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Determination method for dissolution curve of megestrol acetate suspension with distinguishing power

A technology of megestrol acetate and suspension, which is applied in the field of medicine, can solve the problems that megestrol acetate suspension cannot be effectively distinguished, the dissolution curve is not clearly distinguished, and the dissolution process cannot be guaranteed, so as to ensure uniformity , improve precision and accuracy, and achieve good discrimination

Pending Publication Date: 2021-08-20
TOT BIOPHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Commercial preparation of megestrol acetate suspension When using method 1 as the dissolution curve method, the dissolution rate of this method is faster (15min dissolution rate has reached 85%), and the obtained dissolution curve can not effectively distinguish the in vitro release of megestrol acetate suspension and the impact on in vitro release
[0010] Commercial formulation (Specification: 40mg / ml) When fully dissolved under the conditions of method 2 and method 3, the solubility of megestrol acetate is 0.444mg / ml. After determination, the solubility of megestrol acetate raw material in 0.5% SDS aqueous solution is 0.527mg / ml, the conditions of method 2 and method 3 have seriously failed to meet the sink condition, and the dissolution curve is measured by this method, the dissolution rate is slow, and the distinction between the dissolution curves is not obvious
And there is no guarantee that the dissolution process can achieve a dissolution rate of 85% or more

Method used

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  • Determination method for dissolution curve of megestrol acetate suspension with distinguishing power
  • Determination method for dissolution curve of megestrol acetate suspension with distinguishing power
  • Determination method for dissolution curve of megestrol acetate suspension with distinguishing power

Examples

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Comparison scheme
Effect test

Embodiment 1

[0076] In the prior art, the United States Pharmacopoeia (USP) has recorded the method for measuring the dissolution rate of megestrol acetate oral suspension, and the original preparation is measured by using USP method 1 to carry out the dissolution curve measurement: with 0.5% dodecyl Alkyl sodium sulfate (SDS) aqueous solution is the dissolution medium, take 900ml and add it to the dissolution cup, set the speed of the dissolution apparatus to 25 rpm, and when the temperature of the dissolution medium reaches 37±5°C, use a syringe to draw 4ml of mixed formaldehyde acetate Digegestrol oral suspension is injected into the dissolution cup on the surface of the dissolution medium, and 5ml of the solution is taken at 5min, 10min, 15min, 20min, 30min, 45min, and 60min, filtered through a 0.45μm microporous membrane, and the subsequent filtrate is taken as Need testing solution, carries out stripping measurement with high performance liquid chromatography, and chromatographic cond...

Embodiment 2

[0094] A method for measuring the dissolution profile of megestrol acetate oral suspension is provided in the present embodiment, comprising the steps of:

[0095] Step (1) Preparation of dissolution medium

[0096] Dissolution medium is 0.4% sodium lauryl sulfate (or 0.9% polysorbate 80) aqueous solution, and its preparation process is: take by weighing 4.0g sodium lauryl sulfate (or 9.0g polysorbate 80) and place in measuring bottle Add 700ml of water to dissolve, add water to dilute to 1000mL, mix well, degas, and obtain.

[0097] The dissolution medium is pH1.2, contains 0.4% sodium lauryl sulfate (or 0.9% polysorbate 80) aqueous solution, and its preparation process is: take by weighing 4.0g sodium lauryl sulfate (or 9.0g polysorbate 80) ) in a measuring bottle, add 700-800ml of water to dissolve, add 7.65ml of hydrochloric acid, add water to dilute to 1000mL, mix well, and degas to obtain.

[0098] The dissolution medium is pH 4.5, containing 0.4% sodium lauryl sulfate...

Embodiment 3

[0123] According to a kind of discriminating megestrol acetate suspension dissolution curve assay method provided in embodiment 2, respectively to the megestrol acetate oral suspension of original preparation, different prescriptions, different techniques and final prescription technique Dissolution profiles were determined where,

[0124] In step (1), the dissolution medium adopted is in 0.4% sodium lauryl sulfate aqueous solution;

[0125] In the step (5), specifically, high performance liquid chromatography is used to measure the dissolution rate;

[0126] By measuring, the dissolution results of the original preparation, different prescription preparations, different process preparations and final prescription process preparations were obtained, as shown in Table 3 and Figure 7 .

[0127] Table 3 The method of the present invention measures the contrast of dissolution results of different preparations

[0128]

[0129] As can be seen from the measurement results, th...

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Abstract

The invention provides a method for determining a dissolution curve of a megestrol acetate suspension with distinguishing power. The method comprises the following steps of: dissolving a surfactant in water to prepare a dissolution medium, wherein the surfactant comprises lauryl sodium sulfate or polysorbate 80, when the surfactant is lauryl sodium sulfate, the mass concentration range of the lauryl sodium sulfate is 0.35%-0.45%, and when the surfactant is polysorbate 80, the mass concentration range of the polysorbate 80 is 0.8%-1.0%; fully shaking up a megestrol acetate oral suspension to be detected, and performing decompression degassing to obtain a to-be-detected sample; and adding the to-be-detected sample into the dissolution medium through using an automatic sample adding device, determining according to a paddle method of a dissolution instrument, sampling at a sampling time point, and determining the dissolution amounts at different time points.

Description

technical field [0001] The invention relates to the field of medicine, in particular, the invention relates to a method for measuring the dissolution curve of a megestrol acetate suspension with distinguishing power. Background technique [0002] Dissolution: refers to the speed and degree of active drug dissolution from common preparations such as tablets, capsules or granules under specified conditions (that is, the amount of drug released when it reaches a certain time point in the dissolution medium), mainly Investigate whether the release of the drug at the specified time point can reach the limit specified in the standard. [0003] Dissolution Profile: It is the dissolution rate-time curve drawn from the dissolution rate of the preparation obtained at different time points. The dissolution curve reflects the in vitro dissolution and dissolution process of the preparation, and the quality of the generic drug can be evaluated by comparing the similarity of multiple in v...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/36G01N30/74
CPCG01N30/02G01N30/06G01N30/34G01N30/36G01N30/74G01N2030/027
Inventor 王薇丹张伟崔鹏程刘小艳吴再珍陈小宝
Owner TOT BIOPHARM CO LTD
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