CN1027959C - Zn-Ca oral liquid and its preparing method - Google Patents

Zn-Ca oral liquid and its preparing method Download PDF

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Publication number
CN1027959C
CN1027959C CN 93101224 CN93101224A CN1027959C CN 1027959 C CN1027959 C CN 1027959C CN 93101224 CN93101224 CN 93101224 CN 93101224 A CN93101224 A CN 93101224A CN 1027959 C CN1027959 C CN 1027959C
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China
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oral liquid
components
calcium
zinc
gluconate
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CN 93101224
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CN1075080A (en
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李云
李纯正
姜进生
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Lishan Hospital Of Anshan Iron And Steel Co
Angang Steel Co Ltd
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Lishan Hospital Of Anshan Iron And Steel Co
Angang Steel Co Ltd
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Abstract

The present invention relates to Zn and Ca oral liquid and a preparing method thereof. Distilled water is used as a dissolvant in compounding components; calcium gluconate and zinc gluconate are used as effective components; a stabilizing agent, a preservative and a flavor correcting agent are also added as auxiliary components. The oral liquid has the technologic characteristics that (1), all components are compounded by a reasonable proportion; (2), the calcium gluconate is sufficiently dissolved in the boiling distilled water; (3), all the components are added according to a dissolvability incremental sequence for dissolving and uniformly mixing the components one by one; (4), the components are filtered by a microporous filtering film whose nominal pore size is smaller than or equal to 1.2 mu m. The Zn and Ca oral liquid prepared by the formulation and the preparing method is suitable for various diseases due to calcium deficiency, such as rickets, anorexia, growth retardation, etc., and has the advantages of quick effect, high therapeutic effect, convenient administration, stable performance and safe and reliable use; the Zn and Ca oral liquid is welcomed by doctors and patients.

Description

Zn-Ca oral liquid and its preparing method
The present invention relates to a kind of is effective ingredient with the medicinal compound that contains zinc and calcium, and adding Zn-Ca oral liquid and the compound method thereof that adjuvant is made, it is widely used in infant inappetence, monophagia, pica, cretinism and the rickets, the brothers that cause because of zinc deficiency, calcium deficiency and takes out
Figure 931012244_IMG1
Treatment of diseases and preventions such as disease.
At present, the domestic medicine that is used for children water-adding zinc, replenishes the calcium has only single agent of calcium and zinc, and " the zinc gluconate mixture " of P53 record is respectively applied for and treats and prevent calcium, zinc deficiency disease in " gluconic acid Ca oral liquid " and " Chinese Hospitals preparation standard " front page (bureau of drug administration of Ministry of Health of the People's Republic of China volumes) that the Harbin No.3 Pharmaceutical Factory of the 10th volume the 2nd phase back cover publication of publishing as " pharmacy Intelligence Newsletter " 1992.6 months is produced.And the infant of calcium deficiency, its cardinal symptom is hyperhidrosis, and one of main excretion pathway of zinc is exactly to discharge from perspiration in the body.Therefore the most of zinc deficiency of infant of calcium deficiency, and zinc deficiency can reduce the immunologic function of children patient, how sick infant is often, influences appetite, caused the vicious cycle of calcium deficiency, zinc deficiency like this, influenced the growth promoter of infant greatly.So also should zinc supplement when replenishing the calcium, just can receive better therapeutic effect.
If take calcium preparation, zinc agent respectively, infant is taken inconvenience on the one hand, and difficult grasp ratio appropriate dosage, so be difficult to reach therapeutic purposes; The zinc salt of different acid groups and calcium salt 5 usefulness not only do not reach the purpose of treatment sometimes, and can produce harmful substance on the other hand, toxic side effect, as: zinc sulfate and 5 times spent of calcium chloride, the calcium sulfate solubility product of generation is very little, is difficult to reach the purpose of replenishing the calcium; And the zinc chloride that produces has strong impulse to stomach, easily causes gastric ulcer.
Though abroad also have " GEM (the flat 1-242531 of Japanese kokai publication sho 63-70383()) wherein also contain calcium and zinc, its prescription, production technology are all different with this law, and its purposes is also made a world of difference, and is used for the treatment of hepatopathy, and is intravenous fluid.
In view of the foregoing, the objective of the invention is to produce a kind of oral liquid that can replenish calcium and zinc simultaneously with rational component, proportioning and compound method with the problem that exists.
For realizing purpose of the present invention, the technical measures of being taked and the good effect of generation are: (1) batching component is to be effective ingredient with calcium gluconate and zinc gluconate, and sodium citrate is a stabilizing agent, and nipalgin second is antiseptic, simple syrup is a correctives, and distilled water is a solvent.(2) proportioning of each component is: nipalgin second: sodium citrate: zinc gluconate: calcium gluconate: simple syrup (proportion is 1.3g/ml)=1: 4: 13.3~14.7: 95~105: the 260(weight ratio), simple syrup accounts for the 10%(percentage by volume of Zn-Ca oral liquid preparation total amount), all the other are distilled water.(3) compound method is: reinforced by above-mentioned prescription, the distilled water of earlier Zn-Ca oral liquid being prepared total amount 2/3 is added in the preparation bucket, is heated to add calcium gluconate when boiling, and makes it to stop heating after the fully dissolving, add nipalgin second, zinc gluconate while hot more successively, sodium citrate is treated to dissolve one by one the back and is added the simple syrup mixing, with the microporous filter membrane filtration of nominal pore size≤1.2 μ m, last adding distil water is to preparing total amount, mixing, packing gets product.
Rapid-action with the Zn-Ca oral liquid that this prescription and compound method are produced, the curative effect height, taking convenience, untoward reaction is not found in stable performance in application, safe and reliable.
Introduce content of the present invention in detail below in conjunction with embodiment and clinical case.
The prescription of Zn-Ca oral liquid of the present invention and process for preparation are:
1) batching component
With the distilled water is solvent.
As effective ingredient, can be that the patient replenishes zinc and calcium with calcium gluconate and zinc gluconate so simultaneously.Because the infant of calcium deficiency is zinc deficiency often, the use of this oral liquid except that zinc calcium complementary action is arranged, also can be avoided the trouble of using two single agent to bring; Zinc calcium preparation amount is suitable, and the acid group of calcium salt and zinc salt is identical, thus can avoid producing harmful substance, the infant taking convenience, curative effect is obvious.
With the sodium citrate is stabilizing agent, can prevent that producing crystallization because of the calcium gluconate dissolubility is little separates out.
With nipalgin second is antiseptic, to prevent the medicine moldy metamorphism, makes clinical practice safe and reliable.
With the simple syrup is correctives, to eliminate the astringent taste of calcium salt and zinc salt, makes infant be easy to accept.
2) proportioning of each component
Nipalgin second: sodium citrate: zinc gluconate: calcium gluconate: simple syrup (proportion is 1.3g/ml)=1: 4: 13.3~14.7: 95~105: the 260(weight ratio), simple syrup accounts for the 10%(percentage by volume of Zn-Ca oral liquid preparation total amount), all the other are distilled water.
3) process for preparation
Add crude drug by above-mentioned prescription, the distilled water of at first Zn-Ca oral liquid being prepared total amount 2/3 adds in the mixer, be heated to and add calcium gluconate when boiling, make it abundant dissolving (because of calcium gluconate dissolved ratio in cold water is 1: 30, and dissolved ratio is 1: 5 in boiling water), stop heating, press the ascending order of dissolubility while hot respectively with nipalgin second, zinc gluconate, sodium citrate joins in the mixer, treat to add simple syrup again after each component dissolves one by one, stir, microporous filter membrane with nominal pore size≤1.2 μ m filters, after impurity and subparticle filtering, last adding distil water stirs to preparing total amount, packing promptly gets the Zn-Ca oral liquid finished product.
Embodiment:
The upright mountain of Anshan iron and steel plant hospital pharmacy preparation total amount is the Zn-Ca oral liquid of 100,000 ml, and lot number is 900131.
1) prescription:
Zinc gluconate 700g
Calcium gluconate 5000g
Sodium citrate 200g
Nipalgin second 50g
Simple syrup 13000g(10000ml)
Distilled water adds to 100,000 ml
2) process for preparation:
Adding earlier Zn-Ca oral liquid preparation total amount 2/3(in mixer is 66666.7ml) distilled water, be heated to and add the 5000g calcium gluconate when boiling, make it abundant dissolving.Stop heating, add successively respectively while hot after 50g nipalgin second, 700g zinc gluconate, 200g sodium citrate makes it to dissolve one by one, add 13000g(10000ml again) simple syrup, stir, microporous filter membrane (red flag doctorization equipment factory in Haining City Guo shop, Zhejiang Province produces) with nominal pore size≤1.2 μ m filters, and last adding distil water to 10 ten thousand ml stir, packing promptly gets the Zn-Ca oral liquid finished product.
3) period of storage:
Carrying out bacterium inspection result after 127 days is: asepsis growth.
4) clinical case result of use:
The standard diagnostics that to work out by national rickets control scientific research cooperative groups in 1980 at the upright mountain of Anshan iron and steel plant pediatric hospital at the beginning of nineteen ninety is that II is spent active stage rickets 150 examples, and the age is that 1 month to 2 years old (wherein male example 84, women example 66) carried out clinical treatment relatively.
The clinical symptoms performance is as shown in table 1.
After table 1 is seen literary composition
150 routine patients are divided into three groups at random, and each organizes patient age, sex, clinical manifestation proportion basically identical, and learning by statistics to handle has comparability.With calcium treatment group and simple, organize 70 examples merely with the Zn-Ca oral liquid treatment with each 40 example of zinc agent treatment group.
Prepare three kinds of preparations, I as shown in table 2 respectively, II, III number (the preparation total amount is respectively 1000ml).
After table 2 is seen literary composition
The clinician throws wherein a kind of preparation to each group patient under the situation of not understanding each number preparation composition.The each 20ml of sick child more than 6 months, the each 10ml of the sick child below 6 months is a course of treatment all around every day three times, three groups of patients are the vitamin D of intramuscular injection simultaneously all 2300,000 u/ time, totally 1~2 time.
Therapeutic outcome is more as shown in table 3.
After table 3 is seen literary composition
As seen from Table 3, the curative effect of Zn-Ca oral liquid obviously is better than merely with the calcium group and uses the zinc group merely, and except " one on blood zinc " Zn-Ca oral liquid and simple ratio no significant difference with the zinc group, all the other each respective value are learned processing by statistics, the P value all<0.05 has obvious improvement.Three groups of patients all find no untoward reaction at period in a medicine.
Table 1
Growth promoter
The low anorexia of the fidgety hyperhidrosis skeleton change of clinical manifestation muscular strength
Fall behind
Example several 135 145 140 99 108 105
Percentage rate, % 90 96.6 93.3 66 72 70
Clinical manifestation repeated infection X-ray changes blood calcium and reduces AKP ↑ blood zinc reduction zinc reduction
Example several 123 150 138 150 112 93
Percentage rate, % 82 100 92 100 74.6 62
Table 2
Contain into zinc gluconate calcium gluconate sodium citrate nipalgin second
(g) (g) (g) for amount part (g)
Preparation
I numbers 72 0.5
II numbers 7 50 2 0.5
III numbers 50 2 0.5
Contain into monosaccharide acid distillation water
Amount part g(ml) (ml)
Preparation
I 130(100) adds to 1000ml
II 130(100) adds to 1000ml
III 130(100) adds to 1000ml
Table 3
It is normal that curative effect clinical symptom disappearance X-ray recovers blood calcium
The performance example, % example, % example, %
Preparation
Single with calcium preparation 34,/40 85 26,/40 65 32,/40 80
Single with zinc agent 32,/40 80 24,/40 60 30,/40 75
Zn-Ca oral liquid 68,/70 97 58,/70 82 66,/70 94
Curative effect is clinical
It is normal that the normal blood zinc of AKP is normally sent out zinc
Performance
Example, % example, % example, %
Preparation
Single with calcium preparation 29,/40 72 21,/40 52 18,/40 45
Single with zinc agent 26,/40 65 38,/40 95 30,/40 75
Zn-Ca oral liquid 63,/70 90 68,/70 97 63,/70 90

Claims (2)

1, a kind of compound method of Zn-Ca oral liquid is characterized in that:
1) the batching component is to be effective ingredient with calcium gluconate and zinc gluconate, and the crooked sour sodium of Chinese holly is stabilizing agent, and nipalgin second is antiseptic, and simple syrup is a correctives, and distilled water is a solvent;
2) proportioning of each component is: nipalgin second: sodium citrate: zinc gluconate: calcium gluconate: simple syrup (proportion is 1.3g/ml)=1: 4: 13.3~14.7: 95~105: 260 (weight ratio),
Simple syrup accounts for 10% (percentage by volume) of Zn-Ca oral liquid preparation total amount; All the other are distilled water.
2, a kind of method of preparing the described Zn-Ca oral liquid of claim 1, it is characterized in that by component described in the claim 1 and proportioning reinforced, the distilled water of at first Zn-Ca oral liquid being prepared total amount 2/3 is added in the mixer, be heated to and add calcium gluconate when boiling, after making it fully dissolving, stop heating, add nipalgin second, zinc gluconate, sodium citrate while hot more successively, treat to dissolve one by one the back and add the simple syrup mixing, microporous filter membrane with nominal pore size≤1.2 μ m filters, and last adding distil water is to preparing total amount, mixing, packing gets product.
CN 93101224 1992-08-29 1993-01-30 Zn-Ca oral liquid and its preparing method Expired - Fee Related CN1027959C (en)

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Application Number Priority Date Filing Date Title
CN92109854.5 1992-08-29
CN92109854 1992-08-29
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Publication number Priority date Publication date Assignee Title
CN103610207A (en) * 2013-11-20 2014-03-05 浙江小二黑食品有限公司 Calcium-reinforcing beverage
CN104546818A (en) * 2015-02-04 2015-04-29 澳诺(中国)制药有限公司 Pharmaceutical composition with calcium supplement and zinc supplement effects and preparation of pharmaceutical composition

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