Compound preparation of lercanidipine and atorvastatin

A technology of atorvastatin calcium and compound preparations, applied in the field of medicine, to achieve the effects of reducing adverse reactions, good clinical application prospects, and convenient medication

Active Publication Date: 2012-10-31
ZHAOKE PHARMA GUANGZHOU
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] There is still no report on the combined use of lercanidipine and atorvastatin in the treatment of hypertension

Method used

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  • Compound preparation of lercanidipine and atorvastatin
  • Compound preparation of lercanidipine and atorvastatin
  • Compound preparation of lercanidipine and atorvastatin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1: the prescription composition of compound preparation of the present invention

[0030] The compound preparation contains the main drugs lercanidipine hydrochloride and atorvastatin calcium, and the excipients are calcium carbonate, sodium carboxymethyl cellulose, microcrystalline cellulose, pregelatinized starch, polysorbate 80, hydroxypropyl cellulose, purified Water, Colloidal Silicon Dioxide, Magnesium Stearate, Opadry Icing.

[0031] Table 1 prescription composition

[0032]

[0033]

Embodiment 2

[0034] Embodiment 2: the preparation of compound tablet of the present invention

[0035] (1) Weigh lercanidipine hydrochloride raw materials and atorvastatin calcium raw materials and sieve them for later use.

[0036](2) Weigh calcium carbonate, microcrystalline cellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, pregelatinized starch, colloidal silicon dioxide, and stir with raw materials Mix evenly; calcium carbonate 0.01-20% in auxiliary materials, microcrystalline cellulose 10-40%, sodium carboxymethyl cellulose 10-20%, hydroxypropyl cellulose 2-8%, polysorbate 800.1-10%, Magnesium stearate 0.5-2.5%, pregelatinized starch 5-15%, colloidal silicon dioxide 1-10%.

[0037] (3) Vacuum compression, milling, sieving and granulation; tableting, control tablet core hardness to 2-10kg.

[0038] (4) Film coating: Take Opadry (Y-1-7000), add it to ethanol under stirring condition, stir until dispersed, then add purified water an...

Embodiment 3

[0040] Example 3: Quality Research Methods

[0041] Including properties, identification, inspection (related substances, loss on drying, chloride, heavy metal, dissolution rate, content uniformity) and content determination, etc. Wherein the assay method of lercanidipine hydrochloride is as follows:

[0042] Content determination: HPLC method, the stationary phase and mobile phase used are as follows.

[0043] The HPLC assay condition of lercanidipine hydrochloride in the compound preparation of table 2

[0044] mobile phase

[0045] Preparation method of buffer A: dissolve 1.36g of potassium dihydrogen phosphate in 1L of water, add 1g of octane sulphonic acid sodium salt to it after dissolving, and use 10% phosphoric acid (v / v) for ultrasonic treatment Adjust the pH to 2.5 ± 0.05.

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Abstract

The invention relates to the field of medicines and discloses a compound preparation of lercanidipine hydrochloride and atorvastatin calcium. The unit preparation comprises 5-20 mg of lercanidipine hydrochloride and 10-80 mg of atorvastatin calcium. The invention further provides another compound preparation which is prepared to tablets by taking lercanidipine hydrochloride and atorvastatin calcium as the main medicine, taking calcium carbonate, microcrystalline cellulose, sodium salt of carboxy methyl-cellulose, hydroxy propyl cellulose, polysorbate 80, magnesium stearate, amylum pregelatinisatum and colloidal silicon dioxide as auxiliary materials, and taking opadry as the coating. Clinical tests show that the compound preparation of lercanidipine and atorvastatin calcium plays a significant role in reducing pressure and fat, medicinal dose is reduced, incidence of untoward effects is reduced, toleration and medication compliance of patients are good, and the compound preparation has a good clinical application prospect.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a compound preparation of lercanidipine and atorvastatin. Background technique [0002] Hypertension is the most common cardiovascular disease in the Chinese population, the main cause of stroke, and an important risk factor for coronary heart disease. In November 2009, the American Society of Hypertension (ASH) updated the definition of hypertension as "a complex, progressive cardiovascular (CV) syndrome caused by the interaction of multiple etiologies". Studies have found that hypertension is a syndrome of metabolic abnormalities, the most common being the disorder of glucose and lipid metabolism associated with hypertension. Hyperlipidemia is closely related to the morbidity and mortality of coronary heart disease and other atherosclerotic diseases. Hyperlipidemia is a risk factor for stroke, coronary heart disease, myocardial infarction, and sudden death. An important risk factor fo...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61P9/12A61K31/40
CPCA61K9/28A61K31/22A61K31/4422A61K31/40A61K9/2009A61K9/2054A61K9/2059A61K9/2866A61K9/2893A61K31/4418A61P3/06A61P43/00A61P9/12A61K2300/00A61K9/20
Inventor 李小羿张国辉戴向荣凌娟胡代娣
Owner ZHAOKE PHARMA GUANGZHOU
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