CN102813622A - Ornidazole sodium chloride injection composition and preparation method thereof - Google Patents
Ornidazole sodium chloride injection composition and preparation method thereof Download PDFInfo
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- CN102813622A CN102813622A CN2012103310903A CN201210331090A CN102813622A CN 102813622 A CN102813622 A CN 102813622A CN 2012103310903 A CN2012103310903 A CN 2012103310903A CN 201210331090 A CN201210331090 A CN 201210331090A CN 102813622 A CN102813622 A CN 102813622A
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Abstract
The invention provides an ornidazole sodium chloride injection composition and a preparation method thereof. The injection composition provided by the invention comprises the following components in parts by weight: 5 parts of ornidazole, 8.05 parts of sodium chloride and 1000 parts of water for injection and hydrochloric acid using the injection composition with the pH value of 3.1-3.4. The related substances and contents of the injection composition can satisfy the injection quality requirements. The invention has the advantages of simple preparation technique and low cost.
Description
Technical field
The present invention relates to medical technical field, be specifically related to a kind of ornidazole sodium chloride injection composition and method of making the same.
Background technology
Anaerobic infection, protozoacide are a kind of clinical frequently-occurring disease, commonly encountered diseases.According to Epidemiological study data all over the world, the whole world should disease the infected account for 1/10 of population, and wherein the infected of 8-10% has tangible clinical symptoms, and annual 4-11 ten thousand people die from amebiasis.Primary disease mainly is distributed in Asia, Africa, Latin America; Though all there is morbidity in rural area and city, be main with the rural area.Be more common in south in China, but also be common in the north in summer.Because the continuous improvement of China's sanitary condition, the popular and acute case of primary disease is own in recent years obviously reduces.Particularly women's sickness rate is higher.Since metronidazole succeed in developing be used to treat this type of disease since, mankind's better efficacy of always trying every possible means to find, side effect medicine still less, therefore, people develop tinidazole and ornidazole again.
Ornidazole is a kind of good effect, and the antibacterial that toxic and side effects is low is superior to metronidazole on curative effect, slightly is superior to tinidazole or suitable with tinidazole.Clinical many utilization ornidazoles are treated anaerobic infection and protozoacide.But should the disease cause of disease complicated, only use ornidazole to be difficult to reach the purpose of comprehensive treatment.
The inventor finds in ornidazole, to add the sodium chloride of specified quantitative through clinical experiment and application, has very fast releasing patient suffering's advantage, and extensive market prospects is arranged, and can obtain favorable economic benefit and social benefit.
Summary of the invention
The purpose of this invention is to provide a kind of determined curative effect, treatment cycle is short, quality controllable and the ornidazole sodium chloride injection composition and method of making the same of safe without toxic side effect.Injecta composition content of the present invention and related substance all can satisfy the injection prescription.Preparation technology of the present invention is simple, and cost is low.
The objective of the invention is to realize through following technical scheme.
On the one hand; The present invention provides a kind of ornidazole sodium chloride injection compositions, this injecta composition comprise ornidazole, 8.05 weight portions of 5 weight portions sodium chloride, 1000 weight portions water for injection and to make the pH value of said injecta composition be 3.1 ~ 3.4 hydrochloric acid.
Preferably, this injecta composition is by the water for injection of the sodium chloride of the ornidazole of 5 weight portions, 8.05 weight portions, 1000 weight portions with to make the pH value of said injecta composition be that 3.1 ~ 3.4 hydrochloric acid is formed.Be to contain 5g ornidazole, 8.05g sodium chloride and appropriate hydrochloric acid in the 1000mL water for injection, hydrochloric acid content makes that the pH value of injecta composition is 3.1 ~ 3.4 to get final product.
Preferably, the pH value of said injecta composition is 3.3.
Preferably, the method for preparing of said injecta composition comprises the steps:
(1) takes by weighing the sodium chloride of recipe quantity, be dissolved in 70 ℃～85 ℃ the water for injection insulation, stirring and dissolving;
(2) take by weighing the ornidazole of recipe quantity, add in 70 ℃～85 ℃ waters for injection, dissolving;
(3) ornidazole after step (2) dissolving is added in the sodium chloride solution of step (1), adding simultaneously can supply the hydrochloric acid 10mL of venoclysis, stirs;
(4) add 0.02% needle-use activated carbon, under 25 ℃～50 ℃, stir decolouring 20～30min, leave standstill 15min with internal recycle;
(5) take off charcoal through 5 μ m titanium rods, after the filtration, add 70 ℃～85 ℃ waters for injection, add the hydrochloric acid that can supply venoclysis simultaneously and regulate pH value to 3.1 ~ 3.4 to full dose;
(6) with medicinal liquid warp 0.45 μ m microporous filter membrane fine straining, must filtrate lamp inspection;
(7) adopt non-PVC five-layer co-squeezing film packaging material sealing bag under 175 ℃～180 ℃ temperature conditions, and welding junction covers under 155 ℃～165 ℃ temperature conditions, the butyl rubber plug composite cover is welded in fill again;
(8) with the sample that makes at 121 ℃ of following moist heat sterilization 8min.
On the other hand, the present invention provides a kind of method for preparing of above-mentioned injecta composition, and this method for preparing comprises the steps:
(1) takes by weighing the sodium chloride of recipe quantity, be dissolved in 70 ℃～85 ℃ the water for injection insulation, stirring and dissolving;
(2) take by weighing the ornidazole of recipe quantity, add in 70 ℃～85 ℃ waters for injection, dissolving;
(3) ornidazole after step (2) dissolving is added in the sodium chloride solution of step (1), adding simultaneously can supply the hydrochloric acid 10mL of venoclysis, stirs;
(4) add 0.02% needle-use activated carbon, under 25 ℃～50 ℃, stir decolouring 20～30min, leave standstill 15min with internal recycle;
(5) take off charcoal through 5 μ m titanium rods, after the filtration, add 70 ℃～85 ℃ waters for injection, add the hydrochloric acid that can supply venoclysis simultaneously and regulate pH value to 3.1 ~ 3.4 to full dose;
(6) with medicinal liquid warp 0.45 μ m microporous filter membrane fine straining, must filtrate lamp inspection;
(7) adopt non-PVC five-layer co-squeezing film packaging material sealing bag under 175 ℃～180 ℃ temperature conditions, and welding junction covers under 155 ℃～165 ℃ temperature conditions, the butyl rubber plug composite cover is welded in fill again;
(8) with the sample that makes at 121 ℃ of following moist heat sterilization 8min.
Compared with prior art, the present invention has following beneficial effect at least:
1, according to " normal osmotic pressure scope is 280～310mOsM for 2010 editions two ones of Chinese pharmacopoeia, osmotic pressure molar density average out to 298mOsM in the blood of human body; The present invention regulates amount of sodium chloride according to the regulation of pharmacopeia osmotic pressure, and osmotic pressure is adjusted within the normal osmotic pressure scope the most at last; And make in osmotic pressure and the blood of human body of injecta composition of acquisition the osmotic pressure molar density meansigma methods consistent; This makes ornidazole sodium chloride injection compositions optimum human internal environment of the present invention neither can make EF, also can not make the erythrocyte fold; Can not influence the function that erythrocyte carries oxygen, function of human body is normally moved.
2, the present invention separately adds ornidazole and sodium chloride, and ornidazole carries out acidification, has increased the dissolubility of ornidazole, has guaranteed product quality homogeneity.
3, the present invention control water for injection temperature at 70 ~ 85 ℃, injecta composition impurity is lower, active constituent content is high.
4, injecta composition pH value of the present invention is controlled at 3.1-3.4, is preferably 3.3, has guaranteed the stability of product quality.
5, the present invention has adopted the non-PVC five-layer co-squeezing of novel packaging material film, has improved the quality of product greatly.
6, the present invention adopts the moist heat sterilization mode of 121 ℃ of moist heat sterilization 8min, and final products are met the requirements.
The specific embodiment
Specify the present invention through embodiment below, should be appreciated that following embodiment only is used to explain the present invention, and the scope that does not limit the present invention in any way.
The selection foundation of embodiment 1 ornidazole sodium chloride injection compositions of the present invention, method for preparing and prescription
This prescription is the optimum human internal environment, neither can make EF, also can not make the erythrocyte fold, can not influence the function that erythrocyte carries oxygen, and function of human body is normally moved.
2, method for preparing
1) take by weighing the sodium chloride of recipe quantity, be dissolved in 70 ℃～85 ℃ waters for injection of part, and insulation, stirring and dissolving;
2) take by weighing recipe quantity ornidazole, add an amount of 70 ℃～85 ℃ waters for injection dissolving;
3) with step 2) ornidazole after the dissolving adds in the solution of step 1), adds simultaneously to supply the hydrochloric acid 10ml of venoclysis, stir;
4) add 0.02% needle-use activated carbon, stir decolouring 20～30min with internal recycle, leave standstill 15min in 25 ℃～50 ℃;
5) add 70 ℃～85 ℃ waters for injection to full dose through 5 μ m titaniums rod decarbonization filtering;
6) add the hydrochloric acid that can supply venoclysis simultaneously and transfer pH to 3.1-3.4;
7) sampling and measuring pH value and content meet the requirements, through 0.45 μ m microporous filter membrane fine straining;
8) again through clarity embedding after the assay was approved;
9) adopt non-PVC five-layer co-squeezing film packaging material sealing bag under 175 ℃～180 ℃ temperature conditions, and welding junction covers under 155 ℃～165 ℃ temperature conditions, the butyl rubber plug composite cover is welded in fill again;
10) 121 ℃ of moist heat sterilization 8min.
3, prescription is selected foundation
It is 0.5～1.5g that Czech's pharmacopeia is recommended consumption; The prerun result shows that the ornidazole aqueous solution is stable under solutions of weak acidity; For reducing the zest of ornidazole sodium chloride injection compositions, so the development specification is the injecta composition that 100mL contains ornidazole 0.5g to blood vessel.
The non-electrolytic solution that calculates 0.298mol/L according to Van't Hoff (Vant-Hoff) formula equates that with plasma osmotic pressure the osmotic pressure that ornidazole produces in the ornidazole sodium chloride injection compositions is:
P
ONz=(5.0/219.63)×1×1000=22.766mOsM
The osmotic pressure that adds isoosmotic adjusting agent sodium chloride (m gram) generation in the prescription is:
P
NaCl=(m/58.44)×2×1000mOsM
And P
ONZ+ P
NaCl=0.298 * 1000mmol/L
Be 22.766+ (m/58.44) * 2 * 1000=298, therefore, m=8.05 (g/L)
So should add sodium chloride 8.05 grams among every 1000mL, it is reached etc. ooze.
The selection foundation of embodiment 2 ornidazole sodium chloride injection preparation method of composition of the present invention
1, adding mode: the adding mode of the present invention ornidazole and sodium chloride when preparation ornidazole sodium chloride injection compositions is for to separate adding, and ornidazole will carry out acidification.This is that we are directed against ornidazole and are soluble in ethanol, chloroform and glacial acetic acid, and this characteristic of slightly soluble in water in order to increase its dissolubility, guarantees the product quality homogeneity.The adding mode of confirming through repetition test repeatedly, and use hcl acidifying.Concrete test data such as following table:
2, amount of sodium chloride
According to " normal osmotic pressure scope is 280～310mOsM for 2010 editions two ones of Chinese pharmacopoeia, osmotic pressure molar density average out to 298mOsM in the blood of human body.
Sodium chloride content in the ornidazole sodium chloride injection composition prescription of the present invention is 100mL:0.805g, and the osmotic pressure of its generation is: (8.05/58.44) * and 2 * 1000+ (5.0/219.63) * 1 * 1000=298mOsM.
If sodium chloride content is 100mL:0.85g; The osmotic pressure of its generation is: (8.5/58.44) * and 2 * 1000+ (5.0/219.63) * 1 * 1000=313mOsM; This osmotic pressure will be higher than the normal osmotic pressure scope of blood of human body, like this in infusion process, can make cell generation shrinkage; The ability that transmits oxygen reduces, and makes the body anoxia.The normal osmotic pressure scope of human body 280～310mOsM, the experimental result of selective chlorination sodium such as following table:
3, the temperature of water for injection:
The present invention is when preparation ornidazole sodium chloride injection compositions; Requiring the temperature of injecta composition is 70 ℃～85 ℃, and this is that temperature is low excessively because the temperature of water for injection directly affects the dissolubility of medicine; May dissolve not exclusively for insoluble drug; Influence the homogeneity of product, temperature is too high, can the quality of medicine be exerted an influence.Concrete data such as following table:
4, amount of activated: through repetition test, the applicant finds amount of activated 0.02% and 0.05% all available, but as injection, auxiliary material usefulness few more good more; The impurity that brings liquid is just few more, and the side effect of generation is just few more, therefore; The applicant has finally confirmed the consumption 0.02% of active carbon, with low concentration of activated carbon like this, under the bleaching temperature and time conditions of regulation; Promptly accomplish to make product conform to requirement, saved the energy and time again, thereby further reduced production cost.Concrete data such as following table:
5, the pH value of solution: the physicochemical property according to ornidazole is soluble in the acidic materials such as ethanol, chloroform and glacial acetic acid, because of having improved its final sterilization condition, in order to guarantee the stability of product quality; Pass through repetition test; We find that it is stable at acid condition, and acidity is stable more greatly more, but consider the tolerance range of blood of human body to acidity simultaneously; Confirm that the final products pH value is 3.1 ~ 3.4, is preferably 3.3.
Concrete data such as following table:
| PH value | 3.0 | 3.3 | 3.5 | 4.0 | 4.5 | 5.0 | 5.5 |
| Ornidazole content (%) | 99.1 | 99.3 | 99.3 | 99.2 | 99.4 | 99.5 | 99.2 |
| Related substance (%) | 0.25 | 0.36 | 0.37 | 0.45 | 0.55 | 0.73 | 0.73 |
6, packaging material
Traditional transfusion package basically all is a vial, and we adopt the non-PVC five-layer co-squeezing of novel packaging material film, improves the quality of product behind the employing new packaging material greatly, and concrete manifestation is following:
1) the preceding microbial limit of medicine sterilization has reached the requirement of the U.S. and the GMP of European Union.
Make it reach aseptic requirement though the transfusion kind will be passed through final sterilization process, the too high meeting of bacterial population makes product contain certain thermal source before the sterilization, thereby causes heat source response.Make the preceding microbial contamination level of sterilization reach the 10/100mL of standard of the U.S. and European Union after this project implementation, can reach aseptic level, can realize the parameter clearance system of the GMP of European Union appendix 17, thoroughly solved the heat source response problem of infusion products through detecting.Concrete data such as following table:
2) make the particulate matter index of transfusion kind reach the requirement of American Pharmacopeia, obtain very big optimization than this index of domestic transfusion kind.
The project implementation of the packed ornidazole sodium chloride injection compositions of PP TYPE; Production department is carried out under the condition of a sealing; The rank of air cleaning reaches above-mentioned dynamic standard; Thereby make product reduce to and be less than 1/ml, table specific as follows by being less than 10/ml greater than the particulate matter of 10 μ m:
This shows that this of this project standard has reached the requirement of American Pharmacopeia.Its clinical meaning is exactly can avoid particulate matter in the blood capillary of human body, to produce burr effect, artery-clogging to form thromboembolism and produce harm.
3) visible foreign matters reaches the " requirement of Chinese pharmacopoeia version in 2010
For " visible foreign matters " project in the high-capacity injection compositions kind safety indexes in that " requirement of Chinese pharmacopoeia version in 2010 is " to get 20 bottles of test samples, all must not detect visible foreign matters.As the test sample that detects visible foreign matters is no more than 1 bottle, should get 20 bottles in addition with the method inspection, all must not detect ", this is higher than the U.S. and European Union's standard.General glass bottle transfusion kind is owing to vitroclastic, fiber etc. are difficult to accomplish, but the packed ornidazole sodium chloride transfusion of PP TYPE can reach officinal this requirement.
7, sterilising temp and time
The present invention adopts the moist heat sterilization mode of 121 ℃ of moist heat sterilization 8min.According to the characteristic of ornidazole and the requirement of injection kind sterilising conditions, we confirm that through repetition test sterilising conditions is low excessively, can not guarantee the aseptic level of product, and temperature is too high, can produce tangible influence to the content and the related substance of ornidazole.Concrete data are following:
The different sterilising conditions of table 1 are to the influence of product
The Study on Compatibility of embodiment 3 ornidazoles and non-PVC five-layer co-squeezing film
1, accelerated test is investigated
The ornidazole sodium chloride injection compositions of embodiment 1 preparation is adopted non-PVC five-layer coextrusion transfusion bag packing; Put in the carton; Put in 40 ℃ ± 2 ℃, humidity 75% ± 5% climatic chamber, respectively at 1,2,3,6 month sampling and measuring, the high spot reviews index was character, visible foreign matters, pH, related substance, content and aseptic; The result shows and did not relatively have significant difference in 0 month, explains that ornidazole non-PVC five-layer co-squeezing film compatibility under abnormal test conditions is good.Table 2 specific as follows.
Table 2 ornidazole sodium chloride injection compositions accelerated test result
2, long term test is investigated
The ornidazole sodium chloride injection compositions of embodiment 1 preparation is adopted non-PVC five-layer coextrusion transfusion bag packing; Put in the carton, put 25 ℃ ± 2 ℃, in humidity 60 ± 10% climatic chambers; Respectively at 3,6,9,12,18,24 months sampling and measuring; The high spot reviews index is character, visible foreign matters, pH, related substance, content and aseptic, and the result shows and relatively do not have significant difference in 0 month, explains that the long-term placement of ornidazole is good with the compatibility of non-PVC five-layer co-squeezing film.Table 3 specific as follows.
Table 3 ornidazole sodium chloride injection compositions long-term test results
3, packaging material animal migration experimental study
We study the animal migration of non-PVC five-layer co-squeezing film simultaneously, investigate the influence of ornidazole to non-PVC five-layer co-squeezing film, confirm that further the compatibility of ornidazole and non-PVC five-layer co-squeezing film is good.Emphasis has carried out that the mensuration and the migration of antioxidant in the packaging material are measured, the mensuration of styrene monomer and migration mensuration, Determination of Metal Elements and migration are measured.Through repetition test, confirm that the ornidazole sodium chloride injection compositions and the compatibility of non-PVC five-layer co-squeezing film are good, the composition of film material has no effect to drug quality.Concrete experiment as follows
(1) mensuration of antioxidant
Non-PVC five-layer coextrusion transfusion is used bag " being cut into the wide fritter of about 0.5cm "; 2g decided in accurate title; Test method according to formulating is measured antioxidant 1010, antioxidant 330, antioxidant 1076; The result shows single content of antioxidant and total content all less than 0.3%, and the single antioxidant content that meets European Pharmacopoeia the 6th edition (ejection preparation and ophthalmic preparation packaging polypropylene) regulation must not cross 0.3%, and total amount must not be crossed 0.3% limit requirement.Specifically see table 4.
Table 4 five-layer coextrusion transfusion is with antioxidant content (weight %) in the bag
(2) mensuration of antioxidant migration amount
Get the ornidazole sodium chloride injection compositions 100mL of embodiment 1 preparation, pass through solid-phase extraction column with the flow velocity of about 1.5-2ml/min.Use 5mL methanol, 3mL dichloromethane eluting successively respectively, collect eluent, be diluted to 10mL with methanol, direct injected is measured.Measure the result in the ornidazole sodium chloride injection compositions, the migration amount of packaging material antioxidant 1010＜0.0096 μ g/ml, all the other 2 kinds of antioxidant are not migration all.
(3) mensuration of styrene monomer and migration are measured
It is an amount of with bag to get non-PVC five-layer coextrusion transfusion, is cut into fine particle, and accurate the title decided 2g, places the head space bottle, measures by the method for formulating, and the result shows that non-PVC five-layer coextrusion transfusion uses the styrene monomer content in the bag to be 9ng/g.
(4) migration of styrene monomer is measured
Measure fill at the ornidazole sodium chloride injection compositions 2mL of five-layer coextrusion transfusion with 1 preparation of the embodiment in the bag; Place the head space bottle; Place (80 ± 2) ℃ baking oven, balance 40min measures by the method for formulating; The result shows that styrene monomer is not migration in the ornidazole sodium chloride injection compositions.
(5) Determination of Metal Elements
Get five-layer coextrusion transfusion with bag, get film and cut into the fragment that the length of side is about 0.5cm in right amount, 5.0g decided in accurate title; Be heated to slowly blazingly, put coldly, blazingly make complete ashing at 550 ℃ to fully carbonization; Move in the exsiccator, put cold, add hydrochloric acid (1 → 2) (extension rate) 25ml dissolving after; Measure magnesium: flame, 285.2nm according to atomic absorption spectrophotometry (two appendix ivD of Pharmacopoeia of People's Republic of China version in 2010); Aluminum: graphite furnace, 309.3nm; Calcium: flame, 422.7nm; Silicon; Graphite furnace, the 251.6nm wavelength is measured.The result sees table 5.
Metallic element in the table 5 film bag (unit: μ g/g)
| Numbering | Aluminum | Magnesium | Calcium | Silicon |
| 001 | 1 | 11 | 2 | 17 |
(6) migration of metal ion is measured
Get fill and use the troxerutin glucose injection composition in the bag, measure magnesium: flame, 285.2nm according to atomic absorption spectrophotometry (two appendix ivD of Pharmacopoeia of People's Republic of China version in 2010) at five-layer coextrusion transfusion; Aluminum: graphite furnace, 309.3nm; Calcium: flame, 422.7nm; Silicon; Graphite furnace, the 251.6nm wavelength is measured.The result shows that aluminum, magnesium, calcium, the silicon migration amount in the ornidazole sodium chloride injection compositions is not all less than 0.3 μ g/ml.Specifically see table 6.
Table 6: the migration amount (unit: g/ml) of metal ion in the ornidazole sodium chloride injection compositions
| Numbering | Aluminum | Magnesium | Calcium | Silicon |
| 001 | 0.006 | 0.03 | 0.3 | 0.1 |
| 002 | 0.006 | 0.03 | 0.2 | 0.1 |
| 003 | 0.006 | 0.03 | 0.3 | 0.1 |
Claims (5)
1. ornidazole sodium chloride injection compositions, this injecta composition comprise ornidazole, 8.05 weight portions of 5 weight portions sodium chloride, 1000 weight portions water for injection and to make the pH value of said injecta composition be 3.1 ~ 3.4 hydrochloric acid.
2. injecta composition according to claim 1; It is characterized in that this injecta composition is by the water for injection of the sodium chloride of the ornidazole of 5 weight portions, 8.05 weight portions, 1000 weight portions and to make the pH value of said injecta composition be that 3.1 ~ 3.4 hydrochloric acid is formed.
3. injecta composition according to claim 1 and 2 is characterized in that, the pH value of said injecta composition is 3.3.
4. according to each described injecta composition in the claim 1 to 3, it is characterized in that the method for preparing of said injecta composition comprises the steps:
(1) takes by weighing the sodium chloride of recipe quantity, be dissolved in 70 ℃～85 ℃ the water for injection insulation, stirring and dissolving;
(2) take by weighing the ornidazole of recipe quantity, add in 70 ℃～85 ℃ waters for injection, dissolving;
(3) ornidazole after step (2) dissolving is added in the sodium chloride solution of step (1), adding simultaneously can supply the hydrochloric acid 10mL of venoclysis, stirs;
(4) add 0.02% needle-use activated carbon, under 25 ℃～50 ℃, stir decolouring 20～30min, leave standstill 15min with internal recycle;
(5) take off charcoal through 5 μ m titanium rods, after the filtration, add 70 ℃～85 ℃ waters for injection, add the hydrochloric acid that can supply venoclysis simultaneously and regulate pH value to 3.1 ~ 3.4 to full dose;
(6) with medicinal liquid warp 0.45 μ m microporous filter membrane fine straining, must filtrate lamp inspection;
(7) adopt non-PVC five-layer co-squeezing film packaging material sealing bag under 175 ℃～180 ℃ temperature conditions, and welding junction covers under 155 ℃～165 ℃ temperature conditions, the butyl rubber plug composite cover is welded in fill again;
(8) with the sample that makes at 121 ℃ of following moist heat sterilization 8min.
5. the method for preparing of each described injecta composition in the claim 1 ~ 4 is characterized in that this method for preparing comprises the steps:
(1) takes by weighing the sodium chloride of recipe quantity, be dissolved in 70 ℃～85 ℃ the water for injection insulation, stirring and dissolving;
(2) take by weighing the ornidazole of recipe quantity, add in 70 ℃～85 ℃ waters for injection, dissolving;
(3) ornidazole after step (2) dissolving is added in the sodium chloride solution of step (1), adding simultaneously can supply the hydrochloric acid 10mL of venoclysis, stirs;
(4) add 0.02% needle-use activated carbon, under 25 ℃～50 ℃, stir decolouring 20～30min, leave standstill 15min with internal recycle;
(5) take off charcoal through 5 μ m titanium rods, after the filtration, add 70 ℃～85 ℃ waters for injection, add the hydrochloric acid that can supply venoclysis simultaneously and regulate pH value to 3.1 ~ 3.4 to full dose;
(6) with medicinal liquid warp 0.45 μ m microporous filter membrane fine straining, must filtrate lamp inspection;
(7) adopt non-PVC five-layer co-squeezing film packaging material sealing bag under 175 ℃～180 ℃ temperature conditions, and welding junction covers under 155 ℃～165 ℃ temperature conditions, the butyl rubber plug composite cover is welded in fill again;
(8) with the sample that makes at 121 ℃ of following moist heat sterilization 8min.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104069061A (en) * | 2013-03-26 | 2014-10-01 | 江苏奥赛康药业股份有限公司 | Plerixafor-containing composition for injection, and preparation method and application thereof |
| CN110664739A (en) * | 2019-10-08 | 2020-01-10 | 四川太平洋药业有限责任公司 | Ornidazole sodium chloride injection and preparation process thereof |
| CN112220747A (en) * | 2020-10-21 | 2021-01-15 | 山西普德药业有限公司 | Ornidazole injection convenient to store and preparation method thereof |
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| CN112220747A (en) * | 2020-10-21 | 2021-01-15 | 山西普德药业有限公司 | Ornidazole injection convenient to store and preparation method thereof |
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