Medicinal atorvastatin calcium composition capsules for treating coronary heart disease
A technology of atorvastatin calcium and composition, applied in the field of medicine, can solve the problems of high water content of sulfobutyl-β-cyclodextrin, degradation of atorvastatin calcium, low bioavailability and the like, and achieve water and impurities. Low content, reduced myalgia side effects, improved solubility
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[0034] Example 1: Preparation of Atorvastatin Calcium Crystal
[0035] Dissolve atorvastatin calcium in a mixed solvent of ethanol and N-methylpyrrolidone whose volume is 10 times the weight of atorvastatin calcium at 35°C. The volume ratio of ethanol and N-methylpyrrolidone is 3:1. After the dissolution is complete, add chloroform solvent with a volume of 8 times the weight of atorvastatin calcium, reduce the temperature to room temperature within 2 hours, keep it at room temperature for 3 hours, and then further reduce the temperature to -5°C, and then- Place it at 5°C for 3 hours to precipitate crystals and obtain atorvastatin calcium crystals.
[0036] The X-ray powder diffraction pattern of the prepared atorvastatin calcium crystal measured by Cu-Kα rays is as follows figure 1 Shown.
Example Embodiment
[0037] Example 2: Preparation of Atorvastatin Calcium Capsules
[0038] Prescription: 1 part by weight of the atorvastatin calcium crystal compound prepared in Example 1, 15 parts by weight of starch, 0.4 parts by weight of hypromellose, 0.25 parts by weight of dioctyl sulfosuccinate sodium, 95% ethanol 3.1 parts by weight, 0.7 parts by weight of talc;
[0039] Preparation:
[0040] (1) Raw and auxiliary material processing: sieving atorvastatin calcium through 100 mesh;
[0041] (2) Weighing: Weigh according to the craft prescription;
[0042] (3) The preparation of the adhesive: take the prescription amount of hypromellose and dioctyl sodium sulfosuccinate and dissolve it in 95% ethanol for use;
[0043] (4) Mixing granulation: Add atorvastatin calcium and starch to the wet mixing granulator, turn on the mixing motor for dry mixing for 10 minutes; add the prepared binder for wet mixing and cutting, and use a 16 mesh sieve to make soft material;
[0044] (5) Drying: add the wet granul...
Example Embodiment
[0048] Example 3: Preparation of Atorvastatin Calcium Capsules
[0049] Prescription: 1 part by weight of the atorvastatin calcium crystal compound prepared in Example 1, 18 parts by weight of starch, 0.5 parts by weight of hypromellose, 0.3 parts by weight of dioctyl sulfosuccinate sodium, 95% ethanol 3.2 parts by weight, 0.8 parts by weight of talc;
[0050] Preparation:
[0051] (1) Raw and auxiliary material processing: sieving atorvastatin calcium through 100 mesh;
[0052] (2) Weighing: Weigh according to the craft prescription;
[0053] (3) The preparation of the adhesive: take the prescription amount of hypromellose and dioctyl sodium sulfosuccinate and dissolve it in 95% ethanol for use;
[0054] (4) Mixing granulation: Add atorvastatin calcium and starch to the wet mixing granulator, turn on the mixing motor for dry mixing for 10 minutes; add the prepared binder for wet mixing and cutting, and use a 16 mesh sieve to make soft material;
[0055] (5) Drying: add the wet granule...
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