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CN109136091A - A kind of tablet culture medium and preparation method thereof - Google Patents

A kind of tablet culture medium and preparation method thereof Download PDF

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Publication number
CN109136091A
CN109136091A CN201811036236.5A CN201811036236A CN109136091A CN 109136091 A CN109136091 A CN 109136091A CN 201811036236 A CN201811036236 A CN 201811036236A CN 109136091 A CN109136091 A CN 109136091A
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China
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culture medium
parts
tablet
medium
present
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崔生辉
王金恒
解晨光
李佳铱
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BEIJING SANYAO SCIENCE & TECHNOLOGY DEVELOPMENT Co Ltd
National Institutes for Food and Drug Control
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BEIJING SANYAO SCIENCE & TECHNOLOGY DEVELOPMENT Co Ltd
National Institutes for Food and Drug Control
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    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N1/00Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor

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Abstract

The present invention provides a kind of tablet culture mediums, belong to culture medium technical field.The tablet culture medium includes the component of following parts by weight: 84~96 parts of dehydrated medium, 2~6 parts of adhesive, 2~8 parts of disintegrating agent and 0.5~2 part of lubricant.Tablet culture medium prepared by the present invention, quality are stablized, and the shortcomings that dehydrated medium is easy moisture absorption agglomeration is overcome.Meanwhile tablet culture medium prepared by the present invention can significantly reduce sucking of the user to toxic component, reduce allergic reaction, also pollution of the reduction dust to laboratory precision instrument and equipment.Tablet culture medium prepared by the present invention never degenerates, microculture works well for 3 years under room temperature, closed environment.

Description

A kind of tablet culture medium and preparation method thereof
Technical field
The invention belongs to microbiological culture media technical fields, and in particular to a kind of tablet culture medium and preparation method thereof.
Background technique
Microbiological culture media, the mixture of nutriment needed for referring to supply microbial growth, by Different Nutrition Substance formulated in combination forms, generally all containing carbohydrate, nitrogen substance, inorganic salts (including microelement), vitamin and Water etc..Culture medium had both been to provide cytotrophy and had promoted the basic substance of cell Proliferation and the existence of cell growth and breeding Environment.Due to the uniqueness rich in nutriment and application, food and drug microbiological Test all to the preparation of culture medium, Storage and quality control are proposed and are clearly required.
Early in four the fifties, American and Britain, Deng developed country largely use dehydrated medium, and become commercialization Product.China also sets about developing in the fifties, and medicine unit is widely used now.Presently commercially available microbiological culture media is main To be dehydrated synthetic media, it is divided into dehydrated medium and particulate media.
Dehydrated medium is in powdered, is by the various compositions of culture medium by proper treatment, according to various culture mediums Formula aequum mixes well.Dehydrated medium is easy in moisture absorption agglomeration, transport and storage process easily dispersion unevenly, and It is also easy to produce dust in use, a possibility that there are the environmental pollutions of clean area and there are security risks to operator. To solve this problem, it is proposed granular pattern culture medium successively in the market, particulate media is the base in dried powder culture medium By being granulated on plinth, have the advantages that soluble, non-dusting, be conducive to laboratory environment and personnel safety, by The welcome and receiving of more and more users.But there is also some disadvantages for particulate media, such as pelletize unstable, culture medium The problems such as capability and performance declines, protrusion are reflected in growth ability, Indication Characteristics of microorganism etc., not as good as dehydrated medium exhibition The excellent culture performance revealed.And culture medium is the basis of microbiological test, directly affects microbial test results, unavoidably There are the erroneous judgements of inspection result.
Summary of the invention
In view of this, the culture medium quality is stablized the present invention provides a kind of tablet culture medium, simplicity is used.
To solve the above-mentioned problems, the present invention provides following technical schemes:
The present invention provides a kind of tablet culture medium, the component including following parts by weight: 84~96 parts of dehydrated medium is glued 2~6 parts of mixture, 2~8 parts of disintegrating agent and 0.5~2 part of lubricant.
Preferably, the component including following parts by weight: 88~92 parts of dehydrated medium, 3~5 parts of adhesive, disintegrating agent 4~ 6 parts and 1~1.5 part of lubricant.
Preferably, described adhesive includes: starch slurry, microcrystalline cellulose, povidone, gelatin, polyethylene glycol and alginic acid One or more of sodium.
Preferably, the disintegrating agent includes: dried starch, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, the poly- dimension of crosslinking One or more of ketone, croscarmellose sodium and gas-producing disintegrant.
Preferably, the lubricant includes: magnesium stearate, superfine silica gel powder, talcum powder, hydrogenated vegetable oil, polyethylene glycols One or more of with lauryl sodium sulfate.
Preferably, the granularity of the dehydrated medium is 200~300 mesh.
Preferably, by weight percentage, the water content of each component stands alone as 8.0%.
The present invention provides a kind of preparation methods of tablet culture medium described in above scheme, include the following steps:
1) it by adhesive, disintegrating agent, lubricant and accounts for the dehydrated medium of dehydrated medium gross mass 15%~20% and mixes It closes, obtains premix;
2) premix of the step 1) is mixed, tabletting with surplus dehydrated medium, obtains tablet culture medium.
Preferably, the step 1) or 2) in mix mode stand alone as stirring;The time of the stirring stands alone as 4~ The revolving speed of 6min, the stirring stand alone as 5~10r/min.
Preferably, the pressure of the tabletting is 39~41kN, and the diameter of tablet culture medium is 22mm.
The present invention provides a kind of tablet culture medium, the component including following parts by weight: 84~96 parts of dehydrated medium is glued 2~6 parts of mixture, 2~8 parts of disintegrating agent and 0.5~2 part of lubricant.Dehydrated medium provides required nutrition for microorganism growth Ingredient and suitable pH environment etc., auxiliary material adhesive, disintegrating agent and lubricant are played a supporting role in tablet forming process, Stability with higher, does not occur any physical-chemical reaction with major ingredient, nontoxic to microorganism, have no adverse reaction.Wherein, it sticks Mixture makes no stickiness or the insufficient material powders of stickiness be gathered into particle, so that the further processing of particle is more easy.Disintegration Agent can promote preparation to be disintegrated into junior unit rapidly, and then faster dissolve.The effect of lubricant is between reducing particle, particle and solid Frictional force between preparation manufacturing equipment.Tablet culture medium prepared by the present invention will not cause to disperse in transport and storage process Unevenly, to make unstable quality.The shortcomings that dehydrated medium is easy moisture absorption agglomeration is overcome simultaneously.Meanwhile system of the present invention Standby tablet culture medium can significantly reduce sucking of the user to toxic component, reduce allergic reaction;Dust is reduced to laboratory The pollution of precision instrument and equipment.And under room temperature, closed environment, never degenerate within 3 years, microculture works well.
Further, the present invention uses tablet, and the quality of tablet is fixed value, in use every be dissolved in it is quantitatively pure Change in water, it is easy to operate without weighing.
Specific embodiment
The present invention provides a kind of tablet culture medium, the component including following parts by weight: 84~96 parts of dehydrated medium is glued 2~6 parts of mixture, 2~8 parts of disintegrating agent and 0.5~2 part of lubricant.
Tablet culture medium provided by the invention includes dehydrated medium.By weight, the dehydrated medium be 84~ 96 parts, preferably 88~92 parts, more preferably 90 parts.In the present invention, the granularity of the dehydrated medium is preferably 200~300 Mesh, more preferably 250 mesh.In the present invention, the water content of commercially available dehydrated medium is preferably 7.5%~8.5%, more preferably 8%.Nutritional ingredient and suitable pH environment etc. needed for heretofore described dehydrated medium provides microorganism growth.This hair The bright source category to the dehydrated medium is not particularly limited, drug involved in the existing pharmacopeia of this field conventional commercial Examine all culture mediums involved in culture medium and food, cosmetics, drinking water Micro biological Tests current standard.
Tablet culture medium provided by the invention includes adhesive.By weight, described adhesive includes 2~6 parts, preferably It is 3~5 parts, more preferably 4 parts.In the present invention, described adhesive preferably includes starch slurry, microcrystalline cellulose, povidone, bright One or more of glue, polyethylene glycol and sodium alginate.In the present invention, the water content of the water content of described adhesive is preferably 7.5%~8.5%, more preferably 8%.In the present invention, described adhesive makes no stickiness or the insufficient material powders aggregation of stickiness At particle, so that the further processing of particle is more easy.The present invention is not particularly limited the source of described adhesive, uses This field conventional commercial product.Starch slurry, microcrystalline cellulose and povidone are bought from the Anhui mountains and rivers in the embodiment of the present invention Pharmaceutic adjuvant limited liability company;Gelatin is bought from Hangzhou Qun Li gelatin Chemical Co., Ltd.;Polyethylene glycol is bought from Beijing Haidian fellow member of an association or organization's Fine Chemical Works;Sodium alginate is bought from Qingdao Ding Li seaweed Co., Ltd.
Tablet culture medium provided by the invention includes disintegrating agent.By weight, the disintegrating agent includes 2~8 parts, preferably It is 4~6 parts, more preferably 5 parts.In the present invention, the disintegrating agent preferably includes dried starch, sodium carboxymethyl starch, low substitution hydroxyl One or more of third cellulose, crospovidone, croscarmellose sodium and gas-producing disintegrant.In the present invention, institute The water content for stating disintegrating agent is preferably 8.0%.In the present invention, the disintegrating agent can promote preparation to be disintegrated into junior unit rapidly, And then it faster dissolves.The present invention is not particularly limited the source of the disintegrating agent, using this field conventional commercial product. Dried starch, crospovidone are bought from Anhui Shanhe Medicinal Subsidiary Material Co., Ltd. in the embodiment of the present invention;Carboxymethyl starch Sodium, low-substituted hydroxypropyl cellulose are bought from Distributions in Liaocheng of Shandong Province A Hua Pharmacy stock Co., Ltd;Gas-producing disintegrant is bought from traditional Chinese medicines collection Chemical reagent Co., Ltd of group.
Tablet culture medium provided by the invention includes lubricant.By weight, the lubricant includes 0.5~2 part, excellent It is selected as 1~1.5 part, more preferably 1.25 parts.In the present invention, the lubricant preferably includes magnesium stearate, superfine silica gel powder, talcum One or more of powder, hydrogenated vegetable oil, polyethylene glycols and lauryl sodium sulfate.In the present invention, the lubricant Water content is preferably 7.5%~8.5%, and more preferably 8%.In the present invention, the lubricant be can reduce between particle, particle and Frictional force between solid pharmaceutical preparation manufacturing equipment such as tablet punch and the metal contact surface of punch die.The present invention is to the lubricant Source is not particularly limited, using this field conventional commercial product.Magnesium stearate is bought from Shandong in the embodiment of the present invention Liaocheng A Hua Pharmacy stock Co., Ltd);Superfine silica gel powder is bought from Xi'an Yue Lai Pharmaceutical Technology Co., Ltd;Talcum powder purchase is certainly Fu Da talcum powder Co., Ltd of Laizhou City;Hydrogenated vegetable oil purchase matches hundred million Biotechnology Co., Ltd from Hebei;Polyethylene glycols It buys from Beijing Haidian fellow member of an association or organization's Fine Chemical Works;Lauryl sodium sulfate is bought from the limited public affairs of Anhui mountains and rivers pharmaceutic adjuvant share Department.
In the present invention, nutritional ingredient and suitable pH environment etc. needed for dehydrated medium provides microorganism growth are auxiliary Material adhesive, disintegrating agent and lubricant are played a supporting role in tablet forming process, stability with higher, not with major ingredient Any physical-chemical reaction occurs, culture medium clarity is not impacted, it is nontoxic to microorganism, have no adverse reaction.
The present invention provides a kind of preparation methods of tablet culture medium described in above scheme, include the following steps:
1) it by adhesive, disintegrating agent, lubricant and accounts for the dehydrated medium of dehydrated medium gross mass 15%~20% and mixes It closes, obtains premix;
2) premix of the step 1) is mixed, tabletting with surplus dehydrated medium, obtains tablet culture medium.
The present invention is by adhesive, disintegrating agent, lubricant and the dry powder culture for accounting for dehydrated medium gross mass 15%~20% Base mixing, obtains premix.By mass percentage, the present invention preferably mixes 18% dehydrated medium with auxiliary material.This hair In bright, the mixed mode is preferably stirred.The time of the stirring is preferably 4~6min, more preferably 5min.It is described to stir The revolving speed mixed is preferably 5~10r/min, more preferably 8r/min.In the present invention, SBH-600 three-dimensional oscillating is used in embodiment Mixing machine is stirred.
After obtaining premix, the present invention mixes the premix with surplus dehydrated medium, and tabletting obtains tablet culture Base.In the present invention, the mixed mode is preferably stirred.The time of the stirring is preferably 4~6min, more preferably 5min.The revolving speed of the stirring is preferably 5~10r/min, more preferably 8r/min.In the present invention, SBH- is used in embodiment 600 three-dimensional oscillating mixers are stirred.The present invention mixes raw material by several times, it is ensured that the uniformity of product.In the present invention, The pressure when tabletting is preferably 39~41kN, more preferably 40kN.The diameter of obtained tablet is preferably 22mm.
In order to further illustrate the present invention, technical solution provided by the invention is retouched in detail below with reference to embodiment It states, but they cannot be interpreted as limiting the scope of the present invention.
Embodiment 1
It is in air humidity respectively by pancreas junket soya peptone dehydrated medium, starch, sodium carboxymethylcellulose and magnesium stearate 200 meshes are crossed in 35% room, the water content for adjusting each component respectively is 8%.Weigh 905g pancreas junket soya peptone dry powder Culture medium, 40g starch, 40g sodium carboxymethylcellulose and 15g magnesium stearate.Tool in the pancreas junket soya peptone dehydrated medium Body component is as shown in table 1.
1 pancreas junket soya peptone dehydrated medium component list of table
Components Name Percentage (%) The content (g/L) of ingredient in every liter of culture medium
Soybean papain hydrolysis object 10.1 3.0
Trypticase 57.0 17.0
Sodium chloride 16.8 5.0
DEXTROSE ANHYDROUS 7.7 2.3
Dipotassium hydrogen phosphate 8.4 2.5
By 140g pancreas junket soya peptone dehydrated medium and above-mentioned load weighted starch, sodium carboxymethylcellulose and magnesium stearate After stirring 4min with the revolving speed of 5r/min, remaining pancreas junket soya peptone dehydrated medium is being added in mixing.Turned again with 10r/min Speed stirring 6min, is pressed into diameter with the pressure of 39kN as the tablet of 22mm.
Embodiment 2
Weightlessness, pH value, sensitivity and growth rate is dried to the tablet culture medium being prepared in embodiment 1 respectively to examine It surveys, to determine the quality for the tablet culture medium being prepared.Specific examination criteria is as follows:
The preparation of 1.1 test cultures base fluids
The dissolution of 300mL purified water is added in pancreas junket soya peptone fluid nutrient medium (TSB) piece that 4 embodiments 1 are prepared, Packing is into container.121 DEG C of high pressure sterilization 15min.
1.2 strain
The passage number of test bacterial strain must not exceed for 5 generations, and (the freeze-drying strain obtained from Culture Collection Center is 0 Generation), the biological characteristics of guarantee test bacterial strain.
The preparation of 1.3 bacterium solutions
Pseudomonas aeruginosa, staphylococcus aureus, bacillus subtilis are inoculated in the training of pancreas junket soya peptone liquid respectively It supports in base or on pancreas junket soya peptone agar medium inclined-plane, 30~35 DEG C are cultivated 18~24 hours.0.9% nothing of above-mentioned culture The dissolution of bacterium sodium chloride solution, is made 10 compared with normal bacterial opacity tube8Bacteria suspension, then every 1mL is made containing bacterium in 10 times of dilutions The bacteria suspension of number < 100CFU (Colony Forming Unit).
The fresh cultured object of Candida albicans is inoculated with to Sabouraud dextrose fluid nutrient medium or Sabouraud's dextrose agar culture On base inclined-plane, 20~25 DEG C are cultivated 24~48 hours, and above-mentioned culture is dissolved with 0.9% aseptic sodium chloride solution, thin with standard Bacterium opacity tube is relatively made 108Bacteria suspension, then 10 times dilution be made every 1mL containing bacterium number be < 100CFU (Colony Forming Unit) Bacteria suspension.
On the fresh cultured object of inoculated aspergillus niger to Sabouraud's dextrose agar slant medium inclined-plane.20~25 DEG C of cultures 5 ~7 days.0.9% aseptic sodium chloride solution of the 3~5mL containing 0.05% (v/v) polyoxyethylene sorbitan monoleate is added to dissolve, with normal bacterial ratio Turbid pipe is relatively made 108Bacteria suspension, then it is < 100CFU (Colony Forming Unit) that every 1mL, which is made, containing spore count in 10 times of dilutions Spore suspension.
1.4 operating procedure
1. final ph
Tablet culture medium after preparing and sterilize according to the above method after placing room temperature, (presses pH using acidometer measurement in accordance with the law Measuring method), pH value should be 7.3 ± 0.2.
2. loss on drying
This product 1 is taken, is baked to constant weight (weight in 105 DEG C of specific temperature using Mettler HG53 fast tester for water content Measure difference and be no more than 0.3mg), register instrument correlation values, at least 3 parts of parallel testing seek mean value, and less loss weight must not mistake 6.0%.
3. sensitivity
Sample is prepared according to 1.3 method, test strain is inoculated with direct vaccination ways, takes and trained equipped with pancreas junket soya peptone liquid 11, test tube for supporting base are inoculated with above-mentioned bacterium solution each 2 of < 100CFU respectively, and another 1 is not inoculated with as blank control;Similarly Test strain is inoculated into control medium by method, synchronous to be counted using the suitable culture medium that counts.Set 30~35 DEG C In incubator, cultivates 18~48 hours, observe and record result.Blank control pipe answers asepsis growth, be detected culture base tube with it is right Compare according to culture base tube, test organisms pseudomonas aeruginosa, staphylococcus aureus, bacillus subtilis, Candida albicans and black The equal well-grown of aspergillus, is judged to qualification, is otherwise judged to unqualified.
According to above-mentioned examination criteria detect respectively the tablet culture medium that embodiment 1 is prepared be dried weightlessness, pH value, Sensitivity and growth rate, specific testing result are as shown in table 2.
The quality measurements of the tablet culture medium of 2 pancreas junket soya peptone fluid nutrient medium of table
Note: the above test stone is based on depending on Chinese Pharmacopoeia 2015 editions.
As can be seen from Table 1, properties after tablet are made in the pancreas junket soya peptone fluid nutrient medium that the present invention is prepared Meet standards of pharmacopoeia, the results showed that, the tablet culture medium that the present invention is prepared is qualified.
Embodiment 3
Mai Kangkai (MAC) agar dry powder, microcrystalline cellulose, sodium carboxymethylcellulose and magnesium stearate is wet in air respectively For degree to cross 300 meshes in 35% room, the water content for adjusting each component respectively is 8%.885g MAC is weighed, 60g is micro- Crystalline cellulose, 50g sodium carboxymethylcellulose and 5g magnesium stearate.Concrete component such as 3 institute of table in the MAC dehydrated medium Show.
Table 3 Mai Kangkai (MAC) agar dry powder formulation table
177g MAC agar dry powder and above-mentioned load weighted microcrystalline cellulose, carboxymethyl cellulose and magnesium stearate are mixed It closes, after stirring 5min with the revolving speed of 8r/min, remaining pancreas junket soya peptone liquid dehydrated medium is being added.Turned again with 8r/min Speed stirring 6min, is pressed into diameter with the pressure of 41kN as Mai Kangkai (MAC) agar tablet of 22mm.
Embodiment 4
The tablet culture medium being prepared using embodiment 3 as experimental group, while using MAC agar dehydrated medium as pair According to group, weightlessness, pH value, selection performance and growth rate are dried respectively and is detected, to determine the tablet culture being prepared The quality of base.Specific examination criteria is as follows:
The preparation of 1.1 test cultures base fluids
100mL purified water, dissolution, 121 DEG C of height are added in Mai Kangkai (MAC) the agar tablet that 2 embodiments 3 are prepared Pressure sterilizing 15min.It is cooled to 50 DEG C or so after sterilizing, topples in 15~20mL to plate, lets cool spare to solidifying.
100mL purified water, dissolution, as control medium is added in 5.15g Mai Kangkai (MAC) agar dry powder.121 DEG C of height Pressure sterilizing 15min.It is cooled to 50 DEG C or so after sterilizing, topples in 15~20mL to plate, lets cool spare to solidifying.
1.2 strain
The passage number of test bacterial strain must not exceed for 5 generations, and (the freeze-drying strain obtained from Culture Collection Center is 0 Generation), the biological characteristics of guarantee test bacterial strain.
Escherichia coli (Escherichia coli) (ATCC 25922)
Shigella flexneri (Shigellaflexneri) (CMCC (B) 51572)
Staphylococcus aureus (Staphylococcus aureus) (ATCC 6538)
1.3. prepared by bacterium solution
By escherichia coli, shigella flexneri, S. aureus Inoculate to TSB overnight incubation, with 0.9% nothing Bacterium sodium chloride solution prepares 10 times of bacteria suspensions being serially diluted.
1.4 operating procedure
1. final ph
Tablet culture medium after preparing and sterilize according to the above method after placing room temperature, (presses pH using acidometer measurement in accordance with the law Measuring method), pH value should be 7.2 ± 0.2, and with compareing, Mai Kangkai (MAC) agar dry powder is consistent.
2. loss on drying
This product 1 is taken, is baked to constant weight in 105 DEG C of specific temperature using Mettler HG53 fast tester for water content, is remembered Instrument correlation values, at least 3 parts of parallel testing are recorded, mean value is sought, less loss weight must not cross 6.0%, with control Mai Kangkai (MAC) Agar dry powder is consistent.
3. growth promotion ability+Indication Characteristics
Select escherichia coli, shigella flexneri bacteria suspension 0.1mL (the inoculation level of every plate of appropriate dilution For 20CFU~200CFU), even spread is inoculated in master plate and control plate TSA respectively.Each dilution is inoculated with two and puts down Plate.It is placed in constant temperature incubation 20 in 36 ± 1 DEG C of incubators~for 24 hours.1 ring of staphylococcus aureus bacteria suspension is taken with 1 μ L oese, Media surface to be measured draw six parallel lines, while be inoculated with two plates, be placed in constant temperature incubation 20 in 36 ± 1 DEG C of incubators~ 24h。
According to above-mentioned examination criteria respectively to the MAC agar tablet culture medium that embodiment 3 is prepared be dried it is weightless, PH value, sensitivity and growth rate detection, specific testing result are as shown in table 4.
The quality measurements of table 4MAC agar tablet culture medium
Remarks: the above test stone is based on depending on state food safety verification standard.PR is the rate of recovery in table 4, and G is growth Index.Calculation method is as follows:
Object bacteria growth rate quantitative measuring method:
The moderate plate of selection clump count is counted, and calculates growth rate by following formula.
In formula:
PR--- growth rate;
NS--- the total plate count obtained on culture medium flat plate to be measured;
N0--- the total plate count obtained on reference culture medium flat plate (total plate count answers >=100CFU).
2 non-targeted bacterium (selectivity) semidefinite weight testing methods
Growth index G is calculated to culture medium by the following method after culture.
Then G is 1 for every scribing line for having denser bacterium colony to grow, up to 6 points on each culture dish.If only half Line has dense bacterium colony to grow, then G is 0.5.If no bacterium colony growth, increment are raw less than the half or bacterium colony of scribing line in scribing line Length is faint, then G is 0.The score summation for recording each plate just obtains G.
As can be seen from Table 4, Mai Kangkai (MAC) agar dry powder that the present invention is prepared is made after tablet and dry powder form Same kind properties it is almost the same, and growth rate is better than the same veriety of common dehydrated medium, meets state food safety Test stone.
Embodiment 5
By THIOGLYCOLLIC ACID salt broth dry powder, starch, sodium carboxymethyl starch and magnesium stearate respectively in air humidity To cross 250 meshes in 35% room, the water content for adjusting each component respectively is 8%.Weigh 890g THIOGLYCOLLIC ACID salt stream Body culture medium dry powder, 50g starch, 50g sodium carboxymethyl starch and 10g magnesium stearate.In the THIOGLYCOLLIC ACID salt dehydrated medium Concrete component it is as shown in table 5.
5 THIOGLYCOLLIC ACID salt dehydrated medium component list of table
By 160g THIOGLYCOLLIC ACID salt broth dry powder and above-mentioned load weighted starch, sodium carboxymethyl starch and stearic acid After stirring 5min with the revolving speed of 8r/min, remaining pancreas junket soya peptone liquid dehydrated medium is being added in magnesium mixing.Again with 8r/min Revolving speed stir 5min, diameter is pressed into as the THIOGLYCOLLIC ACID salt broth tablet of 22mm with the pressure of 40kN.
Embodiment 6
Weightlessness, pH value, spirit are dried to the THIOGLYCOLLIC ACID salt broth tablet being prepared in embodiment 5 respectively Sensitivity and validity period are detected, to determine the quality for the tablet culture medium being prepared.Specific examination criteria is as follows:
1.1 testing program
Based on the understanding to product property and to the expection of validity period, long term test is chosen 0,3,6,12,18 in storage period, 24,36 months products are investigated.Referring to " Chinese Pharmacopoeia " and ICH (human drugs registration technology requires international coordination meeting) rule Fixed, long-term stable experiment uses temperature for 25 DEG C ± 2 DEG C, relative humidity 60% ± 10%.
The preparation of test sample: 4 THIOGLYCOLLIC ACID salt broth pieces, which are added the heating of 300mL purified water and are boiled, keeps its complete Fully dissolved, packing is spare to sterile test tube, and every pipe loading amount is 12mL.121 DEG C of high pressure sterilization 15min.
1.2 verification methods and content
1. physico-chemical examination
Measuring test sample, pH value, each sample are measured 3 times and are averaged as final ph, final pH at room temperature in 25 DEG C Value should be 7.1 ± 0.2.
2. loss on drying
This product 1 is taken, is baked to constant weight in 105 DEG C of specific temperature using Mettler HG53 fast tester for water content, is remembered Instrument correlation values, at least 3 parts of parallel testing are recorded, seek mean value, less loss weight must not cross 6.0%.
3. following test
The passage number of test bacterial strain must not exceed for 5 generations, and (the freeze-drying strain obtained from Culture Collection Center is 0 Generation), the biological characteristics of guarantee test bacterial strain.
Staphylococcus aureus, pseudomonas aeruginosa, escherichia coli are inoculated in pancreas junket soya peptone Liquid Culture respectively In base, 30~35 DEG C are cultivated 18~24 hours.Clostridium sporogenes is inoculated in THIOGLYCOLLIC ACID salt broth, 30~35 DEG C of trainings Support 18~24 hours, above-mentioned culture with 0.9% aseptic sodium chloride solution be made every 1mL containing bacterium number for no more than bacteria suspension.
It is inoculated with above-mentioned bacterium solution respectively to tested culture medium, each test strain 3 is managed, and another 1 is not inoculated with as blank control, It sets 30~35 DEG C to cultivate 24~72 hours, observes and records result.
Result judgement: blank control pipe answers asepsis growth, test organisms pseudomonas aeruginosa, staphylococcus aureus, large intestine Angstrom uncommon bacterium and the equal well-grown of clostridium sporogenes, are judged to qualification, are otherwise judged to unqualified.The above test stone is based on Chinese Pharmacopoeia Depending on 2015 editions.
The THIOGLYCOLLIC ACID salt fluid tablet culture medium that embodiment 5 is prepared is done respectively according to above-mentioned examination criteria Dry weightlessness, pH value, sensitivity and growth rate detection, specific testing result is as shown in tables 6 and 7.
PH value, the loss on drying of 6 THIOGLYCOLLIC ACID salt fluid tablet culture medium of table
Holding time PH value Loss on drying value
0 month 7.11 2.46%
3 months 7.12 2.46%
6 months 7.11 2.45%
12 months 7.13 2.44%
18 months 7.12 2.44%
24 months 7.11 2.44%
36 months 7.12 2.43%
The sensitivity test result of 7 THIOGLYCOLLIC ACID salt fluid tablet culture medium of table
It is 25 DEG C ± 2 DEG C, stores this product validity period under relative humidity 60% ± 10% in temperature it can be seen from table 6 and 7 It can achieve 3 years, and indices reach Chinese Pharmacopoeia 2015 editions requirements.
The above is only a preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art For member, various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications are also answered It is considered as protection scope of the present invention.

Claims (10)

1.一种片剂培养基,其特征在于,包括如下重量份的组分:干粉培养基84~96份、粘合剂2~6份、崩解剂2~8份和润滑剂0.5~2份。1. a tablet culture medium, is characterized in that, comprises the following components by weight: 84~96 parts of dry powder culture medium, 2~6 parts of binders, 2~8 parts of disintegrants and 0.5~2 parts of lubricant share. 2.根据权利要求1所述的培养基,其特征在于,包括如下重量份的组分:干粉培养基88~92份、粘合剂3~5份、崩解剂4~6份和润滑剂1~1.5份。2. The culture medium according to claim 1, characterized in that it comprises the following components by weight: 88-92 parts of dry powder culture medium, 3-5 parts of binder, 4-6 parts of disintegrant and lubricant 1 to 1.5 servings. 3.根据权利要求1或2所述的培养基,其特征在于,所述粘合剂包括淀粉浆、微晶纤维素、聚维酮、明胶、聚乙二醇和海藻酸钠中的一种或几种。3. culture medium according to claim 1 or 2, is characterized in that, described binder comprises one or in starch slurry, microcrystalline cellulose, povidone, gelatin, polyethylene glycol and sodium alginate several. 4.根据权利要求1或2所述的培养基,其特征在于,所述崩解剂包括干淀粉、羧甲基淀粉钠、低取代羟丙纤维素、交联聚维酮、交联羧甲基纤维素钠和泡腾崩解剂中的一种或几种。4. culture medium according to claim 1 and 2 is characterized in that, described disintegrating agent comprises dry starch, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, crospovidone, croscarmellose One or more of sodium cellulose and effervescent disintegrant. 5.根据权利要求1或2所述的培养基,其特征在于,所述润滑剂包括硬脂酸镁、微粉硅胶、滑石粉、氢化植物油、聚乙二醇类和十二烷基硫酸钠中的一种或几种。5. substratum according to claim 1 and 2 is characterized in that, described lubricant comprises in magnesium stearate, micropowder silica gel, talc, hydrogenated vegetable oil, polyethylene glycols and sodium lauryl sulfate one or more of them. 6.根据权利要求1或2所述的培养基,其特征在于,所述干粉培养基的粒度为200~300目。The medium according to claim 1 or 2, wherein the particle size of the dry powder medium is 200-300 mesh. 7.根据权利要求1或2所述的培养基,其特征在于,按重量百分比计,各组分的含水量独立为7.5%~8.5%。7 . The culture medium according to claim 1 or 2 , wherein the water content of each component is independently 7.5% to 8.5% by weight. 8 . 8.权利要求1~7任意一项所述的片剂培养基的制备方法,包括如下步骤:8. The preparation method of the tablet culture medium according to any one of claims 1 to 7, comprising the steps of: 1)将粘合剂、崩解剂、润滑剂和占干粉培养基总质量15%~20%的干粉培养基混合,得到预混料;1) mixing the binder, disintegrant, lubricant and dry powder medium that accounts for 15% to 20% of the total mass of the dry powder medium to obtain a premix; 2)将所述步骤1)的预混料与余量干粉培养基混合,压片,得到片剂培养基。2) mixing the premix of the step 1) with the remaining dry powder medium, and compressing to obtain a tablet medium. 9.根据权利要求8所述的制备方法,其特征在于,所述步骤1)或2)中混合的方式独立为搅拌;所述搅拌的时间独立为4~6min,所述搅拌的转速独立为5~10r/min。9. The preparation method according to claim 8, wherein the mixing method in the step 1) or 2) is independently stirring; the stirring time is independently 4-6 min, and the rotating speed of the stirring is independently 5~10r/min. 10.根据权利要求8或9所述的制备方法,其特征在于,所述压片的压力为39~41kN,片剂培养基的直径为22mm。10 . The preparation method according to claim 8 or 9 , wherein the tableting pressure is 39-41 kN, and the diameter of the tablet culture medium is 22 mm. 11 .
CN201811036236.5A 2018-09-06 2018-09-06 A kind of tablet culture medium and preparation method thereof Pending CN109136091A (en)

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