Potassium sodium dehydroandroan drographolide succinate (Yanhuning) enteric capsule having stable medicine effect and preparation method of same
A technology of Yanhuning intestine and Yanhuning, applied in the field of Yanhuning enteric-coated capsules and preparation, can solve the problems of lack of universal applicability, affecting the shelf life of medicines, and high requirements on production technology, and achieves increased quality. The effect of controlling difficulty, efficient preparation, and prolonging drying time
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Embodiment 1
[0027] Example 1: Preparation of refined Yanhuning
[0028] Use the commercially available Chuanhuning, after lipidation reaction with sodium sulfite, then directly synthesize Yanhuning with one of sodium bicarbonate and potassium bicarbonate or according to a specific ratio, so as to reduce repeated drying, dissolving, heating and other processes. The specific preparation method is as follows: taking Chuanhuning as raw material, adding anhydrous sodium sulfite and 90% ethanol into an extraction tank, simultaneously passing nitrogen protection, stirring and mixing, heating in a water bath, and controlling the temperature at 60°C. After the raw materials are dissolved, stop heating and slowly add 19% KHCO 3 and 10% Na 2 CO 3 Mix solution (mixed according to mass ratio 1:1), produce CO 2 gas, crystals are precipitated in the reaction solution, and the CO 2 After the production is completed, heat it in a water bath at a temperature of about 60°C until it dissolves, then add a...
Embodiment 2
[0029] Embodiment 2: preferred isolation layer material
[0030] (1) The mass fractions of the formulations of Yanhuning enteric-coated pellets are shown in Table 1.
[0031] Table 1 Recipe of Yanhuning enteric-coated pellets
[0032]
[0033] When preparing the mixture of lactose and microcrystalline cellulose, the mass ratio of 2:1 is prepared at one time, so for the convenience of operation, the ratio of 2:1 is selected throughout the text. In practice, lactose: microcrystalline cellulose = 1:1 to 3:1 is acceptable. If this ratio is exceeded, the lactose is too high, which may cause difficulties in later molding.
[0034] (2) Based on the mass fractions of the prescriptions in Table 1, respectively select Yanhuning with different precisions, and different materials and different mass ratios of the isolation layer materials, and carry out the screening of Yanhuning and isolation layer materials. The specific selection is as follows: Table 2 shows.
[0035] Table 2 Sel...
Embodiment 3
[0049] Example 3: Recipe and preparation method of Yanhuning enteric-coated pellets
[0050] (1) The prescription of Yanhuning enteric-coated pellets is shown in Table 4.
[0051] Table 4 The prescription of Yanhuning enteric-coated pellets
[0052]
[0053]
[0054] (2) The refined Yanhuning was prepared according to the method of Example 1, and the precision was 99.5%.
[0055] (3) Isolation layer coating. With purified water or 80% ethanol aqueous solution, the isolation layer material is mixed, and it is prepared as a solution with a solid content of 5%, and then the antioxidant cysteine is added to form a solution with a solid content of 5% (in order to control product quality, The solid content needs to be controlled at 3%~15%), stir evenly with an air pump mixer. Pass Yanhuning, lactose, microcrystalline cellulose, and micropowder silica gel through a 200-mesh sieve, and put them into a high-speed centrifugal granulator coating machine to directly coat them w...
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