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Preparation method of terlipressin acetate lyophilized powder for injection

A technology of terlipressin and freeze-dried powder injection, which is applied in the direction of freeze-dried transportation, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., which can solve the problems of poor reconstitution effect, high water content, Prone to problems such as spray bottles, to achieve rapid reconstitution, low moisture content, and complete appearance

Active Publication Date: 2019-01-18
南京康舟医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Existing terlipressin is generally produced as an injection, but the terlipressin prepared by the prior art has disadvantages such as poor stability, poor reconstitution effect, high water content, etc., and it is prone to spray bottle phenomenon during the preparation process

Method used

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  • Preparation method of terlipressin acetate lyophilized powder for injection
  • Preparation method of terlipressin acetate lyophilized powder for injection
  • Preparation method of terlipressin acetate lyophilized powder for injection

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preparation example Construction

[0010] A preparation method of terlipressin acetate freeze-dried powder for injection, comprising the following steps:

[0011] S1, preparation of drug solution;

[0012] First, a carrier solution is prepared, which is a liquid obtained by mixing a carrier with a solvent. Specifically, the carrier is mixed with the solvent at a ratio of 0.8-1.25 milliliters of solvent per ten milligrams of the carrier. When the drug is precipitated, the carrier can be used to load the drug on the carrier, which is convenient for the precipitation of the drug, which is conducive to the formation of the drug, and then improves the stability and shape of the drug, and is also conducive to the formation of a fluffy structure of the freeze-dried drug, thereby improving the drug. Reconstitution effect. If the carrier is not used, the drug will be precipitated, but the structure will be tighter and the reconstitution effect will be poor, which will lead to the subsequent preparation of the injectio...

Embodiment 1

[0049] This embodiment provides a preparation method of terlipressin acetate freeze-dried powder for injection, comprising the following steps:

[0050] S1, preparation of drug solution;

[0051] Measure 40L of water for injection into the liquid mixing tank and set aside. Weigh 500 g of mannitol and add it to the water for injection, stir to dissolve it completely; weigh 50 g of the terlipressin acetate raw material drug, add it to the above-mentioned mannitol solution, and stir to dissolve it. Then use 1M hydrochloric acid solution to adjust the pH of the drug solution so that the pH value of the drug solution is 4.0, and use water for injection to set the volume to 50L; then use 0.22 μm water membrane to filter, fill the drug solution into a 7ml vial, and use bromine Use the butyl rubber stopper for half-tightening, and set aside.

[0052] S2, pre-freezing in stages;

[0053] Place the half-stoppered vials on the inner partition of the vacuum dryer after filling. Connec...

Embodiment 2- Embodiment 3

[0075] The operation of the preparation method of the terlipressin acetate lyophilized powder for injection provided in Example 2-Example 3 is basically the same as that of the terlipressin acetate lyophilized powder for injection provided in Example 1, The difference is that the specific operating conditions change.

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Abstract

The invention relates to the pharmaceutical field, in particular to a preparation method of terlipressin acetate freeze-dried powder injection for injection. A method for prepare a terlipressin acetate lyophilized powder for injection comprises that following step of: pre-freezing the drug solution in stages, and then sequentially drying the drug solution in stages for the first time and drying the drug solution in stages for the second time. The invention can effectively improve the phenomenon of spraying bottle, and ensure that the prepared terlipressin acetate freeze-dried powder injectionhas good stability, complete sample appearance, rapid resolution and low moisture content.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a preparation method of terlipressin acetate freeze-dried powder for injection. Background technique [0002] Terlipressin (Terlipressin) chemical name is N-α-triglycyl-8-lysine-vasopressin, white powder, suitable for bleeding of gastrointestinal tract and genitourinary system, such as esophageal varices, Treatment of bleeding from gastric and duodenal ulcers, functional and other causes of uterine bleeding, childbirth and / or miscarriage, etc.; treatment of bleeding after surgery, especially in the abdominal and pelvic regions and localized gynecological surgery Application, eg on the cervix. Existing terlipressin is generally prepared as an injection, but the terlipressin prepared by the prior art has disadvantages such as poor stability, poor reconstitution effect, high water content, and prone to spray bottle phenomenon during the preparation process. Contents of the invention [0...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/26A61K38/095A61P7/04
CPCA61K9/0019A61K9/19A61K47/26A61P7/04
Inventor 张云娟张瑾卜远芬李厚兵苏晴
Owner 南京康舟医药科技有限公司
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