Direct oral decumbent corydalis tuber powder Chinese herbal piece
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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.
Pending Publication Date: 2017-09-15
江苏苏轩堂药业有限公司
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Physical sterilization methods such as dry heat, high temperature and high pressure steam, chemical sterilization methods such as ethylene oxide, and gamma ray sterilization methods such as cobalt-60 all have major defects, and some of the sterilization methods have poor sterilization effects. Some destroy and partially change the chemical properties of active ingredients of different structural types contained in traditional Chinese medicines of different textures, some leave nuclear substance residues, and some have pollution factors, etc.
[0009] Direct oral Chinese herbal decoction pieces are a new type of modern Chinese herbal decoction pieces that have just been defined by the state in recent years. In addition to the microbial limit standards for direct ...
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preparation example Construction
[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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Abstract
The invention provides a direct oral decumbent corydalis tuber powder Chinese herbal piece. A preparation process of the direct oral decumbent corydalis tuber powder Chinese herbal piece is as follows: (1) after being inspected, cleaned and dried, a raw material decumbent corydalis tuber is ground, so that an intermediate is obtained; (2), the intermediate is inspected, and after the intermediate is packaged, electron beam irradiation is carried out for sterilization; (3) final product standard inspection is carried out, and after packaging, the final product is obtained. In step (1), the grinding conditions are as follows: in a grade D clean area, a dust suction type cryogenic system grinding technology is applied to grind the raw material decumbent corydalis tuber into 100 to 300 meshes; and in step (2), the exposure dose of electron beam irradiation for sterilization is 3kGy to 10kGy. The total amount of an aqueous extract of the decumbent corydalis tuber (powder) product and the total amount of water-dissolved protopine and palmatine chloride in the aqueous extract can be increased by 30 to 45 percent in comparison with the total amount of an aqueous extract of the fine powder standard (100 meshes) of Chinese Pharmacopoeia and the total amount of water-dissolved protopine and palmatine chloride in an aqueous extract, and a microbial limit test result can fully come up to a related direct oral piece standard.
Description
Technical field [0001] The invention relates to a summer powder-free direct oral Chinese medicine decoction piece, which belongs to the technical field of medicine. Background technique [0002] Summer inaction, Papaveraceae Corydalis perennial herb Corydalis decumbens Corydalis decumbens [0003] (Thunb.) The dry tuber of Pers., also known as Fudiyanhusuo, Fudiyuanhu, Viola sessile, Xia Wuzong. Xiawuwu completes the life process of flowering and fruiting before the arrival of early summer, and then begins the withering of the whole plant. When the summer heat comes, there will be no plants for Xiawuwu on the ground, hence the name "Xiamenwu" [0004] Xiatianwu is a common Chinese medicinal material. It is warm in nature and pungent in taste. It has the effect of activating blood and relieving pain. It has healing effect on the treatment of congestion, redness, joint pain, bruises and rheumatoid. Moreover, the alkaloids contained in Tianwuwu have a therapeutic effect on cardiovascu...
Claims
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Application Information
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