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Matrix of suppository or paste medicine for treating prostatitis and preparation method thereof

A matrix and ointment technology, applied in the direction of suppository delivery, drug combination, ointment delivery, etc., can solve the problems of destroying the uniformity and appearance of preparations, matrix phase-body separation, etc., and achieve good production smoothness and quality characteristics.

Active Publication Date: 2012-01-25
LIVZON PHARM GRP INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when the amount of drug powder accounts for a large proportion of the preparation or when the preparation is produced using traditional Chinese medicine or natural medicine extracts, the emulsification system formed by the general surfactant cannot meet the stability requirements, and matrix phase separation is prone to occur, which will destroy the uniformity and stability of the preparation. Exterior

Method used

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  • Matrix of suppository or paste medicine for treating prostatitis and preparation method thereof
  • Matrix of suppository or paste medicine for treating prostatitis and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038]Embodiment 1 (composition A)

[0039] According to the clinically commonly used suppository specification of a certain medicine is 2g / grain, 0.6kg of medicinal powder needs to be added to prepare 1000 pills, and the medicinal powder needs to be proportioned with 10% of its weight in purified water. According to the test, to meet the requirements of preparation melting time limit, hardness and delamination resistance, the matrix composition is formulated as follows: the total weight of the matrix is ​​the weight of 1000 suppositories-medicine powder weight-pure water weight, that is: (1000 * 2-660) ( unit is g)

[0040] Various fatty acid glycerides 1183 88.3%

[0041] Macrogol 400 Monolaurate 67 5%

[0042] Macrogol 400 Dilaurate 53.6 4%

[0043] Glyceryl behenate 33.5 2.5%

[0044] Appropriate amount of preservatives

[0045] The total weight of the matrix is ​​1340 (in g) 100%

[0046] A variety of fatty acid glycerides are a mixture of glyceryl monostearate, gly...

Embodiment 2

[0047] Example 2 (composition B)

[0048] According to the commonly used clinical suppository specification of a certain medicine is 2g / granule, 0.7kg of medicinal powder needs to be added to prepare 1000 capsules, and the medicinal powder needs to be mixed with 15% of its weight in purified water. According to the test, it meets the requirements of melting time limit, hardness and anti-stratification of the preparation , formulate matrix composition as follows: the total weight of matrix is ​​the weight of 1000 suppositories-medicine powder weight-pure water weight, namely: (1000 * 2-700-105) (unit is g)

[0049] Various fatty acid glycerides 1055 88.3%

[0050] Macrogol 400 Monopalmitate 47.8 4%

[0051] Macrogol 400 dipalmitate 71.7 6%

[0052] Glyceryl Behenate 17.9 1.5%

[0053] Appropriate amount of preservatives

[0054] The total weight of the matrix is ​​1195 (in g) 100%

[0055] A variety of fatty acid glycerides are mixtures of olein, laurate and palmitin.

Embodiment 3

[0056] Embodiment 3 (composition C)

[0057] According to the commonly used clinical suppository specification of a certain drug is 2g / grain, 0.5kg of medicinal powder needs to be added to prepare 1000 pills, and the medicinal powder needs to be mixed with 8% of its weight in purified water. According to the test, it meets the requirements of the preparation melting time limit, hardness, and anti-stratification , formulate matrix composition as follows: the total consumption of matrix is ​​the weight of 1000 suppositories-medicine powder weight-pure water weight, namely: 1000 * 2-500-40 (unit is g)

[0058] Various fatty acid glycerides 1311 89.8%

[0059] Macrogol 400 Monostearate 73 5%

[0060] Macrogol 400 Distearate 51.1 3.5%

[0061] Glyceryl behenate 21.9 1.5%

[0062] Appropriate amount of preservatives

[0063] The total weight of the matrix is ​​1460 (in g) 100%

[0064] A variety of fatty acid glycerides are a mixture of glyceryl stearate, glyceryl laurate and g...

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Abstract

The invention provides a matrix for a suppository or a paste medicine and a method preparing the suppository or the paste containing the matrix. The matrix comprises (1) fat soluble matrix and (2) polyethylene glycol fatty acid ester. The invention also provides application of the matrix on preparing the suppository or the paste medicine for treating prostatitis. When being used to manufacture the suppository or the paste, the matrix of the invention can carry high dose and at the same time the suppository or the paste containing the matrix can bear high temperature in the transportation process and keep good stability.

Description

technical field [0001] The invention relates to a matrix of suppository or ointment medicine and a preparation method of the matrix, in particular to a matrix of suppository or ointment medicine for treating prostatitis and a preparation method thereof. Background technique [0002] A suppository is a solid preparation that, when applied to the rectum, urethra, and vagina, etc., softens or melts at body temperature, or dissolves in the local mucous membrane, allowing the drug to be absorbed into the body through the mucous membrane. In the existing suppositories, mixed fatty acid glycerides are often used as the suppository matrix, which is less irritating to the mucous membranes, but when mixed with water-soluble powders, some pharmaceutical surfactants need to be added to achieve drug in the matrix. Dissolve, disperse, and form water-in-oil or oil-in-water emulsion systems. However, when the amount of drug powder accounts for a large proportion of the preparation or when ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/34A61K9/02A61K9/06A61P13/08A61K47/14A61K47/10A61K47/26
Inventor 周俊郭国领李颖彭丽娜苏勉诚胡菊华陈春贵
Owner LIVZON PHARM GRP INC