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Tranexamic acid injection and preparation method of same

A technology for tranexamic acid and injection, which is applied in separation methods, chemical instruments and methods, blood diseases, etc., can solve the problems of insignificant metal flow effect and the like

Active Publication Date: 2013-03-20
SHANXI PUDE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] The above inventions have a certain effect on reducing the impurities in tranexamic acid injection, but the invention of CN101199477A only controls the metal ions in the water for injection, and the invention of CN11520809A is used in the vigorous stirring of the preparation of the drug solution, and the micro voltage can prevent the metal from entering the drug solution. The flow effect is not obvious. Therefore, it is a problem we should solve to fully control the metal ions that may be introduced in the preparation of tranexamic acid injection.

Method used

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  • Tranexamic acid injection and preparation method of same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1 Preparation of tranexamic acid injection (specification 2ml: 0.2g)

[0035] prescription:

[0036] Tranexamic acid 10KG

[0037] Add water for injection to 100L

[0038] Preparation Process:

[0039] (1) Preparation: Measure about 80% of the prescribed amount of water for injection at 50-70°C, add the prescribed amount of tranexamic acid, and stir until dissolved;

[0040] (2) Use 6mol / L hydrochloric acid solution to adjust the pH value to 6.0-7.5, heat to about 70°C, add treated 0.1% (g / ml) activated carbon for needles, stir evenly, keep it warm for 30 minutes, and heat it through 0.45 Decarbonize and filter with μm microporous membrane to dilute the tank, take a small amount of water for injection to wash the charcoal, and add water for injection up to the prescription amount;

[0041] (3) After taking a sample from the dilute tank and testing the foreign matter that is found to be qualified, carry out the intermediate test: content, pH value;

[0042...

Embodiment 2

[0051] Embodiment 2 comparative experiment

[0052] 1. Purpose

[0053] According to the preparation of tranexamic acid injection according to embodiment 1 and according to the process of embodiment 1, but only the stability comparison of the untreated activated carbon for needle preparation of tranexamic acid injection;

[0054] Tranexamic acid injection was prepared according to Example 1, which was designated as sample 1;

[0055] According to the process of Example 1, but only activated carbon for needles was prepared without treatment, tranexamic acid injection was designated as sample 2; the stability of samples 1 and 2 was investigated.

[0056] 2. Inspection items and operation methods

[0057] 2.1 Properties: visual method.

[0058] 2.2 pH value: Take this product and measure according to the law (Chinese Pharmacopoeia 2005 Edition, Appendix VI H), the pH value should be 6.0-7.5.

[0059] 2.3 Z-isomer: Take an appropriate amount of this product (approximately ...

Embodiment 3

[0069] Example 3 Preparation of Tranexamic Acid Injection (Specification 5ml: 0.25g)

[0070] prescription:

[0071] Tranexamic acid 5KG

[0072] Add water for injection to 100L

[0073] Preparation Process:

[0074] (1) Preparation: Measure about 80% of the prescribed amount of water for injection at 50-70°C, add the prescribed amount of tranexamic acid, and stir until dissolved;

[0075] (2) Use 6mol / L hydrochloric acid solution to adjust the pH value to 6.0-7.5, heat to about 70°C, add treated 0.1% (g / ml) activated carbon for needles, stir evenly, keep it warm for 30 minutes, and heat it through 0.45 Decarbonize and filter with μm microporous membrane to dilute the tank, take a small amount of water for injection to wash the charcoal, and add water for injection up to the prescription amount;

[0076] (3) After taking a sample from the dilute tank and testing the foreign matter that is found to be qualified, carry out the intermediate test: content, pH value;

[0077...

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Abstract

The invention provides a tranexamic acid injection and a preparation method of the same. In the preparation technology, the added active carbon for needles is preprocessed as follows: washing the active carbon for needles with acetone, alcohol and edetic acid water solution, and drying to remove residual metals and other impurities in the added active carbon for needles. The preprocessed active carbon for needles is used for preparing the tranexamic acid injection, thus, the generation of impurity-Z-isomer can be reduced, and the quality of the tranexamic acid injection is guaranteed.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to tranexamic acid injection and a preparation method thereof. [0002] Background technique [0003] Tranexamic acid, trans-4-(aminomethyl) cyclohexanecarboxylic acid, English name: Tranexamic acid. [0004] Tranexamic acid is mainly used for: [0005] 1. For various bleeding caused by acute or chronic, localized or systemic hyperfibrinolysis. In the secondary hyperfibrinolytic state caused by disseminated intravascular coagulation, this product is generally not used before heparinization. [0006] 2. It is used for trauma or surgical bleeding in organs rich in plasminogen activators, such as prostate, urethra, lung, brain, uterus, adrenal gland, and thyroid gland. [0007] 3. As an antagonist of tissue plasminogen activator (t-PA), streptokinase and urokinase. [0008] 4. It is used for fibrinolytic hemorrhage caused by induced abortion, early placental exfoliat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/195A61P7/04B01J20/20B01J20/34
Inventor 胡成伟李立忠王勇解晓荣李润宝苏志强姚荷云闫洁
Owner SHANXI PUDE PHARMA CO LTD
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