10 results about "Cefcapene" patented technology

The invention provides a cefcapene pivoxil composition and a preparation process thereof, and relates to the field of pharmaceutical preparations. The cefcapene pivoxil composition disclosed by the invention comprises cefcapene pivoxil particles, and the cefcapene pivoxil particles are prepared by the following process: preparing medicine carrying particles containing the cefcapene pivoxil by using the cefcapene pivoxil and pharmaceutically acceptable auxiliary materials; and heating and melting the hydrophobic coating material into a liquid state to obtain a coating solution, and coating the drug-loaded particles with the coating solution to obtain coated particles. The hydrophobic coating material is heated and melted into a liquid state to coat the drug-loaded particles, and compared with a method for coating by using solid powder, the liquid coating material has lower requirements on equipment and can more conveniently realize control on the coating speed so as to form a more uniform coating layer. And the temperature in the coating process is lower, so that the stability of the cefcapene pivoxil is ensured. In addition, no organic solvent is used in the coating process, so that the preparation is environment-friendly, organic solvent residues in the preparation are avoided, and the safety of the preparation is improved. The preparation process provided by the invention perfectly solves the problems of taste, stability and safety of the cefcapene pivoxil, reduces the requirements on production equipment, is environment-friendly, and powerfully promotes the further development and clinical application of the cefcapene pivoxil preparation.

This application relates to the field of pharmaceutical formulation technology, and particularly to a cefcarditol hydrochloride pulse formulation and its preparation method. The cefcarditol hydrochloride pulse formulation of this application comprises a first particle, a second particle, and a third particle. Each particle, from the inside out, has a particle layer, an isolation layer, and a pulse layer. The pulse layer comprises a film-forming agent and an anti-adhesion agent. The film-forming agent in the first, second, and third particles sequentially comprises one or more of the following: butyl methacrylate-(2-dimethylaminoethyl) methacrylate-methyl methacrylate copolymer, methacrylate-ethyl acrylate copolymer, methacrylate-methyl acrylate copolymer, methyl acrylate-methyl methacrylate-methacrylate copolymer, and shellac. The cefcarditol hydrochloride pulse formulation of this application allows for once-daily dosing, effectively alleviating the problems of difficulty in taking cefcarditol hydrochloride tablets and poor patient compliance.

The invention relates to the technical field of pharmaceutical analysis, and particularly discloses a method for detecting related substances in a key parent nucleus of cefcapene pivoxil hydrochloride. Detection is carried out according to the following high performance liquid chromatography conditions: a chromatographic column is GL Sciences InertSustaiin C18, 4.6 mm * 250 mm, 5 [mu] m, and the column temperature is 25 DEG C; a mobile phase is ammonium acetate solution-acetonitrile-tetrahydrofuran; the detection wavelength is 255 nm to 275 nm, the column temperature is 20 DEG C to 30 DEG C, and isocratic elution is carried out. By adopting the method provided by the invention, various impurities such as D-CPC, 7-ADCA, N-acetyl-D-7-ACA, 7-ACA, D-7-ACA lactone, cephalosporin C and the like in the key mother nucleus of the cefcapene pivoxil hydrochloride are effectively detected, and the condition of the impurities in the key mother nucleus of the cefcapene pivoxil hydrochloride is accurately, qualitatively and quantitatively detected. Therefore, the clinical safety of the cefcapene pivoxil hydrochloride product is improved.

This invention provides a method for detecting related substances in cefoperazone hydrochloride particles. The method employs high-performance liquid chromatography (HPLC), wherein mobile phase A is phosphate buffer and mobile phase B is a methanol-water mixture; the chromatographic column is a column packed with octadecylsilane-bonded silica gel; and the sample is diluted with a methanol-water (1:1) mixture at pH 3-4. This method achieves separation of the four related substances in cefoperazone particles using a single analytical method (resolution > 1.5), and the use of a specific diluent ensures the stability of impurity A during detection, thereby guaranteeing the accuracy of the results.

The present invention relates to the technical field of pharmaceutical preparations, and in particular to, a cefcapene pivoxil hydrochloride granule and a preparation method therefor. The cefcapene pivoxil hydrochloride granule has a pellet core, an isolation layer, and a taste masking layer from inside to outside; the composition of the pellet core comprises cefcapene pivoxil hydrochloride; and the composition of the taste masking layer comprises a butyl methacrylate-(2-dimethylaminoethyl) methacrylate-methyl methacrylate copolymer. The cefcapene pivoxil hydrochloride granule can ensure complete taste masking in the administration stage, and can be quickly dissolved out after administration, thereby improving the medication experience of a patient and improving compliance, and maintaining the drug efficacy.

This application relates to the field of pharmaceutical formulation technology, and particularly to a cefcaptin hydrochloride immediate-release / sustained-release composite formulation and its preparation method. The cefcaptin hydrochloride immediate-release / sustained-release composite formulation comprises a first particle and a second particle with a multi-layered coating structure. The first particle, from the inside out, comprises a first element particle (containing a first cefcaptin hydrochloride), a first isolation layer, a first sustained-release layer, an enteric coating layer, and a moisture-proof layer. The second particle, from the inside out, comprises a second element particle (containing a second cefcaptin hydrochloride), a second isolation layer, and a taste-masking layer. This cefcaptin hydrochloride immediate-release / sustained-release composite formulation of this application exhibits rapid release at pH 1–3 and slow release at pH 4–8, achieving a therapeutic effect comparable to traditional tablets administered three times daily after meals. Furthermore, this cefcaptin hydrochloride immediate-release / sustained-release composite formulation has low impurity content and high safety.

The invention discloses cefcapene pivoxil hydrochloride particles as well as a preparation method and application thereof. The cefcapene pivoxil hydrochloride particles comprise hydrophobic taste-masking particles, a hydrophilic taste-modifying layer and a hydrophilic surface modification layer, the hydrophilic taste-modifying layer is coated on at least part of the surface of the hydrophobic taste-masking particles; the hydrophilic surface modification layer is coated on at least part of the surface of the hydrophilic flavoring layer. By optimizing the particle structure design and adopting a multi-layer coated composite particle form, the hydrophilic outer layer is arranged on the basis of keeping the hydrophobic taste-masking function of the core, so that the wettability and the dispersity of the particles are remarkably improved, and the gravel feeling when the particles are taken after being mixed with water is eliminated; moreover, the sweet filler and the water-soluble adhesive are adopted in the granules, so that better dispersion of all the components can be promoted, a good taste masking effect can be ensured, and on the premise of ensuring the curative effect of the medicine, the medication compliance of child patients is remarkably improved by improving the taste, the safety and the convenience; the compound has a good application prospect in preparation of medicines for children.

The application provides a cefcapene pivoxil hydrochloride reaction device, and relates to the technical field of drug synthesis reaction equipment, which comprises a reaction kettle, an annular block is rotatably installed on the outer circumferential surface of the reaction kettle through two groups of bearings, and an extension block body is arranged on the front side of the outer circumferential surface of the annular block. The meshing transmission structure of the motor, the driving gear and the outer circumferential gear of the reaction kettle is used in cooperation with the two groups of bearings to realize the rotating cooperation of the annular block and the reaction kettle, the annular block can accurately control the extension block body to rotate 1 / 6 of the circumference of the reaction kettle clockwise each time, and the whole circumference of the reaction kettle can be completely covered after six cycles of displacement, so that the forced and full-coverage inspection is realized from the mechanical structure, and the problems of missing inspection, incomplete coverage, insufficient investigation depth and personnel absence are solved.

The invention relates to the technical field of pharmaceutical preparations, in particular to cefcapene pivoxil hydrochloride particles and a preparation method thereof. The cefcapene pivoxil hydrochloride granule is provided with a pill core, an isolating layer and a taste masking layer from inside to outside, the pill core is prepared from cefcapene pivoxil hydrochloride; the taste masking layer is prepared from a butyl methacrylate-(2-dimethylaminoethyl) methacrylate-methyl methacrylate copolymer, and the composition of the taste masking layer comprises a butyl methacrylate-(2-dimethylaminoethyl) methacrylate-methyl methacrylate copolymer. The cefcapene pivoxil hydrochloride granules can ensure complete taste masking in the taking stage after being mixed with water, and can be quickly dissolved out after being taken, so that the medicine taking experience of a patient is improved, the compliance is improved, and the curative effect of the medicine is not influenced.

The invention provides a preparation method of cefcapene pivoxil hydrochloride granules, and belongs to the technical field of preparation of pharmaceutical preparations. The preparation method comprises the following steps: S1, putting drug-containing taste-masking particles containing cefcapene pivoxil hydrochloride hydrate into a fluidized bed, adjusting the temperature to 35-45 DEG C, and adding a poloxamer 188 solution by adopting fluidized bed bottom spraying to obtain drug-containing particles of which the surfaces are coated with poloxamer; s2, mixing the silicon dioxide, the ferric oxide, the corn starch and the essence, adding the medicated particles and the sweet particles, and mixing to obtain a product. According to the method, the production process is simplified, the production cost is reduced, the production cycle is shortened, a small amount of poloxamer can be quickly dissolved and uniformly distributed on the surfaces of particles, the effect of reducing surface tension can be better exerted, drug-containing particles are prevented from gathering and floating, the drug stability is effectively improved, and the bioavailability is improved. And the drug release amount is not more than 6% according to the release amount reported by the original research drug, and the taste masking effect is good.