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Medicinal composition containing Esopiclone and preparation method thereof
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A technology of eszopiclone and composition, which is applied in the field of pharmaceutical compositions containing eszopiclone, and can solve problems such as low dissolution rate and poor content uniformity
Active Publication Date: 2013-06-05
CHENGDU KANGHONG PHARMA GRP
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[0014] One of the technical problems to be solved in the present invention is to solve the problems of poor content uniformity and low dissolution rate of the existing eszopiclone pharmaceutical composition
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Embodiment 1 to 8
[0135] Embodiment 1 to 8, see table 17: (by weight)
[0136] Table 17 Examples 1 to 8
[0137]
[0138] The preparation method of above embodiment:
[0139] It adopts wet granulation, compresses tablets or packs capsules, and the preparation process is as follows:
[0140] (1) Take eszopiclone (with a particle size range of 50 μm-165 μm) and dextrin and mix them uniformly;
[0141] (2) Combine the sieved hydroxypropyl cellulose with disintegrating agent, starch, lactose, and microcrystalline cellulose, sieve, and mix evenly to obtain an auxiliary material mixture.
[0142] (3) Take the homogeneously mixed mixture of eszopiclone and dextrin, mix it uniformly with the mixture of auxiliary materials in an equal amount incremental method, add an appropriate amount of 10% povidone K30 solution to make a soft material, granulate, dry at 60°C, and granulate;
[0143] (4) Add micropowder silica gel and magnesium stearate, mix well, measure the content of the main drug in the gra...
Embodiment 9 to 15
[0155] Embodiment 9 to 15, see table 20: (by weight)
[0156] Table 20 Examples 9 to 15
[0157]
[0158] The preparation method of above embodiment:
[0159] It adopts wet granulation, compresses tablets or packs capsules, and the preparation process is as follows:
[0160] (1) Take eszopiclone (with a particle size range of 50 μm-125 μm) and dextrin and mix them uniformly;
[0161] (2) Combine the sieved hydroxypropyl cellulose with disintegrating agent, starch, lactose, and microcrystalline cellulose, sieve, and mix evenly to obtain an auxiliary material mixture.
[0162] (3) Take the homogeneously mixed mixture of eszopiclone and dextrin, mix it uniformly with the mixture of auxiliary materials in an equal amount incremental method, add an appropriate amount of 10% povidone K30 solution to make a soft material, granulate, dry at 60°C, and granulate;
[0163] (4) Add micropowder silica gel and magnesium stearate, mix well, measure the content of the main drug in the g...
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Abstract
The invention discloses a medicinal composition containing Esopiclone and a preparation method thereof. The Esopiclone-containing medicinal composition consists of a main medicine and auxiliary materials. In the invention, by controlling the particle size of the main medicine, a pre-mixing method and the auxiliary materials, the medicinal composition which has high dissolution rate and high content uniformity can be obtained. The preparation method adopts a modern preparation technique, the quality of the product is stable, and an Esopiclone-containing solid oral preparation which is safe, effective, quick in absorption, high in bioavailability and accurate in dosage is provided for patients.
Description
technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition containing eszopiclone. Background technique [0002] Insomnia is one of the most common clinical symptoms, and the incidence rate is very high. According to the survey results in the United States, in the past 20 years, the prevalence rate of insomnia was about 30% to 35%, and 10% to 15% of patients with insomnia The degree is quite serious, and the findings in the UK and Australia are similar. In China, a sample survey by the Chinese Medical Association shows that the incidence of insomnia in the population rose to more than 40% in 2003, and the number of insomnia is still increasing and showing a rising trend. At present, about 300 million adults in China suffer from insomnia symptoms such as insomnia, difficulty falling asleep, not sleeping soundly, dreaming and waking up easily, waking up early and difficulty falling asleep. The resul...
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