CN1153634A - Medicine for prevention and treatment of calcium deficiency and its prepn - Google Patents

Medicine for prevention and treatment of calcium deficiency and its prepn Download PDF

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Publication number
CN1153634A
CN1153634A CN 95117811 CN95117811A CN1153634A CN 1153634 A CN1153634 A CN 1153634A CN 95117811 CN95117811 CN 95117811 CN 95117811 A CN95117811 A CN 95117811A CN 1153634 A CN1153634 A CN 1153634A
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calcium
medicine
treatment
preventing
deficiency
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CN 95117811
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CN1060336C (en
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孔彦平
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Abstract

The medicine for calcium deficiency is prepared with soluble calcium, zinc gluconate or zinc sulfate, glutamine or glutamic acid and water through compounding, filtration and disinfection. Being easy to take and to absorb and capable of raising blood calcium, the said medicine has obvious curative effect on children's rickets and adult's osteoporosis.

Description

A kind of medicine of preventing and treating treatment of calcium deficiency and preparation method thereof
The present invention relates to a kind of medicine of preventing and treating treatment of calcium deficiency and preparation method thereof.
Treatment of calcium deficiency is the medical problem that people generally face.Data shows, has infant about 70% to have in various degree calcium deficiency at present in the world, and it is a lot of that therefore infant is suffered from the rickets patient, in China's patient's ratio up to 25%; 50% people need replenish calcium preparation among the anemia of pregnant woman, and the calcium deficiency of fetal period more and more causes people's attention, and the anemia of pregnant woman will replenish calcium has become conventional health care regulations; Osteoporosis is a kind of commonly encountered diseases of old people, especially postmenopausal women, there is 26% people to suffer from osteoporosis approximately, its symptom mostly is lumbar and back pain, and stature becomes short and fracture etc., has had a strong impact on old people's live and work, increasing along with long-lived population from now on, suffering from osteoporotic number also will increase day by day, expect 2000, and its proportion will increase to 17% from 8%.At this problem of human body treatment of calcium deficiency, people have developed various edible calcium preparation, as calcium gluconate, calcium lactate, calcium chloride or the like, but normal person's intestinal only can absorb 3% of the amount of eating, therefore, though a lot of patients take calcium preparation, can not reach good therapeutic effect owing to absorption difference.
The objective of the invention is to overcome the shortcoming of prior art and provide a kind of absorb fast, effective, taking convenience, nontoxic pair of effect a kind of to prevent or treat medicine of treatment of calcium deficiency and preparation method thereof.
The object of the present invention is achieved like this, selects following ingredient and weight ratio thereof for use:
Solubility calcium preparation 4-8 part
Zinc gluconate or zinc sulfate 0.1-0.4 part
Glutamine or glutamic acid 0.8-1.2 part
The solubility calcium preparation is optional with calcium gluconate, calcium chloride, calcium lactate, calcium carbonate or activated calcium.
When making oral liquid, the weight ratio of its water and described medicine is 100: 3-9.
The formula optimization weight proportion scope of preparation medicine of the present invention is:
Solubility calcium preparation 4-7 part
Zinc gluconate or zinc sulfate 0.2-0.3 part
Glutamine or glutamic acid 0.8-1 part
When making oral liquid, the preferred weight proportioning of its water and described medicine is 100: 3-7.
Medicine optimum weight of the present invention
5 parts of solubility calcium preparation
0.25 part in zinc gluconate or zinc sulfate
1 part in glutamine or glutamic acid
When making oral liquid, the optimum weight proportioning of water and described medicine is 100: 5.
Wherein be convenient to behind the solubility calcium preparation water dissolution absorb, directly increase and take in calcium, glutamine or glutamic acid are the key component of mucous membrane of small intestine calbindin, it can make small intestinal calbindin content increase, and promotes that calcium is shifted in blood vessel by small intestinal, increases the absorption of calcium at small intestinal, trace element zinc is grown skeletal growth important Nutrition, this effect is by somatomedin, and stimulating appetite increases and to realize proteinic synthesizing.
Its preparation method is as follows, in Agitation Tank, add deionized water, be heated to 100 ℃, pour the solubility calcium preparation in described ratio, zinc gluconate or zinc sulfate, glutamine or glutamic acid, stir, dissolving, mixing adds deionized water again, and the part by weight that makes Total Water and medicine is 100: 3-9, sintered glass filter with 80-120 μ m filters then, fill becomes bottle, 10 milliliters every, High Temperature High Pressure or microwave sterilizating, this is oral liquid product of the present invention, certainly, if the said medicine composition is mixed evenly, adds adjuvant and make powder, incapsulate product also of the present invention.
The instructions of taking of this oral liquid is as follows, 1 of child below 3 years old every day; 3-12 year child every day twice, each 1; Every day three times more than 12 years old, each 1 or according to state of an illness dosage, one month is a course of treatment.Powder and capsule is followed the doctor's advice.
Product of the present invention was once done acute toxinology experiment, and lumbar injection LD50 is 1479mg/kg, and toxic reaction does not take place 6000mg/kg when irritating stomach, shows that its toxicity is little.This product route of administration is oral, is a kind of foolproof medicine therefore.This product is done long term toxicity test and is proved, little, in, during big three kinds of dosed administrations 90 days and drug withdrawal observed in 21 days, compare with matched group, rat body weight, appetite, hemogram, blood biochemistry index, main organs weight all do not have significant difference, heavy dose of group is all no abnormal with the matched group histological examination, show that fully this product is a kind of foolproof medicine, but life-time service.For further this product of clinical verification curative effect with have no adverse reaction,
Medicine of the present invention once to children rachitis and adult's osteoporosis, carried out observation of curative effect in different hospitals, and existing division is as follows:
The observation of curative effect of treatment osteoporosis
One, case is selected: 55 routine patients are my the pain clinic patient of institute, male 29 examples, women 26 examples.Age 21-79 year.Average 57 ± 10.48 years old.Observe 40 examples, matched group 15 examples.
Two, observation index: lumbago, have a pain in the leg, movable difficulty, numb, symptoms such as tic.(Chvostek levies the back percussion pain and Trosseau such as levies at sign.Blood, calcium, concentration, X line (lumbar vertebra) blood, routine urinalysis, liver, renal function.
Three, evaluation criterion: produce effects, treatment back symptom, sign have improvement more than 2/3, and blood calcium rises greater than 0.125mmol/L or rises to normal range; Effectively: treatment back symptom and sign is alleviated 1/3-2/3, blood calcium rising 0.025mmol/L-0.125mmol/L; Invalid: treatment back symptom and sign does not have improvement, and blood calcium concentration does not raise.
Four, observational technique: observation group, osteotrophy liquid (oral liquid of the present invention, down with) 10ml every day below 3 years old, 3-14 year, 2 times on the one, each 10ml be grown up 3 times on the one, 10ml at every turn, 15 days courses of treatment.Matched group, calcium gluconate tablet (BJ Pharmaceutical Co., Ltd.), below 3 years old, every day 600mg, every day 2 times in 3-14 year, each 600mg, per day for adults 3 times, each 600mg, 15 days courses of treatment.
Five, experimental result
Method: selecting has typical osteoporotic patient 55 examples through what the X line was made a definite diagnosis, is divided into 2 groups of 1. matched group 15 examples at random, male 6 examples, women 9 examples, 59.7 ± 6.7 years old.2. observation group, male 23 examples, women 17 examples, 54.3 ± 9.6 years old.Before medication and medication the 15th day the last observation index of crossing is measured.
The result
(1) treatment back symptom and sign improves situation
The variation of the table 1 treatment two groups of patient's clinical manifestations in back
Lumbago and skelalgia is alleviated lumbago and skelalgia and is not alleviated
Matched group 96
Observation group 38 2
X 2=10.75 P<0.01
(2) two groups of patients in treatment back, the variation of calcium level
The variation of calcium level before and after the table 2 liang group treatment
Treatment back t p before the treatment
Matched group 2.11 ± 0.30 2.32 ± 0.21 3.89<0.05
Observation group 2.21 ± 0.18 2.49 ± 0.16 6.67<0.01
After treatment, two groups of calcium levels all rise
The comparison of table 3 liang group blood calcium rising spoke degree
Blood calcium rising spoke degree t p
Matched group 0.14 ± 0.16
2.31 <0.05
Observation group 0.26 ± 0.12
From table 2, can see that after the treatment of osteotrophy liquid, observation group's blood calcium increases obvious than matched group.
(3) two groups of observation of curative effect
Table 4 liang group treatment back curative effect relatively
Produce effects enabledisable obvious effective rate (%)
Matched group 3 10 2 20%
Treatment organizes 35 41 87.5%
X 2=10.75 P<0.05
Discuss: osteoporosis is a kind of commonly encountered diseases, and good sending out in the old people especially after women's menopause, can cause, lumbago and backache is fractured and limitation of activity, has a strong impact on old people's quality of life.Confirmed at present to replenish the calcium and to have prevented and treated osteoporosis effectively, improved patient's symptom.Calcium preparation in the market is more, but the calcium preparation of good absorbing seldom.Osteotrophy liquid promptly contains calcium; Contain calcium absorption enhancer again, and be liquid dosage form, therefore, good absorbing, taking convenience, this experimental result shows that it can obviously improve osteoporotic symptom.
Conclusion:
1, this experimental result shows, osteotrophy liquid has the obvious effect that improves the osteoporosis symptom, and its curative effect is better than calcium gluconate tablet.
2, the medication front and back are to blood, routine urinalysis, and the detection of hepatic and renal function shows that this medicine is without any side effects.
3, this medicine is a liquid dosage form, taking convenience.
The observation of curative effect of treatment rickets of child
One, case is selected: 50 routine infants are my institute's department of pediatrics and are in hospital and the outpatient male 28 examples, women 22 examples.1.5 months-12 years old age, observation group's 35 examples, matched group 15 examples.
Two, observation index: hyperhidrosis, easy frightened, sleep disorder, twitch and symptom such as numbness, rest the head on baldly, Chvostk levies, and Trosseau such as levies at sign; The variation of blood calcium, phosphorus, alkali phosphatase, X line; The hematuria routine, liver, renal function.
Three, evaluation criterion: produce effects, treatment back symptom, sign have improvement more than 2/3, and blood calcium rises greater than 0.125mmol/L or rises to normal range; Effectively, treatment back symptom and sign is alleviated 1/3-2/3, blood calcium rising 0.025mmol/L-0.125mmol/L; Invalid, treatment back symptom and sign does not have improvement, and blood calcium concentration does not raise.
Four, observational technique: observation group, osteotrophy liquid (oral liquid of the present invention, down together) 10ml every day below 3 years old; 3-14 year, 2 times on the one, each 10ml, 15 days courses of treatment.Matched group, calcium gluconate tablet (BJ Pharmaceutical Co., Ltd.), below 3 years old, every day 600mg, every day 2 times in 3-14 year, each 600mg, 15 days is a course of treatment.
Five, experimental result
Method: select to have infant 50 examples of typical rickets performance, all cases are all through medical history, and clinical manifestation and blood calcium, phosphorus, alkali phosphatase and X line are made a definite diagnosis, and do not have other concomitant disease during dispensing, and infant is divided into observation group and matched group at random.1. matched group 15 examples, male 9 examples, women 6 examples, 1.4 ± 1.0 years old age.2. observation group's 35 examples, male 19 examples, women 16 examples, 1.3 ± 1.2 years old age.Before medication,, the last observation index of crossing is measured with medication the 15th day.
Six, result
(1) treatment back clinical symptoms is improved (table 1)
The variation of the table 1 treatment two groups of infant clinical manifestations in back
Hyperhidrosis * easily frightened * * sleep disorder △ rests the head on bald △ △
The still existence that disappeared has disappeared, and still existing has disappeared still exists the still existence that disappeared
Observation group 31 1 34 0 27 11 24
Matched group 93 11 28108
*X 2=5.05 **X 2=5.46
P<0.05 P<0.05
△X 2=0.76 △△X 2=0.33
P<0.05 P<0.05
(2) blood calcium, phosphorus, alkaline phosphorus enzyme etc. change (table 2) before and after the treatment
Then significant difference of (P<0.05) blood calcium has no significant change before and after two groups of patients' serium inorganic phosphorus, the alkaline phosphatase enzyme treatment.
The variation of two groups of infant blood calcium before and after table 2 treatment
Treatment back t p before the treatment
mmol/L mmol/L
Matched group 2.10 ± 0.19 2.30 ± 1.05 3.52<0.05
Observation group 2.05 ± 0.22 2.41 ± 1.32 4.46<0.05
The comparison (table 3) of (three) two groups of infant treatment front and back blood calcium ascensional ranges
The comparison of blood calcium rising spoke degree before the table 3 liang group infant treatment
The difference t p of blood calcium
mmol/L
Matched group 0.15 ± 0.32
3.36 <0.05
Observation group 0.23 ± 0.26
Seven checks are carried out with the difference of the preceding blood calcium of treatment in two groups of infant treatment backs, significant difference is arranged.
Routine blood test, routine urinalysis, liver, renal function, all no abnormal discovery of electrocardiogram before and after (four) two groups of infant treatments.
The curative effect of (five) two groups of therapeutic outcomes relatively
Table 4 liang group infant curative effect relatively
The produce effects enabledisable
Observation group 57.1% 40.0% 2.9%
Matched group 33.3% 53.3% 13.4%
As can be seen from the table, the curative effect of osteotrophy liquid obviously is better than calcium gluconate tablet.
Discuss: rickets is a usual diseases of childhood, early discovery, and suitably treatment can reduce disability rate greatly.Therapeutic Method commonly used is oral calcium preparation or intravenous injection calcium gluconate, uses vitamin D simultaneously.But oral calcium tablet, absorbance is low; The intravenous injection calcium gluconate is difficult for being accepted by infant and family members, the osteotrophy liquid that this research is used promptly contains calcium and contains the calcium ion absorption enhancer again, through clinical verification, to compare with calcium gluconate, osteotrophy liquid can be eliminated child suffering from rickets's clinical symptoms significantly.Though the two all can make blood calcium raise, osteotrophy liquid is owing to can promote calcium absorption preferably, and institute is so that calcium level can have rising largely in the identical time.And infant routine blood test, routine urinalysis, hepatic and renal function, all no abnormal discovery of electrocardiogram after the treatment.
Six, conclusion
1, osteotrophy liquid has the obvious child suffering from rickets's of improvement symptom, and blood calcium is raise, and its curative effect obviously is better than calcium gluconate tablet.
2, the medication front and back are to blood, routine urinalysis, and the detection of hepatic and renal function shows that this medicine is without any side effects.
3, this medicine is a liquid dosage form, the infant taking convenience.
Clinical drug of the present invention uses the result to show that following advantage is arranged: human body had no side effect, and taking convenience, good absorbing raises blood calcium, and children rachitis, adult's osteoporosis are had obvious curative effects.
Embodiment 1
Select following ingredient and weight ratio thereof for use
5 parts of calcium gluconate
0.3 part of zinc gluconate
0.8 part in glutamic acid
In Agitation Tank, add deionized water, be heated to 100 ℃, pour described medicine in proportion into, stirring, dissolving, mixing, add deionized water again, making the Total Water that successively adds is 100: 5 with the part by weight of medicine, then with the sintered glass filter filtration of 80 μ m, fill becomes bottle, 10 milliliters every, the high pressure autoclaving, this is product of the present invention.
Embodiment 2
Select following pharmaceutical compositions and weight ratio thereof for use:
6 parts of activated calciums
0.4 part in zinc sulfate
1 part of glu famine
In irritating, dosing adds deionized water, be heated to 100 ℃, pour activated calcium, zinc sulfate, glutamine in described ratio, stirring, dissolving, mixing add deionized water again, the part by weight that makes Total Water and medicine is 100: 6, sintered glass filter with 120 μ m filters then, and fill becomes bottle, 10 milliliters every, microwave sterilizating, this is product of the present invention.

Claims (5)

1, a kind of medicine of preventing and treating treatment of calcium deficiency is characterized in that: it is the medicament of being made by the following weight proportion raw material:
Solubility calcium preparation 4-8 part
Zinc gluconate or zinc sulfate 0.1-0.4 part
Glutamine or glutamic acid 0.8-1.2 part
2, a kind of medicine of preventing and treating treatment of calcium deficiency as claimed in claim 1 is characterized in that described solubility calcium preparation is calcium gluconate, calcium chloride, calcium lactate, calcium carbonate or activated calcium.
3, a kind of medicine of preventing and treating treatment of calcium deficiency as claimed in claim 1 is characterized in that described medicament is powder or oral liquid.
4, a kind of medicine of preventing and treating treatment of calcium deficiency as claimed in claim 3, the part by weight that it is characterized in that oral liquid water and medicine is 100: 3-9.
5, a kind of medicine of preventing and treating treatment of calcium deficiency as claimed in claim 1, it is characterized in that in Agitation Tank, adding deionized water, be heated to 100 ℃, pour solubility calcium preparation, zinc gluconate or zinc sulfate, glutamine or glutamic acid in described ratio, stirring, dissolving, mixing add deionized water again, the part by weight that makes Total Water and medicine is 100: 3-9, sintered glass filter with 80-120 μ m filters then, and fill becomes bottle, High Temperature High Pressure or microwave sterilizating.
CN95117811A 1995-12-05 1995-12-05 Medicine for prevention and treatment of calcium deficiency and its prepn Ceased CN1060336C (en)

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Application Number Priority Date Filing Date Title
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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1446112A1 (en) * 2001-11-23 2004-08-18 Essentys AB USE OF GLUTAMATE, GLUTAMATE DERIVATIVES OR METABOLITES, GLUTAMATE ANALOGUES OR MIXTURES THEREOF FOR THE MANUFACTURE OF A COMPOSITION FOR THE TREATMENT OF OSTEOPOROSIS
WO2005123059A1 (en) * 2004-06-17 2005-12-29 Sgp & Sons Ab Alpha-ketoglutatic acid or derivatives thereof for the treatment of osteoporosis and related diseases
WO2006046880A1 (en) * 2004-10-29 2006-05-04 Sgp & Sons Ab Nutritional and/or pharmaceutical preparation for use in prophylaxis and treatment of disturbances in microelements absorption from the alimentary canal
CN114767719A (en) * 2022-05-30 2022-07-22 北京朗迪制药有限公司 Medicinal composition for preventing and treating rickets and preparation method thereof
CN115089618A (en) * 2022-05-30 2022-09-23 北京朗迪制药有限公司 A pharmaceutical composition for preventing and treating osteoporosis, and its preparation method

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1085425A (en) * 1992-10-13 1994-04-20 张业华 The production of calcium treasured
CN1091007A (en) * 1993-12-03 1994-08-24 北京市三喜化学新技术公司 High nutrition, high curative effect, easy novel calcium preparation---the nanometer calcium (calcium king) that absorbs
CN1110714A (en) * 1995-03-01 1995-10-25 秦九忱 Nutrition health-care beer and its production method

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1446112A1 (en) * 2001-11-23 2004-08-18 Essentys AB USE OF GLUTAMATE, GLUTAMATE DERIVATIVES OR METABOLITES, GLUTAMATE ANALOGUES OR MIXTURES THEREOF FOR THE MANUFACTURE OF A COMPOSITION FOR THE TREATMENT OF OSTEOPOROSIS
CN100531731C (en) * 2001-11-23 2009-08-26 艾森蒂斯股份公司 Use of glutamate, glutamate derivatives or metabolites, glutamate analogues or mixtures thereof for the preparation of composition for the treatment of osteoporosis
EP1446112B1 (en) * 2001-11-23 2013-07-17 Protista Biotechnology AB Use of glutamate, glutamate derivatives or metabolites, glutamate analogues or mixtures thereof for the manufacture of a composition for the treatment of osteoporosis
US8603981B2 (en) 2001-11-23 2013-12-10 Protista Biotechnology Ab Use of glutamate, glutamate derivatives or metabolites, glutamate analogues or mixtures thereof for the manufacture of a composition for the treatment of osteoporosis
US9233088B2 (en) 2001-11-23 2016-01-12 Protista Biotechnology Ab Use of glutamate, glutamate derivatives or metabolites, glutamate analogues or mixtures thereof for the manufacture of a composition for the treatment of osteoporosis
WO2005123059A1 (en) * 2004-06-17 2005-12-29 Sgp & Sons Ab Alpha-ketoglutatic acid or derivatives thereof for the treatment of osteoporosis and related diseases
WO2006046880A1 (en) * 2004-10-29 2006-05-04 Sgp & Sons Ab Nutritional and/or pharmaceutical preparation for use in prophylaxis and treatment of disturbances in microelements absorption from the alimentary canal
AU2005300125B2 (en) * 2004-10-29 2011-07-14 Sgp & Sons Ab Nutritional and/or pharmaceutical preparation for use in prophylaxis and treatment of disturbances in microelements absorption from the alimentary canal
CN114767719A (en) * 2022-05-30 2022-07-22 北京朗迪制药有限公司 Medicinal composition for preventing and treating rickets and preparation method thereof
CN115089618A (en) * 2022-05-30 2022-09-23 北京朗迪制药有限公司 A pharmaceutical composition for preventing and treating osteoporosis, and its preparation method
CN115089618B (en) * 2022-05-30 2023-03-17 北京朗迪制药有限公司 A pharmaceutical composition for preventing and treating osteoporosis, and its preparation method

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