Direct oral decumbent corydalis tuber powder Chinese herbal piece
A Chinese medicine decoction piece, direct technology, applied in the field of medicine, can solve the problems of nuclear material residue, different quality, no data, etc.
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[0059] Preparation of the reference substance solution Take 10 mg of the original opioid reference substance, accurately weigh it, and place it in a 50ml measuring flask. Add 5ml of 1% hydrochloric acid solution to dissolve it, then add methanol to the mark and shake it up. Take another 10mg of palmatine hydrochloride reference substance, accurately weigh it, put it in a 100ml measuring flask, add methanol to dissolve and dilute to the mark, and shake well. Accurately measure 5ml of each of the above two solutions, place them in the same 25ml measuring flask, add methanol to the mark, and shake well to obtain (each lml contains 40ug of original opioid and 20ug of palmatine hydrochloride).
[0060] Preparation of the test solution: Take about 0.5g of the fine powder of this product, accurately weigh it, place it in a stoppered conical flask, accurately add 50ml of methanol, weigh it, heat and reflux for 1 hour, let it cool, and then weigh it. Methanol makes up the lost weight, sha...
Embodiment 1
[0075] 120 kilograms of summer raw medicinal materials, divided into 3 experimental batches (40.0 kilograms per batch), according to the drug GMP specifications, respectively, after purification, drying, and crushing (Class D clean area, application of vacuum low-temperature crushing technology, crushing separately 100, 150, 200-300 mesh), intermediates (inspection), quantitative packaging (6 g / bag, Class D clean area), electron beam irradiation sterilization (the remaining 30% of quantitative packaging in each batch will not be carried out Sterilization process), and the obtained product (test product) is used for the experimental research of the summer powder-free best GMP production process and its quality standard of the present invention.
[0076] 1. The best production process of "Xiamen Wufen" direct oral Chinese medicine decoction pieces:
[0077] (1) The best fineness (number of meshes) production process:
[0078] The size of Xiatian rhizomeless cells is ten to several ten...
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