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Lacidipine soft capsule and preparation method thereof

A lacidipine and capsule technology, applied in the field of medicine, can solve the problems of drug loss, first-pass effect elimination, impact on clinical drug efficacy, poor water solubility, etc., improve water solubility and bioavailability, help storage and storage, Improve the effect of curative effect

Inactive Publication Date: 2014-06-11
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The drug has been used as a clinical cerebrovascular drug for many years, but due to its own physical and chemical properties, it has disadvantages such as poor water solubility and obvious first-pass effect, which directly affect the clinical efficacy.
It has been clinically proven that due to the difference in the preparation process and dosage form of lacidipine, there is a large gap in their bioavailability and vasodilation efficacy. The lacidipine tablets and capsules of the traditional preparation process are absorbed through the gastrointestinal tract. The liver metabolizes, enters the surrounding capillaries or lymphatic vessels, and then enters the blood circulation. There is a long-term absorption and distribution process in the middle, and the drug loses about 80% in the whole process. The first-pass effect is very obvious.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] The composition of the prescription is as follows:

[0034] Lacidipine 6g

[0035] Ethylene glycol monoethyl ether (transcutol) 14 g

[0036] Ethyl oleate 30 g

[0037] Tween 80 70g

[0038] Made 1000 softgels in total

[0039] Preparation process: lacidipine weighed according to the prescription quantity, adding the co-emulsifier ethylene glycol monoethyl ether of the prescription quantity

[0040] (transcutol), ultrasonically dissolve it at 40°C, add oil phase, emulsifier and other auxiliary materials according to the prescription amount, stir evenly, and then press into soft capsules.

Embodiment 2

[0042] The composition of the prescription is as follows:

[0043] Lacidipine 6 g

[0044] Ethylene glycol monoethyl ether (transcutol) 16 g

[0045] Ethyl oleate 34 g

[0046] Tween 80 64g

[0047] Made 1000 softgels in total

[0048] The preparation process is the same as in Example 1.

Embodiment 3

[0050] The composition of the prescription is as follows:

[0051] Lacidipine 6 g

[0052] Ethylene glycol monoethyl ether (transcutol) 16 g

[0053] Ethyl oleate 38 g

[0054] Tween 80 60g

[0055] Made 1000 softgels in total

[0056] The preparation process is the same as in Example 1.

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Abstract

The invention belongs to the technical field of a medicine, and particularly relates to a lacidipine soft capsule and a preparation method thereof. The lacidipine soft capsule has the advantages that the drug can be quickly distributed into the overall gastrointestinal tract, the curative effect of the drug is improved, and the storage and preservation of the drug are also facilitated.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular it is a lacidipine soft capsule and a preparation method thereof. Background technique [0002] Lacidipine is a dihydropyridine calcium channel antagonist. Its action is characterized by being able to pass through the blood-brain barrier and effectively acting on the cerebrovascular. It has obvious effects on the treatment of cerebral infarction, migraine, stroke, arachnoid hemorrhage and sudden deafness. It also has a great effect on promoting memory enhancement and the treatment of senile dementia. [0003] The raw material of lacidipine is light yellow crystalline powder, odorless and tasteless, easily soluble in acetone and chloroform, soluble in ethanol, slightly soluble in ether, but insoluble in water. The drug has been used as a clinical cerebrovascular drug for many years, but due to its own physical and chemical properties, it has disadvantages such as poor water solubil...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4422A61K47/44A61P9/10A61P25/28
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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