WO2022246990A1 - 一种注射用盐臭氧冰药品及其生产 - Google Patents
一种注射用盐臭氧冰药品及其生产 Download PDFInfo
- Publication number
- WO2022246990A1 WO2022246990A1 PCT/CN2021/107211 CN2021107211W WO2022246990A1 WO 2022246990 A1 WO2022246990 A1 WO 2022246990A1 CN 2021107211 W CN2021107211 W CN 2021107211W WO 2022246990 A1 WO2022246990 A1 WO 2022246990A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- ozone
- injection
- gas
- salt
- liquid mixing
- Prior art date
Links
- 239000007924 injection Substances 0.000 title claims abstract description 113
- 238000002347 injection Methods 0.000 title claims abstract description 113
- 239000003814 drug Substances 0.000 title claims abstract description 76
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 55
- CBENFWSGALASAD-UHFFFAOYSA-N Ozone Chemical compound [O-][O+]=O CBENFWSGALASAD-UHFFFAOYSA-N 0.000 claims abstract description 233
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 65
- 239000011780 sodium chloride Substances 0.000 claims abstract description 57
- 208000015181 infectious disease Diseases 0.000 claims abstract description 7
- 238000001990 intravenous administration Methods 0.000 claims abstract description 6
- 239000007788 liquid Substances 0.000 claims description 113
- 238000002156 mixing Methods 0.000 claims description 101
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 77
- 239000007789 gas Substances 0.000 claims description 58
- 239000008354 sodium chloride injection Substances 0.000 claims description 56
- 150000003839 salts Chemical class 0.000 claims description 42
- 229940079593 drug Drugs 0.000 claims description 34
- BMLSTPRTEKLIPM-UHFFFAOYSA-I calcium;potassium;disodium;hydrogen carbonate;dichloride;dihydroxide;hydrate Chemical compound O.[OH-].[OH-].[Na+].[Na+].[Cl-].[Cl-].[K+].[Ca+2].OC([O-])=O BMLSTPRTEKLIPM-UHFFFAOYSA-I 0.000 claims description 26
- 239000008156 Ringer's lactate solution Substances 0.000 claims description 25
- 238000004806 packaging method and process Methods 0.000 claims description 22
- 238000000034 method Methods 0.000 claims description 21
- 239000012267 brine Substances 0.000 claims description 19
- HPALAKNZSZLMCH-UHFFFAOYSA-M sodium;chloride;hydrate Chemical compound O.[Na+].[Cl-] HPALAKNZSZLMCH-UHFFFAOYSA-M 0.000 claims description 19
- 238000009826 distribution Methods 0.000 claims description 18
- 238000004064 recycling Methods 0.000 claims description 15
- 239000007787 solid Substances 0.000 claims description 15
- 238000001514 detection method Methods 0.000 claims description 14
- 238000007710 freezing Methods 0.000 claims description 14
- 230000008014 freezing Effects 0.000 claims description 14
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims description 13
- 239000003595 mist Substances 0.000 claims description 13
- 239000001301 oxygen Substances 0.000 claims description 13
- 229910052760 oxygen Inorganic materials 0.000 claims description 13
- 239000002912 waste gas Substances 0.000 claims description 13
- 239000000203 mixture Substances 0.000 claims description 12
- 238000003908 quality control method Methods 0.000 claims description 12
- 239000007921 spray Substances 0.000 claims description 11
- 238000005057 refrigeration Methods 0.000 claims description 10
- 238000012856 packing Methods 0.000 claims description 9
- 230000008569 process Effects 0.000 claims description 7
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims description 4
- 238000001727 in vivo Methods 0.000 claims description 4
- 238000001802 infusion Methods 0.000 claims description 4
- 210000003205 muscle Anatomy 0.000 claims description 4
- 230000003204 osmotic effect Effects 0.000 claims description 4
- 238000004659 sterilization and disinfection Methods 0.000 claims description 4
- 239000008215 water for injection Substances 0.000 claims description 4
- 238000012372 quality testing Methods 0.000 claims description 3
- 238000005406 washing Methods 0.000 claims description 3
- CYDQOEWLBCCFJZ-UHFFFAOYSA-N 4-(4-fluorophenyl)oxane-4-carboxylic acid Chemical compound C=1C=C(F)C=CC=1C1(C(=O)O)CCOCC1 CYDQOEWLBCCFJZ-UHFFFAOYSA-N 0.000 claims description 2
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims description 2
- 239000001110 calcium chloride Substances 0.000 claims description 2
- 229910001628 calcium chloride Inorganic materials 0.000 claims description 2
- 238000004140 cleaning Methods 0.000 claims description 2
- 238000010790 dilution Methods 0.000 claims description 2
- 239000012895 dilution Substances 0.000 claims description 2
- 239000001103 potassium chloride Substances 0.000 claims description 2
- 235000011164 potassium chloride Nutrition 0.000 claims description 2
- 239000001540 sodium lactate Substances 0.000 claims description 2
- 229940005581 sodium lactate Drugs 0.000 claims description 2
- 235000011088 sodium lactate Nutrition 0.000 claims description 2
- 238000007920 subcutaneous administration Methods 0.000 claims description 2
- 229940124579 cold medicine Drugs 0.000 claims 1
- 238000012545 processing Methods 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 abstract description 18
- 241000894006 Bacteria Species 0.000 abstract description 13
- 230000000694 effects Effects 0.000 abstract description 11
- 241000700605 Viruses Species 0.000 abstract description 9
- 238000011010 flushing procedure Methods 0.000 abstract description 8
- 206010028980 Neoplasm Diseases 0.000 abstract description 6
- 230000005923 long-lasting effect Effects 0.000 abstract description 5
- 206010021143 Hypoxia Diseases 0.000 abstract description 4
- 238000011031 large-scale manufacturing process Methods 0.000 abstract description 4
- 238000002360 preparation method Methods 0.000 abstract description 4
- 230000008439 repair process Effects 0.000 abstract description 4
- 241000233866 Fungi Species 0.000 abstract description 3
- 230000015572 biosynthetic process Effects 0.000 abstract description 3
- 230000006378 damage Effects 0.000 abstract description 3
- 238000003860 storage Methods 0.000 abstract description 3
- 206010048685 Oral infection Diseases 0.000 abstract description 2
- 206010066876 Perineal infection Diseases 0.000 abstract description 2
- 208000011191 Pulmonary vascular disease Diseases 0.000 abstract description 2
- 206010046914 Vaginal infection Diseases 0.000 abstract description 2
- 238000001804 debridement Methods 0.000 abstract description 2
- 206010012601 diabetes mellitus Diseases 0.000 abstract description 2
- 230000007954 hypoxia Effects 0.000 abstract description 2
- 230000002779 inactivation Effects 0.000 abstract description 2
- 208000028867 ischemia Diseases 0.000 abstract description 2
- 206010040872 skin infection Diseases 0.000 abstract description 2
- 238000001356 surgical procedure Methods 0.000 abstract 1
- 239000000243 solution Substances 0.000 description 6
- 210000001519 tissue Anatomy 0.000 description 6
- 230000008901 benefit Effects 0.000 description 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 5
- 238000011160 research Methods 0.000 description 5
- 239000000825 pharmaceutical preparation Substances 0.000 description 4
- 238000005070 sampling Methods 0.000 description 4
- 208000025721 COVID-19 Diseases 0.000 description 3
- 241001678559 COVID-19 virus Species 0.000 description 3
- 241000711573 Coronaviridae Species 0.000 description 3
- 206010035664 Pneumonia Diseases 0.000 description 3
- 238000001816 cooling Methods 0.000 description 3
- 238000010586 diagram Methods 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 238000003780 insertion Methods 0.000 description 3
- 230000037431 insertion Effects 0.000 description 3
- XTEGARKTQYYJKE-UHFFFAOYSA-M Chlorate Chemical compound [O-]Cl(=O)=O XTEGARKTQYYJKE-UHFFFAOYSA-M 0.000 description 2
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 2
- 230000002155 anti-virotic effect Effects 0.000 description 2
- 238000000354 decomposition reaction Methods 0.000 description 2
- 229940126534 drug product Drugs 0.000 description 2
- WQYVRQLZKVEZGA-UHFFFAOYSA-N hypochlorite Chemical compound Cl[O-] WQYVRQLZKVEZGA-UHFFFAOYSA-N 0.000 description 2
- 230000001146 hypoxic effect Effects 0.000 description 2
- 230000000415 inactivating effect Effects 0.000 description 2
- 230000002401 inhibitory effect Effects 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 230000000302 ischemic effect Effects 0.000 description 2
- 210000004185 liver Anatomy 0.000 description 2
- 239000002547 new drug Substances 0.000 description 2
- 238000006213 oxygenation reaction Methods 0.000 description 2
- 239000011734 sodium Substances 0.000 description 2
- 229910052708 sodium Inorganic materials 0.000 description 2
- 230000000451 tissue damage Effects 0.000 description 2
- 231100000827 tissue damage Toxicity 0.000 description 2
- 230000003612 virological effect Effects 0.000 description 2
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 description 1
- 102000004127 Cytokines Human genes 0.000 description 1
- 108090000695 Cytokines Proteins 0.000 description 1
- 241000701022 Cytomegalovirus Species 0.000 description 1
- 206010059866 Drug resistance Diseases 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 108010049003 Fibrinogen Proteins 0.000 description 1
- 102000008946 Fibrinogen Human genes 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
- 208000009889 Herpes Simplex Diseases 0.000 description 1
- 208000007514 Herpes zoster Diseases 0.000 description 1
- 241000701044 Human gammaherpesvirus 4 Species 0.000 description 1
- 102000004895 Lipoproteins Human genes 0.000 description 1
- 108090001030 Lipoproteins Proteins 0.000 description 1
- 241001631646 Papillomaviridae Species 0.000 description 1
- 108010094028 Prothrombin Proteins 0.000 description 1
- 102100027378 Prothrombin Human genes 0.000 description 1
- 241000580858 Simian-Human immunodeficiency virus Species 0.000 description 1
- 208000036142 Viral infection Diseases 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 208000022362 bacterial infectious disease Diseases 0.000 description 1
- 238000010923 batch production Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 230000005587 bubbling Effects 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 210000000170 cell membrane Anatomy 0.000 description 1
- 230000019522 cellular metabolic process Effects 0.000 description 1
- 208000026106 cerebrovascular disease Diseases 0.000 description 1
- 239000000460 chlorine Substances 0.000 description 1
- 229910052801 chlorine Inorganic materials 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 239000002158 endotoxin Substances 0.000 description 1
- 229940012952 fibrinogen Drugs 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 238000010253 intravenous injection Methods 0.000 description 1
- 208000023589 ischemic disease Diseases 0.000 description 1
- 231100001231 less toxic Toxicity 0.000 description 1
- 229920006008 lipopolysaccharide Polymers 0.000 description 1
- 210000005229 liver cell Anatomy 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 210000004379 membrane Anatomy 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 230000035772 mutation Effects 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 210000003463 organelle Anatomy 0.000 description 1
- 230000004792 oxidative damage Effects 0.000 description 1
- 230000036542 oxidative stress Effects 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- 230000036470 plasma concentration Effects 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 238000001243 protein synthesis Methods 0.000 description 1
- 229940039716 prothrombin Drugs 0.000 description 1
- 230000009257 reactivity Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 210000005084 renal tissue Anatomy 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 230000017423 tissue regeneration Effects 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 230000014616 translation Effects 0.000 description 1
- 230000009385 viral infection Effects 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
- F25C—PRODUCING, WORKING OR HANDLING ICE
- F25C1/00—Producing ice
Definitions
- the invention relates to an ozone medicine and its production, in particular to a salt ozone ice medicine for injection and its production.
- Epstein-Barr virus, cytomegalovirus, papillomavirus, HIV, herpes zoster, herpes simplex and other viral diseases are particularly effective.
- ozone has strong reactivity, is easy to decompose, and is very unstable. It will gradually decompose into oxygen at room temperature. And accelerated decomposition into oxygen. But ozone is extremely stable in ice, with a half-life of 2,000 years.
- ozone gas injection therapy is relatively narrow, and it is currently limited to the treatment of aseptic pain in the spine, limbs and joints, and the curative effect is not good; the latest research has confirmed that the injection of 20ppm ozonated saline has a significant inhibitory effect on tumors , and is safe and has no obvious side effects; intravenous injection therapy of ozonated saline can significantly improve the blood flow and oxygenation of ischemic tissue, regulate oxidative stress and cytokine expression, and play an important role in the treatment of pulmonary vascular diseases; ozone Therapy can also improve oxygenation, stabilize liver cell metabolism, and normalize plasma levels of fibrinogen and prothrombin in patients with viral infection, suggesting that ozone therapy can improve liver protein synthesis; , liver, lung, kidney tissue oxidative damage has a protective effect.
- the International Scientific Committee on Ozone Therapy (ISCO3) approved the Potential Use of Ozone in the Treatment of Novel Coronavirus Pneumonia (SARS-CoV-2/COVID19) on March 13, 2020, and also recommended ozonated saline therapy in Application in the treatment of novel coronavirus pneumonia (SARS-CoV-2/COVID19), the method is to add a mixed gas of ozone and oxygen in normal saline (0.9% sodium chloride injection), when bubbling and reaching saturation, Intravenous administration at a rate of 80-120 drops/min, but ozonated saline is easily decomposed by ozone at room temperature, and it is not easy to store, because the number of ozonated saline therapy in medical institutions is small, the cost of self-made is high, and it needs to be prepared in time. Timely use, so it is difficult to popularize, make ozone therapy face difficulties, and it is even more impossible to realize large-scale production, standardization and standardized use.
- the purpose of the present invention is, one is to utilize the characteristic that ozone is particularly effective in inactivating bacteria and viruses;
- the fourth is to use the extremely stable and long-lasting characteristics of ozone in the frozen state to research and develop a kind of anti-virus, anti-bacteria, repair tissue ischemia and hypoxia damage, and can preserve ozone stable, long-lasting and effective.
- a salt ozone ice drug for injection containing medical ozone, medical salt and medical water, it is medical ozone gas and medical saline, after mixing and dissolving, it will reach a predetermined ozone concentration, and then freeze to form ice to obtain a medical drug, It is characterized in that it is a solid ice drug for injection containing medical ozone and medical saline.
- the medical ozone contained in the above-mentioned saline ozone ice medicine for injection is characterized in that the concentration of the contained medical ozone is 0.01ppm-600ppm.
- the medical saline contained in the salt ozone ice medicine for injection is characterized in that: it contains salt for injection and water for injection, and the content of salt for injection and water for injection is equal to the osmotic pressure of the human body after mixing and dissolving, which can be 0.9 % sodium chloride injection can also be Ringer's injection (every 100ml contains 0.02g of calcium chloride, 0.03g of potassium chloride, 0.6g of sodium chloride, and 0.31g of sodium lactate).
- the packaging of the above-mentioned salt-ozone ice medicine product for injection is characterized in that it includes bottle packaging, bag packaging, and syringe packaging.
- the packing specification of the salt-ozone ice drug product for injection is characterized in that: the packing specification is 0.5g-2000g.
- the above-mentioned method of using salt-ozone ice for injection is characterized in that it is used for intravenous infusion, subcutaneous, muscle, joint and other in vivo injection, washing and disinfection of various surgical infections, and cleaning and disinfection of various infections of the human body; or Use after dilution.
- the production of the above-mentioned salt-ozone ice medicine for injection is to upgrade and transform the relevant production lines of the medical oxygen plant, add an ozone system, a gas-liquid mixing and dissolving platform, etc., and inject 0.9% sodium chloride in bottles (bags) Liquid and Ringer's injection products are reprocessed, the needle is inserted into the bottle (bag), ozone gas is passed through, the ozone and brine are mixed and dissolved in the bottle (bag), and then frozen and frozen for production.
- the gas-liquid mixing and dissolving platform is equipped with batch production
- the right air supply needle and exhaust needle the air supply needle is connected to the pipeline and the ozone system
- the exhaust needle is connected to the pipeline and the ozone recycling device, and the waste gas treatment device.
- the quality control and detection system consists of an ozone concentration detection device and an ozone flow control device. , pressurization device, refrigeration equipment, and freezing equipment; the production of this type includes at least the following steps:
- bags 0.9% sodium chloride injection bottles (bags) or Ringer's injection bottles (bags) of 100ml ⁇ 1000ml in batches to form gas and liquid mixing and dissolving bottle (bag);
- step (3) Place the bottled (bag) ozonized saline injection obtained in step (3) in a freezer to freeze and freeze to become a solid saline ozone ice drug for injection with a specification of 100 g to 1000 g.
- the bottled (bag) ozonized saline injection obtained in step (3) is divided into syringes according to the specifications of 0.5ml, 1ml, 5ml, 10ml, and 20ml, and then put into a freezing device to freeze and freeze to become a solid Salt ozone ice medicine for injection (syringe) with specifications of 0.5g, 1g, 5g, 10g, 20g;
- step (4) The saline ozone ice medicine for injection obtained in step (4) is placed in a refrigerator for refrigeration, and quality sampling is regularly carried out.
- Another production of the above-mentioned salt-ozone ice medicine for injection is to upgrade the salt water pharmaceutical factory, set up an ozone system, a gas-liquid mixing and dissolving container, etc., and then pass ozone and brine into a low-temperature, high-pressure gas-liquid mixing and dissolving container , to obtain ozonated brine, then pack it into bottles or bags, and then freeze it for production; it is characterized in that: according to the relevant standards of the pharmaceutical industry, at least a brine system, an ozone system, a gas-liquid mixing and dissolving container, Gas-liquid pipeline system, quality control and testing system, distribution and packaging platform, ozone recycling device, waste gas treatment device; its ozone system includes oxygen source, ozone generator;
- the air pipe, liquid discharge pipe, and the air intake pipe are connected to the ozone system air supply pipe through pipes, the multi-head sprayer is connected to the brine system through pipes, the exhaust pipe is connected to the ozone recycling device and waste gas treatment device through
- the production method of this equipment composition at least comprises the following steps:
- the conventional pharmaceutical process obtains saline for injection and cools it to a low temperature; regulates the concentration of ozone gas, passes medical ozone gas and oxygen into the gas-liquid mixing and dissolving container through the pipeline, and makes the gas-liquid mixing and dissolving container reach a predetermined pressure;
- step (3) Open the drain pipe on the distribution and packaging platform, put the ozonated salt water with predetermined ozone concentration obtained in step (2) into bottles, bags or syringes according to the specifications of 0.5ml to 2000ml, and obtain ozone with predetermined ozone concentration.
- step (3) Place the ozonated saline bottle or bag or syringe with the predetermined ozone concentration obtained in step (3) into a freezer to freeze and freeze to become a solid salt-ozone ice drug for injection with a specification of 0.5g to 2000g.
- step (4) The saline ozone ice medicine for injection obtained in step (4) is placed in a refrigerator for refrigeration, and quality sampling is regularly carried out.
- the gas-liquid mixing and dissolving container composed of another production equipment of the above-mentioned salt ozone ice medicine for injection is characterized in that: one or more gas-liquid mixing and dissolving containers can also be set, and the discharge pipe of the first gas-liquid mixing and dissolving container Connect with the multi-head sprayer of the second gas-liquid mixing and dissolving container, the discharge pipe of the second gas-liquid mixing and dissolving container is connected with the multi-head sprayer of the third gas-liquid mixing and dissolving container, and connect accordingly, and the last gas-liquid mixing and dissolving
- the liquid discharge pipe of the container is connected to the distribution and packaging platform; each intake pipe is connected to the ozone system air supply pipe through a pipe, and each exhaust pipe is connected to an ozone recycling device and a waste gas treatment device through a pipe.
- the present invention utilizes the extremely stable and long-lasting characteristics of ozone stored in a frozen state, and adopts a technical scheme of salt ozone ice medicine for injection, which overcomes the need for medical institutions to arrange complex procedures for the existing ozonated saline therapy.
- Drug preparation rather than the disadvantages of ozonated saline therapy, it solves the problem that ozone is easy to decompose and is not conducive to preservation in the existing ozonated saline therapy, and also solves the problem that the current ozonated saline therapy has no productization and no quality standardization , No technical problems of large-scale production.
- the present invention is beneficial for the production management department to formulate the production process, operation specifications and technical standards, to ensure the product quality, and is more conducive to the medical staff to summarize the relevant ozone treatment experience in clinical application, to formulate the clinical ozone treatment specifications for diseases, and to easily achieve the salt ozone ice for injection.
- the present invention utilizes the characteristic that ozone is particularly effective in inactivating bacteria and viruses, utilizes the special ability of ozone to repair tissue damage, and utilizes the inhibitory effect of local injection of ozonated saline on tumors. According to different medication purposes, it is made into Salt-ozone ice pharmaceutical preparations for injection with different ozone concentrations, specifications, and salt compositions can be used for intravenous infusion, injection into the human body, and flushing inside and outside the human body.
- the fungus has the advantages of good effect, less toxic and side effects, and no drug resistance of bacteria, viruses, and fungi; it has the advantages of better tissue repair and fewer side effects than the existing drugs for the treatment of ischemic and hypoxic diseases in related tissues; Tumor drug, no obvious toxic and side effects; can be used to treat cardiovascular and cerebrovascular diseases, diabetes, tumors, oral infection, body surface skin infection, perineal infection, vaginal infection, intraoperative drug washing of various operations, surgical debridement, surgical infection Waiting for treatment. Conducive to the International Scientific Committee on Ozone Therapy (ISCO3) to promote the application of ozonated saline therapy in the treatment of new coronavirus pneumonia (SARS-CoV-2/COVID19).
- ISCO3 International Scientific Committee on Ozone Therapy
- the present invention adopts the in vivo injection in the technical scheme of saline ozone ice for injection with equal osmotic pressure to the human body, replaces the existing ozone gas in vivo injection treatment, and solves the side effect of pain at the injection site after injection of the existing ozone gas injection therapy, It avoids the damage and stimulation of the tissue caused by direct injection of ozone gas into the body, promotes the repair of tissue damage, relieves the pain of patients, expands the indications for ozone injection therapy, and improves the therapeutic effect of related diseases.
- the present invention can be produced by upgrading the existing medical oxygen factory or salt water pharmaceutical factory, which is conducive to better utilization of social resources; it is also conducive to the production management department to formulate production processes, operating specifications and technical standards to ensure product quality .
- the present invention also adopts the technical scheme of supplying high-concentration ozone gas, low temperature and pressurized conditions, combining multiple gas-liquid mixing and dissolving containers to mix and dissolve ozone and brine, and can produce salt ozone ice for injection with 600ppm ozone concentration on a large scale Drugs can meet the various needs of clinical and scientific research for salt-ozone ice medicines for injection, and realize the promotion and application of salt-ozone ice medicines for injection to a wider range of fields.
- Ordinary refrigerators of the present invention can be stored, and can be transported within ten hours in an incubator with ice packs.
- ordinary refrigerated trucks or refrigerators can be used, which has the advantages of relatively easy refrigeration and transportation.
- the invention has low production cost, low refrigeration cost, low use cost and wide application range, can replace some related medicines, reduce the toxicity and side effects of medicines, enhance curative effect, improve health level, and can also reduce medical expenses. social benefits.
- Fig. 1 is a simple flow chart of the production process of Example 1 of the present invention
- Fig. 2 is a simple flowchart of the production process of Example 4 of the present invention.
- Fig. 3 is a partial simple schematic diagram of the production setup of Example 1 of the present invention.
- Fig. 4 is a partial simple schematic diagram of the production setup of Example 4 of the present invention.
- Fig. 5 is a simple flow chart of the production process of Example 7 of the present invention.
- Fig. 6 is a partial simple schematic diagram of the production setting of Embodiment 7 of the present invention.
- the figure marks include: ozone gas supply pipe 1, residual gas recovery pipe 2, booster device 3, ozone flow controller 4, ozone concentration controller 5, gas supply needle 6, intake directional switch 7, ozone system 8, gas-liquid mixing Dissolving area 9, exhaust directional switch 10, gas-liquid mixing and dissolving platform 11, exhaust pipe 12, waste gas treatment device 13, exhaust needle 14, ozone recycling device 15, liquid discharge pipe 16, distribution and packaging platform 17, liquid discharge Switch 18, ozonized brine 19, multi-head sprayer 20, gas-liquid mixing and dissolving container 21, brine pipe 22, brine system 23.
- a kind of production of salt ozone ice medicine for injection is to upgrade the relevant production line of the medical oxygen factory, after setting up the ozone system, use the 0.9% sodium chloride injection bottle product of the pharmaceutical factory, and insert the needle into the bottle , the method of introducing ozone gas to make ozone and brine mix and dissolve in the container and then freeze and freeze, set according to the relevant standards of the pharmaceutical industry, consisting of an ozone system 8, a gas guide pipeline system, a gas-liquid mixing and dissolving platform 11, and quality control It is composed of a detection system, an ozone recycling device 15, and a waste gas treatment device 13; the ozone system is set according to the production standard of the highest ozone production capacity of 1 kg/h; its gas-liquid mixing and dissolving platform 11 is equipped with batch-paired gas supply needles 6 and exhaust needles 14.
- the gas supply needle 6 is connected to the ozone system 8 through the pipeline, and the exhaust needle 14 is connected to the ozone recycling device and the exhaust gas treatment device 13 through the pipeline; its quality control and detection system consists of an ozone concentration controller 5, an ozone flow control device 4, a pressurized Device 3, composed of refrigeration equipment and freezing equipment.
- the medical ozone gas is passed into the 0.9% sodium chloride injection bottle through the air supply needle 6 at a rate of 20g/h, and the ozone gas and the 0.9% sodium chloride injection are mixed and dissolved to obtain a bottled solution with a concentration of 0.05ppm. ozonated saline injection;
- step (3) the bottled ozonated saline injection that step (3) obtains is placed in freezing equipment and freezes, and becomes ozone concentration and is 0.03ppm, and specification is 100g, 250g, 500g, 1000g injection salt ozone ice medicine.
- step (4) The saline ozone ice drug for injection obtained in step (4) is placed in a cold storage environment at -10° C., and quality sampling inspections are carried out regularly.
- the Ringer's injection bottle product of the pharmaceutical factory is further processed, and the salt for injection of production specification 100g, 250g, 500g, 1000g ozone content 10ppm concentration Ozone ice medicine, the following briefly describes its production method and steps:
- step (3) The bottled ozonated Ringer's injection that step (3) obtains is placed in the freezer to freeze and freeze, and it is 10ppm to become an ozone concentration, and the specification is 100g, 250g, 500g, 1000g salt ozone ice medicine for injection ;
- Method of use the method of use in Example 1.
- the Ringer's injection bottle product of the pharmaceutical factory is further processed, and the production specification is that the ozone content of 0.5g, 1g, 5g, 10g, 20g is The saline ozone ice drug for injection (syringe dress) of 60ppm concentration, following brief description of its production method and steps:
- step (3) The bottled ozonated Ringer's injection of 72ppm concentration obtained in step (3) is divided into syringes according to the specifications of 0.5ml, 1ml, 5ml, 10ml, and 20ml, and then put into freezing equipment to freeze and freeze. Become solid, the specification is 0.5g, 1g, 5g, 10g, 20g and the ozone content is 60ppm concentration saline ozone ice drug for injection (syringe packing).
- Method of use Use according to the doctor's advice, and can be injected subcutaneously, into muscles, in joint cavities, etc.
- Another production of a kind of salt-ozone ice medicine for injection upgrade the salt water pharmaceutical factory, set up the ozone system, gas-liquid mixing and dissolving container, etc., and then pass ozone and brine into the low-temperature, high-pressure gas-liquid mixing and dissolving container , to obtain ozonated brine, repackage, freeze and freeze, set up according to the relevant standards of the pharmaceutical industry; it consists of a brine system 23, an ozone system 8, a gas-liquid mixing and dissolving container 21, a gas-liquid pipeline system, and a quality control and detection system , distribution packaging platform 17, ozone recycling device 15, waste gas treatment device 13 is formed;
- Its ozone system comprises oxygen source, ozone generator; pipe, the air intake pipe is connected with the ozone system gas supply pipe, the multi-head sprayer 20 is connected with the brine system through the pipe, the exhaust pipe is connected with the ozone recycling device 15 and the waste gas treatment device 13, and the liquid discharge pipe is connected with the distribution and packaging platform
- step (2) open the multi-head sprayer switch of gas-liquid mixing and dissolving container, make 0.9% sodium chloride injection form spray mist in the gas-liquid mixing and dissolving container 21 of step (1), make ozone gas and 0.9% sodium chloride inject The solution is mixed and dissolved to obtain an ozonated 0.9% sodium chloride injection with an ozone concentration of 3.6 ppm;
- step (2) Open drain pipe 16 at distribution packaging platform 17, the ozone concentration that step (2) obtains is the ozonated 0.9% sodium chloride injection of 3.6ppm, is packed in the bottle by the specification of 250ml, 500ml, 2000ml ; Obtain an ozonated 0.9% sodium chloride injection bottle;
- the ozone concentration that step (3) obtains is the ozonated 0.9% sodium chloride injection bottle of 3ppm, is placed in freezer and freezes, becomes solid, and the ozone content 3ppm that specification is 250g, 500g, 2000g concentration of saline ozone ice medicine for injection;
- step (4) Place the ice bottle of medical ozonated salt obtained in step (4) in a cold storage environment at -10° C., and conduct regular quality sampling inspections.
- the ozone concentration that step (3) obtains is the ozonated Ringer's injection bottle of 30ppm, is placed in freezer and freezes, and the specification that becomes solid is 100g, 250g, the injection salt of ozone content 25ppm concentration Ozone ice medicine;
- Embodiment 6 is a diagrammatic representation of Embodiment 6
- the production contains 0.9% sodium chloride injection composition, the salt-ozone ice drug for injection with an ozone content of 60ppm concentration, and its production method and steps are briefly described below:
- step (2) Open drain pipe 16 at distribution packaging platform 17, the ozone concentration that step (2) obtains is the ozonated 0.9% sodium chloride injection of 72ppm, is packed in by the specification of 0.5ml, 1ml, 5ml, 10ml In the syringe, obtain the ozonated 0.9% sodium chloride injection syringe;
- step (3) the ozone concentration that step (3) obtains is the ozonated 0.9% sodium chloride injection syringe of 72ppm, is placed in freezing equipment and freezes, becomes solid, and specification is 0.5g, 1g, 5g, 10g , Injection salt ozone ice drug syringe product with an ozone content of 60ppm;
- step (5) With embodiment 4 step (5).
- Method of use Use according to the doctor's advice, and can be injected subcutaneously, into muscles, in joint cavities, etc.
- Embodiment 7 is a diagrammatic representation of Embodiment 7:
- the drainpipe of the first gas-liquid mixing and dissolving container is connected to the multi-head sprayer 20 of the second gas-liquid mixing and dissolving container, the second gas-liquid mixing and dissolving container
- the drain pipe of the mixing and dissolving container is connected to the multi-head sprayer 20 of the third gas-liquid mixing and dissolving container, and the drain pipe of the third gas-liquid mixing and dissolving container is connected with the distribution packaging platform, and other settings are similar to 4 (Fig. 5, Fig. 6) .
- step (2) Open the 3rd gas-liquid mixing and dissolving container discharge pipe 16 at distribution packaging platform 17, the ozone concentration that step (2) obtains is the ozonated 0.9% sodium chloride injection of 360ppm, packs by the specification of 100ml In the bottle, obtain bottled ozonated 0.9% sodium chloride injection;
- step (3) (4) the bottled ozonated 0.9% sodium chloride injection that the ozone concentration that step (3) obtains is 360ppm, is placed in freezing equipment and freezes, and becomes solid, and specification is 100g, and the injection of ozone content 300ppm concentration Ice pharmaceutical products with salt ozone;
- step (5) With embodiment 4 step (5).
- Embodiment 8 is a diagrammatic representation of Embodiment 8
- the drain pipe of the first gas-liquid mixing and dissolving container is connected to the multi-head sprayer 20 of the second gas-liquid mixing and dissolving container, the second gas-liquid mixing and dissolving container
- the drain pipe of the mixing and dissolving container is connected to the multi-head sprayer 20 of the third gas-liquid mixing and dissolving container, and the drain pipe of the third gas-liquid mixing and dissolving container is connected with the distribution packaging platform, and other settings are similar to 4 (referring to Fig. 5, Fig. 6 ).
- step (2) Open the 5th gas-liquid mixing and dissolving container drain 16 at distribution packaging platform 17, the ozone concentration that step (2) obtains is the ozonated 0.9% sodium chloride injection of 720ppm, is packed in by the specification of 200ml In the bottle (or in the bag), obtain bottled (or bagged) ozonated 0.9% sodium chloride injection;
- step (3) (4) the bottled (or bagged) ozone concentration that step (3) obtains is the ozonated 0.9% sodium chloride injection of 720ppm, is placed in freezing equipment and freezes, becomes solid, and specification is 200g, Salt ozone ice medicine for injection with an ozone content of 600ppm;
- step (5) With embodiment 4 step (5).
Landscapes
- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Physics & Mathematics (AREA)
- Mechanical Engineering (AREA)
- Thermal Sciences (AREA)
- General Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Epidemiology (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
利用臭氧对细菌、病毒、真菌特别有效的灭活作用，以及臭氧对组织缺血缺氧损伤的特殊修复作用和臭氧在冰冻状态保存极为稳定、持久的特性，开发出一种注射用盐臭氧冰的新药品，一种臭氧保存稳定、持久，可以进行静脉滴注、人体内注射与人体内外冲洗的新药品，用于治疗肺血管疾病，糖尿病，某些肿瘤，口腔感染，体表皮肤感染，会阴部位感染，阴道感染，各种手术的术中用药冲洗，外科清创，外科感染等，命名为注射用盐臭氧冰药品。其生产方法是将医用臭氧与医用盐水混合溶解达到预定臭氧浓度后，装入瓶中或者袋中或者注射器中，再冷冻结成冰形成；解决了注射用盐臭氧冰药品的规模化生产，标准化、规范化应用的所有技术问题，填补了目前国际上臭氧疗法中，无注射用盐臭氧冰制剂这一空白。
Description
本发明涉及一种臭氧类药品与它的生产，尤其涉及一种注射用盐臭氧冰药品与它的生产。
目前，病毒的变异，细菌的进化，使其抗药性不断增强，特别是病毒与耐药细菌感染，寻找有效的抗病毒、抗耐药细菌药品，一直是临床医生面临的重要课题。臭氧对细菌和病毒的灭活特别有效，一是能氧化分解细菌内部葡萄糖所需的酶，使细菌灭活死亡；二是直接与细菌、病毒作用，破坏它们的细胞器和DNA、RNA，使其新陈代谢受到破坏，导致细菌、病毒死亡；三是透过细胞膜组织，侵入细胞内，作用于外膜的脂蛋白和内部的脂多糖，使细菌发生通透性畸变而溶解死亡，已被证明臭氧对EB病毒、巨细胞病毒、乳头瘤病毒、HIV、带状疱疹、单纯性疱疹等病毒性疾病特别有效。另一方面，臭氧反应活性强，极易分解，很不稳定，在常温下会逐渐分解为氧气，其性质比氧活泼，臭氧会因光、热、水分、金属、金属氧化物以及其他的触媒而加速分解为氧。但臭氧在冰中极为稳定，其半衰期为2000年。再一方面，臭氧气体的注射治疗适用范围较窄,现局限于脊柱四肢关节无菌性疼痛的治疗，疗效欠佳；最新研究证实，20ppm的臭氧化生理盐水的注射对肿瘤有明显的抑制作用，并且安全无明显副作用；臭氧化生理盐水的静脉注射疗法可显著改善缺血组织的血流量和氧合作用，调节氧化应激和细胞因子的表达，在治疗肺血管疾病中具有重要作用；臭氧疗法还能够改善氧合作用，可稳定肝细胞代谢，使病毒感染患者纤维蛋白原和凝血酶原血浆水平趋于正常，提示臭氧疗法使肝蛋白合成得到改善；有大量研究表明，臭氧疗法对心脏、肝、肺、肾的组织氧化损伤具有保护作用。通过在水溶液中臭氧与氯化钠NaCl相互作用的文献资料分析结论，即0.9％氯化钠注射液中臭氧的分解不会伴随着除氧气以外的其他产物的形成，特别是没有观察到明显的次氯酸盐和氯酸盐的生成，这对臭氧化等渗盐溶液的医学应用具有特别重要的意义。臭氧治疗国际科学委员会(ISCO3)，于2020年3月13日批准了《臭氧在新型冠状病毒肺炎(SARS-CoV-2/COVID19)治疗中的潜在用途》，也推荐了臭氧化生理盐水疗法在新型冠状病毒肺炎(SARS-CoV-2/COVID19)治疗中的应用，该方法是在生理盐水(0.9％氯化钠注射液)中加入臭氧与氧气的混合气体，在鼓泡并达到饱和时，以80～120滴/分钟的速度静脉给药，但臭氧化生理盐水在常温下臭氧很容易分解，不易保存，因为医疗机构开展臭氧化盐水疗法的数量少，自制成本高，且需要及时制备，及时使用，所以难以推广，使臭氧治疗面临困境，更无法实现规模化生产，标准化、规范化使用。
发明内容
本发明的目的是，一是利用臭氧对细菌和病毒的灭活特别有效的特点，二是 利用臭氧修复组织缺血缺氧损伤的特殊作用，三是利用局部注射臭氧化生理盐水对肿瘤的抑制作用，四是利用臭氧在冰冻状态保存极为稳定、持久的特性，研究开发出一种既可以抗病毒、抗细菌、修复组织缺血缺氧损伤，又能够保存臭氧稳定、持久、有效，可以进行静脉滴注、人体内注射与人体内外冲洗的新药品，并且能够实现规模化生产，标准化、规范化应用的新药品，用于治疗某些病毒和细菌感染性疾病，某些组织器官的缺血性、缺氧性疾病，某些肿瘤等。因属于冰结构固体制剂，按药品命名规则，命名为注射用盐臭氧冰药品。
为了达到上述发明目的，本发明采用以下技术方案：
一种注射用盐臭氧冰药品，含有医用臭氧和医用盐及医用水，它是医用臭氧气体和医用盐水，混合溶解后，有达到预定的臭氧浓度，然后冻结形成冰，获得一种医用药物，其特征是：含有医用臭氧和医用盐水成分的注射用固体冰药品。
上述注射用盐臭氧冰药品所含的医用臭氧，其特征是：所含医用臭氧浓度为0.01ppm～600ppm。
上述注射用盐臭氧冰药品所含的医用盐水，其特征是：含有注射用盐、注射用水，注射用盐、注射用水的含量是混合溶解后渗透压与人体渗透压相等的含量，可以是0.9％氯化钠注射液，也可以是林格氏注射液(每100ml中，含氯化钙0.02g，氯化钾0.03g，氯化钠0.6g，乳酸钠0.31g)。
上述注射用盐臭氧冰药品产品的包装，其特征：包含有瓶包装、袋包装、注射器包装。
上述注射用盐臭氧冰药品产品的包装规格，其特征是：包装规格为0.5g～2000g。
上述的一种注射用盐臭氧冰药品的使用方法，其特征是：用于静脉滴注，皮下、肌肉、关节等体内注射，各种手术感染的冲洗消毒，人体各种感染的清洗消毒；或稀释后使用。
上述注射用盐臭氧冰药品的生产，一种是将医用氧气厂的相关生产线进行升级改造，增加设置臭氧系统、气液混合溶解平台等后，用瓶(袋)装的0.9％氯化钠注射液和林格氏注射液产品进行再加工，将其瓶(袋)中插入针，通入臭氧气体，使臭氧与盐水在瓶(袋)中混合溶解后冷冻结冰的方法进行生产，其特征是：按制药行业相关标准，至少设置有臭氧系统，导气管道系统，气液混合溶解平台，质量控制与检测系统，臭氧循环利用装置、废气处理装置；其气液混合溶解平台设有批量成对的供气针与排气针，供气针连接管道与臭氧系统，排气针连接管道与臭氧循环利用装置、废气处理装置，其质量控制与检测系统由臭氧浓度检测装置、臭氧流量控制装置、增压装置、制冷设备、冰冻设备组成；这种的生产至少包括以下步骤：
(1)将批量100ml～1000ml规格的0.9％氯化钠注射液瓶(袋)或林格氏注射液瓶(袋)，冷却至低温后置于气液混合溶解平台；
(2)在100ml～1000ml规格的0.9％氯化钠注射液瓶(袋)或林格氏注射液瓶(袋)中，批量成对插入供气针与排气针，形成气、液混合溶解瓶(袋)；
(3)调控臭氧气体浓度，将医用臭氧气体与氧气经供气针通入0.9％氯化钠注射液瓶(袋)或林格氏注射液瓶(袋)中，使臭氧气体与注射液混合溶解，得到预定浓度的瓶(袋)装的臭氧化盐水注射液；
(4)将步骤(3)得到的瓶(袋)装臭氧化盐水注射液置于冷冻设备中冷冻结冰，成为固体的、规格为100g～1000g的注射用盐臭氧冰药品。
或者将步骤(3)得到的瓶(袋)装臭氧化盐水注射液按0.5ml、1ml、5ml、10ml、20ml的规格分装于注射器中，再放入冷冻设备中冷冻结冰，成为固体的规格为0.5g、1g、5g、10g、20g的注射用盐臭氧冰药品(注射器)；
(5)将步骤(4)所得的注射用盐臭氧冰药品，置于冷藏设备中冷藏，定期进行质量抽检。
使用方法：遵照医嘱使用，可静脉滴注，皮下、肌肉、关节腔内等体内注射，人体内、外冲洗。
上述注射用盐臭氧冰药品的另一种生产，是对盐水制药厂进行升级改造，设置臭氧系统、气液混合溶解容器等后，将臭氧和盐水通入低温、高压的气液混合溶解容器中，得到臭氧化盐水，再分装成瓶装或者袋装，然后再冰冻结冰的方法进行生产；其特征是：按制药行业相关标准，至少设置有盐水系统、臭氧系统、气液混合溶解容器、气液管道系统、质量控制与检测系统、分配包装平台、臭氧循环利用装置、废气处理装置；其臭氧系统包括氧气源、臭氧发生器；其气液混合溶解容器设有进气管、多头喷雾器、排气管、排液管，进气管通过管道与臭氧系统供气管连接，多头喷雾器通过管道与盐水系统连接，排气管通过管道与臭氧循环利用装置及废气处理装置连接，排液管通过管道与分配包装平台连接；其质量控制与检测系统由臭氧浓度检测装置、臭氧流量控制装置、增压装置、制冷设备、冰冻设备组成。
这种设备组成的生产方法，至少包括以下步骤：
(1)常规制药流程获得注射用盐水并冷却至低温；调控臭氧气体浓度，将医用臭氧气体与氧气经管道通入气液混合溶解容器内，并使气液混合溶解容器内达到预定气压；
(2)打开气液混合溶解容器的多头喷雾器开关，注射用盐水在气液混合溶解容器内形成喷射状雾，使臭氧气体与注射用盐水混合溶解；得到预定臭氧浓度的臭氧化盐水；
(3)于分配包装平台开通排液管，将步骤(2)得到的预定臭氧浓度臭氧化盐水，按0.5ml～2000ml的规格，分装入瓶或袋或注射器中，得到预定臭氧浓度的臭氧化盐水瓶或预定臭氧浓度的臭氧化盐水袋或预定臭氧浓度的臭氧化盐水注射器；
(4)将步骤(3)得到的预定臭氧浓度的臭氧化盐水瓶或袋或注射器，置于冷冻设备中冷冻结冰，成为固体的、规格为0.5g～2000g的注射用盐臭氧冰药品。
(5)将步骤(4)所得的注射用盐臭氧冰药品，置于冷藏设备中冷藏，定期进行质量抽检。
使用方法：遵照医嘱使用，可静脉滴注，皮下、肌肉、关节腔内等体内注射，人体内、外冲洗。
上述注射用盐臭氧冰药品的另一种生产设备组成的气液混合溶解容器，其特征是：也可以设置或多个气液混合溶解容器，将第一个气液混合溶解容器的排液管与第二个气液混合溶解容器的多头喷雾器连接，第二个气液混合溶解容器的排液管与第三个气液混合溶解容器的多头喷雾器连接，依此连接，最后一个气液混合溶解容器的排液管与分配包装平台连接；各进气管通过管道与臭氧系统供气管连接，各排气管通过管道与臭氧循环利用装置及废气处理装置连接。
本发明的技术方案具有以下优点：
1、本发明利用臭氧在冰冻状态保存极为稳定、持久的特性，采用了一种注射用盐臭氧冰药品的技术方案，克服了现有臭氧化生理盐水疗法中，医疗机构因需要自己安排复杂的药品制备，而不愿开展臭氧化盐水疗法的弊端，解决了现有臭氧化生理盐水疗法中，臭氧易分解，不利于保存的难题，也解决了目前臭氧化盐水治疗无产品化、无质量标准化、无生产规模化的技术问题。本发明有利于生产管理部门制定生产流程、操作规范和技术标准，确保产品质量，更有利于医务人员在临床应用中总结相关臭氧治疗经验，制定疾病临床臭氧治疗规范，易于达成注射用盐臭氧冰药品临床应用治疗的标准化、规范化、普及化目标。填补了目前国际上臭氧疗法中无注射用臭氧冰类制剂这一空白。
2，本发明利用了臭氧对细菌和病毒的灭活特别有效的特点，利用了臭氧修复组织损伤的特殊能力，利用了局部注射臭氧化生理盐水对肿瘤的抑制作用，根据不同用药目的，制成不同臭氧浓度、不同规格、不同盐成分的注射用盐臭氧冰药品制剂，可以进行静脉滴注、人体内注射、人体内外冲洗，在一定情况下，较现有抗生素具有抗病毒，抗细菌，抗真菌效果好，毒副作用少，细菌、病毒、真菌不产生耐药性优点；较现有相关组织缺血缺氧性疾病治疗药物，具有组织修复更好，副作用更少的优点；较现有抗肿瘤药物，无明显毒副作用；可用于治疗心脑血管疾病，糖尿病，肿瘤，口腔感染，体表皮肤感染，会阴部位感染，阴道感染，各种手术的术中用药冲洗，外科清创，外科感染等的治疗。有利于臭氧治疗国际科学委员会(ISCO3)，推广臭氧化生理盐水疗法在新型冠状病毒肺炎(SARS-CoV-2/COVID19)治疗中的应用。
3、本发明采取与人体等渗透压的注射用盐臭氧冰技术方案中的体内注射，取代现有的臭氧气体体内注射治疗，解决了现有臭氧气体注射疗法的注射后注射部位疼痛的副作用，避免了臭氧气体直接注入体内对组织的损伤和刺激，促进了组织损伤的修复，减轻了病人痛苦，扩大了臭氧注射治疗的适应症，提高了相关疾病的治疗效果。
4、本发明可以通过对现有医用氧气厂或盐水制药厂的升级改造来生产，有利于更好地利用社会资源；还有利于生产管理部门制定生产流程、操作规范和技术标准，确保产品质量。
5、本发明还采用供给高浓度臭氧气体、低温、增压条件下，多个气液混合 溶解容器组合混合溶解臭氧与盐水的技术方案，可以大规模生产出600ppm臭氧浓度的注射用盐臭氧冰药品，可以满足临床、科研对注射用盐臭氧冰药品的各种需求，实现注射用盐臭氧冰药品向更广的领域推广应用。
6、本发明普通冰箱可以存放，在放置冰袋的保温箱中可以进行十小时内的运输，长时间的运输可以使用一般的冷藏车或冷藏柜，具有冷藏、运送相对容易的优点。
7、本发明生产成本低，冷藏成本低，使用成本低，应用范围广，可以替代某些相关药品，减少药品的毒、副作用，增强疗效，提高健康水平，还可以降低医疗费用，具有良好的社会效益。
图1是本发明实施例1生产过程简单流程图；
图2是本发明实施例4生产过程简单流程图；
图3是本发明实施例1生产设置的部分简单示意图；
图4是本发明实施例4生产设置的部分简单示意图；
图5是本发明实施例7生产过程简单流程图；
图6是本发明实施例7生产设置的部分简单示意图；
图标记包括：臭氧供气管1，残余气体回收管2，增压装置3，臭氧流量控制器4，臭氧浓度控制器5，供气针6，进气定向开关7，臭氧系统8，气液混合溶解区9，排气定向开关10，气液混合溶解平台11，排气管12，废气处理装置13，排气针14，臭氧循环利用装置15，排液管16，分配包装平台17，排液开关18，臭氧化盐水19，多头喷雾器20，气液混合溶解容器21，盐水管22，盐水系统23。
以下列举了8个实施例，并结合附图说明，对本发明的两种生产方法分别进行了进一步阐明。
实施例1：
一种注射用盐臭氧冰药品的一种生产，是将医用氧气厂的相关生产线进行升级改造，设置臭氧系统后，用制药厂的0.9％氯化钠注射液瓶产品，将其瓶中插入针，通入臭氧气体，使臭氧与盐水在容器中混合溶解后冷冻结冰的方法，按制药行业相关标准进行的设置，由臭氧系统8，导气管道系统，气液混合溶解平台11，质量控制与检测系统，臭氧循环利用装置15、废气处理装置13组成；臭氧系统按臭氧产能最高1kg/h生产标准设置；其气液混合溶解平台11设有批量成对的供气针6与排气针14，供气针6管道连接臭氧系统8，排气针14通过管道连接臭氧循环利用装置、废气处理装置13；其质量控制与检测系统由臭氧浓度控制器5、臭氧流量控制装置4、增压装置3、制冷设备、冰冻设备组成。以生产规格为100g、250g、500g、1000g臭氧含量0.03ppm浓度的注射用盐臭氧冰药品为例，简明阐述其生产方法与步骤：
(1)将批量的100ml、250ml、500ml、1000ml规格的0.9％氯化钠注射液瓶 冷却至5℃后，置于气液混合溶解平台11；
(2)在各个0.9％氯化钠注射液中，成对插入供气针6与排气针14，供气针深度插入注射液中，排气针插入深度在注射液的液平面之上，形成气、液混合溶解瓶；
(3)将医用臭氧气体以20g/h的速率经供气针6通入0.9％氯化钠注射液瓶中，使臭氧气体与0.9％氯化钠注射液混合溶解，得到0.05ppm浓度的瓶装的臭氧化盐水注射液；
(4)将步骤(3)得到的瓶装臭氧化盐水注射液置于冷冻设备中冷冻结冰，成为臭氧浓度为0.03ppm，规格为100g、250g、500g、1000g的注射用盐臭氧冰药品。
(5)将步骤(4)所得的注射用盐臭氧冰药品，置于-10℃冷藏环境中冷藏，定期进行质量抽检。
使用方法：遵照医嘱使用，可静脉滴注，皮下、肌肉、关节腔内等体内注射，人体内、外冲洗。
实施例2：
同实施例1所述的一种注射用盐臭氧冰药品的生产设置，对制药厂林格氏注射液瓶产品进行进一步加工，生产规格100g、250g、500g、1000g臭氧含量10ppm浓度的注射用盐臭氧冰药品，以下简明阐述其生产方法与步骤：
(1)将批量的100ml、250ml、500ml、1000ml规格的林格氏注射液瓶冷却至5℃后，置于气液混合溶解平台11；
(2)在各林格氏注射液瓶中，成对插入供气针6与排气针14，供气针深度插入注射液中，排气针插入深度在注射液的液平面之上，形成气、液混合溶解瓶；
(3)将医用臭氧气体以100g/h的速率经供气针6通入林格氏注射液瓶中，使臭氧气体与林格氏注射液混合溶解，得到12ppm浓度的瓶装臭氧化林格氏注射液；
(4)将步骤(3)得到的瓶装臭氧化林格氏注射液，置于冷冻设备中冷冻结冰，成为臭氧浓度为10ppm，规格为100g、250g、500g、1000g的注射用盐臭氧冰药品；
(5)同实施例1步骤(5)。
使用方法：同实施例1使用方法。
实施例3：
同实施例1所述的一种注射用盐臭氧冰药品的生产设置，对制药厂林格氏注射液瓶产品进行进一步加工，生产规格为0.5g、1g、5g、10g、20g的臭氧含量为60ppm浓度的注射用盐臭氧冰药品(注射器装)，以下简明阐述其生产方法与步骤：
(1)将批量的1000ml规格的林格氏注射液瓶冷却至5℃后，置于气液混合溶解平台11；
(2)在各林格氏注射液瓶中，成对插入供气针6与排气针14，供气针深度 插入注射液中，排气针插入深度在注射液的液平面之上，形成气、液混合溶解瓶；
(3)将医用臭氧气体以500g/h的速率经供气针6通入林格氏注射液瓶中，使臭氧气体与林格氏注射液混合溶解，得到72ppm浓度的瓶装臭氧化林格氏注射液；
(4)将步骤(3)得到72ppm浓度的瓶装臭氧化林格氏注射液，按0.5ml、1ml、5ml、10ml、20ml的规格分装入注射器中，再放入冷冻设备中冷冻结冰，成为固体的、规格为0.5g、1g、5g、10g、20g的臭氧含量为60ppm浓度的注射用盐臭氧冰药品(注射器装)。
(5)同实施例1步骤(5)。
使用方法：遵照医嘱使用，可皮下、肌肉、关节腔等体内注射。
实施例4：
一种注射用盐臭氧冰药品的另一种生产，对盐水制药厂进行升级改造，设置臭氧系统、气液混合溶解容器等后，将臭氧和盐水通入低温、高压的气液混合溶解容器中，得到臭氧化盐水，再分装、冰冻结冰的方法，按制药行业相关标准进行设置；由盐水系统23，臭氧系统8，气液混合溶解容器21，气液管道系统，质量控制与检测系统，分配包装平台17，臭氧循环利用装置15，废气处理装置13组成；其臭氧系统包括氧气源、臭氧发生器；气液混合溶解容器，设有进气管、多头喷雾器20、排气管、排液管，进气管与臭氧系统供气管道连接，多头喷雾器20通过管道与盐水系统连接，排气管与臭氧循环利用装置15及废气处理装置13连接，排液管与分配包装平台连接；质量控制与检测系统，由臭氧浓度检测装置5、臭氧流量控制装置4、增压装置3、制冷设备、冰冻设备组成。以生产规格为250g、500g、2000g臭氧含量3ppm浓度的注射用盐臭氧冰药品为例，简明阐述其生产方法与步骤：
(1)常规制药流程获得0.9％氯化钠注射液并冷却至3℃；将医用臭氧气体以50g/h的速率经管道通入气液混合溶解容器内，并达到预定的0.10Mpa气压；
(2)打开气液混合溶解容器的多头喷雾器开关，使0.9％氯化钠注射液在步骤(1)的气液混合溶解容器21内形成喷射状雾，使臭氧气体与0.9％氯化钠注射液混合溶解，得到臭氧浓度为3.6ppm的臭氧化0.9％氯化钠注射液；
(3)于分配包装平台17开通排液管16，将步骤(2)得到的臭氧浓度为3.6ppm的臭氧化0.9％氯化钠注射液，按250ml、500ml、2000ml的规格分装于瓶中；得到臭氧化0.9％氯化钠注射液瓶；
(4)将步骤(3)得到的臭氧浓度为3ppm的臭氧化0.9％氯化钠注射液瓶，置于冷冻设备中冷冻结冰，成为固体的、规格为250g、500g、2000g的臭氧含量3ppm浓度的注射用盐臭氧冰药品；
(5)将步骤(4)所得的医用臭氧化盐冰瓶，置于-10℃冷藏环境中冷藏，定期进行质量抽检。
使用方法：遵照医嘱使用，可静脉滴注，皮下、肌肉、关节腔内等体内注射，人体内、外冲洗。
实施例5：
同实施例4所述的注射用盐臭氧冰药品的生产设置，生产含有林格氏液成分的，规格100g、250g，臭氧含量25ppm浓度的注射用盐臭氧冰药品产品，以下简明阐述其生产方法与步骤：
(1)常规制药流程获得林格氏注射液并冷却至3℃；将医用臭氧气体以50g/h的速率经管道通入气液混合溶解容器21内，并达到预定的0.20Mpa气压；
(2)打开多头喷雾器开关，使林格氏注射液在步骤(1)的气液混合溶解容器21内形成喷射状雾，使臭氧气体与林格氏注射液混合溶解，得到臭氧浓度为30ppm的臭氧化林格氏注射液；
(3)于分配包装平台17开通排液管16，将步骤(2)得到的臭氧浓度为30ppm的臭氧化林格氏注射液，按100ml、250ml的规格分装于瓶中；得到臭氧化林格氏注射液瓶；
(4)将步骤(3)得到的臭氧浓度为30ppm的臭氧化林格氏注射液瓶，置于冷冻设备中冷冻结冰，成为固体的规格为100g、250g，臭氧含量25ppm浓度的注射用盐臭氧冰药品；
(5)同实施例4步骤(3)。
使用方法：同实施例4使用方法。
实施例6：
同实施例4所述的注射用盐臭氧冰药品的生产设置，生产含有0.9％氯化钠注射液成分的，臭氧含量60ppm浓度的注射用盐臭氧冰药品，以下简明阐述其生产方法与步骤：
(1)常规制药流程获得0.9％氯化钠注射液并冷却至1℃；将医用臭氧气体以300g/h的速率经管道通入气液混合溶解容器内，并达到预定的0.30Mpa气压；
(2)打开气液混合溶解容器的多头喷雾器开关，使0.9％氯化钠注射液在步骤(1)的气液混合溶解容器21内形成喷射状雾，臭氧气体与0.9％氯化钠注射液混合溶解后，得到臭氧浓度为72ppm的臭氧化0.9％氯化钠注射液；
(3)于分配包装平台17开通排液管16，将步骤(2)得到的臭氧浓度为72ppm的臭氧化0.9％氯化钠注射液，按0.5ml、1ml、5ml、10ml的规格分装于注射器中，得到臭氧化0.9％氯化钠注射液注射器；
(4)将步骤(3)得到的臭氧浓度为72ppm的臭氧化0.9％氯化钠注射液注射器，放置于冷冻设备中冷冻结冰，成为固体的、规格为0.5g、1g、5g、10g的，臭氧含量60ppm浓度的注射用盐臭氧冰药品注射器产品；
(5)同实施例4步骤(5)。
使用方法：遵照医嘱使用，可皮下、肌肉、关节腔等体内注射。
实施例7：
类似于实施例4的设置，但设有3个气液混合溶解容器，第一个气液混合溶解容器的排水管连接到第二个气液混合溶解容器的多头喷雾器20，第二个气液混合溶解容器的排水管连接到第三个气液混合溶解容器的多头喷雾器20，第 三个气体液体混合溶解容器的排水管与分配包装平台相连，其他设置类似于4(图5，图6)。以生产浓度为300ppm的可注射盐臭氧冰药，简要描述其生产方法和程序：
(1)常规制药流程获得0.9％氯化钠注射液并冷却至1℃；将医用臭氧气体以500g/h的速率经管道通入3个气液混合溶解容器内，并达到预定的0.30Mpa气压；
(2)打开第1个气液混合溶解容器的多头喷雾器开关，使0.9％氯化钠注射液在步骤(1)的气液混合溶解容器21内形成喷射状雾，臭氧气体与0.9％氯化钠注射液混合溶解后，得到臭氧浓度为150ppm的臭氧化0.9％氯化钠注射液；打开第1个气液混合溶解容器排液管，使150ppm的臭氧化0.9％氯化钠注射液经增压进入打开第2个气液混合溶解容器的多头喷雾器，使臭氧化0.9％氯化钠注射液在第2个气液混合溶解容器21内形成喷射状雾，得到臭氧浓度为260ppm的臭氧化0.9％氯化钠注射液；打开第2个气液混合溶解容器排液管，使260ppm的臭氧化0.9％氯化钠注射液经增压进入打开第3个气液混合溶解容器的多头喷雾器，使臭氧化0.9％氯化钠注射液在第3个气液混合溶解容器21内形成喷射状雾，得到臭氧浓度为360ppm的臭氧化0.9％氯化钠注射液；
(3)于分配包装平台17开通第3个气液混合溶解容器排液管16，将步骤(2)得到的臭氧浓度为360ppm的臭氧化0.9％氯化钠注射液，按100ml的规格分装于瓶中，得到瓶装的臭氧化0.9％氯化钠注射液；
(4)将步骤(3)得到的臭氧浓度为360ppm的瓶装臭氧化0.9％氯化钠注射液，放置于冷冻设备中冷冻结冰，成为固体的、规格为100g的，臭氧含量300ppm浓度的注射用盐臭氧冰药品产品；
(5)同实施例4步骤(5)。
用途：供临床和科研使用。
实施例8：
类似于实施例4的设置，但设有5个气液混合溶解容器，第一个气液混合溶解容器的排水管连接到第二个气液混合溶解容器的多头喷雾器20，第二个气液混合溶解容器的排水管连接到第三个气液混合溶解容器的多头喷雾器20，第三个气体液体混合溶解容器的排水管与分配包装平台相连，其他设置类似于4(参考图5，图6)。
生产含有0.9％氯化钠注射液成分的，规格200g，臭氧含量600ppm浓度的注射用盐臭氧冰药品，以下简明阐述其生产方法与步骤：
(1)常规制药流程获得0.9％氯化钠注射液并冷却至1℃；将医用臭氧气体以900g/h的速率经管道通入3个气液混合溶解容器内，并达到预定的0.30Mpa气压；
(2)打开第1个气液混合溶解容器的多头喷雾器开关，使0.9％氯化钠注射液在步骤(1)的气液混合溶解容器21内形成喷射状雾，臭氧气体与0.9％氯化钠注射液混合溶解后，得到臭氧浓度为260ppm的臭氧化0.9％氯化钠注射液； 打开第1个气液混合溶解容器排液管，使260ppm的臭氧化0.9％氯化钠注射液经增压进入第2个气液混合溶解容器的多头喷雾器，使臭氧化0.9％氯化钠注射液在第2个气液混合溶解容器21内形成喷射状雾，得到臭氧浓度为460ppm的臭氧化0.9％氯化钠注射液；打开第2个气液混合溶解容器排液管，使460ppm的臭氧化0.9％氯化钠注射液经增压进入第3个气液混合溶解容器的多头喷雾器，使臭氧化0.9％氯化钠注射液在第3个气液混合溶解容器21内形成喷射状雾，得到臭氧浓度为560ppm的臭氧化0.9％氯化钠注射液；打开第3个气液混合溶解容器排液管，使560ppm的臭氧化0.9％氯化钠注射液经增压进入第4个气液混合溶解容器的多头喷雾器，使臭氧化0.9％氯化钠注射液在第4个气液混合溶解容器21内形成喷射状雾，得到臭氧浓度为680ppm的臭氧化0.9％氯化钠注射液；打开第4个气液混合溶解容器排液管，使580ppm的臭氧化0.9％氯化钠注射液经增压进入第5个气液混合溶解容器的多头喷雾器，使臭氧化0.9％氯化钠注射液在第5个气液混合溶解容器21内形成喷射状雾，得到臭氧浓度为720ppm的臭氧化0.9％氯化钠注射液；
(3)于分配包装平台17开通第5个气液混合溶解容器排液16，将步骤(2)得到的臭氧浓度为720ppm的臭氧化0.9％氯化钠注射液，按200ml的规格分装于瓶中(或袋中)，得到瓶装(或袋装)的臭氧化0.9％氯化钠注射液；
(4)将步骤(3)得到的瓶装(或袋装)的臭氧浓度为720ppm的臭氧化0.9％氯化钠注射液，放置于冷冻设备中冷冻结冰，成为固体的、规格为200g的，臭氧含量600ppm浓度的注射用盐臭氧冰药品；
(5)同实施例4步骤(5)。
用途：供临床和科研使用。
Claims (10)
- 一种注射用盐臭氧冰药品，含有医用臭氧和医用盐及医用水，它是医用臭氧气体和医用盐水，混合溶解后，有达到预定的臭氧浓度，然后冻结形成冰，获得一种医用药物，其特征是：含有医用臭氧和医用盐水成分的注射用固体冰药品。
- 根据权利要求1所述的一种注射用盐臭氧冰药品所含的医用臭氧气体，其特征是：所含医用臭氧浓度为0.01ppm～600ppm。
- 根据权利要求1所述的一种注射用盐臭氧冰药品所含的医用盐水，其特征是：含有注射用盐、注射用水，注射用盐、注射用水的含量是混合溶解后渗透压与人体渗透压相等的含量，可以是0.9％氯化钠注射液，也可以是林格氏注射液(每100ml中，含氯化钙0.02g，氯化钾0.03g，氯化钠0.6g，乳酸钠0.31g)。
- 根据权利要求1所述的一种注射用盐臭氧冰药品的包装，其特征：包含有瓶包装、袋包装、注射器包装。
- 根据权利要求1所述的一种注射用盐臭氧冰药品的包装规格，其特征是：包装规格为0.5g～2000g。
- 根据权利要求1所述的一种注射用盐臭氧冰药品的使用方法，其特征是：用于静脉滴注，皮下、肌肉、关节等体内注射，各种手术感染的冲洗消毒，人体各种感染的清洗消毒；或稀释后使用。
- 一种注射用盐臭氧冰药品的一种生产设备的组成，其特征是：按制药行业相关标准，至少设置有臭氧系统，导气管道系统，气液混合溶解平台，质量控制与检测系统，臭氧循环利用装置、废气处理装置；其气液混合溶解平台，设有批量成对的供气针与排气针，供气针连接管道与臭氧系统，排气针连接管道与臭氧循环利用装置、废气处理装置；其质量控制与检测系统，由臭氧浓度检测装置、臭氧流量控制装置、增压装置、制冷设备、冰冻设备组成；这种生产设备的生产，至少包括以下步骤：(1)在批量100ml～1000ml规格的0.9％氯化钠注射液瓶(袋)或林格氏注射液瓶(袋)中，批量成对插入供气针与排气针，形成气、液混合溶解瓶(袋)；(2)调控臭氧气体浓度，将医用臭氧气体与氧气经供气针通入0.9％氯化钠注射液瓶(袋)或林格氏注射液瓶(袋)中，使臭氧气体与注射液混合溶解，得到预定臭氧浓度的瓶(袋)装的臭氧化盐水注射液；(3)将得到的瓶(袋)装的臭氧化盐水注射液置于冷冻设备中冷冻结冰，成为固体的、规格为100g～1000g的注射用盐臭氧冰药品；还可以将步骤(3)得到的瓶装(袋装)臭氧化盐水注射液，按0.5ml～50ml的规格分配装于注射器中，再放入冷冻设备中冷冻结冰，成为固体的规格为0.5g～50g的注射用盐臭氧冰药品(注射器装)。
- 一种注射用盐臭氧冰药品的另一种生产设备组成，其特征是：按制药行业相关标准，至少设置了盐水系统、臭氧系统、气液混合溶解容器、气液管道系 统、质量控制与检测系统、分配包装平台、臭氧循环利用装置、废气处理装置；其气液混合溶解容器设有进气管、多头喷雾器、排气管、排液管，进气管通过管道与臭氧系统供气管连接，多头喷雾器通过管道与盐水系统连接，排气管通过管道与臭氧循环利用装置及废气处理装置连接，排液管通过管道与分配包装平台连接；其质量控制与检测系统，由臭氧浓度检测装置、臭氧流量控制装置、增压装置、制冷设备、冰冻设备组成。
- 根据权利要求8所述的一种注射用盐臭氧冰药品的另一种生产设备的气液混合溶解容器，其特征是：可以设置2个以上的多个气液混合溶解容器，第一个气液混合溶解容器的排液管与第二个气液混合溶解容器的多头喷雾器连接，第二个气液混合溶解容器的排液管与第三个气液混合溶解容器的多头喷雾器连接，按照这种连接方式，最后一个气液混合溶解容器的排液管与分配包装平台连接；各个气液混合溶解容器的进气管通过管道与臭氧系统供气管连接，各个气液混合溶解容器的排气管通过管道与臭氧循环利用装置及废气处理装置连接。
- 根据权利要求8、9所述的一种注射用盐臭氧冰药品的另一种生产设备的生产，其特征是：至少包括以下步骤：(1)常规制药流程获得注射用盐水并冷却至低温；调控医用臭氧气体浓度，将医用臭氧气体与氧气经管道通入气液混合溶解容器内，并使气液混合溶解容器内达到预定气压；(2)打开气液混合溶解容器的多头喷雾器开关，注射用盐水在气液混合溶解容器内形成喷射状雾，使医用臭氧气体与注射用盐水混合溶解；得到含有预定臭氧浓度的医用臭氧化盐水；(3)于分配包装平台开通排液管，将含有预定臭氧浓度的医用臭氧化盐水，按0.5ml～2000ml的规格分装入瓶(袋或注射器)中，得到预定臭氧浓度的瓶装(袋装或注射器装)医用臭氧化盐水；(4)将得到含有预定臭氧浓度的瓶装(袋装或注射器装)医用臭氧化盐水，置于冷冻设备中冷冻结冰，成为固体的、规格为0.5g～2000g、臭氧含量0.01～600ppm浓度的注射用盐臭氧冰药品。
Applications Claiming Priority (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110605881 | 2021-05-26 | ||
| CN202110605881.X | 2021-05-26 | ||
| PH12021050250 | 2021-05-31 | ||
| PH12021050250 | 2021-05-31 | ||
| CN202110786169.4 | 2021-07-12 | ||
| CN202110786169 | 2021-07-12 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2022246990A1 true WO2022246990A1 (zh) | 2022-12-01 |
Family
ID=84229407
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/CN2021/107211 WO2022246990A1 (zh) | 2021-05-26 | 2021-07-19 | 一种注射用盐臭氧冰药品及其生产 |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2022246990A1 (zh) |
Citations (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH01131865A (ja) * | 1987-08-19 | 1989-05-24 | Ozo Company Limited Kk | 氷組成物 |
| JPH05196330A (ja) * | 1991-07-22 | 1993-08-06 | Katsumi Takao | オゾン溶解氷製造装置 |
| JP2000039239A (ja) * | 1998-07-21 | 2000-02-08 | Shinko Plant Kensetsu Kk | オゾン氷の製造システムと樹脂製容器に収容されたオゾン氷 |
| JP2006336899A (ja) * | 2005-05-31 | 2006-12-14 | Gunma Univ | オゾンガス含有製氷方法及び装置 |
| CN103120205A (zh) * | 2013-02-28 | 2013-05-29 | 江苏戚伍水产发展股份有限公司 | 臭氧冰在水产品加工和物流中的应用方法 |
| CN103318546A (zh) * | 2013-07-02 | 2013-09-25 | 辽宁自然冰科技有限公司 | 一种高浓度臭氧冰中空包装冰盒 |
| CN104784202A (zh) * | 2015-04-28 | 2015-07-22 | 郭淮铨 | 医用臭氧冰的制备方法 |
| CN105299993A (zh) * | 2015-10-30 | 2016-02-03 | 张旭 | 一种工业化生产臭氧冰的方法 |
| WO2017199827A1 (ja) * | 2016-05-17 | 2017-11-23 | シグマテクノロジー有限会社 | オゾンナノバブルを含む水溶液とその製造方法及び前記オゾンナノバブルを含む水溶液の使用 |
| CN110302148A (zh) * | 2019-07-08 | 2019-10-08 | 杨智勇 | 一种医用臭氧等渗无菌生理盐水及其制备方法和应用 |
| CN111569683A (zh) * | 2020-05-14 | 2020-08-25 | 深圳市陆讯纳米科技有限公司 | 一种高浓度长效臭氧纳米气泡水溶液及制备方法 |
| US20200384018A1 (en) * | 2017-11-30 | 2020-12-10 | Opt Creation Inc. | Ozone nanobubble anticancer agent |
| CN213254222U (zh) * | 2020-09-08 | 2021-05-25 | 深圳奇滨电子有限公司 | 一种臭氧水制备装置 |
-
2021
- 2021-07-19 WO PCT/CN2021/107211 patent/WO2022246990A1/zh active Application Filing
Patent Citations (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH01131865A (ja) * | 1987-08-19 | 1989-05-24 | Ozo Company Limited Kk | 氷組成物 |
| JPH05196330A (ja) * | 1991-07-22 | 1993-08-06 | Katsumi Takao | オゾン溶解氷製造装置 |
| JP2000039239A (ja) * | 1998-07-21 | 2000-02-08 | Shinko Plant Kensetsu Kk | オゾン氷の製造システムと樹脂製容器に収容されたオゾン氷 |
| JP2006336899A (ja) * | 2005-05-31 | 2006-12-14 | Gunma Univ | オゾンガス含有製氷方法及び装置 |
| CN103120205A (zh) * | 2013-02-28 | 2013-05-29 | 江苏戚伍水产发展股份有限公司 | 臭氧冰在水产品加工和物流中的应用方法 |
| CN103318546A (zh) * | 2013-07-02 | 2013-09-25 | 辽宁自然冰科技有限公司 | 一种高浓度臭氧冰中空包装冰盒 |
| CN104784202A (zh) * | 2015-04-28 | 2015-07-22 | 郭淮铨 | 医用臭氧冰的制备方法 |
| CN105299993A (zh) * | 2015-10-30 | 2016-02-03 | 张旭 | 一种工业化生产臭氧冰的方法 |
| WO2017199827A1 (ja) * | 2016-05-17 | 2017-11-23 | シグマテクノロジー有限会社 | オゾンナノバブルを含む水溶液とその製造方法及び前記オゾンナノバブルを含む水溶液の使用 |
| US20200384018A1 (en) * | 2017-11-30 | 2020-12-10 | Opt Creation Inc. | Ozone nanobubble anticancer agent |
| CN110302148A (zh) * | 2019-07-08 | 2019-10-08 | 杨智勇 | 一种医用臭氧等渗无菌生理盐水及其制备方法和应用 |
| CN111569683A (zh) * | 2020-05-14 | 2020-08-25 | 深圳市陆讯纳米科技有限公司 | 一种高浓度长效臭氧纳米气泡水溶液及制备方法 |
| CN213254222U (zh) * | 2020-09-08 | 2021-05-25 | 深圳奇滨电子有限公司 | 一种臭氧水制备装置 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| EP1465688B9 (en) | Bicarbonate-based solutions for dialysis therapies | |
| US20030232114A1 (en) | Method for liquid enrichment with oxygen and applications of enriched liquids | |
| US6986905B1 (en) | Pharmaceutical compositions for treating and saving and the method for the preparation thereof | |
| CN108697826A (zh) | 导管封管液及导管封管法 | |
| EP0510185B1 (en) | Blood platelet storage medium | |
| KR102570322B1 (ko) | 장기 및 조직 보존 용액의 안정성 및 유효 기간을 증가시키기 위한 용액 | |
| EP3427781B1 (en) | Drug and device system for pressurized aerosol therapies into a mammalian hollow space | |
| JPH07502544A (ja) | 眼内組織潅注用および眼内外科処置中の瞳孔散大維持用組成物 | |
| WO2022246990A1 (zh) | 一种注射用盐臭氧冰药品及其生产 | |
| CN105311081A (zh) | 山海丹野菊花注射液在雾化吸入、喷瓶气雾、直肠给药的应用及方法 | |
| CN104706655B (zh) | 注射用环磷腺苷葡胺粉针剂药物组合物和制法 | |
| CN116712452A (zh) | 一种注射用盐臭氧冰药品及其生产 | |
| CN100484512C (zh) | 一种高氧大输液体的制备方法 | |
| CN208114809U (zh) | 一种带开启边的液液双室输液用袋 | |
| US20190015606A1 (en) | Drug and Device System for Pressurized Aerosol Therapies into a Mammalian Hollow Space | |
| CN105267034A (zh) | 一种碳酸氢钠注射液的包装 | |
| RU2815501C1 (ru) | Раствор для предтрансплантационной подготовки донорских легких | |
| CN105213187A (zh) | 一种碳酸氢钠注射液的包装 | |
| CN103393593B (zh) | 一种包含盐酸氨溴索和果糖的药物组合物 | |
| JP4802492B2 (ja) | ヘパリン含有プレフィルドシリンジ製剤 | |
| CN109330979A (zh) | 氟碳携氧乳剂及其制备方法 | |
| CN104784202A (zh) | 医用臭氧冰的制备方法 | |
| CN108309932A (zh) | 一种肌肉注射用青蒿琥酯的溶剂 | |
| CN108926703A (zh) | 骨肽葡萄糖注射液 | |
| CN112675366B (zh) | 一种全息六维层离清奥术清奥剥离溶液的制备方法 |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 21942559 Country of ref document: EP Kind code of ref document: A1 |
|
| NENP | Non-entry into the national phase |
Ref country code: DE |
|
| 122 | Ep: pct application non-entry in european phase |
Ref document number: 21942559 Country of ref document: EP Kind code of ref document: A1 |