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A technology for cephalexin capsules and cephalexin, which is applied in the field of chemical medicine and can solve the problems of low similarity of the dissolution curve of the product and the reference preparation, the detection method not conforming to the quality research, and the inequivalence.
Pending Publication Date: 2020-12-04
NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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Problems solved by technology
[0004] The difficulty of the present invention is that the original prescription process and quality standards cannot meet the technical requirements of the current new policy. For example, the dissolution curves of the products prepared by the prior art and the reference preparation are relatively low in similarity, and there is a risk of non-equivalent in vivo. The method also does not meet the relevant requirements of quality research and needs to be completely redeveloped, and since the consistency evaluation of the two specifications of the variety is carried out at the same time, and the small specification applies for exemption from clinical trials, the same prescription process must be applicable to products of different specifications of the variety
Method used
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Embodiment 1
[0027] Example 1: 0.25g specification production verification batch / clinical experiment batch, batch size 600,000 capsules / batch, batch number E312171161
[0028] A. Weigh the cephalexin raw material (150kg in dry form), microcrystalline cellulose-carboxymethyl cellulose sodium compound and magnesium stearate, first mix the cephalexin raw material, microcrystalline cellulose-carboxymethyl Add the cellulose sodium compound into the hopper, set the mixing speed at 15rpm / min, and the mixing time is 9min. After the mixing is completed, pause, add the internally added magnesium stearate and continue mixing for 5min at the mixing speed of 15rpm / min.
[0029] B. After the mixing is completed, the materials are added to a dry granulator for dry granulation, and the calculated yield is 95.35% after the granulation is completed.
[0030] C. Weigh the added magnesium stearate and add it into the hopper, set the mixing speed to 15rpm / min, and the mixing time to 3min, and store it in the i...
Embodiment 2
[0033] Example 2: 0.125g specification production verification batch, batch size 1.2 million grains / batch, batch number E371190102
[0034] A. Weigh the cephalexin raw material (150kg in dry form), microcrystalline cellulose-carboxymethyl cellulose sodium compound and magnesium stearate, first mix the cephalexin raw material, microcrystalline cellulose and carboxymethyl cellulose Sodium cellulose was added into the hopper, the mixing speed was set to 15rpm / min, and the mixing time was 9min. After the mixing was completed, it was paused, and after adding the internally added magnesium stearate, the mixing was continued for 5min, and the mixing speed was 15rpm / min.
[0035] B. After the mixing is completed, the materials are added to the dry granulator for dry granulation, and the calculated yield after the granulation is 99.1%.
[0036] C. Weigh the added magnesium stearate and add it to the hopper, set the mixing speed to 15rpm / min, and the mixing time to 3min, and store it in...
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Abstract
The invention discloses a preparation method of a cefalexin capsule, and belongs to the technical field of medicines. The method comprises the following steps of: by using cefalexin as a raw material,adding auxiliary materials into the raw material, performing mixing, carrying out dry granulation, filling and packaging to finally obtain a cefalexin capsule preparation, wherein the auxiliary materials include a microcrystalline cellulose-sodium carboxymethylcellulose compound. The national pharmacopoeia standard is met, the effect equal to the quality level of a reference preparation can be achieved, part of quality indexes are even superior to those of the reference preparation, and clinical experiments show that the cefalexin capsule preparation is clinically equivalent to the referencepreparation; and meanwhile, the product quality is improved, consistency evaluation is passed, the method has the advantages of being simple in process, suitable for large-scale industrial productionand the like, and the cefalexin capsule has been commercially produced and sold at present.
Description
technical field [0001] The invention belongs to the field of chemical medicine, and in particular relates to a preparation method of cephalexin capsules. Background technique [0002] Cefalexin belongs to the first generation of oral cephalosporin antibiotics, which was first synthesized by Eli Lilly Company of the United States in 1967. It is a drug widely used in clinical practice. The medicinal chemical name is (6R,7R)-3-methyl-7-[(R)-2-amino-2-phenylacetamido]-8-oxo-5-thia-1-azabicyclo[ 4.2.0] Oct-2-ene-2-carboxylic acid monohydrate, molecular formula C 16 h 17 N 3 o 4 S·H 2 O, with a molecular weight of 365.41, its capsule dosage form is suitable for acute tonsillitis, angina, otitis media, sinusitis, bronchitis, pneumonia and other respiratory tract infections, urinary tract infections and skin and soft tissue infections caused by sensitive bacteria. [0003] According to the "Opinions on Carrying Out the Consistency Evaluation of the Quality and Efficacy of Gene...
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