Preparation process of traditional Chinese medicine mixture

The preparation process of the traditional Chinese medicine mixture is: leaching→purification→concentration→packing→sterilization.

1. Leaching: Generally, it is operated according to the boiling method. Each time it is boiled for 1 to 2 hours, it is boiled for 2 to 3 times. Medicinal materials containing aromatic volatile components such as peppermint, schizonepeta, chrysanthemum, Bupleurum, etc., can be steamed first or according to the characteristics of the active ingredients of the medicinal materials, using different concentrations of ethanol or other solvents, using osmosis, reflux extraction, etc. mention.

2. Purification: Herbal decoction liquid containing starch, mucilage, protein, pectin and sediment, plant tissue and other impurities, after static filtration, further purification is required.

Commonly used purification methods include high-speed centrifugation, ethanol precipitation, adsorption clarification, and the like. The purification method and the selection of its parameters (such as the amount of alcohol, the amount of clarifying agent, and the speed of centrifugation) should be based on the content of the active ingredient.

3. Concentration: The purified decoction should be properly concentrated. The concentration should be based on the thermal stability of the active ingredient of the drug. The appropriate method is used. The method of concentration under reduced pressure or concentrated film is usually used. The concentration is generally 10 per dose. ~20m1 is suitable. The alcohol solution purified by the alcohol precipitation should be first recovered from ethanol and then concentrated. After the liquid is concentrated to the specified requirements, appropriate flavoring agents and preservatives may be added as appropriate.

4. Packing: The prepared liquid should be filled in a clean, dry and sterilized glass bottle as soon as possible, the rubber plug is covered, and the cap is sealed.

5. Sterilization: Sterilization should be carried out immediately after sealing. Small packages are usually steamed or boiled for sterilization, and large packages can be sterilized by hot pressing to ensure sterilization. For the mixture used in a short period of time and prepared under strict escaping conditions, an appropriate amount of preservative may be added without sterilization, but the packaging container used should be clean and dry.

The following points should be noted when preparing Chinese medicine mixture:

1 If the prescription contains tincture, expectorant or extract, it should be slowly added into the liquid with a fine flow. With the stirring, the precipitate is fine and evenly dispersed;

2 should reduce pollution during the preparation process, as fast as possible, shake when serving

[Composition]

The main component of this preparation is human immunoglobulin, which is prepared by cold ethanol fractionation of human plasma from healthy donors. The manufacturing process contains a step to remove anticomplementary activity and a dual viral inactivation process. It contains a suitable amount of glucose or maltose as stabilizer (see table below), but does not contain any antiseptic or antibiotic. The distribution of IgG subclasses is close to the serum level of normal subjects and maintains the bioactivity of Fc fragment of IgG.

[Indications]

1. Primary agammaglobulinemia, such as X-linked hypogammaglobulinemia, common variant immunodeficiency diseases, immunoglobulin G subclass deficiency, etc.

2. Secondary immunoglobulin deficiency diseases, such as severe infection, septicemia of newborn, etc

3. Autoimmune diseases, such as primary thrombocytopenic purpura, Kawasaki disease

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