Kukoline or its salts sustained-release microsphere and preparation thereof and sustained-release injection preparations

A technology for sustained-release microspheres and injection preparations, which is applied in the directions of medical preparations, anti-inflammatory agents, and pharmaceutical formulations containing active ingredients to achieve long-lasting anti-inflammatory and analgesic effects, short process flow, and good reproducibility.

Inactive Publication Date: 2008-08-06
SHANGHAI INST OF PHARMA IND CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, no sustained-release injections have been reported

Method used

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  • Kukoline or its salts sustained-release microsphere and preparation thereof and sustained-release injection preparations
  • Kukoline or its salts sustained-release microsphere and preparation thereof and sustained-release injection preparations
  • Kukoline or its salts sustained-release microsphere and preparation thereof and sustained-release injection preparations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Take 1.0 g of sinomenine hydrochloride, 2.0 g of bovine serum albumin, add 100 ml of water to fully dissolve it, and filter to obtain a clear solution. The solution is spray-dried with a spray drier, and the obtained white powder is placed in a silica gel drier at room temperature for 3 days to obtain drug-loaded albumin sustained-release microspheres. Take 100 mg of microspheres, add 2 ml of soybean oil for injection, and ultrasonicate for 30 seconds to fully suspend the microspheres to obtain the sustained-release injection preparation of sinomenine hydrochloride of the present invention.

Embodiment 2

[0023] Take 2.0 g of sinomenine hydrochloride and 2.0 g of bovine serum albumin, add 100 ml of water to fully dissolve them, and then filter to obtain a clear solution. The solution was spray-dried with a spray dryer, and the obtained white powder was heated and solidified in an oven at 120° C. for 4 hours, and then cooled to room temperature to obtain drug-loaded albumin sustained-release microspheres. Take 75 mg of microspheres, add 2 ml of sesame oil for injection, and ultrasonicate for 30 seconds to fully suspend the microspheres to obtain the slow-release injection preparation of sinomenine hydrochloride of the present invention.

Embodiment 3

[0025] Take 4.0 g of sinomenine hydrochloride and 2.0 g of human serum albumin, add 100 ml of water to make them fully dissolved, and then filter to obtain a clear solution. The solution is spray-dried with a spray dryer, and the obtained white powder is heated and solidified in an oven at 100° C. for 8 hours, and then cooled to room temperature to obtain drug-loaded albumin sustained-release microspheres. Take 50 mg of microspheres, add 0.2 ml of polyethylene glycol 200, 1.8 ml of water for injection, and ultrasonicate for 30 seconds to fully suspend the microspheres to obtain the slow-release injection preparation of sinomenine hydrochloride of the present invention.

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Abstract

The invention discloses sustained release microsphere of sinomenine or sinomenine salts and a preparation method thereof. The sustained release microsphere comprises active constituents of sinomenine or medicine salts of the sinomenine and auxiliary material albumin; weight ratio of the active constituents to the albumin is 1 : 8-2 : 1. The invention also discloses a sustained release injection of the sinomenine or the sinomenine salts, which contains the sustained release microsphere. The sustained release microsphere has relatively higher entrapment efficiency, drug-loading rate as well as remarkable sustained release function. The sustained release injection can be used for injecting muscle or articular cavity and curing rheumatism and rheumatoid arthritis with lasting and stable potency, and can reduce application frequency and improve compliance.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a slow-release microsphere of sinomenine or its salt and a preparation method thereof, and a slow-release injection preparation of sinomenine or its salt containing the slow-release microsphere. Background technique [0002] Sinomenine (sinomenine) is an active ingredient extracted from the traditional Chinese medicine Sinomenium scutum Rehd.etWils. It is an effective monomer for treating rheumatism and rheumatoid arthritis, and its hydrochloride is often used in medicine. In 1996, it was officially approved as a national protected variety of traditional Chinese medicine, and it was included in the eighteenth volume of the Ministry of Health's drug standards (preparations of traditional Chinese medicine). Due to the remarkable curative effect of this variety, it has become a commonly used drug now. [0003] Currently, the sinomenine preparations on the market include sinomenine hydrochlo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/485A61K47/42A61P29/00A61P19/02A61P19/04
Inventor 奉建芳邹凌燕祝林陈满仓
Owner SHANGHAI INST OF PHARMA IND CO LTD
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