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Oral preparation for cardiovascular disease treatment, and preparation method thereof

A technology for oral preparations and disintegrants, applied in the field of pharmaceutical preparations, can solve problems such as undisclosed technical parameters, unsuggested technological level, etc., and achieves the effects of good dissolution performance, good fluidity, and improved preparation quality.

Inactive Publication Date: 2017-04-26
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Patent WO2009061713 discloses an oral preparation containing compound 1, which is prepared by dry granulation process, and the obtained preparation can achieve a dissolution rate of more than 70% in 20 minutes, but this method does not disclose specific technical parameters (such as granulation technology, large sheet density, etc.), and it does not imply that the control of specific technical parameters is conducive to the improvement of the technology level; in fact, for the preparation of compound 1, the same qualified dissolution rate of the preparation can correspond to different preparation processes, although different Preparations with qualified dissolution performance can be prepared by any preparation process, but it is still necessary to optimize the process level through the adjustment of technical parameters, so as to simplify the process and improve product quality (such as pass rate, etc.)

Method used

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  • Oral preparation for cardiovascular disease treatment, and preparation method thereof
  • Oral preparation for cardiovascular disease treatment, and preparation method thereof
  • Oral preparation for cardiovascular disease treatment, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] prescription:

[0065]

[0066] Preparation:

[0067] 1. Pass the original and auxiliary materials through a 40-mesh sieve, and set aside;

[0068] 2. Take the raw and auxiliary materials and mix them to obtain the inner granule total blend powder;

[0069] 3. Use a dry granulator to compress the premixed mixture with a pitch of 0.7mm, a speed of 4r / min, and a feeding speed of 24r / min to obtain a density of 0.97g / cm 3 blockbuster;

[0070] 4, the blockbuster through Obtain internal phase granule (angle of repose 32.1 °) after sieving granulation;

[0071] 5. Mix the internal phase granules and the external auxiliary materials for 10 minutes, mix evenly (RSD value is 1.2%), and compress the obtained mixture to obtain a tablet core of compound 1 (tablet hardness 6.0-10.0kgf);

[0072] 6. The obtained tablet core is coated with the Opadry coating polymer to obtain a coated tablet.

[0073] After testing, the difference in weight of the obtained tablets was ±2.2%....

Embodiment 2

[0075] prescription:

[0076]

[0077]

[0078] Preparation:

[0079] 1. Pass the original and auxiliary materials through a 40-mesh sieve, and set aside;

[0080] 2. Take the raw and auxiliary materials and mix them evenly to obtain the mixed powder of inner particles;

[0081] 3. Use a dry granulator to compress the premixed mixture with a pitch of 0.8mm rollers, a rotating speed of 3r / min rollers, and a feeding speed of 25r / min to obtain a density of 1.19g / cm 3 blockbuster;

[0082] 4, the blockbuster through Obtain internal phase granule (angle of repose 33.3 °) after sieving granulation;

[0083] 5. Mix the internal phase granules and the external auxiliary materials for 10 minutes, mix evenly (RSD value is 1.8%), and compress the obtained mixture to obtain a tablet core of compound 1 (tablet hardness 6.0-10.0kgf);

[0084] 6. The obtained tablet core is coated with the Opadry coating polymer to obtain a coated tablet.

[0085] After testing, the difference i...

Embodiment 3

[0087] prescription:

[0088]

[0089]

[0090] Preparation:

[0091] 1. Pass the original and auxiliary materials through a 40-mesh sieve, and set aside;

[0092]2. Take the raw and auxiliary materials and mix them to obtain the inner granule total blend powder;

[0093] 3. Use a dry granulator to compress the premixed mixture with a pitch of 0.5 mm rollers, a speed of 3 r / min, and a feeding speed of 20 r / min to obtain a density of 1.05 g / cm 3 blockbuster;

[0094] 4, the blockbuster through Obtain internal phase granule (angle of repose 30.8 °) after sieving granulation;

[0095] 5. Mix the internal phase granules and the external auxiliary materials for 10 minutes, mix evenly (RSD value is 1.3%), and compress the obtained mixture to obtain a tablet core of compound 1 (tablet hardness 6.0-10.0kgf);

[0096] 6. The obtained tablet core is coated with the Opadry coating polymer to obtain a coated tablet.

[0097] After testing, the difference in weight of the obta...

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Abstract

The present invention provides a compound 1-containing cardiovascular disease treating oral preparation. According to the present invention, by controlling the bulk density during a dry granulation process within a specific range, the granulation level of the dry granulation is improved, the preparation process is optimized, the preparation quality is improved, and the obtained product is suitable for the clinical application compared to the product prepared in the prior art.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to an oral preparation for treating cardiovascular diseases and a preparation method thereof. Background technique [0002] The prevalence of risk factors for cardiovascular disease in my country is obvious. With the development of society and economy, the national lifestyle has undergone profound changes, especially the aging of the population and the acceleration of urbanization. The prevalence of risk factors for cardiovascular disease in China is on the rise. , leading to a continuous increase in the incidence of cardiovascular disease. Overall, the prevalence and mortality of cardiovascular diseases in my country are still on the rise, and the number of patients with cardiovascular diseases will continue to grow rapidly in the next 10 years. At present, the death caused by cardiovascular disease accounts for the first place in the total death of urban and rural reside...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/216A61K31/41A61P9/00A61P9/10A61P9/04A61P3/10A61P13/12A61P9/12A61P9/06A61P11/00A61P25/00A61P25/06A61P27/06
CPCA61K9/0053A61K9/2866A61K31/216A61K31/41A61K9/1652A61K9/1682A61K9/2054A61P9/04A61P9/06A61P9/10A61P9/12A61P25/06A61P27/02A61K9/1623A61K9/1641
Inventor 宋科周红叶冠豪
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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