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Factors affecting the stability of traditional Chinese medicine

2021-03-18
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Factors affecting the stability of traditional Chinese medicine preparations

    Chemical degradation reactions of drugs: hydrolysis, oxidation, isomerization, polymerization, decarboxylation, etc. Main degradation pathways: hydrolysis and oxidation.

1. Types of drugs that are easily hydrolyzed and easily oxidized

(1) Types of easily hydrolyzed drugs

① Ester drugs: Andrographolide;

②Amide drugs: penicillin;

③Glycoside drugs: Cardiac glycosides are easily hydrolyzed. Digitalis tincture is mostly leached with 70% ethanol.

(2) Types of easily oxidized drugs

① Contains phenolic hydroxyl group or potential phenolic hydroxyl group, such as baicalin;

② Grease and volatile oil with unsaturated carbon chain.

2. Factors affecting the stability of traditional Chinese medicine preparations

(1) Prescription factors:

①pH: Liquid preparations are usually relatively stable in a specific pH range;

②The influence of solvent, matrix and other auxiliary materials.

(2) Preparation technology

(3) Storage conditions:

①Temperature;

②Light: Phenolic drugs-oxidation reaction, ester drugs-reaction, volatile oil-polymerization reaction (appropriate light-shielding container packaging should be selected);

③Oxygen and metal ions;

④Humidity and moisture;

⑤Packaging materials.

3. The packaging and storage of preparations require shading:

Use opaque containers for packaging, such as colorless, transparent, and translucent containers wrapped in brown containers or black packaging materials.

Avoid light: Avoid direct sunlight.

Airtight: Keep the container tightly closed to prevent dust and foreign objects from entering.

Seal: Seal the container to prevent weathering, moisture absorption, volatilization or foreign matter from entering.

Melt seal: Melt seal the container or seal it tightly with a suitable material. To prevent the intrusion of air and moisture and prevent pollution.

Shady and cool place: the storage temperature should not exceed 20℃.

Cool and dark place: Store under dark conditions and the temperature does not exceed 20°C.

Cold place: The storage temperature is 2℃~10℃.

Room temperature: The storage temperature is 10℃~30℃.

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