Classification of Powdered Formulations
Definition: A dry powder preparation made from raw medicinal substances or suitable excipients that have been crushed and uniformly mixed.
Classification methods for powdered formulations:
(1) By method of use: Mainly divided into oral powdered formulations and topical powdered formulations. Oral powdered formulations can be taken with water or dissolved in or dispersed in water or other media before consumption, such as Wu Bei San (Wubei Powder), Bu La Jiao Niang San (Bula Yeast Powder); topical powdered formulations are generally used for the mouth, skin, cavities, and throat, such as Wu Bai San (Wubai Powder), Bing Hua San (Ice Flower Powder).
(2) By number of medicinal components: Mainly divided into single powdered formulations and compound powdered formulations. Single powdered formulations consist of only one medicinal substance, such as Meng Tuo Shi San (Montmorillonite Powder), Kou Fu Liu Suan (Oral Clostridium Butyricum Powder); compound powdered formulations consist of two or more medicinal substances, such as Si Shi San (Four Stone Powder), Fu Fang Kou Qiang San (Compound Oral Powder).
(3) By dosage: Divided into dosed powdered formulations and undosed powdered formulations.
Characteristics of Powdered Formulations
① Small particle size, large specific surface area, easy to disperse, and rapid onset;
② When used externally, they cover a large area and also have protective and astringent effects;
③ Simple preparation process, easy dosage control, convenient for special populations such as infants and the elderly;
④ Convenient for packaging, storage, transportation, and carrying. However, due to the high degree of dispersion of powdered formulations, they are often significantly affected by properties such as moisture absorption, chemical activity, odor, irritability, and volatility, thus drugs sensitive to light, moisture, and heat are generally not suitable for making powdered formulations.
Quality Requirements for Powdered Formulations
(1) The medicinal substances used for powdered formulations should be crushed. Unless otherwise specified, oral powdered formulations should be fine powder, and topical powdered formulations should be the finest powder.
(2) Powdered formulations should be dry, loose, uniformly mixed, and have consistent color. When preparing powdered formulations containing toxic or precious drugs, or drugs with small dosages, the mixing should be done using the method of blending and sieving.
(3) Powdered formulations can be packaged in single doses or multiple doses, and multiple dose packages should include dosing tools. Oral powdered formulations containing toxic drugs should be packaged in single doses.
(4) Powdered formulations may contain or not contain excipients. If necessary, oral powdered formulations can also include flavoring agents, aromatic agents, colorants, etc.
(5) Unless otherwise specified, powdered formulations should be stored in a sealed manner. Powdered formulations containing volatile drugs or hygroscopic drugs should be stored in sealed containers.
Quality Inspection Items for Powdered Formulations Include:
(1) The weight of the powder passing through a No. 7 sieve for external powdered formulations and those used for burns or severe wounds must not be less than 95%.
(2) The moisture content in Chinese herbal powdered formulations should generally not exceed 9.0%.
(3) Except for Chinese herbal powdered formulations, drying at 105°C to constant weight, the weight loss should not exceed 2.0%.
(4) Topical powdered formulations used for burns, severe wounds, or those that are clinically necessary to be sterile must meet sterility requirements.
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