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Sterile and exquisite process of pharmaceutical raw materials

A technology for pharmaceuticals and original drugs, which is applied in the field of sterilization and refined technology of pharmaceutical originals, to achieve the effects of ensuring sterilization, ensuring dryness and internal cleanliness

Active Publication Date: 2021-06-25
CHONGQING MEDICAL & PHARMA COLLEGE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since the equipment used for the purification process of pharmaceutical raw materials is very large, it is very difficult to make all the work rooms to ensure a high degree of aseptic and dust-free environment.

Method used

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  • Sterile and exquisite process of pharmaceutical raw materials
  • Sterile and exquisite process of pharmaceutical raw materials

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0026] Embodiment: the aseptic refinement process of the original drug of pharmaceuticals, comprising the following steps:

[0027] A. Crude drug dissolution: put 100kg of crude drug into a dissolving tank filled with 400L of water for dissolution; keep the liquid temperature at 25°C, and stir with a stirring blade at a stirring speed of 90rpm. After dissolving, adjust pH with hydrochloric acid, add 4.5 to 5.5 kg of activated carbon, decolorize for 10 minutes, and then cool to 15°C.

[0028] B. Crystallization: The crystallization tank was first replaced with nitrogen 5 times, so that the crude drug solution passed through the activated carbon filter, the first filter, the second filter, and the filter plate of the first filter at a specified filtration pressure. The size is smaller than the size of the filter plate for activated carbon filtration, the size of the second filter plate is smaller than the size of the first filter plate, and transferred to the crystallization tan...

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Abstract

The invention relates to the field of preparation of pharmaceuticals, and discloses a process for aseptically refining the original drug of pharmaceuticals, comprising the following steps: A, dissolving the crude original drug; B, crystallization; C, drying; D, charging the drug; in order to solve the existing In the process of preparing the refined original drug existing in the technology, the refined original drug is in contact with people, so that the refined original drug will be mixed with impurities and bacteria. Impurities and bacteria in the original drug are removed or prevented from contacting the original drug with impurities and bacteria, thereby achieving aseptic production and greatly reducing insoluble impurities.

Description

technical field [0001] The invention relates to the technical field of preparation of pharmaceuticals, in particular to the aseptic refinement process of the original medicine of pharmaceuticals. Background technique [0002] Usually, the active ingredient of pharmaceuticals is administered directly into the body by subcutaneous, intradermal or intravenous injection, or administered orally, for example. Therefore, pharmaceutical raw materials are required to be free of impurities and ensure a high degree of sterility or dust-free property. For example, in the case of an active pharmaceutical drug for injection, a chemical substance that is a target product is synthesized in a synthesis process, and then manufactured through a purification process in which impurities are removed. The sterility or dust-freeness of pharmaceutical raw materials is realized through the purification process after synthesis. In the purification process, the synthesized crude drug substance is dis...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61J3/00B02C13/00B02C23/18
Inventor 向小洪
Owner CHONGQING MEDICAL & PHARMA COLLEGE
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