Cefcapene pivoxil hydrochloride composition and preparation method thereof
A technology of cefcapene hydrochloride and composition, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, sugar-coated pills, etc., can solve the problems of unqualified dissolution rate and difficult disintegration of cefcapene hydrochloride tablets, etc. Achieve good disintegration effect
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Embodiment 1
[0062] Embodiment 1: Cefcapene Pixil Hydrochloride Tablets
[0063] Prescription composition (1000 tablets) weight (g) weight percentage (%)
[0064] Cefcapene pivoxil hydrochloride 137 62.3
[0065] Starch 52.2 23.7
[0066] Sucrose 17.6 8
[0067] Croscarmellose sodium 11 5
[0068] 30% ethanol solution appropriate amount
[0069] Magnesium stearate 2.2 1
[0070] Preparation method: first crush and sieve the cefcapene pivoxil hydrochloride raw material to control the particle size to be less than 80 μm, then mix the prescribed amount of cefcapene pixil hydrochloride, starch, sucrose, and croscarmellose sodium, and add 30% Appropriate amount of ethanol solution, wet granulation, drying at 40°C, adding the prescribed amount of magnesium stearate, mixing, tableting, film-coating.
[0071] Determination of dissolution: in 1000ml of buffered saline solution with a pH value of 6.8, the paddle method was used to determine the speed of rotation at 50 rpm. The disintegration ...
Embodiment 2
[0072] Embodiment 2: Cefcapene Pixil Hydrochloride Tablets
[0073] Prescription composition (1000 tablets) weight (g) weight percentage (%)
[0074] Cefcapene pivoxil hydrochloride 137 62.3
[0075] Starch 63.2 28.7
[0076] Sucrose 6.6 3
[0077] Sodium carboxymethyl starch 11 5
[0078] Magnesium stearate 2.2 1
[0079] Preparation method: First, crush and sieve the raw materials of cefcapene hydrochloride to control the particle size to be less than 80 μm, then mix the prescribed amount of cefcapene hydrochloride, starch, sucrose, and sodium carboxymethyl starch, dry granulate After granulation, add the prescribed amount of magnesium stearate, mix well, compress into tablets, and coat with film.
[0080] Determination of dissolution: in 1000ml of buffered saline solution with a pH value of 6.8, the paddle method was used to determine the speed of rotation at 50 rpm. The disintegration time is 8 minutes, and the dissolution rate is 75%.
Embodiment 3
[0081] Embodiment 3: Cefcapene Pixil Hydrochloride Tablets
[0082] Prescription composition (1000 tablets) weight (g) weight percentage (%)
[0083] Cefcapene pivoxil hydrochloride 137 62.3
[0084] Starch 36.7 16.7
[0085] Sucrose 33 15
[0086] Crospovidone 11 5
[0087] Magnesium stearate 2.2 1
[0088] Preparation method: First, crush and sieve the cefcapene pivoxil hydrochloride raw material to control the particle size to be less than 80 μm; After granulation, add the prescribed amount of magnesium stearate, mix well, compress into tablets, and coat with film.
[0089] Determination of dissolution: in 1000ml of buffered saline solution with a pH value of 6.8, the paddle method was used to determine the speed of rotation at 50 rpm. The disintegration time is 4 minutes, and the dissolution rate is 75%.
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