Study On Improvement Of Production Of Metformin Tablets

Diabetes, caused by the excretion metabolizing disorder, has become"the third killer"of human health following the cerebral and cardiovascular diseases and tumours. In 1950's, metformin tablet as a lowering sugar drug was started to be used in the treatment of type 2 diabetes'patients with obesity to insulin resistance. However, this traditional preparation had the disadvantages of the old excipients, the lower dissolution rate and bioavailability. This thesis was to optimize metformin tablet's prescription with the new type of excipients, and to improve the tableting and coating processes.Study on the choosing excipients and prescription's dissolvability to sure the new type of excipients and design prescription, using the solid preparation outside body quality evaluate--examining the dissolution rate and checking tablet's quality other guidline, all these will make prescription filtratd and optimized.The ingredients of the new prescription (mg/tablet) were metformin hydrochloride (250), fecula (21), dextrin (28), low substituent hydroxypropyl fibrin (10), hydroxypropyl fibrin (1.2), magnesium stearate (2.5) and silicon dioxide (8.0). The excipients and metformin hydrochloride were smashed and filtrated through 80 mesh, the stirring time was controlled within 2 minutes after the adhesive agent added. The soft granules were prepared through 12 mesh, dried with air under in the oven at 60-70℃, and the water content between 3.0% to 3.5%. After lubricate was added, the granules were mixed in 20 minutes and past 12 mesh. The core tablets were pressed under 3.00 Mpa. Using the membrane coating technique, the core tablets were coated with ethanol-dissolved pre-coating powder (Opadry) at 40℃, the rotate speed of 2.8r/min and the spray rate of 35-40 ml/min.The new prescription and tableting process were tested at small batches and scale-up production. The results were showed that the dissolve radio of metformin hydrochloride was increased to over 98%, the dissolution rate of the tablet producted was on the low side (often about 80%, little above 90%), and that the problem of former tablets quality was solved. The quality of the new tablets completely met the criteria of Chinese Pharmacopoeia 2000 to adapt to commercial production.The improvement of the prescription and process decreased the cost and increased the benefit. Compared with the old excipients and process energy, the cost of the new ones declined 10 Yuan/10000 tablets, of which the cost of materials was 7.78 Yuan/10000 tablets, and the coat of energy was 4.4 Yuan/10000 tablets. This...