Pancreatic enzymes enteric coated pellets and preparation
An enteric-coated pellet and pancreatin technology, which can be used in pharmaceutical formulations, medical preparations containing active ingredients, and digestive systems, etc., can solve the problems of adhesion, pancreatin globules that easily drop powder, and slow pancreatin speed. To achieve the effect of simple method, no decrease in potency, and high drug release rate
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Embodiment 1
[0025] Example 1 Preparation of trypsin pellets
[0026] Pancreatin pellet prescription
[0027] Name of main drug and excipients
Weight / grams)
trypsin powder
150
40
10
100
[0028] Preparation of trypsin pellets
[0029] At normal temperature, dry mix 150 grams of trypsin powder, 40 grams of mannitol and 10 grams of sodium carboxymethyl starch. Transfer the dry-mixed material to a small fluidized bed used in the laboratory, and spray 100 grams of purified water on the top under a low fluidization state; extrude the material wetted by water on a single-screw machine with a mesh diameter of 1.0mm ; spheronization; drying at 40°C; screening with 24 mesh to 18 mesh to obtain 181 grams of trypsin pellets.
Embodiment 2-4
[0030] Example 2-4 Pancreatin pellet prescription
[0031]
[0032]
[0033] Example 2-4 The preparation process of trypsin pellets was the same as Example 1 . Example 2 , Reality Example 3 and Example 4 The finished product yields are respectively: 91%, 94% and 96%.
[0034] Press Chinese Pharmacopoeia 2005 edition two appendices XD first method to measure the release degree of pancreatin pellet in the solution of pH=6.5, measuring condition is: phosphate buffered saline (get potassium dihydrogen phosphate 6.8g, add water 900ml and make dissolving, Use sodium hydroxide test solution to adjust the pH value to 6.5, add water to 1000ml) 900ml, and the rotating speed is 100r / min, and take samples for analysis at 20, 30 and 45 minutes respectively. According to the Chinese Pharmacopoeia, the potency of pancreatic lipase in the released pancreatic enzymes was determined. The results are as follows:
[0035] Release of trypsin pellets in pH=6.5 solution
[0036...
Embodiment 5
[0038] Example 5 Preparation of trypsin pellets
[0039] Pancreatin pellet prescription
[0040] Name of main drug and excipients
[0041] Example 5 The preparation process of trypsin pellets was the same as Example 1 . Example 5 The finished product yield is: 95%.
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