CN113577018A - Preparation process of sodium bicarbonate injection - Google Patents
Preparation process of sodium bicarbonate injection Download PDFInfo
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- CN113577018A CN113577018A CN202110844665.0A CN202110844665A CN113577018A CN 113577018 A CN113577018 A CN 113577018A CN 202110844665 A CN202110844665 A CN 202110844665A CN 113577018 A CN113577018 A CN 113577018A
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- sodium bicarbonate
- injection
- carbon dioxide
- diluting
- tank
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- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 title claims abstract description 344
- 235000017557 sodium bicarbonate Nutrition 0.000 title claims abstract description 172
- 229910000030 sodium bicarbonate Inorganic materials 0.000 title claims abstract description 172
- 238000002360 preparation method Methods 0.000 title claims abstract description 98
- 238000002347 injection Methods 0.000 title claims abstract description 69
- 239000007924 injection Substances 0.000 title claims abstract description 69
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 claims abstract description 165
- 238000007865 diluting Methods 0.000 claims abstract description 86
- 229910002092 carbon dioxide Inorganic materials 0.000 claims abstract description 82
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 82
- 239000001569 carbon dioxide Substances 0.000 claims abstract description 80
- 230000001954 sterilising effect Effects 0.000 claims abstract description 69
- 238000004659 sterilization and disinfection Methods 0.000 claims abstract description 63
- 239000007788 liquid Substances 0.000 claims abstract description 61
- 239000003814 drug Substances 0.000 claims abstract description 51
- 239000000243 solution Substances 0.000 claims abstract description 46
- 238000011049 filling Methods 0.000 claims abstract description 38
- 239000008215 water for injection Substances 0.000 claims abstract description 34
- 238000004519 manufacturing process Methods 0.000 claims abstract description 29
- 238000000034 method Methods 0.000 claims abstract description 24
- 238000003756 stirring Methods 0.000 claims abstract description 7
- 238000001914 filtration Methods 0.000 claims abstract description 4
- 238000010790 dilution Methods 0.000 claims description 13
- 239000012895 dilution Substances 0.000 claims description 13
- 238000005259 measurement Methods 0.000 claims description 9
- 238000007639 printing Methods 0.000 claims description 8
- 230000035939 shock Effects 0.000 claims description 5
- 239000000498 cooling water Substances 0.000 claims description 4
- 238000001816 cooling Methods 0.000 claims description 3
- 239000011159 matrix material Substances 0.000 claims description 3
- 238000005429 filling process Methods 0.000 claims description 2
- 230000007423 decrease Effects 0.000 claims 1
- 230000000694 effects Effects 0.000 abstract description 8
- 229940079593 drug Drugs 0.000 abstract description 5
- 238000001802 infusion Methods 0.000 abstract description 4
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 15
- 239000000047 product Substances 0.000 description 13
- 238000009826 distribution Methods 0.000 description 9
- 239000002994 raw material Substances 0.000 description 8
- 238000004140 cleaning Methods 0.000 description 7
- 239000007789 gas Substances 0.000 description 7
- 238000005303 weighing Methods 0.000 description 7
- QGZKDVFQNNGYKY-UHFFFAOYSA-N Ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 description 6
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 description 6
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 6
- 239000000463 material Substances 0.000 description 6
- VNWKTOKETHGBQD-UHFFFAOYSA-N methane Chemical compound C VNWKTOKETHGBQD-UHFFFAOYSA-N 0.000 description 6
- 238000003860 storage Methods 0.000 description 6
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 5
- 235000011121 sodium hydroxide Nutrition 0.000 description 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
- JCXJVPUVTGWSNB-UHFFFAOYSA-N Nitrogen dioxide Chemical compound O=[N]=O JCXJVPUVTGWSNB-UHFFFAOYSA-N 0.000 description 4
- XYFCBTPGUUZFHI-UHFFFAOYSA-N Phosphine Chemical compound P XYFCBTPGUUZFHI-UHFFFAOYSA-N 0.000 description 4
- RAHZWNYVWXNFOC-UHFFFAOYSA-N Sulphur dioxide Chemical compound O=S=O RAHZWNYVWXNFOC-UHFFFAOYSA-N 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 239000008213 purified water Substances 0.000 description 4
- RWSOTUBLDIXVET-UHFFFAOYSA-N Dihydrogen sulfide Chemical compound S RWSOTUBLDIXVET-UHFFFAOYSA-N 0.000 description 3
- 239000002253 acid Substances 0.000 description 3
- 238000005273 aeration Methods 0.000 description 3
- 239000003513 alkali Substances 0.000 description 3
- 229910021529 ammonia Inorganic materials 0.000 description 3
- 238000006243 chemical reaction Methods 0.000 description 3
- 229910000037 hydrogen sulfide Inorganic materials 0.000 description 3
- 238000007689 inspection Methods 0.000 description 3
- 238000004806 packaging method and process Methods 0.000 description 3
- 229910000073 phosphorus hydride Inorganic materials 0.000 description 3
- 229910000029 sodium carbonate Inorganic materials 0.000 description 3
- 235000017550 sodium carbonate Nutrition 0.000 description 3
- 238000005507 spraying Methods 0.000 description 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- GRYLNZFGIOXLOG-UHFFFAOYSA-N Nitric acid Chemical compound O[N+]([O-])=O GRYLNZFGIOXLOG-UHFFFAOYSA-N 0.000 description 2
- 241000973497 Siphonognathus argyrophanes Species 0.000 description 2
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 description 2
- 230000001580 bacterial effect Effects 0.000 description 2
- 238000010923 batch production Methods 0.000 description 2
- 238000009835 boiling Methods 0.000 description 2
- 238000004364 calculation method Methods 0.000 description 2
- 230000000249 desinfective effect Effects 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 238000011068 loading method Methods 0.000 description 2
- 238000012423 maintenance Methods 0.000 description 2
- 239000003345 natural gas Substances 0.000 description 2
- 229910017604 nitric acid Inorganic materials 0.000 description 2
- 238000003672 processing method Methods 0.000 description 2
- 238000004064 recycling Methods 0.000 description 2
- 238000010992 reflux Methods 0.000 description 2
- 238000001223 reverse osmosis Methods 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 238000010561 standard procedure Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 238000004448 titration Methods 0.000 description 2
- 235000001674 Agaricus brunnescens Nutrition 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 239000004215 Carbon black (E152) Substances 0.000 description 1
- 239000003570 air Substances 0.000 description 1
- 239000012670 alkaline solution Substances 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 230000001174 ascending effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000036770 blood supply Effects 0.000 description 1
- 238000009395 breeding Methods 0.000 description 1
- 230000001488 breeding effect Effects 0.000 description 1
- 239000006227 byproduct Substances 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- 238000003763 carbonization Methods 0.000 description 1
- 230000008094 contradictory effect Effects 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 238000007405 data analysis Methods 0.000 description 1
- 239000000645 desinfectant Substances 0.000 description 1
- 238000000502 dialysis Methods 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 239000003651 drinking water Substances 0.000 description 1
- 235000020188 drinking water Nutrition 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 238000013467 fragmentation Methods 0.000 description 1
- 238000006062 fragmentation reaction Methods 0.000 description 1
- 229930195733 hydrocarbon Natural products 0.000 description 1
- 150000002430 hydrocarbons Chemical class 0.000 description 1
- 230000002209 hydrophobic effect Effects 0.000 description 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 239000012452 mother liquor Substances 0.000 description 1
- 239000008238 pharmaceutical water Substances 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 238000005086 pumping Methods 0.000 description 1
- 238000000746 purification Methods 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 230000008929 regeneration Effects 0.000 description 1
- 238000011069 regeneration method Methods 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 230000029058 respiratory gaseous exchange Effects 0.000 description 1
- 235000019643 salty taste Nutrition 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 238000010008 shearing Methods 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 238000012414 sterilization procedure Methods 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 230000002194 synthesizing effect Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0023—Heat
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/21—Pharmaceuticals, e.g. medicaments, artificial body parts
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a preparation process of a sodium bicarbonate injection, and relates to a preparation method of an infusion preparation. The method comprises the following steps: preparing liquid in a diluting preparation tank; carbon dioxide is filled in the diluting preparation tank and is used for adjusting the PH value of the sodium bicarbonate solution; filtering and filling; and (3) sterilization: when sodium bicarbonate and water for injection are added into a diluting preparation tank, part of the water for injection is added firstly to determine the content, and then the rest of the water for injection is added according to the measured result. Wherein, the impact motion of stirring and sterilization achieved by filling carbon dioxide is continued until the filling of the sodium bicarbonate liquid medicine in the diluting preparation tank is finished. Wherein, during sterilization, the soft bag placement is well adjusted, and good sterilization effect is obtained. The invention obtains better sterilization effect and ensures the drug effective components of the drug under the condition of well controlling the production cost and the production efficiency.
Description
Technical Field
The invention relates to a processing method of an infusion preparation.
Background
Sodium bicarbonate solution preparations are directly infused into the venous blood of the human body, and therefore, the sodium bicarbonate solution must have safety and must ensure necessary drug efficacy in order to achieve therapeutic effects for use. The effective components of the drug effect have clear and relevant regulations in Chinese pharmacopoeia.
The safety requirement is also related to the requirement that the total amount of heat source substances which are easy to cause heat source reaction in the finished infusion soft bag must be controlled within a standard range, wherein the main control is the sterilization process.
Therefore, the sterilization work must be done in an effort to solve the efficacy of the preparation in consideration of the reduction of the production cost.
Disclosure of Invention
In order to solve the technical problems, the invention provides a processing method of an infusion preparation, in particular to a preparation process of a sodium bicarbonate injection, which comprises the following steps:
(1) and adding sodium bicarbonate and water for injection into a diluting preparation tank to obtain sodium bicarbonate liquid medicine.
(2) And filling carbon dioxide into the sodium bicarbonate liquid medicine, wherein the pH of the sodium bicarbonate liquid medicine is adjusted to 7.8-8.0.
(3) Filtering and filling the sodium bicarbonate liquid medicine to obtain the sodium bicarbonate injection soft bag.
(4) And sterilizing:
(i) placing the sodium bicarbonate injection soft bag on a sterilization vehicle, pushing the sodium bicarbonate injection soft bag into a sterilization cabinet, and closing the sterilization cabinet door; operating the sterilization cabinet; operating the sterilization cabinet; wherein the steam for sterilization is 0.4-0.6 Mpa, the compressed air is 0.4-0.7 Mpa, and the pressure of the sterilized cooling water is 0.3-0.4 Mpa.
(ii) And after sterilization, taking out the sodium bicarbonate injection soft bag, cooling and removing water marks on the surface of the bag.
The preparation process of the sodium bicarbonate injection comprises the following steps of:
(i) the water for injection is added into a diluting tank, wherein the amount of the water for injection is more than 90% of the prescription amount, and sodium bicarbonate is dissolved and diluted into sodium bicarbonate liquid medicine containing less than 105% of sodium bicarbonate in the marked amount in the content measurement.
Then, (ii) adding the remaining prescribed amount of the sodium bicarbonate solution and diluting the sodium bicarbonate solution into water for injection containing more than 95% of the sodium bicarbonate solution in the indicated amount by content measurement.
Wherein the prescription amount is as follows: adding sodium bicarbonate according to the total production quantity of the production batches, wherein when 8.4g of sodium bicarbonate is contained in each 100ml of water for injection, the amount of the water for injection is required to be added to meet the condition that the content of the sodium bicarbonate in the content measurement is equal to 100% of the marked amount.
The preparation process of the sodium bicarbonate injection comprises the following steps of: the carbon dioxide is filled into the sodium bicarbonate liquid medicine, and the shock motion which has the functions of stirring and sterilizing the sodium bicarbonate liquid medicine is continuously generated until the filling of the sodium bicarbonate liquid medicine in the diluting tank is finished.
The preparation process of the sodium bicarbonate injection comprises the following steps of filling carbon dioxide from the bottom of a dilution tank, uniformly dispersing the carbon dioxide into a plurality of thin flows, and allowing the thin flows to enter the sodium bicarbonate liquid.
The preparation process of the sodium bicarbonate injection comprises the step of discontinuously spraying carbon dioxide from the densely distributed air holes with the diameter of less than 5mm at the bottom of the diluting preparation tank to form dense carbon dioxide bubbles in the sodium bicarbonate liquid in the diluting preparation tank.
The preparation process of sodium bicarbonate injection comprises the steps of mixing sodium bicarbonate solution with carbon dioxide, and then adding sodium bicarbonate solution into a dilution tank, wherein the sodium bicarbonate solution is mixed with the carbon dioxide to form a mixture, wherein the mixture is mixed with the carbon dioxide, and the mixture is stirred for a while.
The preparation process of the sodium bicarbonate injection comprises the following steps of preparing a diluted distribution tank, wherein the bottom of the diluted distribution tank is densely provided with air holes with the diameter smaller than 5mm, specifically, the diameter of the air holes at the bottom of the diluted distribution tank is different, the air holes with different diameters are adjacently arranged to form an air hole group, the air hole group is formed by a plurality of air hole groups which are distributed at the bottom of the diluted distribution tank in a matrix manner, the air bubbles at different depth positions in the diluted distribution tank are continuously broken from different positions on the same plane, and the impact for sterilization is approximately and uniformly formed at each position in the diluted distribution tank.
The preparation process of the sodium bicarbonate injection comprises the step of filling carbon dioxide, wherein the carbon dioxide is gaseous, and the inflation pressure is 0.1-0.8 Mpa.
The preparation process of the sodium bicarbonate injection comprises the following steps of:
(i) further, the charging pressure of carbon dioxide into the diluting tank is reduced, and the carbon dioxide bubbles of at least 2/3 are kept to be broken below the water level of the sodium bicarbonate solution.
The method specifically comprises the following steps: when the sodium bicarbonate liquid medicine in the diluting preparation tank exceeds 2/3 of the total volume of the diluting preparation tank, the inflation pressure of the carbon dioxide is below 0.4 Mpa; when the sodium bicarbonate liquid medicine in the diluting preparation tank is 2/3-1/3 of the total volume of the diluting preparation tank, the inflation pressure of the carbon dioxide is 0.4-0.6 Mpa;
when the sodium bicarbonate solution in the diluting tank is below 1/3 of the total volume of the diluting tank, the inflation pressure of carbon dioxide is above 0.6 Mpa.
(ii) And then reduce the flow of filling into carbon dioxide to the diluting preparation jar, specifically do: when the sodium bicarbonate liquid medicine in the diluting preparation tank exceeds 1/2 of the total volume of the diluting preparation tank, the air holes of the bottom of the diluting preparation tank which are completely filled with carbon dioxide are opened at the same time to fill the diluting preparation tank with carbon dioxide; when the sodium bicarbonate liquid medicine in the diluting preparation tank is lower than 1/2 of the total volume of the diluting preparation tank, at least 1/2 air holes for filling carbon dioxide at the bottom of the diluting preparation tank are closed, and the residual air holes are used for filling the carbon dioxide into the diluting preparation tank.
The preparation process of the sodium bicarbonate injection comprises the following steps of:
(i) the sodium bicarbonate injection soft bags are arranged in a way that the printing surface faces upwards, the back faces downwards, and the mouth seals and the top seals of all the sodium bicarbonate injection soft bags face to the same direction;
(ii) the placing quantity of the sodium bicarbonate injection soft bags is as follows:
setting the number of the sodium bicarbonate injection soft bags with the maximum sterilization per batch and the number of sterilization vehicles in the sterilization cabinet per time; and the number of the first sterilization vehicles;
and when each batch of products are loaded according to the mode and the quantity, if the last sterilization cabinet is not full, the blank water bag which has the same external shape and the same filling volume as the batch of the sodium bicarbonate injection soft bags and is provided with a mark in a striking way is adopted for filling.
The invention obtains better sterilization effect and ensures the drug effective components of the drug under the condition of well controlling the production cost and the production efficiency.
Drawings
FIG. 1 is a schematic view of the process for preparing water for injection according to the present invention.
FIG. 2 is a flow chart of the preparation process of the sodium bicarbonate injection soft bag of the invention.
FIG. 3 is a bubble distribution diagram as seen in a cross-sectional view of the letdown tank.
Figure 4 is a bubble distribution diagram as seen in longitudinal section through the letdown tank.
Detailed Description
In the production line of the invention, the raw and auxiliary materials are weighed and diluted in a C-level purification area, the batch production instructions are rechecked before weighing, and the batch production instructions are rechecked independently during weighing, so that calculation errors are avoided; cleaning and disinfecting a diluting preparation tank, a pipeline, a filter, various tools and a container before use, and immediately cleaning and regularly disinfecting after use; the weighing apparatus should be accurately and regularly checked.
Example 1
In this patent, sodium bicarbonate is used as a pharmaceutical grade, for example, a pharmaceutical grade sodium bicarbonate obtained by the following process: refer to patent CN102476815A "a process for producing pharmaceutical grade sodium bicarbonate".
Preparing a plurality of edible sodium carbonate, edible sodium bicarbonate, caustic soda and pure water or mother liquor into an alkaline solution with the pH value of 10-11 (5 percent concentration) and the density of 11.5-12.5 at the temperature of 70-90 ℃. Keeping the temperature for precipitation for several hours, then performing precision filtration, and decoloring by using active carbon if necessary. The solution is placed in a carbonization reactor. Introducing edible carbon dioxide and tail gas of the reaction from the bottom of the reactor, controlling the gas flow at 5-30 m3/hr and the tail gas flow at 5-30 m3/hr, reacting for 10-60 min, and taking out the feed liquid. And (4) separating the feed liquid in a centrifugal machine, and washing the solid with a proper amount of pure water according to the concentration of the chloride until the chloride is qualified. And (4) conveying the washed solid into an air flow dryer or a boiling dryer for drying to obtain a finished product.
The product meets all indexes of sodium bicarbonate item in Chinese pharmacopoeia 2010 version [ for blood supply dialysis ], oral administration and injection ]. The chemical reaction formula of the process is as follows:
Na2CO3+H2O+CO2＝2NaHCO3
NaOH+CO32+＝NaHCO3+H2O
NaOH+NaHCO3＝Na2CO3+H2O
the quality control standard is in accordance with the standards of Chinese pharmacopoeia 2010 edition (second edition) and enterprises. Part of the criteria are as follows:
the characteristics are as follows: the product is white crystalline powder; no odor, salty taste; slowly decomposing in humid air; the aqueous solution is left for a long time, or shaken, or heated, and the alkalinity is increased. The product is soluble in water and insoluble in ethanol.
Content determination: weighing about 1g of the product, accurately weighing, adding 50mL of water for dissolving, adding 10 drops of mixed indicator solution of methyl red-bromocresol green, titrating with hydrochloric acid titration solution (0.5mo/L) until the solution is changed from green to purple, boiling for 2 minutes, cooling to room temperature, and continuously titrating until the solution is changed from green to dark purple. Each 1mL of hydrochloric acid titration solution (0.5mol/L) corresponds to 42.00mg of NaHCO 3.
The pharmaceutical grade sodium bicarbonate can be prepared by the above method.
Example two
The carbon dioxide used in the technology is obtained by adopting a system for preparing and filling the industrial carbon dioxide with the carbon dioxide in the patent CN 209977709U.
The carbon dioxide raw material is high-purity industrial liquid carbon dioxide which is a byproduct in ammonia synthesis by taking natural gas as a raw material and does not contain substances such as PH3, H2S, SO2, NO2 and NH 4. Of course, the source of the raw material is not necessarily limited to carbon dioxide by-produced in the process of synthesizing ammonia by using natural gas as the raw material, and the carbon dioxide can be high-purity industrial liquid carbon dioxide which has the content of each component within the content range defined by pharmacopoeia and does not contain PH3, H2S, SO2, NO2 and NH 4. The carbon dioxide product meets the requirements of 2015 edition of Chinese pharmacopoeia on carbon dioxide indexes of the medicine as follows, and comprises the following components:
the content of CO2 is more than or equal to 99.5 percent; the water content is less than or equal to 67 PPM; SO2 is less than or equal to 2 PPM; CO is less than or equal to 5 PPM; phosphine is less than or equal to 0.3 PPM; hydrogen sulfide is less than or equal to 1.0 PPM; ammonia is less than or equal to 25 PPM; the hydrocarbon is less than or equal to 20PPM (calculated by methane).
Example three
The water for injection used in the technology is the water for pharmacy.
Referring to fig. 1, the preparation, storage and circulation process of water for injection is schematically shown. The purified water is prepared by taking drinking water as raw water through pretreatment and a secondary reverse osmosis device, the injection water is prepared by taking the purified water as a water source through a multi-effect distilled water machine, and the purified water is stored in a 316L stainless steel storage tank qualified in cleaning and disinfection.
The preparation system comprises the following steps: the mechanical filter, the activated carbon filter and the softener are periodically regenerated and backwashed according to the maintenance regulation of the preparation system; the pretreatment system carries out disinfection treatment according to the process flow every half year; the activated carbon column and the softening resin bed are replaced periodically every year; the filter element of the breathing filter of the reverse osmosis intermediate water tank is replaced every 3 months, and the filter element is disinfected on line every month.
The storage and circulation requirements of the water for injection are as follows:
after the injection water storage and circulation system is cleaned and disinfected and put into production use, the circulation water pump generally does not stop running, so that microorganisms are prevented from breeding in the system; a hydrophobic sterilization filter is arranged at an air port of the storage tank and is replaced every 3 months; conveying the mixture to a full loop for recycling, and performing online disinfection every month; the water for injection is stored at a temperature above 70 ℃ and is subjected to heat preservation circulation (by a backwater thermometer) and is conveyed to a full loop for recycling.
Management of water for injection: during short-time production stoppage and maintenance of equipment, accumulated water in a storage tank and a pipeline is drained, and meanwhile, online sterilization is carried out when the equipment is started; cleaning with alkali solution (1% NaOH) or acid solution (3% HNO3 or 2% citric acid) once every half year, and sterilizing online; stopping production for more than one week, cleaning with alkali solution (1% NaOH) or acid solution (3% HNO3 or 2% citric acid) during regeneration, and sterilizing online; stopping production for more than 1 day, and sterilizing online.
After each acid or alkali cleaning, a newly prepared water system for injection (including a distribution system) is used for cleaning and qualified, and then pure steam online sterilization is carried out for 30 minutes at the temperature of 121 ℃.
The quality standard of the pharmaceutical water is as follows:
| quality standard | Quality standard numbering | |
| Water for injection | Quality Standard of Water for injection | STP-10-07-003 |
Example four
The sterilization of sodium bicarbonate injection soft bag adopts overheated water bath backpressure formula sterilizer to sterilize, before beginning sterilization, open machine power and relevant technology medium (industrial steam, compressed air, purified water, cooling water), whether inspection industrial steam reaches 0.4 ~ 0.6Mpa, whether compressed air reaches 0.4 ~ 0.7Mpa, whether cooling water pressure reaches 0.3 ~ 0.4Mpa, open the automatic sliding door of sterilizer, in will already according to the 19 layers of sterilization car (total 6 cars) that the soft bag was placed according to the regulation push into the sterilizer, close the machine door, according to each kind of production instruction, set up the sterilization procedure parameter: the temperature and time values were measured and the equipment was run according to "Standard operating procedure for Water bath Sterilization cabinets".
During sterilization, the sodium bicarbonate injection soft bag is arranged in a way that the printing surface faces upwards and the back surface faces downwards, and when the sodium bicarbonate injection soft bag is placed, the opening seal and the top seal face towards the same direction respectively. The printing surface is the surface printed with the product name and the production information, and because the printing surface is printed by the ink, if the printing surface is downward and is directly contacted with the tray, the printing ink can be adhered to the tray, and the printing ink falls off the tray at high temperature. The mouth seal is one side of the sodium bicarbonate injection soft bag with a tube mouth, and the top seal is the other side opposite to the tube mouth side.
The placing quantity of the sodium bicarbonate injection soft bags is as follows:
according to the specification example of the sodium bicarbonate injection soft bag of 250 ml: the maximum sterilization amount of each batch is 13680 bags, the batch is sterilized by 2 cabinets (the outer package is marked with serial numbers), and the maximum loading amount of each cabinet is 6840 bags of 6 vehicles; the number of each vehicle is 1140 bags, so each vehicle is loaded with 19 sterilization trays, and each tray is provided with 10 transverse rows and 6 vertical rows of sodium bicarbonate injection soft bags.
Each batch of products are loaded strictly according to the mode and the quantity (full load), if the last sterilization cabinet is not full, the loading mode cannot be changed, and a blank water bag is adopted for filling so as to prevent the products from being mixed. The blank water bag is filled by the blank water bag which has the same external shape and the same filling volume as the batch of the sodium bicarbonate injection soft bag and is provided with marks in a striking way, for example, a plurality of striking characters of 'empty bags' can be arranged, and the blank water bag is printed by adopting a color different from that of the product.
Sterilization parameters:
wherein, the F0 value is the standard sterilization time, which is the equivalent sterilization time of a product at 121 ℃ given by the sterilization process. Thus, during the sterilization process, the F0 value can be calculated by the formula by recording the temperature and time of the sterilized article. When the F0 value was greater than 8 minutes, it was confirmed that a reliable sterilization effect was achieved.
The present exemplary sterilization process can achieve a more reliable sterilization effect.
Example five
A process for preparing sodium bicarbonate solution.
The raw materials (mainly sodium bicarbonate) and auxiliary materials which are qualified by inspection are transported into an external packaging removal room according to the standard operation procedure of a clean production area, after the external packaging is removed, the surface of the internal packaging is wiped and disinfected by a specified disinfectant and then is transported to a goods shelf of an air lock room, after the batching personnel arrive at the air lock room to pick up the raw materials and the auxiliary materials, the accurate calculation and the accurate weighing are carried out according to the prescription specification, and after the raw materials and the auxiliary materials are rechecked by other people, the raw materials and the auxiliary materials are prepared according to the following processes:
opening a valve of the water for injection, adding 90 percent of the injection water according to the prescription amount into a diluting preparation tank, and controlling the temperature to be 40-50 ℃. Starting a stirrer for stirring, accurately weighing (and rechecking) the sodium bicarbonate with the prescription amount, adding the sodium bicarbonate into a diluting preparation tank until the sodium bicarbonate is completely dissolved (20-30 minutes), adding water for injection to the full amount, starting the stirrer for stirring for 10 minutes, monitoring the pH value, filling carbon dioxide until the pH value is 7.8-8.0, keeping the filling of the carbon dioxide until the filling is finished, recording the pressure of the preparation tank, and starting a refilter pump to refilter the sodium bicarbonate liquid medicine for 25 minutes through a refilter system.
Samples were taken from the sampling point (after the first 0.22 μm filter) for intermediate detection.
And after the intermediate is detected to be qualified, an intermediate inspection report is received.
And refluxing the sodium bicarbonate liquid medicine for 20 minutes through a second 0.22 mu m filter, adjusting a total reflux valve to ensure that the water outlet pressure of the terminal filter is between 0.10 and 0.30Mpa, simultaneously sending a filling signal, and opening a filling related valve to discharge for 10 seconds.
The method comprises the following steps:
the preparation of sodium bicarbonate solution should not exceed 6 hours (including intermediate detection time) from the beginning of feeding to the end of preparation.
(II) the time from the preparation of the sodium bicarbonate liquid medicine to the sterilization of the last cabinet of the batch is not more than 16 hours.
(III) intermediate quality standard: STP-14-03-003 of sodium bicarbonate injection intermediate quality Standard.
Example six
When sodium bicarbonate and water for injection are prepared, the sodium bicarbonate and the water for injection are prepared in a diluting preparation tank, and when the sodium bicarbonate and the water for injection are prepared according to the process, because the material dosage is accurately calculated and accurately weighed, and the sodium bicarbonate and the water for injection are prepared after being rechecked by other people without errors, various contents in the sodium bicarbonate liquid medicine are within the standard regulation.
However, because the preparation amount is very large and errors exist in the process, the content of the finally prepared sodium bicarbonate solution is determined to have certain deviation from the highest standard, and in order to reduce the deviation as much as possible and improve the quality of the sodium bicarbonate injection soft bag, the following method can be adopted for preparation, so that the deviation can be further reduced. The method comprises the following steps:
firstly, adding more than 90% of injection water into a diluting preparation tank, wherein the injection water can dissolve and dilute sodium bicarbonate, and the sodium bicarbonate liquid after the 90% of injection water is diluted achieves that the content of the sodium bicarbonate in the sodium bicarbonate liquid is lower than 105% of the marked amount in the content measurement, must be ensured to be between 95% and 105%, and optimally is kept to be 103%.
Secondly, thereafter, the remaining prescribed amount (approximately 10%) of water for injection is added and the solution is further diluted so that the sodium bicarbonate solution obtained, as measured by the content, contains more than 95% of the indicated amount of sodium bicarbonate and must be guaranteed to be between 95% and 105%, optimally between 100% and 101%.
In the two steps, if the total amount of water is added for the first time, the sodium bicarbonate contained in the sodium bicarbonate liquid medicine is found to be lower than the marked amount (required to be 100%) through content measurement, and the correction cannot be carried out through means again at the moment, so that the content-measured sodium bicarbonate contained in the sodium bicarbonate injection soft bag product off-line in the production line is lower than the marked amount (lower than 100%), and in order to avoid the phenomenon, only 90% of the amount of the prescription is added when the water for injection is added for the first time; after the content is measured, calculating the amount of the injection water needed to be supplemented, so that the sodium bicarbonate is better between 100% and 101%, and then adding the calculated amount of the injection water for the second time. The sodium bicarbonate content in the first injection water was less than 105% of the indicated amount in the determination of the content, which is the margin for the second adjustment.
The prescribed amount of the water for injection mentioned here is the amount of the water for injection which is required to be added to satisfy the requirement that the content of the sodium bicarbonate is equal to 100% of the indicated amount in the content measurement when 8.4g of the sodium bicarbonate is contained in 100ml of the water for injection in the total amount of the production lot. The calculated prescription amount is accurate, but only a theoretical value is calculated, an error exists in the actual operation, the actual operation is not a fixed value, and after the rest prescription amount of the injection water is added in the second step, the prescription amount is the sum of the injection water actually added for the first time and the injection water actually added for the second time.
Example seven
Generally, only one function of injecting carbon dioxide into the diluting preparation tank is to adjust the pH value of the sodium bicarbonate liquid in the diluting preparation tank. In this embodiment, when the carbon dioxide is introduced into the diluting preparation tank, the pressure and the flow rate of the introduction are set, so that the impact motion continuously generated when the carbon dioxide is filled can be obtained, the stirring and sterilizing effects on the sodium bicarbonate liquid medicine are achieved, and the stirring and sterilizing effects are continued until the filling of the sodium bicarbonate liquid medicine in the diluting preparation tank is completed.
Through experimental observation and data analysis, it can be considered that: small bubbles with the diameter of about 5mm are approximately spherical in water and rise spirally; the medium air bubbles with the diameter of 5-8 mm are generally in an elliptical sphere shape with the main shaft in the horizontal direction and also move upwards in a spiral manner; large bubbles having a diameter of 8mm or more are more deformed and rise linearly in a mushroom shape, but are easily broken into small bubbles. The fragmentation of the bubbles can also be accelerated if the speed at which they travel through the liquid is increased.
Therefore, the method comprises the following steps:
1. carbon dioxide is filled from the bottom of the diluting preparation tank 2 and is uniformly dispersed into a plurality of thin flows to enter the sodium bicarbonate liquid medicine. When the bottom is filled, the bubbles 1 which go upwards are formed by the huge buoyancy generated by the gas in the sodium bicarbonate liquid medicine, so that the carbon dioxide can be accelerated and quickly go upwards to generate larger impact force.
The carbon dioxide is dispersed into a plurality of thin flows, so that the carbon dioxide can be better distributed in the whole diluting and distributing tank. The trickle is adopted, so that the flow is reduced, the outlet pressure of the carbon dioxide is increased and larger impact force is generated under the condition that the total amount of the introduced carbon dioxide is not changed. Therefore, the method comprises the following steps:
the diameter of the dense diameter of the bottom of the diluting preparation tank is less than 5mm, and the diameters of the air holes are different, such as the diameters of 1mm, 3mm, 4mm and 5mm (the air holes can correspondingly generate the air bubbles 1 with the diameters of 3-5 mm, 4-8 mm, 5-12 mm and 8-20 mm, and the diameters of the air bubbles 1 do not have an artificially controllable pumping rule at random). The air holes with different diameters are arranged adjacently to form an air hole group, and a plurality of air hole groups are distributed at the bottom of the diluting and distributing tank in a matrix mode. With this arrangement, after the sodium bicarbonate solution in the dilution tank is filled with the carbon dioxide bubbles ejected from the air holes, the bubbles are broken at different positions in the dilution tank (see fig. 4) and at different positions on the same plane (see fig. 3), and shock waves for sterilization are formed substantially uniformly in each part of the dilution tank. The instant the bubbles burst, a large shock will be generated, resulting in a sterilization effect.
2. The carbon dioxide gas is discontinuously sprayed, dense carbon dioxide bubbles 1 are formed in the sodium bicarbonate liquid medicine in the diluting preparation tank, the carbon dioxide bubbles are sprayed intermittently, the carbon dioxide bubbles are sprayed irregularly, and for example, the concentrated spraying is set to be carried out once every 2 to 3 seconds, or the concentrated spraying is carried out once every second, or the air holes are sprayed alternately. In short, the discontinuous gushing is formed, the sodium bicarbonate liquid medicine forms turbulent flow, the water gushing is utilized to form shearing force, sterilization is carried out, and at least an environment which is not beneficial to the growth of bacteria can be formed. The filled sodium bicarbonate injection has better effect of controlling the bacterial count, or can reduce the bacterial control pressure in other links.
3. Filling carbon dioxide in gaseous state, or converting liquid state into gaseous state.
Because the faster the air bubble passes through the liquid, the more easily the air bubble is broken and split, and the better impact can be formed by the broken air bubble, at least the inflation pressure of 0.1-0.8 MPa is reached at the outlet of the air hole, and under the condition that the conditions allow, the larger the ejection pressure is, the larger the air bubble impact is, the more densely the air bubble is broken, and the sterilization is more favorable, wherein the embodiment selects 0.3, 0.5, 0.7MPa, and preferentially 0.5 MPa.
Example eight
When the sodium bicarbonate solution is reduced to a certain amount due to the filling in the diluting preparation tank 2, if the liquid is filled with the same filling amount, most of the gas directly penetrates through the sodium bicarbonate solution and enters the top of the diluting preparation tank. The volume of the sodium bicarbonate liquid medicine in the diluting preparation tank is reduced in the filling process, and the aeration working condition needs to be synchronously adjusted, including the reduction of aeration quantity; but requires increased impact and therefore increased pressure.
(i) The aeration pressure for filling the dilute tank with carbon dioxide is reduced, and carbon dioxide bubbles at least 2/3 are maintained to be broken below the liquid level line 3 of the sodium bicarbonate solution.
The method specifically comprises the following steps: when the sodium bicarbonate liquid medicine in the diluting preparation tank exceeds 2/3 of the total volume of the diluting preparation tank, the inflation pressure of the carbon dioxide is below 0.4 Mpa; when the sodium bicarbonate liquid medicine in the diluting preparation tank is 2/3-1/3 of the total volume of the diluting preparation tank, the inflation pressure of the carbon dioxide is 0.4-0.6 Mpa.
When the sodium bicarbonate solution in the diluting tank is below 1/3 of the total volume of the diluting tank, the inflation pressure of carbon dioxide is above 0.6 Mpa.
When the amount of the sodium bicarbonate liquid medicine in the final diluting and dispensing tank is already small, most bubbles lose the rupture space and basically do not rupture any more, but still keep the bubbles ascending to impact the liquid medicine.
(ii) The flow rate of filling carbon dioxide into the diluting preparation tank is reduced.
The method specifically comprises the following steps: when the sodium bicarbonate liquid medicine in the diluting preparation tank exceeds 1/2 of the total volume of the diluting preparation tank, the air holes of the bottom of the diluting preparation tank which are completely filled with carbon dioxide are opened at the same time to fill the diluting preparation tank with carbon dioxide; when the sodium bicarbonate liquid medicine in the diluting preparation tank is lower than 1/2 of the total volume of the diluting preparation tank, at least 1/2 air holes for filling carbon dioxide at the bottom of the diluting preparation tank are closed, and the residual air holes are used for filling the carbon dioxide into the diluting preparation tank. Because the air holes with different diameters form a unit and are distributed at the bottom of the diluting and dispensing tank by the units, each unit can be provided with the air valve independently, when the sodium bicarbonate liquid medicine in the diluting and dispensing tank is lower than 1/2 of the total capacity of the diluting and dispensing tank, a part of the air valves can be closed.
The control of the gas flow and the pressure of the invention can be controlled by people according to experience, and the control is preferably automatically controlled by arranging a liquid level meter and recording instrument. Good results are obtained.
In the above examples, each example is not an isolated example, and all of the examples can be reasonably combined to form a new example capable of completing the spirit of the present invention. But cannot be combined if some example combinations form a solution that is contradictory.
The protection scope of the present invention is not limited to the above examples, and there are many examples that can implement the spirit of the present invention and are not shown, but do not represent technical solutions that are not shown and are accomplished by using the spirit of the present invention, and do not belong to the present invention.
In fact, if the technical effects of the invention are obtained by adopting the technical solutions achieved by the spirit of the invention and the technical solutions defined by the invention are adopted and belong to the same technical field as the invention, the technology still falls into the protection scope of the invention.
Claims (10)
1. The preparation process of the sodium bicarbonate injection comprises the following steps:
(1) adding sodium bicarbonate and water for injection into a diluting preparation tank to obtain sodium bicarbonate liquid medicine;
(2) filling carbon dioxide into the sodium bicarbonate liquid medicine, wherein the pH of the sodium bicarbonate liquid medicine is adjusted to 7.8-8.0;
(3) filtering and filling the sodium bicarbonate liquid medicine to obtain a sodium bicarbonate injection soft bag;
(4) and (5) sterilizing.
2. The process for preparing sodium bicarbonate injection according to claim 1, wherein the steps of adding sodium bicarbonate and water for injection into a dilution tank comprise:
(i) adding water for injection which is more than 90% of the prescription amount and dissolves and dilutes sodium bicarbonate into sodium bicarbonate liquid medicine containing sodium bicarbonate less than 105% of the marked amount in the content measurement into a diluting tank;
then, (ii) adding the rest prescription amount of the sodium bicarbonate solution, and diluting the sodium bicarbonate solution into water for injection containing 95% of sodium bicarbonate solution with the content higher than the marked amount in the content measurement;
wherein the prescription amount is as follows: adding sodium bicarbonate according to the total production quantity of the production batches, wherein when 8.4g of sodium bicarbonate is contained in each 100ml of water for injection, the amount of the water for injection is required to be added to meet the condition that the content of the sodium bicarbonate in the content measurement is equal to 100% of the marked amount.
3. The process for preparing sodium bicarbonate injection according to claim 1, wherein the step of filling carbon dioxide into the sodium bicarbonate solution comprises adjusting the pH of the sodium bicarbonate solution, and further comprises the following steps: the carbon dioxide is filled into the sodium bicarbonate liquid medicine, and the shock motion which has the functions of stirring and sterilizing the sodium bicarbonate liquid medicine is continuously generated until the filling of the sodium bicarbonate liquid medicine in the diluting tank is finished.
4. The process for preparing sodium bicarbonate injection according to claim 3, wherein the carbon dioxide is filled from the bottom of the dilution tank and uniformly dispersed into a plurality of thin streams to enter the sodium bicarbonate solution.
5. The process for preparing sodium bicarbonate injection according to claim 4, wherein the carbon dioxide is discontinuously sprayed from the densely distributed air holes with the diameter less than 5mm at the bottom of the diluting preparation tank to form dense carbon dioxide bubbles in the sodium bicarbonate solution in the diluting preparation tank.
6. The process for preparing sodium bicarbonate injection according to claim 5 wherein the carbon dioxide forms dense carbon dioxide bubbles in the sodium bicarbonate solution in the diluting and dispensing tank, and the carbon dioxide bubbles are continuously broken at different positions and at positions more uniform in the diluting and dispensing tank, so as to form shock for sterilization.
7. The process for preparing sodium bicarbonate injection according to claim 5, wherein the bottom of the dilution tank is densely provided with air holes with a diameter less than 5mm, specifically, the air holes at the bottom of the dilution tank have different diameters, and a plurality of air hole groups are formed by adjacently arranging the air holes with different diameters and are distributed at the bottom of the dilution tank in a matrix manner, so that the air bubbles at different depth positions in the dilution tank are continuously broken from different positions on the same plane, and the impact for sterilization is approximately uniformly formed at each position in the dilution tank.
8. The process for preparing sodium bicarbonate injection according to claim 1, wherein the carbon dioxide is gaseous, and the inflation pressure is 0.1 to 0.8 Mpa.
9. The process for preparing sodium bicarbonate injection according to claim 8, wherein the volume of the sodium bicarbonate solution decreases with the amount of the sodium bicarbonate solution in the dilution tank during the filling process,
(i) further increasing the charging pressure of carbon dioxide into the diluting preparation tank, and keeping at least 2/3 carbon dioxide bubbles to be broken below the water level of the sodium bicarbonate solution;
the method specifically comprises the following steps: when the sodium bicarbonate liquid medicine in the diluting preparation tank exceeds 2/3 of the total volume of the diluting preparation tank, the inflation pressure of the carbon dioxide is below 0.4 Mpa; when the sodium bicarbonate liquid medicine in the diluting preparation tank is 2/3-1/3 of the total volume of the diluting preparation tank, the inflation pressure of the carbon dioxide is 0.4-0.6 Mpa;
when the sodium bicarbonate liquid medicine in the diluting preparation tank is below 1/3 of the total volume of the diluting preparation tank, the inflation pressure of the carbon dioxide is above 0.6 Mpa;
(ii) and then reduce the flow of filling into carbon dioxide to the diluting preparation jar, specifically do: when the sodium bicarbonate liquid medicine in the diluting preparation tank exceeds 1/2 of the total volume of the diluting preparation tank, the air holes of the bottom of the diluting preparation tank which are completely filled with carbon dioxide are opened at the same time to fill the diluting preparation tank with carbon dioxide; when the sodium bicarbonate liquid medicine in the diluting preparation tank is lower than 1/2 of the total volume of the diluting preparation tank, at least 1/2 air holes for filling carbon dioxide at the bottom of the diluting preparation tank are closed, and the residual air holes are used for filling the carbon dioxide into the diluting preparation tank.
10. The preparation process of the sodium bicarbonate injection of claim 1, wherein the sterilization specifically comprises:
putting the sodium bicarbonate injection soft bag on a sterilization vehicle, pushing the sodium bicarbonate injection soft bag into a sterilization cabinet, and closing a sterilization cabinet door; operating the sterilization cabinet; wherein the steam for sterilization is 0.4-0.6 Mpa, the compressed air is 0.4-0.7 Mpa, and the pressure of the sterilized cooling water is 0.3-0.4 Mpa;
wherein, put the soft bag of sodium bicarbonate injection on the sterilization car, specifically do:
(i) the sodium bicarbonate injection soft bags are arranged in a way that the printing surface faces upwards, the back faces downwards, and the mouth seals and the top seals of all the sodium bicarbonate injection soft bags face to the same direction;
(ii) the placing quantity of the sodium bicarbonate injection soft bags is as follows:
setting the number of the sodium bicarbonate injection soft bags with the maximum sterilization per batch and the number of sterilization vehicles in the sterilization cabinet per time; and the number of the first sterilization vehicles;
when each batch of products are loaded according to the mode and the quantity, if the last sterilization cabinet is not full, the blank water bag which has the same external shape and the same filling volume as the batch of the sodium bicarbonate injection soft bags and is provided with a mark in a striking way is adopted for filling;
and (II) taking out the sodium bicarbonate injection soft bag after sterilization, cooling and removing water marks on the surface of the bag.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102488617A (en) * | 2011-11-22 | 2012-06-13 | 四川科伦药物研究有限公司 | Sodium bicarbonate injection plastic soft bag package and preparation method thereof |
| CN103768091A (en) * | 2014-01-08 | 2014-05-07 | 中国大冢制药有限公司 | Sodium bicarbonate injection and preparation method thereof |
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- 2021-07-26 CN CN202110844665.0A patent/CN113577018A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102488617A (en) * | 2011-11-22 | 2012-06-13 | 四川科伦药物研究有限公司 | Sodium bicarbonate injection plastic soft bag package and preparation method thereof |
| CN103768091A (en) * | 2014-01-08 | 2014-05-07 | 中国大冢制药有限公司 | Sodium bicarbonate injection and preparation method thereof |
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| 李富岭: "《单重态氧发生器》", 大连海事大学出版社 * |
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Application publication date: 20211102 |