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Preparation analysis
From;    Author:Stand originally

Preparation analysisIt is the medicaments of pair of different the form of a drug, use physics, chemical, microbial even determining method undertakes an analysis, whether does the preparation that is checked in order to examine accord with the formulary requirement of quality standard.
Because preparation and raw material remedy are different, they often contain excipient, thinner and additional agent (stabilizing agent, antiseptic or colorant) , these adding extremely existence, often affect right advocate of medicine determine. And different the form of a drug, pharmacopoeia raises different requirement again to them, accordingly, often make the problem complications.
Normally, make the raw material of preparation, should accord with officinal norms the requirement is rear can cast makings, press proper manufacturing technology preparation, reason was not necessary to go to all examining repeating raw material medicaments again in preparation analysis project. The foreign matter examination of preparation basically is to examine the becomes with degenerative have a youthful look foreign matter that medicaments brings in preparation process.
The content of preparation measures calm method, mix besides the sensitivity that should consider a method exclusive outside the gender, even the property according to medicaments, of the amount of content and ode the form of a drug, additional agent affect and decide. After making different the form of a drug as a kind of medicaments, can not use certainly same kind the method determines.
In addition, the impact of excipient and additional agent should consider not only in preparation of medicine made of two or more ingredients, and still need to consider two kinds or a variety of active ingredient mutual the interference between.
The basic measure that tablet analyses: Want to have the examination of the physical character such as exterior colour and lustre, smell, flavour to tablet above all, undertake foreign matter is checked differentiating mixing next, undertake content determines finally.
The convention of tablet is checked
(one) general examination:
1, weight difference experiments;
2, collapse solution time limit experiments;
3, tablet ply and diametical uniformity experiment;
4, hardness experiment is waited a moment.
(2) content uniformity checks (Content Uniformity Test) : As a result of the relation of craft and operation, often make tablet medium advocate medical content appears inhomogenous condition.
(3) dissolve gives degree of examination (Dissolution Test) : Medicaments from tablet (or capsule agent) the rate that gives in the dissolve in setting solvent or degree.

The content of tablet determines:
(one) determine directly: Advocate medical content is bigger, adoption method does not suffer the effect of excipient, or the influence is negligible do not time, all use the method that determines directly commonly.
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