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Amlodipine atorvastatin calcium liquid-solid compressed tablet and preparation method thereof

A technology of atorvastatin calcium and amlodipine, which is applied in the direction of pharmaceutical formulas, medical preparations with no active ingredients, and medical preparations containing active ingredients, etc., which can solve the problem that the stability of atorvastatin calcium cannot be guaranteed and affects Amlodipine stability, lack of alkaline stabilizers and other issues, achieve the effect of low cost, avoid instability, and ensure stability

Pending Publication Date: 2020-11-20
沐邦(北京)医药科技有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the hot and humid conditions in the liposome preparation process will affect the stability of amlodipine, and lack of alkaline stabilizers, the stability of atorvastatin calcium can not be guaranteed

Method used

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  • Amlodipine atorvastatin calcium liquid-solid compressed tablet and preparation method thereof
  • Amlodipine atorvastatin calcium liquid-solid compressed tablet and preparation method thereof
  • Amlodipine atorvastatin calcium liquid-solid compressed tablet and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0048] 1. Selection of non-volatile solvents: non-volatile solvents need to have a certain dissolution or suspension effect on atorvastatin calcium, and choosing a solvent with a higher solubility for atorvastatin calcium is beneficial to improve the atorvastatin calcium. The dissolution rate of calcium, therefore, is screened for the non-volatile solvents by measuring their equilibrium solubility. The equilibrium solubility determination method is as follows:

[0049] Weigh the excess atorvastatin calcium raw material, place it in a 25mL conical flask, add 10mL of liquid excipients PEG400, PEG600, and propylene glycol respectively, vortex for 5min, and ultrasonicate for 30min to fully mix the drug with the liquid excipient Afterwards, place in an air bath shaker, shake at a constant temperature at 25°C, and rotate at 200 rpm / min. After 72 hours, take an appropriate amount of sample, centrifuge at 10,000rpm / min for 15min with a centrifuge, take the supernatant, dilute it with...

Embodiment 2

[0058] According to the result obtained in embodiment 1, determine the prescription of amlodipine atorvastatin calcium liquid-solid compressed tablet:

[0059] Table 2 Prescription 1 (amount per tablet / mg)

[0060] Atorvastatin Calcium calcium carbonate Propylene Glycol MCC-PH102 fumed silica Amlodipine Plus MCC-PH102 CMS-Na MS Sheet weight 10.8 20.0 108 616.9 30.8 6.9 127.57 50 9 980

[0061] Preparation:

[0062] (1) Add atorvastatin calcium and calcium carbonate to propylene glycol and grind evenly;

[0063] (2) Slowly drop the mixture obtained in step (1) into MCC-PH102, grind while adding, continue grinding for 1 hour until completely uniform after dropping, add fumed silica and continue grinding for 0.5 hours.

[0064] (3) Mix the material obtained in step (2) with amlodipine besylate, plus MCC-PH102, CMS-Na, and magnesium stearate, and then directly press into tablets to obtain amlodipine atorvastatin calcium solution Soli...

Embodiment 3

[0066] Table 3 Prescription 2 (amount per tablet / mg)

[0067] Atorvastatin Calcium calcium carbonate Propylene Glycol MCC-PH102 fumed silica Amlodipine Plus MCC-PH102 CMS-Na MS Sheet weight 10.8 20.0 72 456.9 22.8 6.9 162.6 40 8 800

[0068] The preparation method of this embodiment is the same as that of Example 2.

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Abstract

The invention relates to an amlodipine atorvastatin calcium liquid-solid compressed tablet and a preparation method thereof. The amlodipine atorvastatin calcium liquid-solid compressed tablet containsan effective dose of amlodipine besylate and atorvastatin calcium, and also contains an alkaline stabilizer, a liquid excipient, a lubricant, a filler, a disintegrating agent, a carrier material anda coating material. The invention also provides the corresponding preparation method. According to the amlodipine atorvastatin calcium liquid-solid compressed tablet, the existing state of the atorvastatin calcium in a preparation is mainly changed from a crystalline state to a molecular or amorphous state, the dissolution rate of atorvastatin calcium is greatly increased, and the problem of asynchronous dissolution of the atorvastatin calcium and the amlodipine besylate is solved. The preparation method of the liquid-solid compressed tablet provided by the invention is low in cost, simple andfeasible, free of use of special equipment and suitable for industrial mass production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an amlodipine atorvastatin calcium liquid-solid compressed tablet and a preparation method thereof. Background technique [0002] With the rapid development of my country's economy and the continuous improvement of residents' living conditions, the incidence of cardiovascular and cerebrovascular diseases continues to rise, and has gradually become the number one fatal disease in China. According to the survey, the number of deaths from cardiovascular and cerebrovascular diseases caused by hyperlipidemia is close to 36 million in the world every year. The incidence of hyperlipidemia among the middle-aged and elderly people in my country has exceeded 50%, and about 43% of them suffer from high blood pressure. , when these two diseases co-exist, can significantly increase the mortality rate. For such patients, it is also very important to lower blood ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/10A61K47/38A61K47/04A61K31/4422A61K31/40A61P3/06A61P9/12G16C20/20
CPCA61K9/2095A61K9/2013A61K9/2054A61K9/2009A61K31/4422A61K31/40A61P3/06A61P9/12G16C20/20A61K2300/00
Inventor 李善坤邢昊楠
Owner 沐邦(北京)医药科技有限公司
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