CN109044966B - Glucose oral liquid and preparation method and application thereof - Google Patents
Glucose oral liquid and preparation method and application thereof Download PDFInfo
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- CN109044966B CN109044966B CN201811106878.8A CN201811106878A CN109044966B CN 109044966 B CN109044966 B CN 109044966B CN 201811106878 A CN201811106878 A CN 201811106878A CN 109044966 B CN109044966 B CN 109044966B
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- glucose
- sodium citrate
- stirring
- zinc gluconate
- potassium chloride
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- 239000007788 liquid Substances 0.000 title claims abstract description 51
- 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 title claims abstract description 30
- 239000008103 glucose Substances 0.000 title claims abstract description 30
- 238000002360 preparation method Methods 0.000 title claims abstract description 17
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims abstract description 126
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims abstract description 102
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 102
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims abstract description 80
- 229960001031 glucose Drugs 0.000 claims abstract description 80
- 239000001509 sodium citrate Substances 0.000 claims abstract description 55
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims abstract description 55
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 52
- WHMDKBIGKVEYHS-IYEMJOQQSA-L Zinc gluconate Chemical compound [Zn+2].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O WHMDKBIGKVEYHS-IYEMJOQQSA-L 0.000 claims abstract description 51
- 239000001103 potassium chloride Substances 0.000 claims abstract description 51
- 235000011164 potassium chloride Nutrition 0.000 claims abstract description 51
- 239000011780 sodium chloride Substances 0.000 claims abstract description 51
- 239000011670 zinc gluconate Substances 0.000 claims abstract description 51
- 229960000306 zinc gluconate Drugs 0.000 claims abstract description 51
- 235000011478 zinc gluconate Nutrition 0.000 claims abstract description 51
- 238000003756 stirring Methods 0.000 claims description 65
- 239000011259 mixed solution Substances 0.000 claims description 29
- 239000003814 drug Substances 0.000 claims description 26
- 238000011049 filling Methods 0.000 claims description 20
- 238000003860 storage Methods 0.000 claims description 18
- 238000005070 sampling Methods 0.000 claims description 15
- 238000001514 detection method Methods 0.000 claims description 11
- 238000000034 method Methods 0.000 claims description 9
- 238000001914 filtration Methods 0.000 claims description 8
- 238000007789 sealing Methods 0.000 claims description 7
- 238000005303 weighing Methods 0.000 claims description 7
- 239000000243 solution Substances 0.000 claims description 4
- 206010014418 Electrolyte imbalance Diseases 0.000 claims description 3
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims description 3
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims description 3
- 229910052700 potassium Inorganic materials 0.000 claims description 3
- 239000011591 potassium Substances 0.000 claims description 3
- 239000011701 zinc Substances 0.000 claims description 3
- 229910052725 zinc Inorganic materials 0.000 claims description 3
- 229910000831 Steel Inorganic materials 0.000 claims description 2
- 239000002253 acid Substances 0.000 claims description 2
- 230000003750 conditioning effect Effects 0.000 claims description 2
- 239000010959 steel Substances 0.000 claims description 2
- 238000002156 mixing Methods 0.000 claims 2
- RGHNJXZEOKUKBD-UHFFFAOYSA-N D-gluconic acid Natural products OCC(O)C(O)C(O)C(O)C(O)=O RGHNJXZEOKUKBD-UHFFFAOYSA-N 0.000 claims 1
- RGHNJXZEOKUKBD-SQOUGZDYSA-N Gluconic acid Natural products OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O RGHNJXZEOKUKBD-SQOUGZDYSA-N 0.000 claims 1
- 239000000174 gluconic acid Substances 0.000 claims 1
- 235000012208 gluconic acid Nutrition 0.000 claims 1
- 238000007689 inspection Methods 0.000 claims 1
- 239000003792 electrolyte Substances 0.000 abstract description 21
- 230000000694 effects Effects 0.000 abstract description 9
- 238000010521 absorption reaction Methods 0.000 abstract description 5
- 230000007659 motor function Effects 0.000 abstract description 5
- 238000011084 recovery Methods 0.000 abstract description 5
- 235000013305 food Nutrition 0.000 abstract description 4
- 230000002503 metabolic effect Effects 0.000 abstract description 4
- 230000036039 immunity Effects 0.000 abstract description 3
- 239000000126 substance Substances 0.000 abstract description 3
- 239000013589 supplement Substances 0.000 abstract description 3
- 231100000331 toxic Toxicity 0.000 abstract description 3
- 230000002588 toxic effect Effects 0.000 abstract description 3
- 230000009286 beneficial effect Effects 0.000 abstract description 2
- 230000000052 comparative effect Effects 0.000 description 8
- 206010012735 Diarrhoea Diseases 0.000 description 6
- 206010047700 Vomiting Diseases 0.000 description 6
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 6
- 206010016256 fatigue Diseases 0.000 description 5
- 230000004060 metabolic process Effects 0.000 description 5
- 230000001225 therapeutic effect Effects 0.000 description 5
- 230000008673 vomiting Effects 0.000 description 5
- 230000033228 biological regulation Effects 0.000 description 4
- 239000008280 blood Substances 0.000 description 4
- 210000004369 blood Anatomy 0.000 description 4
- 208000035475 disorder Diseases 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 238000001727 in vivo Methods 0.000 description 4
- 239000000047 product Substances 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 3
- 230000007774 longterm Effects 0.000 description 3
- 238000012423 maintenance Methods 0.000 description 3
- 230000001105 regulatory effect Effects 0.000 description 3
- 208000024891 symptom Diseases 0.000 description 3
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 2
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 2
- 208000013016 Hypoglycemia Diseases 0.000 description 2
- 206010061428 decreased appetite Diseases 0.000 description 2
- 238000009826 distribution Methods 0.000 description 2
- 230000003203 everyday effect Effects 0.000 description 2
- 230000002218 hypoglycaemic effect Effects 0.000 description 2
- 235000012054 meals Nutrition 0.000 description 2
- 230000001737 promoting effect Effects 0.000 description 2
- 230000009885 systemic effect Effects 0.000 description 2
- 235000019640 taste Nutrition 0.000 description 2
- 208000020154 Acnes Diseases 0.000 description 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 1
- 208000006083 Hypokinesia Diseases 0.000 description 1
- 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 1
- 208000037273 Pathologic Processes Diseases 0.000 description 1
- 241001482237 Pica Species 0.000 description 1
- 206010048259 Zinc deficiency Diseases 0.000 description 1
- CANRESZKMUPMAE-UHFFFAOYSA-L Zinc lactate Chemical compound [Zn+2].CC(O)C([O-])=O.CC(O)C([O-])=O CANRESZKMUPMAE-UHFFFAOYSA-L 0.000 description 1
- 150000001298 alcohols Chemical class 0.000 description 1
- 239000003708 ampul Substances 0.000 description 1
- 208000022531 anorexia Diseases 0.000 description 1
- 208000002399 aphthous stomatitis Diseases 0.000 description 1
- 235000019606 astringent taste Nutrition 0.000 description 1
- 238000003321 atomic absorption spectrophotometry Methods 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- 239000006172 buffering agent Substances 0.000 description 1
- 239000004067 bulking agent Substances 0.000 description 1
- 208000020670 canker sore Diseases 0.000 description 1
- 210000000748 cardiovascular system Anatomy 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000003995 emulsifying agent Substances 0.000 description 1
- 238000003912 environmental pollution Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 235000013373 food additive Nutrition 0.000 description 1
- 239000002778 food additive Substances 0.000 description 1
- 235000013355 food flavoring agent Nutrition 0.000 description 1
- 210000004907 gland Anatomy 0.000 description 1
- 235000011187 glycerol Nutrition 0.000 description 1
- 230000000642 iatrogenic effect Effects 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 239000013067 intermediate product Substances 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 210000000653 nervous system Anatomy 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 210000004789 organ system Anatomy 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 230000009054 pathological process Effects 0.000 description 1
- 230000035790 physiological processes and functions Effects 0.000 description 1
- 230000010287 polarization Effects 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000002335 preservative effect Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 230000035484 reaction time Effects 0.000 description 1
- 230000000306 recurrent effect Effects 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 230000003867 tiredness Effects 0.000 description 1
- 208000016255 tiredness Diseases 0.000 description 1
- 230000007306 turnover Effects 0.000 description 1
- 239000011576 zinc lactate Substances 0.000 description 1
- 229940050168 zinc lactate Drugs 0.000 description 1
- 235000000193 zinc lactate Nutrition 0.000 description 1
- 229940091251 zinc supplement Drugs 0.000 description 1
- IPCXNCATNBAPKW-UHFFFAOYSA-N zinc;hydrate Chemical compound O.[Zn] IPCXNCATNBAPKW-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
-
- 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
- A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
-
- 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
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/30—Zinc; Compounds thereof
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/02—Nutrients, e.g. vitamins, minerals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Diabetes (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Molecular Biology (AREA)
- Nutrition Science (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention is suitable for the technical field of chemical industry, and provides a glucose oral liquid, a preparation method and application thereof; wherein, every 1000ml of the oral liquid comprises the following components: 12-21g |, of anhydrous glucose; 0.5-1.5g of sodium chloride; 1.4-2.2g of potassium chloride; 3-5g of sodium citrate; 0.6-1.6g of citric acid; 0.09-0.17g of zinc gluconate; the rest is water. The invention combines the anhydrous glucose, the sodium chloride, the potassium chloride, the sodium citrate, the citric acid and the zinc gluconate according to the proportion, is beneficial to the absorption of human bodies, has no toxic or side effect, can quickly supplement the water and electrolyte lost in the human bodies, regulates the content of elements in the human bodies, effectively improves the metabolic disturbance of the water and the electrolyte in the human bodies caused by various factors such as environment, water source and food pollution, improves the motor function and the immunity of the organisms and promotes the fatigue recovery.
Description
Technical Field
The invention belongs to the technical field of chemical industry, and particularly relates to a glucose oral liquid, and a preparation method and application thereof.
Background
Water and electrolyte are the components of basic substances for maintaining life, water is not separated when human body metabolizes, the volume, distribution and dissolution of water in body and the concentration of electrolyte in water are all regulated and controlled by human body, so that the volume, electrolyte concentration, osmotic pressure and the like of body fluid of human body can be maintained in normal range to maintain life activities of human body.
Disorders of water and electrolyte metabolism are quite common clinically. Many diseases of the organ system and some systemic pathological processes (e.g. vomiting, diarrhea, etc.) can cause or accompany disorders of water and electrolyte metabolism; certain changes in the external environment or certain iatrogenic factors such as improper use of drugs also often lead to disorders of water and electrolyte metabolism. If not regulated in time, disturbances in water and electrolyte metabolism can cause corresponding disturbances in the physiological functions of the systemic organs, in particular the cardiovascular system and the nervous system, and in the metabolism of the body, which can lead to death in severe cases.
At present, aiming at the water and electrolyte disorder in the body, the treatment is mainly carried out through infusion or the related electrolyte medicines are taken, but various electrolyte supplements provided on the market at present generally have unscientific contents of formula components, not only the clinical curative effect is not satisfied, but also the imbalance of the electrolyte and the water of the body is even aggravated.
Disclosure of Invention
The embodiment of the invention provides a glucose oral liquid, aiming at solving the technical problems.
The embodiment of the invention is realized by that, every 1000ml of the glucose oral liquid comprises the following components:
the rest components are water;
the embodiment of the invention also provides a preparation method of the glucose oral liquid, which comprises the following steps:
weighing anhydrous glucose, sodium chloride, potassium chloride, sodium citrate, citric acid and zinc gluconate at the ambient temperature of 25-35 ℃ for later use;
placing the anhydrous glucose and the zinc gluconate in a stirring tank, and adding part of water to stir uniformly for later use under the conditions that the stirring speed is 40-60 r/min and the stirring temperature is 50-70 ℃;
placing the sodium chloride, the potassium chloride and the sodium citrate into a stirring tank, adding part of water and stirring uniformly for later use under the conditions that the stirring speed is 60-90 r/min and the stirring temperature is 25-35 ℃;
placing the mixed solution of the anhydrous glucose and the zinc gluconate and the mixed solution of the sodium chloride, the potassium chloride and the sodium citrate into a liquid preparation tank, adding citric acid, stirring for 15-25 min, sealing the tank and standing for 10-30 min at room temperature;
sampling and sampling the mixed solution of the anhydrous glucose, the sodium chloride, the potassium chloride, the sodium citrate, the citric acid and the zinc gluconate;
filtering the anhydrous glucose, sodium chloride, potassium chloride, sodium citrate, citric acid and zinc gluconate mixed solution which is qualified by spot check into a storage tank through a 150-250-mesh sieve;
and (3) after the mixed liquid in the storage tank is qualified through clarity detection, filling and capping are carried out according to the requirement that the filling amount is 98-102 ml per medicine bottle, and the medicine is obtained.
The embodiment of the invention also provides application of the glucose oral liquid in the turbulent regulation of water and electrolyte in vivo.
In the embodiment of the invention, the anhydrous glucose, the sodium chloride, the potassium chloride, the sodium citrate, the citric acid and the zinc gluconate are matched according to the proportion, so that the taste is good, the solution is uniform and stable, the absorption by a human body is facilitated, no toxic or side effect is caused, the water and electrolyte lost in the body can be quickly supplemented, the content of elements in the body is adjusted, the metabolic disturbance phenomenon of the water and the electrolyte in the body caused by various factors such as environmental pollution, water source pollution and food pollution is effectively improved, the motor function and the immunity of the body are improved, and the fatigue recovery is promoted.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
According to the glucose oral liquid provided by the invention, the anhydrous glucose, the sodium chloride, the potassium chloride, the sodium citrate, the citric acid and the zinc gluconate are matched in proportion, so that the glucose oral liquid is good in taste, uniform and stable in solution, beneficial to absorption by a human body and free of toxic and side effects, can quickly replenish water and electrolyte lost in the body, regulates the content of elements in the body, effectively improves the metabolic disturbance of water and electrolyte in the human body caused by various factors such as environment, water source and food pollution, improves the motor function and immunity of the body, and promotes fatigue recovery.
In the embodiment of the invention, the weight ratio of the anhydrous glucose to the zinc gluconate is preferably 16-16.4: 0.12-0.14.
In the embodiment of the invention, the weight ratio of the sodium chloride to the potassium chloride to the sodium citrate is preferably 1.1-1.2: 1.8-1.9: 3.9-4.
In the embodiment of the invention, the zinc gluconate is white crystalline or granular powder; no odor, slightly astringent taste. It is very soluble in boiling water, soluble in water, and insoluble in anhydrous alcohol, chloroform or diethyl ether, and is the second generation zinc supplement drug together with zinc lactate. Is clinically applicable to zinc deficiency diseases such as infantile anorexia, various skin acnes, recurrent aphthous ulcer and the like.
In the embodiment of the invention, the sodium citrate, also called sodium citrate, is easy to dissolve in water, soluble in glycerin and insoluble in alcohols and other organic solvents. Sodium citrate is non-toxic and has pH adjusting properties and good stability, and thus can be used in the food industry. Sodium citrate is used as food additive, with the greatest demand, mainly as flavoring agent, buffering agent, emulsifier, bulking agent, stabilizer, preservative, etc.
In the embodiment of the invention, in the liquid preparation process, 7000-14100 mg/L of potassium is sampled and detected according to the Standard operation protocol for intermediate product sampling (SOP-QA-1045-00); 3-20 mg/L of zinc; the total acid (counted by citric acid) is more than or equal to 1.0g/100g, and the lead is less than or equal to 0.3 mg/L.
In the embodiment of the invention, the clarity test of the mixed liquid in the storage tank is carried out according to standard operation and maintenance procedures of YB-3 clarity detector (SOP-ZHcJ-3047-00), the lamp detection illuminometer 2000-3000LX is adjusted, and the unqualified product with turbidity or foreign matters in the liquid medicine is rejected by the test of the illuminometer.
In the embodiment of the invention, the operation is carried out according to standard operation and maintenance regulations (SOP-ZHCJ-3038-00) of a DYG-100 liquid filling machine, liquid medicine is filtered into a storage tank through a 200-mesh screen, the storage tank is started to test filling, the filling amount is adjusted to be 98-102 ml per bottle, and formal filling and capping are carried out after the clarity is checked to be qualified. Loading into container, counting, and marking name, batch number, quantity, production date and operator. The filling quantity, the gland quality and the like are checked at any time in the operation process, unqualified products are removed, and the filtration and filling are finished within 12 hours.
In the embodiment of the invention, the filled medicine bottle is inverted and put into a white steel disc of a leakage detecting machine for leakage detection according to standard operation and maintenance regulations of an ampoule leakage detecting and sterilizing cabinet (SOP-ZHCJ-3042-00), the vacuum degree is 0.027-0.03 MPa, and the vacuum timing is 5 minutes. The overflow and the amount of the liquid medicine are obviously reduced, the qualified products are put into a turnover box, the name, the batch number, the quantity, the date and the operator are marked, and the next procedure is handed over. The reject count is sent to the reject zone. Processing according to the 'unqualified product management rules'.
In the embodiment of the invention, the glucose oral liquid prepared by matching anhydrous glucose, sodium chloride, potassium chloride, sodium citrate, citric acid, zinc gluconate and water and adjusting and optimizing the content of each component and the preparation process conditions in one step can be taken orally by half an hour after a meal, and an adult can take two bottles per day, and a child can take no more than one bottle per day and each bottle is 98-102 ml, so that the glucose oral liquid is used for treating and conditioning symptoms such as water and electrolyte disturbance in the body during diarrhea and vomiting, improving the motor function of the body, promoting quick recovery of fatigue, improving the resistance of the body after long-term taking, and has obvious curative effect proved by long-term practice.
Example 1
In the embodiment of the invention, every 1000ml of the glucose oral liquid comprises the following components: 12g of anhydrous glucose; 0.5g of sodium chloride; 1.4g of potassium chloride; 3g of sodium citrate; 0.6g of citric acid; 0.09g of zinc gluconate; the rest is water.
Weighing anhydrous glucose, sodium chloride, potassium chloride, sodium citrate, citric acid and zinc gluconate at 25 deg.C; placing the anhydrous glucose and the zinc gluconate in a stirring tank, and adding water to stir uniformly for later use under the conditions that the stirring speed is 40r/min and the stirring temperature is 50 ℃; placing the sodium chloride, the potassium chloride and the sodium citrate into a stirring tank, adding part of water and stirring uniformly for later use under the conditions that the stirring speed is 60r/min and the stirring temperature is 25 ℃; placing the mixed solution of the anhydrous glucose and the zinc gluconate and the mixed solution of the sodium chloride, the potassium chloride and the sodium citrate into a liquid preparation tank, adding the citric acid, stirring for 15min, sealing the tank at room temperature, and standing for 10 min; sampling and sampling the mixed solution of the anhydrous glucose, the sodium chloride, the potassium chloride, the sodium citrate, the citric acid and the zinc gluconate; filtering the anhydrous glucose, sodium chloride, potassium chloride, sodium citrate, citric acid and zinc gluconate mixed solution which is qualified by spot check into a storage tank through a 150-mesh sieve; and after the mixed liquid in the storage tank is qualified through clarity detection, filling and capping are carried out according to the requirement that the filling quantity is 98 per medicine bottle, and the medicine is obtained.
Example 2
In the embodiment of the invention, every 1000ml of the glucose oral liquid comprises the following components: 21g of anhydrous glucose; 1.5g of sodium chloride; 2.2g of potassium chloride; 5g of sodium citrate; 1.6g of citric acid; 0.17g of zinc gluconate; the rest is water.
Weighing anhydrous glucose, sodium chloride, potassium chloride, sodium citrate, citric acid and zinc gluconate at 35 deg.C; placing the anhydrous glucose and the zinc gluconate in a stirring tank, and adding water to stir uniformly for later use under the conditions that the stirring speed is 60r/min and the stirring temperature is 70 ℃; placing the sodium chloride, the potassium chloride and the sodium citrate into a stirring tank, adding part of water and stirring uniformly for later use under the conditions that the stirring speed is 90r/min and the stirring temperature is 35 ℃; placing the mixed solution of the anhydrous glucose and the zinc gluconate and the mixed solution of the sodium chloride, the potassium chloride and the sodium citrate into a liquid preparation tank, adding the citric acid, stirring for 25min, sealing the tank at room temperature, and standing for 30 min; sampling and sampling the mixed solution of the anhydrous glucose, the sodium chloride, the potassium chloride, the sodium citrate, the citric acid and the zinc gluconate; filtering the anhydrous glucose, sodium chloride, potassium chloride, sodium citrate, citric acid and zinc gluconate mixed solution which is qualified by spot check into a storage tank through a 250-mesh sieve; and (3) after the mixed liquid in the storage tank is qualified through clarity detection, filling and capping are carried out according to the requirement that the filling quantity is 102ml per medicine bottle, and the medicine is obtained.
Example 3
In the embodiment of the invention, every 1000ml of the glucose oral liquid comprises the following components: 15g of anhydrous glucose; 0.8g of sodium chloride; 1.6g of potassium chloride; 3.5g of sodium citrate; 0.9g of citric acid; 0.11g of zinc gluconate; the rest is water.
Weighing anhydrous glucose, sodium chloride, potassium chloride, sodium citrate, citric acid and zinc gluconate at an ambient temperature of 30 deg.C; placing the anhydrous glucose and the zinc gluconate in a stirring tank, and adding water to stir uniformly for later use under the conditions that the stirring speed is 45r/min and the stirring temperature is 55 ℃; putting the sodium chloride, the potassium chloride and the sodium citrate into a stirring tank, adding part of water and stirring uniformly for later use under the conditions that the stirring speed is 70r/min and the stirring temperature is 27 ℃; placing the mixed solution of the anhydrous glucose and the zinc gluconate and the mixed solution of the sodium chloride, the potassium chloride and the sodium citrate into a liquid preparation tank, adding the citric acid, stirring for 20min, sealing the tank at room temperature, and standing for 20 min; sampling and sampling the mixed solution of the anhydrous glucose, the sodium chloride, the potassium chloride, the sodium citrate, the citric acid and the zinc gluconate; filtering the anhydrous glucose, sodium chloride, potassium chloride, sodium citrate, citric acid and zinc gluconate mixed solution which is qualified by the spot check into a storage tank through a 200-mesh sieve; and (3) after the mixed liquid in the storage tank is qualified through clarity detection, filling and capping are carried out according to the requirement that the filling quantity is 100ml per medicine bottle, and the medicine is obtained.
Example 4
In the embodiment of the invention, every 1000ml of the glucose oral liquid comprises the following components: 18g of anhydrous glucose; 1.3g of sodium chloride; 2g of potassium chloride; 4.5g of sodium citrate; 1.4g of citric acid; 0.15g of zinc gluconate; the rest is water.
Weighing anhydrous glucose, sodium chloride, potassium chloride, sodium citrate, citric acid and zinc gluconate at an ambient temperature of 30 deg.C; placing the anhydrous glucose and the zinc gluconate in a stirring tank, and adding water to stir uniformly for later use under the conditions that the stirring speed is 55r/min and the stirring temperature is 65 ℃; putting the sodium chloride, the potassium chloride and the sodium citrate into a stirring tank, adding part of water and stirring uniformly for later use under the conditions that the stirring speed is 85r/min and the stirring temperature is 30 ℃; placing the mixed solution of the anhydrous glucose and the zinc gluconate and the mixed solution of the sodium chloride, the potassium chloride and the sodium citrate into a liquid preparation tank, adding the citric acid, stirring for 20min, sealing the tank at room temperature, and standing for 20 min; sampling and sampling the mixed solution of the anhydrous glucose, the sodium chloride, the potassium chloride, the sodium citrate, the citric acid and the zinc gluconate; filtering the anhydrous glucose, sodium chloride, potassium chloride, sodium citrate, citric acid and zinc gluconate mixed solution which is qualified by the spot check into a storage tank through a 200-mesh sieve; and (3) after the mixed liquid in the storage tank is qualified through clarity detection, filling and capping are carried out according to the requirement that the filling quantity is 101ml per medicine bottle, and the medicine is obtained.
Example 5
In the embodiment of the invention, every 1000ml of the glucose oral liquid comprises the following components: 16.2g of anhydrous glucose; 1.17g of sodium chloride; 1.86g of potassium chloride; 3.92g of sodium citrate; 1.28g of citric acid; 0.13g of zinc gluconate; the rest is water.
Weighing anhydrous glucose, sodium chloride, potassium chloride, sodium citrate, citric acid and zinc gluconate at an ambient temperature of 30 deg.C; placing the anhydrous glucose and the zinc gluconate in a stirring tank, and adding water to stir uniformly for later use under the conditions that the stirring speed is 50r/min and the stirring temperature is 60 ℃; placing the sodium chloride, the potassium chloride and the sodium citrate into a stirring tank, adding part of water and stirring uniformly for later use under the conditions that the stirring speed is 75r/min and the stirring temperature is 30 ℃; placing the mixed solution of the anhydrous glucose and the zinc gluconate and the mixed solution of the sodium chloride, the potassium chloride and the sodium citrate into a liquid preparation tank, adding the citric acid, stirring for 20min, sealing the tank at room temperature, and standing for 20 min; sampling and sampling the mixed solution of the anhydrous glucose, the sodium chloride, the potassium chloride, the sodium citrate, the citric acid and the zinc gluconate; filtering the anhydrous glucose, sodium chloride, potassium chloride, sodium citrate, citric acid and zinc gluconate mixed solution which is qualified by the spot check into a storage tank through a 200-mesh sieve; and (3) after the mixed liquid in the storage tank is qualified through clarity detection, filling and capping are carried out according to the requirement that the filling quantity is 100ml per medicine bottle, and the medicine is obtained.
Comparative example 1
The contents of the remaining components and the preparation process were the same as those of example 5 except that the anhydrous glucose content was 22g and zinc gluconate was 0.25 g.
Comparative example 2
The contents of the remaining components and the preparation process were the same as in example 5 except that 0.72g of sodium chloride, 0.25g of potassium chloride and 0.6g of sodium citrate were used.
The glucose oral liquid prepared in the embodiments 1-5 and the comparative examples 1-2 of the invention is used for clinically treating patients with symptoms of inappetence, pica, diarrhea, vomiting, tiredness, hypodynamia and the like existing in 468 cases since 2016, wherein the group of the embodiments is 368 cases, and the embodiments are randomly divided into five groups; the comparative example group has 100 cases, and is randomly divided into 2 groups, and the age distribution of each group is equivalent; in addition, 80 patients with diarrhea and emesis are randomly selected, and the content change of zinc, sodium and potassium in blood before and after administration is detected by atomic absorption spectrophotometry using PE3100 type atomic absorption spectrometer and Hitachi 180-80 type polarization Zeeman atomic absorption spectrometer. The results of the experiments are shown in the following table.
TABLE 1 therapeutic criteria
TABLE 2 statistical results of the therapeutic effects
| Number of cases | Show effect | Is effective | Invalidation | Deterioration of | The total effective rate% | Not efficiency% | |
| Example 1 | 74 | 47 | 17 | 10 | 0 | 86.49 | 13.51 |
| Example 2 | 74 | 51 | 15 | 8 | 0 | 89.19 | 10.81 |
| Example 3 | 73 | 55 | 12 | 6 | 0 | 91.78 | 8.22 |
| Example 4 | 73 | 53 | 14 | 6 | 0 | 91.78 | 8.22 |
| Example 5 | 74 | 58 | 14 | 2 | 0 | 97.30 | 2.70 |
| Comparative example 1 | 50 | 18 | 10 | 22 | 0 | 56 | 40 |
| Comparative example 2 | 50 | 19 | 8 | 23 | 0 | 54 | 46 |
TABLE 3 measurement results of the content of elements in blood
In summary, according to the statistics of the therapeutic effects of examples 1 to 5 and comparative examples 1 to 2, the total effective rate of the glucose oral liquid prepared in examples 1 to 5 of the present invention is higher than 86%, and the total effective rate of the glucose oral liquid prepared in example 5 reaches 97.3%; in addition, the test results of the element content in the blood of the diarrhea and vomiting patients before and after taking the medicine show that the glucose oral liquid prepared by the embodiment of the invention can quickly supplement the water and electrolyte lost in the bodies of the patients, regulate the element content in the bodies, has quick response to treatment, does not have any side effect, can effectively regulate the metabolic disturbance of the water and the electrolyte, and promotes fatigue recovery.
It is to be noted that the therapeutic effect of example 5 of the present invention is far superior to that of the glucose oral liquid prepared in comparative examples 1 to 2, and it is clear that the therapeutic effect is very important to the combination of anhydrous glucose, sodium chloride, potassium chloride, sodium citrate, citric acid and zinc gluconate, and to the adjustment and optimization of the contents of the respective drug components, the reaction temperature, the reaction time and other conditions.
The embodiment of the invention also provides application of the glucose oral liquid in regulation of water and electrolyte in vivo, a patient can take two bottles every day by half an hour after a meal, and a child takes no more than one bottle every day, wherein each bottle is 98-102 ml, and the glucose oral liquid is used for treating and regulating symptoms of water and electrolyte disturbance in vivo during diarrhea and vomiting, improving the motor function of an organism, promoting fatigue to recover quickly, improving the resistance of the human body after being taken for a long time, and the curative effect is proved to be remarkable in long-term practice; in addition, the oral liquid can be taken by people with hypoglycemia and patients with hypoglycemia caused by diabetes to regulate blood sugar concentration in vivo.
It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Furthermore, it should be understood that although the present description refers to embodiments, not every embodiment may contain only a single embodiment, and such description is for clarity only, and those skilled in the art should integrate the description, and the embodiments may be combined as appropriate to form other embodiments understood by those skilled in the art.
Claims (8)
1. The glucose oral liquid is characterized by comprising the following components in every 1000 ml:
16.2g of anhydrous glucose;
1.17g of sodium chloride;
1.86g of potassium chloride;
3.92g of sodium citrate;
1.28g of citric acid;
0.13g of zinc gluconate;
the rest is water.
2. The method for preparing the glucose oral liquid according to claim 1, which comprises the following steps:
weighing anhydrous glucose, sodium chloride, potassium chloride, sodium citrate, citric acid and zinc gluconate at the ambient temperature of 25-35 ℃ for later use;
placing the anhydrous glucose and the zinc gluconate in a stirring tank, and adding part of water to stir uniformly for later use under the conditions that the stirring speed is 40-60 r/min and the stirring temperature is 50-70 ℃;
placing the sodium chloride, the potassium chloride and the sodium citrate into a stirring tank, adding part of water and stirring uniformly for later use under the conditions that the stirring speed is 60-90 r/min and the stirring temperature is 25-35 ℃;
placing the mixed solution of the anhydrous glucose and the zinc gluconate and the mixed solution of the sodium chloride, the potassium chloride and the sodium citrate into a liquid preparation tank, adding citric acid, stirring for 15-25 min, sealing the tank and standing for 10-30 min at room temperature;
sampling and sampling the mixed solution of the anhydrous glucose, the sodium chloride, the potassium chloride, the sodium citrate, the citric acid and the zinc gluconate;
filtering the anhydrous glucose, sodium chloride, potassium chloride, sodium citrate, citric acid and zinc gluconate mixed solution which is qualified by spot check into a storage tank through a 150-250-mesh sieve;
and (3) after the mixed liquid in the storage tank is qualified through clarity detection, filling and capping are carried out according to the requirement that the filling amount is 98-102 ml per medicine bottle, and the medicine is obtained.
3. The method for preparing a glucose oral liquid according to claim 2, wherein the stirring speed and the stirring temperature are 50r/min and 60 ℃ respectively, when the anhydrous glucose and the gluconic acid are mixed.
4. The method of claim 2, wherein the mixing speed of the sodium chloride, potassium chloride and sodium citrate is 75r/min and the mixing temperature is 30 ℃.
5. The method for preparing glucose oral liquid according to claim 2, wherein the anhydrous glucose, sodium chloride, potassium chloride, sodium citrate, citric acid and zinc gluconate mixed solution which is qualified in the spot check is filtered by a 200-mesh filter and is put into a storage tank.
6. The method of claim 2, wherein the sample quality criteria comprises: potassium is 200-8000 mg/L; 3-20 mg/L of zinc; total acid is less than or equal to 2.0 g/100 ml; lead is less than or equal to 0.2 mg/L.
7. The method of preparing a glucose oral liquid of claim 2, further comprising:
and (3) inverting the filled medicine bottle, putting the inverted medicine bottle into a white steel disc of a leak detection machine for leak detection, measuring the vacuum degree of 0.027-0.03 Mpa, timing for 5 minutes in vacuum, and warehousing the finished product after the finished product is qualified through inspection.
8. Use of the oral glucose solution of claim 1 for the preparation of a medicament for the conditioning of water and electrolyte disturbances in the body.
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| CN109805236A (en) * | 2019-01-11 | 2019-05-28 | 陆一江 | Add the hypotonic fluid infusion salt formula of zinc agent |
| CN110604311A (en) * | 2019-10-30 | 2019-12-24 | 山东若尧特医食品有限公司 | Electrolyte composite liquid preparation and preparation method thereof |
| CN111387391A (en) * | 2020-04-27 | 2020-07-10 | 山东亿海鹏生经贸有限公司 | Production method of prebiotics electrolyte beverage |
| CN111869878A (en) * | 2020-07-27 | 2020-11-03 | 广东君悦营养医学有限公司 | A kind of carbohydrate oral clear liquid with low 5-HMF content and preparation method thereof |
| CN118384105B (en) * | 2024-04-25 | 2024-12-13 | 浙江同伍生物医药有限公司 | Potassium chloride oral solution and preparation method thereof |
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