CN1830440A - Metronidazule injection and its preparation method and use - Google Patents
Metronidazule injection and its preparation method and use Download PDFInfo
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- CN1830440A CN1830440A CN 200510051481 CN200510051481A CN1830440A CN 1830440 A CN1830440 A CN 1830440A CN 200510051481 CN200510051481 CN 200510051481 CN 200510051481 A CN200510051481 A CN 200510051481A CN 1830440 A CN1830440 A CN 1830440A
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- 238000002347 injection Methods 0.000 title claims abstract description 51
- 239000007924 injection Substances 0.000 title claims abstract description 51
- 238000002360 preparation method Methods 0.000 title claims description 12
- VAOCPAMSLUNLGC-UHFFFAOYSA-N metronidazole Chemical compound CC1=NC=C([N+]([O-])=O)N1CCO VAOCPAMSLUNLGC-UHFFFAOYSA-N 0.000 claims abstract description 67
- 229960000282 metronidazole Drugs 0.000 claims abstract description 67
- 239000007788 liquid Substances 0.000 claims abstract description 43
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 32
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 18
- 239000011780 sodium chloride Substances 0.000 claims abstract description 16
- 239000008215 water for injection Substances 0.000 claims abstract description 14
- 208000015181 infectious disease Diseases 0.000 claims abstract description 13
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 45
- 238000001914 filtration Methods 0.000 claims description 20
- 230000001954 sterilising effect Effects 0.000 claims description 14
- 238000004659 sterilization and disinfection Methods 0.000 claims description 13
- 238000007689 inspection Methods 0.000 claims description 12
- 239000000203 mixture Substances 0.000 claims description 12
- 238000003756 stirring Methods 0.000 claims description 11
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 10
- 229910052799 carbon Inorganic materials 0.000 claims description 10
- 238000005262 decarbonization Methods 0.000 claims description 10
- 238000012856 packing Methods 0.000 claims description 9
- 239000012528 membrane Substances 0.000 claims description 4
- ULWHHBHJGPPBCO-UHFFFAOYSA-N propane-1,1-diol Chemical compound CCC(O)O ULWHHBHJGPPBCO-UHFFFAOYSA-N 0.000 abstract 1
- 239000000047 product Substances 0.000 description 20
- 239000000243 solution Substances 0.000 description 14
- 238000000034 method Methods 0.000 description 11
- 230000037396 body weight Effects 0.000 description 8
- 238000012797 qualification Methods 0.000 description 8
- 238000012360 testing method Methods 0.000 description 7
- 239000003814 drug Substances 0.000 description 6
- 238000001990 intravenous administration Methods 0.000 description 6
- 230000000694 effects Effects 0.000 description 5
- 238000005516 engineering process Methods 0.000 description 5
- 241000224489 Amoeba Species 0.000 description 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
- 238000003556 assay Methods 0.000 description 4
- 230000000052 comparative effect Effects 0.000 description 4
- 238000012423 maintenance Methods 0.000 description 4
- SQGYOTSLMSWVJD-UHFFFAOYSA-N silver(1+) nitrate Chemical compound [Ag+].[O-]N(=O)=O SQGYOTSLMSWVJD-UHFFFAOYSA-N 0.000 description 4
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 238000006243 chemical reaction Methods 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 238000004448 titration Methods 0.000 description 3
- 241000186046 Actinomyces Species 0.000 description 2
- 241000606125 Bacteroides Species 0.000 description 2
- 241000606124 Bacteroides fragilis Species 0.000 description 2
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 2
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 2
- 241000193403 Clostridium Species 0.000 description 2
- 241001478240 Coccus Species 0.000 description 2
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 2
- 206010059866 Drug resistance Diseases 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N EtOH Substances CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 241000186394 Eubacterium Species 0.000 description 2
- 241000186660 Lactobacillus Species 0.000 description 2
- 241000191992 Peptostreptococcus Species 0.000 description 2
- 241000186429 Propionibacterium Species 0.000 description 2
- 206010046914 Vaginal infection Diseases 0.000 description 2
- 201000008100 Vaginitis Diseases 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 239000003708 ampul Substances 0.000 description 2
- 230000000845 anti-microbial effect Effects 0.000 description 2
- 230000003115 biocidal effect Effects 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000002158 endotoxin Substances 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 238000000338 in vitro Methods 0.000 description 2
- 229940039696 lactobacillus Drugs 0.000 description 2
- QJGQUHMNIGDVPM-UHFFFAOYSA-N nitrogen group Chemical group [N] QJGQUHMNIGDVPM-UHFFFAOYSA-N 0.000 description 2
- 238000006479 redox reaction Methods 0.000 description 2
- 229910001961 silver nitrate Inorganic materials 0.000 description 2
- 238000001228 spectrum Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 1
- 239000004375 Dextrin Substances 0.000 description 1
- 229920001353 Dextrin Polymers 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 231100000215 acute (single dose) toxicity testing Toxicity 0.000 description 1
- 238000011047 acute toxicity test Methods 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 229910000019 calcium carbonate Inorganic materials 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000002425 crystallisation Methods 0.000 description 1
- 230000008025 crystallization Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 235000019425 dextrin Nutrition 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000007938 effervescent tablet Substances 0.000 description 1
- GNBHRKFJIUUOQI-UHFFFAOYSA-N fluorescein Chemical compound O1C(=O)C2=CC=CC=C2C21C1=CC=C(O)C=C1OC1=CC(O)=CC=C21 GNBHRKFJIUUOQI-UHFFFAOYSA-N 0.000 description 1
- 239000013505 freshwater Substances 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 230000002607 hemopoietic effect Effects 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 239000003978 infusion fluid Substances 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 239000013067 intermediate product Substances 0.000 description 1
- 230000003907 kidney function Effects 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000002075 main ingredient Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 238000012207 quantitative assay Methods 0.000 description 1
- -1 regulate pH6.0 Substances 0.000 description 1
- 159000000000 sodium salts Chemical class 0.000 description 1
- 231100000456 subacute toxicity Toxicity 0.000 description 1
- 239000000829 suppository Substances 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
A liquid injection of metronidazole for treating anaerobe infection is prepared from metronidazole, sodium chloride, prepanediol, and the water for injection through dissolving the metronidazole in propanediol and conventional steps.
Description
Technical field
The present invention relates to a kind of metronidazole injection and its production and use, belong to chemical field of medicaments.
Background technology
The metronidazole injection Main Ingredients and Appearance is a metronidazole, and chemical name 2-methyl-5-nitro imidazoles-1-ethanol is white or yellowish crystallization or crystalline powder, have little smelly, bitter in the mouth and slightly salty.Molten in the ethanol part omitted, slightly soluble in water or chloroform, soluble,very slightly in ether, fusing point are 159～163 ℃.
Metronidazole has the strong antibiotic effect to most of anaerobe, but aerobe and facultative anaerobe there is not effect, antimicrobial spectrum comprises bacteroides fragilis and other Bacteroides, fusiform bacilarmature, aerogenesis clostridium, Eubacterium, Wei Rong coccus, dyspepsiacoccus and peptostreptococcus etc., and actinomyces, Lactobacillus, propionibacterium are to this product drug resistance.The a little higher than Mlc of its bacteriocidal concentration.
This product still can suppress the ameba redox reaction, and the protozoon nitrogen chain is ruptured.In vitro tests proves, when drug level was 1～2mg/L, amoeba histolytica form can take place in 6～20 hours changes, and all is killed in 24 hours, when concentration is 0.2mg/L, can kill amoeba histolytica in 72 hours.This product has the powerful effect of killing infusorian, and its mechanism is not bright.Show by acute toxicity testing and sub-acute toxicity test: metronidazole does not all have influence to hemopoietic system, liver, renal function and blood fat.
At present, be that main active is applied to clinical having with the metronidazole: Metronidazole Tablet, metronidazole effervescent tablet, metronidazole suppository, metronidazole capsule, metronidazole glucose infusion solutions, metronidazole injection etc.
Metronidazole injection is mainly used in the treatment of anaerobic infection.Intravenous drip (1) adult usual amounts: maintenance dose is by body weight 7.5mg/kg by body weight 15mg/kg (the 70kg adult is 1g) first for anaerobic infection, intravenously administrable, and intravenous drip in per 6～8 hours once.(2) children's's usual amounts: the injected dose of anaerobic infection is with the adult.
The metronidazole that contains 5mg so far in the metronidazole injection with small volume among every ml, because dissolubility slightly soluble in water of metronidazole, can not make the big preparation of concentration, clinical use is extremely inconvenient, 10 of once minimum uses, can only rely on the transfusion high capacity to satisfy injected dose, infusion preparation itself is inconvenient to transport, injection with small volume of the present invention can be produced the preparation of big concentration, concentration is up to the metronidazole that contains 25mg among every ml, and once using only needs 2 positive usual amounts that can satisfy human body.
Summary of the invention
The object of the present invention is to provide a kind of metronidazole injection, during clinical use, 2 positive usual amounts that can satisfy human body only once.
A further object of the present invention is to provide a kind of preparation method of metronidazole injection.
Another object of the present invention is to provide of the application of a kind of metronidazole injection at disease medicaments such as preparation treatment anaerobic infections.
A kind of metronidazole injection of the present invention comprises metronidazole, sodium chloride, propylene glycol, water for injection, it is characterized in that, in order effectively to dissolve metronidazole, uses the propylene glycol of 1～50 times of amount, and sodium chloride is 0.4～0.9%.
For guaranteeing the quality of the pharmaceutical preparations, the employed filter membrane of technical process of the present invention is organic filter membrane.
The preparation method of a kind of metronidazole injection of the present invention, comprise the steps: earlier with the propylene glycol dissolving of metronidazole with 1～50 times of amount, other gets 1～100 times water for injection dissolving sodium chloride, and two kinds of medicinal liquids are mixed, and regulates pH value, sterilizes and make metronidazole injection.
The preparation method of metronidazole injection of the present invention specifically comprises the steps:
Earlier metronidazole is dissolved in the propylene glycol of 1～50 times of amount, gets medicinal liquid A; Other gets the water for injection of 1～100 times of amount, and adding sodium chloride fully stirs and makes dissolving fully, gets medical liquid B; With medicinal liquid A and the abundant mix homogeneously of medical liquid B, add 0.01%～0.5% active carbon, heated and boiled 15～30 minutes, decarbonization filtering, last adjust pH is 4.5～7.0, fill behind end-filtration, sterilization, lamp inspection, packing form injection.
The pH of metronidazole injection of the present invention is 4.5～7.0, is preferably pH5.8～6.2, and the pH value regulator can be selected this area regulator commonly used for use, such as 10% sodium hydroxide or 10% hydrochloric acid solution.
Sterilizing installation and technology that described sterilization can adopt those skilled in the art to use always.For example, use water-bath sterilization or steam sterilization, sterilized 30-45 minute down at 100-110 ℃.
Preferably, the preparation method of metronidazole injection of the present invention comprises the steps:
Earlier metronidazole is dissolved in the propylene glycol of 20～30 times of amounts, gets medicinal liquid A; Other gets the water for injection of 10～30 times of amounts, and adding sodium chloride fully stirs and makes dissolving fully, gets medical liquid B; With medicinal liquid A and the abundant mix homogeneously of medical liquid B, add 0.01%～0.5% active carbon, heated and boiled 15～30 minutes, decarbonization filtering, last adjust pH is 5.8～6.2, fill behind end-filtration, sterilization, lamp inspection, packing form injection.
The metronidazole injection that adopts preparation method of the present invention and get, character is colourless or almost colourless clear liquid, specification can be 10ml: 50mg, 20ml: 100mg, 20ml: 500mg, 100ml: 500mg, 250ml: 500mg, and most preferred specification is 20ml: 500mg.
Be mainly used in the treatment of anaerobic infection during metronidazole injection clinical practice of the present invention.Intravenous drip (1) adult usual amounts: maintenance dose is by body weight 7.5mg/kg by body weight 15mg/kg (the 70kg adult is 1g) first for anaerobic infection, intravenously administrable, and intravenous drip in per 6～8 hours once.(2) children's's usual amounts: the injected dose of anaerobic infection is with the adult.But injection long term administration of the present invention.
Metronidazole has the strong antibiotic effect to most of anaerobe, but aerobe and facultative anaerobe there is not effect, antimicrobial spectrum comprises bacteroides fragilis and other Bacteroides, fusiform bacilarmature, aerogenesis clostridium, Eubacterium, Wei Rong coccus, dyspepsiacoccus and peptostreptococcus etc., and actinomyces, Lactobacillus, propionibacterium are to this product drug resistance.The a little higher than Mlc of its bacteriocidal concentration.
This product still can suppress the ameba redox reaction, and the protozoon nitrogen chain is ruptured.In vitro tests proves, when drug level was 1～2mg/L, amoeba histolytica form can take place in 6～20 hours changes, and all is killed in 24 hours, when concentration is 0.2mg/L, can kill amoeba histolytica in 72 hours.This product has the powerful effect of killing infusorian, and its mechanism is not bright.
The specific embodiment
Following embodiment further describes the present invention, but described embodiment only is used to illustrate the present invention rather than restriction the present invention.
Embodiment 1
Earlier metronidazole is dissolved in the propylene glycol of 10 times of amounts, gets medicinal liquid A; Other gets the water for injection of 10 times of amounts, add 0.4% sodium chloride and fully stir and make fully dissolving, medical liquid B; With medicinal liquid A and the abundant mix homogeneously of medical liquid B, add 0.02% active carbon, heated and boiled 15 minutes, decarbonization filtering, standardize solution, last adjust pH is 4.8, fill behind end-filtration, sterilization, lamp inspection, packing form injection.
Embodiment 2
Earlier metronidazole is dissolved in the propylene glycol of 20 times of amounts, gets medicinal liquid A; Other gets the water for injection of 20 times of amounts, add 0.8% sodium chloride and fully stir and make fully dissolving, medical liquid B; With medicinal liquid A and the abundant mix homogeneously of medical liquid B, add 0.03% active carbon, heated and boiled 20 minutes, decarbonization filtering, standardize solution, last adjust pH is 5.2, fill behind end-filtration, sterilization, lamp inspection, packing form injection.
Embodiment 3
Earlier metronidazole is dissolved in the propylene glycol of 30 times of amounts, gets medicinal liquid A; Other gets the water for injection of 30 times of amounts, add 0.9% sodium chloride and fully stir and make fully dissolving, medical liquid B; With medicinal liquid A and the abundant mix homogeneously of medical liquid B, add 0.06% active carbon, heated and boiled 20 minutes, decarbonization filtering, standardize solution, last adjust pH is 6.5, fill behind end-filtration, sterilization, lamp inspection, packing form injection.
Embodiment 4
Earlier metronidazole is dissolved in the propylene glycol of 50 times of amounts, gets medicinal liquid A; Other gets the water for injection of 80 times of amounts, add 0.7% sodium chloride and fully stir and make fully dissolving, medical liquid B; With medicinal liquid A and the abundant mix homogeneously of medical liquid B, add 0.3% active carbon, heated and boiled 20 minutes, decarbonization filtering, standardize solution, last adjust pH is 6.8, fill behind end-filtration, sterilization, lamp inspection, packing form injection.
Embodiment 5
Earlier metronidazole is dissolved in the propylene glycol of 50 times of amounts, gets medicinal liquid A; Other gets the water for injection of 40 times of amounts, add 0.85% sodium chloride and fully stir and make fully dissolving, medical liquid B; With medicinal liquid A and the abundant mix homogeneously of medical liquid B, add 0.5% active carbon, heated and boiled 20 minutes, decarbonization filtering, standardize solution, last adjust pH is 6.0, fill behind end-filtration, sterilization, lamp inspection, packing form injection.
Experimental example 1
This experimental example is most preferably specification 20ml of injection of the present invention: the detection of relevant every gainer under 500mg outward appearance, pH value, the injection item.
Character: medicine composition injection of the present invention is colourless or almost colourless clear liquid.
PH value: measure according to two appendix VI of Chinese Pharmacopoeia version in 2000 H, medicine composition injection pH value of the present invention is 4.5-7.0, meets quality standard.
Bacterial endotoxin: get this product, contain the endotoxin amount among inspection (two appendix XI of Chinese Pharmacopoeia version in 2000 E mensuration) every 1ml should be less than 0.35EU in accordance with the law, and this product is up to specification.
Aseptic: get this product, check (two appendix XI of Chinese Pharmacopoeia version in 2000 H mensuration) in accordance with the law, this product is up to specification.
Clarity: get this product, check that according to " clarity test detailed rules and regulations and criterion " this product is up to specification.
Experimental example 2
This experimental example is most preferably specification 20ml of injection of the present invention: the qualitative determination of composition among the 500mg.
(1) get this product an amount of (being equivalent to metronidazole 10mg approximately),, according to the test of the discriminating (1) under the metronidazole item, show identical reaction.
(2) get this product an amount of (being equivalent to metronidazole 0.1g approximately), put evaporate to dryness in the water-bath, residue shows identical result according to the test of the discriminating (2) under the metronidazole item.
(3) get solution under the assay item, (two appendix IV of Chinese Pharmacopoeia version in 2000 A measures, and at the wavelength place of 277nm absorption maximum is arranged, and at the wavelength place of 241nm minimal absorption is arranged according to spectrophotography.
(4) this product shows sodium salt and muriatic identification.
Injection of the present invention is all up to specification with the inspection of beginning a project.
Experimental example 3
This experimental example is for being most preferably specification 20ml of injection of the present invention: muriatic mensuration among the 500mg.
Precision is measured this product an amount of (being equivalent to metronidazole 50mg approximately) and is added water to 50ml, add 5～8 of 2% dextrin solution 5ml, calcium carbonate 0.1g and fluorescein indicator solutions, after shaking up,, become blush by yellow green to turbid solution with silver nitrate titration liquid (0.1mol/L) titration.Consume silver nitrate titration liquid (0.1mol/L) and should be 13.2～14.6ml or 35.1～38.8ml (specification of 250ml: 500mg) or 2.1～5.4ml (specification of 20ml: 500mg).
Injection of the present invention is through three batches mensuration, and chloride is checked up to specification.
Experimental example 4
This experimental example is the most preferably quantitative assay of specification 20ml: 500mg of injection of the present invention.
It is an amount of that precision is measured this product, adds hydrochloric acid solution (9 → 1000) and quantitatively be diluted to the solution that contains metronidazole 12.5 μ g among every 1ml approximately, according to spectrophotography (two appendix IV of Chinese Pharmacopoeia version in 2000 A), measures trap at the wavelength place of 277nm, presses C
6H
9N
3O
3Absorptance (E
1% 1cm) be 377 calculating, promptly.
Injection of the present invention is through three batches assay, result's following (seeing Table 1):
Table 1: metronidazole assay result
| Lot number (20ml: 500mg) | Account for labelled amount % |
| 20040601 | 99.6 |
| 20040602 | 102.8 |
| 20040603 | 100.3 |
Comparative example 1
The metronidazole injection clarity that the explanation of this comparative example is produced with process using propylene glycol processing of the present invention is better than producing with conventional compound method.
Table 2: the comparison of technology of the present invention and common process clarity
| One technology of the present invention | Two common process | |
| Method for making | Earlier metronidazole is dissolved in the propylene glycol of 30 times of amounts, gets medicinal liquid A; Other gets the water for injection of 30 times of amounts, add 0.85% sodium chloride and fully stir and make fully dissolving, medical liquid B; With medicinal liquid A and the abundant mix homogeneously of medical liquid B, the active carbon of adding 0.2%, heated and boiled 20 minutes, decarbonization filtering, standardize solution, last adjust pH is 6.0, fill behind end-filtration, sterilization, lamp inspection, packing forms injection. | A) get the fresh water for injection of amount of preparation 40%, add the sodium chloride in the prescription, fully stir and make dissolving fully, add the metronidazole in the prescription, fully stir and make dissolving fully, add 0.2% active carbon, decarbonization filtering, standardize solution, regulate pH6.0, intermediate products after the assay was approved, with medicinal liquid through the end-filtration fill, sterilization, lamp inspection, pack the metronidazole injection finished product. |
| Clarity (is closed | Get 200 of this product, by " clarity test is thin | Get 200 of this product, by " clarity test |
| The lattice rate is greater than 95%) | Then and criterion " check: 20040601 batches: qualification rate 99.6%.20040602 batches: qualification rate 99.5%.20040603 batches: qualification rate 99.5%.The chips of glass factor of breaking and producing because of ampoule when getting rid of fill, after this PROCESS FOR TREATMENT, the clarity qualification rate reaches 100% substantially. | Detailed rules and regulations and criterion " check: 220040601 batches: qualification rate 79.8%.20040602 batches: qualification rate 79.5%.20040603 batches: qualification rate 80.5%.The chips of glass factor of breaking and producing because of ampoule when getting rid of fill, after this PROCESS FOR TREATMENT, the clarity qualification rate is between 85～87%. |
Comparative example 2
This comparative example explanation has identical curative effect when using metronidazole injection clinical practice with common process production clinically with metronidazole injection of the present invention, does not have other untoward reaction.
Table 3: the comparison of technology of the present invention and common process clinical efficacy
| Metronidazole injection of the present invention | The metronidazole injection of common process | |
| Usage and dosage | (1) adult's usual amounts: anaerobic infection, maintenance dose is by body weight 7.5mg/kg by body weight 15mg/kg (the 70kg adult is 1g) first for intravenously administrable, and intravenous drip in per 6～8 hours once.(2) children's's usual amounts: the injected dose of anaerobic infection is with the adult. | (1) adult's usual amounts: anaerobic infection, maintenance dose is by body weight 7.5mg/kg by body weight 15mg/kg (the 70kg adult is 1g) first for intravenously administrable, and intravenous drip in per 6～8 hours once.(2) children's's usual amounts: the injected dose of anaerobic infection is with the adult. |
| Clinical use | Treat 53 routine vaginitis patients | Treat 40 vaginitis patients |
| Other untoward reaction are observed | Do not have. | Do not have. |
| Zest is observed | No pain phenomenon. | No pain phenomenon. |
Claims (5)
1. a metronidazole injection comprises metronidazole, sodium chloride, propylene glycol, water for injection, it is characterized in that, for guaranteeing that metronidazole can fully be dissolved in the water for injection, needs with the propylene glycol of 1～50 times of amount metronidazole fully to be dissolved.
2. a kind of metronidazole injection according to claim 1 is characterized in that described sodium chloride content is preferably 0.4～0.9%.
3. according to any one metronidazole injection in claim 1 or 2, it is characterized in that described filter membrane all adopts organic filter membrane to filter.
4. the preparation method of metronidazole injection according to claim 1 is characterized in that, comprises the steps: earlier metronidazole to be dissolved in the propylene glycol of 1～50 times of amount, gets medicinal liquid A; Other gets the water for injection of 1～100 times of amount, and adding sodium chloride fully stirs and makes dissolving fully, gets medical liquid B; With medicinal liquid A and the abundant mix homogeneously of medical liquid B, add 0.01%～0.5% active carbon, heated and boiled 15～30 minutes, decarbonization filtering, last adjust pH is 4.5～7.0, fill behind end-filtration, sterilization, lamp inspection, packing form injection.
5. metronidazole injection according to claim 1 is used for the treatment of anaerobic infection.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510051481 CN1830440A (en) | 2005-03-08 | 2005-03-08 | Metronidazule injection and its preparation method and use |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510051481 CN1830440A (en) | 2005-03-08 | 2005-03-08 | Metronidazule injection and its preparation method and use |
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| Publication Number | Publication Date |
|---|---|
| CN1830440A true CN1830440A (en) | 2006-09-13 |
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| CN 200510051481 Pending CN1830440A (en) | 2005-03-08 | 2005-03-08 | Metronidazule injection and its preparation method and use |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102274167A (en) * | 2011-07-20 | 2011-12-14 | 蚌埠丰原涂山制药有限公司 | Method for preparing metronidazole injection |
| CN102552127A (en) * | 2012-01-31 | 2012-07-11 | 石家庄开发区博欣医药科技开发有限公司 | Ornidazole injection |
| CN106619501A (en) * | 2017-01-02 | 2017-05-10 | 江苏恒丰强生物技术有限公司 | Metronidazole glucose injection and preparation method thereof |
| CN108096198A (en) * | 2017-12-26 | 2018-06-01 | 金华智济药物科技合伙企业（有限合伙） | Novel antibacterial pharmaceutical composition when prevention and treatment aerobic bacteria and anaerobic bacteria mixed infection and preparation method thereof |
| CN111012738A (en) * | 2019-11-26 | 2020-04-17 | 江苏恒丰强生物技术有限公司 | Metronidazole injection and preparation method thereof |
| WO2020259464A1 (en) * | 2019-06-28 | 2020-12-30 | 石家庄四药有限公司 | Metronidazole and sodium chloride injection and preparation method therefor |
-
2005
- 2005-03-08 CN CN 200510051481 patent/CN1830440A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102274167A (en) * | 2011-07-20 | 2011-12-14 | 蚌埠丰原涂山制药有限公司 | Method for preparing metronidazole injection |
| CN102274167B (en) * | 2011-07-20 | 2013-01-09 | 安徽丰原淮海制药有限公司 | Method for preparing metronidazole injection |
| CN102552127A (en) * | 2012-01-31 | 2012-07-11 | 石家庄开发区博欣医药科技开发有限公司 | Ornidazole injection |
| CN106619501A (en) * | 2017-01-02 | 2017-05-10 | 江苏恒丰强生物技术有限公司 | Metronidazole glucose injection and preparation method thereof |
| CN108096198A (en) * | 2017-12-26 | 2018-06-01 | 金华智济药物科技合伙企业（有限合伙） | Novel antibacterial pharmaceutical composition when prevention and treatment aerobic bacteria and anaerobic bacteria mixed infection and preparation method thereof |
| WO2020259464A1 (en) * | 2019-06-28 | 2020-12-30 | 石家庄四药有限公司 | Metronidazole and sodium chloride injection and preparation method therefor |
| CN111012738A (en) * | 2019-11-26 | 2020-04-17 | 江苏恒丰强生物技术有限公司 | Metronidazole injection and preparation method thereof |
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