CN102784230A - Pharmaceutical composition preparation for treating nutritional anemia - Google Patents
Pharmaceutical composition preparation for treating nutritional anemia Download PDFInfo
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- CN102784230A CN102784230A CN2011101313353A CN201110131335A CN102784230A CN 102784230 A CN102784230 A CN 102784230A CN 2011101313353 A CN2011101313353 A CN 2011101313353A CN 201110131335 A CN201110131335 A CN 201110131335A CN 102784230 A CN102784230 A CN 102784230A
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- Prior art keywords
- water
- add
- thick paste
- adds
- corii asini
- Prior art date
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Landscapes
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Abstract
The invention discloses a pharmaceutical composition preparation for treating nutritional anemia, and a preparation method thereof. The pharmaceutical composition preparation comprises radix astragali, arillus longan, angelica, donkey-hide gelatin, ferrous gluconate, brown granulated sugar, and auxiliary materials, and is mainly used for treating and improving nutritional anemia. Compared with the prior art, the pharmaceutical composition preparation of the invention is safe in use, definite in therapeutic effect, simple in prescription, simple in manufacturing process, and suitable for industrial mass production.
Description
Technical field: the present invention relates to a kind of drug combination preparation of treating nutritional anemia, belong to the technical field of medicine and health food.
Technical background: add up according to World Health Organization (WHO): the whole world has 3,000,000,000 people anemia in various degree approximately, and cause that because of suffering from anemia the dead number of all kinds of diseases is up to ten million every year.The population probability of middle national trouble anemia is higher than western countries, and in the crowd who suffers from anemia, the women is apparently higher than the male, and old man and child are higher than the young and the middle aged.
Nutritional anemia is meant because of the necessary nutrient substance of body hemopoietic, reduces relatively or utterly like materials such as ferrum, folic acid, dimension biogen D, makes the formation of hemoglobin or erythrocytic generation not enough, so that the low a kind of disease of hemopoietic function.The relatively poor patient of absorption of nutrient ingredients due to the infant that is mainly in 6 months to 2 years old, trimester of pregnancy or the diseases such as women breast-feeding their children and gastrointestinal tract.
Nutritional anemia can be divided into three kinds of iron deficiency anemia, megaloblastic anemia and Combination anemias.Iron deficiency anemia be to form gradually in the long period.Iron loss exhausts the phase, stores iron loss to the greatest extent, and SF lowers, and do not have anemia this moment, if iron deficiency further increases the weight of, stores iron loss to the greatest extent, and SF and serum levels of iron descend, and total iron binding capacity increases, and iron deficiency anemia occurs; And megaloblastic anemia, mainly due to the vitamin B12 Deficiency of Intake, absorb and utilize reasons such as obstacle and the increase of hemopoietic material demand amount to cause; Chinese medicine belongs to primary disease categories such as " asthenia ", " blood deficiency ".Think that blood derives from spleen, at all at kidney and relate to the heart, liver two is dirty.If weakness of the spleen and stomach, inability of food and drink to be digested and transported is precise and tiny, and source of generating QI and blood is not enough, produces anemia.The blood deficiency the five internal organs lose supports, and just diseases such as deficiency of heart-blood, both liver and kidney deficiency can occur.Common sympton is that the primary disease onset is slower, and the lighter shows as skin, mucosal pallor or greenish yellow, and is more obvious with positions such as lip, dental bed, eyelid, fingernails.Serious anemia is visible dizzy, malaise, and dysphoria, inappetence etc. are often with malnutrition.Anemia is of a specified duration excessively, can cause dysplasia.
In the process of clinical treatment nutritional anemia, doctor trained in Western medicine directly adopts oral or injection chalybeate treatment iron deficiency anemia, and patient Chang Yin is to the malabsorption of ferrum and serious gastrointestinal reaction and TD; Or adopt vitamin B12 and folic acid drug combination to add ascorbic therapy for treating megaloblastic anemia again, but onset is slower, long action time, and nervous system recovers slower.The traditional Chinese medical science executes with dialectical that to control be the Therapeutic Principle, and from integral body, prescription flexibly can not only improve the clinical symptoms of anemia, also can nurse one's health physical function, improves resistance, and few side effects, but that shortcoming is onset is slow, and medicine time is long, and patient's length can not be adhered to.
Summary of the invention: the objective of the invention is to: provide a kind of rapid-action, evident in efficacy, prescription is simple, processing technology is easy, the drug combination preparation of the treatment nutritional anemia of few side effects, and the method for preparing of said composition preparation.
The drug combination preparation of treatment nutritional anemia of the present invention is on the basis of Chinese medicine astragalus, Radix Angelicae Sinensis, Arillus Longan and Colla Corii Asini, increases Ferrous gluconate, and the prescription that adopts Chinese medicine and western medicine to combine reaches the purpose of treating nutritional anemia.
The drug combination preparation of treatment nutritional anemia provided by the invention is to be prepared from following raw materials by weight proportions and suitable adjuvant:
Radix Astragali 240-360 part, Arillus Longan 120-180 part, Radix Angelicae Sinensis 48-72 part, Colla Corii Asini 30-45 part, Ferrous gluconate 3.36-5.04 part, brown sugar (Saccharum Sinensis Roxb.) 80-120 part.
Further, on the basis that the above-mentioned raw materials medicine is formed, the weight proportion of its crude drug can be adopted as:
Radix Astragali 270-330 part, Arillus Longan 135-165 part, Radix Angelicae Sinensis 54-66 part, Colla Corii Asini 33.75-41.25 part, Ferrous gluconate 3.78-4.62 part, brown sugar (Saccharum Sinensis Roxb.) 90-110 part.
Preparation technology of the present invention is:
(1) get the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 5-12 times of water gaging and soaked 0.5-2 hour, water decocts 1-4 time; Each 1-4 hour, filter merging filtrate; Under 50-80 ℃ of condition, be evaporated to the thick paste that relative density is 1.05-1.20, add ethanol then and be 30%-50%, hold over night to containing the alcohol amount; Filter, filtrate recycling ethanol continues to be concentrated into that relative density is the thick paste of 1.15-1.25 under the 50-80 ℃ of condition;
(2) Colla Corii Asini adds in the 100-200ml water, in 50-70 ℃ of molten;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in the 150-250ml water, fully dissolving, and the Colla Corii Asini solution with molten adds in the thick paste of step (1) then, adds suitable adjuvant, is prepared into the preparation formulation that needs with conventional method.
Preparation of the present invention can be oral liquid, granule and capsule, is preferably oral liquid.
Technology when the present invention processes oral liquid is:
(1) get the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 5-12 times of water gaging and soaked 0.5-2 hour, water decocts 1-4 time; Each 1-4 hour, filter merging filtrate; Under 50-80 ℃ of condition, be evaporated to the thick paste that relative density is 1.05-1.20, add ethanol then and be 30%-50%, hold over night to containing the alcohol amount; Filter, filtrate recycling ethanol continues to be concentrated into that relative density is the thick paste of 1.15-1.25 under the 50-80 ℃ of condition;
(2) with the thick paste that obtains in the step (1), add water to the 50%-60% of total amount, cold good 36-60 hour, it was subsequent use to get supernatant;
(3) Colla Corii Asini adds in the 100-200ml water, in 50-70 ℃ of molten;
(4) get recipe quantity Ferrous gluconate, brown sugar (Saccharum Sinensis Roxb.), the sodium benzoate of 1-4 weight portion adds in the 150-250ml water, fully dissolves subsequent use;
(5) the Colla Corii Asini solution with molten mixes with above-mentioned each solution, boils, and adds water to total amount, and sterilization is filtered, and fill promptly gets oral liquid.
Technology when the present invention processes granule is:
(1) get the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 5-12 times of water gaging and soaked 0.5-2 hour, water decocts 1-4 time; Each 1-4 hour, filter merging filtrate; Under 50-80 ℃ of condition, be evaporated to the thick paste that relative density is 1.05-1.20, add ethanol then and be 30%-50%, hold over night to containing the alcohol amount; Filter, filtrate recycling ethanol continues to be concentrated into that relative density is the thick paste of 1.15-1.25 under the 50-80 ℃ of condition;
(2) Colla Corii Asini adds in the 100-200ml water, in 50-70 ℃ of molten;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in the 150-250ml water, fully dissolving, and the Colla Corii Asini solution with molten adds in the thick paste of step (1) then; Fully mix, add the dextrin of total formulation weight amount 10%-20% then, mix homogeneously; Drying, granulate, packing promptly gets granule.
Technology when the present invention processes capsule is:
(1) get the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 5-12 times of water gaging and soaked 0.5-2 hour, water decocts 1-4 time; Each 1-4 hour, filter merging filtrate; Under 50-80 ℃ of condition, be evaporated to the thick paste that relative density is 1.05-1.20, add ethanol then and be 30%-50%, hold over night to containing the alcohol amount; Filter, filtrate recycling ethanol continues to be concentrated into that relative density is the thick paste of 1.15-1.25 under the 50-80 ℃ of condition;
(2) Colla Corii Asini adds in the 100-200ml water, in 50-70 ℃ of molten;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in the 150-250ml water, fully dissolving, and the Colla Corii Asini solution with molten adds in the thick paste of step (1) then; Fully mix, add the microcrystalline Cellulose of total formulation weight amount 9%-11% then, the magnesium stearate of 1%-2%; Mix homogeneously 60-70 ℃ of drying, is processed granule; Drying incapsulates, and promptly gets capsule.
The Radix Astragali that the present invention is used is the dry root of leguminous plant Radix Astagali or Radix Astragali A.membranaceus (Fisch.) Bge..Have invigorating QI to consolidate the body surface resistance, the effect of hidroschesis detoxification, granulation promoting, diuresis, detumescent is used to treat that the deficiency of vital energy is weak, sinking of QI of middle-JIAO, chronic diarrhea proctoptosis, the metrorrhagia of having blood in stool, blood deficiency and yellow complexion, exterior deficiency spontaneous perspiration etc.Research shows that Milkvetch Root mainly contains saponins, flavone and glycoside thereof and polysaccharide composition.Pharmacological research shows that the Radix Astragali has significant antioxidation, removes the ability of free radical; Can also improve body's immunological function; In addition, the Radix Astragali can reduce the T-CHOL in generation of cytolipin peroxide and the blood plasma, anticoagulant, reduction blood viscosity and coagulability; Improve blood circulation, have many-sided pharmacological actions such as antiviral in addition.
The Arillus Longan that the present invention is used is the mature sarcocarp of sapindaceous plant longan Euphoria longan (Lour.) Stend., sweet in the mouth warm in nature.Have reinforcing the heart spleen, replenishing QI and blood effect.Mainly contain compositions such as glucose, sucrose, acids, protein, adenine, choline, fat and vitamin A, B1, B2, C, P.Pharmacology and clinical effect show, Arillus Longan has anti-stress, immunity, antibiotic effect such as anticancer, but invigorating the heart and spleen, nourishing blood to tranquillize the mind, strongly invigorating QI and blood.
The Radix Angelicae Sinensis that the present invention is used is the root of umbelliferae angelica Angelica sinensis (Oliv.) Diels, sweet in the mouth warm in nature, suffering.Having enriches blood invigorates blood circulation, pain relieving intestine moistening effect.Mainly contain volatile oil, also have aminoacid in the multiple polysaccharide, 13, phospholipid, 23 kinds of inorganic elementss (wherein in 16 be human body institute must composition), vitamin etc. in addition.Pharmacological action shows that Radix Angelicae Sinensis has resisting myocardial ischemia, arrhythmia, blood fat reducing and promotes hemopoietic function, raise immunity, and effects such as antioxidation are the good medicine of enriching blood and invigorating blood circulation.
The Colla Corii Asini that the present invention is used, for the dry skin of equine species donkey Equus asinus L. or Cortex Dictamni through decocting, concentrate the solid gum of processing, sweet in the mouth, property are flat, return lung, liver, kidney channel, have the YIN nourishing of enriching blood, and moisturize the hemostatic effect.Colla Corii Asini is called " panacea of enriching blood " by the successive dynasties physician; With Radix Ginseng, Cornu Cervi Pantotrichum and title " Chinese medicine SANBAO ", modern medicine study confirms that Colla Corii Asini mainly is made up of collagen protein; Can be divided into tens of seed amino acids after the hydrolysis; Also contain aminopolysaccharide, like hyaluronic acid, dermatan sulfate etc., and fiber mucus albumen and several mineral materials etc.Colla Corii Asini has good facilitation to hemopoietic system, can increase sharply erythrocyte and amount of hemoglobin, and its mechanism of action can also provide the raw material of hemopoietic except that the hemopoietic function that promotes body, so have powerful blood nourishing function is arranged.Colla Corii Asini not only can be enriched blood by hemopoietic, can also be through improving solidifying of hematoblastic content and collagen protein in the blood, promotion blood, to reach the hemostatic purpose.
The Ferrous gluconate that the present invention is used is organic ferrous salt, odorless, tasteless; Water-soluble easy absorption; Curative effect and ferrous sulfate are suitable, but the latter is big to the zest of stomach, side effect such as be prone to cause constipation, vomiting, feel sick; And Ferrous gluconate does not have zest to stomach, is a kind of comparatively ideal organic iron supplement agent.
The brown sugar (Saccharum Sinensis Roxb.) that the present invention is used is the Caulis Sacchari sinensis commerieal sugar of band honey, a kind of for brown sugar; Almost keep the whole compositions in the sugarcane juice, except the function that possesses sugar, also contained vitamin and trace element; Like ferrum, zinc, manganese, chromium etc.; 90 milligrams of per 100 gram brown sugar calcics, 4 milligrams of iron content also contain a spot of riboflavin and carotene.The traditional Chinese medical science is thought: brown sugar is warm in nature, sweet in the mouth, go into spleen, have QI replenishing and blood tonifying, spleen invigorating warming the stomach, slow in the effect of pain relieving, activating blood circulation to dissipate blood stasis.
In sum, pharmaceutical formulation of the present invention is scientific and reasonable, and Radix Astragali invigorating QI to consolidate the body surface resistance, Chinese angelica blood supplementing are invigorated blood circulation, Arillus Longan reinforcing the heart spleen replenishing QI and blood, Colla Corii Asini nourishing blood YIN nourishing, brown sugar (Saccharum Sinensis Roxb.) QI replenishing and blood tonifying, and five kinds of Chinese medicine is tool blood-enriching qi-invigorating, the effect that takes care of health and invigorate blood circulation altogether; Adding Ferrous gluconate enriches blood as organic iron supplement agent and protects the intestines and stomach simultaneously.So it is the drug combination preparation that the present invention treats nutritional anemia can be applicable to nutritional anemia person, evident in efficacy, side effect is low, processing technology is easy, is suitable for industrialized great production.
In order to make those of ordinary skills better understand the present invention, the applicant has carried out series of experiment research, to prove effect of the present invention:
One, drug efficacy study
Experimental example 1: present composition preparation improves the experimentation of nutritional anemia
1.1 experiment material and method:
1.1.1 medicine and study subject:
Medicine: oral liquid of the present invention: according to the oral liquid that the method for preparing of the embodiment of the invention 1 is prepared into, the 20ml/ bottle recommends consumption to be adult every day 2 times, each 1, the per kilogram of body weight 0.667ml that is equivalent to be grown up (with the 60kg weighing machine).
Animal: male ablactation Wistar rat, 60～90g; Provide by Guiyang Medical College.
1.1.2 experimental apparatus: atomic absorption spectrophotometer (Spectr AA-20 type); F4000 spectrofluorophotometer (FDAC); Hbl002 hemoglobin determinator (Shanghai Yue Hai Huimin scientific instrument company limited), FT-630 γ-enumerator (Beijing nuclear medicine instrument plant).
1.1.3 experimental technique
40 of Wistar rats are raised low iron base feedstuff, consume empty 3 weeks; Cause the nutritional anemia animal model, get blood, measure content of hemoglobin through the tail vein; When content of hemoglobin is lower than 100g/L, rat is divided into iron deficiency matched group (raise low iron base feedstuff, irritate stomach 2.0ml deionized water) at random and the basic, normal, high dose groups of oral liquid of the present invention (is raised low iron base feedstuff by content of hemoglobin; Irritate stomach every day and give oral liquid of the present invention 3.35,6.67,20.0ml/kg respectively; 5,10,30 times of recommended amounts are equivalent to respectively to be grown up) totally 4 groups, 10 every group, 4 weeks of successive administration.When experiment finishes, use the etherization rat, behind abdominal aortic blood, win liver and spleen, it is subsequent use to put-30 ℃ of refrigerators.
1.1.4 biochemical indicator is measured
1.1.4.1 hemoglobin (Hb) adopts the high iron processes of cyaniding to measure content of hemoglobin; Get rat tail blood with the quantitative capillary tube of 10 μ l, put into the plastic tube that fills 2.5ml high-potassium ferricyanide reagent, fully vibration; Make the complete stripping of blood; After lucifuge is placed 15min, measure, measure hemoglobin standard and primary standard substance simultaneously with the hemoglobin appearance.
1.1.4.2 packed cell volume (HCT) is got blood with the quantitative capillary tube of 9 μ l, and an end is sealed with plasticine, adopts the packed cell volume analyzer to measure, and reads the result behind the 2min, measures the basis reference blood sample simultaneously.
1.1.4.3 free erythrocyte protoporphyrin (FEP) on special filter paper, deposits droplets of whole blood in 4 ℃ of refrigerators subsequent use (time is no more than 2 months) after to be dried.During mensuration, the filter paper that will have drop of blood with card punch is squeezed in the teat glass, adds 2% tripolite solution; Put into 4 ℃ of refrigerator overnight eluting; Add ethyl acetate: the extraction of glacial acetic acid (4: 1) mixed liquor, centrifugal 10min gets supernatant and adds 0.5mol/L hydrochloric acid; It is centrifugal to vibrate, and takes off layer liquid and uses fluorescent spectrophotometer assay.
1.1.4.4 ferrum is got about 0.2g tissue and is put into the teat glass through the hydrochloric acid dry cleansing in liver, the spleen tissue; Add nitric acid: perchloric acid (4: 1) mixed acid 2ml; After the digestion; Be settled to 5ml or 10ml with deionized water, adopt flame atomization to measure iron content in the tissue, measure with Hepar Bovis seu Bubali powder (NBS1577a of NBS) as the Quality Control material at every turn.
1.1.5 any 2 indexs are superior to iron deficiency matched group (FEP is lower than the iron deficiency matched group) (P＜0.05) in the content of hemoglobin of decision method oral liquid group of the present invention rat, packed cell volume, FEP, liver and the spleen iron content as a result, this is tried decidable thing and is had the effect that improves the rat nutritional anemia.
1.1.6 statistical procedures adopts the t check data to be compared inspection level α=0.05.
1.2 result
1.2.1 respectively organize Hb content, packed cell volume, the erythrocyte FEP content difference not statistically significant (P＞0.05) of respectively organizing rat before the comparative experiments of rat hemoglobin content (Hb), packed cell volume (HCT), erythrocyte FEP content; Hb content, the packed cell volume of experiment back each dose groups rat of oral liquid of the present invention all are significantly higher than iron deficiency matched group (P＜0.05); Erythrocyte FEP content significantly is lower than iron deficiency matched group (P＜0.05); And the Hb content of the middle and high dose groups rat of oral liquid of the present invention, packed cell volume all are significantly higher than low dose group (P＜0.05), see table 1.
Table 1 is respectively organized the comparison (x ± s) of rat hemoglobin content, packed cell volume, erythrocyte FEP content
Annotate: compare * P＜0.05 with the iron deficiency matched group; Compare Δ P＜0.05 with oral liquid low dose group of the present invention
1.2.2 respectively organize liver and the spleen weight difference not statistically significant (P＞0.05) of respectively organizing rat before the comparative experiments of iron content in rat liver and the spleen; Iron content and total iron content all are significantly higher than iron deficiency matched group and low dose group (P＜0.05) in liver of the middle and high dose groups rat of experiment back oral liquid of the present invention and the spleen, see table 2.
Table 2 is respectively organized the comparison (x ± s) of iron content in rat liver and the spleen tissue
Annotate: with table 1
This experimental result shows; Irritate stomach and give oral liquid of the present invention after 4 weeks; Rat hemoglobin content and packed cell volume and value added significantly raise, and the FEP content of each dose groups and value added all significantly be lower than the iron deficiency matched group, and supplementary copy invention oral liquid can obviously increase iron content in liver and the spleen of rat; And iron content is significantly higher than the iron deficiency matched group in liver of middle and high dose groups rat and the spleen; Show that the oral fluid power of the present invention improves the nutritional anemia of rat effectively, can be used as a kind of functional product that improves nutritional anemia and apply to have vast market prospect.
Experimental example 2: present composition preparation for treating improves infant nutrition property anemia observation of curative effect
2.1 data and method
2.1.1 case is selected: 215 routine patients, male 119 examples, women 96 examples, age 0.5-12 year, average 4.26 years old, anemia 167 examples wherein, anemia 36 examples, anemia 10 examples, extremely anemia 3 examples are iron deficiency anemia.And primary disease persons such as the nonjoinder chronic infectious disease and the heart, liver,kidney,spleen.215 routine infants are divided into treatment group and each 44 example of matched group at random, make each group, have comparability at equal no difference of science of statistics in aspect (P＞0.05) such as sex, age, nutriture, clinical manifestation, severity of anemia.
Include standard in: meet the Chinese hematology of Society of Pediatrics and organize relevant " infant nutrition property anemia " diagnostic criteria that the academic meeting of national children's's hematopathy is worked out: be slight: 90＜Hb＜110g/L; Moderate: 60＜Hb＜90g/L; Severe: 30＜Hb＜60g/L; Utmost point severe: Hb＜30g/L, age>=6 month or≤12 years old.
2.1.2 curative effect judging standard:
" pediatrics and document are drafted: (1) recovery from illness: after the course of treatment, it is normal that indexs such as hemoglobin content, serum levels of iron total iron binding capacity are recovered, clinical symptom disappearance in reference the 6th edition; (2) produce effects: clinical symptoms is clearly better, and the classification of anemia severity transfers slightly (improving more than 2 grades) to by severe and reaches more than 50%; (3) effective: clinical symptoms take a favorable turn, and the anemia severity improves 1 grade and reaches more than 50%; (4) invalid: clinical symptoms and the classification of anemia severity do not have improvement.Obvious effective rate calculates with recovery from illness+produce effects.
2.1.3 Therapeutic Method
Matched group 1: give conventional western medical treatment, comprise oral dextran iron dispersing agent, 5mg/ (kg*d), 3 times/d, after the meal directly with mixing in water for oral taking or to put in an amount of eliminating cold for resuscitation water of people the dissolving back oral; Oral lysine B12 granule, 5-10g, 2 times/d.
Matched group 2: oral stilbene blood granule (the auspicious prosperous pharmaceutcal corporation, Ltd in Shanghai Communications University, Xi'an), every day 3 times, each 1 bag, can directly put into an amount of warm water dissolving back clothes after the meal.
Treatment group 1: the oral liquid that the embodiment of the invention 1 prepares, every 20ml, oral, every day 2 times, each 1, children's reduces by half.
Treatment group 2: the granule that the embodiment of the invention 3 prepares, every packed 10 grams, boiled water is taken after mixing it with water, and 2 times on the one, each 10 grams, children's reduces by half.
Treatment group 3: the capsule that the embodiment of the invention 5 prepares, every dress 0.4g, oral, every day 3 times, each 4, children's reduces by half.
Observation index was for 8 weeks the course of treatment, the case of including observation in respectively before smelting is treated, finish the value of back detection hemoglobin (Hb), RBC number (Rbc), SF (SF), total iron binding capacity (TLBC) course of treatment.
2.1.4 statistical method: adopt t check and x
2Check
2.2 result
2.2.1 table 3 is seen in the variation of Hb, RBC, SF, TIBC before and after each group treatment.
The variation of Hb, RBC, SF, TIBC before and after each group treatment of table 3
Annotate: with preceding relatively * P＜0.01 of treatment; Compare * * P＜0.05 with matched group
2.2.2 respectively organize the infant clinical efficacy relatively, see table 4.
Table 4 is respectively organized the infant clinical efficacy relatively
| Group | The example number | Recovery from illness | Produce effects | Effectively | Invalid | Obvious effective rate (%) |
| Treatment group 1 | 44 | 25 | 16 | 3 | 0 | 93.2 |
| Treatment group 2 | 44 | 24 | 16 | 4 | 0 | 90.9 |
| Treatment group 3 | 44 | 24 | 15 | 5 | 0 | 88.6 |
| Matched group 1 | 44 | 20 | 12 | 12 | 0 | 72.7 |
| Matched group 2 | 44 | 21 | 13 | 10 | 0 | 77.3 |
Compare * P＜0.05 with matched group
Above experimental result shows, the oral liquid of the present composition, granule and three kinds of dosage forms of capsule are in treatment and improve and good result is all arranged aspect the infant nutrition property anemia, and its curative effect is superior to using separately Western medicine or treatment by Chinese herbs.Show that the preparation that the present composition is processed is being feasible aspect the treatment nutritional anemia especially infant nutrition property anemia.
Two, technical study
Experimental example 3: the research of medicinal material extract technology
The medical material soak time, the addition of extraction solvent, extraction time and number of times are the principal elements that influences extraction process, are index with glycyrrhizic acid content and total solid yield, and above parameter is investigated, preferred optimum process condition.
5.1 the investigation of soak time
Take by weighing the recipe quantity Radix Astragali, Arillus Longan, Radix Angelicae Sinensis 510g altogether, soak, the according to the form below time period leaches medicinal residues and weighs, and till medicinal residues weight no longer changes, can be judged as medical material and no longer absorb water, and is calculated as follows water absorption rate writing time, and the result sees the following form.
Medical material is in the water absorption of each time
Result of the test shows: medical material soaks basically no longer suction after 1 hour, and water absorption rate is 120.4%, so before decocting, soaked 0.5-2 hour.
5.2 the investigation of extraction time
Sample preparation: with aforementioned three kinds of medical materials 510g altogether, soaks and decoct after 2 hours, decoct altogether five times, each 2 hours, collect each decocting liquid respectively, filtration.With Astragaloside content and total solid yield is index, investigates the influence of extraction time.The result sees the following form.
Extraction time-Astragaloside content, total solid yield table
| Extraction time | Astragaloside content (mg/g medical material) | Total solid yield (%) |
| 1 | 0.37 | 18.7 |
| 2 | 0.85 | 23.0 |
| 3 | 1.22 | 26.5 |
| 4 | 1.36 | 29.4 |
| 5 | 1.39 | 30.6 |
Data show in the table, when extracting four times, astragaloside and other materials have almost extracted fully, confirm that therefore extraction time is 1-4 time, wherein extract 3 times and are optimised process, and less expensive is reasonable.
5.3 extraction time is investigated
Take by weighing three kinds of medical materials 510g altogether, totally 6 parts, equal amount of water decocted respectively 0.5,1,1.5,2,3,4 hour, filtered, and was settled to certain volume, sampling and measuring Astragaloside content and total solid yield.The result sees the following form.
Extraction time-Astragaloside content, total solid yield
| Extraction time h | Astragaloside content (mg/g medical material) | Total solid yield (%) |
| 0.5 | 0.39 | 19.5 |
| 1 | 0.77 | 22.2 |
| 2 | 1.16 | 27.6 |
| 3 | 1.28 | 29.7 |
| 4 | 1.32 | 36.4 |
Last table can be known extraction after 3 hours, and Astragaloside content and total solid yield basically no longer change, and explained and extracted after 3 hours, and the stripping of astragaloside and other materials is tending towards saturation.Therefore confirm that extraction time is 1-4 hour, wherein extract 2 hours for best.
5.4 extracting amount of water investigates
Sample preparation: take by weighing three kinds of medical materials 510g altogether, totally 3 parts, comply with the different water yield of surface condition adding down, decoct 3 times, each 2 hours, filter, collect respectively and filtrate, measure glycyrrhizic acid content and total solid yield.The result sees the following form.
Amount of water-Astragaloside content, total solid yield table
| Amount of water is the medical material multiple | Astragaloside content (mg/g medical material) | Total solid yield (%) |
| 3 | 0.41 | 18.2 |
| 5 | 0.67 | 21.4 |
| 8 | 0.92 | 25.7 |
| 10 | 1.24 | 29.4 |
[0114]?
| 12 | 1.30 | 31.3 |
| 15 | 1.33 | 32.1 |
When extracting water yield increasing, the not bigger increase of the amount of astragaloside and total solid yield is that 5-12 doubly measures so select amount of water, and wherein 8-10 doubly measures and is the best.
5.5 extraction process checking
Sample preparation: take by weighing three kinds of medical materials of recipe quantity, totally three parts, the water logging that adds 10 times of amounts was steeped 1 hour, and water boiling and extraction is 3 times then, each 2 hours, filters merging filtrate.Measure Astragaloside content and total solid yield.The result sees the following form.
Extraction process confirmatory experiment result
| Tested number | Astragaloside content (mg/g medical material) | Total solid yield (%) |
| 1 | 1.26 | 31.5 |
| 2 | 1.28 | 31.3 |
| 3 | 1.25 | 30.9 |
| Meansigma methods | 1.263 | 31.2 |
| RSD(％) | 1.21 | 0.98 |
Extraction process confirmatory experiment result, the astragaloside average content is the 1.263mg/g medical material.RSD is 1.21%, and average total solid yield is 31.2, and RSD is 0.98%, proves that this process stabilizing is feasible, and is quality controllable.
Compared with prior art, the present invention has benefiting QI for activating blood circulation, the effect of the YIN nourishing of enriching blood, and can improve the symptom of nutritional anemias such as iron deficiency anemia and megaloblastic anemia rapidly; Dosage forms such as the oral liquid that provides simultaneously, granule and capsule are all easy to use, are easy to carry about with one and preserve, and applicable to the crowd who accepts different modes of administration, reached the purpose of invention.
The specific embodiment:
Embodiment 1:
Prescription: Radix Astragali 300g, Arillus Longan 150g part, Radix Angelicae Sinensis 60g, Colla Corii Asini 37.5g, Ferrous gluconate 4.2g, brown sugar (Saccharum Sinensis Roxb.) 100g
Method for making: the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis are got in (1), add 10 times of water gagings and soak 1 hour, and water decocts 3 times; Each 2 hours, filter merging filtrate; Under 60 ℃ of conditions, be evaporated to the thick paste that relative density is 1.10-1.15, adding ethanol then is 40% to containing the alcohol amount, hold over night; Filter, filtrate recycling ethanol continues to be concentrated into that relative density is the thick paste of 1.15-1.20 under 60 ℃ of conditions;
(2) with the thick paste that obtains in the step (1), add water to 60% of total amount, cold preservation 48 hours, it is subsequent use to get supernatant;
(3) Colla Corii Asini adds in the 200ml water, in 60 ℃ of moltens;
(4) get Ferrous gluconate, brown sugar (Saccharum Sinensis Roxb.), the 2g sodium benzoate adds in the 200ml water, fully dissolves subsequent use;
(5) the Colla Corii Asini solution with molten mixes with above-mentioned each solution, boils, and adds water to total amount 2000ml, and sterilization is filtered, and fill promptly gets 100 of oral liquids.Every 20ml of these article, oral, every day 2 times, each 1.
Embodiment 2:
Prescription: Radix Astragali 270g, Arillus Longan 135g, Radix Angelicae Sinensis 54g, Colla Corii Asini 33.75g, Ferrous gluconate 3.78g, brown sugar (Saccharum Sinensis Roxb.) 90g.
Method for making: the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis are got in (1), add 8 times of water gagings and soak 2 hours, and water decocts 2 times; Each 3 hours, filter merging filtrate; Under 80 ℃ of conditions, be evaporated to relative density and be 1.05 thick paste, adding ethanol then is 50% to containing the alcohol amount, hold over night; Filter, filtrate recycling ethanol continues to be concentrated into relative density under 80 ℃ of conditions and is 1.15 thick paste;
(2) with the thick paste that obtains in the step (1), add water to 50% of total amount, cold preservation 36 hours, it is subsequent use to get supernatant;
(3) Colla Corii Asini adds in the 100ml water, in 70 ℃ of moltens;
(4) get recipe quantity Ferrous gluconate, brown sugar (Saccharum Sinensis Roxb.), the 4g sodium benzoate adds in the 250ml water, fully dissolves subsequent use;
(5) the Colla Corii Asini solution with molten mixes with above-mentioned each solution, boils, and adds water to total amount 2000ml, and sterilization is filtered, and fill promptly gets 100 of oral liquids.Every 20ml of these article, oral, every day 2 times, each 1.
Embodiment 3:
Prescription: Radix Astragali 240g, Arillus Longan 120g, Radix Angelicae Sinensis 48g, Colla Corii Asini 30g, Ferrous gluconate 3.36g, brown sugar (Saccharum Sinensis Roxb.) 80g.
Method for making: the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis are got in (1), add 5 times of water gagings and soak 2 hours, and water decocted 4 hours; Filter, merging filtrate is evaporated to relative density and is 1.15 thick paste under 50 ℃ of conditions; Adding ethanol then is 30% to containing the alcohol amount, and hold over night filters; Filtrate recycling ethanol continues to be concentrated into relative density under 50 ℃ of conditions and is 1.20 thick paste;
(2) Colla Corii Asini adds in the 150ml water, in 50 ℃ of moltens;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in the 150ml water, fully dissolving, and the Colla Corii Asini solution with molten adds in the thick paste of step (1) then; Fully mix, add the dextrin of total formulation weight amount 10% then, mix homogeneously; Drying, granulate, packing promptly gets granule 1000 grams.Every packed 10 grams of these article, boiled water is taken after mixing it with water, and 2 times on the one, each 10 grams.
Embodiment 4:
Prescription: Radix Astragali 360g, Arillus Longan 180g, Radix Angelicae Sinensis 72g, Colla Corii Asini 45g, Ferrous gluconate 5.04g, brown sugar (Saccharum Sinensis Roxb.) 120g.
Method for making: the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis are got in (1), add 12 times of water gagings and soak 0.5 hour, and water decocts 4 times; Each 1 hour, filter merging filtrate; Under 70 ℃ of conditions, be evaporated to relative density and be 1.10 thick paste, adding ethanol then is 35% to containing the alcohol amount, hold over night; Filter, filtrate recycling ethanol continues to be concentrated into relative density under 70 ℃ of conditions and is 1.15 thick paste;
(2) Colla Corii Asini adds in the 100ml water, in 55 ℃ of moltens;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in the 180ml water, fully dissolving, and the Colla Corii Asini solution with molten adds in the thick paste of step (1) then; Fully mix, add the dextrin of total formulation weight amount 20% then, mix homogeneously; Drying, granulate, packing promptly gets granule 1000 grams.Every packed 10 grams of these article, boiled water is taken after mixing it with water, and 2 times on the one, each 10 grams.
Embodiment 5:
Prescription: Radix Astragali 330g, Arillus Longan 165g, Radix Angelicae Sinensis 66g, Colla Corii Asini 41.25g, Ferrous gluconate 4.62g, brown sugar (Saccharum Sinensis Roxb.) 110g.
Method for making: the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis are got in (1), add 10 times of water gagings and soak 1.5 hours, and water decocts 2 times; Each 3 hours, filter merging filtrate; Under 65 ℃ of conditions, be evaporated to relative density and be 1.15 thick paste, adding ethanol then is 45% to containing the alcohol amount, hold over night; Filter, filtrate recycling ethanol continues to be concentrated into relative density under 65 ℃ of conditions and is 1.25 thick paste;
(2) Colla Corii Asini adds in the 150ml water, in 65 ℃ of moltens;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in the 220ml water, fully dissolving, and the Colla Corii Asini solution with molten adds in the thick paste of step (1) then; Fully mix, add the microcrystalline Cellulose of total formulation weight amount 11% then, 1% magnesium stearate; Mix homogeneously 60-70 ℃ of drying, is processed granule; Drying incapsulates, and promptly gets 1000 of capsules.Every dress of these article 0.4g, oral, every day 3 times, each 4.
Embodiment 6:
Prescription: Radix Astragali 330g, Arillus Longan 165g, Radix Angelicae Sinensis 48g, Colla Corii Asini 45g, Ferrous gluconate 4.62g, brown sugar (Saccharum Sinensis Roxb.) 90g.
Method for making: the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis are got in (1), add 9 times of water gagings and soak 1 hour, and water decocts 3 times; Each 2 hours, filter merging filtrate; Under 75 ℃ of conditions, be evaporated to relative density and be 1.20 thick paste, adding ethanol then is 40% to containing the alcohol amount, hold over night; Filter, filtrate recycling ethanol continues to be concentrated into relative density under 75 ℃ of conditions and is 1.25 thick paste;
(2) Colla Corii Asini adds in the 200ml water, in 60 ℃ of moltens;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in the 200ml water, fully dissolving, and the Colla Corii Asini solution with molten adds in the thick paste of step (1) then; Fully mix, add the microcrystalline Cellulose of total formulation weight amount 9% then, 2% magnesium stearate; Mix homogeneously 60-70 ℃ of drying, is processed granule; Drying incapsulates, and promptly gets 1000 of capsules.Every dress of these article 0.4g, oral, every day 3 times, each 4.
Claims (8)
1. drug combination preparation of treating nutritional anemia, it is characterized in that: calculate according to composition by weight: it is to be prepared from following raw materials by weight proportions and suitable adjuvant:
Radix Astragali 240-360 part, Arillus Longan 120-180 part, Radix Angelicae Sinensis 48-72 part, Colla Corii Asini 30-45 part, Ferrous gluconate 3.36-5.04 part, brown sugar (Saccharum Sinensis Roxb.) 80-120 part.
2. according to the drug combination preparation of the described treatment nutritional anemia of claim 1, it is characterized in that: the weight proportion of its crude drug can be adopted as:
Radix Astragali 270-330 part, Arillus Longan 135-165 part, Radix Angelicae Sinensis 54-66 part, Colla Corii Asini 33.75-41.25 part, Ferrous gluconate 3.78-4.62 part, brown sugar (Saccharum Sinensis Roxb.) 90-110 part.
3. according to the drug combination preparation of claim 1 or 2 arbitrary described treatment nutritional anemias, it is characterized in that: said preparation is oral liquid, granule and capsule.
4. according to the drug combination preparation of the described treatment nutritional anemia of claim 3, it is characterized in that: said preparation is an oral liquid.
5. like the drug combination preparation of claim 1 or 2 arbitrary described treatment nutritional anemias, it is characterized in that:
Method for preparing is: the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis are got in (1), add 5-12 times of water gaging and soak 0.5-2 hour, and water decocts 1-4 time; Each 1-4 hour, filter merging filtrate; Under 50-80 ℃ of condition, be evaporated to the thick paste that relative density is 1.05-1.20, add ethanol then and be 30%-50%, hold over night to containing the alcohol amount; Filter, filtrate recycling ethanol continues to be concentrated into that relative density is the thick paste of 1.15-1.25 under the 50-80 ℃ of condition;
(2) Colla Corii Asini adds in the 100-200ml water, in 50-70 ℃ of molten;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in the 150-250ml water, fully dissolving, and the Colla Corii Asini solution with molten adds in the thick paste of step (1) then, adds suitable adjuvant, is prepared into the preparation formulation that needs with conventional method.
6. according to the drug combination preparation of the described treatment nutritional anemia of claim 5, it is characterized in that:
Technology when processing oral liquid is:
(1) get the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 5-12 times of water gaging and soaked 0.5-2 hour, water decocts 1-4 time; Each 1-4 hour, filter merging filtrate; Under 50-80 ℃ of condition, be evaporated to the thick paste that relative density is 1.05-1.20, add ethanol then and be 30%-50%, hold over night to containing the alcohol amount; Filter, filtrate recycling ethanol continues to be concentrated into that relative density is the thick paste of 1.15-1.25 under the 50-80 ℃ of condition;
(2) with the thick paste that obtains in the step (1), add water to the 50%-60% of total amount, cold preservation 36-60 hour, it was subsequent use to get supernatant;
(3) Colla Corii Asini adds in the 100-200ml water, in 50-70 ℃ of molten;
(4) get recipe quantity Ferrous gluconate, brown sugar (Saccharum Sinensis Roxb.), the sodium benzoate of 1-4 weight portion adds in the 150-250ml water, fully dissolves subsequent use;
(5) the Colla Corii Asini solution with molten mixes with above-mentioned each solution, boils, and adds water to total amount, and sterilization is filtered, and fill promptly gets oral liquid.
7. according to the drug combination preparation of the described treatment nutritional anemia of claim 5, it is characterized in that: the technology when processing granule is:
(1) get the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 5-12 times of water gaging and soaked 0.5-2 hour, water decocts 1-4 time; Each 1-4 hour, filter merging filtrate; Under 50-80 ℃ of condition, be evaporated to the thick paste that relative density is 1.05-1.20, add ethanol then and be 30%-50%, hold over night to containing the alcohol amount; Filter, filtrate recycling ethanol continues to be concentrated into that relative density is the thick paste of 1.15-1.25 under the 50-80 ℃ of condition;
(2) Colla Corii Asini adds in the 100-200ml water, in 50-70 ℃ of molten;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in the 150-250ml water, fully dissolving, and the Colla Corii Asini solution with molten adds in the thick paste of step (1) then; Fully mix, add the dextrin of total formulation weight amount 10%-20% then, mix homogeneously; Drying, granulate, packing promptly gets granule.
8. according to the drug combination preparation of the described treatment nutritional anemia of claim 5, it is characterized in that: the technology when processing capsule is:
(1) get the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 5-12 times of water gaging and soaked 0.5-2 hour, water decocts 1-4 time; Each 1-4 hour, filter merging filtrate; Under 50-80 ℃ of condition, be evaporated to the thick paste that relative density is 1.05-1.20, add ethanol then and be 30%-50%, hold over night to containing the alcohol amount; Filter, filtrate recycling ethanol continues to be concentrated into that relative density is the thick paste of 1.15-1.25 under the 50-80 ℃ of condition;
(2) Colla Corii Asini adds in the 100-200ml water, in 50-70 ℃ of molten;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in the 150-250ml water, fully dissolving, and the Colla Corii Asini solution with molten adds in the thick paste of step (1) then; Fully mix, add the microcrystalline Cellulose of total formulation weight amount 9%-11% then, the magnesium stearate of 1%-2%; Mix homogeneously 60-70 ℃ of drying, is processed granule; Drying incapsulates, and promptly gets capsule.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103230007A (en) * | 2013-05-03 | 2013-08-07 | 高益槐 | Health food with function of improving nutritional anemia and preparation method thereof |
| CN107638467A (en) * | 2017-10-12 | 2018-01-30 | 安徽亳药千草国药股份有限公司 | It is a kind of that there is Chinese medicinal granule for improving alimentary anemia function and preparation method thereof |
| CN107693802A (en) * | 2017-10-12 | 2018-02-16 | 安徽亳药千草国药股份有限公司 | It is a kind of to verify the method with the composition validity for improving alimentary anemia function |
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| CN101152005A (en) * | 2006-09-27 | 2008-04-02 | 上海水产大学 | A convenient medicated food bag with blood-enriching effect and manufacturing method thereof |
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| CN101152005A (en) * | 2006-09-27 | 2008-04-02 | 上海水产大学 | A convenient medicated food bag with blood-enriching effect and manufacturing method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103230007A (en) * | 2013-05-03 | 2013-08-07 | 高益槐 | Health food with function of improving nutritional anemia and preparation method thereof |
| CN107638467A (en) * | 2017-10-12 | 2018-01-30 | 安徽亳药千草国药股份有限公司 | It is a kind of that there is Chinese medicinal granule for improving alimentary anemia function and preparation method thereof |
| CN107693802A (en) * | 2017-10-12 | 2018-02-16 | 安徽亳药千草国药股份有限公司 | It is a kind of to verify the method with the composition validity for improving alimentary anemia function |
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