CN102784230B - Pharmaceutical composition preparation for treating nutritional anemia - Google Patents

Pharmaceutical composition preparation for treating nutritional anemia Download PDF

Info

Publication number
CN102784230B
CN102784230B CN201110131335.3A CN201110131335A CN102784230B CN 102784230 B CN102784230 B CN 102784230B CN 201110131335 A CN201110131335 A CN 201110131335A CN 102784230 B CN102784230 B CN 102784230B
Authority
CN
China
Prior art keywords
water
add
thick paste
corii asini
colla corii
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CN201110131335.3A
Other languages
Chinese (zh)
Other versions
CN102784230A (en
Inventor
窦啟玲
安崇惠
林瑶
朱亭潘
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Guizhou Yibai Pharmaceutical Co Ltd
Original Assignee
Guizhou Yibai Pharmaceutical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Guizhou Yibai Pharmaceutical Co Ltd filed Critical Guizhou Yibai Pharmaceutical Co Ltd
Priority to CN201110131335.3A priority Critical patent/CN102784230B/en
Publication of CN102784230A publication Critical patent/CN102784230A/en
Application granted granted Critical
Publication of CN102784230B publication Critical patent/CN102784230B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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

A kind of drug combination preparation for the treatment of nutritional anemia
Technical field: the present invention relates to a kind of drug combination preparation for the treatment of nutritional anemia, belong to the technical field of medicine and health food.
Technical background: add up according to World Health Organization (WHO): approximately there is 3,000,000,000 people anemia in various degree in the whole world, causes that because suffering from anemia the dead number of various diseases is up to ten million every year.The population probability of middle national trouble anemia is higher than western countries, and in suffering from the crowd of anemia, women is apparently higher than male, and old man and child are higher than the young and the middle aged.
Nutritional anemia refers to because of the necessary nutrient substance of body hemopoietic, as the materials such as ferrum, folic acid, dimension biogen D reduce relatively or utterly, makes the formation of hemoglobin or erythrocytic generation not enough, so that the low a kind of disease of hemopoietic function.The poor patient of absorption of nutrient ingredients due to the diseases such as the infant that is mainly in 6 months to 2 years old, trimester of pregnancy or 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 serum ferritin lowers, and now there is no anemia, if iron deficiency further increases the weight of, stores iron loss to the greatest extent, and serum ferritin and serum levels of iron decline, and total iron binding capacity increases, and occurs iron deficiency anemia; And megaloblastic anemia, mainly due to vitamin B12 Deficiency of Intake, absorb and utilize the reasons such as obstacle and the increase of hemopoietic material demand amount to cause; Chinese medicine belongs to primary disease the 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.Blood deficiency the five internal organs lose supports, and just can occur the diseases such as deficiency of heart-blood, both liver and kidney deficiency.Common sympton is that primary disease onset is slower, and the lighter shows as skin, mucosal pallor or greenish yellow, more obvious with positions such as lip, dental bed, eyelid, fingernails.Serious anemia is dizzy as seen, malaise, and dysphoria, inappetence etc., often with malnutrition.Anemia is excessively of a specified duration, can cause dysplasia.
In the process of clinical treatment nutritional anemia, doctor trained in Western medicine directly adopts oral or injection iron in treatment iron deficiency anemia, and patient Chang Yin is to the malabsorption of ferrum and serious gastrointestinal reaction and therapy discontinued; Or adopt vitamin B12 and folic acid drug combination to add again ascorbic therapy for treating megaloblastic anemia, but onset is slower, long action time, and nervous system recovers slower.The traditional Chinese medical science be take dialectical treating as 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 object 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 preparation method of said composition preparation.
The drug combination preparation for the treatment of 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 object for the treatment of nutritional anemia.
The drug combination preparation for the treatment of nutritional anemia provided by the invention is to be prepared from by the crude drug of following weight proportioning 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 forming at above-mentioned raw materials medicine, 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 soak 0.5-2 hour, water decocts 1-4 time, each 1-4 hour, filter, merging filtrate is evaporated to the thick paste that relative density is 1.05-1.20 under 50-80 ℃ of condition, and then adding ethanol is 30%-50% to containing alcohol amount, standing over night, filter, filtrate recycling ethanol, continues to be concentrated into the thick paste that under 50-80 ℃ of condition, relative density is 1.15-1.25;
(2) Colla Corii Asini adds in 100-200ml water, in 50-70 ℃ of molten;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in 150-250ml water, fully dissolve, and then add in the thick paste of step (1) with together with the Colla Corii Asini solution of molten, add suitable adjuvant, are prepared into the preparation formulation needing by conventional method.
Preparation of the present invention can be oral liquid, granule and capsule, is preferably oral liquid.
Technique when the present invention makes oral liquid is:
(1) get the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 5-12 times of water gaging and soak 0.5-2 hour, water decocts 1-4 time, each 1-4 hour, filter, merging filtrate is evaporated to the thick paste that relative density is 1.05-1.20 under 50-80 ℃ of condition, and then adding ethanol is 30%-50% to containing alcohol amount, standing over night, filter, filtrate recycling ethanol, continues to be concentrated into the thick paste that under 50-80 ℃ of condition, relative density is 1.15-1.25;
(2) by the thick paste obtaining in step (1), add water to the 50%-60% of total amount, cold good 36-60 hour, gets supernatant standby;
(3) Colla Corii Asini adds in 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 150-250ml water, fully dissolves standby;
(5) the Colla Corii Asini solution of molten is mixed with above-mentioned each solution, boil, add water to total amount, sterilizing, filters, and fill, obtains oral liquid.
Technique during granulation agent of the present invention is:
(1) get the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 5-12 times of water gaging and soak 0.5-2 hour, water decocts 1-4 time, each 1-4 hour, filter, merging filtrate is evaporated to the thick paste that relative density is 1.05-1.20 under 50-80 ℃ of condition, and then adding ethanol is 30%-50% to containing alcohol amount, standing over night, filter, filtrate recycling ethanol, continues to be concentrated into the thick paste that under 50-80 ℃ of condition, relative density is 1.15-1.25;
(2) Colla Corii Asini adds in 100-200ml water, in 50-70 ℃ of molten;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in 150-250ml water, fully dissolve, then add in the thick paste of step (1) with together with the Colla Corii Asini solution of molten, fully mix, then the dextrin that adds total formulation weight amount 10%-20%, mix homogeneously, dry, granulate, packs and obtains granule.
Technique when the present invention makes capsule is:
(1) get the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 5-12 times of water gaging and soak 0.5-2 hour, water decocts 1-4 time, each 1-4 hour, filter, merging filtrate is evaporated to the thick paste that relative density is 1.05-1.20 under 50-80 ℃ of condition, and then adding ethanol is 30%-50% to containing alcohol amount, standing over night, filter, filtrate recycling ethanol, continues to be concentrated into the thick paste that under 50-80 ℃ of condition, relative density is 1.15-1.25;
(2) Colla Corii Asini adds in 100-200ml water, in 50-70 ℃ of molten;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in 150-250ml water, fully dissolve, then add in the thick paste of step (1) with together with the Colla Corii Asini solution of molten, fully mix, then the microcrystalline Cellulose that adds total formulation weight amount 9%-11%, the magnesium stearate of 1%-2%, mix homogeneously, dry at 60-70 ℃, granulation, dry, incapsulate, obtain 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 for the treatment of 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, Milkvetch Root is mainly containing saponins, flavone and glycoside and polysaccharide composition.Pharmacological research shows, the Radix Astragali has significant antioxidation, remove the ability of free radical, can also improve the immunologic function of body, in addition, the Radix Astragali can reduce the T-CHOL in the generation of cytolipin peroxide and blood plasma, anticoagulant, reduction blood viscosity and coagulability, improve blood circulation, there is in addition many-sided pharmacological actions such as antiviral.
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.There is reinforcing the heart spleen, replenishing QI and blood effect.Main containing 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, the antibacterial effect such as anticancer, can 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, pungent.Having enriches blood invigorates blood circulation, pain relieving intestine moistening effect.Main containing volatile oil, also have in addition aminoacid in multiple polysaccharide, 13, phospholipid, 23 kinds of inorganic elementss (wherein 16 in be human body institute essential component), vitamin etc.Pharmacological action show Radix Angelicae Sinensis have resist myocardial ischemia, arrhythmia, blood fat reducing and promote hemopoietic function, strengthen immunologic function, the 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, the concentrated solid gum of making, sweet in the mouth, property are flat, return lung, liver, kidney channel, have the YIN nourishing of enriching blood, and moisturize the effect of hemostasis.Colla Corii Asini is called " panacea of enriching blood " by successive dynasties physician, with Radix Ginseng, Cornu Cervi Pantotrichum title " Chinese medicine three essentials-essence ", modern medicine study confirms, Colla Corii Asini is mainly comprised of collagen protein, after hydrolysis, can be divided into tens of seed amino acids, also contain aminopolysaccharide, as 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, except promoting the hemopoietic function of body, can also provide the raw material of hemopoietic, so have, has powerful blood nourishing function.Colla Corii Asini not only can be enriched blood by hemopoietic, can also be by improving solidifying of hematoblastic content and collagen protein in blood, promotion blood, to reach the object of hemostasis.
The Ferrous gluconate that the present invention is used, it is organic ferrous salt, odorless, tasteless, water-soluble easy absorption, curative effect and ferrous sulfate are suitable, but the latter is large to the zest of stomach, the side effect such as easily cause constipation, vomiting, feel sick, and Ferrous gluconate does not have zest to stomach, it is a kind of comparatively desirable organic iron supplement agent.
The brown sugar (Saccharum Sinensis Roxb.) that the present invention is used, with sweet Caulis Sacchari sinensis commerieal sugar, a kind of for brown sugar, almost retain the whole compositions in sugarcane juice, except possessing sugared function, also contained vitamin and trace element, as ferrum, zinc, manganese, chromium etc., 90 milligrams of every 100 grams of brown sugar calcics, 4 milligrams of iron content, also contain a small amount of riboflavin and carotene.The traditional Chinese medical science is thought: brown sugar is warm in nature, sweet in the mouth, enter spleen, have vigorate qi and replenish the blood, 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.) vigorate qi and replenish the blood, 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 and protects the intestines and stomach simultaneously as organic iron supplement agent.Therefore the present invention treats the drug combination preparation of nutritional anemia and 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 materials and method:
1.1.1 medicine and study subject:
Medicine: oral liquid of the present invention: the oral liquid being prepared into according to the preparation method of the embodiment of the present invention 1,20ml/ bottle, recommends consumption for adult every day 2 times, and each 1, the per kilogram of body weight 0.667ml that is equivalent to be grown up (with 60kg weighing machine).
Animal: male ablactation Wistar rat, 60~90g; By Guiyang Medical College, provided.
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, raise low iron base feedstuff, consumption 3 weeks, cause nutritional anemia animal model, through tail venous blood sampling, Measuring hemoglobin content, when content of hemoglobin is during lower than 100g/L, by content of hemoglobin, rat is divided into iron deficiency matched group at random and (raises low iron base feedstuff, gavage 2.0ml deionized water) and oral liquid of the present invention low, in, high dose group (is raised low iron base feedstuff, every day, gavage gave respectively oral liquid 3.35 of the present invention, 6.67, 20.0ml/kg, be equivalent to respectively 5 of the recommended amounts of being grown up, 10, 30 times) totally 4 groups, every group 10, successive administration 4 weeks.When experiment finishes, use etherization rat, after abdominal aortic blood, win liver and spleen, put-30 ℃ of refrigerators standby.
1.1.4 Biochemical Indexes
1.1.4.1 hemoglobin (Hb) adopts HemoCue Measuring hemoglobin content, with 10 μ l quantitative capillary tubes, get rat tail blood, put into the plastic tube that fills 2.5ml high-potassium ferricyanide reagent, fully vibration, make the complete stripping of blood, lucifuge is placed after 15min, measures, simultaneously Measuring hemoglobin standard and primary standard substance with Hemoglobin Meter.
1.1.4.2 packed cell volume (HCT) is got blood with 9 μ l quantitative capillary tubes, and one end is sealed with plasticine, adopts hematocrit measurement instrument to measure, and reading result after 2min is measured basis reference blood sample simultaneously.
1.1.4.3 free erythrocyte protoporphyrin (FEP), by droplets of whole blood on special filter paper, deposits 4 ℃ of refrigerators standby (time is no more than 2 months) in after to be dried.During mensuration, with card punch, will squeeze in teat glass with the filter paper of drop of blood, add 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, vibrate centrifugal, take off a layer liquid fluorescent spectrophotometer assay.
1.1.4.4 in liver, spleen tissue, ferrum is got about 0.2g tissue and is put into the teat glass through hydrochloric acid dry cleansing, add nitric acid: perchloric acid (4: 1) mixed acid 2ml, after digestion, with deionized water, be settled to 5ml or 10ml, adopt flame atomization to measure iron content in tissue, each mensuration with Hepar Bovis seu Bubali powder (NBS1577a of NBS) as Quality Control material.
1.1.5 in the content of hemoglobin of result decision method oral liquid group of the present invention rat, packed cell volume, FEP, liver and spleen iron content, any 2 indexs are better than iron deficiency matched group (FEP is lower than iron deficiency matched group) (P < 0.05), can judge that this tested material has the effect that improves rat nutritional anemia.
1.1.6 statistical procedures adopts t check to compare data, inspection level α=0.05.
1.2 result
1.2.1 respectively organize rat hemoglobin content (Hb), packed cell volume (HCT), before the comparative experiments of erythrocyte FEP content, respectively organize the Hb content of rat, packed cell volume, erythrocyte FEP content difference not statistically significant (P > 0.05), the Hb content of each dosage group rat of oral liquid of the present invention after experiment, packed cell volume is all significantly higher than iron deficiency matched group (P < 0.05), erythrocyte FEP content is significantly lower than iron deficiency matched group (P < 0.05), and in oral liquid of the present invention, the Hb content of high dose group rat, packed cell volume is all significantly higher than low dose group (P < 0.05), in Table 1.
Table 1 is respectively organized the comparison (x ± s) of rat hemoglobin content, packed cell volume, erythrocyte FEP content
Note: compare * P < 0.05 with 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 spleen, in the liver of the rear middle and high dosage group of the oral liquid of the present invention rat of experiment and spleen, iron content and total iron content are all significantly higher than iron deficiency matched group and low dose group (P < 0.05), in Table 2.
Table 2 is respectively organized the comparison (x ± s) of iron content in rat liver and spleen tissue
Note: with table 1
This experimental result shows, gavage gave 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 dosage group and value added are all significantly lower than iron deficiency matched group, supplementary copy invention oral liquid can obviously increase iron content in the liver of rat and spleen, and in, in the liver of high dose group rat and spleen, iron content is significantly higher than iron deficiency matched group, show that oral liquid of the present invention can improve the nutritional anemia of rat effectively, can be used as a kind of functional product that improves nutritional anemia applies, there is wide market prospect.
Experimental example 2: present composition preparation for treating improves infant nutrition anemia observation of curative effect
2.1 data and method
2.1.1 case selection: 215 routine patients, male 119 examples, female's 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 the primary disease persons such as nonjoinder chronic infectious disease and the heart, liver,kidney,spleen.215 routine infants are divided into treatment group and each 44 examples of matched group at random, make each group at equal no difference of science of statistics in aspect (P > 0.05) such as sex, age, nutriture, clinical manifestation, severity of anemia, there is comparability.
Inclusive criteria: meet the hematology of Pediatrics association and organize relevant " infant nutrition anemia " diagnostic criteria that national children hematopathy academic conference 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:
With reference to the 6th edition < < pediatrics > > and document, draft: (1) recovery from illness: after the course for the treatment of, it is normal that the indexs such as hemoglobin content, serum levels of iron total iron binding capacity are recovered, clinical symptom disappearance; (2) effective: clinical symptoms is clearly better, anemia Severity gradation transfers slightly (improving more than 2 grades) to by severe and reaches more than 50%; (3) effective: clinical symptoms take a favorable turn, anemia severity improves 1 grade and reaches more than 50%; (4) invalid: clinical symptoms and anemia Severity gradation are without improvement.Obvious effective rate is with recovery from illness+effective calculating.
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 put after dissolving in the appropriate warm water of people oral; Oral lysine B12 granule, 5-10g, 2 times/d.
Matched group 2: oral stilbene blood granule (Xi'an Jiao great Rui Xin pharmaceutcal corporation, Ltd), every day 3 times, each 1 bag, can directly put into after the meal after appropriate warm water dissolves and take.
Treatment group 1: the oral liquid that the embodiment of the present 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 present 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 present invention 5 prepares, every dress 0.4g, oral, every day 3 times, each 4, children's reduces by half.
Observation index is 8 weeks the course for the treatment of, the case of including observation in respectively before smelting is treated, detect the value of hemoglobin (Hb), RBC number (Rbc), serum ferritin (SF), total iron binding capacity (TLBC) course for the treatment of after finishing.
2.1.4 statistical method: adopt t check and x 2check
2.2 result
2.2.1 the variation of Hb, RBC, SF, TIBC before and after each group treatment, in Table 3.
The variation of Hb, RBC, SF, TIBC before and after each group treatment of table 3
Note: with the front relatively * P for the treatment of < 0.01; With matched group comparison, * * P < 0.05
2.2.2 respectively organize infant Clinical efficacy comparison, in Table 4.
Table 4 is respectively organized infant Clinical efficacy comparison
Group Number of cases Recovery from illness Effective 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
With matched group comparison, * P < 0.05
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 aspect infant nutrition anemia and all have good result, and its curative effect is better than applying separately Western medicine or treatment by Chinese herbs.Show that the preparation that the present composition is made is being feasible aspect treatment nutritional anemia especially infant nutrition anemia.
Two, technical study
Experimental example 3: the research of medicinal material extract technique
Medical material soak time, extracts the addition of solvent, and extraction time and number of times are the principal elements that affect extraction process, and take glycyrrhizic acid content and total solid yield is index, above parameter is investigated to preferred optimum process condition.
The investigation of 5.1 soak times
Take 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, until medicinal residues weight no longer changes, can be judged as medical material and no longer absorb water, and writing time, is calculated as follows water absorption rate, the results are shown in following table.
Medical material is in the water absorption of each time
Result of the test shows: medical material soaks substantially no longer water suction after 1 hour, and water absorption rate is 120.4%, therefore soaked 0.5-2 hour before decocting.
The investigation of 5.2 extraction times
Sample preparation: aforementioned three kinds of medical materials are total to 510g, soak and decoct after 2 hours, decoct altogether five times, each 2 hours, collect respectively each decocting liquid, filter.Take Astragaloside content and total solid yield is index, investigates the impact of extraction time.The results are shown in following table.
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 table, while extracting four times, astragaloside and other materials have almost extracted completely, therefore determine that extraction time is 1-4 time, wherein extract 3 times for optimised process, and less expensive is reasonable.
5.3 extraction times were investigated
Take three kinds of medical materials 510g altogether, totally 6 parts, equal amount of water decocts respectively 0.5,1,1.5,2,3,4 hour, filters, and is settled to certain volume, sampling and measuring Astragaloside content and total solid yield.The results are shown in following table.
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
The known extraction of upper table is after 3 hours, and Astragaloside content and total solid yield substantially no longer change, and illustrates and extracts after 3 hours, and the stripping of astragaloside and other materials is tending towards saturation.Therefore determine that extraction time is 1-4 hour, wherein extract 2 hours for best.
5.4 extract amount of water investigates
Sample preparation: take three kinds of medical materials 510g altogether, totally 3 parts, according to lower surface condition, add the different water yields, decoct 3 times, each 2 hours, filter, collect respectively filtrate, measure glycyrrhizic acid content and total solid yield.The results are shown in following table.
Amount of water-Astragaloside content, total solid yield table
Amount of water is 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
12 1.30 31.3
15 1.33 32.1
When extracting water yield increasing, the not larger 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 as the best.
5.5 extraction process checkings
Sample preparation: take three kinds of medical materials of recipe quantity, totally three parts, add the water soaking 1 hour of 10 times of amounts, then water boiling and extraction is 3 times, each 2 hours, filters merging filtrate.Measure Astragaloside content and total solid yield.The results are shown in following table.
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, astragaloside average content is 1.263mg/g medical material.RSD is 1.21%, and average total solid yield is that 31.2, RSD is 0.98%, proves that this process stabilizing is feasible, 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 rapidly the symptom of the nutritional anemias such as iron deficiency anemia and megaloblastic anemia; The dosage forms such as the oral liquid simultaneously providing, 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 object 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: (1) gets the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 10 times of water gagings and soak 1 hour, water decocts 3 times, each 2 hours, filter, merging filtrate is evaporated to the thick paste that relative density is 1.10-1.15 under 60 ℃ of conditions, and then adding ethanol is 40% to containing alcohol amount, standing over night, filter, filtrate recycling ethanol, continues to be concentrated into the thick paste that under 60 ℃ of conditions, relative density is 1.15-1.20;
(2) by the thick paste obtaining in step (1), add water to 60% of total amount, cold preservation 48 hours, gets supernatant standby;
(3) Colla Corii Asini adds in 200ml water, in 60 ℃ of moltens;
(4) get Ferrous gluconate, brown sugar (Saccharum Sinensis Roxb.), 2g sodium benzoate adds in 200ml water, fully dissolves standby;
(5) the Colla Corii Asini solution of molten is mixed with above-mentioned each solution, boil, add water to total amount 2000ml, sterilizing, filters, and fill, obtains 100 of oral liquids.Every 20ml of this product, 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: (1) gets the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 8 times of water gagings and soak 2 hours, water decocts 2 times, each 3 hours, filter, merging filtrate is evaporated to relative density and is 1.05 thick paste under 80 ℃ of conditions, then adds ethanol to being 50% containing alcohol amount, standing over night, filter, filtrate recycling ethanol, continues to be concentrated into the thick paste that under 80 ℃ of conditions, relative density is 1.15;
(2) by the thick paste obtaining in step (1), add water to 50% of total amount, cold preservation 36 hours, gets supernatant standby;
(3) Colla Corii Asini adds in 100ml water, in 70 ℃ of moltens;
(4) get recipe quantity Ferrous gluconate, brown sugar (Saccharum Sinensis Roxb.), 4g sodium benzoate adds in 250ml water, fully dissolves standby;
(5) the Colla Corii Asini solution of molten is mixed with above-mentioned each solution, boil, add water to total amount 2000ml, sterilizing, filters, and fill, obtains 100 of oral liquids.Every 20ml of this product, 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: (1) gets the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, adding 5 times of water gagings soaks 2 hours, water decocts 4 hours, filters merging filtrate, under 50 ℃ of conditions, be evaporated to relative density and be 1.15 thick paste, then add ethanol to being 30% containing alcohol amount, standing over night, filters, filtrate recycling ethanol, continues to be concentrated into the thick paste that under 50 ℃ of conditions, relative density is 1.20;
(2) Colla Corii Asini adds in 150ml water, in 50 ℃ of moltens;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in 150ml water, fully dissolve, and then add in the thick paste of step (1) with together with the Colla Corii Asini solution of molten, fully mix, then add the dextrin of total formulation weight amount 10%, mix homogeneously, dry, granulate, packs and obtains 1000 grams of granules.Every packed 10 grams of this product, 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: (1) gets the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 12 times of water gagings and soak 0.5 hour, water decocts 4 times, each 1 hour, filter, merging filtrate is evaporated to relative density and is 1.10 thick paste under 70 ℃ of conditions, then adds ethanol to being 35% containing alcohol amount, standing over night, filter, filtrate recycling ethanol, continues to be concentrated into the thick paste that under 70 ℃ of conditions, relative density is 1.15;
(2) Colla Corii Asini adds in 100ml water, in 55 ℃ of moltens;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in 180ml water, fully dissolve, and then add in the thick paste of step (1) with together with the Colla Corii Asini solution of molten, fully mix, then add the dextrin of total formulation weight amount 20%, mix homogeneously, dry, granulate, packs and obtains 1000 grams of granules.Every packed 10 grams of this product, 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: (1) gets the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 10 times of water gagings and soak 1.5 hours, water decocts 2 times, each 3 hours, filter, merging filtrate is evaporated to relative density and is 1.15 thick paste under 65 ℃ of conditions, then adds ethanol to being 45% containing alcohol amount, standing over night, filter, filtrate recycling ethanol, continues to be concentrated into the thick paste that under 65 ℃ of conditions, relative density is 1.25;
(2) Colla Corii Asini adds in 150ml water, in 65 ℃ of moltens;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in 220ml water, fully dissolve, then add in the thick paste of step (1) with together with the Colla Corii Asini solution of molten, fully mix, then the microcrystalline Cellulose that adds total formulation weight amount 11%, 1% magnesium stearate, mix homogeneously, dry at 60-70 ℃, granulation, dry, incapsulate, obtain 1000 of capsules.Every dress 0.4g of this product, 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: (1) gets the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 9 times of water gagings and soak 1 hour, water decocts 3 times, each 2 hours, filter, merging filtrate is evaporated to relative density and is 1.20 thick paste under 75 ℃ of conditions, then adds ethanol to being 40% containing alcohol amount, standing over night, filter, filtrate recycling ethanol, continues to be concentrated into the thick paste that under 75 ℃ of conditions, relative density is 1.25;
(2) Colla Corii Asini adds in 200ml water, in 60 ℃ of moltens;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in 200ml water, fully dissolve, then add in the thick paste of step (1) with together with the Colla Corii Asini solution of molten, fully mix, then the microcrystalline Cellulose that adds total formulation weight amount 9%, 2% magnesium stearate, mix homogeneously, dry at 60-70 ℃, granulation, dry, incapsulate, obtain 1000 of capsules.Every dress 0.4g of this product, oral, every day 3 times, each 4.

Claims (7)

1. a drug combination preparation for the treatment of nutritional anemia, is characterized in that: according to composition by weight, calculate: it is to be prepared from by the crude drug of following weight proportioning 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;
Preparation method is: (1) gets the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 5-12 times of water gaging and soak 0.5-2 hour, water decocts 1-4 time, each 1-4 hour, filter, merging filtrate is evaporated to the thick paste that relative density is 1.05-1.20 under 50-80 ℃ of condition, and then adding ethanol is 30%-50% to containing alcohol amount, standing over night, filter, filtrate recycling ethanol, continues to be concentrated into the thick paste that under 50-80 ℃ of condition, relative density is 1.15-1.25;
(2) Colla Corii Asini adds in 100-200ml water, in 50-70 ℃ of molten;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in 150-250ml water, fully dissolve, and then add in the thick paste of step (1) with together with the Colla Corii Asini solution of molten, add suitable adjuvant, are prepared into the preparation formulation needing by conventional method.
2. according to the drug combination preparation for the treatment of nutritional anemia claimed in claim 1, it is characterized in that: the weight proportion of its crude drug is:
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 the arbitrary described treatment nutritional anemia of claim 1 or 2, it is characterized in that: described preparation is oral liquid, granule and capsule.
4. according to the drug combination preparation for the treatment of nutritional anemia claimed in claim 3, it is characterized in that: described preparation is oral liquid.
5. according to the drug combination preparation for the treatment of nutritional anemia claimed in claim 1, it is characterized in that:
Technique while making oral liquid is:
(1) get the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 5-12 times of water gaging and soak 0.5-2 hour, water decocts 1-4 time, each 1-4 hour, filter, merging filtrate is evaporated to the thick paste that relative density is 1.05-1.20 under 50-80 ℃ of condition, and then adding ethanol is 30%-50% to containing alcohol amount, standing over night, filter, filtrate recycling ethanol, continues to be concentrated into the thick paste that under 50-80 ℃ of condition, relative density is 1.15-1.25;
(2) by the thick paste obtaining in step (1), add water to the 50%-60% of total amount, cold preservation 36-60 hour, gets supernatant standby;
(3) Colla Corii Asini adds in 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 150-250ml water, fully dissolves standby;
(5) the Colla Corii Asini solution of molten is mixed with above-mentioned each solution, boil, add water to total amount, sterilizing, filters, and fill, obtains oral liquid.
6. according to the drug combination preparation for the treatment of nutritional anemia claimed in claim 1, it is characterized in that: technique during granulation agent is:
(1) get the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 5-12 times of water gaging and soak 0.5-2 hour, water decocts 1-4 time, each 1-4 hour, filter, merging filtrate is evaporated to the thick paste that relative density is 1.05-1.20 under 50-80 ℃ of condition, and then adding ethanol is 30%-50% to containing alcohol amount, standing over night, filter, filtrate recycling ethanol, continues to be concentrated into the thick paste that under 50-80 ℃ of condition, relative density is 1.15-1.25;
(2) Colla Corii Asini adds in 100-200ml water, in 50-70 ℃ of molten;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in 150-250m1 water, fully dissolve, then add in the thick paste of step (1) with together with the Colla Corii Asini solution of molten, fully mix, then the dextrin that adds total formulation weight amount 10%-20%, mix homogeneously, dry, granulate, packs and obtains granule.
7. according to the drug combination preparation for the treatment of nutritional anemia claimed in claim 1, it is characterized in that: the technique while making capsule is:
(1) get the Radix Astragali, Arillus Longan, Radix Angelicae Sinensis, add 5-12 times of water gaging and soak 0.5-2 hour, water decocts 1-4 time, each 1-4 hour, filter, merging filtrate is evaporated to the thick paste that relative density is 1.05-1.20 under 50-80 ℃ of condition, and then adding ethanol is 30%-50% to containing alcohol amount, standing over night, filter, filtrate recycling ethanol, continues to be concentrated into the thick paste that under 50-80 ℃ of condition, relative density is 1.15-1.25;
(2) Colla Corii Asini adds in 100-200ml water, in 50-70 ℃ of molten;
(3) brown sugar (Saccharum Sinensis Roxb.), Ferrous gluconate add in 150-250ml water, fully dissolve, then add in the thick paste of step (1) with together with the Colla Corii Asini solution of molten, fully mix, then the microcrystalline Cellulose that adds total formulation weight amount 9%-11%, the magnesium stearate of 1%-2%, mix homogeneously, dry at 60-70 ℃, granulation, dry, incapsulate, obtain capsule.
CN201110131335.3A 2011-05-20 2011-05-20 Pharmaceutical composition preparation for treating nutritional anemia Active CN102784230B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201110131335.3A CN102784230B (en) 2011-05-20 2011-05-20 Pharmaceutical composition preparation for treating nutritional anemia

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201110131335.3A CN102784230B (en) 2011-05-20 2011-05-20 Pharmaceutical composition preparation for treating nutritional anemia

Publications (2)

Publication Number Publication Date
CN102784230A CN102784230A (en) 2012-11-21
CN102784230B true CN102784230B (en) 2014-09-24

Family

ID=47149949

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201110131335.3A Active CN102784230B (en) 2011-05-20 2011-05-20 Pharmaceutical composition preparation for treating nutritional anemia

Country Status (1)

Country Link
CN (1) CN102784230B (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103230007B (en) * 2013-05-03 2014-04-09 高益槐 Health food with function of improving nutritional anemia 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
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

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101152005A (en) * 2006-09-27 2008-04-02 上海水产大学 Convenient medicinal food package with nourishing blood function and producing method of the same

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101152005A (en) * 2006-09-27 2008-04-02 上海水产大学 Convenient medicinal food package with nourishing blood function and producing method of the same

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
中西医结合治疗小儿缺铁性贫血77例观察;秦春优;《甘肃中医》;20070128;第20卷(第01期);29-30 *
秦春优.中西医结合治疗小儿缺铁性贫血77例观察.《甘肃中医》.2007,第20卷(第01期),29-30.

Also Published As

Publication number Publication date
CN102784230A (en) 2012-11-21

Similar Documents

Publication Publication Date Title
CN103877263B (en) A kind of antifatigue health preparation of the compound Chinese medicine such as red ginseng, maca, green-tea extract (theanine)
CN103285231A (en) Medicine composition for diabetes adjunctive therapy and preparation method thereof
CN102293927B (en) Compound Chinese medicinal preparation with antifatigue and antioxidation effects, and preparation method thereof
CN111035649A (en) NMN + GLP compound nutritional supplement and preparation method and application thereof
CN112972547A (en) Traditional Chinese medicine composition for treating qi-blood deficiency syndrome and preparation method and application thereof
CN107853517B (en) Traditional Chinese medicine beverage capable of refreshing and resisting fatigue and preparation method thereof
CN107006856A (en) One kind enhancing endurance, raising anti anoxia tolerance nutritional agents and preparation method thereof
CN104857154A (en) Traditional Chinese medicine composition for treating three-high diseases and preparation method therefor
CN102784230B (en) Pharmaceutical composition preparation for treating nutritional anemia
CN101711840B (en) Medicine-food dual-purpose composition suitable for cancerous patients and preparation method thereof
CN103735937B (en) There is the medicine and health products promoting ferrous components to absorb and to enrich blood
CN102885975A (en) Traditional Chinese medicine composition for treating diabetes mellitus
CN103585479A (en) Blood-replenishing pill and blood-replenishing capsule for treating iron-deficiency anemia
CN102228620B (en) Chinese medicinal compound preparation having the functions of supplementing iron and enriching the blood and preparation method thereof
CN104547523A (en) Medicine for enhancing immunity and preparation method thereof
CN103719661B (en) Blood-enriching oral liquid health products
CN102949681B (en) Composition for preventing or treating colds, and its preparation method
CN103393938B (en) Traditional Chinese medicine composition for reducing blood sugar
CN103525640B (en) Energy-keeping yang-tonifying wine
CN102552677B (en) Coptis chinensis and radix rehmanniae Anxiao capsule and preparation method thereof
CN104587300A (en) Traditional Chinese medicine composition for treating acute leukemia and preparation method of traditional Chinese medicine composition
CN103751692B (en) Special invigorating capsule of a kind of Testis et penis callorhini and preparation method thereof
CN104000180A (en) Ginseng compound assisting in blood sugar level regulation and preparing method and application thereof
CN102579713B (en) Traditional Chinese medicine for treating children obesity and preparation method
CN110755523B (en) Composition for improving hyperglycemia and preparation method thereof

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
C14 Grant of patent or utility model
GR01 Patent grant