detected, the related detection is carried out according to the method specified by tranexamic acid injection in the 'Chinese pharmacopoeia' 2015 edition, and the result is shown in the table I.
Watch 1
As can be seen from the table I, the quality index of the finished tranexamic acid injection product obtained by production meets the regulation of the tranexamic acid injection in the 2015 edition of Chinese pharmacopoeia, and the production process is controllable.
(II) carrying out heavy metal element detection on the tranexamic acid injection obtained in the embodiment 1 and the embodiment 2, wherein the heavy metal detection is carried out according to a method specified by the tranexamic acid injection in the 'Chinese pharmacopoeia' 2015 edition, and the detection results are shown in the following table II:
watch two
As can be seen from Table II, the heavy metal content of the tranexamic acid injection product is far lower than the limit standard of ICHQ 3D.
(III) long-term test: the tranexamic acid injection solutions produced in example 1 and example 2 were placed under 60% + -10% RH and 25 deg.C + -2 deg.C, and sampled at the end of 0, 3, 6, 9, 12, 18, 24 and 36 months, respectively, to observe their properties, and the pH, the cycloolefin, the aminomethylbenzoic acid, the Z-isomer and the total impurity content were measured, as shown in Table III.
Watch III
As can be seen from the table III, under the long-term storage of the product, the clarity, the pH value, the contents of the cycloolefin, the aminomethylbenzoic acid, the Z-isomer and the total impurities are stable, the shape of the product is stable, the clinical safety of the product is higher, and the method is suitable for commercial production and popularization.
The foregoing shows and describes the general principles, essential features, and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are described in the specification and illustrated only to illustrate the principle of the present invention, but that various changes and modifications may be made therein without departing from the spirit and scope of the present invention, which fall within the scope of the invention as claimed. The scope of the invention is defined by the appended claims and equivalents thereof.
Claims (9)
1. A preparation method of tranexamic acid injection is characterized by comprising the following steps:
1) preparing raw materials: performing quality detection on tranexamic acid and water for injection, and selecting the tranexamic acid and the water for injection which are qualified in quality detection as raw materials;
2) configuration: adding 60-80 ℃ injection water accounting for 60-80% of the prescription amount and tranexamic acid accounting for the prescription amount into a concentration preparation tank, stirring until the injection water and the tranexamic acid are dissolved, pumping the dissolved solution into a dilution preparation tank, adding the injection water to the full amount when the solution is cooled to 20-30 ℃, and controlling the pH value to be 7.0-8.0;
3) ampoule treatment: raising the temperature of a sterilization area of the tunnel type sterilization drying oven to 300 ℃ and keeping the temperature stable for later use, cleaning the ampoule, and sending the ampoule into the tunnel type sterilization drying oven for dry heat sterilization for 15-20 min after the ampoule is cleaned;
4) and (6) filling, sterilizing and packaging.
2. The method of claim 1, wherein the preparation process does not include an activated carbon adsorption step.
3. The method of claim 1, wherein the pH of the solution is adjusted by 10% diluted hydrochloric acid or 1% sodium hydroxide solution in the step 2).
4. The method for preparing tranexamic acid injection according to claim 1, wherein the sterilization is performed at 121 ℃ for 15 min.
5. The method for preparing tranexamic acid injection as claimed in claim 1, wherein in step 1), the content of the heavy metal is less than ten ppm when the bacterial endotoxin of qualified tranexamic acid is less than or equal to 0.2EU/mg and the detection is performed according to 0821 heavy metal detection method of Chinese pharmacopoeia general rules.
6. The method for preparing tranexamic acid injection as claimed in claim 1, wherein in step 1), the acceptable water for injection has a bacterial endotoxin of 0.25EU/ml or less and a total number of aerobic bacteria of 0.25EU/ml or less
10cfu/100ml, and the content of the heavy metal is lower than one millionth according to the detection method of the heavy metal of 0821 in the general rules of Chinese pharmacopoeia.
7. The method for preparing tranexamic acid injection according to claim 1, wherein the bacterial endotoxin of the prepared tranexamic acid injection finished product is less than or equal to 0.15 EU/mg.
8. The method of claim 1, wherein the ampoule is a medium borosilicate glass ampoule.
9. A tranexamic acid injection, characterized in that the injection solution is composed of tranexamic acid and water for injection, wherein each 1000ml of the injection contains 100g of tranexamic acid, and is prepared by the method of any one of claims 1 to 8.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115778896A (en) * | 2022-12-01 | 2023-03-14 | 湖南洞庭药业股份有限公司 | Tranexamic acid injection and its preparation method and use |
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Application publication date: 20200313 |