Nateglinide tablet and preparation method thereof
A technology for nateglinide and glinide tablets, applied to the field of nateglinide tablets and their preparation, can solve the problems of exhausted β-cell function, long action time, increased hypoglycemia, etc.  The effect of complete dissolution and simple excipients
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Embodiment 1
[0044] 10,000 tablets of nateglinide tablets (specification 30mg) contain the following components:
[0045] Nateglinide 300g 36.3%
[0046] Starch 35g 4.2% Bulking agent
[0047] Microcrystalline Cellulose 100g 12.1% Filler
[0048] Silica 15g 1.8% glidant
[0049] Substituted hypromellose (L-HOLC 31 ) 25g 3.0% binder
[0050] Sodium Carboxymethyl Starch 350g 42.3% Disintegrant
[0051] in:
[0052] Add sodium carboxymethyl starch 130g 15.7%
[0053] Extra sodium carboxymethyl starch 220g 26.6%
[0054] Magnesium Stearate 2g 0.3% Lubricant
[0055] The preparation method comprises the following steps:
[0056] Step 1: Pass nateglinide through a 60-mesh sieve, and microcrystalline cellulose, starch, and sodium carboxymethyl starch through a 80-mesh sieve or a 60-mesh sieve for later use;
[0057] The second step: prepare the main drug and auxiliary materials according to the prescription quantity:
[0058] A. Preparation of the main drug: Weigh the prescribed amount...
Embodiment 2
[0062] 10,000 tablets of nateglinide (specification 60mg) contain the following components:
[0063] Nateglinide 600g 39.9%
[0064] Starch 80g 5.3% filler
[0065] Microcrystalline Cellulose 240g 16.0% Filler
[0066] Silica 40g 2.6% Glidant
[0067] Substituted hypromellose (L-HOLC 31 ) 60g 4.0% binder
[0068] Sodium Carboxymethyl Starch 480g 32.0% Disintegrant
[0069] in:
[0070] Add sodium carboxymethyl starch 180g 12.0%
[0071] Add sodium carboxymethyl starch 300g 20.0%
[0072] Magnesium Stearate 3g 0.2% Lubricant
[0073] The preparation method is the same as in Example 1.
Embodiment 3
[0075] 10,000 tablets of nateglinide (specification 120mg) contain the following components:
[0076] Nateglinide 1200g 50.6%
[0077] Starch 120g 5.1% filler
[0078] Microcrystalline Cellulose 320g 13.5% Filler
[0079] Silica 60g 2.5% glidant
[0080] Substituted hypromellose (L-HOLC 31 ) 100g 4.2% binder
[0081] Sodium Carboxymethyl Starch 570g 24.1% Disintegrant
[0082] in:
[0083] Add sodium carboxymethyl starch 220g 9.3%
[0084] Extra sodium carboxymethyl starch 350g 14.8%
[0085] Magnesium Stearate 6g 0.3% Lubricant
[0086] The preparation method is the same as in Example 1.
[0087] Three batches of samples were prepared according to the prescription process provided by the present invention. At a temperature of 25°C and a humidity of 60% + 10%, a long-term 12-month investigation has been completed. The inspection results: one side is smooth, the disintegration time limit, and content uniformity meet the requirements of the Pharmacopoeia. The dissoluti...
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