Powder Formulations
Classification
By Medical Use:Internal Powder Formulations, Topical Powder Formulations
By Composition:Single Herb Powder Formulations, Compound Powder Formulations
By Nature of the Medicine:Common Powder Formulations, Special Powder Formulations
By Dosage:Measured Powder Formulations, Non-measured Powder Formulations
Quality Requirements
Regulations on Production and Storage
(1) The raw materials for powder formulations must be crushed; internal powder formulations should be fine powder; pediatric and topical powder formulations should be the finest powder.
(2) Powder formulations should be dry, loose, uniformly mixed, and of consistent color. When preparing powder formulations containing toxic, precious herbs or small doses of medicine, a mixing method should be used and sieved.
(3) Multi-dose packaged powder formulations should include measuring tools; internal powder formulations containing toxic herbs should be single-dose packaged.
(4) Powder formulations may or may not contain excipients. Oral powder formulations may also include flavoring agents, aromatic agents, colorants, etc., if necessary.
(5) Powder formulations should be stored in a sealed manner; those containing volatile drugs or hygroscopic powders should be stored in airtight containers.
(6) To prevent gastric acid from destroying the active ingredients in biological powder formulations, neutralizing components may be added to the diluents of the powder formulations.
(7) For powder formulations used in burn treatment that are not sterile preparations, the label should indicate “non-sterile preparation”; the product instructions should state “this product is a non-sterile preparation,” and under indications, it should clearly state “for mild burns”; under precautions, it should specify “should be used as directed by a physician.”
Quality Inspection Items and Requirements
Particle Size: The weight of the powder passing through a No. 7 sieve (for Chinese medicine, through a No. 6 sieve) for chemical topical powder formulations and those used for burns or severe wounds, as well as pediatric powder formulations, must not be less than 95%.
Uniformity of Appearance: Color should be uniform, without patterns or color spots.
Moisture: Must not exceed 9.0%
Editor: Hou Po
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