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A kind of asarone injection and preparation method thereof

A technology of asarone and injection, which is applied in the field of pharmaceutical preparations, can solve the problems of high content and instability of β-asarone, and achieve the effects of increased solubility, convenient clinical use, and good clarity

Active Publication Date: 2017-10-31
张蕊
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The present invention aims to solve the defect that the content of the active ingredient and the clarity of the asarone injection preparations in the prior art are relatively stable, the content of related substances identified as β-asarone as a standard is relatively high, and when the requirements of the standard are met It is not easy to meet the lower requirements as much as possible under 1% of the total amount, and provide a kind of asarone injection and its preparation method. Xinnao Injection
It is mainly to solve the technical problem of high and unstable content of β-asarone in Asarone injection

Method used

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  • A kind of asarone injection and preparation method thereof
  • A kind of asarone injection and preparation method thereof
  • A kind of asarone injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1 (1 part by weight of α-asarone, 14 parts of polyethylene glycol-12-hydroxystearate, 50 parts of propylene glycol, melting temperature of 30°C, non-sterilized)

[0029] Take by weighing 4g α-asarone, 56g polyethylene glycol-12-hydroxystearate, 200g propylene glycol of prescription quantity, seal and stand-by; prepare the hydrochloric acid solution of 0.01mol / L with concentrated hydrochloric acid, seal and stand-by; Accurately weighed prescription quantities of α-asarone and polyethylene glycol-12-hydroxystearate were first melted in a water bath at 50°C, then placed in a clean anhydrous container, and heated at a temperature of 30°C Stir to dissolve, add the prescribed amount of propylene glycol after dissolution, stir to dissolve; then add water for injection to the full amount, adjust the pH to 5.01 with 0.01mol / L hydrochloric acid solution, mix well, first filter through a 0.45μm microporous membrane, and then pass through Filter through a 0.22 μm microporou...

Embodiment 2

[0030] Example 2 (1 part by weight of α-asarone, 16 parts of polyethylene glycol-12-hydroxystearate, 50 parts of propylene glycol, dissolution temperature of 45°C, non-sterilized)

[0031] Take by weighing 4g α-asarone, 64g polyethylene glycol-12-hydroxystearate, 200g propylene glycol of prescription quantity, seal and stand-by; prepare the hydrochloric acid solution of 0.01mol / L with concentrated hydrochloric acid, seal and stand-by; Accurately weighed prescription quantities of α-asarone and polyethylene glycol-12-hydroxystearate were first melted in a water bath at 50°C, then placed in a clean anhydrous container, and heated at a temperature of 45°C Stir to dissolve, add the prescribed amount of propylene glycol after dissolution, stir to dissolve; then add water for injection to the full amount, adjust the pH to 5.22 with 0.01mol / L hydrochloric acid solution, mix well, first filter through a 0.45μm microporous membrane, and then pass through Filter through a 0.22 μm microp...

Embodiment 3

[0032] Example 3 (1 part by weight of α-asarone, 20 parts of polyethylene glycol-12-hydroxystearate, 50 parts of propylene glycol, dissolution temperature of 50°C, non-sterilized)

[0033] Take by weighing 4g α-asarone, 80g polyethylene glycol-12-hydroxystearate, 200g propylene glycol of prescription quantity, seal and stand-by; prepare the hydrochloric acid solution of 0.01mol / L with concentrated hydrochloric acid, seal and stand-by; Accurately weighed prescription quantities of α-asarone and polyethylene glycol-12-hydroxystearate were first melted in a water bath at 50°C, then placed in a clean anhydrous container, and heated at a temperature of 50°C Stir to dissolve, add the prescribed amount of propylene glycol after dissolution, stir to dissolve; then add water for injection to the full amount, adjust the pH to 5.90 with 0.01mol / L hydrochloric acid solution, mix well, first filter through a 0.45μm microporous membrane, and then pass through Filter through a 0.22 μm microp...

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Abstract

The invention relates to asarin injection and a preparation method thereof, and belongs to the technical field of medicine preparations. The asarin injection is prepared by dissolving the following raw materials in parts by weight: 1 part of alpha-asarin, 14 to 20 parts of polyethylene glycol-12-hydroxystearate, 50 parts of propylene glycol and injection water; then regulating the pH; filtering; and sub-packing; the ratio of all injection water to alpha-asarin based on ml / mg is (1-10): 10. The preparation method can solve the problems that the content of beta-asarin used as the relative material identified by the standard is high and the possibly less content is difficult to achieve while the requirement on more than 1% of content as specified by the standard is met in the prior art that an asarin injection agent is relatively stable in active ingredient content and clarity; the prepared asarin injection is stable in quality; the content of beta-asarin used as the relative material is minimized; therefore, the safety of clinical application is further ensured.

Description

technical field [0001] The invention relates to an injection preparation and a preparation method thereof. More specifically, the invention relates to an asarone injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. technical background [0002] Asarone, also known as α-asarone or α-asarone, its chemical name is 2,4,5-trimethoxy-1-propenylbenzene, which is the main active ingredient of the traditional Chinese medicine Shichangpu, with sedative, Anticonvulsant, antispasmodic, antiasthmatic, expectorant, cough relieving, hypolipidemic, choleretic, anticancer and other pharmacological effects; at the same time, it has different degrees of inhibition on the growth of pneumococcus, staphylococcus aureus and Escherichia coli. Clinically, asarone has been widely used in the treatment of diseases such as upper respiratory tract infection, bronchitis, bronchial asthma, acute and chronic cholecystitis, cholelithiasis, and grand ma...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/09A61K47/14A61P11/00A61P31/04A61P11/06A61P1/16A61P25/08
Inventor 张蕊
Owner 张蕊