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Method for determining dissolution rate of meisuoshuli tablets

A technology of mesosulide tablets and mesosulide tablets, applied in the field of medicine, can solve the problems of no mesosulide, etc., and achieve the effects of good precision and repeatability, short analysis time and high accuracy

Inactive Publication Date: 2016-03-02
WUHAN OPTICS VALLEY HUMANWELL BIO PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, there is no literature report related to the dissolution test of mesosulide

Method used

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  • Method for determining dissolution rate of meisuoshuli tablets
  • Method for determining dissolution rate of meisuoshuli tablets
  • Method for determining dissolution rate of meisuoshuli tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Mesosulide tablets with a specification of 50 mg are prepared according to the following method:

[0055] 1. Prescription composition:

[0056] Name of raw material

Dosage (g)

Mesosulide

50

microcrystalline cellulose

180

Povidone K30 (10% aqueous solution (g / g))

8

Crospovidone (PVPP)

12

Magnesium stearate

2.5

Co-made

1000 pieces

[0057] 2. Preparation method:

[0058] (1) material preparation: after the principal ingredient is pulverized, pass through a 60-mesh sieve, and the auxiliary materials pass through an 80-mesh sieve, and set aside;

[0059] (2) Preparation of adhesive: Weigh a certain amount of povidone K30 (PVPK30) in a beaker, add an appropriate amount of purified water, and stir until clear to obtain 10% PVPK30 aqueous solution I, which is set aside;

[0060] (3) Mixing: Weigh the main ingredient, lactose, microcrystalline cellulose, PVPP (internal addition) in the pres...

Embodiment 2

[0068] Mesosulide tablets with a specification of 100 mg are prepared according to the following method:

[0069] 1. Prescription composition:

[0070] Name of raw material

Dosage (g)

Mesosulide

100

lactose

80

microcrystalline cellulose

40

Povidone K30 (10% aqueous solution (g / g))

7

Crospovidone (PVPP)

12

Magnesium stearate

2

Co-made

1000 pieces

[0071] 2. Preparation method:

[0072] The preparation method is the same as in Example 1.

Embodiment 3

[0074] Adopt the mesosulide tablet prepared by embodiment 1 and 2, determine respectively the stripping condition of mesosulide tablet according to the following methods:

[0075] 1. Selection of dissolution medium

[0076] In order to select a suitable dissolution medium, the condition of the sink is set as follows: the dissolution medium is water, 0.1mol / L hydrochloric acid solution, acetate buffer solution of pH 4.5, phosphate buffer solution of pH 6.8 and pH 8.8 Phosphate buffer solution (preparation method: sodium hydroxide 2.30g, potassium dihydrogen phosphate 7.65g, add water to dissolve to 1000ml, adjust pH to 8.8 with phosphoric acid) put a piece of Messocid with a specification of 100mg / tablet Sharp sheet (prepared and obtained in Example 2), the dissolution medium volume is 330ml, the paddle method, the rotating speed is 75 revolutions per minute, the temperature is 37°C ± 0.5°C, sampling is carried out at 75min, and the absorbance is measured at a detection wavelen...

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Abstract

The invention discloses a method for determining the dissolution rate of meisuoshuli tablets. The method comprises the steps that the meisuoshuli tablets are dissolved by taking a phosphate buffer solution with the pH valve of 8.5-8.9 as a dissolution medium to obtain a test solution; absorbancy detection is performed on the test solution, and the dissolution rate of the meisuoshuli tablets is determined on the basis of a result of the absorbancy detection. According to the method, the dissolution rate of the meisuoshuli tablets can be effectively determined, the specificity is high, the needed analysis time is short, the precision and the repeatability are good, and the accuracy is high.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a method for measuring the dissolution rate of tablets. Specifically, the invention relates to a method for measuring the dissolution rate of mesosulide tablets. Background technique [0002] The dissolution rate of a drug is an internal indicator for evaluating the quality of a drug. It is an in vitro test method that simulates the disintegration and dissolution of an oral solid preparation in the gastrointestinal tract, and its purpose is to ensure the effectiveness of the preparation. According to the guiding principles of new drug research, when determining the dissolution rate of a drug, it is necessary to study and select the corresponding method and dissolution rate condition according to the specific conditions such as the dissolution characteristics of the drug and the characteristics of the preparation. [0003] Mesosulide raw materials and preparations are the world's f...

Claims

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Application Information

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IPC IPC(8): G01N21/31G01N21/33
Inventor 李莉娥王学海许勇黄怡廖娟娟黄璐涂荣华杨仲文乐洋江曦朱垒余艳平刘荃王伟田华肖强范昭泽杨菁张毅
Owner WUHAN OPTICS VALLEY HUMANWELL BIO PHARMA
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