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Preparation method of lovastatin dispersible tablet

A technology for lovastatin and dispersible tablets, which is applied in the field of preparation of lovastatin dispersible tablets, can solve the problems of easy energy consumption, unfavorable large-scale production, complicated processes, etc., and achieves the advantages of reducing process operation steps, reducing input cost and increasing dissolution. Effect

Inactive Publication Date: 2017-01-04
CHENGDU BAOKE BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] When the existing lovastatin dispersible tablets are prepared, the raw materials and auxiliary materials are mixed, after the soft material is made, they are uniformly dried, and then crushed and then granulated with an adhesive, and dried; two-step mixing and two-step drying, the process is cumbersome and unfavorable for large-scale production , and it is easy to consume energy and increase the cost

Method used

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  • Preparation method of lovastatin dispersible tablet
  • Preparation method of lovastatin dispersible tablet
  • Preparation method of lovastatin dispersible tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] The selection test of embodiment 1 lovastatin dissolving solvent

[0026] Take about 20 mg of the raw materials and put them in a beaker, gradually add ethanol solutions of different concentrations (50%, 75%, 95%), observe while shaking until the solution is clear, and weigh the amount of solvent added. According to the amount of different ethanol concentrations, 180 mg of mixed auxiliary materials were used to make soft materials, and the humidity of the soft materials was observed, and sieved with a 20-mesh sieve. The results are shown in Table 1.

[0027] Table 1 The selection and investigation results of the main drug dissolution solvent

[0028]

[0029] Results: The above-mentioned ethanol solutions with different concentrations can dissolve 20mg of raw materials well under a certain amount, have a good wetting effect on 180mg, and have good formability on material particles. It is determined that 50-95% ethanol is used as the granulation solvent for this produ...

experiment example 2

[0031] The prescription of lovastatin tablets consists of the ingredients shown in Table 2.

[0032] Table 2 Prescription of lovastatin tablets

[0033]

[0034] The preparation method of above-mentioned lovastatin dispersible tablet is as follows:

[0035] Preparation Process:

[0036] 1. The lovastatin and povidone of prescription quantity are ultrasonically dissolved in about 60g of 75% ethanol solution simultaneously, as the adhesive containing principal agent, this adhesive is colorless and transparent, without lumps and bubbles.

[0037] 2. Take the prescribed amount of sodium carboxymethyl starch, pregelatinized starch, talcum powder, and sodium saccharin and mix them through a 100-mesh sieve for 3 times.

[0038] 3. Add the binder containing the main ingredient to the mixture in step 2, prepare the soft material, granulate with a 20-mesh sieve, and dry in an oven at 60°C (moisture content 1-3%).

[0039] 4. The granules are passed through a 24-mesh sieve for gran...

experiment example 3

[0042] The prescription of lovastatin tablets consists of the ingredients shown in Table 3.

[0043] Table 3 Prescription of lovastatin tablets

[0044]

[0045]

[0046] The preparation method of above-mentioned lovastatin dispersible tablet is as follows:

[0047] Preparation Process:

[0048] 1. Dissolve the prescribed amount of lovastatin and hydroxypropyl methylcellulose in about 60g of 50% ethanol solution at the same time, and use it as an adhesive containing the main drug. The adhesive is colorless and transparent without lumps Blocks and bubbles.

[0049] 2. Take the prescribed amount of microcrystalline cellulose, cross-linked polyvinylpyrrolidone, talcum powder, and aspartame and mix them through a 100-mesh sieve for 3 times.

[0050] 3. Add the binder containing the main ingredient to the mixture in step 2, prepare the soft material and granulate it with a 20-mesh sieve, and dry it in an oven at 40°C (moisture content 1-3%).

[0051] 4. The granules are p...

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Abstract

The invention provides a preparation method of a lovastatin dispersible tablet. The preparation method comprises the following steps: a, weighing raw materials and adjuvant materials in parts by weight: 10-20 parts of lovastatin, 30-80 parts of a disintegrant, 100-200 parts of a filler, 1-3 parts of an adhesive, 1.5-2.5 parts of a flow aid and 1-3 parts of a lubricant; b, dissolving the lovastatin and the disintegrant in 50-95% ethanol, so as to prepare a drug-containing adhesive; c, sieving a mixture of the filler, the lubricant and the adhesive, and conducting mixing; and d, adding the drug-containing adhesive obtained in the step b to the mixture prepared in the step c, and conducting granulating, drying, straightening, totally mixing and tableting so as to prepare the tablet. With the application of the preparation method of the lovastatin dispersible tablet provided by the invention, the uniformity of drug content can be guaranteed, the raw materials do not need to be subjected to micronization, and the particle size is controlled; and according to the preparation method, the dissolution of insoluble drugs can be enhanced; and by conducting co-dissolving, technological operating steps can be reduced, energy can be saved and cost can be reduced.

Description

technical field [0001] The invention relates to a preparation method of lovastatin dispersible tablets, belonging to the field of pharmaceutical preparations. Background technique [0002] Lovastatin (lovastatin) is the first statin lipid-lowering drug used in clinical practice. It was approved for marketing in my country in 1996. Lovastatin can significantly reduce cholesterol and low-density lipoprotein cholesterol levels, and has a good blood lipid-lowering effect, and there is no accumulation of cholesterol substances, and it will not affect the amount of cholesterol required for the normal function of cell membranes under therapeutic doses, and the adverse reactions are relatively small . Lovastatin is well absorbed orally, but because of its poor solubility in water and low bioavailability, in order to improve bioavailability and reduce adverse reactions, research on new formulations of lovastatin emerged as the times require. [0003] Lovastatin is poorly soluble in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/47A61K47/38A61K47/32A61P3/06
Inventor 陈立春
Owner CHENGDU BAOKE BIOTECH
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