Clopidogrel hydrogen sulfate tablets and preparation method thereof
A technology of clopidogrel bisulfate and tablets, which is applied in the fields of pharmaceutical formulations, blood diseases, extracellular fluid diseases, etc., and can solve the problems of restricting the large-scale production of clopidogrel bisulfate medicine, instability of humidity and heat, easy hydrolysis and degreasing, etc. , to achieve the effect of ensuring effectiveness and safety, smooth surface and strong stability
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Embodiment 1
[0020] Prescription (preparation of 1000 tablets)
[0021] 1. Project
2. Parts by mass
3. Clopidogrel bisulfate II crystal form (calculated as C16H16ClNO2S)
4.98
5. Pregelatinized starch
6.30
7. Mannitol
8.50
9. Microcrystalline Cellulose
10.25
11. Low-substituted hydroxypropyl cellulose
12.30
13. PEG6000
14. 5
15. Hydrogenated castor oil
16. 5
17. Coating material
18. 1000
[0022] Concrete steps during preparation are as follows:
[0023] 1) Dry microcrystalline cellulose, pregelatinized starch, and mannitol at 80°C until the moisture content is <10% respectively; pass polyethylene glycol 6000 through a 100-mesh sieve with a vibrating sieve, and set aside;
[0024] 2) Preparation of coating solution Add appropriate amount of coating material to 80% ethanol solution 1.2 times its weight, stir well to dissolve it, and set aside;
[0025] 3) For granule production, adjust the fan ...
Embodiment 2
[0030] Prescription (preparation of 1000 tablets)
[0031] 19. Items
20. Parts by mass
21. Clopidogrel bisulfate II crystal form (calculated as C16H16ClNO2S)
22. 98
23. Pregelatinized starch
24. 25
25. Mannitol
26. 55
27. Microcrystalline cellulose
28. 30
29. Low-substituted hydroxypropyl cellulose
30. 20
31. PEG6000
32. 10
33. Hydrogenated castor oil
34. 5
35. Coating material
36. 1000
[0032] Concrete steps during preparation are as follows:
[0033] 1) Dry microcrystalline cellulose, pregelatinized starch, and mannitol at 80°C until the moisture content is <10% respectively; pass polyethylene glycol 6000 through a 100-mesh sieve with a vibrating sieve, and set aside;
[0034] 2) Preparation of coating solution Add appropriate amount of coating material to 80% ethanol solution 1.2 times its weight, stir well to dissolve it, and set aside;
[0035] 3) For granule production, ad...
Embodiment 3
[0040] Prescription (preparation of 1000 tablets)
[0041] 37. Items
38. Parts by mass
39. Clopidogrel bisulfate II crystal form (calculated as C16H16ClNO2S)
40. 98
41. Pregelatinized starch
42. 30
43. Mannitol
44. 45
45. Microcrystalline cellulose
46. 30
47. Low-substituted hydroxypropyl cellulose
48. 25
49. PEG6000
50. 10
51. Hydrogenated castor oil
52. 5
53. Coating material
54. 1000
[0042] Concrete steps during preparation are as follows:
[0043] 1) Dry microcrystalline cellulose, pregelatinized starch, and mannitol at 80°C until the moisture content is <10% respectively; pass polyethylene glycol 6000 through a 100-mesh sieve with a vibrating sieve, and set aside;
[0044] 2) Preparation of coating solution Add appropriate amount of coating material to 80% ethanol solution 1.2 times its weight, stir well to dissolve it, and set aside;
[0045] 3) For granule production, adju...
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