9 results about "Rosuvastatin Calcium" patented technology

The invention relates to a detection method for related substances of a rosuvastatin calcium intermediate and application of the detection method, and provides a specific detection method for related substances of the rosuvastatin calcium intermediate as shown in a formula (I), an impurity 1 compound, an impurity 2 compound and an impurity 3 compound. Wherein the separation degrees of peak positions of the impurities (the impurity 1, the impurity 2 and the impurity 3) and the target intermediate (the compound of the formula (I)) are good (the separation degrees are all greater than 1.5, and the tailing factors are all between 0.8 and 1.8), the content of each impurity can be detected at a lower concentration, and the detection sensitivity is higher; the detection method is used for central control detection of the key intermediate of the rosuvastatin calcium, the detection efficiency is improved, and the method can be used for impurity attribution and detection of related substances of the key intermediate of the rosuvastatin calcium, and has positive effects and practical application values; in addition, the safety control of the rosuvastatin calcium medicine can be enhanced.

The application discloses a method for detecting the dissolution curve of ezetimibe and rosuvastatin calcium tablets, and belongs to the technical field of drug detection. The method uses an aqueous solution containing 0.1-0.3 wt% polysorbate 80 as a dissolution medium, and performs dissolution according to a dissolution instrument basket method, wherein the rotating speed of the rotating basket is 50-100 revolutions per minute, and the mesh number of the rotating basket is 10 meshes. The method provided by the application has good dissolution for both ezetimibe and rosuvastatin calcium, and has the characteristics of strong specificity, high sensitivity, high accuracy, good durability and the like, can effectively distinguish the difference between self-prepared preparations and reference preparations, and is more universal and practical, and is more simple and efficient in operation.

A solid pharmaceutical composition comprising amlodipine or its pharmaceutically acceptable salt, in particular amlodipine besylate, ramipril and rosuvastatin or its pharmaceutically acceptable salt, in particular rosuvastatin calcium, in a single dosage unit, a process for its preparation and a single dosage unit comprising it. The composition finds its use in the treatment of cardiovascular diseases.

The invention discloses a preparation method of rosuvastatin calcium tablets, and belongs to the field of pharmacy. The rosuvastatin calcium tablet comprises the following components: a raw material medicine: rosuvastatin calcium, and auxiliary materials: lactose, microcrystalline cellulose, hydrophobic colloidal silicon dioxide and magnesium stearate. The preparation method of the rosuvastatin calcium tablet comprises the steps of weighing according to the prescription amount, crushing and sieving pretreatment of the raw materials, sieving pretreatment of whole particles of the auxiliary materials, premixing, feeding and total mixing, tabletting and the like. The prepared rosuvastatin calcium tablet is relatively good in medicine quality, high in stability and relatively few in waste products.

The invention provides the preparation method of the ezetimibe and rosuvastatin calcium composition, which ensures the long-term stability of the preparation, is simple and convenient in process and is suitable for industrial production. According to the preparation method, conventional accessible equipment is adopted for preparation, key quality attributes of intermediate products in the preparation process are strictly controlled, the prepared finished product is stable in quality in the long-term storage process, and the total degradation product is smaller than 2.5% after the finished product is stored for 36 months.

The application provides a nanocrystal drug composition containing rosuvastatin calcium, which contains the following components in parts by weight: 100 parts of rosuvastatin calcium, 20-150 parts of a stabilizer and 200-2000 parts of a pharmaceutically acceptable carrier; the stabilizer is composed of a steric hindrance stabilizer and an electrostatic stabilizer, and the weight ratio of the two is 1:0.5 to 1:2; in the nanocrystal drug composition, the average particle size of rosuvastatin calcium is distributed between 200 nm and 800 nm, and the polydispersity index (PDI) is less than 0.2; by using a specific stabilizer combination and a preparation process, the application prepares rosuvastatin calcium into a nanocrystal with an average particle size of 200 nm-800 nm, significantly improves the solubility and dissolution rate of the drug, and the nanocrystal drug composition exhibits excellent physical stability and chemical stability under accelerated test conditions, overcomes the problems that rosuvastatin calcium is unstable to light, moisture and heat and the bioavailability of existing preparations is limited, and has significant clinical application value.

This invention discloses a compound tablet containing sacubitril / valsartan and rosuvastatin calcium, and its preparation method, belonging to the field of pharmaceutical preparation technology. The technical solution comprises: an active ingredient and pharmaceutical excipients; the active ingredient includes sacubitril / valsartan sodium and rosuvastatin calcium; the pharmaceutical excipients include fillers, binders, disintegrants, stabilizers, glidants, lubricants, and a gastrointestinal film-coating premix; the tablets are prepared using a dry granulation process. This invention solves the problems of poor adherence to single-drug use, asynchronous dissolution, and insufficient stability, achieving a synergistic effect of lowering blood pressure and lipids. Furthermore, the preparation process is simple, efficient, and suitable for industrial production.

The invention provides a rosuvastatin calcium oral instant film preparation. The rosuvastatin calcium oral instant film preparation comprises rosuvastatin calcium, a stabilizer, a high-water-solubility film-forming material and pharmaceutically acceptable auxiliary materials. The rosuvastatin calcium oral instant film preparation has good stability, the dissolution rate of the rosuvastatin calcium oral instant film preparation in a hydrochloric acid medium with the pH value of 1.0 within 15 min is larger than 85%, and the dissolution curve of the rosuvastatin calcium oral instant film preparation is close to that of commercially available rosuvastatin calcium oral disintegrating tablets. The invention also provides a preparation method of the rosuvastatin calcium oral instant film preparation, which comprises the following steps: (1) mixing rosuvastatin calcium with the stabilizer, and carrying out micronization treatment to obtain a mixture 1; (2) dispersing a high-water-solubility film-forming material into purified water, and dissolving to obtain a film-forming solution; and (3) adding the mixture in the step (1) into the film forming liquid, and uniformly mixing to obtain a mixture 2.

This invention relates to the field of pharmaceutical analysis technology and discloses a method for detecting the content of ezetimibe and rosuvastatin calcium tablets using a reversed-phase chromatography system. The method employs high-performance liquid chromatography (HPLC) with 0.1% trifluoroacetic acid solution as mobile phase A, acetonitrile as mobile phase B, and methanol as mobile phase C. Gradient elution is performed using an octadecylsilane-bonded silica column. The detection wavelength is 242 nm, and the injection volume is 10 μL. The content of ezetimibe and rosuvastatin calcium is calculated using the external standard method. This method can effectively separate the two main components from various degradation impurities, exhibiting good peak shape and excellent resolution. It meets the requirements for pharmaceutical quality control in terms of specificity, limit of quantitation, limit of detection, linear range, precision, accuracy, repeatability, and robustness. The system is stable and provides a reliable technical solution for the quality detection of ezetimibe and rosuvastatin calcium tablets.