Metformin hydrochloride tablet and application thereof
A technology of metformin hydrochloride tablets and metformin hydrochloride, applied in pill delivery, medical preparations containing non-active ingredients, medical preparations containing active ingredients, etc., can solve problems such as not being suitable for the medical field, and achieve high absorption and utilization in the small intestine , The effect of stable dissolution efficiency and stable dissolution rate
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Embodiment 1
[0029] A metformin hydrochloride tablet, its formula is as follows (each tablet contains metformin hydrochloride 500mg):
[0030] Metformin hydrochloride 500g, low molecular weight xanthan gum (2.5×10 6 Da) 105g, high molecular weight xanthan gum (15 x 10 6 Da) 50g, stearyl alcohol 80g, microcrystalline cellulose 175g, hydroxypropyl methylcellulose 60g, magnesium stearate 8g;
[0031] The preparation process is as follows:
[0032] Weigh all the medicines in each prescription (except magnesium stearate), pass through 80-mesh sieve respectively, then add them to the wet mixing granulator in turn, dry mix for 10 minutes, then add appropriate amount of distilled water as wetting agent to make soft material, pass 16 Mesh sieve granulation;
[0033] Dry the wet granules in an oven at 50°C, pass through a 14-mesh sieve for granulation;
[0034] Put the whole granules in a mixer, then add magnesium stearate to make it evenly mixed;
Embodiment 2
[0036] A kind of metformin hydrochloride tablet, its formula is as follows:
[0037] Metformin hydrochloride 500g, low molecular weight xanthan gum (3×10 6 Da) 100g, high molecular weight xanthan gum (14 x 10 6 Da) 55g, stearyl alcohol 75g, microcrystalline cellulose 173g, hydroxypropyl methylcellulose 65g, magnesium stearate 10g;
[0038] The preparation process is as follows:
[0039] Weigh all the medicines in each prescription (except magnesium stearate), pass through 80-mesh sieve respectively, then add them to the wet mixing granulator in turn, dry mix for 10 minutes, then add appropriate amount of distilled water as wetting agent to make soft material, pass 16 Mesh sieve granulation;
[0040] Dry the wet granules in an oven at 50°C, pass through a 14-mesh sieve for granulation;
[0041] Put the whole granules in a mixer, then add magnesium stearate to make it evenly mixed;
Embodiment 3
[0057] 1. Stability test:
[0058] Adopt the tablet among the embodiment 1 to carry out stability study, investigate the tablet that makes with this prescription process at 30 ℃, the stability of placing 6 months under the condition of relative humidity 80%. They were measured at the 0th, 1st, 3rd, and 6th months respectively, see Table 1 for details.
[0059] Table 1
[0060] time month content% Release% 0 100 qualified 1 100 qualified 3 100 qualified 6 99.9 qualified
[0061] Above stability test result shows, with the tablet of embodiment 1 through the stability accelerated test of 6 months, each index all reaches the standard, and its stability meets the requirement.
[0062] 2. Dissolution test.
[0063] From figure 1 It can be seen that the dissolution rate of metformin hydrochloride in the artificial intestinal juice in the tablet of Example 1 was 24.9% in 1 hour, 47.6% in 3 hours, 60.7% in 6 hours, 81.4% in 9 hours, and...
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Abstract
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