Ornidazole

sodium chloride injection composition and preparation method thereof

CN 102813622 A
SANTRAUKA
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.

IEKINIAI(5) iversta i Kin

A ornidazole sodium chloride injection compositions, the injection composition comprises 5 parts by weight of ornidazole, 8.05 parts by weight of sodium chloride, 10 parts by weight of water for injection and make the injection The
pH value of the liquid composition 3. 3. 4 hydrochloric acid.
The injection composition according to claim I, characterized in that the injection composition consists of 5 parts by weight of ornidazole, 8.05 parts by weight of sodium chloride, 10 parts by weight of water for injection and make
The injection compositions a pH of 3. 3. 4 hydrochloride composition.
According to claim I or 2, wherein the injection fluid composition, characterized in that said injection composition pH of 3.3.
Injection I according to the composition according to any one of claims 3, characterized in that the injection preparation composition comprising the steps of: (1) Weigh prescribed amount of sodium chloride dissolved at 70 C~85
C water for injection, heat, stirring to dissolve; (2) Weigh prescription Ornidazole, adding 70 C~85 C water for injection, dissolved; (3) the step ( 2) dissolved Ornidazole added step (I) sodium chloride solution for intravenous
infusion, while adding hydrochloric acid 10mL, stir; (4) was added to the needle O. 02% activated carbon, 25 C Case Within ~50 C under stirring bleaching cycle 20~30min, standing 15min; (5) by 5 m titanium rod off the
charcoal, filtered, supplemented with 70 C~85 C water for injection to the total amount, while adding available adjusted intravenous infusion of hydrochloric acid PH value to 3. 3 4;. (6) the liquid by O. 45 m microporous
membrane fine filter to give filtrate, light inspection; (7) The five co-extruded non-PVC film packaging material at 175 C~180 C temperature conditions-sealed bag, and at 155 C~165 C temperature conditions soldering
connector cover, filling, and then welding Dingjijiaosai portfolio covered; (8) The prepared samples 121 C under moist heat sterilization 8min.
Wide injection preparation composition according to any one of claims 4 5. A claims, characterized in that the preparation process comprises the following steps: (1) Weigh prescribed amount of sodium chloride, was dissolved in
70 water for injection C~85 C, the heat, stirring to dissolve; (2) Weigh prescription Ornidazole, adding 70 C~85 C water for injection, dissolved; (3) the step (2) was dissolved Ornidazole added after step (I) sodium chloride
solution while adding hydrochloric acid 10mL for intravenous infusion, stir; (4) was added to the needle O. 02% activated carbon, at 25 C~50 C within the next loop mixing bleaching 20~30min, standing 15min; (5) by 5 m
titanium rod off the charcoal, filtered, supplemented with 70 C~85 C water for injection to the total amount, while adding for intravenous infusion The hydrochloric acid to adjust the PH value to 3. 3 4;. (6) the liquid by O. 45 m
microporous membrane fine filter to give filtrate, light inspection; (7) non-PVC five co-extruded film packaging material at 175 C~180 C temperature conditions-sealed bag, and connector cover welding at 155 C~165 C
temperature conditions, filling, and then welding Dingjijiaosai portfolio covered; (8) the prepared The sample was 121 C under moist heat sterilization 8min.

APRAAS iversta i Kin

One kind of ornidazole sodium chloride injection composition and its preparation method
Technical Field

[0001] The present invention relates to the field of medical technology, in particular to injection composition and preparation method Ornidazole sodium chloride.
Background
[0002] anaerobic infections, protozoan is a clinical disease, common diseases.According to epidemiological survey around the world, around the world infected with the disease accounts for about one-tenth of the population, of
which 8-10% of those infected have obvious clinical symptoms, 4-11 million people die each year amebiasis. The disease mainly in Asia, Africa and Latin America; although the incidence of both rural and urban areas, but ruralbased. In China found in the south, but in the summer is also common in the north. Due to the continuous improvement of the health situation in recent years, the prevalence of this disease and acute cases have been significantly
reduced. Especially higher incidence of women. Since metronidazole developed for the treatment of such diseases since humans have been trying to find better efficacy, fewer side effects of drugs, and therefore, it has developed
tinidazole and ornidazole.
[0003] Ornidazole is a good efficacy, low toxicity of antimicrobial agents on effective than metronidazole or tinidazole tinidazole slightly better than pretty.Clinical use more Ornidazole to treat anaerobic infections and protozoal. But
more complex causes of the disease, only Ornidazole difficult to achieve the purpose of comprehensive treatment.
[0004] The present inventors have conducted clinical trials and applications found in Ornidazole in a specific amount of sodium chloride, has the advantage of a faster relieve the suffering of patients, there is a broad market
prospects, can achieve better economic and social benefits.
DISCLOSURE
[0005] The object of the present invention is to provide an effective, shorter treatment cycles, controlled quality and safe non-toxic side effects of ornidazole sodium chloride injection composition and preparation methods. Injection
compositions and related substances in the present invention are able to meet the quality requirements of injection. The preparation process is simple, low cost.
[0006] The object of the present invention are achieved by the following technical solutions to achieve.
[0007] - aspect, the present invention provides a ornidazole sodium chloride injection compositions, the injection composition comprises 5 parts by weight of ornidazole, 8 05 parts by weight of sodium chloride, 10 parts by weight.
water for injection so that the injection and pH of the composition is 3. f of hydrochloric acid 3.4.
[0008] Preferably, the injection composition consists of 5 parts by weight of ornidazole, 8.05 parts by weight of sodium chloride, 10 parts by weight of water for injection and make the injection composition PH value is 3.
Composition r3. 4 hydrochloric acid. That IOOOmL water for injection containing 5g Ornidazole, 8. 05g of sodium chloride, and an appropriate amount of hydrochloric acid, the amount of hydrochloric acid so that the pH of the
composition is injection 3. r3. 4 can be.
[0009] Preferably, the injection composition pH of 3.3.
[0010] Preferably, the preparation of injection compositions comprising the steps of:
[0011] (I) weighed prescribed amount of sodium chloride, dissolved in 70 C~85 C water for injection, incubated and stirred to dissolve;

[0012] (2) Weigh prescription Ornidazole, adding 70 C~85 C water for injection to dissolve;
[0013] (3) the step (2) Ornidazole added after dissolving step (I) sodium chloride solution while adding hydrochloric acid 10mL for intravenous infusion, stir; [0014] (4) is added 0.02% needle with activated charcoal, to less than 25
C~50 C under stirring bleaching cycle 20~30min, standing 15min;
[0015] (5) by 5 iim titanium rod off the charcoal, filtered, supplemented with 70 C~85 C water for injection to the total amount, while adding for intravenous infusion of hydrochloric acid to adjust the PH value to 3. r3 4.;
[0016] (6) the liquid by 0. 45 ii m fine microporous membrane filter to give filtrate, light inspection;
[0017] (7) The use of non-PVC five co-extruded film packaging material at 175 C~180 C temperature conditions-sealed bag, and connector cover welding at 155 C~165 C temperature conditions, filling , then welded
Dingjijiaosai portfolio covered;
[0018] (8) The prepared samples 121 C under moist heat sterilization 8min.
[0019] another aspect, the present invention provides a method for preparing the above-described injection compositions, the process comprising the steps of:
[0020] (I) weighed prescribed amount of sodium chloride, dissolved in 70 C~85 C water for injection, incubated and stirred to dissolve;
[0021] (2) Weigh prescription Ornidazole, adding 70 C~85 C water for injection to dissolve;
[0022] (3) the step (2) was dissolved Ornidazole added after step (I) sodium chloride solution, while adding hydrochloric acid 10mL for intravenous infusion, stir;
[0023] (4) added 0.02% needle with activated charcoal, to less than 25 C~50 C under stirring bleaching cycle 20~30min, standing 15min;
[0024] (5) by 5 iim titanium rod off the charcoal, filtered, supplemented with 70 C~85 C water for injection to the total amount, while adding for intravenous infusion of hydrochloric acid to adjust the PH value to 3. r3 4.;
[0025] (6) the liquid by 0. 45 ii m fine microporous membrane filter to give filtrate, light inspection;
[0026] (7) The use of non-PVC five co-extruded film packaging material at 175 C~180 C temperature conditions-sealed bag, and connector cover welding at 155 C~165 C temperature conditions, filling , then welded
Dingjijiaosai portfolio covered;
[0027] (8) The prepared samples 121 C under moist heat sterilization 8min.
[0028] Compared with the prior art, the present invention has at least the following advantageous effects:
[0029] I, according to the second unit, "Chinese Pharmacopoeia" 2010 version, human blood osmolarity average 298m0sM, normal osmotic pressure in the range of 280~310m0sM, the present invention is based on the provisions
of pharmacopoeia osmotic pressure, the amount of sodium chloride adjusted final osmotic pressure regulating osmotic pressure within the normal range, and the osmolarity of the osmotic pressure of the obtained mean injection

compositions are consistent with human blood, which makes Ornidazole chloride of the present invention Sodium Injection optimal body composition environment will neither rupture of red blood cells, red blood cells do not make
wrinkles, it does not affect the function of red blood cells to carry oxygen, the body function normally.
[0030] 2, the present invention will ornidazole and sodium chloride added separately, and Ornidazole acidification, increase the solubility of ornidazole, ensuring product quality uniformity.
[0031] 3, the present invention is to control the temperature of water for injection at 7 (T85 C, low impurity injection compositions, the active ingredient content of the news.
[0032] 4, injection pH of the composition of the present invention to control the 3. 1-3. 4, preferably 3.3 to ensure the stability of product quality.
[0033] 5, the present invention employs a new type of packaging material non-PVC five co-extruded film, greatly improving the quality of the product.
[0034] 6, the present invention uses 121 C heat sterilization Smin of heat sterilization, so that the final product meets the requirements.
DETAILED DESCRIPTION [0035] The following detailed description of embodiments of the present invention through, it should be understood that the present invention is for illustration only the following examples, without in any
way limit the scope of the present invention.
[0036] Example I selected on the basis of ornidazole sodium chloride injection composition, preparation and formulation of the present invention.
[0037]
I BU
I,
Ornidazole appropriate amount of hydrochloric acid 5.0g sodium chloride 8.05g
[0038]
Water for injection to IOOOml
[0039] The prescription is the most appropriate body environment, will neither rupture of red blood cells, red blood cells do not make wrinkles, does not affect the function of red blood cells to carry oxygen, the body function
normally.
[0040] 2. Preparation method
[0041] I) weighed prescribed amount of sodium chloride, dissolved in part of 70 C~85 C in water for injection, and incubated the mixture was stirred to dissolve;

[0042] 2) weighed amount of prescription Ornidazole, add some 70 C~85 C is dissolved in water for injection;
[0043] 3) Step 2) dissolved Ornidazole added step I) solution, while adding 10ml intravenous infusion for hydrochloric acid, stir;
[0044] 4) added 0.02 percent needles with charcoal, circulation was stirred at 25 C~50 C or less bleaching 20~30min, standing 15min;
[0045] 5) by 5 ii m titanium rod off the charcoal filter additional 70 C~85 C water for injection to the full amount;
[0046] 6) for simultaneous intravenous infusion of hydrochloric acid was added to adjust pH to 3. 4 1-3.;
Determination of pH value and the content of the [0047] 7) sampling, to meet the requirements, the microporous membrane 0.45 fine filter;.
[0048] 8) and then the clarity inspection after potting;
[0049] 9) The non-PVC five co-extruded film packaging material at 175 C~180 C temperature conditions-sealed bag, and at 155 C~165 C temperatures connector cover welding, filling, then welded Dingjijiaose portfolio
covered;
[0050] 10) 121 C heat sterilization 8min.
[0051] 3, according to prescription options
[0052] The Czech Pharmaceutical recommended dosage is 0. 5~I. 5g, pre-test results in Table Mingao metronidazole aqueous stable under weakly acidic conditions, in order to reduce ornidazole sodium chloride injection
composition of vascular irritation, so Development of specifications for IOOmL ornidazole injection containing composition of 0. 5g.
[0053] calculated according to van't Hoff (Vant-Hoff) formula of 0. 298mol / non-electrolyte solution and plasma osmolality is equal to L and the osmotic pressure in ornidazole sodium chloride injection compositions produced
Ornidazole as follows:
[0054] Ponz = (5. 0/219. 63) XIX 1000 = 22. 766m0sM
[0055] The formulation isotonic modifier added sodium chloride (m g) osmotic pressure generated as follows:
[0056] PNaC1 = (m / 58. 44) X 2 X IOOOmOsM
[0057] and PONZ + PNaC1 = 0. 298 X 1000mmol / L
[0058] That 22. 766+ (m / 58. 44) X 2X 1000 = 298, and therefore, m = 8. 05 (g / L)

[0059] Therefore, in each IOOOmL 8.05 grams of sodium chloride should be added to make up to isotonic. Ornidazole [0060] Example 2 of the present invention a method for preparing sodium chloride injection compositions are
chosen on the basis of
[0061] I, joined by: adding method of the present invention ornidazole and sodium chloride is added separately during the preparation of ornidazole sodium chloride injection composition and Ornidazole to acidification. This is our
Ornidazole against soluble in ethanol, chloroform and acetic acid, slightly soluble in water this feature, in order to increase their solubility, to ensure product quality uniformity. After much trial and error to determine the mode of
addition, and acidified with hydrochloric acid. The specific test data as follows:
[0062]

[0063] 2, the amount of sodium chloride

[0064] According to the second section, "Chinese Pharmacopoeia" 2010 version, human blood osmolarity average 298m0sM, normal osmotic pressure in the range of 280~310m0sM.
[0065] ornidazole sodium chloride injection composition of the formulation of the present invention, the sodium chloride content of IOOmL:. 0 805g, osmotic pressure which produces as: (.. 8 05/58 44) X 2 X 1000 + (5. 0/219. 63)
XIX 1000 = 298m0sM.
[0066] If the chloride content is IOOmL:. 0 85g, osmotic pressure which is generated by: (.. 8 5/58 44) X 2X 1000+ (.. 5 0/219 63) XIX 1000 = 313m0sM, the osmotic pressure will be higher than normal human blood osmolality
range, so that the infusion process, allows cells to shrink, reducing the ability to transfer oxygen to the body hypoxia. The body's normal osmotic pressure range 280~310m0sM, select sodium chloride results in the following table:

Google pagrindinis puslapis - Svetains schema - USPTO masiniai atsisiuntimai - Privatumo politika - Paslaug teikimo slygos - Apie Google patentus - Sisti atsiliepim

Ornidazole and sodium chloride injection packaged by non-polyvinyl chloride (PVC) soft bag and
preparation method thereof
CN 102743332 A
TIIVISTELM
The invention provides an ornidazole and sodium chloride injection packaged by a non-polyvinyl chloride (PVC) soft bag and a preparation method thereof. The preparation
method comprises the following steps of raw material weighing, concentration preparation, dilution preparation, loading and sterilization. The sterilization comprises the
following steps of adjusting an initial temperature in a sterilization device to 50 to 70 DEG C, heating to a temperature of 120 to 122 DEG C, carrying out sterilization for 8 to
15 minutes, carrying out spraying by chilled water having a temperature of 0 to 30 DEG C for cooling for 5 to 15 minutes and keeping a temperature of a sterilized product in
a range of 30 to 50 DEG C. The preparation method shortens high-temperature contact time of an ornidazole aqueous solution thereby reducing ornidazole degradation,
wherein total sterilization time is reduced to 35 to 45 minutes so that the content of related substances obtained by ornidazole degradation is reduced to 0.64%, and thus
product quality is greatly improved. The preparation method adopts a simple feeding mode, allows a low preparation temperature, realizes a small concentrated volume, has
low requirements on production equipment and conditions, realizes short preparation time and can be operated by production people easily.

VAATIMUKSET(6) knnetty kielest kiina

1. A non-PVC soft bag preparation ornidazole sodium chloride injection, characterized in that it comprises the following steps: (1) material, said: said ornidazole sodium
chloride injection water for injection solvent, each injection containing IL Ornidazole 4. 65 ~5 35g and sodium chloride 7. 88 ~8 72g; (2) the concentration distribution: with
tank added to the concentrated 30 C~40 C, 5 (T70% prescription volume of water for injection, sodium chloride is added weighed stir until dissolved, adding weighing
Ornidazole mixture was stirred until dissolved, add charcoal, activated carbon added to the proportion of quality and volume of prescriptions was 0.01% ~ 0 05%, heat,
stirring, adsorption 10~30 minutes, filtered carbon cycle except 20 to 30 minutes, checking the mixture clarified, and the mixture is transferred from tank to dilute concentrated
equipped with tanks;. ( 3) dilute with: Add dilute tank 30~40 C with water for injection prescription, stirring 20 to 30 minutes, adjusting the pH to 3. 8~4 0 to give the drug
solution, stirring was continued for 20 minutes, turn on. liquid pump, so that liquid were treated with 5 um, 0 45 um filter and return pipe loop 20 to 30 minutes; (4) Filling:
filling after passing inspection; (5) Sterilization: inside the sterilization device The initial temperature was adjusted to 50~70 C, the injection into the sterilizer, the sterilizing

apparatus is adjusted to a temperature of 120~122 C, the timing sterilization 8~15 minutes, after use of 0~30 C so sterile water spray to cool the apparatus 5 ~ 15 minutes
after injection taken control of sterilization temperature 30~50 C.
2. A method for preparing a non-PVC I said soft bag of sodium chloride injection Ornidazole claim, wherein: said step (3) with 2-5mol / l dilute hydrochloric acid to adjust the
pH value.
3. A method for preparing a non-PVC I said soft bag of sodium chloride injection Ornidazole claim, wherein: said step (5) by letting the sterilizer load operation or in advance
The method leads to 90-110 C hot steam, adjusting the initial temperature of the sterilizing apparatus.
4. The preparation method I described in a non-PVC soft bag of sodium chloride injection Ornidazole claim, wherein: said step (5) by 5 ~ 15 minutes of heating time for the off
Bacteria apparatus temperature was raised to 120~122 C.
5. A method for preparing a non-PVC soft bags of 2, 3 or 4, wherein the sodium chloride injection Ornidazole claim, characterized in that: the preparation method further
comprising the step after sterilization in 2000 light inspection step ~30001X under lights.
According to any one of claims 1 to 4 was prepared by the method of non-PVC soft bags of ornidazole and sodium chloride injection.

KUVAUS knnetty kielest kiina

A non-PVC soft bags of ornidazole sodium chloride injection and its preparation method
FIELD
[0001] PVC soft bags of ornidazole sodium chloride injection and preparation method of the present invention belongs to the field of medical technology, in particular to a non.
BACKGROUND
[0002] ornidazole, following the metronidazole, tinidazole new generation of anti-anti-Trichomonas vaginalis and anaerobic bacteria and amoeba drugs. Compared with the
previous two generations of the drug, its higher efficacy, fewer drug-resistant strains, biodistribution wider patient tolerability and better compliance, low adverse reactions,
and reduce medication dosage and frequency, showing a favorable pharmacological features, safety and efficacy.
[0003] The present ornidazole sodium chloride injection in clinical use have glass bottles and non-PVC soft bags two, due to the non-PVC soft bag has good mechanical
properties, heat sealing, processing, air tightness, moisture resistance and good transparency and gloss, and can meet the high capacity preparation sterilization and
packaging requirements, and thus represents the development direction of the bulk preparation of packagings. However, due to Ornidazole thermally unstable solution, easily
degrade under high temperature conditions, resulting in related substances, now its large capacity injection production process only emphasizes its preparation process,
optimizing its sterilization process did not pay attention, cause ornidazole sodium chloride injection degradation occurs in high-temperature sterilization process, resulting in a
large number of related substances, seriously affecting the quality of products.
SUMMARY

[0004] For the art of Africa PVC soft bags ornidazole sodium chloride injection in high-temperature sterilization of easily degradable and other defects, the present invention is
to provide a non-PVC soft bags of chlorine Ornidazole sodium injection and its preparation method to solve the problem of its Ornidazole prone to degradation at high
temperature sterilization process, affect product quality.
[0005] To achieve the above object of the invention, the present invention adopts the following technical scheme to be realized:
[0006] A non-PVC soft bags of ornidazole sodium chloride injection preparation method, which comprises the following steps:
[0007] (I), said material: the ornidazole sodium chloride injection to injection water as the solvent, each injection containing IL Ornidazole 4. 65~5 35g and sodium chloride 7.
88~8. . 72g;
[0008] (2) with conc: was added to the concentrate tank with 30 C~40 C, water for injection 5 (T70% by volume of the prescribed amount, the weighing of sodium chloride
was added with stirring until dissolved, add the weighed Ornidazole mixture was stirred until dissolved, adding activated carbon, adding quality and prescription volume of the
carbon ratio of 0.01% ~ 0. 05%, heat, stirring, adsorption 10~30 minutes, in addition to carbon filtration cycle 20~ 30 minutes, check clarified mixture, the mixture was
transferred from the rich to lean with the tank with the tank;
[0009] (3) dilute with: Add dilute tank 30~40 C with water for injection prescription, stirred for 20 to 30 minutes, adjusting the pH to 3. 8~4 0 to give the drug solution, and
stirring was continued 20. Minutes later, the liquid pump is turned on, so that liquid were treated with 5 um, 0 45 um filter and return pipe loop 20 to 30 minutes.;
[0010] (4) Filling: After passing inspection filling;
[0011] (5) Sterilization: the initial temperature of the sterilization apparatus is adjusted to 50~70 C, the injection into the sterilizer, the sterilizing apparatus is adjusted to a
temperature of 120~122 C, timer sterilization 8~15 minutes after use 0~30 C water spray to cool the inner sterilization device 5 ~ 15 minutes after injection taken control of
sterilization temperature 30~50 C.
[0012] Further improvement of the above-mentioned technical scheme: said step (3) adjusting the pH with 2_5mol / l dilute hydrochloric acid.
[0013] Further improvement of the above-mentioned technical scheme: said step (5) by having the sterilizing device through the no-load operation or in advance 90-110 C
hot steam method, adjusting the initial temperature of the sterilizing apparatus.
[0014] Further improvement of the above-mentioned technical scheme: said step (5) by 5 ~ 15 minutes of heating time for the sterilization apparatus, the temperature rose
120~122 C.
[0015] Further improvement of the above aspect: the preparation after sterilization step further comprises at 2000~30001x lamp light detecting step.
[0016] The present invention also provides a method for preparing the above obtained non-PVC soft bags of ornidazole and sodium chloride injection.

[0017] Compared with the prior art, the advantages and positive effects of the invention are: the preparation process of the present invention to optimize the sterilization step,
the sterilization step is generally available when the product is loaded into the cabinet from the panel needs to 50 ~ 70 minutes, using the method of the invention can shorten
the time for the entire sterilization process to 35~45 minutes Ornidazole solution by shortening the time of exposure to high temperatures, thereby reducing the degradation of
ornidazole makes Ornidazole related substances from degradation after I. ordinary sterilization process when 04% (does not meet the quality standards) was reduced to
0.64%, greatly improving the quality of the product. Preparation method of the present invention also has a simple way of feeding, the preparation of low temperature,
concentrated with a small size, low production equipment conditions require, the preparation time is short, etc., and is easy to operate production personnel.
DETAILED DESCRIPTION
[0018] In the following with reference to specific embodiments of the aspect of the present invention will be further described in detail.
[0019] Example I
[0020] In this embodiment, the preparation of 750L ornidazole sodium chloride injection, for example, include the following specific steps:
[0021] I, said material: Weigh Ornidazole 3. 97kg, sodium chloride 6. 23kg.
[0022] 2, concentrated with: adding to the rich with the tank 36 C, 450L fresh water for injection, and after opening stirring, stirring until the weighing of sodium chloride
dissolved, then add weighed Ornidazole stir until was dissolved in a mixture.Plus 0. 02% ff / V (W / V for the total amount of volume of the activated carbon mass ratio) the
amount of activated carbon, insulation, stirred 20 minutes adsorption, charcoal was removed by filtration cycle 30 minutes, after checking clarified mixture, the mixture from
equipped with a tank to dilute the concentration tank transfer, while circulating shift, when the end of the transfer the mixture to 35 C water for injection (a few times) rinse
tank preparation, and preparation of a tank, piping and filter the mixture completely transferred to dilute with cans.
[0023] 3, dilute with: plus 36 C water for injection prescription, stirring for 25 minutes. Adjusting the pH with 3mol / l to 3.8 with dilute hydrochloric acid to give the drug
solution, and stirring was continued for 20 minutes, the liquid pump is turned on, so that liquid were treated with 5 um, 0. 45 um filter and return pipe, circulation for 30
minutes, the sample Determination of pH value and content.
[0024] 4, inspection and adjustment of installed capacity after passing the liquid filling in non-PVC plastic infusion bags, stopper, sealing.
[0025] 5, sterilization: to run into a cabinet or in advance through about 100 C hot steam sterilizer load method so that the initial temperature sterilization cabinet adjusted to
55 C. Then the product to be sterilized is placed in the sterile vehicle push sterilizer sterilized by 10 minutes of heating time for the sterilizing cabinet after the temperature
reached 122 C, time sterilization 8 minutes, 20 after use C chilled water spray to make sterilization cabinet cooling, 15 minutes after the end of the product cooling control
after sterilization Ornidazole Sodium Chloride Injection temperature out of the closet at 40~50 C.
[0026] 6, light inspection: inspection carried out under 2000~30001x lamp lights background.
[0027] 7. Packing: ordinary package bag outside, packing can be.

[0028] The following further illustrate the process of the present invention by product quality indicators beneficial effects, the experimental results shown in Table I and shown.
[0029] Table I: preparation method of the invention obtained ornidazole sodium chloride injection physicochemical properties [0030]

[0031]
[0032] Table 2: Stability of the test result of the preparation process of the present invention obtained Ornidazole Sodium Chloride Injection
[0033]