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Paracetamol pseudophedrine sulfateand clemastine fumarate tablets, film-coated tablets and preparation method thereof

A kind of technology of Machuotine tablets and paracetamol, which is applied in the field of pharmaceutical preparations and achieves the effects of simple process and excellent dissolution rate

Active Publication Date: 2015-09-02
JINAN LIMIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there is no report on the import and use of this drug in China

Method used

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  • Paracetamol pseudophedrine sulfateand clemastine fumarate tablets, film-coated tablets and preparation method thereof
  • Paracetamol pseudophedrine sulfateand clemastine fumarate tablets, film-coated tablets and preparation method thereof
  • Paracetamol pseudophedrine sulfateand clemastine fumarate tablets, film-coated tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1 prescription screening

[0026] The main medicines of this product are acetaminophen, pseudoephedrine hydrochloride, and clemastine fumarate. When designing the prescription, the active ingredients are complicated, and the stability and dissolution rate of the preparation are difficult to meet the understanding requirements. Prescription screening is as follows:

[0027] Table 1 Prescription screening (500 tablets dosage)

[0028]

[0029]

[0030] The applicant unexpectedly found in the prescription screening experiment that when glyceryl behenate was added to the prescription and the amount of glyceryl behenate was 1 / 3-1 / 2 of that of magnesium stearate, the drug dissolution rate and stability Significantly improved. In the process step, glyceryl behenate, hydroxypropyl cellulose and magnesium stearate are added simultaneously.

[0031] The test results show that the compressibility of the granules of the five prescriptions is good, and the appear...

Embodiment 2

[0037] Embodiment 2 best prescription and technology

[0038] prescription:

[0039]

[0040]

[0041] Coating layer prescription:

[0042] Gastric Opadry 20.0g

[0043] 75% ethanol 400ml

[0044] Process:

[0045] (1) fully mixing clemastine fumarate with pregelatinized starch in a ratio of 1:100 by weight to obtain clemastine fumarate mother powder for subsequent use;

[0046] (2) adding water to the starch of the prescription amount to make a weight ratio of 6% starch slurry for subsequent use;

[0047] (3) Acetaminophen, pseudoephedrine hydrochloride, clemastine fumarate mother powder, microcrystalline cellulose and the remaining amount of pregelatinized starch are weighed and mixed thoroughly;

[0048] (4) Add starch slurry to make soft material, and granulate with 14 mesh sieves;

[0049] (5) Blast drying at 60°C, granulation with a 16-mesh sieve;

[0050] (6) Add hydroxypropyl cellulose and magnesium stearate of prescription quantity, fully mix;

[0051] (...

Embodiment 3

[0055] Experimental data and literature data of embodiment 3 drug stability research

[0056] 1. Sample source and batch number

[0057] Sample: Prepared by Jinan Limin Pharmaceutical Co., Ltd. according to the prescription and process of Example 2.

[0058] Batch numbers: 1401104, 1401105, 1401106.

[0059]Specifications: Acetaminophen 500mg, Pseudoephedrine Hydrochloride 30mg, Clemastine Fumarate 0.335mg.

[0060] Quantity: 10,000 pieces per batch.

[0061] 2. Inspection items and testing methods

[0062] Properties, dissolution rate, related substances, content. The above items are determined by the methods in the quality standards except for the "related substances" which are determined by the related substances determination method in the quality research.

[0063] 3. Experimental research

[0064] (1) Influencing factor test

[0065] Light test:

[0066] Get this product (batch number: 1401104) and set the light intensity 4500LX to irradiate for 10 days, take sam...

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Abstract

The invention discloses paracetamol pseudophedrine sulfateand clemastine fumarate tablets which are composed of the following ingredients: 400-600 parts of paracetamol, 0.3-0.4 part of clemastine fumarate, 25-35 parts of pseudoephedrine hydrochloride, 60-80 parts of pregelatinized starch, 35-45 parts of microcrystalline cellulose, 4-6 parts of starch, 12-15 parts of low-substituted hydroxy propyl cellulose and 6-8 parts of magnesium stearate. The invention also discloses paracetamol pseudophedrine sulfateand clemastine fumarate film-coated tablets and their preparation method. The paracetamol pseudophedrine sulfateand clemastine fumarate tablets have excellent dissolubility and stability and have properties of other preparations. In addition, the technology is simple and is easy for industrial mass production.

Description

technical field [0001] The invention relates to an acetaminophen pseudoephedrine tablet, a film-coated tablet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Cold is a common disease and frequently-occurring disease in people's daily life. According to statistics, about 75% of people in my country suffer from at least one cold every year, and nearly one billion people need to use cold medicine at least once every year. In 2000, among cold patients 85% have taken cold medicine. Corresponding to the frequent occurrence of cold diseases, the market size of anti-cold medicines is also very large. In 1998, the total retail sales of global anti-cold medicines was US$4.57 billion, ranking first in the world's over-the-counter (OTC) retail list. With the enhancement of people's health care awareness, the cold medicine market has shown a steady upward trend. It is estimated that the global cold and cough...

Claims

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Application Information

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IPC IPC(8): A61K31/40A61K9/36A61P31/16A61P29/00A61P37/08A61P11/02A61P11/04A61K31/167A61K31/137
Inventor 周爱霞秦怀国张明铭苏磊
Owner JINAN LIMIN PHARMA
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