A kind of terlipressin acetate preparation and preparation method thereof

A technology of terlipressin and acetic acid is applied in the directions of pharmaceutical formulations, medical preparations with inactive ingredients, medical preparations containing active ingredients, etc., and can solve the problems of low product yield, poor stability, limited application and the like, To achieve the effect of improving stability and reconstitution, improving stability and shape, and being easy to industrialize production

Active Publication Date: 2021-11-09
南京诺卡医药技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Terlipressin preparations in the prior art have poor stability, low product yield, high water content, high impurity content, and poor reconstitution effect, which limits its application in medical treatment

Method used

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  • A kind of terlipressin acetate preparation and preparation method thereof
  • A kind of terlipressin acetate preparation and preparation method thereof

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preparation example Construction

[0015] The present invention relates to a method of preparing acetate-specific pressurin preparation, comprising the steps of:

[0016] The drug solution obtained by mixing acetate, glycine, and drug solvent is frozen and dried to obtain a teelectric acid supplement preparation;

[0017] The weight ratio of the vine acid special-absorbent and glycine is 1: 10-20;

[0018] The pH of the drug solution was 3.5-4.5.

[0019] In the present invention, glycine is used as a carrier, and the glycine has a good compatibility with acetate-specific pressurin, and glycine can be used as an antioxidant, and has a certain antibacterial effect. The use of acetic acid of acetic acid with a weight ratio of 1: 10-20 and glycine in the drug, the drug load is carried on the carrier, more conducive to the precipitation and molding of the drug, thereby improving the stability and shape of the drug. It is conducive to lyophilized drugs to form fluffy structures, thereby improving the solubility and stab...

Embodiment 1

[0072] Having an acetic acid terlipressin preparation of pigment formulations, comprising the steps of:

[0073] (A) amount of water for injection to 40L dosing tank, spare; glycine weighed 938g water for injection was added, stirred and completely dissolved; Terry weighed 62.5g drug vasopressin acetate was added to the glycine solution stirred dissolved; using 1mol / L hydrochloric acid solution was adjusted to pH 4.0, water for injection qs to 50L;

[0074] (B) Intermediate detection: Apply chemical intermediate, intermediate index measured content and the like;

[0075] (C) Filter: using 0.22μm PVDF membrane filter sterilized by filtration;

[0076] (D) Filling: The intermediate liquid detection result, the liquid filling the borosilicate resistant to 7mL vial, using semi-bromobutyl rubber stopper tamponade standby;

[0077] (E) freeze-drying process:

[0078] The vials containing liquid is placed on the partition plate lyophilizer, firstly to cool the separator, and then turn ...

Embodiment 2

[0091] Having an acetic acid terlipressin preparation of pigment formulations, comprising the steps of:

[0092] (A) amount of water for injection to 40L dosing tank, spare; glycine weighed 1000g water for injection was added, stirred and completely dissolved; 50g weighed Terry drug vasopressin acetate was added to the glycine solution, stirred was dissolved; using 1mol / L hydrochloric acid solution was adjusted to pH 3.8, water for injection qs to 50L;

[0093] (B) Intermediate detection: Apply chemical intermediate, intermediate index measured content and the like;

[0094] (C) Filter: using 0.22μm PVDF membrane filter sterilized by filtration;

[0095] (D) Filling: The intermediate liquid detection result, the liquid filling the borosilicate resistant to 7mL vial, using semi-bromobutyl rubber stopper tamponade standby;

[0096] (E) freeze-drying process:

[0097] The vials containing liquid is placed on the partition plate lyophilizer, firstly to cool the separator, and then t...

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Abstract

The invention relates to the technical field of pharmacy, in particular to a terlipressin acetate preparation and a preparation method thereof. The preparation method of the terlipressin acetate preparation comprises the following steps: freezing and drying a drug solution obtained by mixing terlipressin acetate, glycine and a drug solvent to obtain a terlipressin acetate preparation; The weight ratio of terlipressin acetate and glycine is 1:10-20; the pH of the drug solution is 3.5-4.5. The terlipressin acetate preparation obtained by the specific preparation method of the present invention has a complete appearance, which improves the product yield; the water content of the preparation is low, which improves the stability of the preparation during transportation and storage; it can be quickly reconstituted; and Under the conditions of high temperature and light, the impurity content is small, which improves the safety of the preparation in clinical administration.

Description

Technical field [0001] The present invention relates to the field of pharmaceutical techniques, and in particular, a specific pressurin preparation thereof and a preparation method thereof thereof. Background technique [0002] Television is known as N-α-tritlatin-8-lysine-plug, is a white powder. It can be used for bleeding of gastrointestinal and urinary reproductive systems, such as esteem veins, stomach and duodenal ulcers, functionalities and other reasons caused by bleeding caused by bleeding, etc., can be used for surgery The treatment of the post-bleeding, especially bleeding in the abdominal cavity and pelvic area. [0003] The prior art is poorly stabilized, the product yield is low, the moisture content is large, the impurity content is more, and the solubility is poor, and it limits its in medical applications. [0004] In view of this, the present invention is proposed. Inventive content [0005] The present invention relates to a method of preparing acetate-specifi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K47/18A61K38/095A61P7/04
CPCA61K9/0019A61K9/19A61K47/183A61P7/04A61K38/095
Inventor 孙浩张瑾苏晴徐健峰李厚兵陈鹏
Owner 南京诺卡医药技术有限公司
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