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Medicine composition containing cinacalcet hydrochloride and production method of medicine composition containing cinacalcet hydrochloride

A technique for cinacalcet hydrochloride and its composition, which is applied in the field of pharmaceutical composition containing cinacalcet hydrochloride and its preparation, and can solve problems such as difficult popularization, high requirements for equipment and operation, and complicated preparation process

Pending Publication Date: 2020-07-28
FUJIAN HAIXI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The patent CN 105106144 A disclosed by Hengrui Pharmaceutical Co., Ltd. uses solid dispersion technology to prepare cinacalcet hydrochloride into a freeze-dried powder injection to improve drug dissolution, but the preparation process is complicated, and the actual production process requires equipment and operations. The requirements are high and it is not easy to popularize

Method used

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  • Medicine composition containing cinacalcet hydrochloride and production method of medicine composition containing cinacalcet hydrochloride
  • Medicine composition containing cinacalcet hydrochloride and production method of medicine composition containing cinacalcet hydrochloride
  • Medicine composition containing cinacalcet hydrochloride and production method of medicine composition containing cinacalcet hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Cinacalcet hydrochloride 25mg specification

[0017] According to the proportioning of table 1 and following process, Xi'an Caleb hydrochloride tablet is prepared, and dissolution rate is measured, and compared with commercially available cinacalcet hydrochloride tablet, data are listed in the following table:

[0018] Table 1

[0019]

[0020] Tablet core preparation: Weigh the prescribed amount of cinacalcet hydrochloride, add microcrystalline cellulose 102, pregelatinized starch, and disintegrant citric acid to pass through a No. 3 sieve, mix well and add the viscose prepared by povidone K30. Mixture soft material, dried in fluidized bed or oven, granulated by granulator, added prescription amount of microcrystalline cellulose, colloidal silicon dioxide and mixed evenly, then added magnesium stearate and mixed for 3-5min, after tableting That is the tablet core.

[0021] Coating: Prepare a coating solution with a concentration of 8-16%, put the tablet core into ...

Embodiment 2

[0023] Cinacalcet hydrochloride 25mg specification

[0024] The preparation method of this 25mg cinacalcet tablet is the same as Example 1, except that the disintegrant citric acid in the tablet core is replaced with sodium carboxymethyl starch or crospovidone. The specific prescription composition is shown in Table 2 below.

[0025] Table 2

[0026]

Embodiment 3

[0028] Cinacalcet hydrochloride 25mg specification

[0029] The preparation method of this 25mg cinacalcet tablet is the same as embodiment 1, and difference is that the ratio of microcrystalline cellulose 102 in the tablet core is added inside and outside is different, and concrete prescription composition is shown in Table 3.

[0030] table 3

[0031]

[0032]

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Abstract

The invention discloses a medicine composition containing cinacalcet hydrochloride and a production method of the medicine composition containing the cinacalcet hydrochloride. The medicine compositioncontaining the cinacalcet hydrochloride is mainly characterized in that accessories of an effervescent disintegrant, such as citric acid, tartaric acid or sodium bicarbonate, and another pharmaceutically-acceptable excipient, such as a binder, a filler or a lubricant, are used, wet granulation is adopted, the production technology is simplified, the production cost is reduced, and produced tablets have the advantages that the appearance is excellent, dissolution is good, the stability is high, internal absorption is good, and the like.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a pharmaceutical composition containing cinacalcet hydrochloride and a preparation method thereof. Background technique [0002] Cinacalcet hydrochloride is a calcimimetic agent, which reduces the secretion of parathyroid hormone by binding to the calcium-sensing receptor of the parathyroid gland, which in turn leads to a decrease in the level of calcium and calcium phosphate products in serum. Secondary hyperparathyroidism in patients with chronic kidney disease (CKD) is a progressive disease in which calcium and phosphorus metabolism disorders are caused by elevated levels of parathyroid hormone (PTH). Elevated PTH stimulates osteoclastic activity, causing bone resorption. The purpose of the treatment of secondary hyperparathyroidism is to reduce PTH, blood calcium and blood phosphorus, and prevent bone disease and systemic effects caused by mineral metabol...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/46A61K47/12A61K47/38A61K47/32A61K47/04A61K31/137A61P3/14A61P5/20A61P35/00A61P13/12
CPCA61K9/0007A61K9/2009A61K9/2013A61K9/2027A61K9/2054A61K31/137A61P3/14A61P5/20A61P13/12A61P35/00
Inventor 洪文智李恒东林舒丹黄灯冯岩康心汕
Owner FUJIAN HAIXI PHARMA
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