A kind of Yanhuning enteric-coated capsule with stable drug effect and its preparation method
A technology of Yanhuning intestine and Yanhuning, which is applied in the field of Yanhuning enteric-coated capsules and preparation, can solve the problems of lack of universal applicability, high production process requirements, affecting the shelf life of medicines, etc. Difficulty in quality control, prolonged drying time, and the effect of efficient preparation
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Embodiment 1
[0027] Example 1: Preparation of refined Yanhuning
[0028] The commercially available Chuanhuning is used for esterification reaction with sodium sulfite, and then directly synthesized with one of sodium bicarbonate and potassium bicarbonate or according to a specific ratio 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 an appro...
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] Embodiment 3: Yanhuning enteric-coated pellet formulation and preparation method
[0050] (1) The formulation of Yanhuning enteric-coated pellets is shown in Table 4.
[0051] Table 4 Yanhuning enteric-coated pellet formula
[0052]
[0053]
[0054] (2) The refined Yanhuning was prepared according to the method of Example 1, and the precision was 99.5%.
[0055] (3) Barrier coating. Mix the isolation layer material with purified water or 80% ethanol aqueous solution, prepare a solution with a solid content of 5%, then add the antioxidant cysteine, and configure it into a solution with a solid content of 5% (in order to control product quality, The solid content needs to be controlled at 3% to 15%), and stir evenly with an air pump mixer. Pass Yanhuning, lactose, microcrystalline cellulose, and micropowder silica gel through a 200-mesh sieve, and add them to a high-speed centrifugal granulation coating machine for direct isolation layer coating to reduce the ch...
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