Enki Biopharmaceuticals(Shanghai) Limited.

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    お問い合わせ

    本社所在地: 上海市松江区涞亭南路125号B幢(2号楼) 708室

    Tel: +86-21-57680326  受付電話番号: +86-21-57680965

    〒: 201615

製剤開発

Pharmaceutical preparation R & D services include one-stop services from pre-prescription research, preparation research and development, supporting analysis support and clinical trial preparation production and drug registration services, so as to help customers research and develop superior and stable prescription processes.

The preparation research and development services we provide include, but are not limited to:

Pre-prescription research.

The specific dosage forms were determined according to its physical and chemical properties, clinical drug use characteristics, excipients that can be used, process equipment and so on.

The study on the physical and chemical properties of the drug includes appearance, hardness, fluidity, compressibility and stability of the preparation.

Salt screening;

The study of polycrystalline form;

Study on the powder properties (bulk density, vibrating density, particle size distribution and fluidity);

Study on the compatibility of pharmaceutical excipients.



Screening and optimization of preparation prescription.

According to its physical and chemical properties, a reasonable solid (tablet, pellet, etc.) or nanoparticle system (liposome, micelle, microsphere, etc.) is designed.

Study on the preparation technology of cymbidium;

Quality research and quality standard formulation;

Stability study.


Testing of chemical and physicochemical properties of drugs.

Determination of potassium content (such as high performance liquid chromatography, chromatography, ultraviolet spectrophotometry, LC-MS);

Identification of the structure of active substances (such as nuclear magnetic resonance, infrared chromatography);

Identification of physical and chemical properties (e.g., pH, viscosity, melting point, osmotic pressure, drying weight loss, DSC);

Limit test (heavy metal);

Residual solvent;

Pharmaceutical technical analysis (disintegration time analysis, dissolution determination, hardness, brittleness).


Preparation equipment and facilities.

The pharmaceutical preparation laboratory is equipped with excellent dissolution meter, automatic hardness meter, brittleness detector, low temperature photometer, clarity detector, disintegration meter, moisture meter, high precision electronic balance, airflow grinder, nano ball mill, freeze dryer, fluidized bed, coating machine, dry granulator, wet granulator, pressing machine, crusher, sealing machine, sterilizing pot, Special equipment for preparation, such as drug stability test chamber.