WO2018126639A1 - 低温蒸汽灭菌中药的一种灭菌方法 - Google Patents

低温蒸汽灭菌中药的一种灭菌方法 Download PDF

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WO2018126639A1
WO2018126639A1 PCT/CN2017/093269 CN2017093269W WO2018126639A1 WO 2018126639 A1 WO2018126639 A1 WO 2018126639A1 CN 2017093269 W CN2017093269 W CN 2017093269W WO 2018126639 A1 WO2018126639 A1 WO 2018126639A1
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sterilization
vacuum
steam
chinese medicine
temperature
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French (fr)
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张建斌
王儒涛
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连云港佑源医药设备制造有限公司
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0023—Heat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/26—Accessories or devices or components used for biocidal treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10—Apparatus features
    • A61L2202/12—Apparatus for isolating biocidal substances from the environment
    • A61L2202/121—Sealings, e.g. doors, covers, valves, sluices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/21—Pharmaceuticals, e.g. medicaments, artificial body parts

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  • the invention relates to the technical field of traditional Chinese medicine sterilization methods, in particular to a sterilization method for low temperature steam sterilization traditional Chinese medicine.
  • High temperature and high pressure steam sterilization uses high temperature and high pressure steam to sterilize and dry the traditional Chinese medicine, and the sterile Chinese medicine powder is in the aseptic area. After being packaged and sold, the method can maintain the uniformity of the original Chinese medicine powder.
  • the sugary part will be gelatinized, and other parts may also undergo a series of chemical reactions due to high temperature and high pressure steam treatment, resulting in sterilization of Chinese medicine powder.
  • the actual content and composition have changed a lot, and the original Chinese medicine can not be maintained.
  • the present invention provides a method for sterilizing traditional Chinese medicine by low temperature and low pressure steam, so that the traditional Chinese medicine maintains the original efficiency and uniformity, and completely kills various bacteria in the traditional Chinese medicine, thereby saving a lot of energy and materials. cost.
  • a sterilization method for low temperature steam sterilization Chinese medicine the steps are as follows:
  • step (7) After the end of step (7), the power is still not turned off, after standing for 24 hours, repeat steps (2)-(6) again;
  • the sterilization parameter in the step (2) is: a pressure in the jacket and the moisture-proof tube (-0.025)-(-0.035) Mpa, a sterilization temperature of 80 ° C, a sterilization time of 60 min, a preheating stabilization time of 20 min, and a vacuum.
  • the traditional Chinese medicine is a Chinese medicine powder or a Chinese medicine material.
  • the invention provides a sterilization method for low temperature steam sterilization traditional Chinese medicine, which is positioned for sterilization of Chinese medicine powder or Chinese herbal medicine, and the sterilization equipment comprises isolation arrangement of front and rear doors, which can effectively ensure effective isolation between the cleaning area and the sterile area;
  • the vacuum system is set to the negative pressure to realize vacuum sterilization;
  • the vacuum buffer tank can reduce the noise of the equipment, and at the same time ensure the pressure of the equipment when the steam is hydrophobic;
  • the jacket and the moisture-proof tube can play the role of heating and heat preservation; preheating before sterilization
  • the stabilization stage stabilizes the sterilization pressure between the sterilization chamber and the sterilization temperature, and gradually heats up on the basis of pressure stability.
  • the whole process is gradual, which is beneficial to the control of sterilization conditions; the high temperature and high pressure steam entering the vacuum environment It quickly turns into low-temperature and low-pressure steam, and the exhaust steam trap is continuously drained to the vacuum buffer tank, which ensures the steam saturation of the sterilization chamber, so that the temperature and pressure of the whole sterilization process are kept constant; wait for 24h sterilization, waiting for spore growth It can further kill the newly formed bacteria of spores to achieve better sterilization effect; avoid the use of sterilizing agents to cause environmental damage Dyeing and modification of traditional Chinese medicine; the sterilization method is convenient to operate, greatly reduces energy consumption, maintains the original Chinese medicine efficacy, characteristics, uniformity, and at the same time ensures mold in Chinese medicine powder (temperature resistance 60 ° C), The complete killing of most kinds of bacteria such as Escherichia coli (temperature resistance 80 ° C) saves a lot of energy and material costs, and is a novel green sterilization method that is worthy of widespread promotion.
  • FIG. 1 is a general assembly diagram of the sterilization equipment, the markings are as follows:
  • a sterilization method for low temperature steam sterilization Chinese medicine powder the steps are as follows:
  • sterilization pressure -0.030Mpa sterilization temperature 80 °C
  • sterilization time 60min preheating stabilization time 20min
  • vacuum buffer tank upper pressure -0.07Mpa sterilization time 60min
  • preheating stabilization time 20min preheating stabilization time 20min
  • vacuum buffer tank upper pressure -0.07Mpa sterilization time 60min
  • preheating stabilization time 20min preheating stabilization time 20min
  • vacuum buffer tank upper pressure -0.07Mpa lower limit pressure -0.09Mpa
  • vacuum Drying time 20min return air time 10min
  • step (8) After the end of step (8), the power is still not turned off, and allowed to stand for 24 hours, waiting for the spore growth of residual bacteria. After 24 hours, steps (2)-(7) are repeated to completely kill the remaining bacteria.
  • step (10) After the end of step (9), the entire sterilization process is finished, and the back door is opened to take out the traditional Chinese medicine powder, and the next process is carried out.
  • a sterilization method for low temperature steam sterilization of Chinese medicinal materials the steps are as follows:
  • sterilization pressure -0.035Mpa sterilization temperature 80 °C
  • sterilization time 60min preheating stabilization time 20min
  • vacuum buffer tank upper pressure -0.07Mpa sterilization time 60min
  • preheating stabilization time 20min preheating stabilization time 20min
  • vacuum buffer tank upper pressure -0.07Mpa sterilization time 60min
  • preheating stabilization time 20min preheating stabilization time 20min
  • vacuum buffer tank upper pressure -0.07Mpa lower limit pressure -0.09Mpa
  • vacuum Drying time 25min return air time 10min
  • step (8) After the end of step (8), the power is still not turned off, and allowed to stand for 24 hours, waiting for the spore growth of residual bacteria. After 24 hours, steps (2)-(7) are repeated to completely kill the remaining bacteria.
  • step (10) After the end of step (9), the entire sterilization process is finished, and the back door is opened to take out the Chinese herbal medicine and proceed to the next process.
  • a sterilization method for low temperature steam sterilization Chinese medicine powder the steps are as follows:
  • sterilization pressure -0.035Mpa sterilization temperature 85 °C
  • sterilization time 90min preheating stabilization time 30min
  • vacuum buffer tank upper pressure -0.06Mpa lower limit pressure -0.08Mpa
  • vacuum Drying time 20min return air time 10min;
  • step (8) After the end of step (8), the power is still not turned off, and allowed to stand for 24 hours, waiting for the spore growth of residual bacteria. After 24 hours, steps (2)-(7) are repeated to completely kill the remaining bacteria.
  • step (10) After the end of step (9), the entire sterilization process is finished, and the back door is opened to take out the traditional Chinese medicine powder, and the next process is carried out.
  • the invention provides a sterilization method for low temperature steam sterilization traditional Chinese medicine, and is a method for low temperature steam sterilization traditional Chinese medicine which is not available at home and abroad, and can completely solve the current situation that Chinese medicine can not be sterilized or high temperature sterilization modified. It is a unique and novel low-temperature sterilization method, which uses low-temperature steam sterilization, low sterilization temperature, reduces equipment heating energy consumption, saves equipment operation cost and a large amount of manpower and material resources, and also saves a lot of intermediate work links.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

低温蒸汽灭菌中药的一种灭菌方法，涉及中药灭菌方法，将中药放入灭菌室（2）后，首先对灭菌室（2）抽真空，同时向灭菌室（2）进高温高压蒸汽，当灭菌室（2）压力达到灭菌压力时，进行预热稳定，然后继续进高温高压蒸汽，使灭菌室（2）温度升高到灭菌温度，开始灭菌，灭菌结束后，进入干燥过程，干燥后静置24h，等待芽孢生长，再次进行灭菌，灭菌后再重复等待、灭菌过程，灭菌结束。该灭菌方法运行方便，极大地减少了能源消耗，保持了原有的中药效能、特色、均一性，同时又保证中药粉内的霉菌、大肠杆菌等多数种类细菌的彻底杀灭，节省了大量能源、物资成本。

Description

低温蒸汽灭菌中药的一种灭菌方法 技术领域
本发明涉及中药灭菌方法技术领域，具体涉及低温蒸汽灭菌中药的一种灭菌方法。
背景技术
国家食品药品监督管理总局颁布的新版《药品生产质量管理规范》对中药及其制剂的灭菌操作做了详细的规定，《中国药典》也对中药及其制剂的微生物限度检查提出了严格的要求，灭菌操作作为影响中药及其制剂质量的关键操作单元，将直接影响着药品安全、有效及质量稳定。目前中药的灭菌现状为不灭菌或者采用高温高压蒸汽灭菌，不做灭菌处理的中药直接将中药材洗净后烘干，进入破碎机破碎，过滤，形成中药粉，将带菌的中药粉直接包装出售，虽能保持原有的中药的效能，性状，但是因含有杂菌(如霉菌、大肠杆菌等)容易产生霉变，再生长其他细菌，造成药品带有危害性的病原体，导致药品含有不同的菌种而使效能起到不一样的效果，无法达到药品的性状均一性；高温高压蒸汽灭菌利用高温高压蒸汽对中药灭菌、干燥，将无菌的中药粉在无菌区经过包装出售，该方法可以保持原有中药粉的性状均一性，但药粉经过高温处理，含糖部分会糊化，其他部分也可能因高温高压蒸汽处理发生一系列化学反应，造成灭菌中药粉的实际含量、成分都有了很大的改变，不能保持原有的中药疗效。
发明内容
(一)解决的技术问题
针对现有技术的不足，本发明提供了一种低温低压蒸汽灭菌中药的方法，使得中药保持原有效能、均一性的同时，彻底杀灭中药内的多种细菌，节省了大量能源、物资成本。
(二)技术方案
为实现以上目的，本发明通过以下技术方案予以实现：
低温蒸汽灭菌中药的一种灭菌方法，步骤如下：
(1)打开灭菌设备前门，将装有中药的托盘装进灭菌车，灭菌车推进灭菌室，关闭灭菌设备前门；
(2)设定灭菌参数；
(3)开启真空系统和夹套及防潮列管真空阀门，当真空缓冲罐内压力达到设定值时，开启进蒸汽阀门向夹套及防潮列管进高温高压蒸汽并且开启夹套 及防潮列管排汽疏水阀门，使夹套及防潮列管内压力稳定在设定值，预热稳定；
(4)不断向灭菌室进高温高压蒸汽，蒸汽进入真空环境后迅速变成低温低压蒸汽，同时灭菌室不断疏水到真空缓冲罐中，真空缓冲罐的压力稳定在设定的上限值和下限值之间，当灭菌室温度达到设定值时，自动转到灭菌行程；
(5)进入灭菌行程后，继续向灭菌室进高温高压蒸汽，同时灭菌室不断疏水到真空缓冲罐，保持灭菌室的蒸汽饱和度，保证中药的温度稳定在设定值，进行灭菌；
(6)灭菌结束后，关闭进蒸汽阀门，真空系统继续抽真空，进行真空干燥；
(7)关闭真空、排汽疏水阀门，开启回空气阀门，回空气时间到后，关闭回空气阀门，打开真空、排汽疏水阀门，继续抽真空，进行真空干燥；
(8)干燥结束后，不关闭电源，静置24h后，重复步骤(2)-(6)；
(9)步骤(7)结束后，依然不关闭电源，静置24h后，再次重复重复步骤(2)-(6)；
(10)灭菌结束，打开后门取出中药，进入下一道工序。
优选的，步骤(2)所述灭菌参数为：夹套及防潮列管内压力(-0.025)-(-0.035)Mpa，灭菌温度80℃，灭菌时间60min，预热稳定时间20min，真空缓冲罐压力(-0.07)-(-0.09)Mpa，真空干燥时间20min，回空气时间10min。
优选的，所述中药为中药粉或中药材。
(三)有益效果
本发明提供了低温蒸汽灭菌中药的一种灭菌方法，定位于中药粉或中药材的灭菌，灭菌设备包含前后门的隔离设置，可有效保证清洁区与无菌区的有效隔离；真空系统设到负压，实现真空灭菌；真空缓冲罐可以降低设备噪音，同时保证设备排汽疏水时的压力稳定；夹套和防潮列管可以起到加热保温的作用；灭菌前预热稳定阶段使得灭菌室在达到灭菌温度之间先将灭菌压力稳定，在压力稳定的基础上逐渐升温，整个过程循序渐进，有利于灭菌条件的控制；进入的高温高压蒸汽进入真空环境后迅速变成低温低压蒸汽，同时排汽疏水阀门不断疏水到真空缓冲罐，保证了灭菌室的蒸汽饱和度，使得整个灭菌过程温度与压力得以保持恒定；反复等待24h灭菌，等待芽孢生长后可以进一步杀灭芽孢新生成的细菌，达到更好的灭菌效果；避免使用灭菌剂对环境造成污染、对中药造成改性；该灭菌方法运行方便，极大地减少了能源消耗，保持了原有的中药效能、特色、均一性，同时又保证中药粉内的霉菌(耐温60℃)、大肠杆菌(耐温80℃)等多数种类细菌的彻底杀灭，节省了大量能源、物资成本，是一款值得广泛推广的新颖的绿色灭菌方法。
附图说明
图1是灭菌设备总装图，图中各标记如下：
1、前门，2、灭菌室，3、夹套，4、防潮列管，5、后门，6、真空缓冲罐，7、真空系统，8、进蒸汽阀门，9、回空气阀门，10、真空阀门，11、排汽疏水阀门。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚，下面将结合本发明实施例，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
实施例1：
低温蒸汽灭菌中药粉的一种灭菌方法，步骤如下：
(1)开启灭菌设备前门，将中药粉放入托盘，将托盘装进灭菌车，并将灭菌车推进灭菌室，关闭灭菌设备前门；
(2)设定灭菌各个参数：灭菌压力-0.030Mpa、灭菌温度80℃、灭菌时间60min、预热稳定时间20min、真空缓冲罐上限压力-0.07Mpa，下限压力-0.09Mpa、真空干燥时间20min，回空气时间10min；
(3)开启真空系统抽真空，同时开启夹套及防潮列管真空阀门，真空缓冲罐内压力开始下降，当下降到-0.09Mpa时，开启进蒸汽阀门向夹套及防潮列管进高温高压蒸汽，同时开启夹套及防潮列管排汽疏水阀门，当夹套及防潮列管内压力稳定在-0.030Mpa时，进入预热稳定阶段，稳定20min；
(4)不断向灭菌室进高温高压蒸汽，高温高压蒸汽进入真空状态下的灭菌室，迅速发散热量，变成低温低压蒸汽，同时灭菌室不断疏水到真空缓冲罐，真空缓冲罐的压力稳定在(-0.07)-(-0.09)Mpa之间，进一步保证室内低温低压蒸汽的饱和度，随着不断地进蒸汽、疏水，灭菌室的低温低压蒸汽饱和度不断提高，灭菌室内的中药粉温度不断升高到80℃，此时自动转到灭菌行程；
(5)进入灭菌行程后，继续向灭菌室进高温高压蒸汽，同时灭菌室不断疏水到真空缓冲罐，保持灭菌室的蒸汽饱和度，保证中药粉的温度稳定在80℃，灭菌60min；
(6)灭菌结束后，自动转到干燥行程，关闭进蒸汽阀门停止向灭菌室进高温高压蒸汽，真空系统继续对灭菌室抽真空，真空干燥20min；
(7)关闭真空、排汽疏水阀门，开启回空气阀门10min，关闭回空气阀门，再次开启真空、排汽疏水阀门，对灭菌室抽真空，干燥20min；
(8)干燥结束后，不关闭电源，静置24h，等待已灭菌细菌的芽孢生长，24h后，重复步骤(2)-(7)，将芽孢刚生长出来的细菌杀灭；
(9)步骤(8)结束后，依然不关闭电源，静置24h，等待残余细菌的芽孢生长，24h后，重复步骤(2)-(7)，将最后残余的细菌彻底杀灭。
(10)步骤(9)结束后，整个灭菌过程结束，打开后门取出中药粉，进入下一道工序。
实施例2：
低温蒸汽灭菌中药材的一种灭菌方法，步骤如下：
(1)开启灭菌设备前门，将中药材放入托盘，将托盘装进灭菌车，并将灭菌车推进灭菌室，关闭灭菌设备前门；
(2)设定灭菌各个参数：灭菌压力-0.035Mpa、灭菌温度80℃、灭菌时间60min、预热稳定时间20min、真空缓冲罐上限压力-0.07Mpa，下限压力-0.09Mpa、真空干燥时间25min，回空气时间10min；
(3)开启真空系统抽真空，同时开启夹套及防潮列管真空阀门，真空缓冲罐内压力开始下降，当下降到-0.09Mpa时，开启进蒸汽阀门向夹套及防潮列管进高温高压蒸汽，同时开启夹套及防潮列管排汽疏水阀门，当夹套及防潮列管内压力稳定在-0.035Mpa时，进入预热稳定阶段，稳定20min；
(4)不断向灭菌室进高温高压蒸汽，高温高压蒸汽进入真空状态下的灭菌室，迅速发散热量，变成低温低压蒸汽，同时灭菌室不断疏水到真空缓冲罐，真空缓冲罐的压力稳定在(-0.07)-(-0.09)Mpa之间，进一步保证室内低温低压蒸汽的饱和度，随着不断地进蒸汽、疏水，灭菌室的低温低压蒸汽饱和度不断提高，灭菌室内的中药材温度不断升高到80℃，此时自动转到灭菌行程；
(5)进入灭菌行程后，继续向灭菌室进高温高压蒸汽，同时灭菌室不断疏水到真空缓冲罐，保持灭菌室的蒸汽饱和度，保证中药材的温度稳定在80℃，灭菌60min；
(6)灭菌结束后，自动转到干燥行程，关闭进蒸汽阀门停止向灭菌室进高温高压蒸汽，真空系统继续对灭菌室抽真空，真空干燥25min；
(7)关闭真空、排汽疏水阀门，开启回空气阀门10min，关闭回空气阀门，再次开启真空、排汽疏水阀门，对灭菌室抽真空，干燥25min；
(8)干燥结束后，不关闭电源，静置24h，等待已灭菌细菌的芽孢生长，24h后，重复步骤(2)-(7)，将芽孢刚生长出来的细菌杀灭；
(9)步骤(8)结束后，依然不关闭电源，静置24h，等待残余细菌的芽孢生长，24h后，重复步骤(2)-(7)，将最后残余的细菌彻底杀灭。
(10)步骤(9)结束后，整个灭菌过程结束，打开后门取出中药材，进入下一道工序。
实施例3：
低温蒸汽灭菌中药粉的一种灭菌方法，步骤如下：
(1)开启灭菌设备前门，将中药粉放入托盘，将托盘装进灭菌车，并将灭菌车推进灭菌室，关闭灭菌设备前门；
(2)设定灭菌各个参数：灭菌压力-0.035Mpa、灭菌温度85℃、灭菌时间90min、预热稳定时间30min、真空缓冲罐上限压力-0.06Mpa，下限压力-0.08Mpa、真空干燥时间20min，回空气时间10min；
(3)开启真空系统抽真空，同时开启夹套及防潮列管真空阀门，真空缓冲罐内压力开始下降，当下降到-0.08Mpa时，开启进蒸汽阀门向夹套及防潮列管进高温高压蒸汽，同时开启夹套及防潮列管排汽疏水阀门，当夹套及防潮列管内压力稳定在-0.035Mpa时，进入预热稳定阶段，稳定30min；
(4)不断向灭菌室进高温高压蒸汽，高温高压蒸汽进入真空状态下的灭菌室，迅速发散热量，变成低温低压蒸汽，同时灭菌室不断疏水到真空缓冲罐，真空缓冲罐的压力稳定在(-0.06)-(-0.08)Mpa之间，进一步保证室内低温低压蒸汽的饱和度，随着不断地进蒸汽、疏水，灭菌室的低温低压蒸汽饱和度不断提高，灭菌室内的中药粉温度不断升高到85℃，此时自动转到灭菌行程；
(5)进入灭菌行程后，继续向灭菌室进高温高压蒸汽，同时灭菌室不断疏水到真空缓冲罐，保持灭菌室的蒸汽饱和度，保证中药粉的温度稳定在85℃，灭菌90min；
(6)灭菌结束后，自动转到干燥行程，关闭进蒸汽阀门停止向灭菌室进高温高压蒸汽，真空系统继续对灭菌室抽真空，真空干燥20min；
(7)关闭真空、排汽疏水阀门，开启回空气阀门10min，关闭回空气阀门，再次开启真空、排汽疏水阀门，对灭菌室抽真空，干燥20min；
(8)干燥结束后，不关闭电源，静置24h，等待已灭菌细菌的芽孢生长，24h后，重复步骤(2)-(7)，将芽孢刚生长出来的细菌杀灭；
(9)步骤(8)结束后，依然不关闭电源，静置24h，等待残余细菌的芽孢生长，24h后，重复步骤(2)-(7)，将最后残余的细菌彻底杀灭。
(10)步骤(9)结束后，整个灭菌过程结束，打开后门取出中药粉，进入下一道工序。
综上，本发明实施例具有如下有益效果：
本发明提供了低温蒸汽灭菌中药的一种灭菌方法，是目前国内国际上都没有的一种低温蒸汽灭菌中药的方法，能够彻底解决中药不能灭菌或高温灭菌改性的现状，是一种独特新颖的低温灭菌方法，使用低温蒸汽灭菌，灭菌温度低，降低了设备加热能耗，节省了设备运营成本和大量的人力物力，也节省了很多中间工作环节。
需要说明的是，在本文中，诸如第一和第二等之类的关系术语仅仅用来将一个实体或者操作与另一个实体或操作区分开来，而不一定要求或者暗示这些实体或操作之间存在任何这种实际的关系或者顺序。而且，术语“包括”、 “包含”或者其任何其他变体意在涵盖非排他性的包含，从而使得包括一系列要素的过程、方法、物品或者设备不仅包括那些要素，而且还包括没有明确列出的其他要素，或者是还包括为这种过程、方法、物品或者设备所固有的要素。在没有更多限制的情况下，由语句“包括一个……”限定的要素，并不排除在包括所述要素的过程、方法、物品或者设备中还存在另外的相同要素。
以上实施例仅用以说明本发明的技术方案，而非对其限制；尽管参照前述实施例对本发明进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本发明各实施例技术方案的精神和范围。

Claims (3)

  1. 低温蒸汽灭菌中药的一种灭菌方法，其特征在于，步骤如下：
    (1)打开灭菌设备前门，将装有中药的托盘装进灭菌车，灭菌车推进灭菌室，关闭灭菌设备前门；
    (2)设定灭菌参数；
    (3)开启真空系统和夹套及防潮列管真空阀门，当真空缓冲罐内压力达到设定值时，开启进蒸汽阀门向夹套及防潮列管进高温高压蒸汽并且开启夹套及防潮列管排汽疏水阀门，使夹套及防潮列管内压力稳定在设定值，预热稳定；
    (4)不断向灭菌室进高温高压蒸汽，蒸汽进入真空环境后迅速变成低温低压蒸汽，同时灭菌室不断疏水到真空缓冲罐中，真空缓冲罐的压力稳定在设定的上限值和下限值之间，当灭菌室温度达到设定值时，自动转到灭菌行程；
    (5)进入灭菌行程后，继续向灭菌室进高温高压蒸汽，同时灭菌室不断疏水到真空缓冲罐，保持灭菌室的蒸汽饱和度，保证中药的温度稳定在设定值，进行灭菌；
    (6)灭菌结束后，关闭进蒸汽阀门，真空系统继续抽真空，进行真空干燥；
    (7)关闭真空、排汽疏水阀门，开启回空气阀门，回空气时间到后，关闭回空气阀门，打开真空、排汽疏水阀门，继续抽真空，进行真空干燥；
    (8)干燥结束后，不关闭电源，静置24h后，重复步骤(2)-(6)；
    (9)步骤(7)结束后，依然不关闭电源，静置24h后，再次重复重复步骤(2)-(6)；
    (10)灭菌结束，打开后门取出中药，进入下一道工序。
  2. 如权利要求1所述的低温低压蒸汽灭菌中药的方法，其特征在于，步骤(2)所述灭菌参数为：夹套及防潮列管内压力(-0.025)-(-0.035)Mpa，灭菌温度80℃，灭菌时间60min，预热稳定时间20min，真空缓冲罐压力(-0.07)-(-0.09)Mpa，真空干燥时间20min，回空气时间10min。
  3. 如权利要求1所述的低温低压蒸汽灭菌中药的方法，其特征在于，所述中药为中药粉或中药材。
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