CN112569256A - Zinc sulfate and lysine oral liquid and preparation method thereof - Google Patents

Zinc sulfate and lysine oral liquid and preparation method thereof Download PDF

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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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CN202011575149.4A
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Chinese (zh)
Inventor
舒强
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Childrens Hospital of Zhejiang University School of Medicine
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Childrens Hospital of Zhejiang University School of Medicine
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/30Zinc; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic 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
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/02Nutrients, e.g. vitamins, minerals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics

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  • 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

Zinc sulfate and lysine oral liquid and preparation method thereof
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:
Figure RE-GDA0002951499180000021
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.
CN202011575149.4A 2020-12-28 2020-12-28 Zinc sulfate and lysine oral liquid and preparation method thereof Pending CN112569256A (en)

Priority Applications (1)

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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

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Citations (2)

* Cited by examiner, † Cited by third party
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

Patent Citations (2)

* Cited by examiner, † Cited by third party
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