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Preparation method of fenofibrate and pravastatin sodium compound preparation

A technology of pravastatin sodium and fenofibrate, which is applied in the field of pharmaceutical preparations and can solve problems such as difficult industrial production, cumbersome design and preparation methods, etc.

Inactive Publication Date: 2013-10-23
肖广常
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This shows that the entire prescription design and preparation method of pravafenix is ​​relatively cumbersome. At present, there is no capsule production line for filling capsules and tablets at the same time in China, so it is difficult to realize industrial production of this process in China.

Method used

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  • Preparation method of fenofibrate and pravastatin sodium compound preparation
  • Preparation method of fenofibrate and pravastatin sodium compound preparation
  • Preparation method of fenofibrate and pravastatin sodium compound preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] Prescription of pravastatin sodium pellets:

[0066]

[0067] Prescription of fenofibrate semi-solid granules:

[0068]

[0069]

[0070] Preparation:

[0071] Preparation of pravastatin sodium pellets: Dissolve pravastatin sodium, sodium bicarbonate, vitamin C, and povidone K30 in 50% ethanol solvent, add blank pellet cores to the fluidization chamber, adjust the air volume, and make most of the micropellets The pills are blown up in the fluidization chamber, and the physicochemical pressure and the flow rate of the constant-flow pump are adjusted to make the drug solution atomized well, and then the drug is sprayed and the drug is applied. After the drug is applied, the hot air is used for 5 minutes to dry. After drying, continue to coat in the same way as applying the medicine, and you get it.

[0072] (2) Preparation of fenofibrate semi-solid granules: dissolving fenofibrate in glycerol acetate; heating and melting macrogol glyceryl laurate and macrogol ...

Embodiment 2

[0075] Prescription of pravastatin sodium pellets:

[0076]

[0077] Prescription of fenofibrate solid particles:

[0078]

[0079] Preparation:

[0080] Preparation of pravastatin sodium pellets: Dissolve pravastatin sodium, sodium bicarbonate, BHT, and povidone K30 in 50% ethanol solvent, add blank ball cores to the fluidization chamber, adjust the air volume, and make most of the pellets It is blown up in the fluidization chamber, and the physicochemical pressure and the flow rate of the constant flow pump are adjusted to make the drug solution atomized well, and then the drug is sprayed and applied. After the drug is applied, the hot air is used for 5 minutes to dry. After drying, continue to coat in the same way as applying the medicine, and you get it.

[0081] (2) Preparation of fenofibrate solid particles: dissolve fenofibrate, polyoxyethylene hydrogenated castor oil, and povidone K30 in 50% ethanol; mix lactose and pregelatinized starch evenly, add the liquid...

Embodiment 3

[0084] Prescription of pravastatin sodium pellets:

[0085]

[0086] Prescription of fenofibrate solid particles:

[0087]

[0088] Preparation:

[0089] (1) Preparation of pravastatin sodium pellets: pass the raw materials through a 100-mesh sieve, fully mix with microcrystalline cellulose, calcium hydrogen phosphate, and sodium bisulfite; add hypromellose 50% ethanol solution to make a soft material ; Extrude the soft material into strips through the extruder to form a smooth short branch; quickly add the extruded product to the spheronizer for spheronizing, and take it out after a certain period of time to obtain pellets; : the prepared pellets Dry at 50°C to obtain the finished drug-containing pellets. Finally, the drug-containing pellets are placed in a fluidized bed for coating.

[0090] (2) Preparation of fenofibrate solid particles: Dissolve fenofibrate, poloxamer F188, and povidone K30 in 50% ethanol; mix lactose and microcrystalline cellulose evenly, add li...

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Abstract

The invention provides a preparation method of a compound composition containing active ingredients fenofibrate and pravastatin sodium. The preparation method is characterized in that the pravastatin sodium exists in the composition in the form of quick-release pellets; the fenofibrate exists in the composition in the form of solid dispersoid or semi-solid particles. The preparation method of the composition aims to solve the problem about the bioavailability of the fenofibrate and the pravastatin sodium with completely different solubility and the problem about the stability when the fenofibrate and the pravastatin exist in the same component commonly.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations. More specifically, the present invention relates to a preparation method of a pharmaceutical composition containing fenofibrate and pravastatin sodium as active ingredients. Background technique [0002] Fenofibrate is a blood lipid regulating drug derived from clofibrate, which can reduce blood low-density lipoprotein, cholesterol and triglyceride by inhibiting the formation of very low-density lipoprotein and triglyceride and simultaneously increasing its catabolism; It also increases the generation of apolipoprotein A1 and A11, thereby increasing high-density lipoprotein. This product still has the function of reducing blood uric acid in normal people and patients with hyperuricemia. [0003] The results of pharmacokinetic studies show that this product is well absorbed in the gastrointestinal tract after oral administration, and taking it with food can increase the absorption of f...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/48A61K9/20A61K31/22A61K31/366A61P3/06A61K31/216
Inventor 孙英肖广常王建华信秀灵
Owner 肖广常
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