CN110251651A - A kind of full powder formulation of orthopedics and traumatology Chinese medicine and its sterilizing methods - Google Patents
A kind of full powder formulation of orthopedics and traumatology Chinese medicine and its sterilizing methods Download PDFInfo
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- CN110251651A CN110251651A CN201910695267.XA CN201910695267A CN110251651A CN 110251651 A CN110251651 A CN 110251651A CN 201910695267 A CN201910695267 A CN 201910695267A CN 110251651 A CN110251651 A CN 110251651A
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Abstract
The invention discloses a kind of full powder formulation of orthopedics and traumatology Chinese medicine and its new methods of sterilizing.Preparation prescription includes: pilose antler, radix achyranthis bidentatae, Cortex Eucommiae, psoralea corylifolia, ginseng, Radix Astragali, Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Radix Paeoniae Alba, Rhizoma Chuanxiong, the root of Dahurain angelica, stir-baked CORTEX MAGNOLIAE OFFICINALIS with rhizoma zingiberis recens juice, Fructus Aurantii, pyritum ignited, safflower, rheum officinale, dried orange peel, stir-baked OLIBANUM with vinegar, stir-baked MYRRHA with vinegar, rhizoma corydalis, cortex cinnamomi, rhizoma atractylodis, Poria cocos, rhizoma zingiberis, gentianae macrophyllae, pawpaw, campanulaceae, Rhizoma Et Radix Notopterygii, Radix Angelicae Pubescentis, radix saposhnikoviae, borax, the 32 taste prepared slices of Chinese crude drugs of Radix Glycyrrhizae.Sterilizing methods: room temperature interval ethyl alcohol sterilization is used.The full powder form of Chinese medicine, including the dosage form for needing to sterilize when the mixing of traditional Chinese powder medicine, hard capsule, the water-bindered pill, granule and other medicinal powder in process of production.The sterilizing methods have outstanding advantages of capable of significantly improving sterilization effect, reducing sterilizing cost, do not destroy drug ingedient, radiationless residual, are a kind of full powder sterilizing methods of the new medicine that science is excellent.
Description
Technical field
The present invention relates to a kind of sterilizing methods of full powder formulation of orthopedics and traumatology Chinese medicine, belong to the skill of drug and preparation method thereof
Art field.
Background technique
Pharmacy health is an important content of pharmaceutical production management, is related to the overall process of pharmaceutical production, raw in drug
The links of production strengthen pharmacy administration of health, implement items pharmacy health measure, are to ensure that the important means of drug quality,
It is also the specific requirement for implementing GMP.Drug will not only have exact curative effect, it is necessary to which use is safe, and quality is reliable and stable.Drug
Once by the pollution of microorganism, under certain conditions microorganism will growth and breeding, corruption rotten so as to cause drug,
Curative effect reduces or failure, in some instances it may even be possible to generate the substance being harmful to the human body, therefore, stringent medicine sanitary standard is to judge drug
The important indicator of quality good or not.
The formulation generally very big attention by various countries of drug microorganism sterilizing method and the limit of microorganism, 20th century
The beginning of the sixties, non-regulation Bactericidal medicine microbiological contamination limit was included in national standard in succession by some developed countries, became the normal of drug inspection
Advise one of inspection project.State Food and Drug Administration (CFDA) has promulgated new edition GMP, to the disinfecting action of pharmaceutical preparation
More detailed regulation is done, " Chinese Pharmacopoeia " version in 2015 also revises microorganism detection method, proposes tightened up
Requirement.
Domestic traditional sterilization technology is these sides based on hot air sterilization, moist heat sterilization and eo sterilization
Method has an impact the chemical component of microorganism and metabolism using physics, chemical factor, to achieve the effect that sterilizing, goes out
Bacterium effect is reliable, easy to operate, and instrument and equipment is relatively inexpensive, is widely used in preparation production.Radiation sterilization is
A kind of newer sterilization technology most to grow up in the past 40 years, can room temperature sterilizing, the time is shorter, and penetration power is strong, suitable for containing
The drug of the intact packaging of volatile component, heat-sensitive ingredients has preferable development prospect.However, the above method also has deficiency,
Some methods can destroy the effective component of drug, affect the treatment；Or have radiation residual, dissolvent residual etc., influence drug safety；Or
Energy consumption is high, the time is long, influences economic benefit.Defect existing for these methods and problem influence the quality of Chinese medicine and its preparation non-
Chang great.
The development of sterilization technology tends to the exploitation of cold sterilization novel sterilizing technology, such as high-voltage pulse electric field sterilization in the world
Method, Low-temperature Plasma Sterilization method and the instantaneous ultra-high pressure sterilization method of room temperature etc. have place relative to traditional high temperature sterilization
It manages that the time is short, energy consumption is low, heating is small, sterilizing efficiency is high and does not influence the remarkable advantages such as effective ingredient, especially shows pair
In the sterilizing of temperature-sensitive sex pill, therefore, these technologies are studied with its good application feature by foreign scholar extensively.The U.S., moral
The country such as state, Japan, Canada all competitively carries out the research of novel sterilizing technology, but mostly also in laboratory research, lab scale
Or the pilot scale stage, not yet it is widely used in industrialized production, failing to change with conventional sterilization methods is leading production status.
Disinfecting action should remove or kill microorganism, guarantee quality stability, therapeutic effect and the medication of drug again
Safety, therefore must be in conjunction with effective sterilizing methods of comprehensive selections such as property, the dosage forms of drug, reasonably with sterilizing when sterilizing
Technology.Currently, the sterilization technology of the sterilizing especially preparation containing Chinese medicinal raw powder or containing volatile component of Chinese patent drug is still
Problem urgently to be resolved.
Summary of the invention
The present invention be directed to the full powder formulation sterilization technology of existing Chinese medicine deficiency, from sterilized principle for germ, using status, advantage and
There are the problem of centering medicine and its preparation in various sterilization technologies carry out network analyses, to existing Research on Problems countermeasure,
And according to the characteristic of preparation medicine composition characteristic and preparation, in conjunction with the experience of current domestic, international Chinese materia medica preparation sterilization technology,
Research and develop that a kind of high efficiency, at low cost, sterilization effect is significant, does not influence the sterilization technology of drug initial quality.
This product is the water-bindered pill of full crude drug powder preparation, and prescription amounts to 32 taste Chinese medicines, Radix Angelicae Sinensis, Rhizoma Chuanxiong, cortex cinnamomi in prescription, vinegar milk
The kinds of traditional Chinese medicines medicine materical crude slice such as perfume, stir-baked MYRRHA with vinegar contains volatile component, this early test uses hot-air sterilization and moist heat sterilization
Method, in experimentation, high temperature, high humidity environment in, volatile component loss is larger in prescription, illustrates heat sterilization discomfort
With the sterilizing of this product.Flavour of a drug ingredient is more simultaneously, and animal drugs, botanical medicine, mineral drug have, and complicated component, radiation sterilization is to medicine
The quality of product may cause the variation of chemical component in prescription, bioactive substance, such as cause the oxidation of anthraquinone component；And
And radiation residue detection technology be not also it is very mature, safety is still disputable in academia, therefore product is quasi- goes out without using irradiation
The method of bacterium.
For room temperature tyndallization sterilising temp between 25 DEG C~35 DEG C, sterilising temp is low, suitable for going out for non-refractory
Bacterium, but gemma cannot be killed, it repeats to sterilize after spore development is at brood body, circulation 3 times or more, sterilization time is long, kills bud
Spore is often not complete enough.Ethyl alcohol sterilization is intracellular by infiltration microbial reproduction body, makes protein denaturation, to kill breeding
Body, but for the microbial spores being in hibernation, since gemma is thicker, ethyl alcohol is not easy to penetrate, and causes ethyl alcohol to gemma
Killing effect it is undesirable.By the initial trial research to above two method, experimental result determines its method sterilization effect
It is undesirable.The advantages of this research combines two kinds of sterilizing methods, respectively takes the chief, creative to have used 75% ethyl alcohol sterilizing+often
The synthesis sterilizing methods of warm tyndallization.
Pre-stage test research, explores the main technologic parameters and horizontal extent for influencing sterilization effect, determines the use of ethyl alcohol
Amount, for the first time time of sterilizing, the time to sterilize for second are the main technologic parameters for influencing sterilization effect；Parameter level is
75% ethanol consumption (V) accounts for about 25% or so of the total medicinal powder weight (W) of sterilizing, and first time sterilization time is 7 minutes or so；Second
Secondary sterilization time is 4 minutes or so, and 75% ethanol consumption (V) accounts for about 12.5% or so of the total medicinal powder weight (W) of sterilizing.It is small to have a try
Test research: with the dosage of 75% ethyl alcohol, the time of sterilizing, the time of second of sterilizing are investigation factor, factor level for the first time
For above-mentioned parameter level value float ± 50%, with the microbial limit of four general rules of " Chinese Pharmacopoeia " version in 2015 1105,1106
Standard and prescription in Isopsoralen total amount be index, using orthogonal test L9 (33) table is to the sterilizing factor of crude drug powder
And it is horizontal carry out conceptual design, tested, preferably the best sterilization process of lab scale out.
Pilot scale research and verifying: scale up test is carried out by the Optimizing Process Parameters of small-scale experiment, to lab scale craft parameter
Confirmed and optimized, and the reproducibility of different batches of product is investigated by the amplification of 3 batches of samples of pilot scale production, is investigated
And establish finally suitable technological parameter.
A kind of sterilization technology of the full powder of Chinese materia medica preparation, includes the following steps:
(1) by prescription drug co-grinding, 80 meshes are crossed；
(2) it by the mixed-powder of step (1) 80 mesh of mistake, is sealed in stainless steel barrel, 75% ethyl alcohol, dosage is added
For a quarter of medicinal powder gross weight, sprinkling is stirred evenly, closed, is carried out bored profit and is sterilized 6 minutes；
(3) first time sterile powder described in step (2) is taken out, is divided in stainless steel pallet, it is closed to dry, continue
Time is 24 hours；
(4) first time sterile powder described in step (3) is taken out, is placed in stainless steel barrel, 75% ethyl alcohol, dosage is added
It is 1/8th of medicinal powder gross weight, sprinkling is mixed thoroughly, and it is closed, it carries out bored profit and sterilizes 4 minutes；
(5) powder of second of sterilizing described in step (4) is taken out, is placed in stainless steel pallet, volatilizes solvent, i.e.,
It can.
In the operating process of step (1), botanical medicine and mineral drug are contained in preparation, wherein botanical medicine occupies the majority, and can mix
It closes and crushes, and cross 80 meshes, obtain uniformly mixed drug powder；
75% ethyl alcohol used in step (2), for the concentration by trial test screening, under this concentration, sterilization effect is best；
Step is pointed out in (3), medicinal powder and 75% ethyl alcohol is stirred evenly, and closed, is facilitated 75% ethyl alcohol and is penetrated into medicinal powder
Portion, sterilization effect are more preferable；
Step points out that is sterilized for the first time is the mature body of bacterium in (4), room temperature is needed 24 hours, to bacterium bud
Spore is mature, carries out second and sterilizes, that is, can reach sterilization effect.
The beneficial effects of the present invention are:
1. 75% ethyl alcohol sterilizing+room temperature tyndallization synthesis sterilizing methods are used, with such as hot pressing of conventional sterilization technique
Detailed comparative study has been done in sterilizing, hot air sterilization, radiation sterilization lamp, the conventional sterilization methods of this law ratio, have can room temperature go out
Bacterium, sterilize at low cost, radiationless and chemical agent residue, the ideal advantage of sterilization effect.
2. sterilizing methods are easy to operate, the irradiation sterilization of sterilizing cost ratio reduces at least 50%, and safety is higher；Than it
Autoclaving and hot-air sterilization more can guarantee medicine on the bioactive ingredients of drug especially volatile component without influence
The quality of product.75% ethyl alcohol sterilization time is short, average at 5 minutes or so, and ethyl alcohol is volatile materials, and it is residual will not to generate solvent
It stays, human body will not be damaged, use is safer.
3. using orthogonal design L9 (33) table contrived experiment, the preferably suitable technological parameter of science, with less test time
The test parameters that number is optimized changes the test method that previous experiences formula explores parameter, not only saves experimental cost, and
And obtain more scientific accurate test result.
4. quality index: on the basis of samples met dosage form examines general rule, using microbial limit data and sample
Assay data Two indices carry out preferably the various process parameters of sterilizing, the otherness of each sterilizing methods of scientific evaluation.
Specific embodiment
In order to make the foregoing objectives, features and advantages of the present invention clearer and more comprehensible, below to specific reality of the invention
The mode of applying is described in detail.In the following description, numerous specific details are set forth in order to facilitate a full understanding of the present invention.But
The invention can be embodied in many other ways as described herein, and those skilled in the art can be without prejudice to this hair
Similar improvement is done in the case where bright intension, therefore the present invention is not limited by the specific embodiments disclosed below.
Unless otherwise defined, all technical and scientific terms used herein and belong to technical field of the invention
The normally understood meaning of technical staff is identical.Term as used herein in the specification of the present invention is intended merely to description tool
The purpose of the embodiment of body, it is not intended that in the limitation present invention.Term as used herein "and/or" includes one or more
Any and all combinations of relevant listed item.
Embodiment 1
Present embodiments provide the formula of preparation, sterilizing and has carried out microbial limit to the effect after sterilizing at detailed process
With the measurement of content's index, to determine sterilization effect.It is made of in every 1000 ball of preparation the prepared slices of Chinese crude drugs of following weight, such as table 1
It is shown:
The formula table of preparation in 1 embodiment 1 of table
By the above 32 taste prepared slices of Chinese crude drugs, co-grinding crosses 80 meshes, and the mixed-powder for crossing 80 meshes is placed in stainless steel
In bucket, by configured 75% ethanol solution, a quarter of medicinal powder total weight is taken, is sent forth in medicinal powder, stirred in sprinkling,
Until mixing thoroughly, by stainless steel barrel closed 10 minutes.After ten minutes, stainless steel barrel is opened, medicinal powder is taken out, is divided sterilized in
Stainless steel pallet in, placed 24 hours in closed environment.Medicinal powder is again placed in stainless steel barrel, by configured 75%
Ethanol solution takes 1/8th of medicinal powder total weight, sends forth in medicinal powder, stirs in sprinkling, until mixing thoroughly, by stainless steel barrel
Closed 5 minutes.After five minutes, stainless steel barrel is opened, medicinal powder is taken out.According to " Chinese Pharmacopoeia " 2015 version four
1105,1106 general rule is tested, inspection result such as the following table 2:
2 embodiment of table, 1 microorganism detection result
Table 2 the result shows that, in 3 batches test agent using above-mentioned condition sterilize, sterilization effect is fine, meets standards of pharmacopoeia.
Detection is carried out further according to content assaying method to be detected using HPLC method, as a result such as the following table 3:
3 embodiment of table, 1 assay result
Table 3 the result shows that, in 3 batches test agent using above-mentioned condition sterilize, sterilization effect is good, meets the quality standard.
Embodiment 2
Prescription is same as Example 1, but the process conditions to sterilize are adjusted, and sterilization process is as follows:
By the above 32 taste prepared slices of Chinese crude drugs, co-grinding crosses 80 meshes, and the mixed-powder for crossing 80 meshes is placed in stainless steel
In bucket, by configured 75% ethanol solution, a quarter of medicinal powder total weight is taken, is sent forth in medicinal powder, stirred in sprinkling,
Until mixing thoroughly, by stainless steel barrel closed 8 minutes.After 8 minutes, stainless steel barrel is opened, medicinal powder is taken out, is divided sterilized in
In stainless steel pallet, placed 24 hours in closed environment.Medicinal powder is again placed in stainless steel barrel, by configured 75% second
Alcoholic solution takes 1/8th of medicinal powder total weight, sends forth in medicinal powder, stirs in sprinkling, until mix thoroughly, stainless steel barrel is close
It closes 4 minutes.After 4 minutes, stainless steel barrel is opened, medicinal powder is taken out.According to " Chinese Pharmacopoeia " version in 2015 four 1105,
1106 general rules, test, inspection result such as the following table 4:
4 embodiment of table, 2 microorganism detection result
Table 4 the result shows that, in 3 batches test agent using above-mentioned condition sterilize, sterilization effect is fine, meets standards of pharmacopoeia.
Detection is carried out further according to content assaying method to be detected using HPLC method, as a result such as the following table 5:
5 embodiment of table, 2 assay result
Table 5 the result shows that, in 3 batches test agent using above-mentioned condition sterilize, sterilization effect is good, meets the quality standard.
Embodiment 3
Prescription is same as Example 1, but the process conditions to sterilize carry out Continuous optimization, and sterilization process is as follows:
By the above 32 taste prepared slices of Chinese crude drugs, co-grinding crosses 80 meshes, and the mixed-powder for crossing 80 meshes is placed in stainless steel
In bucket, by configured 75% ethanol solution, a quarter of medicinal powder total weight is taken, is sent forth in medicinal powder, stirred in sprinkling,
Until mixing thoroughly, by stainless steel barrel closed 6 minutes.After 6 minutes, stainless steel barrel is opened, medicinal powder is taken out, is divided sterilized in
In stainless steel pallet, placed 24 hours in closed environment.Medicinal powder is again placed in stainless steel barrel, by configured 75% second
Alcoholic solution takes 1/8th of medicinal powder total weight, sends forth in medicinal powder, stirs in sprinkling, until mix thoroughly, stainless steel barrel is close
It closes 4 minutes.After 4 minutes, stainless steel barrel is opened, medicinal powder is taken out.According to " Chinese Pharmacopoeia " version in 2015 four 1105,
1106 general rules, test, inspection result such as the following table 6:
6 embodiment of table, 3 microorganism detection result
Table 6 the result shows that, in 3 batches test agent using above-mentioned condition sterilize, sterilization effect is fine, meets standards of pharmacopoeia.
Detection is carried out further according to content assaying method to be detected using HPLC method, as a result such as the following table 7:
7 embodiment of table, 3 assay result
Table 7 the result shows that, in 3 batches test agent using above-mentioned condition sterilize, sterilization effect is good, meets the quality standard.
Embodiment 4
Prescription is same as Example 1, but the process conditions to sterilize carry out Continuous optimization, and sterilization process is as follows:
By the above 32 taste prepared slices of Chinese crude drugs, co-grinding crosses 80 meshes, and the mixed-powder for crossing 80 meshes is placed in stainless steel
In bucket, by configured 75% ethanol solution, a quarter of medicinal powder total weight is taken, is sent forth in medicinal powder, stirred in sprinkling,
Until mixing thoroughly, by stainless steel barrel closed 5 minutes.After five minutes, stainless steel barrel is opened, medicinal powder is taken out, is divided sterilized in
In stainless steel pallet, placed 24 hours in closed environment.Medicinal powder is again placed in stainless steel barrel, by configured 75% second
Alcoholic solution takes 1/8th of medicinal powder total weight, sends forth in medicinal powder, stirs in sprinkling, until mix thoroughly, stainless steel barrel is close
It closes 3 minutes.After 3 minutes, stainless steel barrel is opened, medicinal powder is taken out.According to " Chinese Pharmacopoeia " version in 2015 four 1105,
1106 general rules, test, inspection result such as the following table 8:
8 embodiment of table, 4 microorganism detection result
Table 8 the result shows that, in 3 batches test agent using above-mentioned condition sterilize, sterilization effect is bad, does not meet pharmacopeia mark
It is quasi-.
Detection is carried out further according to content assaying method to be detected using HPLC method, as a result such as the following table 9:
9 embodiment of table, 3 assay result
Table 9 the result shows that, in 3 batches test agent using above-mentioned condition sterilize, sterilization effect is good, meets the quality standard.
Pass through the Analysis of test results to embodiment 1, embodiment 2, embodiment 3 and embodiment 4: each test parameters condition
Under, the content detection achievement data of preparation is essentially identical, illustrates, which does not have an impact the ingredient of drug substantially,
There is no the phenomenon that destroying drug ingedient.Data to microorganism detection analysis shows, embodiment 1, embodiment 2 and implement
3 microorganism of example meets standards of pharmacopoeia, and 4 total number of bacteria of embodiment is exceeded, illustrates that sterilization time is too short, sterilization effect is bad.It is real
It applies example 1, embodiment 2,3 microorganism detection limit of embodiment to comply with standard, but in embodiment 3, sterilization time is most short, sterilizing speed
Degree is fast, can save time cost, therefore the mode of optional embodiment 3 sterilizes.
The embodiments described above only express several embodiments of the present invention, and the description thereof is more specific and detailed, but simultaneously
It cannot therefore be construed as limiting the scope of the patent.It should be pointed out that coming for those of ordinary skill in the art
It says, without departing from the inventive concept of the premise, various modifications and improvements can be made, these belong to protection of the invention
Range.Therefore, the scope of protection of the patent of the invention shall be subject to the appended claims.
Claims (6)
1. a kind of Chinese materia medica preparation of set a broken bone section, it is characterised in that: prescription include pilose antler, radix achyranthis bidentatae, Cortex Eucommiae, psoralea corylifolia, ginseng,
Radix Astragali, Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Radix Paeoniae Alba, Rhizoma Chuanxiong, the root of Dahurain angelica, stir-baked CORTEX MAGNOLIAE OFFICINALIS with rhizoma zingiberis recens juice, Fructus Aurantii, pyritum ignited, safflower, rheum officinale, dried orange peel, stir-baked OLIBANUM with vinegar, vinegar do not have
Medicine, rhizoma corydalis, cortex cinnamomi, rhizoma atractylodis, Poria cocos, rhizoma zingiberis, gentianae macrophyllae, pawpaw, campanulaceae, Rhizoma Et Radix Notopterygii, Radix Angelicae Pubescentis, radix saposhnikoviae, borax, Radix Glycyrrhizae.
2. a kind of Chinese materia medica preparation of set a broken bone section according to claim 1, it is characterised in that: prescription is according to following weight
Meter, 50~150g of pilose antler, 25~75g of radix achyranthis bidentatae, 25~75g of Cortex Eucommiae, 20~60g of psoralea corylifolia, 20~60g of ginseng, Radix Astragali 20~
60g, 20~60g of Rhizoma Atractylodis Macrocephalae, 20~60g of Radix Angelicae Sinensis, 20~60g of Radix Paeoniae Alba, 20~60g of Rhizoma Chuanxiong, 10~30g of the root of Dahurain angelica, 8~25g of stir-baked CORTEX MAGNOLIAE OFFICINALIS with rhizoma zingiberis recens juice,
10~30g of Fructus Aurantii, 8~25g of pyritum ignited, 10~60g of safflower, 3~9g of rheum officinale, 20~60g of dried orange peel, 3~9g of stir-baked OLIBANUM with vinegar, vinegar do not have
3~9g of medicine, 15~45g of rhizoma corydalis, 10~30g of cortex cinnamomi, 20~60g of rhizoma atractylodis, 10~30g of Poria cocos, 10~30g of rhizoma zingiberis, gentianae macrophyllae 8~
25g, 20~60g of pawpaw, 20~60g of campanulaceae, 20~60g of Rhizoma Et Radix Notopterygii, 20~60g of Radix Angelicae Pubescentis, 10~60g of radix saposhnikoviae, borax 0.5~
1.5g, 10~30g of Radix Glycyrrhizae.
3. a kind of Chinese materia medica preparation of set a broken bone section according to claim 2, it is characterised in that: pilose antler 100g, radix achyranthis bidentatae
50g, Cortex Eucommiae 50g, psoralea corylifolia 40g, ginseng 40g, Radix Astragali 40g, Rhizoma Atractylodis Macrocephalae 40g, Radix Angelicae Sinensis 40g, Radix Paeoniae Alba 40g, Rhizoma Chuanxiong 40g, the root of Dahurain angelica
20g, stir-baked CORTEX MAGNOLIAE OFFICINALIS with rhizoma zingiberis recens juice 15g, Fructus Aurantii 20g, pyritum ignited 15g, safflower 40g, rheum officinale 6g, dried orange peel 40g, stir-baked OLIBANUM with vinegar 6g, stir-baked MYRRHA with vinegar 6g, prolong
Hu rope 30g, cortex cinnamomi 20g, rhizoma atractylodis 40g, Poria cocos 20g, rhizoma zingiberis 20g, gentianae macrophyllae 15g, pawpaw 40g, campanulaceae 20g, Rhizoma Et Radix Notopterygii 40g, Radix Angelicae Pubescentis
40g, radix saposhnikoviae 40g, borax 1g, Radix Glycyrrhizae 15g.
4. a kind of Chinese materia medica preparation of set a broken bone section according to claim 3, it is characterised in that: whole medicines of the prescription
After object co-grinding, the mixed-powder after sterilizing can prepare common oral solid formulation, and the oral solid formulation is scattered
Agent or hard capsule.
5. a kind of Chinese materia medica preparation of set a broken bone section according to claim 4, it is characterised in that the preparation is that drug is complete
The encapsulated dosage form of powder, the preparation of preparation are hard capsule.
6. a kind of sterilizing methods of the Chinese materia medica preparation of set a broken bone section, feature described in a kind of claim 1-5 any one
Be: the sterilizing methods of the full powder of preparation use following sterilization process:
(1) by prescription drug co-grinding, 80 meshes are crossed；
(2) it by the mixed-powder of step (1) 80 mesh of mistake, is sealed in stainless steel barrel, 75% ethyl alcohol of addition, described 75%
Ethanol consumption is a quarter of medicinal powder gross weight, and sprinkling stirs evenly, closed, carries out bored profit and sterilizes 6 minutes；
(3) first time sterile powder described in step (2) is taken out, is divided in stainless steel pallet, closed to dry, the duration
It is 24 hours；
(4) first time sterile powder described in step (3) is taken out, is placed in stainless steel barrel, 75% ethyl alcohol of addition, described 75%
Ethanol consumption is 1/8th of medicinal powder gross weight, and sprinkling stirs evenly, closed, carries out bored profit and sterilizes 4 minutes；
(5) powder of second of sterilizing described in step (4) is taken out, is placed in stainless steel pallet, dries.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110664972A (en) * | 2019-10-07 | 2020-01-10 | 罗成 | Menstruation-inducing and bone-penetrating oil |
| CN114377161A (en) * | 2021-12-14 | 2022-04-22 | 安徽中医药大学 | Sterilizing method of classic famous prescription yixinsan |
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2019
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110664972A (en) * | 2019-10-07 | 2020-01-10 | 罗成 | Menstruation-inducing and bone-penetrating oil |
| CN114377161A (en) * | 2021-12-14 | 2022-04-22 | 安徽中医药大学 | Sterilizing method of classic famous prescription yixinsan |
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