CN109953980A - A kind of Zinc calcium gluconate oral solution and preparation method thereof - Google Patents
A kind of Zinc calcium gluconate oral solution and preparation method thereof Download PDFInfo
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- CN109953980A CN109953980A CN201711425752.2A CN201711425752A CN109953980A CN 109953980 A CN109953980 A CN 109953980A CN 201711425752 A CN201711425752 A CN 201711425752A CN 109953980 A CN109953980 A CN 109953980A
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- Prior art keywords
- calcium gluconate
- parts
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- zinc
- oral solution
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- 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
- A61K31/191—Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic acid
-
- 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, pantothenic acid
- A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
Abstract
A kind of Zinc calcium gluconate oral solution and preparation method thereof.It mainly solves that existing sucrose sugar content is higher, has used the technical issues of substances such as aspartame, benzoic acid or sodium benzoate.Its key points of the technical solution are that including main ingredient and adjuvant, the main ingredient includes calcium gluconate, zinc gluconate and lysine hydrochloride, which is characterized in that contain Steviosin, refrigerant alcohol and ethyl hydroxy benzoate in the adjuvant.It is mainly applied to pharmaceutical technology field.
Description
Technical field
The invention belongs to pharmaceutical technology field more particularly to it is a kind of replenish the calcium, the oral administration solution of zinc and preparation method thereof.
Background technique
Zinc calcium gluconate oral solution is a kind of marketed drug, indication be because of calcium deficiency, zinc caused by disease, including
Osteoporosis, tetany disease, rickets, gravid woman, breast feeding women and menopausal women supplement calcium and children are raw
Long hypoevolutism, anorexia, apositia, recurrent oral ulceration and acne etc..Its conventional prescriptions are as follows: calcium gluconate
60g, zinc gluconate 3g, lysine hydrochloride 10g, sucrose 100g, sodium chloride 0.1g, essence 1.2g, Sodium hydroxide q.s., purifying
Water adds to 1000ml.There is research to improve prescription in recent years, the corrigent in prescription is changed to Aspartame, peace is applied alone
Aspartame, acesulfame potassium are used in mixed way by match honey, and add benzoic acid or sodium benzoate as preservative.
Zinc calcium gluconate oral solution after above-mentioned improvement still remains following disadvantage: (1) sucrose sugar content is higher, can
Can lead to children's decayed tooth, Gestational hyperglycemia and senile diabetes, in addition, sucrose sugar content height will lead to solution viscosity compared with
Greatly, filtering with microporous membrane is slow, and production efficiency is low；Cause calcium gluconate in oral administration solution in addition, sucrose sugar content is higher
In hypersaturated state, easily crystallization is precipitated, and stability is poor.(2) substances such as aspartame, benzoic acid or sodium benzoate have been used, though
So the prescription additive amount of these types substance meets national standard, but also has experimental study to prove that aspartame, sodium benzoate have
Certain physiological-toxicity.
Summary of the invention
The technical problem to be solved by the present invention is to overcome the shortcomings of to mention in background above technology and defect, one kind is provided
Without sucrose, highly-safe Zinc calcium gluconate oral solution, and accordingly provide preparation method.It is asked to solve above-mentioned technology
Topic, technical solution proposed by the present invention are as follows:
A kind of Zinc calcium gluconate oral solution, including main ingredient and adjuvant, the main ingredient include calcium gluconate, zinc gluconate
With lysine hydrochloride, Steviosin, refrigerant alcohol and ethyl hydroxy benzoate are contained in the adjuvant.
In above-mentioned Zinc calcium gluconate oral solution, it is preferred that comprise the following components in parts by weight:
600 parts of calcium gluconate；
30 parts of zinc gluconate；
100 parts of lysine hydrochloride；
120 parts of lactic acid；
10~14 parts of Steviosin；
8~14 parts of refrigerant alcohol；
5 parts of ethyl hydroxy benzoate；
12~16 parts of essence；
Sodium hydroxide q.s.；
10000 parts of purified water.
In above-mentioned Zinc calcium gluconate oral solution, it is preferred that the weight ratio of the Steviosin, essence and refrigerant alcohol is 6:
6:7.
A kind of preparation method of Zinc calcium gluconate oral solution, comprising the following steps:
(1) calcium gluconate is added after boiling purified water, and boiling is kept to obtain reagent 1；
(2) zinc gluconate, lysine hydrochloride, Steviosin and refrigerant alcohol are added in the reagent 1 obtained in step (1), and protects
Hold the reagent 2 that boiling obtains；
(3) ethyl hydroxy benzoate is added in reagent 2 obtained in step (2), and keeps boiling, the reagent 3 obtained after cooling；
(4) lactic acid and essence are added in the reagent 3 obtained in step (3), remaining purified water is added, with sodium hydroxide tune
The reagent 4 that section pH is obtained；
(5) it by the micro-filtrate membrane filtration of reagent 4 obtained in step (4), collects filtrate and obtains Zinc calcium gluconate oral solution.
In the preparation method of above-mentioned Zinc calcium gluconate oral solution, it is preferred that in the step (1), keep boiling
10min；In the step (2), boiling 40min is kept；In the step (3), 40 DEG C are cooled to after keeping boiling 5min.
In the preparation method of above-mentioned Zinc calcium gluconate oral solution, it is preferred that with sodium hydroxide tune pH to 4.0-5.0.
In the preparation method of above-mentioned Zinc calcium gluconate oral solution, it is preferred that when the micro-filtrate membrane filtration, by the examination
The micro-filtrate membrane filtration of 0.8um, 0.45um are successively used in agent 4.
Sucrose is replaced using Steviosin in the present invention, the sugariness of Steviosin is about 300 times of sucrose, it is not absorbed by the body,
Heat is not generated, is not interacted with body fat, therefore can not cause blood glucose fluctuation while keeping finished product mouthfeel,
For puberty children, pregnancy women and the old side effect that will not cause related fields per capita.Hydroxyl is used in the present invention
Phenethyl ester replaces the conventional preservatives such as sodium benzoate, and there are some researches prove the dosage of sodium benzoate and mouse sperm teratogenesis number are in positive
Pass relationship, and the main adverse reaction of oxybenzene esters preservative concentrates on allergic reaction, the part especially at skin injury
In terms of external application, therefore, said from severity, ethyl hydroxy benzoate is safer than sodium benzoate, the Portugal obtained using ethyl hydroxy benzoate
The safety of grape Calciofon zinc oral administration solution product is higher.
Compared with the prior art, the advantages of the present invention are as follows:
1, the present invention replaces Aspartame/sucrose using Steviosin, reduces drug to people while obtaining better mouthfeel
The influence of body blood sugar concentration also reduces auxiliary material bring security risk；In addition, due to the sugarcane without containing high concentration in the present invention
Sugar, solution viscosity is low, and when using micro-filtrate membrane filtration, the rate of filtration is fast.
2, the present invention replaces the conventional preservatives such as sodium benzoate, the peace of Zinc calcium gluconate oral solution using ethyl hydroxy benzoate
It has a distinct increment in terms of full property.
Specific embodiment
In a kind of Zinc calcium gluconate oral solution, comprise the following components in parts by weight:
600 parts of calcium gluconate；
30 parts of zinc gluconate；
100 parts of lysine hydrochloride；
120 parts of lactic acid；
10 parts of Steviosin；
10 parts of refrigerant alcohol；
5 parts of ethyl hydroxy benzoate；
10 parts of essence；
Sodium hydroxide q.s. (adjust dosage required for pH to 4.0-5.0)；
10000 parts of purified water.
The preparation method of above-mentioned Zinc calcium gluconate oral solution, comprising the following steps:
(1) calcium gluconate is added after 8L purified water being boiled 20min, and boiling 10min is kept to obtain reagent 1；
(2) zinc gluconate, lysine hydrochloride, Steviosin and refrigerant alcohol are added in the reagent 1 obtained in step (1), and protects
Hold the reagent 2 that boiling 40min is obtained；
(3) ethyl hydroxy benzoate is added in reagent 2 obtained in step (2), and keeps boiling 5min, obtained after being cooled to 40 DEG C
Reagent 3；
(4) lactic acid and essence are added in the reagent 3 obtained in step (3), remaining purified water is added, with sodium hydroxide tune
The reagent 4 that section pH to 4.0-5.0 is obtained；
(5) micro-filtrate membrane filtration that reagent 4 obtained in step (4) is successively used to 0.8um, 0.45um collects filtrate with 10mL palm fibre
Color vial is filling/envelope bottle.
Embodiment 2-4:
The recipe ingredient of embodiment 2-4 and preparation method are same as Example 1, the difference is that Steviosin, ethyl hydroxy benzoate with
Essence dosage is different, and specific dosage is referring to table 1.
The Zinc calcium gluconate oral solution obtained using the formula in embodiment 1-4 is subjected to mouthfeel and fragrance is tested,
As a result as shown in table 1 below.
Table 1: the experimental result (parts by weight) of the Steviosins of different amounts, ethyl hydroxy benzoate and essence
In upper table, essence includes but are not limited to apple aroma essence, sweet orange juice taste essence.It can be seen by the experimental result of upper table
Out, the weight ratio of Steviosin, essence and refrigerant alcohol is that 12:12:14 experiment effect is best.
Embodiment 5-8:
The recipe ingredient of embodiment 5-8 and preparation method are same as Example 1, the difference is that the dosage of ethyl hydroxy benzoate is
Difference, specific dosage is referring to table 2.
The Zinc calcium gluconate oral solution obtained using the formula in embodiment 5-8 is subjected to inhibitory effect test, knot
Fruit is as shown in table 2 below.
Table 2: inhibitory effect test bacterium number decline lg value (parts by weight) of the ethyl hydroxy benzoate of different amounts
When inhibitory effect is tested, antibacterial power test test sample 10ml is taken, adds pH7.0 sterile NaCl-peptone buffer agent extremely
The test liquid of 1:10 is made in 100ml.Prepare 5 parts of test samples, blank takes orally liquor, diluent.Every portion solution inoculum to be measured
One test organisms, takes test sample appropriate, is transferred in 5 suitable sterile chambers respectively, and each container is inoculated with a kind of test organisms,
1ml quantity of microorganism inoculated is 105~106Cfu, the volume for being inoculated with bacterium solution must not exceed the 0.5%~1% of test sample volume, be sufficiently mixed,
It is uniformly distributed the test organisms in test sample.Then the test sample of inoculation is set 20~25 DEG C during test, stored protected from light is store
The variation for depositing temperature should be controlled in minimum zone as far as possible, and prevent from being contaminated.The preservative configured in parallel of various concentration, every part
Sample operation repetitive is three times.
By upper table 2 it is found that using the ethyl hydroxy benzoate of parts by weight in embodiment 7 as bacteriostatic agent, while guaranteeing fungistatic effect
The use of bacteriostatic agent can also be reduced to the greatest extent.
Inhibitory effect judgment basis:
Note: NI: not increasing, refers to that, to previous minute, the increased quantity of test organisms is no more than 0.5lg.
Claims (7)
1. a kind of Zinc calcium gluconate oral solution, including main ingredient and adjuvant, the main ingredient includes calcium gluconate, gluconic acid
Zinc and lysine hydrochloride, which is characterized in that contain Steviosin, refrigerant alcohol and ethyl hydroxy benzoate in the adjuvant.
2. Zinc calcium gluconate oral solution according to claim 1, it is characterized in that: the wherein weight proportion of each raw material point
It is not: 600 parts of calcium gluconate；
30 parts of zinc gluconate；
100 parts of lysine hydrochloride；
120 parts of lactic acid；
10~14 parts of Steviosin；
8~14 parts of refrigerant alcohol；
5 parts of ethyl hydroxy benzoate；
12~16 parts of essence；
Sodium hydroxide q.s.；
10000 parts of purified water.
3. Zinc calcium gluconate oral solution according to claim 1, it is characterized in that: the Steviosin, essence with it is refrigerant
The weight ratio of alcohol is 6:6:7.
4. a kind of preparation method of Zinc calcium gluconate oral solution according to claim 2 or 3, which is characterized in that packet
Include following steps:
(1) calcium gluconate is added after boiling purified water, and boiling is kept to obtain reagent 1；
(2) zinc gluconate, lysine hydrochloride, Steviosin and refrigerant alcohol are added in the reagent 1 obtained in step (1), and protects
Hold the reagent 2 that boiling obtains；
(3) ethyl hydroxy benzoate is added in reagent 2 obtained in step (2), and keeps boiling, the reagent 3 obtained after cooling；
(4) lactic acid and essence are added in the reagent 3 obtained in step (3), remaining purified water is added, with sodium hydroxide tune
The reagent 4 that section pH is obtained；
(5) it by the micro-filtrate membrane filtration of reagent 4 obtained in step (4), collects filtrate and obtains Zinc calcium gluconate oral solution.
5. the preparation method of Zinc calcium gluconate oral solution according to claim 4, which is characterized in that the step
(1) in, boiling 10min is kept；In the step (2), boiling 40min is kept；In the step (3), after keeping boiling 5min
It is cooled to 40 DEG C.
6. the preparation method of Zinc calcium gluconate oral solution according to claim 4 or 5, which is characterized in that use hydrogen-oxygen
Change sodium tune pH to 4.0-5.0.
7. the preparation method of Zinc calcium gluconate oral solution according to claim 4 or 5, which is characterized in that described micro-
When membrane filtration, the reagent 4 is successively used to the micro-filtrate membrane filtration of 0.8um, 0.45um.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711425752.2A CN109953980A (en) | 2017-12-25 | 2017-12-25 | A kind of Zinc calcium gluconate oral solution and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711425752.2A CN109953980A (en) | 2017-12-25 | 2017-12-25 | A kind of Zinc calcium gluconate oral solution and preparation method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN109953980A true CN109953980A (en) | 2019-07-02 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201711425752.2A Pending CN109953980A (en) | 2017-12-25 | 2017-12-25 | A kind of Zinc calcium gluconate oral solution and preparation method thereof |
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| Country | Link |
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| CN (1) | CN109953980A (en) |
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2017
- 2017-12-25 CN CN201711425752.2A patent/CN109953980A/en active Pending
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Application publication date: 20190702 |