Amoxicillin orally disintegrating tablet and preparation method thereof

[0025] Concrete each component consumption ratio is as shown in table 1 below:

[0026] Table 1

[0027]

[0028] Concrete preparation steps:

[0029] 1. Main drug granules: Amoxicillin (light powder) and silicon dioxide are placed in a wet granulator and mixed evenly, then an appropriate amount of 95% ethanol (volume percentage) of 5% K30 is added, the soft material is passed through 18 mesh, and dried at 40°C After 3-4 hours, granulate with 18 mesh sieve.

[0030] 2. Auxiliary material granules: except those added, use 5% K30 (75% ethanol) solution in an appropriate amount for the remaining adjuvant (croscarmellose sodium 1 / 2). Pass the soft material through 18-mesh sieve, dry at 60°C for 3-4 hours, and granulate with 18-mesh sieve.

[0031] 3. Total blending: main drug granules, excipient granules and external excipients.

[0032] 4. Tablet compression: Tablet compression is performed according to the particle content, and the pressure is controlled at about 1.5-3KG t

[0051] Table 7 Small scale scale-up of 100,000 prescriptions

[0052]

[0053] Concrete preparation steps are:

[0054] 1. Glycine and anhydrous citric acid were crushed to 80 meshes respectively. The croscarmellose sodium, microcrystalline cellulose and aspartame were respectively passed through an 80-mesh sieve. The crushed and sieved raw and auxiliary materials are stored in a transfer barrel with a clean plastic bag and covered. Attach the material label and transport it to the weighing and batching room. The crushed and sieved raw materials should be used within 10 days.

[0055] 2. Granulation and mixing

[0056] a. Preparation of adhesive

[0057] Adhesive I: 0.4kg of povidone K30 was placed in a stainless steel barrel, and 8L of 95% ethanol was added, and stirred slowly until it was completely dissolved, to prepare a 5% povidone K30 ethanol solution as the adhesive I.

[0058] Adhesive II: 0.35kg of povidone K30 was placed in a stainless steel barrel, and 7L of 7

[0103] Table 15 Screening prescriptions (designed according to each prescription)

[0104]

[0105] The preparation process is the same as in Example 2.