Rapid-dissolution mitiglinide preparation, and preparation method and detection method thereof
A technology for mitiglinide calcium and preparations, which is applied to rapidly dissolving mitiglinide calcium preparations and the fields of preparation and testing thereof, can solve the problems of affecting patient confidence, high failure rate, weight gain, etc., and avoid granulation time. And the mixing speed is too low, it is not easy to generate dust, and the properties are uniform.
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Embodiment 1
[0031] Embodiment 1 A kind of mitiglinide calcium tablet of rapid dissolution
[0032] 5 parts of mitiglinide calcium; 40 parts of lactose; 30 parts of microcrystalline cellulose; 20 parts of starch; 55 parts of hypromellose E; 5 parts of carboxymethyl starch; 0.1 part of magnesium stearate.
[0033] The particle size of the mitiglinide calcium bulk drug D(0.5)≤10 μm, D(0.9)≤40 μm.
[0034] Prepare the method for the described mitiglinide calcium preparation of right, described method comprises the following steps:
[0035] 1) Miglinide calcium and lactose were mixed for 10 minutes to obtain material 1;
[0036] 2) Material 1 was put into a wet mixing granulator together with lactose, microcrystalline cellulose, starch, and 30% sodium carboxymethyl starch, and mixed at a stirring speed of 120 rpm / min for 8 minutes to obtain material 2;
[0037] 3) Prepare hypromellose E3 or E5 into an aqueous solution with a concentration of 1%-10%, add material 2 to it, and granulate to obt...
Embodiment 2
[0042] Embodiment 2 A kind of rapidly dissolving mitiglinide calcium capsule
[0043] A mitiglinide calcium preparation, characterized in that the preparation comprises the following components in parts by weight:
[0044] 5 parts of mitiglinide calcium; 30 parts of lactose; 20 parts of microcrystalline cellulose; 30 parts of starch; 1.5 parts of sodium carboxymethyl starch; 32 parts of hypromellose E; 4 parts of sodium carboxymethyl starch; 0.1 part of magnesium stearate.
[0045] The particle size of the mitiglinide calcium bulk drug D(0.5)≤10 μm, D(0.9)≤40 μm.
[0046] Prepare the method for the described mitiglinide calcium preparation of right, described method comprises the following steps:
[0047] 1) mitiglinide calcium and lactose were mixed for 5 minutes to obtain material 1;
[0048] 2) Material 1 was put into a wet mixing granulator together with lactose, microcrystalline cellulose, starch, and 40% sodium carboxymethyl starch, and mixed at a stirring speed of 10...
Embodiment 3
[0054] Embodiment 3, different granularity mitiglinide calcium crude drug preparation mitiglinide calcium tablet dissolution rate influence
[0055] Adopt the method of the present invention, other raw material proportioning and method are consistent, compare the impact of different raw material particle sizes on the dissolution rate of mitiglinide calcium tablets, the specific results are shown in Table 1 (slurry method, 50rpm, 900ml, n=6).
[0056] The influence of table 1 different granularity mitiglinide calcium bulk drug preparation mitiglinide calcium tablet dissolution
[0057]
[0058] As can be seen from Table 1, the particle size of the mitiglinide calcium raw material has a significant impact on the dissolution rate of the mitiglinide calcium tablet. The dissolution rate of mitiglinide calcium tablets can reach more than 90% in 10 minutes.
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