Dry-heat low-pressure continuous sterilization method

Abstract

The invention belongs to the technical field of material sterilization. The invention relates to a dry-heat low-pressure continuous sterilization method. A sterilization inner cavity is heated througha heating device; the sterilization inner cavity is vacuumized through a vacuum device; the temperature of the sterilization inner cavity is adjusted and set during sterilization; materials are fed from one end of the tubular sterilization inner cavity, the material is conveyed from a feeding port to a discharging port through a conveying packing auger. In the sterilization process, the maintaining time of the vacuum degree and the pressure is controlled according to the number of microorganisms and the water content of materials, in the material conveying process, sterilization is conductedat the temperature lower than 100 DEG C under the positive-pressure and negative-pressure combined action, and the sterilization time is adjusted by adjusting the staying time of the materials in thesterilization inner cavity by adjusting the rotating speed of the conveying auger. A traditional dry heat sterilization mode is combined with preset positive and negative pressure, a physical sterilization process without any sterilizing agent works under a relatively low temperature condition, the medicine property of the materials is kept, and continuous sterilization is realized.

Description

technical field [0001] The invention belongs to the technical field of material sterilization, and in particular relates to a dry heat and low pressure continuous sterilization method. Background technique [0002] Sterilization refers to the use of appropriate physical or chemical methods to reduce the residual probability of contaminated microorganisms in materials to a certain level to meet the requirements. Among the 459 preparations recorded in the 2015 edition of "Chinese Pharmacopoeia", 343 varieties contain native drug powder, accounting for 74.73% of the total preparations, and the microbial limit of preparations containing native drug powder is 10 to 100 times higher than other preparations Many, the number of bacteria contained in the original powder of traditional Chinese medicine or the decoction pieces of traditional Chinese medicine seriously affects the quality of preparations and finished products. Article 7023 of the "Drug GMP Certification Inspection and ...

AI Technical Summary

Problems solved by technology

The disadvantages of moist heat sterilization are: 1. High temperature (121°C) is extremely destructive to Chinese medicine ingredients, heat-sensitive ingredients are reduced, volatile aromatic ingredients are seriously lost, and many product ingredients cannot meet the inspection standards; 2. Change the properties of medicine: Chinese medicine prescriptions The raw medicinal materials in the Chinese herbal medicine have become mature medicinal materials, and some curative effects have the opposite effect, and the processing of traditional Chinese medicinal materials has completely lost its effect. Rehmannia glutinosa, raw rehmannia root clears away heat and cools blood and is used for diarrhea, while rehmannia glutinosa nourishes yin and nourishes blood and is used for tonifying. The raw rhubarb of Niuhuangjiedu pills becomes mature rhubarb after sterilization, and the curative effect is opposite. Material loss 1.5-2%; 4. High energy consumption

The disadvantages of the dry heat sterilization method are: 1. High temperature (115°C) is extremely destructive to the ingredients of traditional Chinese medicine, the heat-sensitive ingredients are reduced, the volatile aromatic ingredients are seriously lost, and many product ingredients cannot meet the inspection standards; 2. Change the properties of the medicine: The raw medicinal materials in the prescription of traditional Chinese medicine have become mature medicinal materials, and some curative effects have had the opposite effect, and the processing of traditional Chinese medicinal materials has completely lost its effect. Rehmannia glutinosa has been transformed into rehmannia glutinosa, rehmannia glutinosa clears heat and cools blood and is the main source of diarrhea, rehmannia glutinosa nourishes yin and nourishes blood and is the main source of tonic, the raw rhubarb of Niuhuang Jiedu pills becomes mature rhubarb after sterilization, the curative effect is opposite, etc.; 3. Contains volatile oil components, bran or Fine powder of medicinal materials with a high proportion of oil components is not suitable for dry heat sterilization. 4. High energy consumption

[0006] Therefore, the existing dry heat sterilization method and wet heat sterilization method may destroy the ingredients, reduce the curative effect, and change the drug properties. Cobalt-60 ( 60 Co)-γ irradiation sterilization method, ethanol low temperature sterilization method, ethylene oxide sterilization method, ozone sterilization method, ultraviolet sterilization method, microwave sterilization method, superheated steam sterilization method, soaking sterilization method exist May change ingredients, produce toxicity, change traits, etc.

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