CN102813622B - 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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- CN102813622B CN102813622B CN 201210331090 CN201210331090A CN102813622B CN 102813622 B CN102813622 B CN 102813622B CN 201210331090 CN201210331090 CN 201210331090 CN 201210331090 A CN201210331090 A CN 201210331090A CN 102813622 B CN102813622 B CN 102813622B
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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 obvious 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, take the rural area as main.Be more common in south in China, but also be common in the north in summer.Due to 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 for the treatment of 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 again tinidazole and ornidazole.
Ornidazole is a kind of good effect, and the antibacterial that toxic and side effects is low is better than metronidazole on curative effect, slightly is better than tinidazole or suitable with tinidazole.The clinical ornidazole that uses is treated anaerobic infection and protozoacide more.But should the disease cause of disease more complicated, only use ornidazole to be difficult to reach the purpose of comprehensive treatment.
The inventor finds to add the sodium chloride of specified quantitative through clinical experiment and application in ornidazole, have advantages of very fast releasing patient suffering, and market prospect is widely arranged, and can obtain economic benefit and social benefit preferably.
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 be achieved through the following technical solutions.
On the one hand, the 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 described 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 described injecta composition be that 3.1 ~ 3.4 hydrochloric acid forms.Be to contain 5g ornidazole, 8.05g sodium chloride and appropriate hydrochloric acid in 1000mL water for injection, it is 3.1 ~ 3.4 to get final product that hydrochloric acid content makes the pH value of injecta composition.
Preferably, the pH value of described injecta composition is 3.3.
Preferably, the preparation method of described injecta composition comprises the steps:
(1) take the sodium chloride of recipe quantity, be dissolved in the water for injection of 70 ℃～85 ℃ insulation, stirring and dissolving;
(2) take 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), add simultaneously and can for the hydrochloric acid 10mL of venoclysis, stir;
(4) add 0.02% needle-use activated carbon, stir decolouring 20～30min, standing 15min with internal recycle under 25 ℃～50 ℃;
(5) take off charcoal through 5 μ m titanium rods, after filtration, add 70 ℃～85 ℃ waters for injection to full dose, add simultaneously and can regulate pH value to 3.1 ~ 3.4 for the hydrochloric acid of venoclysis;
(6) with medicinal liquid through 0.45 μ m microporous filter membrane fine straining, get 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, fill, then weld the butyl rubber plug composite cover;
(8) with the sample that makes at 121 ℃ of lower moist heat sterilization 8min.
On the other hand, the invention provides a kind of preparation method of above-mentioned injecta composition, this preparation method comprises the steps:
(1) take the sodium chloride of recipe quantity, be dissolved in the water for injection of 70 ℃～85 ℃ insulation, stirring and dissolving;
(2) take 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), add simultaneously and can for the hydrochloric acid 10mL of venoclysis, stir;
(4) add 0.02% needle-use activated carbon, stir decolouring 20～30min, standing 15min with internal recycle under 25 ℃～50 ℃;
(5) take off charcoal through 5 μ m titanium rods, after filtration, add 70 ℃～85 ℃ waters for injection to full dose, add simultaneously and can regulate pH value to 3.1 ~ 3.4 for the hydrochloric acid of venoclysis;
(6) with medicinal liquid through 0.45 μ m microporous filter membrane fine straining, get 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, fill, then weld the butyl rubber plug composite cover;
(8) with the sample that makes at 121 ℃ of lower moist heat sterilization 8min.
Compared with prior art, the present invention has following beneficial effect at least:
1, according to " 2010 editions two ones of Chinese pharmacopoeia, osmotic pressure molar density average out to 298mOsM in blood of human body, normal osmotic pressure scope is 280～310mOsM, the present invention is according to the regulation of pharmacopeia osmotic pressure, consumption to sodium chloride is regulated, within osmotic pressure is adjusted in normal osmotic pressure scope the most at last, and make the osmotic pressure of injecta composition of acquisition consistent with osmotic pressure molar density meansigma methods in blood of human body, this makes ornidazole sodium chloride injection compositions optimum human internal environment of the present invention, neither can make erythrocyte fragmentation, can not make the erythrocyte fold yet, can not affect 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 the homogeneity of product quality.
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 greatly improved the quality of product.
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
Describe the present invention in detail below by embodiment, should be appreciated that following embodiment only is used for explanation 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, preparation method and prescription
This prescription is the optimum human internal environment, neither can make erythrocyte fragmentation, also can not make the erythrocyte fold, can not affect the function that erythrocyte carries oxygen, and function of human body is normally moved.
2, preparation method
1) take the sodium chloride of recipe quantity, be dissolved in 70 ℃～85 ℃ waters for injection of part, and insulation, stirring and dissolving;
2) take recipe quantity ornidazole, add appropriate 70 ℃～85 ℃ waters for injection dissolving;
3) with step 2) ornidazole after dissolving adds in the solution of step 1), adds simultaneously and can for the hydrochloric acid 10ml of venoclysis, stir;
4) add 0.02% needle-use activated carbon, stir decolouring 20～30min, standing 15min in 25 ℃～50 ℃ with internal recycle;
5) add 70 ℃～85 ℃ waters for injection to full dose through 5 μ m titanium rod decarbonization filterings;
6) add simultaneously and can transfer pH to 3.1-3.4 for the hydrochloric acid of venoclysis;
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, fill, then weld the butyl rubber plug composite cover;
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, pre-test result shows that the ornidazole aqueous solution is stable under solutions of weak acidity, for reducing the ornidazole sodium chloride injection compositions to the zest of blood vessel, therefore the development specification is the injecta composition that 100mL contains ornidazole 0.5g.
The non-electrolytic solution that calculates 0.298mol/L according to Van't Hoff (Vant-Hoff) formula equates with plasma osmotic pressure, and 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 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)
Therefore should add sodium chloride 8.05 grams in every 1000mL, it be reached etc. ooze.
The selection foundation of embodiment 2 ornidazole sodium chloride injection preparation method of composition of the present invention
1, add mode: the present invention's mode that adds of ornidazole and sodium chloride when preparation ornidazole sodium chloride injection compositions adds for separating, and ornidazole will carry out acidification.This is that we are soluble in ethanol, chloroform and glacial acetic acid for ornidazole, and this characteristic of slightly soluble in water in order to increase its dissolubility, guarantees the product quality homogeneity.Add mode through what repetition test was repeatedly determined, and use hcl acidifying.Concrete test data such as following table:
2, the consumption 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 blood of human body.
Sodium chloride content in 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) * 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) * 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.Human normal osmotic pressure scope 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 ℃, this is because the temperature of water for injection directly affects the dissolubility of medicine, temperature is too low, may dissolve not exclusively for insoluble drug, affect the homogeneity of product, excess Temperature can be on the mass formation impact of medicine.Concrete data such as following table:
4, activated carbon dosage: by repetition test, the applicant finds activated carbon dosage 0.02% and 0.05% all available, but as injection, what auxiliary material was used is more few better, the impurity that brings liquid is just fewer, and the side effect of generation is just fewer, therefore, the applicant has finally determined the consumption 0.02% of active carbon, with low concentration of activated carbon like this, under the bleaching temperature and time conditions of regulation, namely accomplish to make product conform to requirement, save again the energy and time, thereby further reduced production cost.Concrete data such as following table:
5, the pH value of solution: be soluble in the acidic materials such as ethanol, chloroform and glacial acetic acid according to the physicochemical property of ornidazole, because 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 more large more stable, but consider that simultaneously blood of human body is to the tolerance range of acidity, determine 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 is substantially all vial, and we adopt the non-PVC five-layer co-squeezing of novel packaging material film, greatly improves the quality of product after the employing new packaging material, and concrete manifestation is as follows:
1) the front microbial limit of medicine sterilization has reached the requirement of the U.S. and the GMP of European Union.
Although the transfusion kind will make it reach aseptic requirement through final sterilization process, before sterilization, the too high meeting of bacterial population makes product contain certain thermal source, thereby causes heat source response.Make the front 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 by detecting, can realize the parametric release system of the GMP of European Union appendix 17, thoroughly solved the heat source response problem of infusion products.Concrete data such as following table:
2) make the particulate matter index of transfusion kind reach the requirement of American Pharmacopeia, obtain very large 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 be down 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, this standard of this project has reached the requirement of American Pharmacopeia.Its clinical meaning is exactly can avoid particulate matter to produce burr effect, artery-clogging in the blood capillary of human body 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 high-capacity injection compositions kind safety indexes " 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 separately get 20 bottles 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 because vitroclastic, fiber etc. is difficult to accomplish, but the packed ornidazole sodium chloride transfusion of PP TYPE can reach this requirement of pharmacopeia.
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 by repetition test, and sterilising conditions is too low, can not guarantee the aseptic level of product, and excess Temperature can produce obvious impact to content and the related substance of ornidazole.Concrete data are as follows:
The impact of the different sterilising conditions of table 1 on 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 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 is character, visible foreign matters, pH, related substance, content and aseptic, the result demonstration relatively without significant difference, illustrated that ornidazole non-PVC five-layer co-squeezing film compatibility under abnormal test conditions was good with 0 month.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 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 demonstration relatively without significant difference, illustrated that the long-term placement of ornidazole and the compatibility of non-PVC five-layer co-squeezing film were good with 0 month.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 ornidazole to the impact of 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 mensuration and the migration of antioxidant in the packaging material are measured, mensuration and the migration of styrene monomer are measured, mensuration and the migration of metallic element are measured.By repetition test, confirm that 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 is as follows
(1) mensuration of antioxidant
With non-PVC five-layer coextrusion transfusion with the bag " being cut into the approximately wide fritter of 0.5cm ", accurately weighed 2g, according to the test method of formulating, antioxidant 1010, antioxidant 330, antioxidant 1076 are measured, result shows that the single content of antioxidant and total content are all less than 0.3%, 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 antioxidant content (% by weight) in 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 about flow velocity of 1.5-2ml/min.Use respectively 5mL methanol, 3mL dichloromethane eluting successively, collect eluent, be diluted to 10mL with methanol, direct injected is measured.Measurement result is in the ornidazole sodium chloride injection compositions, and the migration amount of packaging material antioxidant 1010＜0.0096 μ g/ml, all the other 2 kinds of antioxidant be not migration all.
(3) mensuration of styrene monomer and migration are measured
Get non-PVC five-layer coextrusion transfusion appropriate with bag, be cut into fine particle, accurately weighed 2g is placed in the head space bottle, measures by the method for formulating, and result shows that non-PVC five-layer coextrusion transfusion is 9ng/g with the styrene monomer content in bag.
(4) migration of styrene monomer is measured
Measure fill at the ornidazole sodium chloride injection compositions 2mL of five-layer coextrusion transfusion with embodiment 1 preparation in bag, be placed in the head space bottle, be placed in (80 ± 2) ℃ baking oven, balance 40min, measure by the method for formulating, result demonstration, styrene monomer be migration in the ornidazole sodium chloride injection compositions.
(5) mensuration of metallic element
Get the five-layer coextrusion transfusion bag, get film and cut in right amount the fragment that the length of side is about 0.5cm, accurately weighed 5.0g is heated to slowly blazing to carbonization fully, let cool, blazingly make complete ashing at 550 ℃, move in exsiccator, let cool, after adding hydrochloric acid (1 → 2) (extension rate) 25ml dissolving, 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, 251.6nm wavelength place measures.The results are shown in Table 5.
Metallic element in 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 the Troxerutin and glucose injection compositions of fill in five-layer coextrusion transfusion use 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); Aluminum: graphite furnace, 309.3nm; Calcium: flame, 422.7nm; Silicon; Graphite furnace, 251.6nm wavelength place measures.Result shows that aluminum, magnesium, calcium, the migration amount of silicon in the ornidazole sodium chloride injection compositions be 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 |
[0121]
| 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 (3)
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 described injecta composition be 3.1～3.4 hydrochloric acid, the preparation method of described injecta composition comprises the steps:
(1) take the sodium chloride of recipe quantity, be dissolved in the water for injection of 70 ℃～85 ℃ insulation, stirring and dissolving;
(2) take 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), add simultaneously and can for the hydrochloric acid 10mL of venoclysis, stir;
(4) add 0.02% needle-use activated carbon, stir decolouring 20～30min, standing 15min with internal recycle under 25 ℃～50 ℃;
(5) take off charcoal through 5 μ m titanium rods, after filtration, add 70 ℃～85 ℃ waters for injection to full dose, add simultaneously and can regulate pH value to 3.1～3.4 for the hydrochloric acid of venoclysis;
(6) with medicinal liquid through 0.45 μ m microporous filter membrane fine straining, get 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, fill, then weld the butyl rubber plug composite cover;
(8) with the sample that makes at 121 ℃ of lower moist heat sterilization 8min.
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 described injecta composition be that 3.1～3.4 hydrochloric acid forms.
3. injecta composition according to claim 1 and 2, is characterized in that, the pH value of described injecta composition is 3.3.
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| CN1314396C (en) * | 2005-04-28 | 2007-05-09 | 南京圣和药业有限公司 | Application of levoornidazole in preparation of anti anaerobic bacteria infection medicine |
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