CN104622860A - Pharmaceutical composition having calcium supplementation and zinc supplementation functions - Google Patents
Pharmaceutical composition having calcium supplementation and zinc supplementation functions Download PDFInfo
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- CN104622860A CN104622860A CN201510058717.6A CN201510058717A CN104622860A CN 104622860 A CN104622860 A CN 104622860A CN 201510058717 A CN201510058717 A CN 201510058717A CN 104622860 A CN104622860 A CN 104622860A
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Abstract
The invention belongs to the technical field of medicines and discloses a pharmaceutical composition having calcium supplementation and zinc supplementation functions. The pharmaceutical composition comprises calcium lactate, zinc gluconate, L-lysinate, erythritol and citric acid. Pharmacological experiments indicate that oral liquid prepared from the pharmaceutical composition disclosed by the invention has better calcium supplementation and zinc supplementation functions, and a stability experiment indicates that the oral liquid has good preparation stability.
Description
Technical field
The invention belongs to medical art, be specifically related to a kind of containing calcium lactate, the pharmaceutical composition of zinc gluconate and preparation thereof.
Background technology
Calcium is the element that people's in-vivo content is maximum, about has 1200 grams, and wherein 99% form skeleton, 1% is present in blood soft tissue, is one of element of the most easily lacking of human body.In Chinese residents meals every day, frumentum and vegetable account for about 90% of food.And containing a large amount of phytic acid in these foods, thus stop calcium absorption.Calcium deficiency can cause a lot of disease, such as: 1, night sweat; 2, easily wake up with a start, easily startle; 3, often there is dysphoria daytime, cry well; 4, rest the head on bald (occipitalia alopecia circle); 5, teething late or tooth arrangement uneven; 6, learn to walk late; 7, often there is cramp phenomenon; 8, fingernail is greyish white or have white macula.
Zinc is a kind of trace element existed in human body, and adult normal is containing zinc 1.5--2.5g, and wherein 60% is present in muscle, and 30% is present in skeleton.The organ that in health, Zn content is maximum is eye, hair and testis.With the composition of a bit similar to be zinc be also the multiple enzyme of copper, discovered in recent years has more than 90 kind of enzyme relevant with zinc, and in body, the synthesis of any one protein all needs the enzyme containing zinc.The effect of zinc is mainly: the growth promoter 1, promoting human body; 2, the appetite of human normal is maintained; 3, body immunity is improved; 4, the normal reproductive function of male is maintained; 5, the healing of wound or wound is promoted.
Therefore, for needing to replenish the calcium, the patient of zinc supplement, research and development have a kind of new product, to adapt to the needs of different patient, significant.
Summary of the invention
For these reasons, applicant is by research, obtain a kind of having and replenish the calcium and the pharmaceutical composition of zinc supplement effect newly, containing calcium lactate, zinc gluconate and L-lysine hydrochloride in said composition, combine with pharmaceutic adjuvant erythritol and citric acid, for the preparation of oral liquid, research shows, this oral liquid has good stability, has replenishing the calcium and zinc supplement effect of excellent effect.
The present invention is achieved through the following technical solutions.
Have a pharmaceutical composition of replenishing the calcium with zinc supplement effect, pharmaceutical composition comprises calcium lactate, zinc gluconate, L-lysine hydrochloride, erythritol and citric acid.
Calcium lactate 100-200 weight portion in preferred pharmaceutical composition, zinc gluconate 2-4 weight portion, L-lysine hydrochloride 8-12 weight portion, erythritol 1.0-1.5 weight portion, citric acid 5-8 weight portion.
Calcium lactate 150 weight portion in preferred pharmaceutical composition, zinc gluconate 3 weight portion, L-lysine hydrochloride 10 weight portion, erythritol 1.2 weight portion, citric acid 6 weight portion.
Calcium lactate 150 weight portion in preferred pharmaceutical composition, zinc gluconate 3 weight portion, L-lysine hydrochloride 10 weight portion, erythritol 1.3 weight portion, citric acid 6.5 weight portion.
Calcium lactate 150 weight portion in preferred pharmaceutical composition, zinc gluconate 3 weight portion, L-lysine hydrochloride 10 weight portion, erythritol 1.4 weight portion, citric acid 7 weight portion.
Pharmaceutical composition described above is prepared into pharmaceutical preparation.
Pharmaceutical preparation described above comprises oral liquid.
The preparation method of oral liquid described above is: get erythritol, inject with water, dissolve completely, add L-lysine hydrochloride, add water, be heated to 50 DEG C-70 DEG C, add calcium lactate, zinc gluconate and citric acid successively, filter, add water, medicinal liquid through filtering with microporous membrane to receiver mix homogeneously; Qualified rear for embedding, lamp inspection, outer package, obtains finished product.
One, pharmacodynamics test
Trial drug:
Trial drug 1 group: calcium lactate oral administration solution (Beijing Beida Pharmaceutical Industry Co., Ltd.).
Trial drug 2 groups: embodiment 1.
Trial drug 3 groups: embodiment 2.
Trial drug 4 groups: embodiment 3.
Above-mentioned test preparation, according to commercially available back, at temperature 40 DEG C ± 2 DEG C, relative humidity 75% ± 5%, is placed 1 month, is carried out following pharmacology test.
Test 1 is tested the impact of rat calcium supplementing effect
Test method: the wean in raw latter 28 days of wister rat, body weight 55-65g, male and female half and half, random packet, sacrificed by decapitation 1 treated animal before on-test, adopts bilateral femur and surveys its calcium content, other group feeding different tests group, 28 days experimental periods, the single cage of animal is raised, freely drink water and lose to the greatest extent, every day is identical to appetite, dosage identical (gastric infusion, dosage is 2ml/kg), within every 4 days, weigh 1 time, adopt bilateral femur during off-test and survey femur calcium content.Result of the test is in table 1:
Table 1 Mus femur calcium content
Note: compare * * P<0.01 with blank group, * P<0.05; #P<0.05 is compared with test 1 group.
Test brief summary: above-mentioned test shows, pharmaceutical composition of the present invention is prepared into oral liquid, has better calcium supplementing effect than commercially available the oral liquid of calcium lactate, the excellent effect of its calcium supplementing effect.
Test 2
To the zinc supplement influential effect of mice
Experimental animal: Kunming mouse, 16-20g, male.
Test method:
The preparation of mice zinc deficiency feedstuff: select cheap and contain the little rice protein powder of zinc as protein sources, " Jin Longyu " board salad oil is as fat source, medical glucose is as sugared source, vitamin mixtures and mineral salt mixture (not adding zinc salt) list of references [REEVES P G, NIELSEN F H, FAHEY G C J.AIN-93puri-fied diets for laboratory rodents:final report of the AmericanInstitute of Nutrition ad hoc writing committee on the reformu-lation of the AIN-76A rodent diet[J]。J Nutr，1993，123(11)：1939-1951。] formula designed, designed, preparation zinc deficiency feedstuff.
The foundation of mice zinc deficiency model: zinc deficiency feedstuff, actual measurement Zn content is less than 2mg/kg.Get mice, random packet, often organize 10, feed in plastics cage, 5, every cage, raise in zoopery indoor, indoor environment relative humidity (60 ± 5) %, temperature (23 ± 1) DEG C.After the 3d laundering period feeds, zinc deficiency group is fed low zinc feed, control group fed chow diet, and free choice feeding, freely drinks deionized water, observes mice symptom.All test tools all clean with EDTA solution.Feed 16d, record food-intake every day, every 3d surveys body weight 1 time.Be divided into matched group (normal group), zinc deficiency group, zinc deficiency+said medicine test group, often organize 10.Condition of feeding is the same, trial drug group gastric infusion, and dosage is 2ml/kg, continuous gavage 16d, and record food-intake every day, every 3d surveys body weight 1 time.Test eye socket in latter stage gets blood, and separation of serum is standby to be surveyed; Put to death immediately and cut open the belly and get mouse liver, with 0.9% normal saline rinsing, removing blood and connective tissue, filter paper is wiped dry, is make liver homogenate at 1: 9 with 0.9% normal saline with mass ratio.Measure serum and liver Zn content.
Mouse liver, Determination of Zinc Concentration in Serum change after table 2 zinc supplement
Note: compare * * P<0.01 with zinc deficiency group, * P<0.05.
Test brief summary: above-mentioned test shows, the oral liquid that pharmaceutical composition of the present invention is prepared into has better zinc supplement effect.
Two, stability test research
Trial drug 1 group: embodiment 1
Trial drug 2 groups: embodiment 2.
Trial drug 3 groups: embodiment 3.
Trial drug 4 groups: embodiment 4.
Above-mentioned test preparation detects the content of calcium lactate, zinc gluconate and L-lysine hydrochloride, then according to commercially available back, in temperature 60 C ± 5 DEG C, relative humidity 75% ± 5%, place 1 month, then detect the content of calcium lactate, zinc gluconate and L-lysine hydrochloride.
Above-mentioned testing result:
[assay]
L-lysine hydrochloride measures according to high performance liquid chromatography (Chinese Pharmacopoeia two annex V D).
Chromatographic condition octadecylsilane chemically bonded silica is filler; With the phosphate buffer-acetonitrile (88:12) containing 5mmol/L perfluorooctane sulfonate for mobile phase, determined wavelength is 203nm, and column temperature is 40 DEG C, and flow velocity is 0.5ml/min.Number of theoretical plate calculates should be not less than 2000 by L-lysine hydrochloride peak.
(note: phosphate buffer: get dipotassium hydrogen phosphate 2.282g, is dissolved in water and is diluted to 1000ml, adjusts pH value to 4.8 with phosphoric acid)
Algoscopy precision measures this product in right amount, and quantitatively dilute the solution made about containing L-lysine hydrochloride 1mg in every 1ml with water, precision measures 10 μ l injection liquid chromatographies, record chromatogram; Separately get L-lysine hydrochloride reference substance, accurately weighed, be dissolved in water and quantitatively dilute the solution made about containing L-lysine hydrochloride 1mg in every 1ml, being measured in the same method, by external standard method with calculated by peak area, obtaining final product.
Calcium lactate, zinc gluconate
Calcium lactate
Need testing solution precision measures this product 5ml, and put in 100ml measuring bottle, be diluted with water to scale, shake up, precision measures 2ml, puts in 100ml measuring bottle, is diluted with water to scale, shake up, as need testing solution.
Calcium lactate algoscopy precision measures standard calcium liquid (1000 μ g/ml) 10ml, puts in 100ml measuring bottle, is diluted with water to scale, shake up, precision measures 3ml, 4ml, 5ml, 6ml, 7ml, puts in 100ml measuring bottle and is diluted with water to scale, shake up, as standard calcium liquid.Get standard calcium liquid and need testing solution, according to atomic absorption spectrophotometry (annex IV D first method), measure at the wavelength place of 422.7nm.Calculate the content of calcium lactate.
Calcium lactate content:
Zinc gluconate algoscopy precision measures zinc titer (1000 μ g/ml) 1ml, puts in 100ml measuring bottle, is diluted with water to scale, shake up, precision measures 3ml, 4ml, 5ml, 6ml, 7ml, puts in 100ml measuring bottle and is diluted with water to scale, shake up, as Zinc standard solution.Get Zinc standard solution and need testing solution, according to atomic absorption spectrophotometry (Chinese Pharmacopoeia two annex IV D first methods), measure at the wavelength place of 213.9nm.Calculate the content of zinc gluconate.
Gluconic acid Zn content:
Note: C calcium: the measured concentration (μ g/ml) of calcium in sample solution
C zinc: the measured concentration (μ g/ml) of zinc in sample solution.
Result of the test is in table 3.
Table 3 stability test result
Conclusion (of pressure testing): aforementioned stable test shows, pharmaceutical composition of the present invention is prepared into pharmaceutical preparation and has extraordinary stability.
Preparation embodiment
Embodiment 1
Calcium lactate 1500g, zinc gluconate 30g, L-lysine hydrochloride 100g, erythritol 12g, citric acid 60g;
Get erythritol, inject with water, dissolve completely, add L-lysine hydrochloride, add water, be heated to 60 DEG C, add calcium lactate, zinc gluconate and citric acid successively, filter, add water, medicinal liquid through filtering with microporous membrane to receiver mix homogeneously; Qualified rear for embedding, lamp inspection, outer package, obtains finished product 1000 (often propping up 10ml).
Embodiment 2
Calcium lactate 1500g, zinc gluconate 30g, L-lysine hydrochloride 100g, erythritol 13g, citric acid 65g.
Get erythritol, inject with water, dissolve completely, add L-lysine hydrochloride, add water, be heated to 60 DEG C, add calcium lactate, zinc gluconate and citric acid successively, filter, add water, medicinal liquid through filtering with microporous membrane to receiver mix homogeneously; Qualified rear for embedding, lamp inspection, outer package, obtains finished product 1000 (often propping up 10ml).
Embodiment 3
Calcium lactate 1500g, zinc gluconate 30g, L-lysine hydrochloride 100g, erythritol 14g, citric acid 70g.
Get erythritol, inject with water, dissolve completely, add L-lysine hydrochloride, add water, be heated to 60 DEG C, add calcium lactate, zinc gluconate and citric acid successively, filter, add water, medicinal liquid through filtering with microporous membrane to receiver mix homogeneously; Qualified rear for embedding, lamp inspection, outer package, obtains finished product 1000 (often propping up 10ml).
Embodiment 4
Calcium lactate 1000g, zinc gluconate 25g, L-lysine hydrochloride 95g, erythritol 11g, citric acid 55g.
Get erythritol, inject with water, dissolve completely, add L-lysine hydrochloride, add water, be heated to 60 DEG C, add calcium lactate, zinc gluconate and citric acid successively, filter, add water, medicinal liquid through filtering with microporous membrane to receiver mix homogeneously; Qualified rear for embedding, lamp inspection, outer package, obtains finished product 1000 (often propping up 10ml).
Embodiment 5
Calcium lactate 1050g, zinc gluconate 38g, L-lysine hydrochloride 115g, erythritol 14.5g weight portion, citric acid 72.5g.
Get erythritol, inject with water, dissolve completely, add L-lysine hydrochloride, add water, be heated to 60 DEG C, add calcium lactate, zinc gluconate and citric acid successively, filter, add water, medicinal liquid through filtering with microporous membrane to receiver mix homogeneously; Qualified rear for embedding, lamp inspection, outer package, obtains finished product 1000 (often propping up 10ml).
Embodiment 6
Calcium lactate 1100g, zinc gluconate 20g, L-lysine hydrochloride 80g, erythritol 10g, citric acid 50g.
Get erythritol, inject with water, dissolve completely, add L-lysine hydrochloride, add water, be heated to 60 DEG C, add calcium lactate, zinc gluconate and citric acid successively, filter, add water, medicinal liquid through filtering with microporous membrane to receiver mix homogeneously; Qualified rear for embedding, lamp inspection, outer package, obtains finished product 1000 (often propping up 10ml).
Embodiment 7
Calcium lactate 1950g, zinc gluconate 40g, L-lysine hydrochloride 120g, erythritol 15g, citric acid 80g.
Get erythritol, inject with water, dissolve completely, add L-lysine hydrochloride, add water, be heated to 60 DEG C, add calcium lactate, zinc gluconate and citric acid successively, filter, add water, medicinal liquid through filtering with microporous membrane to receiver mix homogeneously; Qualified rear for embedding, lamp inspection, outer package, obtains finished product 1000 (often propping up 10ml).
Described embodiment includes but not limited to above-mentioned.
Claims (8)
1. there is a pharmaceutical composition of replenishing the calcium with zinc supplement effect, it is characterized in that pharmaceutical composition comprises calcium lactate, zinc gluconate, L-lysine hydrochloride, erythritol and citric acid.
2. according to claim 1 a kind of have replenish the calcium and the pharmaceutical composition of zinc supplement effect, wherein calcium lactate 100-200 weight portion, zinc gluconate 2-4 weight portion, L-lysine hydrochloride 8-12 weight portion, erythritol 1.0-1.5 weight portion, citric acid 5-8 weight portion.
3. according to claim 1 a kind of have replenish the calcium and the pharmaceutical composition of zinc supplement effect, wherein calcium lactate 150 weight portion, zinc gluconate 3 weight portion, L-lysine hydrochloride 10 weight portion, erythritol 1.2 weight portion, citric acid 6 weight portion.
4. according to claim 1 a kind of have replenish the calcium and the pharmaceutical composition of zinc supplement effect, wherein calcium lactate 150 weight portion, zinc gluconate 3 weight portion, L-lysine hydrochloride 10 weight portion, erythritol 1.3 weight portion, citric acid 6.5 weight portion.
5. according to claim 1 a kind of have replenish the calcium and the pharmaceutical composition of zinc supplement effect, wherein calcium lactate 150 weight portion, zinc gluconate 3 weight portion, L-lysine hydrochloride 10 weight portion, erythritol 1.4 weight portion, citric acid 7 weight portion.
6. a kind of according to any one of claim 1-5 has and replenishes the calcium and the pharmaceutical composition of zinc supplement effect, it is characterized in that pharmaceutical composition is prepared into pharmaceutical preparation.
7. according to claim 6 a kind of have replenish the calcium and the pharmaceutical composition of zinc supplement effect, its pharmaceutical formulations comprises oral liquid.
8. according to claim 7 a kind of have replenish the calcium and the pharmaceutical composition of zinc supplement effect, wherein the preparation method of oral liquid is: get erythritol, inject with water, dissolve completely, add L-lysine hydrochloride, add water, be heated to 50 DEG C-70 DEG C, add calcium lactate, zinc gluconate and citric acid successively, filter, add water, medicinal liquid through filtering with microporous membrane to receiver mix homogeneously; Qualified rear for embedding, lamp inspection, outer package, obtains finished product.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105077280A (en) * | 2015-09-01 | 2015-11-25 | 张伟 | Liquid preparation for supplementing zinc and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103191092A (en) * | 2013-04-02 | 2013-07-10 | 澳诺（中国）制药有限公司 | Pharmaceutical composition with effects of supplying calcium and zinc |
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- 2015-02-04 CN CN201510058717.6A patent/CN104622860A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103191092A (en) * | 2013-04-02 | 2013-07-10 | 澳诺（中国）制药有限公司 | Pharmaceutical composition with effects of supplying calcium and zinc |
Non-Patent Citations (1)
| Title |
|---|
| 魏太星等: "《医生专用药物手册》", 31 January 2015, 郑州：河南科学技术出版社 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105077280A (en) * | 2015-09-01 | 2015-11-25 | 张伟 | Liquid preparation for supplementing zinc and preparation method thereof |
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