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Disintegration time limit testing standard substance and preparation method thereof

A technology of testing standards and disintegration time limit, which is applied in the field of chemical measurement, can solve problems such as unreliable measurement data of disintegration time limit, and achieve the effects of reliable measurement performance evaluation, improving efficiency and improving accuracy

Inactive Publication Date: 2013-09-04
辽宁省计量科学研究院
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The purpose of the present invention is to provide a disintegration time limit test standard substance and its preparation method, which solves the unreliable defect of the disintegration time limit measurement data of the existing disintegration instrument, and the disintegration time limit test standard substance has good uniformity, Stable and accurate limit value of disintegration, its raw material sources are extensive, the preparation process is easy to operate, convenient to use, can accurately and reliably evaluate the measurement performance of the disintegration instrument, realize the uniform value, and further improve the disintegration instrument The traceability of the quantity value and the accuracy of the quantity value transmission ensure the accuracy and reliability of the measurement data, thereby significantly improving the quality control of drug production

Method used

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  • Disintegration time limit testing standard substance and preparation method thereof
  • Disintegration time limit testing standard substance and preparation method thereof
  • Disintegration time limit testing standard substance and preparation method thereof

Examples

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preparation example Construction

[0014] The specific process steps of the preparation method of the above-mentioned disintegration time limit test standard substance are as follows:

[0015] Step 1 Pass lactose and starch through a 100-mesh sieve respectively; weigh lactose, starch and hydroxypropyl methylcellulose according to the above weight ratio, place them in a wet mixing granulator, and dry mix for 10 minutes;

[0016] Step 2: Gradually add water according to the amount, stir for 8 minutes to 25 minutes, granulate, pass through a 20-mesh sieve, dry at a temperature of 40°C to 60°C for 2 hours, pass through a 20-mesh sieve for granulation; add according to the total weight ratio of dry granules Sodium carboxymethyl starch and magnesium stearate, mixed well;

[0017] Step 3 Use the forming die to stamp into tablets, each piece weighs 0.40g-0.60g, the pressure of tableting is controlled at 10kN-50kN, the hardness is controlled at 3.0kgf-6.0kgf, and the tablets with good uniformity are selected from them, ...

Embodiment 1

[0036] Example 1, Preparation of the disintegration time limit test standard substance whose value is 312s

[0037] Step 1 Pass the lactose and starch through a 100-mesh sieve respectively; weigh 500g of lactose, 50g of starch, and 20g of hydroxypropylmethylcellulose, place them in a wet mixing granulator, and dry mix for 10 minutes.

[0038] Step 2: Gradually add 50 g of water, stir for 8 minutes, granulate, pass through a 20-mesh sieve, dry at 40°C for 2 hours, pass through a 20-mesh sieve for granulation; add 29 g of sodium carboxymethyl starch and 3 g of magnesium stearate ,well mixed.

[0039] Step 3 Use a molding die to stamp into tablets, each tablet weighs 0.49g to 0.51g, the tablet pressure is controlled at 10kN, the hardness is controlled at 3.0kgf, about 700 tablets are pressed, and 600 tablets with good uniformity are selected from them. The slices should be bottled and sealed for later use. Sampling equipment should be clean and dry to prevent contamination, an...

Embodiment 2

[0043] Example 2, Preparation of the disintegration time limit test standard substance whose value is 472s

[0044] Step 1 Pass lactose and starch through a 100-mesh sieve respectively; weigh 600g of lactose, 70g of starch, and 23g of hydroxypropylmethylcellulose, place them in a wet mixing granulator, and dry mix for 10 minutes.

[0045] Step 2: Gradually add 80 g of water, stir for 18 minutes, granulate, pass through a 20-mesh sieve, dry at 50°C for 2 hours, pass through a 20-mesh sieve for granulation; add 27 g of sodium carboxymethyl starch and 4 g of magnesium stearate, well mixed.

[0046] Step 3 Use the molding die to stamp into tablets, each piece weighs 0.49g to 0.51g, the tablet pressure is controlled at 25kN, the hardness is controlled at 3.5kgf, about 800 tablets are pressed, and 600 tablets with good uniformity are selected from them. The slices should be bottled and sealed for later use. Sampling equipment should be clean and dry to prevent contamination, and ...

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Abstract

The invention provides a disintegration time limit testing standard substance and a preparation method thereof, which overcome the defect that the disintegration time limit measuring data of the conventional disintegration tester is unreliable. The disintegration time limit testing standard substance takes lactose, starch, hydroxy propyl methyl cellulose, water, magnesium stearate and sodium carboxymethyl starch as main raw materials, and is prepared by screening, weighing and mixing in a ratio, granulating, drying and tabletting. The disintegration time limit testing standard substance has high uniformity, high stability and a precise disintegration time limit fixed value, and is rich in raw material sources, easy to prepare and convenient to use; by using the disintegration time limit testing standard substance, the metering performance of an overall disintegration tester can be evaluated precisely and reliably, uniform metered values can be realized, the accuracy of tracing metered value sources and transmitting metered values of the disintegration tester can be further perfected, and the precision and the reliability of the measurement data of the disintegration tester can be ensured, so that quality control over medicine production can be obviously improved. The disintegration time limit testing standard substance can be used for analyzing quality evaluation, monitoring quality, correcting certain analysis instruments and the like in medicine, customs, quality inspection, commodity inspection and the like, and also can be used for laboratory proficiency testing and personnel appraisal.

Description

technical field [0001] The invention relates to a measurement standard for evaluating and calibrating a disintegration time limit tester, in particular to a disintegration time limit test standard substance for evaluating and calibrating the accuracy of a disintegration time limit tester and a preparation method thereof, which can be used in a laboratory Capability verification and personnel assessment. Belongs to the field of stoichiometry. Background technique [0002] As we all know, the existing disintegration time limit tester (hereinafter referred to as the disintegration tester) is a drug testing instrument specified in Appendix XA "Disintegration Time Limit Inspection Method" of the Pharmacopoeia of the People's Republic of China in 2010, and is used to check the disintegration of solid preparations under specified conditions. . Disintegration refers to the complete disintegration, dissolution or granulation of oral solid preparations under specified conditions. A...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/15
Inventor 黄涛艾明泽肖哲房芳琦
Owner 辽宁省计量科学研究院
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