Pill Formulations
Classification
1. By Excipients: Water pills, honey pills, water-honey pills, concentrated pills, paste pills, wax pills, etc.2. By Preparation Method:General pills – water pills and some water-honey pills, concentrated pills, paste pills;Plastic pills – honey pills and some paste pills, concentrated pills;Drop pills.
Water Pills
1. Characteristics:Advantages:(1) Small particles, smooth surface, easy to take, not easily absorb moisture, beneficial for storage;(2) Can be layered according to the properties of the herbs. Volatile and irritating herbs can be placed in the inner layer to mask unpleasant odors and enhance the stability of volatile components; or slow-release and fast-release herbs can be placed in the inner and outer layers, respectively, to create long-acting formulations;(3) Easily dissolve and absorb, showing effects quickly, especially suitable for herbal formulas that release exterior pathogens and digestive aids;(4) Simple production equipment, can be prepared in small or large quantities.Disadvantages:Often made from finely powdered herbs, which can lead to microbial contamination; uniformity and dissolution time of the herbs can be difficult to control. 2. Excipients:Moistening agents, binders, water (the most commonly used excipient), alcohol, vinegar, herbal juices.
Honey Pills
1. Purpose::To remove impurities, destroy enzymes, kill microorganisms, reduce moisture content, increase viscosity, etc.2. Honey Refining Specifications:① Young HoneyRefining temperature: 105–115°C;Moisture content: 17%–20%;Refining degree: slightly sticky;Applicable herbal powders: suitable for those with high mucilage, cavity, sugar, starch, fat, animal tissue, etc.② Medium HoneyRefining temperature: 116–118°C;Moisture content: 14%–16%;Refining degree: fish-eye bubbles, sticky, no long white threads;Applicable herbal powders: medium stickiness, used in most honey pills.③ Old HoneyRefining temperature: 119–122°C;Moisture content: <10%;Refining degree: cow-eye bubbles, drops form beads, strong stickiness, forms white threads;Applicable herbal powders: poorly sticky mineral herbs, high-fiber herbal powders.
Concentrated Pills
1. Alias::Also known as medicinal paste pills, extract pills. 2. Characteristics::Advantages:— Small volume and dosage, easy to absorb, convenient for taking, carrying, and storage;Disadvantages:— The concentration process requires longer heating time, and some components may be affected. 3. Classification::Concentrated water pills, concentrated honey pills, concentrated water-honey pills.
Paste Pills
Characteristics:(1) Slow dissolution, slow drug release, can prolong efficacy, reduce gastrointestinal irritation;(2) Toxic or irritating herbs, as well as those requiring delayed efficacy, can be made into paste pills.
Wax Pills
Characteristics:(1) Insoluble in the body, slowly and persistently releases medication, prolonging efficacy;(2) Strongly toxic or irritating drugs can be made into wax pills to reduce toxicity and irritation;(3) The control of drug release rate is difficult, and there are few varieties of wax pills.
Drop Pills
1. Characteristics:(1) High bioavailability, poorly soluble drugs can form homogeneous dispersions in water-soluble matrices, with fast dissolution speed and rapid effect, suitable for emergency treatment;(2) Accurate dosage, uniform dispersion of drugs in the matrix, small weight differences;(3) Different matrices can be selected to create formulations with different drug release rates (such as sustained-release, controlled-release formulations), allowing liquid medications to be homogenized;(4) Simple production equipment, short production cycle, high degree of automation, and lower production costs;(5) Smaller drug loading capacity, and currently, there are few ideal matrices and condensing agents available, limiting its development. 2. Matrices:(1) Water-soluble matrices—polyethylene glycol (4000, 6000), sodium stearate, poloxamer, glycerin gelatin, gelatin;(2) Non-water-soluble matrices—stearic acid, monostearin, beeswax, carnauba wax, octadecanol, hydrogenated vegetable oil.
Sugar Pills
Sweet taste, easy to dissolve, suitable for pediatric use, commonly used in vaccine formulations.
Coating of Pills1. Types and Materials:① Medicinal CoatingMaterials:Extremely fine powder made from prescription herbs;Common medicinal coatings:Red lead coating, Huangbai coating, realgar coating, Qingdai coating, Baicao powder coating; ② Protective Coating:Film coating, sugar coating, colored sugar coating, gelatin coating; ③ Enteric Coating:Acrylic resin, cellulose acetate phthalate, etc. Quality Requirements 1. Moisture Requirements:(1) In honey pills and concentrated honey pills ≤15.0%;(2) In water-honey pills and concentrated water-honey pills ≤12.0%;(3) In water pills, paste pills, and concentrated water pills ≤9.0%;(4) Wax pills and drop pills are not checked for moisture. 2. Dissolution Time Limits:(1) Large honey pills are not checked for dissolution time limits;(2) Small honey pills, water-honey pills, water pills, coated drop pills: all should dissolve within 1 hour;(3) Concentrated pills and paste pills: all should dissolve within 2 hours;(4) Drop pills: all should dissolve within 30 minutes;(5) Wax pills: 2 hours, 1 hour; in hydrochloric acid solution (9→1000) checked for 2 hours, no cracks, disintegration, or softening should occur, then checked in phosphate buffer (pH 6.8), all should disintegrate within 1 hour.
Editor: Shuicao
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