CN1252279A - Soluble heme and its preparation process and hematic composite with it - Google Patents
Soluble heme and its preparation process and hematic composite with it Download PDFInfo
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- CN1252279A CN1252279A CN99116822A CN99116822A CN1252279A CN 1252279 A CN1252279 A CN 1252279A CN 99116822 A CN99116822 A CN 99116822A CN 99116822 A CN99116822 A CN 99116822A CN 1252279 A CN1252279 A CN 1252279A
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- haemachrome
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Abstract
The product of soluble protoheme provided by the present invention has high solubility, is well absorbed by and may be used for assistant treatment of iron-deficiency anemia patient, and has effective prevention of iron-deficiency anemia. The preparation process of the present invention is simple and results in high-quality product. In addition, the mother liquor is used to recover acetic acid and amino acid, and this can reduce production cost greatly.
Description
The present invention relates to health product, relate more specifically to correct the health product of enriching blood of iron deficiency anemia.
(Iron Deficiency ID) is the most general nutrition problem in the world today to iron deficiency.According to the WHO statistics, in most of developing countries, have 2/3rds the child and the women of child-bearing age to be subjected to the iron deficiency infringement approximately: wherein 1/3rd are in more serious imbalance state.Iron deficiency is difficult to be aware usually.Because generally all think, as pale, do not have not entail dangers to life of light symptoms such as refreshing and tired.In fact, iron deficiency can produce multiple consequence to human body, even can cause death.A large amount of research work results of home and abroad show, low and other behavior metamorphosis of iron deficiency and learning ability of children are related, and brain function is also had tangible adverse effect.Adult's iron deficiency can influence its ability to work and production efficiency.And, immune function depression suffers from infectious disease and therefore dead chance because of increasing.Slight iron deficiency also has similar harmful effect.The U.S. once reported, the achievement of 3～6 years old slight sideropenic child in cover behavior test than body in the normal preschooler of iron level poor.But behind the enriched nutritive iron supplement through 11～12 weeks, achievement has had tangible improvement.Add with Thailand in Egypt, Guatemala, Indonesia, Chile, brother Si Dary and also to have carried out same research.Found that, have tangible dependency between iron deficiency and children intelligence and the performance of the test; Iron level is higher in the body, and achievement better.The research of other various places has all been found this kind contact as India, Papua New Guinea etc. in the world.
Once carried out Harvard step test (HST) to the workman of Guatemala Caulis Sacchari sinensis and cafetal the seventies.Found that performance of the test difference and be considered to blunt slow-witted person and all be proved to be and be the iron deficiency person.
Iron deficiency is bigger to women's harm.Usually male every day is by 1mg ferrum that runs off approximately such as urine, skin, feces.But the flowing molten iron vector of women every month is but much more than the male.They are mensal hemorrhagely to cause the fail to keep an appointment ferrum of 0.4～0.5mg of average multithread every day, and 10 women's flowing molten iron vector is bigger approximately 3 times than this.Intrauterine device can cause more having more blood.Though period of pregnancy, mensal hemorrhage stop during the 4th to nine month, roughly will provide about 5mg ferrum for fetus and Placenta Hominis every day.Like this, during to childbirth, the total number of dropouts of the ferrum of parent is about 900mg.Birth process and the puerperal flowing molten iron that also can cause appreciable amount of bleeding lose.Obviously, healthy meeting causes serious harm to the phenolics iron deficiency to female, baby, and it can increase mother and the baby produces forward and backward mortality rate productive rate early.Also (PollittE. etc. write the baby that the iron deficiency anemia of pregnant woman is given birth to: iron deficiency: the biochemical and behavior 1982 of brain, Raven Press because of iron deficiency is in morbid state; Hallberg etc. write: iron deficiency and work achievement 1983, threpsology basis, Washington, DC; Pollitt E etc. writes: iron deficiency and behavior progress, U.S. clinical nutriology supplementary issue Vol.50, No.3,1989).
Known, the contained ferrum of human body has 73% to be incorporated into haemachrome, and it can help haemachrome molecule to combine with oxygen molecule in lung, and it is transported to each organ of whole body and tissue.Along with the constantly dead and new erythrocyte of old erythrocyte constantly produces, ferrum constantly circulates in haemachrome all the time.The formation of asiderosis mainly is because due to unreasonable and some disease of diet structure.Though vegetable, particularly Herba Spinaciae contain abundant ferrum, have only 1.4% can be absorbed by the body; Ferrum in other vegetables absorbs much better, is 1.6% as Semen sojae atricolor, Caulis et Folium Lactucae sativae 4.4%, Semen Glycines 7%.And by comparison, there is nearly 20% hematochrome sections to be absorbed in the red lean meat.Poultry is also suitable with it with the ferruginous absorbance of Fish institute.Obviously, the ferrum that the hematochrome sections promptly is incorporated in the haemachrome molecule in the food is easily absorbed by the body, and its relative bioavailability is higher than general iron salt, and it absorbs the interference that is not subjected to gastrointestinal content.The good efficacy of clinical practice haemachrome treatment iron deficiency anemia (IDA) early has report.
Being not only a kind of medicine for the treatment of iron deficiency anemia in view of the popularity of Patients with iron deficiency anemia and natural haemachrome also is a kind of food additive, therefore the present inventor is that the functional health product of enriching blood of main component are concentrated on studies with the haemachrome to development, complex (below the be called soluble heme) dissolubility of finding haemachrome and lysine is better than haemachrome, easier is absorption of human body, has finished the present invention on the basis of this discovery.
About the existing many bibliographical informations of the preparation of haemachrome.Nippe etc. adopt glacial acetic acid digestion hemoglobin (Nippe et al. the earliest, Org.Syn.21:53 (1941)), employings such as Wu Zhenggui also be this method (internal organs biochemical pharmacy, 1982,22 (4): 11), this method yield is low, and can't recycle acetic acid from mother solution, and cost is higher; The acid acetone method of usefulness such as Lindroos prepares haemachrome, and (this method not only can't reclaim acetone for Lindroos PGS et al., J.Food Sci.40:155 (1975), and has increased by a step deacidification technology, and production cost more is higher than method of acetic acid; European patent EP 200783/1979 adopts the methanol legal system to be equipped with haemachrome, though this method cost is low, yield is not high, and the toxicity of methanol has been brought outstanding labor protection problem again.In order to overcome above-mentioned shortcoming, the present inventor has studied new haemachrome preparation method.
Therefore, an object of the present invention is to provide a kind of soluble heme, be beneficial to the absorption of haemachrome.
Another object of the present invention provides the preparation method of soluble heme.
It is the health composition of enriching blood of effective ingredient with the soluble heme that a further object of the present invention provides a kind of.
It is 1 that soluble heme of the present invention comprises weight ratio: 2-1: 10 haemachrome and lysine.
The preparation method of soluble heme of the present invention be with haemachrome and lysine with 1: 2-1: 10 ratio is fully mixed.Wherein the preparation process of haemachrome is as follows:
(1) preparation serum deprivation and fibrinous red blood cell suspension;
(2) under 100-106 ℃ of temperature with contain NaCl 〉=85% acetic acid is digestion of hemoglobin 15-20 minute;
(3) filtered while hot will precipitate with spirit of vinegar, water, rare pure and mild ether and wash successively, get crude product;
(4) with crude product refining.
The health composition of enriching blood of the present invention comprises soluble heme (haemachrome lysine complex) and pharmaceutic adjuvant, and the weight ratio of described soluble heme and pharmaceutic adjuvant is 1: 15-1: 20.
Below the present invention will be described in more detail.
Soluble heme of the present invention is the complex of natural haemachrome and lysine, and wherein the weight ratio of haemachrome and lysine is 1: 2-1: 10, be preferably 1: 2-1: 4.
Soluble heme provided by the present invention (haemachrome amino acid complex) is with by 1: 2-1: 10, be preferably 1: 2-1: dry haemachrome that 4 (W/W) take by weighing and lysine in mortar fully ground and mixed evenly make.
Wherein, the preparation technology of haemachrome is made up of following four steps:
(1) blood anticoagulant, serum deprivation and fibrin
Access the blood of newly slaughtering pig (or cattle), stir the 4% sodium citrate normal saline solution that adds 1/10 volume down.Stir and to remove the fibrin of separating out with the coarse rod that stirs of contact surface.Place, treat the serum layering after, divide serum deprivation, the gained red cell suspension is for step digestion down;
(2) digestion of hemoglobin
Above-mentioned erythrocyte suspension is slowly injected 2-5 times of volume 〉=85% acetic acid and an amount of sodium chloride that are preheated to 100～106 ℃ (be preferably 0.5-10g/1000ml, be more preferred from 5g/1000ml) solution in, finish in 100～106 ℃ of digestion 15～20 minutes until fully.
(3) separation of crude product haemachrome
Take advantage of heat (about 80 ℃) to filter above-mentioned digestion of hemoglobin liquid, gained crude product haemachrome is successively respectively with spirit of vinegar, water, rare pure and mild ether washing, drain, put treat in the air that ether is waved to the greatest extent after, (1L erythrocyte suspension can get crude product haemachrome 7～11g) to be dried to constant weight in 100 ℃.
(4) refining
A. the above-mentioned dry crude product haemachrome of primary purification added glacial acetic acid and 1～2g NaCl azeotropic 1 hour by 1: 10 (V/V).With the crude product lock out operation, get the primary purification product.
B. recrystallization is got the crude product haemachrome by 1: 5 (W/V) adding pyridine, stirs and makes dissolving.The chloroform that adds 1.5 times of volumes then, jolting after treating all to dissolve, is filtered.Other gets the glacial acetic acid that is about 15 times of pyridine amounts and is heated to and boils, and adds the concentrated hydrochloric acid of 1/100 volume and sodium-chloride water solution in a small amount, removes thermal source.Above-mentioned haemachrome solution is injected hot pyridiniujm acid solution in stirring down, and mixed liquor was placed 12 hours.Filter and collect the haemachrome of separating out, and wash with spirit of vinegar, water, Diluted Alcohol and ether respectively with the crude product lock out operation.The recrystallization response rate 75～85%.
The health composition of enriching blood of the present invention comprises soluble heme (haemachrome lysine complex) as effective ingredient, and pharmaceutic adjuvant.The weight ratio of described soluble heme and pharmaceutic adjuvant is 1: 15-1: 20.Described pharmaceutic adjuvant can be the necessary aminoacid (as lysine) of lactose, sucrose, starch, fructose, Polyethylene Glycol (PEG), chitin, sodium bicarbonate, magnesium silicate, cosolvent (as medicinal tween) and human body etc.
The health composition of enriching blood of the present invention can be made into dosage forms such as gastric solubleness or enteric coated capsule, tablet (comprising special-shaped sheet), pill, powder, dissolved granule, oral liquid, and wherein the content of effective ingredient soluble heme lysine complex is: every dose of 30～50mg/ (as 1 capsules, 1 special-shaped sheet, 1 bag electuary, 1 bottle oral liquid etc.).
Soluble heme lysine complex of the present invention is except the health composition of making as above dosage form, also can mix the various food of people (as milk product, confection, wheaten food etc.), make the health food (as strengthening milk powder, cookies, chewing gum, jelly work etc.) of prevention iron deficiency anemia.
Thereby the present invention provides a kind of first makes water-insoluble haemachrome become the haemachrome lysine complex that soluble heme is easy to absorb, form is that Patients with iron deficiency anemia (especially infant) provides supplement therapy more easily, for wider iron deficiency anemia high-risk group provides effective prevention.
Particularly, be subjected to the maximum crowd-infant of iron deficiency harm, because general inorganic chalybeate not only can cause untoward reaction, and its absorption is subjected to the intestines and stomach content and disturbs, and brings certain difficulty for sideropenic control.And soluble heme is easy to absorption, easy to use, is the sideropenic a kind of ideal organic chalybeate of control infant.
Not only step is simple for industrial extraction process of heme of the present invention, quality of finished product good (content in crude product＞90%), and because of utilizing mother solution to reclaim acetic acid and reduced production cost significantly, thereby make the production technology of haemachrome push ahead a step with mother solution concentrated solution hydrolytic producing amino-acid.
The present invention is vast healthy population (the particularly child and the women of child-bearing age) prevention iron deficiency and iron deficiency anemia with the form of health product first; Promote the rehabilitation of vast iron deficiency and Patients with iron deficiency anemia.
The embodiment that below provides illustrates of the present invention, rather than limitation of the present invention.
Embodiment 1 capsule (gastric solubleness)
Prescription (every capsules):
Haemachrome 10mg
Lysine 20-40mg
Sucrose 150-170mg
Preparation technology: weighing is by dry chlorhematin, lysine and the sucrose of 1000 capsules respectively, after 80 ℃ of dryings, the porphyrize mixing is made soft material with 75% medicinal alcohol, cross 20 mesh sieves and granulate, granule is in filling after 60 ℃ of intensive dryings in No. two gastric-dissolved capsules.The full scale production process is all carried out under the GMP condition of the food hygiene standard that meets national regulation.
Embodiment 2 capsules (enteric)
With example 1 prescription, the preparation that uses the same method, but with the gastric-dissolved capsule in the enteric coated capsule replacement example 1.
Embodiment 3 tablets (enteric)
Prescription (every):
Haemachrome 10mg
Lysine 20-40mg
Starch 100mg
Pulvis Talci (in right amount)
Preparation technology: " two appendix 1 ruless of preparations of Chinese pharmacopoeia: the 1A tablet item specification requirement of regulation was down made green different (ball) shape enteric coated tablet by in 1995 version.
Embodiment 4 electuaries
Prescription (each uses fractional pack):
Haemachrome 10mg
Lysine 20-40mg
Sucrose 3000mg
Radix Glycyrrhizae powder 250mg
Preparation technology: earlier haemachrome and lysine are ground well, add Radix Glycyrrhizae powder, sucrose more successively, fully after the grinding evenly, add an amount of dextrin and starch, make soft material, abundant stirring and evenly mixing in blender with 75% medicinal alcohol, sieve, after the drying, by one nine nine five editions " Chinese Pharmacopoeias.Granule is made in the specification requirement of two following regulations of appendix 11:1N granule item.
The threpsology of experimental example 1 haemachrome lysine complex estimates
Be copied into the IDA rat model by document (6) method, on this animal model, estimate the health care of enriching blood of haemachrome lysine complex.Test group IDA rat gavages the haemachrome lysine complex (soluble heme) that is equivalent to 1～2mg haemachrome/100g body weight, continuous 30 days every day; Matched group IDA rat only gavages excipient.Two treated animals all give the iron deficiency feedstuff, freely drink water.Experimental result shows, the RBC number and the hemoglobin concentration that give the IDA rat of haemachrome lysine complex all significantly raise, recover normal level gradually, and the variation on control rats experiment front and back erythrocyte and the equal not statistically significant of hemoglobin concentration.Shown that soluble heme of the present invention has significant reinforcement blood nourishing function.
The administration phase increases average (g/L) before the moving administration of effect (mean value SD) the group administration chalybeate amount of table 1 soluble heme rising IDA rat hemoglobin
7 days 14 days 21 days 28 days solubilities of approach mg/kg.d thing (g/L) are irritated stomach 1.93 10 91.4 ± 12.6 18.8 ± 9.3
*24.7 ± 17.6
*26.1 ± 5.1
*21.6 ± 11.1
*The haemachrome carboxymethyl is irritated stomach-10 92.3 ± 21.3 20.7 ± 15.3 10.7 ± 7.0 9.6 ± 11.6 3.6 ± 10.8 celluloses
*With relatively increase highly significant p＜0.01 before the medicine.
Last table data show, soluble heme of the present invention (haemachrome lysine complex) the intravital hemoglobin content of IDA rat that can obviously raise.Point out its function of preventing and treating to iron deficiency anemia.
Reference and citing document
1.Pollitt E. etc. write: iron deficiency: the biochemical and behavior 1982 of brain, Raven Press.
2.Hallberg Deng writing: iron deficiency and work achievement 1983, the threpsology basis, Washington,
DC。
3.Pollitt E etc. write: iron deficiency and behavior progress, U.S. clinical nutriology supplementary issue Vol.50,
No.3，1989。
4.Crill O. etc. write: sideropenic significance, Meharry Medical, 1990.
5. just cloud, Ma Fenglou of clock: the biological utilisation research of haemachrome.Journal of Nutrition 1989,11 (2): 135～
139。
6. Li Jin baby, Sun Aihua: the iron deficiency rat model duplicates and observes.Shanghai Medicine 1991,14:88～
92。
7. Ministry of Health of the People's Republic of China: provisions for new drugs approval, promulgation in 1988.
8. People's Republic of China's food standard.
9. it is surplus to be permitted moral: the research of hematoporphyrin photosensitizer.The 2nd Army Medical College journal to 1983,4 (3): 161～
165。
10. Tang Minglong, gold trip are raised: the applied research progress of haemachrome.Medical industry 1985,16 (8): 37～
40。
11. open Chu Fu: the pyridine hemochromogen determination of light absorption of chlorhematin, biochemistry and biophysics are advanced
Exhibition 1991,18 (1): 73～74.
12. Xu Yu show, Ying Xiaoqin, Wen Wanling: protohemin treatment iron deficiency anemia 30 examples, new drug and clinical 1990 (9): 353～354.13. Wang Shao third of the twelve Earthly Branches, Tian Zongzhi, Xu Deyu: separate the amino acid whose research of preparation in the haemachrome preparation, aminoacid magazine 1987,3:6～8.14. the king passes the bosom, etc.: with the research that Sanguis sus domestica prepares aminoacids complex, aminoacid magazine 1992,1:13～15.15. Yuan Xi, etc.: the development of chlorhematin oral liquid and observation of curative effect, Chinese Pharmaceutical Journal 1995,30 (11): 664～666.
Claims (10)
1. soluble heme, comprising weight ratio is 1: 2-1: 10 haemachrome and lysine.
2. soluble heme as claimed in claim 1, wherein the weight ratio of haemachrome and lysine is 1: 2-1: 4.
3. as the preparation method of soluble heme as described in claim 1 or the claim 2, it is characterized in that: haemachrome and lysine are fully mixed with described ratio.
4. method as claimed in claim 3, wherein the preparation process of haemachrome is as follows:
(1) preparation serum deprivation and fibrinous red blood cell suspension;
(2) under 100-106 ℃ of temperature with 2-5 times of volume contain NaCl 〉=85% acetic acid is digestion of hemoglobin 15-20 minute;
(3) filtered while hot, the precipitation of separating out in the filtrate is washed successively with spirit of vinegar, water, rare pure and mild ether, and drying gets crude product;
(4) with crude product refining.
5. method as claimed in claim 4, wherein said step (1) comprising: get the fresh blood of pig or cattle, stir the 4% sodium citrate normal saline solution that adds 1/10 volume down; Stir and to remove the fibrin of separating out with the coarse rod that stirs of contact surface; After placing layering, divide serum deprivation, get red cell suspension.
6. method as claimed in claim 4, wherein said step (4) comprising:
A. primary purification added glacial acetic acid and 1～2gNaCl azeotropic 1 hour with dry crude product haemachrome by 1: 10 (V/V), repeated the lock out operation of above-mentioned steps (3), the primary purification product;
B. recrystallization is got the crude product haemachrome by 1: 5 (W/V) adding pyridine, stirring makes dissolving, adds the chloroform of 1.5 times of volumes then, jolting, after treating all dissolvings, filter, the glacial acetic acid that other gets 15 times of pyridine amounts is heated to and boils, and adds the concentrated hydrochloric acid of 1/100 volume and sodium-chloride water solution in a small amount, remove thermal source, solution injects hot pyridiniujm acid solution down in stirring, and mixed liquor is placed the precipitation that 12 hours after-filtration collection are separated out, and repeats the lock out operation of above-mentioned steps (3).
7. the Halth-care composition of enriching blood comprises described soluble heme of claim 1 or claim 2 and adjuvant, and the weight ratio of described soluble heme and adjuvant is 1: 15-1: 20.
8. compositions as claimed in claim 7, wherein adjuvant is selected from the necessary aminoacid of lactose, sucrose, starch, fructose, Polyethylene Glycol, medicinal tween, chitin, sodium bicarbonate, magnesium silicate and human body.
9. compositions as claimed in claim 7, its form is selected from capsule, tablet, pill, electuary, powder, oral liquid, chewing gum and jelly work.
10. compositions as claimed in claim 9, wherein capsule and tablet are the enteric solubility preparation.
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| Application Number | Priority Date | Filing Date | Title |
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| CN99116822A CN1252279A (en) | 1999-08-30 | 1999-08-30 | Soluble heme and its preparation process and hematic composite with it |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102178019A (en) * | 2010-12-08 | 2011-09-14 | 叶建斌 | Formula of chewable tablets for preventing anemia in pregnant women and preparation method thereof |
| CN106566278A (en) * | 2016-11-07 | 2017-04-19 | 中国农业科学院农产品加工研究所 | Hemoglobin coloring agent and preparation method thereof |
| CN108129485A (en) * | 2018-01-15 | 2018-06-08 | 中国农业科学院特产研究所 | Make ferroheme and preparation method, converted starch solubilising ferroheme and preparation method by oneself |
-
1999
- 1999-08-30 CN CN99116822A patent/CN1252279A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102178019A (en) * | 2010-12-08 | 2011-09-14 | 叶建斌 | Formula of chewable tablets for preventing anemia in pregnant women and preparation method thereof |
| CN102178019B (en) * | 2010-12-08 | 2012-09-19 | 叶建斌 | Formula of chewable tablets for preventing anemia in pregnant women and preparation method thereof |
| CN106566278A (en) * | 2016-11-07 | 2017-04-19 | 中国农业科学院农产品加工研究所 | Hemoglobin coloring agent and preparation method thereof |
| CN108129485A (en) * | 2018-01-15 | 2018-06-08 | 中国农业科学院特产研究所 | Make ferroheme and preparation method, converted starch solubilising ferroheme and preparation method by oneself |
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