Itopride hydrochloride oral preparation
A technology for itopride hydrochloride and oral preparations, which is applied in the directions of pill delivery, medical preparations of inactive ingredients, and digestive system, etc., can solve problems such as non-compliance with product standards, prolonged product dispersion time, etc., and achieve short disintegration time. , The effect of rapid drug dissolution and convenient administration
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Embodiment 1
[0018] Embodiment 1. The selection of disintegrating agent
[0019] Sodium lauryl sulfate, povidone K30, and low-substituted hydroxypropyl cellulose were selected as disintegrants, and the dosage was 18%, half of which was added before and after granulation, and then the appearance and uniformity of the tablets were detected, and the results See Table 1.
[0020] Table 1. Preliminary selection of disintegrants
[0021]
[0022] Composition C's appearance, color change and dispersion uniformity after low-temperature storage all meet the requirements, and it is a better solution.
Embodiment 2
[0023] Example 2. Selection of Adhesive
[0024] Based on the selection of filler microcrystalline cellulose, disintegrant povidone K30, and sodium lauryl sulfate, the concentration of the binder was investigated, with dispersion uniformity as the main index, and tablet appearance and compressibility as the secondary Indicators for selecting the best prescription. The results are shown in Table 2.
[0025] Table 2. Choice of Binder Concentration
[0026]
[0027] Note: Measuring method for dispersion uniformity (s): Take 2 tablets of the test product, place in 100ml water at 20°C±1°C, shake, and record the total disintegration time.
[0028] It can be seen from Table 2 that considering the uniformity of tablet dispersion, appearance and compressibility, the most preferred 2% aqueous solution of hydroxyethyl cellulose is the binder.
Embodiment 3
[0029] Embodiment 3. The preparation of itopride hydrochloride oral preparation A
[0030] prescription:
[0031]
[0032] Take the prescribed amount of itopride hydrochloride, microcrystalline cellulose, lactose, povidone K30, sodium lauryl sulfate, and Tween 80, mix and sieve evenly, and mix with 60mL of 1% hydroxyethylcellulose aqueous solution (Concentration unit is g / mL, that is, 1g hydroxyethyl cellulose is dissolved in 100mL water, the same below) to make soft materials, granulate with 20-mesh nylon sieve, dry at 70°C for 2 hours, granulate with 24-mesh nylon sieve, and then add micropowder silica gel And, determine the content, compress into tablets, and pack after passing the inspection.
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