Terlipressin acetate injection and preparation method thereof

A technology of terlipressin and injection, which is applied in blood diseases, pharmaceutical formulations, extracellular fluid diseases, etc., can solve the problems of high water content, poor reconstitution effect, easy occurrence of spray bottles, etc., and achieves low water content. , improve stability, ensure safety and effectiveness

Active Publication Date: 2018-12-18
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 made into injections, but the terlipressin injection prepared by the prior art has poor stability, and the lyophilized powder injection has disadvantages such as poor reconstitution effect and high water content, and the preparation Spray bottle phenomenon is prone to occur in the process of powder injection

Method used

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  • Terlipressin acetate injection and preparation method thereof
  • Terlipressin acetate injection and preparation method thereof
  • Terlipressin acetate injection and preparation method thereof

Examples

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Effect test

preparation example Construction

[0012] A preparation method of terlipressin acetate injection, comprising the following steps:

[0013] S1, preparation of drug solution;

[0014] 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 injection containing solid subst...

Embodiment 1

[0056] The present embodiment provides a kind of preparation method of terlipressin acetate injection, comprises the following steps:

[0057] S1, preparation of drug solution;

[0058] 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.

[0059] S2, pre-freezing in stages;

[0060] Place the half-stoppered vials on the inner partition of the vacuum dryer after filling. Connect the inle...

Embodiment 2- Embodiment 3

[0090] The preparation method of the terlipressin acetate injection provided in Example 2-Example 3 is basically the same as the operation of the preparation method of the terlipressin acetate injection provided in Example 1, the difference is that the specific operating conditions change .

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Abstract

The invention relates to the field of pharmacy, in particular to a terlipressin acetate injection and a preparation method thereof. The preparation method of the terlipressin acetate injection comprises the following steps that a terlipressin acetate freeze-dried powder injection and a sodium chloride solution with the pH of 3.0 to 4.0 are mixed to obtain the injection, wherein after a medicine solution is subjected to staged pre-freezing, staged first drying and staged second drying are conducted in sequence. By means of the reparation method of the terlipressin acetate injection, the eruption phenomenon can be effectively improved, moreover, the fact that the prepared terlipressin acetate freeze-dried powder injection is good in stability, intact in sample appearance and capable of fastredissolving is guaranteed, meanwhile, the sodium chloride solution with the pH of 3.0 to 4.0 is adopted for redissolving, the injection stability is improved, and the safety and the effectiveness ofclinical medication are guaranteed.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a terlipressin acetate injection and a preparation method thereof. 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 made into injections, but the terlipressin injection prepared by the prior art has poor stability, and the lyophilized powder injection has disadvantages such as poor reconstitution effect and high water content, and the preparation The spray bottle phenomenon is prone to occu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/11A61K9/08A61K47/02A61P7/04A61P13/00A61P1/00A61P15/00A61K38/095
CPCA61K9/0019A61K9/08A61K47/02A61P1/00A61P7/04A61P13/00A61P15/00
Inventor 苏晴张云娟徐健峰孔萍卜远芬
Owner 南京康舟医药科技有限公司
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