CN1759877A - Composition of medication for treating anemia, and application - Google Patents
Composition of medication for treating anemia, and application Download PDFInfo
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- CN1759877A CN1759877A CNA2005100808531A CN200510080853A CN1759877A CN 1759877 A CN1759877 A CN 1759877A CN A2005100808531 A CNA2005100808531 A CN A2005100808531A CN 200510080853 A CN200510080853 A CN 200510080853A CN 1759877 A CN1759877 A CN 1759877A
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Abstract
A composite medicine for treating the hemorrhagic anemia, iron-deficiency anemia and nutritional anemia is prepared from the arnono acid chelated iron, one or more Chinese-medicinal materials for nourishing blood, and pharmacologically, acceptable salt. Its advantages are high curative rate and biologic utilization rate, and low irritation to enterogastric tract.
Description
Technical field
The present invention relates to a kind of medical composition and its use, relate to specifically a kind ofly contain that aminoacid is stung the pharmaceutical composition that closes ferrum and pharmaceutically acceptable salt and one or more blood tonics and in the medicine of preparation treatment anemia or the purposes in the health product.
Background technology
Anemia is commonly encountered diseases, the frequently-occurring disease in the whole world, and its sickness rate occupies first of the human four big nutritional disease, and iron deficiency anemia accounts for more than 95% of anemia, and the iron deficiency anemia sickness rate is more high than world average level in the population of China.Among 18～60 years old crowd of China, Patients with iron deficiency anemia accounts for 25%, and especially the sickness rate with period of duration women, gravid woman, child and baby is a height, is respectively 43%, 66% and 30%, and the rural area is higher than the city.Period of duration women's sickness rate height is because menstrual cycle is lost blood; Male's gastrointestinal hemorrhage is the main cause that causes iron deficiency anemia; The ferrum reserves loss that stomach excision, diarrhoea, malabsorption cause, child and infant physical growth need cause iron deficiency; The change of life style, workload, momental increase, conventional physical work often causes the ferrum needs; The anemia of pregnant woman particularly later stage of pregnancy ferrum needs more obvious.Ferrum is to form erythrocyte, hemoglobin and give muscle, organ and other tissue of body with the strong indispensable element that keeps fit nutrition and energy delivery.Thereby wish to obtain the suitable supplements-iron of taking for a long time, thereby reduce the anemia sickness rate.
Supplements-iron commonly used is comparatively limited, as ferrous sulfate, ferrous porphyrin etc., and general less independent use.The commercially available health food kind that contains iron formula is also very limited: as " the strange glucose of distinguishing the flavor of " of child and adolescent nutrition food by glucose, calcium lactate, ferrum glycinate, casein peptide calcium, taurine, vitamin C, A, B
1, B
2, D and nicotinic acid forms; The stellar eclipse product company limited production " iron oxide red is strong " of Beijing Olympic is made up of ferrum glycinate, glycine, folic acid, cupric glycinate, succinic acid; CN1059827 discloses the bonded anti-anemia complex ferrous sulfate tablet of Chinese medicine and western medicine, by ferrous sulfate, folic acid, yeast with when being grouped into; Heart K is made up of ferrous porphyrin, Fructus Lycii, Fructus Jujubae, zinc; XUEER is made up of bright crow, Radix Angelicae Sinensis, the Radix Astragali, ferrous porphyrin; Woman's cause ferrous porphyrin, vitamin C, vitamin E, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, the Radix Astragali are formed.
Iron-amino acid chelate as a kind of newtype drug for the treatment of iron deficiency anemia, has the advantage of nonheme iron and heme iron concurrently.The PCT/Us03/13663 of U.S. Albion house journal discloses iron-amino acid chelate, multivitamin and non-iron microelement composite nutrient food supplement, and WO0078161 discloses the cereal grain kernels with fortified with amino acid chelates.Iron-amino acid chelate compares with nonheme iron (ferrous sulfate etc.) that to have mouthfeel good, and GI irritation is little, bioavailability height advantages such as (influences of ferrum absorption inhibitor that often has in the bioavailability unable to take food product such as phenols, phytic acid, fiber etc.); Compare with heme iron (ferrous porphyrin etc.) and to have the digestive enzyme of making and advantage such as gastric acid is stable, and price is low.At home, iron-amino acid chelate mixes animal feed as trace mineral supplement under most situations behind prescription, is used for fowl poultry prevention iron deficiency anemia.
But use the chelating amino acids iron preparation to have certain rust flavor separately, be difficult for adhering to, and single iron supplement, be difficult to bring into play heterogeneous regulating action.In Chinese medicine, QI invigorating hematonic such as Radix Angelicae Sinensis, the Radix Astragali have significant effect to improving anemia.Treatment that tcm clinical practice is commonly used or the blood tonic that improves anemia have its special advantages, can produce multiple hemopoietic cell (platelet, erythrocyte, leukocyte), can obviously strengthen hemopoietic function of bone marrow by effective stimulus bone marrow, fundamentally improve anemia, the long-term treatment effect is remarkable; But that shortcoming is a pharmaceutical quantities is big, flavour of a drug heavy, mouthfeel is bad, be difficult to take for a long time, therapeutic effect is slow.Do not see that so far iron-amino acid chelate and blood tonic are the report of the pharmaceutical composition of feedstock production treatment anemia.
Summary of the invention
In order to overcome the above-mentioned defective of simple chelating amino acids iron preparation and simple blood tonic preparation, the purpose of this invention is to provide a kind of pharmaceutical composition for the treatment of anemia, it is a kind of new iron-amino acid chelate compound medicament composition.The present invention also provides the purposes of this pharmaceutical composition.
The pharmaceutical composition of treatment anemia provided by the invention, it is to be the medicament that raw material is made with iron-amino acid chelate and one or more blood tonics.
Wherein, the weight proportion of the dosage of elemental iron and blood tonic is in the iron-amino acid chelate: 0.001～0.2 part of elemental iron, 1～50 part of blood tonic in the iron-amino acid chelate.
Wherein, amino-acid chelate ferrum comprises at least a aminoacid aglucon, and the aglucon of this chelate and the mol ratio of ferrum are 1: 1～4: 1, and preferably 2: 1,3: 1, preferably 2: 1 again.Described aminoacid aglucon is naturally occurring aminoacid, is selected from: a kind of in alanine, arginine, aspartic acid, cystine, cysteine, glutamic acid, the acid of paddy acyl, glycine, histidine, isoleucine, lysine, leucine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, the valine etc. or dipeptides, tripeptides, tetrapeptide that they combination in any are formed.
Further, iron-amino acid chelate is diglycine ferrous chelate Ferrous bisglycinate chelate, dithreonine ferrous chelate or dilysineferrous chelate.
Wherein said blood tonic is one or more the mixing in Radix Angelicae Sinensis, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae, Radix Codonopsis, Radix Ginseng, Radix Panacis Quinquefolii, Fructus Jujubae, Colla Corii Asini, Radix Polygoni Multiflori, Fructus Lycii, Fructus Corni, Radix Rehmanniae Preparata, Cornu Cervi Pantotrichum, Rhizoma Dioscoreae, the Rhizoma Atractylodis.
Further, blood tonic is Radix Angelicae Sinensis, the Radix Astragali, and its weight proportion is: 1～10 part of Radix Angelicae Sinensis, 5～15 parts of the Radixs Astragali.Aforementioned pharmaceutical compositions is to be stung by aminoacid that to close ferrum and one or more blood tonics be active component, adds acceptable accessories or complementary composition and is prepared into preparation pharmaceutically commonly used.
Wherein, the raw material of pharmaceutical composition of the present invention also comprises: non-iron mine material and pharmaceutically acceptable salt thereof, its consumption are to add 0.0001～2 part of non-iron mine material in per 1～50 part blood tonic.
Further, non-iron mine material is one or more the mixing in calcium (0.01～2 part), magnesium (0.001～0.7 part), copper (0.0001～0.003 part), the zinc (0.005～0.035 part).
Wherein, the raw material of pharmaceutical composition of the present invention also comprises: vitamin and pharmaceutically acceptable salt thereof, its consumption are to add 0.000001～1 part of vitamin in per 1～50 part blood tonic.
Further, described vitamin is one or more the mixing in VA (0.00015～0.002 part), VB (0.00012～0.002 part), VC (0.01～1 part), VD (0.000001～0.00002 part), VE (0.001～0.02 part), nicotiamide (0.001～0.1 part), the folic acid (0.00002～0.008 part).
Further, described VB is: VB
1(0.0006～0.002 part), VB
2(0.0005～0.003 part), VB
6(0.0003～0.002 part), VB
12The mixing of one or more in (0.000001～0.00003 part).
Wherein, the raw material of pharmaceutical composition of the present invention also comprises other nutrient, as aminoacid, trace iodine, selenium, fluorine etc.
Aforementioned pharmaceutical compositions is to be active component by iron-amino acid chelate and one or more blood tonics, adds acceptable accessories or complementary composition and is prepared into pharmaceutically acceptable preparation.
Wherein, described preparation is: pill, tablet, capsule, oral liquid.
Further, it is the preparation that is prepared from by following each materials of weight proportions: 0.001～0.2 part of elemental iron, 1～5 part of Radix Angelicae Sinensis, 5～15 parts of the Radixs Astragali in the diglycine ferrous chelate.
Further, it is the preparation that is prepared from by following each materials of weight proportions: 0.008 part of elemental iron, 2 parts of Radix Angelicae Sinensis, 10 parts of the Radixs Astragali in the diglycine ferrous chelate.
The present invention also provides described each raw material to treat the health food of hemorrhagic anemia, iron deficiency anemia and/or nutritional anemia or the purposes in the medicine in preparation.
The pharmaceutical composition that the present invention provides contains iron-amino acid chelate and one or more blood tonics, stings the advantage of closing ferrum and blood tonic with aminoacid, for the treatment anemia provides a kind of new selection approach.Pharmaceutical composition provided by the invention because the synergism of chelated iron and blood tonic, than single aminoacid sting close ferrum, the blood tonic preparation has heterogeneous regulating action, can significantly improve Anemia.Simultaneously, the said composition preparation can significantly improve existing iron supplement agent gastrointestinal is stimulated, and mouthfeel is good, no rust flavor; Advantages such as simple relatively blood tonic has that taking dose is less relatively, taking convenience, flavour of a drug are light provide a kind of new selection for clinical.
The specific embodiment
The invention will be further described below in conjunction with specific embodiments and the drawings, but should not be construed as is limitation of the invention further, according to foregoing of the present invention, ordinary skill knowledge and customary means according to this area, do not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite, the technology that modification, replacement or change realized of making other various ways all belongs to scope of the present invention.
The preparation of embodiment 1 pharmaceutical composition 1 of the present invention (QF-1)
Get Radix Angelicae Sinensis 200g, pulverize, water is proposed dipping 2 times, each 24h (during dipping, mechanical agitation impregnation liquid 1h).Merge impregnation liquid, concentrated, centrifugal, discard precipitation, the supernatant precipitate with ethanol gets precipitate A, pure liquid B.
Get Radix Astragali 1000g, cut into joint, water is proposed dipping 2 times, each 24h (during dipping, mechanical agitation impregnation liquid 1h).Merge impregnation liquid, concentrated, precipitate with ethanol, centrifugal discard precipitation, get pure liquid C.
Merge B, C, concentrating under reduced pressure gets extractum D.Merge precipitate A, extractum D, be divided into two parts, be respectively extract E and F.
The preparation of oral liquid of the present invention: in extract E, add 3.0g diglycine ferrous chelate (U.S. Albion company produces, trade name Ferrochel), add adjuvant, regulate pH value cold preservation, centrifugal embedding, sterilize 100 of compound recipe double-glycine iron oral liquids.
The preparation of tablet of the present invention: add 3.0g diglycine ferrous chelate (U.S. Albion company produces, trade name Ferrochel) in extract F, adding adjuvant tabletting, coating get 100 of compound recipe double-glycine iron plates.
The preparation of HUANGQI DANGGUI KOUFUYE (HD-1): repeat the method for making of above-mentioned precipitate A, extractum D, merge precipitate A, extractum D, mixing adds adjuvant, transfers pH value cold preservation, centrifugal embedding, sterilize 200 of HUANGQI DANGGUI KOUFUYE.
The preparation of embodiment 2 pharmaceutical compositions of the present invention (QF-2)
Radix Angelicae Sinensis 200g
Radix Astragali 800g
Diglycine ferrous chelate 6g
Preparation method is the same.
The preparation of embodiment 3 pharmaceutical compositions 3 of the present invention (QF-3)
Radix Angelicae Sinensis 300g
Radix Astragali 900g
The ferrous chelate 6g of double-glycine
Preparation method is the same.
The preparation of embodiment 4 pharmaceutical compositions 4 of the present invention (QF-4)
Radix Angelicae Sinensis 500g
Radix Astragali 1000g
Diglycine ferrous chelate 6g
Preparation method is the same.
The preparation of embodiment 5 pharmaceutical compositions 5 of the present invention (QF-5)
Radix Angelicae Sinensis 1000g
Radix Astragali 1000g
Diglycine ferrous chelate 6g
Preparation method is the same.
Embodiment 6 Radix Angelicae Sinensis 1000g
Radix Astragali 200g
Diglycine ferrous chelate 6g
Preparation method is the same.
Embodiment 7 Radix Angelicae Sinensis 800g
Radix Astragali 200g
Diglycine ferrous chelate 6g
Preparation method is the same.
Embodiment 8 Radix Angelicae Sinensis 600g
Radix Astragali 200g
Diglycine ferrous chelate 6g
Preparation method is the same.
Embodiment 9 Radix Angelicae Sinensis 800g
Radix Astragali 400g
Diglycine ferrous chelate 6g
Preparation method is the same.
Embodiment 10 Radix Codonopsis 1500g
Radix Polygoni Multiflori 1000g
Dithreonine ferrous chelate 8.5g
Embodiment 11 Radix Ginseng 1000g
Colla Corii Asini 1000g
Dilysineferrous chelate 6g
Embodiment 12 Radix Angelicae Sinensis 200g
Radix Astragali 1000g
Diglycine ferrous chelate 6g
Vc 3g
VB1 0.06g
VB6 0.06g
Embodiment 13 Radix Angelicae Sinensis 200g
Radix Astragali 1000g
Diglycine ferrous chelate 6g
Calcium 10g
Magnesium 5g
Copper 0.06g
Zinc 0.6g
Folic acid 0.014g
VB1 0.06g
Embodiment 14 pharmaceutical composition mouthfeel contrast experiments of the present invention
The inventor confirms that through years of researches and clinical trial iron-amino acid chelate and one or more blood tonics mix by proper proportion (0.001～0.2 part of elemental iron, 1～50 part of blood tonic in the iron-amino acid chelate), the two synergism can obviously improve ferrum at the gastrointestinal absorbance, improves the effect of enriching blood; Easier swallowing of while, taking convenience (1～2 time/day); And the rust that can cover single amino acid chelated iron preparation is fully distinguished the flavor of.
| Oral liquid | Flavour |
| Chelating amino acids iron oral liquid amino acid chelated iron oral liquid | Rust is distinguished the flavor of little sweet, no rust flavor |
(annotate: wherein iron-amino acid chelate is diglycine ferrous chelate, two iron (II)-threonine oral liquid, the ferrous oral liquid of two lysine; The amino acid chelated iron is that above-mentioned iron-amino acid chelate+blood tonic is a raw material, by embodiment 1 described method preparation)
Pharmaceutical composition provided by the invention can significantly improve existing iron supplement agent gastrointestinal is stimulated, and mouthfeel is good, no rust flavor.
Below by pharmacodynamics test beneficial effect of the present invention is described.
Test example 1 pharmaceutical composition of the present invention is to the therapeutical effect of mice hemorrhagic anemia
180 of Kunming mouses, and body weight 18～22g (the one-level animal, animal housing provides by the Traditional Chinese Medicine Research Institute, Sichuan Province, the quality certification number: the real moving word 2002-33 in river), male and female half and half are divided into 14 groups at random, and the tail vein is got hematometry mouse red blood cell (RBC) and hemoglobin (Hb) as losing blood preceding value.Except that the normal control group, all the other respectively organize eye socket venesection modeling, 0.5ml/ time, every other day once, totally 4 times.24h after the last blood-letting, adopt Japanese East Asia F-820 automatic hemacytometer survey RBC and Hb as the back value of losing blood, according to RBC and Hb value the modeling mice is divided into groups again, it is model group, GF organizes (diglycine ferrous chelate group), the HD height, low dose group (Radix Astragali 10g, Radix Angelicae Sinensis 2g, pulverize, water is proposed dipping 2 times, 24h/ time, during dipping, mechanical agitation impregnation liquid 1h merges impregnation liquid, concentrate and make), the HD-1 height, low dose group, the QF-1 height, low dose group, the QF-2 group, the QF-3 group, the QF-4 group, (Guilin Pharmaceutical (Shanghai) Co., Ltd. produces for QF-5 group and ferrous sulfate tablet group, specification: the 0.3g/ sheet, lot number: 021203), gastric infusion, continuous 10 days, respectively at administration the 6th, the tail vein was got hematometry mice RBC and Hb value in 10 days.The results are shown in Table 1, table 2.
Table 1 compound recipe diglycine ferrous chelate is to the influence of hemorrhagic anemia mouse red blood cell (X ± s)
| Group | Dosage (mg/kg) | Number of animals (only) | RBC(×10 12/L) | |||
| Before losing blood | After losing blood | Administration 6 days | Administration 10 days | |||
| The high QF-2 group of the low QF-1 of the low high QF-1 of HD-1 of the low high HD-1 of HD of normal group model group GF group HD QF-3 group QF-4 group QF-5 group ferrous sulfate | - - 8.57 340 680 130 260 140 280 280 280 280 280 300 | 14 14 13 13 13 13 13 13 13 12 12 12 12 13 | 8.05±1.30 7.89±0.68 7.74±0.84 8.14±1.10 7.95±0.79 7.89±0.83 7.69±1.05 7.67±1.57 7.71±0.91 8.01±1.17 7.95±1.02 7.82±0.83 7.89±0.76 7.90±0.92 | 8.96±0.93 5.36±0.92 ΔΔΔ 5.62±0.85 5.59±0.92 5.22±0.88 5.39±0.88 5.19±1.11 5.01±0.95 5.34±0.55 5.33±1.59 5.64±1.56 5.53±0.96 5.26±0.91 5.40±0.80 | 10.64±1.34 8.73±1.11 ΔΔΔ 9.81±1.16 * 10.00±0.96 ** 10.06±0.78 ** 9.64±1.06 * 9.69±0.87 * 10.34±1.02 *** 10.04±1.21 ** 9.22±1.06 * 9.69±2.14 * 9.33±0.88 * 10.01±1.29 ** 9.95±1.07 * | 10.79±1.20 7.14±1.64 ΔΔΔ 9.25±1.43 ** 9.27±1.34 ** 8.94±1.44 ** 9.05±2.05 * 8.95±1.26 ** 8.95±1.59 ** 9.97±0.90 *** 8.74±1.61 * 9.01±1.35 * 8.56±1.21 * 9.58±1.35 ** 9.71±0.71 *** |
Annotate: compare with normal group,
Δ Δ ΔP＜0.001; Compare with model group,
*P＜0.05,
*P＜0.01,
* *P＜0.001
Table 2 compound recipe diglycine ferrous chelate is to the influence of hemorrhagic anemia mice hemoglobin (X ± s)
| Group | Dosage (mg/kg) | Number of animals (only) | Hb(g/L) | |||
| Before losing blood | Behind the fire blood | Administration 6 days | Administration 10 days | |||
| The high QF-2 group of the low QF-1 of the low high QF-1 of HD-1 of the low high HD-1 of HD of normal group model group GF group HD QF-3 group QF-4 group QF-5 group ferrous sulfate | - - 8.57 340 680 130 260 140 280 280 280 280 280 300 | 14 14 13 13 13 13 13 13 13 12 12 12 12 13 | 124.86 ± 20.15 123.29 ± 8.62 120.23 ± 8.15 123.69 ± 16.78 122.69 ± 8.57 122.00 ± 14.02 120.08 ± 11.92 117.85 ± 20.68 116.15 ± 13.89 121.27 ± 11.83 120.63 ± 9.75 122.56 ± 10.55 123.56 ± 14.5l 120.25 scholars 12.32 | 135.43±13.00 81.43±13.65 ΔΔΔ 82.46±13.65 83.92±13.70 78.00±16.00 82.15±9.58 79.69±14.66 76.85±14.72 78.92±6.06 79.66±13.15 78.26±14.33 80.56±l2.59 81.22±13.56 80.75±9.74 | 157.07 ± 14.95 124.34 scholars 15.08 ΔΔΔ139.33±20.03 *137.92±16.89 *137.39±16.74 *136.85±13.75 *137.77±15.37 *140.92±16.75 *139.08±12.54 *137.21±16.22 *134.22±9.78 *136.55±18.25 *131.77±15.96 *148.17 ± field 11.27 *** | 157.43±13.20 100.92±21.34 ΔΔΔ 132.82±21.58 *** 131.08±23.32 ** 126.77±16.65 ** 125.91±29.58 * 129.17±18.87 ** 124.00±21.66 * 130.55±13.09 *** 128.46±19.28 ** 127.23±10.37 ** 127.134±16.46 ** 125.43±18.62 * 138.92±9.03 *** |
Annotate: compare with normal group,
Δ Δ ΔP＜0.001; Compare with model group,
*P＜0.05,
*P＜0.01,
* *P＜0.001
Found out that by table 1, table 2 model control group is in back, the administration 6 days and 10 days of losing blood, mice RBC and Hb level all obviously reduce, and with following normal matched group significant difference are arranged more all, illustrate that modeling is successful.(with reference to Xu Shuyun etc., pharmacological experimental methodology, the third edition, 1260 pages)
Anemia mice is irritated the stomach ferrous sulfate after 6 days and 10 days, and RBC, Hb level all obviously raise, and significant difference is compared in the back with losing blood.
GF irritated stomach after 6 days, and RBC, Hb level all obviously raise, and compare the back with losing blood, significant difference, P value are respectively less than 0.05 and 0.001: irritate stomach after 10 days, though RBC, Hb level have downward trend during than 6 days slightly, but compare with the back of losing blood, significant difference, the P value is respectively less than 0.05 and 0.01.
HD is low, high dose group was irritated stomach 6 days and 10 days, and RBC, Hb level are all lost blood, and the back is obvious to raise, and has significant statistical significance.
HD-1 is low, high dose group was irritated stomach 6 days and 10 days, and RBC, Hb level are all lost blood, and the back is obvious to raise, and has significant statistical significance.
QF-1 is low, high dose group was irritated stomach 6 days and 10 days, and RBC, Hb level are all lost blood, and the back is obvious to raise, and has significant statistical significance, and its effect is better than taking separately GF and HD-1 group.
QF-2, QF-3, QF-4, QF-5 irritated stomach respectively 6 days and 10 days, the effect of rising RBC, Hb level is all arranged, and compare the back with losing blood, has significant statistical significance, but the effect of its rising erythrocyte (RBC) and hemoglobin (Hb) is all not as good as the group of the QF-1 under the identical administration concentration, and the drug regimen ratio that the QF-1 group is described is the optimal proportion of treatment anemia.
Test example 2 pharmaceutical compositions of the present invention are to the therapeutic effect of Patients with iron deficiency anemia
Get 600 slight Patients with iron deficiency anemia of women (90g/L＜Hb＜120g/L), be divided into 10 groups at random by hemoglobin level, be matched group (ferrous sulfate tablet group), observation group 1 (compound recipe diglycine ferrous chelate oral liquid of the present invention, each 1,2 times/day), matched group 1A (diglycine ferrous chelate, 60mg/ days, take at twice), matched group 1B (HD-1 oral liquid, each 1,2 times/day), observation group 2 (compound recipe dithreonine ferrous chelate oral liquid, each 1,2 times/day), matched group 2A (dithreonine ferrous chelate, 60mg/ days, take at twice), matched group 2B (DANGGUI HESHOUWU KOUFUYE, each 1,2 times/day), observation group 3 (compound recipe dilysineferrous chelate oral liquid, each 1,2 times/day), matched group 3A (dilysineferrous chelate 60mg/ days, is taken at twice), matched group 3B (RENSHEN EJIAO KOUFUYE, each 1,2 times/day).Duration of test does not change original dietary habit, and it is 30 days that normal diet, given the test agent give the time, and the red eggs of having a blood test are worth in vain.And observe Anemia (weak, irritated, dizzy, energy is not concentrated, have palpitation, breathe hard etc.).The results are shown in Table 3.
Curative effect determinate standard:
Produce effects: treatment back clinical symptoms is obviously improved, and the Hb value is than the preceding rising＞20g/L of treatment;
Effectively: treatment back clinical symptoms is partly improved, and the Hb value is than the preceding 10～20g/L that raises of treatment;
Invalid: treatment back clinical symptoms does not have improvement, and the Hb value is than the preceding rising＜10g/L of treatment.
Table 3 pharmaceutical composition of the present invention is to the therapeutic effect of Patients with iron deficiency anemia
| Group | Total routine number | Produce effects example number/obvious effective rate (%) | Effective routine number/obvious effective rate (%) | Invalid routine number/obvious effective rate (%) | Total effective routine number/obvious effective rate (%) |
| The 1 matched group 1A matched group 1B of matched group observation group | 60 60 60 60 | 35(58.33) 58(96.67) 38(63.33) 23(38.33) | 15(25.00) 1(1.67) 15(25.00) 20(33.33) | 10(16.67) 1(1.67) 7(11.67) 17(28.33) | 50(83.33) 59(98.33) 53(88.33) 43(71.67) |
| The 2 matched group 2A matched group 2B of observation group | 60 60 60 | 54(90.00) 35(58.33) 20(33.33) | 4(6.67) 16(26.67) 21(35.00) | 2(3.33) 9(15.00) 19(31.67) | 58(96.67) 51(85.00) 41(68.33) |
| The 3 matched group 3A matched group 3B of observation group | 60 60 60 | 55(91.66) 36(60.00) 20(33.33) | 3(5.00) 14(23.33) 24(40.00) | 2(3.33) 10(16.67) 16(26.67) | 58(96.67) 50(83.33) 44(73.33) |
(Nintaus is equal, the addition in the drug combination, Acta Pharmacologica Sinica, 1980,1 (2): 70), judge the result (q＞1.15 are collaborative, q＜0.85 antagonism, q=0.85～1.15 additions) that two medicines share with the q value according to the equal computational methods of Nintaus.
Computing formula:
In the table 3, the diglycine ferrous chelate and the Radix Angelicae Sinensis Radix Astragali share, dithreonine ferrous chelate and the Radix Angelicae Sinensis Radix Polygoni Multiflori share, dilysineferrous chelate and ginseng donkey-hide gelatin share, from obvious effective rate demonstration synergism, the q value is respectively 1.249,1.246,1.249 all greater than 1.15; From the total effective rate rate, show summation action, the q value is respectively 1.017,1.015,1.012.
Compare with matched group, obvious effective rate and total effective rate after observation group's 1,2,3 treatments all are higher than matched group, wherein the therapeutic effect of observation group 1 is better than other each group, show that the compound recipe diglycine ferrous chelate integrates the ferrous advantage of enriching blood with astragalus, angelica of double-glycine, Patients with iron deficiency anemia is demonstrated heterogeneous regulating action, can significantly improve patient's Anemia.
Above-mentioned pharmacodynamics test explanation, pharmaceutical composition provided by the invention, because the synergism of chelated iron and blood tonic, has heterogeneous regulating action than single iron-amino acid chelate, blood tonic preparation, can significantly improve Anemia, the performance synergistic function, and taking dose is little, taking convenience, flavour of a drug are light, mouthfeel good.More than the description of effect of the present invention is not limited the present invention, those skilled in the art can make various changes according to the present invention, only otherwise break away from spirit of the present invention, all should belong to the scope of accompanying Claim definition of the present invention.
Claims (18)
1, a kind of pharmaceutical composition for the treatment of anemia is characterized in that: it is to be the medicament that raw material is made by containing iron-amino acid chelate and one or more blood tonics.
2, the pharmaceutical composition of treatment anemia according to claim 1 is characterized in that: the weight proportion of the dosage of elemental iron and blood tonic is in the described iron-amino acid chelate: 0.001～0.2 part of elemental iron, 1～50 part of blood tonic in the iron-amino acid chelate.
3, the pharmaceutical composition of treatment anemia according to claim 2 is characterized in that: iron-amino acid chelate comprises at least a aminoacid aglucon, and the mol ratio of this aminoacid aglucon and ferrum is 1: 1～4: 1.
4, the pharmaceutical composition of treatment anemia according to claim 3 is characterized in that: the aglucon of this chelate and the mol ratio of ferrum are 2: 1.
5, according to the pharmaceutical composition of claim 3 or 4 described treatment anemias, it is characterized in that: described aminoacid aglucon is naturally occurring aminoacid, is selected from: dipeptides, tripeptides, tetrapeptide that alanine, arginine, aspartic acid, the acid of Radix Asparagi acyl, cystine, cysteine, glutamic acid, the acid of paddy acyl, glycine, histidine, isoleucine, lysine, leucine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine or they combination in any are formed.
6, the pharmaceutical composition of treatment anemia according to claim 5 is characterized in that: iron-amino acid chelate is diglycine ferrous chelate, dithreonine ferrous chelate or dilysineferrous chelate.
7, the pharmaceutical composition of treatment anemia according to claim 1 is characterized in that: blood tonic is one or more mixing in Radix Angelicae Sinensis, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae, Radix Codonopsis, Radix Ginseng, Radix Panacis Quinquefolii, Fructus Jujubae, Colla Corii Asini, Radix Polygoni Multiflori, Fructus Lycii, Fructus Corni, Radix Rehmanniae Preparata, Cornu Cervi Pantotrichum, Rhizoma Dioscoreae, the Rhizoma Atractylodis.
8, the pharmaceutical composition of treatment anemia according to claim 7 is characterized in that: blood tonic is Radix Angelicae Sinensis, the Radix Astragali, and its weight proportion is: 1～10 part of Radix Angelicae Sinensis, 5～15 parts of the Radixs Astragali.
9, according to the pharmaceutical composition of any described treatment anemia of claim 1-8, it is characterized in that: raw material also comprises: non-iron mine material or its pharmaceutically acceptable salt, its consumption are to add 0.0001～2 part of non-iron mine material in per 1～50 part blood tonic.
10, the pharmaceutical composition of treatment anemia according to claim 9 is characterized in that: add a kind of or its mixing in 0.005～0.035 part of 0.01～2 part of the non-iron mine material calcium, 0.001～0.7 part in magnesium, 0.0001～0.003 part of copper, zinc in per 1～50 part blood tonic.
11, the pharmaceutical composition of treatment anemia according to claim 9 is characterized in that: raw material also comprises vitamin or its pharmaceutically acceptable salt, and its consumption is to add 0.000001～1 part of vitamin in per 1～50 part blood tonic.
12, the pharmaceutical composition of treatment anemia according to claim 11 is characterized in that: described vitamin is: a kind of or its mixture in VA, VB, VC, VD, VE, nicotiamide, the folic acid.
13, the pharmaceutical composition of treatment anemia according to claim 12 is characterized in that: described VB is: VB
1, VB
2, VB
6, VB
12In a kind of or its mixing.
14, according to the pharmaceutical composition of any described treatment anemia of claim 1～13, it is characterized in that: it is to be active component by iron-amino acid chelate and one or more blood tonics, adds acceptable accessories or complementary composition and is prepared into preparation pharmaceutically commonly used.
15, the pharmaceutical composition of treatment anemia according to claim 14, it is characterized in that: it is to be active component by following each materials of weight proportions, adds the preparation that acceptable accessories or complementary composition are prepared from: 0.001～0.2 part of elemental iron, 1～5 part of Radix Angelicae Sinensis, 5～15 parts of the Radixs Astragali in the diglycine ferrous chelate.
16, the pharmaceutical composition of treatment anemia according to claim 15, it is characterized in that: it is to be active component by following each materials of weight proportions, adds the preparation that acceptable accessories or complementary composition are prepared from: 0.008 part of elemental iron, 2 parts of Radix Angelicae Sinensis, 10 parts of the Radixs Astragali in the diglycine ferrous chelate.
17, according to the pharmaceutical composition of any described treatment anemia of claim 14 to 16, it is characterized in that: described preparation is: pill, tablet, capsule, oral liquid.
18, the described pharmaceutical composition of claim 1 purposes in health food for preparing treatment hemorrhagic anemia, iron deficiency anemia and/or nutritional anemia or medicine.
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| CNB2005100808531A CN100540031C (en) | 2004-07-28 | 2005-06-30 | A kind of pharmaceutical composition and purposes for the treatment of anemia |
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| CN200410040323 | 2004-07-28 | ||
| CN200410040323.X | 2004-07-28 | ||
| CNB2005100808531A CN100540031C (en) | 2004-07-28 | 2005-06-30 | A kind of pharmaceutical composition and purposes for the treatment of anemia |
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| CN100540031C CN100540031C (en) | 2009-09-16 |
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