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Fluvastatin sodium composition capsule and preparation method thereof

A technology of fluvastatin sodium and its composition, which is applied in the field of fluvastatin sodium composition capsule and its preparation, which can solve the problems of high price and achieve the effects of cheap price, simple process flow and easy availability of raw materials

Active Publication Date: 2015-06-03
SHANDONG LUOXIN PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing drugs are mainly simvastatin group, the price is higher, the absorption effect is better, and there are certain side effects

Method used

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  • Fluvastatin sodium composition capsule and preparation method thereof
  • Fluvastatin sodium composition capsule and preparation method thereof
  • Fluvastatin sodium composition capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] A fluvastatin sodium composition capsule with a specification of 20 mg.

[0032] Fluvastatin sodium is C 24 h 26 FNO 4 Calculated, the active ingredient of the medicine in the raw material of making 1000 is as follows:

[0033]

[0034]

[0035] The specific preparation method is as follows:

[0036] Step 1: Pass fluvastatin sodium, microcrystalline cellulose, hydroxypropyl cellulose, and lactose through a 100-mesh sieve respectively, and set aside;

[0037] Step 2: Weigh fluvastatin sodium, microcrystalline cellulose, hydroxypropyl cellulose and lactose in the prescribed amount, and mix them uniformly to obtain the first mixture;

[0038] Step 3: Add 3% starch slurry in the prescribed amount to the first mixture to make a soft material, pass through an 18-mesh sieve and granulate to obtain wet granules of the fluvastatin sodium composition.

[0039] Step 4: Dry the wet granules of the fluvastatin sodium composition through a blast drying oven at 50-60°C unti...

Embodiment 2

[0043] A fluvastatin sodium composition capsule with a specification of 40 mg.

[0044] Fluvastatin sodium is C 24 h 26 FNO 4 Calculated, the active ingredient of the medicine in the raw material of making 1000 is as follows:

[0045]

[0046] The specific preparation method is as follows:

[0047] Step 1: Pass fluvastatin sodium, microcrystalline cellulose, hydroxypropyl cellulose, and lactose through a 100-mesh sieve respectively, and set aside;

[0048] Step 2: Weigh fluvastatin sodium, microcrystalline cellulose, hydroxypropyl cellulose and lactose in the prescribed amount, and mix them uniformly to obtain the first mixture;

[0049] Step 3: Add 3% starch slurry in the prescribed amount to the first mixture to make a soft material, pass through an 18-mesh sieve and granulate to obtain wet granules of the fluvastatin sodium composition.

[0050] Step 4: Dry the wet granules of the fluvastatin sodium composition through a blast drying oven at 50-60°C until the water ...

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Abstract

The invention relates to the field of medicaments, and discloses a fluvastatin sodium composition capsule; the medicament effective components prepared into one thousand capsules include 15 to 40grams of fluvastatin sodium, 20 to 50grams of microcrystalline cellulose, 120-250grams of lactose, 4 to 10grams of hydroxypropylcellulose, 50 to 100grams of 3% starch slurry and 0.5 to 2.5grams of magnesium stearate. The invention also discloses a preparation method of the fluvastatin sodium composition capsule. The fluvastatin sodium composition capsule provided by the invention has the characteristics of low cost, high absorption rate after being taken, excellent therapeutic dose tolerance of patients, light adverse reaction and the like, and is a safe and effective lipid lowering medicament; in the preparation method, the whole process is simple and the process control parameter is easy to control, and therefore the preparation method is suitable for large-scale industrialized popularization.

Description

technical field [0001] The invention relates to the field of medicine, and discloses a fluvastatin sodium composition capsule and a preparation method thereof. Background technique [0002] Primary hypercholesterolemia refers to hypercholesterolemia that is not caused by other diseases and may be caused by genetic defects or acquired eating habits, lifestyle, and other natural environmental factors. The opposite is secondary hypercholesterolemia, which is secondary to certain diseases, such as hypercholesterolemia caused by liver and gallbladder diseases. [0003] Hypercholesterolemia refers to the high plasma cholesterol concentration, more than 7.51mmol / L is severe hypercholesterolemia. Familial dyslipidemias known to be genetic factors that cause elevated plasma cholesterol levels include: familial hypercholesterolemia, familial apolipoprotein B100 deficiency, polygenic familial hypercholesterolemia, and familial mixed hypercholesterolemia Lipidemia, familial dysbeta li...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/405A61P3/06
Inventor 杨恒哲李明杰陈雨高菲菲刘延珍邵杨
Owner SHANDONG LUOXIN PHARMA GRP CO LTD
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