阅读说明：本技术 一种复方制剂缬沙坦氨氯地平片及其制备方法 (Compound preparation valsartan amlodipine tablet and preparation method thereof ) 是由 毛白杨 王彬 荆戟 赵晓红 王思清 于 2019-11-22 设计创作，主要内容包括：本发明提供了一种复方制剂缬沙坦氨氯地平片及其制备方法,本发明中的复方制剂包括素片、薄膜衣层。素片包括主药和辅料,主药包括缬沙坦、苯磺酸氨氯地平,辅料包括填充剂、崩解剂、润滑剂、助流剂。本发明解决了该品种湿法制粒导致有关物质增加,从而影响药物使用安全的问题。本发明同时解决了使用干法制粒技术颗粒不均一引起的含量不均匀、溶出度不均一带来的批内质量差异过大的问题。本发明解决了制剂因吸湿性导致的降解问题,提高了产品的稳定性。(The invention provides a valsartan amlodipine tablet and a preparation method thereof. The tablet comprises main drugs and auxiliary materials, wherein the main drugs comprise valsartan and amlodipine besylate, and the auxiliary materials comprise a filling agent, a disintegrating agent, a lubricating agent and a flow aid. The invention solves the problem that the wet granulation of the variety causes the increase of related substances, thereby influencing the use safety of the medicine. The invention simultaneously solves the problems of uneven content caused by uneven particles by using a dry granulation technology and overlarge quality difference in batches caused by uneven dissolution. The invention solves the degradation problem of the preparation caused by hygroscopicity and improves the stability of the product.)

1. A compound preparation of valsartan amlodipine tablets and a preparation method thereof are characterized in that: the tablet comprises a plain tablet and a film coating layer; the tablet comprises main drug and adjuvant; the main medicines comprise valsartan and amlodipine besylate; the auxiliary materials comprise a filling agent, a disintegrating agent, a lubricating agent and a glidant;

the preparation method of the valsartan amlodipine tablet comprises the following steps of:

(1) the raw materials and the auxiliary materials are pretreated for standby,

(2) weighing valsartan, amlodipine besylate, a disintegrating agent, a filling agent and a flow aid according to the prescription amount, placing the mixture into a mixer, mixing for 10min, adding a lubricant according to the prescription amount, continuously mixing for 15min,

(3) after the intermediate is detected, the tablet weight is calculated and the tablet is directly pressed,

(4) coating is carried out by using a 10% gastric-soluble coating premix solution prepared by 40% ethanol.

2. The prescription composition of a plain film according to claim 1 is:

amlodipine besylate (calculated as amlodipine) 5mg

Valsartan 80mg

Microcrystalline cellulose PH 10235 mg

Lactose 30mg

Anhydrous calcium hydrogen phosphate 20mg

Carboxymethylcellulose calcium 20mg

Talcum powder 7mg

Magnesium stearate 3mg

The formula of the film coating liquid comprises the following components:

preparing a suspension with the concentration of 10% by using a gastric-soluble film coating premix and a 40% ethanol solution, wherein the weight of the film coating premix is increased by 3%.

3. The filler according to claim 1, characterized in that: is selected from one or more of microcrystalline cellulose, lactose, corn starch and anhydrous calcium hydrogen phosphate.

4. The disintegrant according to claim 1, wherein: is selected from one or more of croscarmellose sodium, crospovidone, sodium carboxymethyl starch and calcium carboxymethyl cellulose.