CN112569256A - Zinc sulfate and lysine oral liquid and preparation method thereof - Google Patents
Zinc sulfate and lysine oral liquid and preparation method thereof Download PDFInfo
- Publication number
- CN112569256A CN112569256A CN202011575149.4A CN202011575149A CN112569256A CN 112569256 A CN112569256 A CN 112569256A CN 202011575149 A CN202011575149 A CN 202011575149A CN 112569256 A CN112569256 A CN 112569256A
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- Prior art keywords
- lysine
- zinc sulfate
- zinc
- purified water
- preparation
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- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 title claims abstract description 26
- 239000004472 Lysine Substances 0.000 title claims abstract description 26
- NWONKYPBYAMBJT-UHFFFAOYSA-L zinc sulfate Chemical compound [Zn+2].[O-]S([O-])(=O)=O NWONKYPBYAMBJT-UHFFFAOYSA-L 0.000 title claims abstract description 20
- 229960001763 zinc sulfate Drugs 0.000 title claims abstract description 20
- 229910000368 zinc sulfate Inorganic materials 0.000 title claims abstract description 20
- 238000002360 preparation method Methods 0.000 title claims abstract description 19
- 239000007788 liquid Substances 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 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 13
- 239000008213 purified water Substances 0.000 claims abstract description 12
- 235000007119 Ananas comosus Nutrition 0.000 claims abstract description 6
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 claims abstract description 6
- 235000010228 ethyl p-hydroxybenzoate Nutrition 0.000 claims abstract description 6
- 239000004403 ethyl p-hydroxybenzoate Substances 0.000 claims abstract description 6
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 claims abstract description 6
- 229940100688 oral solution Drugs 0.000 claims abstract description 6
- 235000020374 simple syrup Nutrition 0.000 claims abstract description 6
- 229960003646 lysine Drugs 0.000 claims description 19
- 239000000203 mixture Substances 0.000 claims description 9
- 238000003756 stirring Methods 0.000 claims description 9
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 6
- 238000001914 filtration Methods 0.000 claims description 6
- 241000234671 Ananas Species 0.000 claims description 5
- BVHLGVCQOALMSV-JEDNCBNOSA-N L-lysine hydrochloride Chemical compound Cl.NCCCC[C@H](N)C(O)=O BVHLGVCQOALMSV-JEDNCBNOSA-N 0.000 claims description 5
- 229960005337 lysine hydrochloride Drugs 0.000 claims description 5
- 238000011049 filling Methods 0.000 claims description 3
- 239000011521 glass Substances 0.000 claims description 3
- 238000007689 inspection Methods 0.000 claims description 3
- 238000004806 packaging method and process Methods 0.000 claims description 3
- 238000007789 sealing Methods 0.000 claims description 3
- 230000001954 sterilising effect Effects 0.000 claims description 3
- 238000009472 formulation Methods 0.000 claims description 2
- 239000011701 zinc Substances 0.000 abstract description 12
- 229910052725 zinc Inorganic materials 0.000 abstract description 12
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 abstract description 10
- 230000012010 growth Effects 0.000 abstract description 8
- 208000007502 anemia Diseases 0.000 abstract description 3
- 206010061428 decreased appetite Diseases 0.000 abstract description 3
- 208000002720 Malnutrition Diseases 0.000 abstract description 2
- 230000007812 deficiency Effects 0.000 abstract description 2
- 230000001071 malnutrition Effects 0.000 abstract description 2
- 235000000824 malnutrition Nutrition 0.000 abstract description 2
- 208000015380 nutritional deficiency disease Diseases 0.000 abstract description 2
- 230000001502 supplementing effect Effects 0.000 abstract description 2
- 239000011573 trace mineral Substances 0.000 abstract description 2
- 235000013619 trace mineral Nutrition 0.000 abstract description 2
- 244000099147 Ananas comosus Species 0.000 abstract 1
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 abstract 1
- 235000015165 citric acid Nutrition 0.000 abstract 1
- 239000000686 essence Substances 0.000 abstract 1
- 235000018977 lysine Nutrition 0.000 abstract 1
- 230000002503 metabolic effect Effects 0.000 abstract 1
- 230000033228 biological regulation Effects 0.000 description 11
- 230000018109 developmental process Effects 0.000 description 7
- 238000000034 method Methods 0.000 description 4
- 230000001737 promoting effect Effects 0.000 description 4
- 239000008187 granular material Substances 0.000 description 3
- 235000015097 nutrients Nutrition 0.000 description 3
- 230000036039 immunity Effects 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 230000000813 microbial effect Effects 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 102000002260 Alkaline Phosphatase Human genes 0.000 description 1
- 108020004774 Alkaline Phosphatase Proteins 0.000 description 1
- 208000019901 Anxiety disease Diseases 0.000 description 1
- 102000016928 DNA-directed DNA polymerase Human genes 0.000 description 1
- 108010014303 DNA-directed DNA polymerase Proteins 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 206010028813 Nausea Diseases 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 206010048259 Zinc deficiency Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 208000022531 anorexia Diseases 0.000 description 1
- 230000036506 anxiety Effects 0.000 description 1
- 230000004596 appetite loss Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 231100000020 developmental retardation Toxicity 0.000 description 1
- 208000002173 dizziness Diseases 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000037149 energy metabolism Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 235000020776 essential amino acid Nutrition 0.000 description 1
- 239000003797 essential amino acid Substances 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 206010016256 fatigue Diseases 0.000 description 1
- 230000036737 immune function Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 235000021266 loss of appetite Nutrition 0.000 description 1
- 208000019017 loss of appetite Diseases 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000003340 mental effect Effects 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 230000008693 nausea Effects 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 230000035790 physiological processes and functions Effects 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 230000037152 sensory function Effects 0.000 description 1
- 230000001568 sexual effect Effects 0.000 description 1
- 230000037380 skin damage Effects 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 230000009469 supplementation Effects 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 230000008673 vomiting Effects 0.000 description 1
- 230000037314 wound repair Effects 0.000 description 1
- 229940091251 zinc supplement Drugs 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- 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
- 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
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
-
- 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
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/06—Antianaemics
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hematology (AREA)
- Nutrition Science (AREA)
- Diabetes (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Inorganic Chemistry (AREA)
- Obesity (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention provides a zinc sulfate and lysine oral solution and a preparation method thereof. The oral liquid is prepared from zinc sulfate, lysine, citric acid, simple syrup, pineapple essence, ethylparaben and purified water. The oral liquid provided by the invention is designed for children, has good taste, strong stability and high bioavailability of zinc and lysine, and can be used for scientifically and reasonably supplementing the trace elements of zinc and lysine required by children. Meanwhile, the zinc sulfate and lysine oral liquid provided by the invention can regulate the metabolic balance in children and promote growth and development, is used for growth and development retardation, inappetence, anemia, malnutrition and the like caused by the deficiency of zinc and lysine in children, and has the advantages of good taste, strong stability and simple preparation process.
Description
Technical Field
The invention belongs to the field of pharmacy, relates to a pharmaceutical preparation composition, and particularly relates to zinc sulfate and lysine oral liquid and a preparation method thereof.
Background
Zinc is one of essential trace elements for human body, and plays an important role in the growth and development process of human body. Zinc participates in the synthesis of various enzymes such as human DNA polymerase, alkaline phosphatase and the like, can accelerate growth and development, promote wound repair, participate in sensory function regulation, participate in energy metabolism, regulate immune function and the like. Zinc deficiency can cause the decline of children's immunity, growth and development retardation, mental maldevelopment, anorexia, cause vision problems, skin damage, cause incomplete development of sexual organs, etc.
Lysine is one of essential amino acids for human body, and cannot be synthesized by itself. Lack of lysine can cause symptoms such as fatigue, weakness, nausea, vomiting, dizziness, loss of appetite, developmental retardation, anemia, and the like. Lysine has positive nutritional significance in promoting growth and development of human body, enhancing immunity of organism, resisting virus, promoting fat oxidation, relieving anxiety, promoting absorption of certain nutrients, and has synergistic effect with certain nutrients to exert physiological functions of various nutrients.
Oral zinc supplement preparations are divided into solid preparations and liquid preparations. The solid preparation mainly comprises tablets and granules, the compliance of the tablets in the using process of children is poor, and the granules are taken after being soaked in water in the using process, so that the operation is relatively inconvenient. The liquid preparation is prepared into single-dose oral solution, and has convenient use and good compliance.
According to the medicine information, the marketed composition of the two components of zinc and lysine only contains the lysine-zinc tablet and the lysine-zinc granule, and the oral preparation of the composition of the two components of zinc and lysine is lacked.
Disclosure of Invention
The invention aims to provide a zinc sulfate and lysine oral solution, and the formulation of each 1000ml is as follows: 1.1g of zinc sulfate, 20g of lysine hydrochloride, 6g of citric acid, 200ml of simple syrup, 2ml of pineapple essence, 0.15g of ethylparaben and purified water of which the volume is 1000 ml.
The invention also aims to provide a preparation method of the zinc sulfate and lysine oral liquid, which is realized by the following steps:
(1) dissolving zinc sulfate and citric acid in appropriate amount of purified water, and filtering;
(2) dissolving lysine hydrochloride in warm purified water, and filtering;
(3) after the simple syrup is added, slowly adding the pineapple essence, and stirring the mixture at any time;
(4) then slowly adding ethylparaben solution dissolved by a little ethanol in advance, and stirring along with the addition;
(5) adding purified water to full volume, and stirring;
(6) filling and sealing by using a 10ml glass bottle;
(7) sterilizing the filled and sealed sample for 30 minutes at 100 ℃ by circulating steam;
(8) and (6) performing light inspection on the sterilized sample, and packaging.
The zinc sulfate and lysine oral liquid provided by the invention is specially designed for children, is an oral liquid preparation suitable for supplementing zinc and lysine for children, is more reasonable in single-dose zinc and lysine supplementation, good in taste, strong in stability, simple in preparation process, capable of regulating metabolism balance in vivo and promoting growth and development of infants and children, and can be used for growth and development retardation, inappetence, anemia, malnutrition and the like caused by zinc and lysine deficiency of children. According to the invention, through research on the preparation method, the stability of the oral solution preparation of zinc sulfate and lysine, the content of zinc sulfate and lysine and the microbial limit are inspected, and the oral preparation formula of the composition of the two components of zinc sulfate and lysine and the preparation method thereof are obtained.
Detailed Description
The present invention will be further described with reference to specific examples, but it should not be construed that the scope of the above-described subject matter of the present invention is limited to the examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention. The auxiliary materials in the following examples can be replaced by the same type of pharmaceutically acceptable auxiliary materials, or reduced or increased.
Example 1
1. Prescription:
2. the process comprises the following steps:
(1) dissolving zinc sulfate and citric acid in appropriate amount of purified water, and filtering;
(2) dissolving lysine hydrochloride in warm purified water, and filtering;
(3) after the simple syrup is added, slowly adding the pineapple essence, and stirring the mixture at any time;
(4) then slowly adding ethylparaben solution dissolved by a little ethanol in advance, and stirring along with the addition;
(5) adding purified water to full volume, and stirring;
(6) filling and sealing by using a 10ml glass bottle;
(7) sterilizing the filled and sealed sample for 30 minutes at 100 ℃ by circulating steam;
(8) and (6) performing light inspection on the sterilized sample, and packaging.
Example 2 oral liquid stability evaluation
And placing the sample in a light-shielding closed environment at normal temperature, and respectively inspecting the solution properties, the zinc sulfate and lysine content and the microbial limit in 0 month, 3 months, 6 months, 9 months and 12 months.
The results are shown in Table 1 below.
TABLE 1
Time of standing | Traits | Content (wt.) | Limit of microorganism |
0 month | Colorless to pale yellow clear liquid | Compliance with regulations | Compliance with regulations |
3 month | Colorless to pale yellow clear liquid | Compliance with regulations | Compliance with regulations |
6 month | Colorless to pale yellow clarityLiquid, method for producing the same and use thereof | Compliance with regulations | Compliance with regulations |
9 month | Colorless to pale yellow clear liquid | Compliance with regulations | Compliance with regulations |
12 month | Colorless to pale yellow clear liquid | Compliance with regulations | Compliance with regulations |
The above embodiments are intended to illustrate the present invention in detail, and it should not be construed that the present invention is limited to these embodiments. For those skilled in the art to which the invention pertains, several simple deductions or substitutions can be made without departing from the spirit of the invention, and all shall be considered as belonging to the protection scope of the invention.
Claims (2)
1. The zinc sulfate and lysine oral solution is characterized in that the formulation of each 1000ml of the oral solution is as follows: 1.1g of zinc sulfate, 20g of lysine hydrochloride, 6g of citric acid, 200ml of simple syrup, 2ml of pineapple essence, 0.15g of ethylparaben and purified water of which the volume is 1000 ml.
2. The preparation method of the zinc sulfate and lysine oral liquid of claim 1 is characterized by comprising the following steps:
(1) dissolving zinc sulfate and citric acid in appropriate amount of purified water, and filtering;
(2) dissolving lysine hydrochloride in warm purified water, and filtering;
(3) after the simple syrup is added, slowly adding the pineapple essence, and stirring the mixture at any time;
(4) then slowly adding ethylparaben solution dissolved by a little ethanol in advance, and stirring along with the addition;
(5) adding purified water to full volume, and stirring;
(6) filling and sealing by using a 10ml glass bottle;
(7) sterilizing the filled and sealed sample for 30 minutes at 100 ℃ by circulating steam;
(8) and (6) performing light inspection on the sterilized sample, and packaging.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202011575149.4A CN112569256A (en) | 2020-12-28 | 2020-12-28 | Zinc sulfate and lysine oral liquid and preparation method thereof |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202011575149.4A CN112569256A (en) | 2020-12-28 | 2020-12-28 | Zinc sulfate and lysine oral liquid and preparation method thereof |
Publications (1)
Publication Number | Publication Date |
---|---|
CN112569256A true CN112569256A (en) | 2021-03-30 |
Family
ID=75140059
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN202011575149.4A Pending CN112569256A (en) | 2020-12-28 | 2020-12-28 | Zinc sulfate and lysine oral liquid and preparation method thereof |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN112569256A (en) |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101181258A (en) * | 2007-11-30 | 2008-05-21 | 广东华生泰医药有限公司 | Lysinepuzinc oral liquid and preparation method thereof |
CN103690561A (en) * | 2014-01-20 | 2014-04-02 | 湖南康寿制药有限公司 | Preparation method of oral liquid |
-
2020
- 2020-12-28 CN CN202011575149.4A patent/CN112569256A/en active Pending
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101181258A (en) * | 2007-11-30 | 2008-05-21 | 广东华生泰医药有限公司 | Lysinepuzinc oral liquid and preparation method thereof |
CN103690561A (en) * | 2014-01-20 | 2014-04-02 | 湖南康寿制药有限公司 | Preparation method of oral liquid |
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Application publication date: 20210330 |