A kind of esomeprazole magnesium intestinal capsule and preparation method thereof
A technology of esomeprazole magnesium enteric coating and esomeprazole magnesium, which is applied in the field of esomeprazole magnesium enteric coating capsule and its preparation, can solve the problems of drug oxidative degradation, etc., to prevent oxidative degradation, facilitate Marketing and clinical use, the effect of preventing decomposition
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Embodiment 1
[0023] Example 1 The preparation of esomeprazole magnesium enteric-coated pellets
[0024] (1) Preparation of blank pellet cores
[0025] Starch 400g
[0026] Sucrose 477g
[0027] Sodium hydroxide 30g
[0028] Syrup (60%) 200g
[0029] It is prepared with production equipment such as centrifugal granulator, extrusion extrusion spheronizer, high-efficiency coating machine and fluidized bed coating granulator. The prepared blank pellet cores are screened, and pellets with a particle diameter of 0.4-0.6 mm are selected for drug packaging.
[0030] (2) Preparation of the drug-loaded layer
[0031] Esomeprazole Magnesium 1000g
[0032] Microcrystalline Cellulose 300g
[0033] Sodium hydroxide 50g
[0034] Polysorbate 80 10g
[0035] Hydroxypropyl Methyl Cellulose 150g
[0036] Water 10000g
[0037]Pass esomeprazole magnesium through a 200-mesh sieve for later use, dissolve sodium hydroxide in about 2kg of water, disperse the hypromellose with hot water, add the remainin...
example 1
[0083]Experiments were carried out on the influencing factors of high temperature (temperature 60°C±2°C), high humidity (RH75%, RH92.5%) and light (illuminance 4500±500LX).
[0084] Influencing factor test results
[0085]
example 2
[0087] Take the example sample and carry out acceleration (at a temperature of 40°C±2°C and a relative humidity of 75%±5%) for 6 months and a long-term period (at a temperature of 25°C±2°C and a relative humidity of 60%±5%) according to the package on the market. 10% condition) 6-month pilot study.
[0088] Accelerated test (temperature 40℃±2℃, relative humidity 75%±5%) 6-month test results
[0089]
[0090] Long-term (temperature 25 ℃ ± 2 ℃, relative humidity 60% ± 10%) test results for 6 months
[0091]
[0092] According to the experimental data, according to the results of the test and investigation of the influencing factors of this product, the appearance of the sample has not changed, and the measured indicators have no obvious changes. It has been placed under high temperature, high humidity, and light conditions for 10 days, except for a slight increase in related substances under light conditions. There was no significant change in other indicators. Accelerat...
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