Magnesium valproate sustained release tablet and preparation process thereof

Abstract

The invention relates to a magnesium valproate sustained release tablet and a preparation process thereof. The magnesium valproate sustained release tablet is prepared from the following two parts: A,a tablet core prepared from the following substances: 29 to 54 percent of magnesium valproate, 17 to 21 percent of hydroxypropyl methylcellulose, 2 to 9 percent of ethylcellulose, 22 to 30 percent ofethyl alcohol, 0.8 to 4 percent of magnesium stearate, and 3 to 7 percent of talcum powder; B, a sustained release tablet coating formula prepared from the following substances: 0.7 to 2 percent of ethylcellulose, 0.7 to 1.3 percent of glycerinum, 1.3 to 4 percent of hydroxypropyl methylcellulose, and 0.3 to 1.3 percent of talcum powder. The preparation process comprises: A, a preparation processof the tablet core, comprising the steps of weighing raw materials according to tablet core formula amounts uniformly mixing, adding an appropriate amount of the ethyl alcohol, preparing a soft material, sieving and pelletizing, then baking and drying at the temperature of 55 DEG C to 65 DEG C, adding the magnesium stearate and the talcum powder, uniformly mixing, measuring the content, and pressing to form an oval tablet; B, a preparation process of the coating comprising the steps of weighing ingredients according to sustained release tablet coating formula amounts, dissolving through an appropriate amount of 50 to 100 percent ethyl alcohol, and then spraying a coating on the tablet core.

Description

technical field [0001] The invention relates to an antiepileptic drug, in particular to a sustained-release magnesium valproate tablet and a preparation process thereof. Background technique [0002] Valproic acid series drugs belong to broad-spectrum antiepileptic drugs, which are recommended as the first choice for antiepileptic drugs because of their definite curative effect, stable effect and less toxic and side effects. Ordinary magnesium valproate tablets made of magnesium valproate generally need to be taken three times a day, and the course of treatment is long, making it difficult for patients to persist for a long time. At the same time, because the blood concentration fluctuates greatly and the peak blood concentration is high, some side effects related to the peak concentration often occur. [0003] Xiangzhong Pharmaceutical Co., Ltd. of Hunan Province (CN1302607) discloses a magnesium valproate slow-release tablet and a preparation process thereof. It adopts hy...

AI Technical Summary

Problems solved by technology

Ordinary magnesium valproate tablets made of magnesium valproate generally need to be taken three times a day, and the course of treatment is long, making it difficult for patients to persist for a long time

At the same time, due to large fluctuations in blood concentration and high peak blood concentration, some side effects related to peak concentration often occur

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