Analgesic tramadol hydrochloride oral disintegrating tablet and preparing method thereof
A technology of tramadol hydrochloride and orally disintegrating tablet is applied in the field of analgesic tramadol hydrochloride tablet orally disintegrating tablet and its preparation field, which can solve the problem of inconvenient administration and insufficient release of ordinary tablets and capsules. and other problems, to achieve the effect of short development cycle, alleviation of gastrointestinal discomfort, and small capital investment
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Embodiment 1
[0031] Suspend 50 g of the main drug tramadol hydrochloride in 75 g of hydroxyethyl cellulose aqueous solution to form solution A. According to the formula in auxiliary material 1, 25 g of gelatin, 645 g of mannitol, 5 g of spices and 250 g of sucrose are mixed and dissolved to form a solution B. Mix the formed solution A with solution B, add an appropriate amount of water to dilute, and mix well, add it to the mold to freeze at low temperature, put it in a freeze dryer to vacuum, sublimate the ice until the material is completely dry, press seal, and pack.
[0032] The total weight of five kinds of auxiliary materials is 1kg, and 1000 tablets are made, each auxiliary material is 1g, and the main drug tramadol hydrochloride is 50mg.
Embodiment 2
[0034] Suspend 100g of the main drug tramadol hydrochloride in 100g of hydroxyethyl cellulose aqueous solution to form solution A, according to the formula in auxiliary material 1, then mix and dissolve 45g of gelatin, 800g of mannitol, 10g of spices and 300g of sucrose to form a solution B. Mix the formed solution A with solution B, add an appropriate amount of water to dilute, and mix well, add it to the mold to freeze at low temperature, put it in a freeze dryer to vacuum, sublimate the ice until the material is completely dry, press seal, and pack.
Embodiment 3
[0036] prescription:
[0037] Tramadol Hydrochloride 50g
[0038] Ethylcellulose 17.45g
[0039] Polyvinylpyrrolidone 4.40g
[0040] Silica 3.65g
[0041] Cross-linked polyvinylpyrrolidone 50.0g
[0042] Granular Mannitol 173.0g
[0044] Lemon essence 5.0g
[0045] Aspartame 20.0g
[0046] Magnesium Stearate 2.0g
[0047] Makes 1000 pieces
[0048] Preparation method:
[0049] 1. Dissolve ethyl cellulose in ethanol, add polyvinylpyrrolidone and 1 / 3 amount of silicon dioxide while stirring, and keep stirring (the suspension should be kept stirring during the whole granulation and coating process).
[0050] 2. Put the sieved tramadol hydrochloride raw material and 2 / 3 amount of silicon dioxide into the fluidized bed, heat under the air flow, spray the prepared suspension on the raw material, and granulate.
[0051] 3. When the suspension is sprayed to about 1 / 3 of the volume, take out the raw material granules and sieve through a 500μm ...
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