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Tranexamic acid sustained-release solid composition and preparation method thereof

A solid composition, tranexamic acid technology, applied in the directions of drug combination, pharmaceutical formulation, drug delivery, etc., to achieve the effects of simple preparation process, maintaining blood drug concentration, and solving excessively fast dissolution

Inactive Publication Date: 2012-07-04
BEIJING WANQUAN SUNSHINE MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, tranexamic acid is easily soluble in water and has strong hydrophilicity. Therefore, how to control its drug release rate so that it can maintain a steady-state blood drug concentration during menstruation has become a difficult point in the preparation of the drug.

Method used

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  • Tranexamic acid sustained-release solid composition and preparation method thereof
  • Tranexamic acid sustained-release solid composition and preparation method thereof
  • Tranexamic acid sustained-release solid composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] This example is presented as a tablet, wet granulated.

[0016]

[0017]

[0018] Preparation process: Weigh tranexamic acid according to the prescription amount, crush it through a 120-mesh sieve, weigh the prescription amount of mannitol and hypromellose (K15M), mix it uniformly by equal addition method, and add binder pure water Making soft material, granulating with 16 mesh sieve. Dry and measure the moisture content; granulate through a 24-mesh sieve, mix with the prescribed amount of magnesium stearate, and then mix with the granules. Ф10mm shallow concave stamping sheet.

Embodiment 2

[0020] The present example is in the form of a tablet, and the powder is directly compressed.

[0021]

[0022] Preparation process: Weigh tranexamic acid according to the prescription amount, crush it through a 120-mesh sieve, weigh the prescription amount of microcrystalline cellulose, pregelatinized starch, hypromellose (K4M), povidone (K30), and use After mixing evenly by equal-volume incremental method, mix it with the prescribed amount of micropowder silica gel and magnesium stearate, and directly press the powder into tablets with a Ф12mm shallow concave punch.

[0023]

Embodiment 3

[0025] This embodiment is in the form of a capsule.

[0026]

[0027] Preparation process: Weigh tranexamic acid according to the prescription amount, crush it through a 120-mesh sieve, weigh the prescription amount of lactose, starch, and hypromellose (K15M), mix them uniformly by equal addition method, and then add 10% starch slurry Appropriate amount of soft material, granulated with 16 mesh sieve. Dry and measure the moisture content; sieve the 24-mesh sieve and mix with the prescribed amount of talcum powder to obtain the granules. 2# Capsule shell filling.

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Abstract

The invention discloses a tranexamic acid sustained-release solid composition and a preparation method thereof. The sustained-release solid composition is prepared by taking tranexamic acid as a raw material and adding a sustained-release framework material in a proper proportion. The prepared preparation is capable of achieving zero-order release within 3 h to keep blood concentration steady and is used for treating women suffering from menorrhagia clinically.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a sustained-release solid composition of tranexamic acid and a preparation method thereof. Background technique [0002] Menorrhagia is a common disease in gynecology. Dysmenorrhea, anemia, fatigue and anxiety caused by it have caused great harm to women's body and mind. In severe cases, it can cause ischemic heart disease and endanger life, so it should be paid attention to. At present, hormone drugs are mostly used for treatment in China, which has great toxic and side effects. [0003] Tranexamic acid, the first non-hormonal drug used to treat menorrhagia, is an antifibrinolytic hemostatic drug, the main mechanism is: by blocking the lysine binding point of plasminogen and plasmin molecular sieve And inhibit their combination with fibrin, block the degradation of fibrin, and stabilize coagulation factors at the same time, resulting in rapid hemostasis. [0004] S...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/16A61K9/20A61K9/48A61K31/195A61K47/38A61P15/00A61P7/04
Inventor 陈晓艳黄雪
Owner BEIJING WANQUAN SUNSHINE MEDICAL TECH CO LTD
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