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Oseltamivir dry syrup and preparation method thereof

A technology of oseltamivir and oseltamivir phosphate, which is applied in antiviral agents, pharmaceutical formulas, medical preparations of non-active ingredients, etc., can solve the problems of impurities without considering stability, and achieve uniform appearance and convenient administration , the effect of uniform content

Pending Publication Date: 2022-01-04
HARBIN PHARMA GROUP TECH CENT
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Does not consider whether the stability impurities are lower than the original research impurities

Method used

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  • Oseltamivir dry syrup and preparation method thereof
  • Oseltamivir dry syrup and preparation method thereof
  • Oseltamivir dry syrup and preparation method thereof

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Experimental program
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preparation example Construction

[0034] 4. Preparation of adhesive (50% ethanol): Weigh the prescribed amount of ethanol:purified water=1:1 to prepare an adhesive for later use.

[0035] 5. Mixing and granulation: put the mixed material in a wet mixing granulator, add ethanol to make a soft material with a binder according to the weight of the material at 40-50% by weight, the specific conditions are as follows: stirring parameters 500rpm, shearing 1000rpm for granulation The time is 3 minutes. The prepared soft material is placed in an extrusion spheronizer with a screen size of 0.6.

[0036] 6. Drying: Use a fluidized bed to dry the granulation, the drying temperature is 30-40°C, and the drying moisture is controlled below 0.5%.

[0037] 7. Packing: Calculated based on the product content of 30 mg / g, each pack should contain 0.9 g of oseltamivir phosphate, and the filling volume is about 30 g.

Embodiment 1

[0040] Embodiment 1 Oseltamivir phosphate dry syrup detection result is as follows:

[0041]

[0042] Cumulative dissolution test results

[0043] In order to observe the performance of the reference preparation more intuitively, put the product prepared according to the above process into a stability box, and place it at a high temperature of 60°C and a high humidity of 90% for 10 days to evaluate the formulation differences of the samples under different conditions. The result is shown in table 3, as can be seen, the stability of embodiment 1, 2 is better, and the stability of embodiment 3 is poor, all does not exceed the item of prescribed limit, in total miscellaneous items, the impurity amount of implementation case 1 It is obviously less than the implementation case 2, and has the advantage of being more stable. It shows that the selection of sorbitol can significantly improve the stability of the preparation, and the preparation of the present invention has similar ...

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Abstract

The invention discloses oseltamivir dry syrup and a preparation method thereof, relates to the field of medicine preparation, and aims to provide the oseltamivir dry syrup and the preparation method thereof, the dry syrup is good in taste, high in dissolution rate and convenient to clinically take, and the preparation method is simple in process, controllable in quality and suitable for industrial production. The oseltamivir dry syrup is prepared from the following components in percentage by weight: 4.0 percent of oseltamivir, 89.0-93.0 percent of a filling agent, 0.5-2.0 percent of a preservative, 0.5-2.0 percent of an antioxidant, 0.5-2.0 percent of a flow aid and 0.5-2.0 percent of a sweetening agent. The granules prepared according to the formula and the method are good in uniformity and stability, low in content of related substances, high in dissolution rate and high in bioavailability, and the preparation process is convenient and easy to implement, low in cost, free of any special equipment and suitable for industrial production. The method is applied to the field of medicine preparation.

Description

technical field [0001] The invention relates to the field of medicine preparation, in particular to a dry oseltamivir syrup and a preparation method thereof. Background technique [0002] Oseltamivir phosphate, ethyl (3R,4R,5S)-4-acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylate phosphate , CAS No.204255-11-8, molecular formula C 16 h 28 N 2 o 4 .H 3 PO 4 , molecular weight 410.40. Neuraminidase (NA) inhibitor antiviral drugs are a class of anti-influenza virus drugs. As a new neuraminidase inhibitor, oseltamivir phosphate is effective for both A and B influenza viruses, It is not easy to drug resistance, well tolerated by patients, and has high safety. It is clinically used for the prevention and treatment of influenza. [0003] The application number is 201510049631.7, which discloses oseltamivir dry syrup and its preparation method in the Chinese patent application. The granule adopts auxiliary materials of sucrose and sodium aracycline to improve ...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/215A61K47/32A61K47/12A61K47/26A61K47/18A61K47/04A61P31/16
CPCA61K9/1635A61K9/1617A61K9/1623A61K9/1611A61K9/0056A61K31/215A61P31/16
Inventor 魏涛姜海涛杨蕾徐岩杨景杰关晓丽梁佳辉郑倩葛京城李宏亮李玉娟陈丹杨槐张玉华
Owner HARBIN PHARMA GROUP TECH CENT
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