CN112190725A - Radiation sterilization method for traditional Chinese medicine powder - Google Patents
Radiation sterilization method for traditional Chinese medicine powder Download PDFInfo
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- CN112190725A CN112190725A CN202011315052.XA CN202011315052A CN112190725A CN 112190725 A CN112190725 A CN 112190725A CN 202011315052 A CN202011315052 A CN 202011315052A CN 112190725 A CN112190725 A CN 112190725A
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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
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/08—Radiation
- A61L2/087—Particle radiation, e.g. electron-beam, alpha or beta radiation
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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
- 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
Abstract
The invention belongs to the technical field of traditional Chinese medicine sterilization, and particularly relates to an irradiation sterilization method of traditional Chinese medicine powder. The irradiation sterilization method of the traditional Chinese medicine powder provided by the invention comprises the following steps: s1 grinding the dried traditional Chinese medicine into powder to obtain traditional Chinese medicine powder; s2, packaging the Chinese medicinal powder prepared in the step S1, then performing vacuum-pumping treatment and sealing; s3, placing the sealed traditional Chinese medicine powder prepared in the step S2 in an environment with the temperature of 0-8 ℃ for 12-24 hours to prepare pre-cooled traditional Chinese medicine powder; s4, placing the precooled Chinese medicine powder prepared in the step S3 into an irradiation sterilization device, and performing irradiation sterilization for 1-3h to obtain the Chinese medicine powder. The irradiation sterilization method of the traditional Chinese medicine powder provided by the invention has the advantages of simple process, easy operation and cost saving, and the stability of the powder is not damaged on the basis of realizing sterilization by adopting lower radiation quantity.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicine sterilization, and particularly relates to an irradiation sterilization method of traditional Chinese medicine powder.
Background
The pharmaceutical sanitation is an important content of drug production management, relates to the whole process of drug production, strengthens the pharmaceutical sanitation management in each link of drug production, implements each pharmaceutical sanitation measure, is an important means for ensuring the drug quality, and is also a specific requirement for implementing GMP. The medicine not only needs to have exact curative effect, but also needs to ensure safe use and stable and reliable quality.
The traditional Chinese medicine powder is often polluted by microorganisms due to the environmental air, equipment and tools and operators in the preparation process, so that the quality and the clinical curative effect of the traditional Chinese medicine powder are influenced. Once the medicine is polluted by microorganisms, the microorganisms grow and reproduce under certain conditions, so that the medicine is deteriorated, rotten, reduced in curative effect or ineffective, and even substances harmful to human bodies can be generated, so that the establishment of a scientific and effective sterilization method is very important.
At present, the traditional sterilization methods in production practice include dry heat sterilization, wet heat sterilization, microwave sterilization, ethylene oxide gas sterilization and the like, and the methods utilize physical or chemical factors to influence chemical components and metabolism of microorganisms so as to achieve the sterilization effect. The dry heat sterilization method is convenient to operate and simple in equipment, but the required temperature is high, the energy consumption is high, the complete sterile effect is difficult to achieve, the traditional Chinese medicine powder contains a lot of volatile or heat-sensitive substances, and the volatile substances are volatilized and the heat-sensitive substances are denatured by the dry heat sterilization method, so that the drug effect is influenced. The wet heat sterilization method has ideal sterilization effect, but has high requirements on sterilization equipment, so that the production cost of the traditional Chinese medicine powder is greatly increased, and the industrial production is not facilitated.
The development of the international sterilization technology is gradually biased towards the direction of radiation sterilization, but the history of the radiation sterilization applied to the traditional Chinese medicine is short, the basic research needs to be continuously perfected, and important safety, effectiveness, stable quality and the like need to be ensured in the practical application. Patent publication No. CN107875410A discloses a sterilization method for superfine Chinese medicinal powder, which comprises pretreating superfine Chinese medicinal powder, bagging, sealing, and sterilizing60And (5) performing irradiation sterilization treatment by using a Co-gamma radioactive source to finally obtain the sterilized traditional Chinese medicine powder. Although the method can play a role in sterilization, the radiation dose is large, and the quality stability of the traditional Chinese medicine powder is influenced. Patent publication No. CN110251651A discloses a Chinese medicinal powder preparation for orthopedics and traumatology and its sterilization method, which comprises pulverizing Chinese medicinal materials, sequentially placing in a sealed stainless steel barrel, adding 75% ethanol, moistening and sterilizing for 2 times, spreading in a stainless steel tray, sealing, and air drying. Although the method can play a role in sterilization, the repeated ethanol moistening prolongs the period of the sterilization process, increases the complexity of the sterilization process and greatly increases the sterilization cost.
In conclusion, the technical problems of complex sterilization process, high cost, inappropriate radiation dose for irradiation sterilization, poor quality stability of medicinal powder and the like generally exist in the prior art.
Disclosure of Invention
In order to overcome the defects of the prior art, the invention aims to provide a method for sterilizing traditional Chinese medicine powder by irradiation. The irradiation sterilization method of the traditional Chinese medicine powder provided by the invention has the advantages of simple process, easy operation and cost saving, and the stability of the powder is not damaged on the basis of the sterilization technology by adopting lower radiation quantity.
In order to achieve the purpose, the technical scheme of the invention is as follows:
a radiation sterilization method of traditional Chinese medicine powder comprises the following steps:
s1, grinding the dried traditional Chinese medicine into powder to obtain traditional Chinese medicine powder;
s2, packaging the Chinese medicinal powder prepared in the step S1, then performing vacuum-pumping treatment and sealing;
s3, placing the sealed traditional Chinese medicine powder prepared in the step S2 in an environment with the temperature of 0-8 ℃ for 12-24 hours to prepare pre-cooled traditional Chinese medicine powder;
s4, placing the precooled Chinese medicine powder prepared in the step S3 into an irradiation sterilization device, and performing irradiation sterilization for 1-3h to obtain the Chinese medicine powder.
Further, the Chinese medicinal powder is prepared from notoginseng, ginseng, codonopsis pilosula, American ginseng, bighead atractylodes rhizome, poria cocos, astragalus mongholicus, angelica sinensis, American ginseng, ginger, burdock, radix bupleuri, coptis chinensis, plantain seed, desmodium, polygonum cuspidatum, fennel, clove, dried orange peel, folium artemisiae argyi, turmeric, bulbus fritillariae cirrhosae, spina date seed, ganoderma lucidum, concha haliotidis, bezoar and polygonum multiflorum in the step S1.
Further, the fineness of the Chinese medicinal powder in the step S1 of the radiation sterilization method of the Chinese medicinal powder is 80-100 meshes.
Further, the packaging material in the step S2 of the method for sterilizing by irradiation of the traditional Chinese medicine powder is one of plastic, paper, metal, glass and composite material.
Furthermore, the composite material in the packaging material of the traditional Chinese medicine powder irradiation sterilization method is a composite material taking starch and cellulose as base materials.
Further, the weight of the Chinese medicinal powder after being sealed in step S2 is 5.0-7.0 kg.
Further, the irradiation source for irradiation sterilization in the method S4 for irradiation sterilization of the Chinese medicinal powder is an electron accelerator, the beam intensity of the electron accelerator is 1500-1900 μ a, and the pulse repetition frequency is 620-670 pps.
Furthermore, the radiation sterilization in the method S4 for sterilizing the traditional Chinese medicine powder is electron beam double-sided radiation, the dose range is 5.0-9.0kGy, the scanning current of an electron accelerator is 2.7-3.0A, and the speed under the beam is 25-28 mm/S.
Further, the unevenness of the radiation sterilization in the step S4 of the radiation sterilization method of the Chinese medicinal powder is 1.5-2.0; the irradiation sterilization temperature is 15-25 ℃.
Compared with the prior art, the irradiation sterilization method of the traditional Chinese medicine powder provided by the invention has the following advantages:
(1) the irradiation sterilization method of the traditional Chinese medicine powder provided by the invention adopts electron beam double-sided irradiation, has higher energy and strong penetrating power, and can effectively kill various bacteria and microorganisms in the traditional Chinese medicine powder;
(2) the irradiation sterilization method of the traditional Chinese medicine powder provided by the invention is characterized in that the traditional Chinese medicine powder is subjected to cooling treatment in advance before irradiation, and the irradiation temperature is controlled to be 15-25 ℃, so that the process can avoid the inactivation of active substances in the traditional Chinese medicine due to irradiation and reduce the drug effect;
(3) the irradiation sterilization method of the traditional Chinese medicine powder provided by the invention has the advantages of simple process, easy operation and cost saving, and is suitable for most traditional Chinese medicines.
Detailed Description
The present invention will be further described below by way of specific embodiments, but the present invention is not limited to only the following examples. Various modifications can be made by those skilled in the art based on the basic idea of the invention, but it is within the scope of the invention as long as it does not depart from the basic idea of the invention.
Example 1A method for sterilizing Chinese medicinal powder by irradiation
The irradiation sterilization method of the traditional Chinese medicine powder is that the traditional Chinese medicine powder is ginseng powder and comprises the following steps:
s1, grinding the dried ginseng into powder with the fineness of 80 meshes to obtain ginseng powder;
s2, bagging the ginseng powder prepared in the step S1 in a PE bag, vacuumizing, and sealing, wherein the sealed weight is 5.0 kg;
s3, placing the sealed ginseng powder obtained in the step S2 in an environment with the temperature of 0 ℃ for 12 hours to obtain precooled ginseng powder;
s4, putting the pre-cooled ginseng powder prepared in the step S3 into an irradiation sterilization device, and performing electron beam double-sided irradiation for 1h, wherein the beam intensity of an electron accelerator is 1500 muA, the pulse repetition frequency is 620pps, the irradiation dose is 5.0kGy, the scanning current of the electron accelerator is 2.7A, the under-beam speed is 25mm/S, the unevenness is 1.5, and the temperature is 15 ℃, so that the ginseng powder is obtained.
Example 2A method for sterilizing Chinese medicinal powder by irradiation
The irradiation sterilization method of the traditional Chinese medicine powder is that the traditional Chinese medicine powder is tuckahoe powder, and comprises the following steps:
s1, grinding the dried tuckahoe into powder with the fineness of 100 meshes to prepare tuckahoe powder;
s2, bagging the tuckahoe powder prepared in the step S1 with paper bags, vacuumizing, and sealing, wherein the weight of the sealed tuckahoe powder is 7.0 kg;
s3, placing the sealed tuckahoe powder prepared in the step S2 in an environment with the temperature of 8 ℃ for 24 hours to prepare pre-cooled tuckahoe powder;
s4, putting the pre-cooled Poria cocos powder prepared in the step S3 into an irradiation sterilization device, and performing electron beam double-sided irradiation for 3 hours, wherein the beam intensity of an electron accelerator is 1900 mu A, the pulse repetition frequency is 670pps, the irradiation dose is 9.0kGy, the scanning current of the electron accelerator is 3.0A, the under-beam speed is 28mm/S, the unevenness is 2.0, and the temperature is 25 ℃, so that the poria cocos powder is obtained.
Example 3A method for sterilizing Chinese medicinal powder by irradiation
The radiation sterilization method of the traditional Chinese medicine powder is that the traditional Chinese medicine powder is bupleurum powder, and comprises the following steps:
s1, grinding the dried radix bupleuri into powder with the fineness of 90 meshes to obtain the bupleurum powder;
s2, carrying out aluminum film bagging on the radix bupleuri powder prepared in the step S1, then carrying out vacuum-pumping treatment, and sealing, wherein the weight of the sealed bag is 5.5 kg;
s3, placing the sealed bupleurum powder prepared in the step S2 in an environment with the temperature of 3 ℃ for 15 hours to prepare precooled bupleurum powder;
s4, putting the pre-cooled bupleurum powder prepared in the step S3 into an irradiation sterilization device, and performing electron beam double-sided irradiation for 1.5h, wherein the beam intensity of an electron accelerator is 1600 muA, the pulse repetition frequency is 630pps, the irradiation dose is 6.5kGy, the scanning current of the electron accelerator is 2.8A, the speed under the beam is 26mm/S, the non-uniformity is 1.6, and the temperature is 17 ℃, so that the Chinese thorowax root powder is obtained.
Example 4A method for sterilizing Chinese medicinal powder by irradiation
The radiation sterilization method of the traditional Chinese medicine powder is that the traditional Chinese medicine powder is pseudo-ginseng powder and comprises the following steps:
s1, grinding the dried pseudo-ginseng into powder with the fineness of 90 meshes to obtain pseudo-ginseng powder;
s2, filling the pseudo-ginseng powder prepared in the step S1 in a glass bottle, vacuumizing, and sealing, wherein the weight of the sealed pseudo-ginseng powder is 6.0 kg;
s3, placing the sealed pseudo-ginseng powder obtained in the step S2 in an environment with the temperature of 5 ℃ for 17 hours to obtain precooled pseudo-ginseng powder;
s4, putting the pre-cooled pseudo-ginseng powder prepared in the step S3 into an irradiation sterilization device, and performing electron beam double-side irradiation for 2.1 hours, wherein the beam intensity of an electron accelerator is 1700 mu A, the pulse repetition frequency is 650pps, the irradiation dose is 7.5kGy, the scanning current of the electron accelerator is 2.9A, the under-beam speed is 27mm/S, the non-uniformity is 1.8, and the temperature is 20 ℃, so that the pseudo-ginseng powder is obtained.
Example 5A method for sterilizing Chinese medicinal powder by irradiation
The irradiation sterilization method of the traditional Chinese medicine powder is that the traditional Chinese medicine powder is folium artemisiae argyi powder and comprises the following steps:
s1, grinding the dried folium artemisiae argyi into powder with the fineness of 100 meshes to obtain folium artemisiae argyi powder;
s2, bagging the blumea balsamifera powder prepared in the step S1 in a biodegradable plastic bag, wherein the biodegradable plastic bag takes starch as a base material, and then is vacuumized and sealed, and the weight of the sealed plastic bag is 6.5 kg;
s3, placing the sealed folium artemisiae argyi powder prepared in the step S2 in an environment with the temperature of 7 ℃ for 21 hours to prepare precooled folium artemisiae argyi powder;
s4, putting the precooled folium artemisiae argyi powder prepared in the step S3 into an irradiation sterilization device, and performing electron beam double-side irradiation for 2.5 hours, wherein the beam intensity of an electron accelerator is 1800 muA, the pulse repetition frequency is 660pps, the irradiation dose is 8.0kGy, the scanning current of the electron accelerator is 2.8A, the speed under the beam is 26mm/S, the unevenness is 1.9, and the temperature is 23 ℃, so that the preparation method is obtained.
Comparative example 1 irradiation sterilization method of traditional Chinese medicine powder
The method of radiation sterilization of the powder of the present comparative example was similar to that of example 4.
The comparative example differs from example 4 in that: in this comparative example, no packaging was performed for the notoginseng powder.
Comparative example 2 irradiation sterilization method of traditional Chinese medicine powder
The method of radiation sterilization of the powder of the present comparative example was similar to that of example 4.
The comparative example differs from example 4 in that: the weight of the packaged notoginseng powder in this comparative example is 10 kg.
Comparative example 3 irradiation sterilization method of traditional Chinese medicine powder
The method of radiation sterilization of the powder of the present comparative example was similar to that of example 4.
The comparative example differs from example 4 in that: in the comparative example, the notoginseng powder was not left at 5 ℃ for 17 hours.
Comparative example 4 irradiation sterilization method of traditional Chinese medicine powder
The method of radiation sterilization of the powder of the present comparative example was similar to that of example 4.
The comparative example differs from example 4 in that: the beam intensity of the electron accelerator in this comparative example was 3000 μ a.
Comparative example 5 irradiation sterilization method of Chinese medicinal powder
The method of radiation sterilization of the powder of the present comparative example was similar to that of example 4.
The comparative example differs from example 4 in that: the irradiation dose in this comparative example was 12 kGy.
Test example I, Chinese medicinal powder sterilization effect test
Test samples: the Chinese medicinal powder prepared in examples 1-5 and comparative examples 1-5;
the test method comprises the following steps: according to the 'Chinese pharmacopoeia' 2015 edition, aerobic bacteria, mould and yeast in the test sample are detected before and after irradiation;
and (3) test results: the test results are shown in Table 1.
TABLE 1 bacterial content before and after radiation sterilization
As can be seen from Table 1, aerobic bacteria, mold and yeast in the test sample are not detected after the irradiation sterilization treatment, which indicates that the irradiation sterilization method of the traditional Chinese medicine powder provided by the invention can effectively remove the aerobic bacteria, mold and yeast in the traditional Chinese medicine powder to achieve the purpose of sterilization. In comparative example 1, the traditional Chinese medicine powder is not packaged, resulting in secondary pollution of the traditional Chinese medicine powder during irradiation, and in comparative example 2, the packaging amount of the traditional Chinese medicine powder in example 4 is increased, but the sterilization effect is deteriorated due to incomplete sterilization caused by excessive amount of the traditional Chinese medicine powder subjected to irradiation.
Test example II, Chinese medicinal powder composition test
Test samples: pseudo-ginseng powder obtained in example 4, comparative example 1, comparative examples 3 to 5;
the test method comprises the following steps: testing total extract in the test sample according to 'Chinese pharmacopoeia' 2015 edition; testing the content of the saponin in the test sample by adopting a liquid chromatography; testing the content of amino acid in the test sample according to 'Chinese pharmacopoeia' 2015 edition and GB/T5009.124-2003 'determination of amino acid in food';
and (3) test results: the test results are shown in tables 2 and 3.
TABLE 2 Total extract and Saponin content before and after irradiation
TABLE 3 amino acid contents before and after irradiation
As can be seen from tables 2 and 3, the total extract and saponin content of the test sample of the notoginseng powder prepared in example 4 after the irradiation sterilization treatment is similar to the result before irradiation, and the amino acid content of the notoginseng powder after the irradiation sterilization is similar to the result before irradiation, which indicates that the irradiation sterilization method provided by the present invention has no influence on the components of the Chinese medicinal powder. Compared with the embodiment 4, the content of total extract and saponin and the content of each amino acid of the traditional Chinese medicine powder prepared in the comparative examples 1 and 3-5 before irradiation have larger difference with the result after irradiation, because the traditional Chinese medicine powder is not packaged, the traditional Chinese medicine powder is subjected to secondary pollution in the irradiation process, so that active substances in the traditional Chinese medicine powder are absorbed by microorganisms, and the precooling treatment can avoid the inactivation of the active ingredients in the traditional Chinese medicine powder; increasing the irradiation dose and the beam intensity of electron beam can cause the Chinese medicinal powder to be over irradiated, thereby affecting the activity of active substances in the Chinese medicinal powder and reducing the effective components.
The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the invention. Those skilled in the art will recognize that changes may be made to the embodiments described above without departing from the spirit and scope of the invention. Therefore, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the technical spirit of the present invention are covered by the claims of the present invention.
Claims (9)
1. The radiation sterilization method of the traditional Chinese medicine powder is characterized by comprising the following steps:
s1, grinding the dried traditional Chinese medicine into powder to obtain traditional Chinese medicine powder;
s2, packaging the Chinese medicinal powder prepared in the step S1, then performing vacuum-pumping treatment and sealing;
s3, placing the sealed traditional Chinese medicine powder prepared in the step S2 in an environment with the temperature of 0-8 ℃ for 12-24 hours to prepare pre-cooled traditional Chinese medicine powder;
s4, placing the precooled Chinese medicine powder prepared in the step S3 into an irradiation sterilization device, and performing irradiation sterilization for 1-3h to obtain the Chinese medicine powder.
2. The method for radiation sterilization of traditional Chinese medicine powder according to claim 1, wherein the traditional Chinese medicine in step S1 is selected from the group consisting of notoginseng, ginseng, codonopsis pilosula, american ginseng, atractylodes macrocephala, poria cocos, astragalus mongholicus, angelica sinensis, american ginseng, ginger, burdock, radix bupleuri, coptis chinensis, plantain seed, lysimachia christinae, polygonum cuspidatum, fennel, clove, dried orange peel, artemisia leaf, turmeric, bulbus fritillariae cirrhosae, spina date seed, ganoderma lucidum, concha haliotidis, bezoar and polygonum multiflorum.
3. The method for sterilizing by irradiation of the Chinese medicinal powder according to claim 1, wherein the fineness of the Chinese medicinal powder in the step S1 is 80-100 mesh.
4. The method for sterilizing by irradiation of Chinese medicinal powder according to claim 1, wherein the packaging material in step S2 is one of plastic, paper, metal, glass, and composite material.
5. The method for sterilizing by irradiation of Chinese medicinal powder according to claim 4, wherein the composite material in the packaging material is a starch and cellulose based composite material.
6. The method for sterilizing by irradiation of the Chinese medicinal powder according to claim 1, wherein the Chinese medicinal powder in the step S2 has a weight of 5.0-7.0kg after sealing.
7. The method for radiation sterilization of traditional Chinese medicine powder according to claim 1, wherein the radiation source for radiation sterilization in step S4 is an electron accelerator, the beam intensity of the electron accelerator is 1500-1900 μ Α, and the pulse repetition frequency is 620-670 pps.
8. The method for radiation sterilization of traditional Chinese medicine powder according to claim 1, wherein the radiation sterilization in step S4 is electron beam double-sided irradiation, the dose range is 5.0-9.0kGy, the scanning current of an electron accelerator is 2.7-3.0A, and the under-beam speed is 25-28 mm/S.
9. The method for radiation sterilization of Chinese medicinal powder according to claim 1, wherein the radiation sterilization in the step S4 has a non-uniformity of 1.5-2.0; the irradiation sterilization temperature is 15-25 ℃.
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Cited By (4)
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| CN113484426A (en) * | 2021-05-12 | 2021-10-08 | 湖南省核农学与航天育种研究所 | Method for sterilizing lonicera confusa by utilizing electron beam irradiation |
| CN113855821A (en) * | 2021-10-08 | 2021-12-31 | 湖北科技学院 | Sterilizing method of lotus leaf powder |
| CN114129745A (en) * | 2021-12-07 | 2022-03-04 | 新疆全安药业股份有限公司 | Sterilization process of qi-moving tanakal capsule |
| CN114984261A (en) * | 2022-06-10 | 2022-09-02 | 西南科技大学生命科学与工程学院 | Sterilizing method of Xuanmai Ganju granules |
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Application publication date: 20210108 |