CN112641878A - Traditional Chinese medicine composition for treating anemia and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating anemia and preparation method thereof Download PDFInfo
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- CN112641878A CN112641878A CN202011463433.2A CN202011463433A CN112641878A CN 112641878 A CN112641878 A CN 112641878A CN 202011463433 A CN202011463433 A CN 202011463433A CN 112641878 A CN112641878 A CN 112641878A
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- folic acid
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Abstract
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating anemia and a preparation method thereof. The raw material medicines of the traditional Chinese medicine composition comprise angelica sinensis, dried orange peel, astragalus membranaceus, rhizoma polygonati, Chinese wolfberry, red dates, hawthorn, lemon, an iron nutrition enhancer, folic acid compounds and sodium chloride. According to the invention, through scientific compatibility and reasonable proportion of the prescription, the anemia caused by various reasons is improved, and meanwhile, the digestion and absorption of nutrient substances of the organism can be promoted, the immunity of the organism is improved, and the fatigue is relieved.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating anemia and a preparation method thereof.
Background
Anemia (anemia) refers to a reduction in the total number of red blood cells in the circulating blood of the whole body below normal. However, since the measurement technique of total amount of red blood cells in the whole body circulation blood is complicated, the clinical level generally means that the concentration of hemoglobin in peripheral blood is lower than the normal standard of patients of the same age group, the same sex and the same region. The normal standards in China are slightly lower than those in foreign countries. In coastal and plain areas, anemia can be considered to be present if the hemoglobin is below 12.5g/dl for adult men and below 11.0g/dl for adult women. Patients with anemia often have palpitation, amnesia, insomnia, dreaminess, lusterless complexion, and the like; or dizziness, tinnitus, palpitation, uneasiness, menoxenia, amenorrhea, scaly complexion, etc.; or sallow complexion, mental fatigue, anorexia, dizziness, and dim eyesight.
The anemia includes iron deficiency anemia, giant cell anemia, aplastic anemia and hemolytic anemia. Among them, iron deficiency anemia is the most common. The severity of anemia symptoms depends primarily on the degree of anemia and the cause and rate of anemia, with anemia occurring more rapidly and more severely, and anemia occurring slowly, which is relatively much less severe due to human fitness. Generally, iron deficiency anemia does not require medical treatment, and blood cells are regulated on diet and hemoglobin level is restored to normal level. Most anemic patients need to be restored to normal level by drug intervention. At present, western medicine treatment mainly comprises symptomatic treatment and immunosuppressive treatment, has great adverse reaction, and the immunosuppressive treatment causes the resistance of patients to be reduced and is easy to cause some complications; the western medicine treatment has low cure rate, is easy to relapse after being cured, has large damage to human bodies by adopting the western medicine treatment and has long treatment course. The traditional Chinese medicine and the traditional Chinese medicine have advantages in the aspect of treating anemia, and the traditional Chinese medicine can have treatment effects on various types of anemia.
In traditional Chinese medicine, anemia is classified into the category of blood deficiency or blood loss due to consumptive disease, which is a general term for various chronic diseases caused by viscera deficiency and primordial qi deficiency. According to the traditional Chinese medicine, the generation and regulation of blood are closely related to the viscera such as heart, liver, spleen, kidney and the like, so that the traditional Chinese medicine is called 'heart governing blood, liver storing blood and spleen governing blood'. The full play of these zang-fu organs depends on the warm and hot fire of the kidney. Therefore, the function of heart, liver, spleen and kidney is weakened, which can lead to blood deficiency. Blood is generated from qi, and qi must depend on blood, so qi and blood are mutually dependent and mutually promoted to keep relative balance. If the qi and blood are disharmony, diseases will be caused. Therefore, patients with blood deficiency usually have qi deficiency. The spleen and stomach are the source of qi and blood generation, blood mainly comes from food essence, and the generation of food essence depends on the digestion and absorption of the spleen and stomach. If the food and drink are not sufficient in nutrient intake or the functions of the spleen and stomach in transportation and transformation are disordered for a long time, the blood generation is insufficient, and the pathological change of anemia is formed. According to the theory of traditional Chinese medicine, aiming at the pathogenesis of anemia, dialectical compatibility formula is carried out by taking nourishing liver and kidney, regulating qi and strengthening spleen, and nourishing blood and activating blood as the treatment principle, so as to achieve the purpose of treating both principal and secondary aspects of diseases.
By combining the modern traditional Chinese medicine development theory, from the viewpoint of improving the curative effect of the medicine and reducing the side effect, the preparation prepared by screening, extracting and/or matching the traditional Chinese medicine components has small side effect and high safety and has incomparable advantages compared with the chemical synthetic medicine. At present, Chinese patent medicines for treating anemia have the defects of slow effect, insufficient curative effect and the like in different degrees and need to be improved.
Chinese patent CN104825927B discloses a Chinese herbal compound preparation capable of improving hematopoietic function, which comprises the following raw material medicaments: 30-60 parts of astragalus membranaceus, 9-18 parts of angelica sinensis, 15-24 parts of glossy privet fruit, 15-24 parts of wolfberry fruit, 15-24 parts of rhizoma curculiginis, 15-24 parts of epimedium herb, 9-18 parts of rhizoma polygonati, 15-24 parts of scorched medicated leaven, 15-24 parts of scorched hawthorn fruit, 15-24 parts of scorched malt, 15-24 parts of stir-fried bighead atractylodes rhizome, 9-18 parts of dried orange peel, 9-18 parts of poria cocos and 3-9 parts of Chinese date. The preparation method comprises decocting 14 raw materials in water twice for 1.5 hr each time, mixing decoctions, filtering, and concentrating the filtrate to obtain fluid extract with relative density of 1.25-1.30(60 deg.C); drying at 70 deg.C under reduced pressure, and pulverizing into fine powder; adding dextrin, mixing, granulating, and drying at 60 deg.C. The traditional Chinese medicine has more medicinal flavors, and the complete extraction of active ingredients of different medicinal materials is not facilitated by decocting the medicinal materials in one pot, so that the exertion of the medicinal effect and the utilization of medicinal material resources are influenced.
The Chinese invention patent CN100400075C discloses a qi-tonifying and blood-nourishing pharmaceutical composition and a preparation method thereof, wherein the pharmaceutical composition is prepared from the following raw materials in parts by weight: 10-14 parts of tortoise-shell glue, 22-26 parts of wolfberry fruit, 50-70 parts of glossy privet fruit, 5-7 parts of deer-horn glue, 22-26 parts of astragalus root, 50-74 parts of rhizoma polygonati, 20-40 parts of donkey-hide gelatin, 20-28 parts of angelica, 50-70 parts of salvia miltiorrhiza, 30-42 parts of dried orange peel and 60-84 parts of hawthorn.
Therefore, it is very necessary to develop a Chinese medicinal composition for treating anemia and a preparation method thereof, which can solve the above technical problems.
Disclosure of Invention
The invention aims to overcome the defects of slow effect, insufficient and obvious curative effect, great side effect and the like of the existing medicine for treating anemia and provide the traditional Chinese medicine composition for preventing and treating anemia, which has the advantages of quick effect, wide medicine source, reliable effect, exact curative effect and no side effect.
A traditional Chinese medicine composition for treating anemia comprises the following components:
15-30 parts of angelica, 8-15 parts of dried orange peel, 8-15 parts of astragalus root, 6-12 parts of sealwort, 6-12 parts of medlar, 10-15 parts of red date, 3-8 parts of hawthorn, 3-8 parts of lemon, 0.1-1 part of iron nutrition enhancer and 0.01-0.1 part of folic acid compound
Preferably, the Chinese angelica is 20-25 parts, the dried orange peel is 10-13 parts, the astragalus is 10-15 parts, the rhizoma polygonati is 10-12 parts, and the medlar is 8-12 parts.
Preferably, the traditional Chinese medicine composition for treating anemia further comprises 0.1-1 part of sodium chloride.
Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 25 parts of angelica sinensis, 10 parts of dried orange peel, 12 parts of astragalus membranaceus, 10 parts of rhizoma polygonati, 10 parts of medlar, 12 parts of red dates, 5 parts of hawthorn, 5 parts of lemon, 0.5 part of iron nutrition enhancer, 0.05 part of folic acid compounds and 0.5 part of sodium chloride.
Preferably, the folic acid compounds are one or more of folic acid, leucovorin, L-methyl folic acid, pharmaceutically acceptable salts of folic acid, active metabolites of folic acid or pharmaceutically acceptable salts of folic acid, and substances capable of metabolizing and/or generating folic acid in vivo.
Preferably, the iron nutrition enhancer is selected from one or more of ferrous lactate, ferrous gluconate, ferric citrate, ferric ammonium citrate and ferrous fumarate.
The invention also relates to a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
(1) extracting radix Angelicae sinensis, pericarpium Citri Tangerinae, fructus Lycii, fructus Citri Limoniae and sodium chloride with water under reflux, filtering, concentrating the medicinal liquid, and centrifuging to remove impurities to obtain extract 1;
(2) soaking radix astragali, rhizoma Polygonati, fructus Jujubae and fructus crataegi in water, decocting, filtering to obtain total decoction, concentrating, filtering, cooling the filtrate to room temperature, and concentrating under reduced pressure to obtain extract 2;
(3) spray drying the extract 1 and the extract 2, preparing into extract powder, adding folic acid compounds and iron nutrition enhancer, mixing well to obtain a mixture, mixing the mixture with a pharmaceutically acceptable carrier, and preparing into a preparation.
Preferably, the volume of water added in step (1) is 8-15ml/g of the total weight of the added medicine.
Preferably, the extraction times in the step (1) are 2-3 times, and each time lasts for 1-2 h.
Preferably, the relative density of the concentrate of step (1) is 1.05-1.20 when the concentrate is cooled to room temperature.
Preferably, the number of times of decoction in step (2) is 3;
preferably, the ratio of the volume of the water added in the step (2) to the total weight of the added medicines is 10-13ml/g, the soaking time is 1.2-1.8h, and the first decoction time is 1.2-1.8 h.
Preferably, the water adding amount of the second decoction is 6-8ml/g of the total weight of the medicine, the soaking time is 0.5-1h, and the decocting time is 1-2 h.
Preferably, the water adding amount of the third decoction is 6-8ml/g of the total weight of the medicine, and the decoction time is 0.5-1 h.
Preferably, the concentration in the step (3) is reduced pressure concentration, and the relative density is 1.03-1.10 when the concentration is carried out to 35 ℃; concentrating under reduced pressure again until the relative density is 1.10-1.30.
The invention also relates to the application of the traditional Chinese medicine composition or the medicine composition obtained by the preparation process in preparing a medicine for treating anemia.
The prescription of each medicine of the invention has the following chemical effects:
chinese angelica: sweet, pungent and warm in nature, entering liver, heart and spleen meridians, and mainly has the effects of enriching blood and regulating menstruation, promoting blood circulation and relieving pain, and relaxing bowel. Dang Gui is sweet and warm, moist in property, good at tonifying blood and is the holy herb for tonifying blood. In combination with qi-tonifying herbs of Huang Qi, it can tonify qi and blood, i.e., "tangible blood cannot be generated by itself but originates from intangible qi. Dang Gui is pungent and warm in property and acts for activating blood and qi, and also has a certain curative effect on constipation due to blood deficiency and intestinal dryness. Modern pharmacological research finds that angelica has various pharmacological actions: has effects in inhibiting smooth muscle, resisting blood coagulation, promoting blood coagulation, tonifying blood, resisting oxidation, resisting aging, relieving inflammation, enhancing immunity, protecting ischemic injury, promoting cell proliferation, and resisting tumor.
Dried orange peel: has the functions of regulating qi, lowering adverse flow of qi, regulating the middle warmer, stimulating appetite, eliminating dampness and phlegm. It can be used for treating stagnation of qi of spleen and stomach, damp obstruction, fullness and oppression in chest and diaphragm, abdominal pain, anorexia, emesis, constipation, lung qi stagnation, cough, and excessive phlegm. Through years of research, the tangerine peel is known to have a plurality of pharmacological effects. 1) Action on digestive system: the volatile oil contained in the dried orange peel has mild stimulation effect on gastrointestinal tracts, can promote the secretion of digestive juice and eliminate pneumatosis in intestinal tracts, and shows the effects of aromatic stomach strengthening and wind dispelling and qi descending. 2) Effect on the cardiovascular system: tangerine peel decoction and alcohol extract can excite cardiac muscle, but if the dosage is too large, inhibition occurs. In addition, it can also produce slight constriction of blood vessel and raise blood pressure rapidly. The pectin in pericarpium Citri Tangerinae also has certain effect in preventing arteriosclerosis caused by high fat diet. 3) Effect on the respiratory system: the volatile oil contained in the dried orange peel has the functions of stimulating and passively eliminating phlegm, so that the phlegm is easy to be expectorated. Tangerine peel decoction has weak effect of dilating bronchus. The alcohol extract has higher asthma relieving potency. 4) Effects on the urogenital system: decoction of pericarpium Citri Tangerinae can cause renal vasoconstriction and reduce urine volume. 5) Anti-inflammatory action: the decoction of pericarpium Citri Tangerinae can be used together with vitamin C and vitamin K to enhance antiinflammatory effect. The tangerine peel decoction has little side effect, and no acute poisoning is found in animal tests. It should be used with cautions for qi deficiency syndrome, yin deficiency dry cough, hematemesis syndrome, red tongue with little fluid and excessive heat inside.
Astragalus root: light smell, slightly sweet taste, slightly beany flavor when chewed. Sweet and warm. It enters lung and spleen meridians. Tonify qi, strengthen superficies, induce diuresis, expel pus, heal wound and promote tissue regeneration. Can be used for treating deficiency of vital energy, asthenia, anorexia, loose stool, collapse of middle-warmer energy, chronic diarrhea, rectocele, hematochezia, metrorrhagia, superficial deficiency, spontaneous perspiration, qi deficiency, edema, carbuncle, cellulitis, intractable ulcer, blood deficiency, debility with yellowish complexion, internal heat, and diabetes; proteinuria due to chronic nephritis and diabetes. Ben Cao Jing Shu (the book of materia Medica Prime and Dredging): the body has the function of excess exterior and is not used by the patients with exterior evil; can help qi, and is not used for people with excessive qi; can be used for treating internal obstruction, deficiency, obstruction of chest and diaphragm, and stagnation of intestine and stomach; it is contraindicated for yang excess and yin deficiency; it is contraindicated for the cases with excessive heat in the upper energizer and deficiency-cold in the lower energizer; patients are angry and liver qi disharmony is avoided; it is contraindicated for acne with hot blood.
Rhizoma polygonati: sweet in flavor and neutral in nature. Has effects in replenishing kidney essence, moistening lung, invigorating spleen, and invigorating qi. Contains aspartic acid, digitoxin, anthraquinone compounds, mucilaginous substances, saccharides, nicotinic acid, zinc, copper and iron. Has effects in resisting anoxia, relieving fatigue, and resisting aging; can enhance immunity and metabolism; has effects in lowering blood sugar and tonifying heart. Can be used for treating yin deficiency, lung dryness, dry cough and little phlegm; thirst quenching and polydipsia; weakness of the spleen and stomach, deficiency of spleen qi or spleen yin; kidney deficiency and essence deficiency, soreness and weakness of the waist and knees, early white beard and hair.
Medlar: mild in nature and sweet in taste; entering liver and kidney meridians; has effects in nourishing liver and kidney, nourishing liver, improving eyesight, regulating immunity, resisting aging, relieving fatigue, regulating blood lipid, and lowering blood pressure.
Hawthorn fruit: is dried mature fruit of Crataegus Pinnatafida Bge, var. major N.E.Br. or Crataegus Pinnatafida Bge. Collected in autumn when the fruit is ripe, sliced and dried. The efficacy is as follows: promoting digestion, removing blood stasis, expelling tapeworm. It is used for treating meat stagnation, abdominal mass, phlegm retention, abdominal distention, acid regurgitation, dysentery, intestinal wind, lumbago, infantile colic, abdominal pain, lochiorrhea, and infantile dyspepsia. Promote digestion, invigorate stomach, promote qi circulation and dissipate blood stasis. Can be used for treating dyspepsia, flatulence, dysentery, abdominal pain, blood stasis, amenorrhea, puerperal stagnation, heart and abdominal pain, hernia pain, and hyperlipidemia. Ben Cao Jing Shu (the book of materia Medica Prime and Dredging): enter the foot yangming and taiyin meridians. The book Ben Cao Jing Jie (explanation of materia Medica): the lung meridian of Taiyin and the liver meridian of foot jueyin.
Red dates: sweet and warm. It enters spleen, stomach and heart meridians. Tonify middle-jiao and Qi, nourish blood and soothe the nerves.
Lemon: the lemon not only can exert the drug effect with the traditional Chinese medicines of the formula, but also can improve the taste of the traditional Chinese medicine composition.
The invention has the beneficial effects that:
(1) the traditional Chinese medicine composition has the advantages of quick response, wide medicine sources, definite curative effect, no side effect and simple prescription;
(2) the formula has the effects of strengthening spleen and stomach, benefiting qi and nourishing blood; can enhance the anti-fatigue and anti-anoxia ability of organism;
(3) the traditional Chinese medicine composition can obviously improve the clinical symptoms and biochemical indexes of various anemias such as aplastic anemia, iron deficiency anemia and the like, and the curative effect is superior to that of a simple iron preparation;
(4) the invention fully exerts the synergistic effect among the medicines by scientific compatibility and reasonable proportion of the medicines, and experiments show that the formula can improve anemia caused by various reasons, promote digestion and absorption of nutrient substances of the organism, improve the immunity of the organism and relieve fatigue.
Detailed Description
The invention will be further described with reference to specific embodiments, and the advantages and features of the invention will become apparent as the description proceeds. These examples are illustrative only and do not limit the scope of the present invention in any way. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention, and that such changes and modifications may be made without departing from the spirit and scope of the invention.
Example 1
A traditional Chinese medicine composition for treating anemia comprises the following raw materials: 15 parts of angelica sinensis, 8 parts of dried orange peel, 15 parts of astragalus membranaceus, 12 parts of rhizoma polygonati, 6 parts of wolfberry, 10 parts of red dates, 8 parts of hawthorn, 8 parts of lemon, 1 part of iron nutrition enhancer and 0.1 part of folic acid compounds. Wherein the iron nutrition enhancer is ferrous gluconate, and the folic acid compound is L-methyl folic acid.
The preparation process of the traditional Chinese medicine composition comprises the following steps:
1) mixing radix Angelicae sinensis, pericarpium Citri Tangerinae, fructus Lycii and fructus Citri Limoniae, adding 8 times of water, reflux extracting for 2 times (each time for 1 hr), filtering, mixing filtrates, concentrating the medicinal liquid under reduced pressure, cooling the concentrated solution to room temperature to obtain a relative density of 1.05, and removing impurities with high speed centrifuge to obtain extract 1;
2) mixing radix astragali, rhizoma polygonati, red dates and hawthorn, adding 10 times of water, soaking for 1 hour, decocting for 1 hour to obtain a first decoction liquid and a first decoction residue, adding 8 times of water into the first decoction residue again, soaking for 0.5 hour, decocting for 2 hours to obtain a second decoction liquid and a second decoction residue, adding 8 times of water into the second decoction residue again, decocting for 0.5 hour to obtain a third decoction liquid and a third decoction residue, combining the first decoction liquid, the second decoction liquid and the third decoction liquid, filtering to obtain a total decoction liquid, measuring the relative density to be 1.03 when concentrating under reduced pressure to 35 ℃, cooling the filtrate to room temperature, concentrating under reduced pressure again to obtain an extract 2, and obtaining a second extract;
3) spray drying the two extracts to obtain extract powder, adding folic acid compounds and iron nutrition enhancer, mixing well to obtain mixture, mixing the mixture with 30% maltodextrin and 0.02% silicon dioxide, granulating, and drying.
Example 2
A traditional Chinese medicine composition for treating anemia comprises the following raw materials: 30 parts of angelica sinensis, 15 parts of dried orange peel, 8 parts of astragalus membranaceus, 6 parts of rhizoma polygonati, 12 parts of wolfberry, 15 parts of red dates, 3 parts of hawthorn, 3 parts of lemon, 0.1 part of iron nutrition enhancer, 0.01 part of folic acid compound and 0.1 part of sodium chloride. Wherein the iron nutrition enhancer is ferrous fumarate, and the folic acid compound is leucovorin.
The preparation process of the traditional Chinese medicine composition comprises the following steps:
1) extracting radix Angelicae sinensis, pericarpium Citri Tangerinae, fructus Lycii, fructus Citri Limoniae, and sodium chloride with 15 times of water under reflux for 3 times, each time for 2 hr, filtering, mixing filtrates, concentrating the medicinal liquid under reduced pressure, cooling the concentrated solution to room temperature, measuring relative density to be 1.05, and removing impurities with high speed centrifuge to obtain extract 1;
2) adding 13 times of water into astragalus membranaceus, rhizoma polygonati, red dates and hawthorn, soaking for 1.8 hours, decocting for 1.8 hours to obtain a first decoction and a first decoction residue, adding 6-8 times of water into the first decoction residue again, soaking for 1 hour, decocting for 1 hour to obtain a second decoction and a second decoction residue, adding 6 times of water into the second decoction residue again, decocting for 1 hour to obtain a third decoction and a third decoction residue, combining the first decoction, the second decoction and the third decoction, filtering to obtain a total decoction, determining the relative density to be 1.03 when concentrating under reduced pressure to 35 ℃, cooling the filtrate to room temperature, concentrating under reduced pressure again to obtain an extract 2 when the relative density is 1.10;
3) spray drying the two extracts to obtain extract powder, adding folic acid compounds and iron nutrition enhancer, mixing well to obtain mixture, mixing the mixture with 15% of compressible starch and 0.05% of silicon dioxide, granulating, and drying.
Example 3
A traditional Chinese medicine composition for treating anemia comprises the following raw materials: 25 parts of angelica sinensis, 15 parts of dried orange peel, 10 parts of astragalus membranaceus, 10 parts of rhizoma polygonati, 10 parts of medlar, 12 parts of red dates, 5 parts of hawthorn, 5 parts of lemon, 0.5 part of iron nutrition enhancer, 0.05 part of folic acid compounds and 1 part of sodium chloride. Wherein the iron nutrition enhancer is ferrous lactate, and the folic acid compound is leucovorin.
The preparation process of the traditional Chinese medicine composition comprises the following steps:
1) adding 10 times of water into angelica sinensis, dried orange peel, medlar, lemon and sodium chloride, carrying out reflux extraction for 2 times, carrying out 1.5h each time, filtering, combining filtrates, concentrating the liquid medicine under reduced pressure, measuring the relative density of the concentrated solution to be 1.10 when the concentrated solution is cooled to room temperature, and removing impurities by using a high-speed centrifuge to obtain an extract 1;
2) adding 10 times of water into astragalus membranaceus, rhizoma polygonati, red dates and hawthorn, soaking for 1.5 hours, decocting for 1.5 hours to obtain a first decoction and a first decoction residue, adding 6 times of water into the first decoction residue again, soaking for 0.5 hours, decocting for 1.5 hours to obtain a second decoction and a second decoction residue, adding 6 times of water into the second decoction residue again, decocting for 1 hour to obtain a third decoction and a third decoction residue, combining the first decoction, the second decoction and the third decoction, filtering to obtain a total decoction, determining the relative density to be 1.03 when concentrating under reduced pressure to 35 ℃, cooling the filtrate to room temperature, concentrating under reduced pressure again to obtain an extract 2, and obtaining an extract after the filtrate is cooled to room temperature and concentrated under reduced pressure to have the relative density of 1.30;
3) spray drying the two extracts, preparing into extract powder, adding folic acid compounds and iron nutrition enhancer, mixing well to obtain mixture, mixing the mixture with 30% lactose and 0.02% silicon dioxide, granulating, and drying.
Comparative example 1
The difference from example 3 is that the composition does not contain lemon, the rest remaining in accordance with example 3.
Comparative example 2
The difference from the embodiment 3 is that, 35 parts of angelica, 6 parts of dried orange peel, 15 parts of medlar, 1 part of lemon and 0.05 part of sodium chloride, and the rest is consistent with the embodiment 3.
Comparative example 3
The difference from the embodiment 3 is that, 20 parts of astragalus root, 4 parts of rhizoma polygonati, 20 parts of red date, 1 part of hawthorn, 0.01 part of iron nutrition enhancer and 0.3 part of folic acid compound. Wherein the iron nutrition enhancer is ferrous lactate, and the folic acid compound is leucovorin.
Test example 1 test of the Effect of the Chinese medicinal composition of the present invention on animal models of aplastic anemia
Medicine preparation: examples 1 to 3, comparative examples 1 to 2; ferrous lactate; cyclophosphamide
Animals: wistar rat, body weight 200-220 g.
The method comprises the following steps: healthy Wistar rats were randomly divided into 8 groups of 5 rats each. The ferrous lactate of the positive group is administrated according to 0.06 g/kg; examples 1 to 3 and comparative examples 1 to 3 were administered at 1g/kg in the morning, cyclophosphamide was simultaneously injected daily, 50mg/kg was continuously administered for 2 weeks, blood was collected from rat eyeballs, and the hemoglobin value [ Hgb ], the red blood cell count [ RBC ], the hematocrit value [ HCT ], and the platelet count were measured by a fully automatic hemocytometer.
As a result: compared with the model group, the rats RBC, Hgb, HCT and PLT of the administration example 1 are obviously improved, P is less than 0.05, and the difference is significant. Specific results are shown in table 1.
TABLE 1 Effect of groups on RBC, Hgb, HCT, PLT in cyclophosphamide-modeled rat peripheral hemograms
| Group of | RBC(*1012/L) | Hgb(g/L) | HCT(％) | PLT(*109/L) |
| Model set | 2.90±0.24a | 50.10±12.89a | 16.73±2.35a | 62.36±5.90a |
| Ferrous lactate group | 4.10±0.56b | 67.24±16.09b | 22.09±1.93b | 77.09±19.21b |
| Example 1 | 4.52±0.35b | 74.27±24.10c | 26.58±5.09b | 84.20±15.53c |
| Example 2 | 4.83±0.99b | 76.50±31.21c | 31.06±9.42b | 87.16±10.81c |
| Example 3 | 4.79±0.67b | 77.12±21.02c | 29.68±4.85b | 88.25±11.82c |
| Comparative example 1 | 3.80±0.78b | 63.39±19.93b | 20.45±2.11b | 75.04±12.30b |
| Comparative example 2 | 4.19±0.92b | 65.94±11.06b | 24.05±3.78b | 79.26±14.67b |
| Comparative example 3 | 3.89±0.84b | 67.83±12.23b | 23.03±8.19b | 74.75±15.84b |
Note: p is less than 0.05 between different letter data.
Test example 2 Effect on swimming endurance of Qi-deficiency and spleen-deficiency type mice
45 male mice (20. + -.10 g) were selected and randomly divided into 9 groups, i.e., a normal group, a model group, a ferrous lactate group, examples 1 to 3 groups, and comparative examples 1 to 3 groups. The normal group is given with equal amount of distilled water, the other groups are decocted twice according to the proportion that magnolia officinalis, immature bitter orange and rhubarb are in a ratio of 3:3:2, the stomach is perfused with 1.5g of crude drug/kg, diet irregularity is supplemented at the same time, the duration is about 15 days, the ferrous lactate group is given with 0.09mg/g of ferrous lactate (9.1 times of the daily dose of an adult), each example group and comparative example group are perfused with 1mg/g of the drug in each example group and comparative example group for 10 days continuously, after the last administration, the mice are placed into a small enamel straight barrel, and the swimming duration of the mice is observed and recorded. The results of t-test are shown in Table 2.
Test example 3 Effect on hypoxia tolerance of Qi-deficiency and spleen-deficiency type mice
45 male mice, 18-22g, were taken. 5 mice were divided into groups, molded, administered in the same manner as in test example 2, and after the last administration, the mice were placed in a 500ml jar, and the jar was sealed with vaseline. The survival time of the mice under the normal-pressure oxygen-deficient environment is observed and recorded, and the results are shown in table 2 after the group t test treatment.
TABLE 2 Effect of groups on swimming endurance and hypoxia tolerance of mice
| Group of | Duration of swimming (minutes) | Survival time (minutes) |
| Normal group | 2.80±0.14a | 25.0±0.2a |
| Model set | 1.32±0.37b | 19.9±0.5b |
| Ferrous lactate group | 2.65±0.29a | 25.2±0.6a |
| Example 1 | 3.21±0.83c | 30.7±0.4b |
| Example 2 | 3.64±0.32c | 34.0±0.3b |
| Example 3 | 3.55±0.58c | 33.5±0.6b |
| Comparative example 1 | 2.98±0.47a | 25.9±1.2a |
| Comparative example 2 | 2.86±0.98a | 27.4±1.7a |
| Comparative example 3 | 2.56±0.35a | 24.2±0.6a |
Note: p <0.05 between the values represented by the different letters.
Test example 4 Effect of each drug group on iron-deficiency anemia animal model
Experimental materials: 45 Wistar rats with the weight of 200 +/-20 g;
low-iron feed: is prepared from milk powder, soybean oil, corn starch and NaCl; a clean grade feed; tap water.
Molding: 1) wistar rats were randomly divided into 2 groups and recorded as 40 iron-deficient groups and 5 normal groups. Both groups of rats were housed in stainless steel cages; 2) feeding the iron-deficient group with low-iron feed; the control group was fed normal clean grade feed. The rats in the normal group have unchanged behaviors and physical states after being fed for four weeks, and the rats in the iron deficiency group have lusterless fur, rough and sparse fur and lean body types.
Grouping: the iron-deficient rats successfully molded were grouped as: the normal group, model group, ferrous lactate group, examples 1-3 groups, comparative examples 1-3 groups, were then weighed.
Administration: normal group and model group are perfused with normal saline with the same volume; the ferrous lactate group is administrated according to the administration of 0.06 g/kg; the other groups of the medicines prepared in the corresponding embodiment with the stomach perfusion of 1g/kg are continuously perfused for 2 weeks, 2 hours after the last administration, weighed, blood is taken from rat eyeballs, and the hemoglobin value [ Hgb ] and the red blood cell count [ RBC ] are measured. The results are as follows:
| group of | Body weight (g) | Hemoglobin content (g/L) | Number of erythrocytes (. about.10)12/L) |
| Normal group | 213.86±25.98a | 138.90±12.25a | 6.80±0.10a |
| Model set | 170.10±21.54b | 76.18±10.33b | 3.51±0.47b |
| Ferrous lactate group | 210.23±16.20a | 136.25±14.56a | 6.64±0.22a |
| Example 1 | 213.19±29.03a | 137.86±10.71a | 6.38±0.19a |
| Example 2 | 219.24±10.26a | 140.59±16.85a | 6.71±0.37a |
| Example 3 | 220.04±15.78a | 148.20±13.63a | 6.89±0.54a |
| Comparative example 1 | 181.23±12.93c | 108.90±11.59c | 5.32±0.23b |
| Comparative example 2 | 190.04±16.34c | 125.90±18.70c | 5.98±0.92b |
| Comparative example 3 | 185.74±17.29c | 118.92±10.96c | 5.56±0.37b |
Note: p <0.05 between the values represented by the different letters.
The above detailed description is specific to one possible embodiment of the present invention, and the embodiment is not intended to limit the scope of the present invention, and all equivalent implementations or modifications without departing from the scope of the present invention should be included in the technical scope of the present invention.
Claims (10)
1. The traditional Chinese medicine composition is characterized by comprising the following components in parts by weight:
15-30 parts of angelica, 8-15 parts of dried orange peel, 8-15 parts of astragalus root, 6-12 parts of sealwort, 6-12 parts of medlar, 10-15 parts of red date, 3-8 parts of hawthorn, 3-8 parts of lemon, 0.1-1 part of iron nutrition enhancer and 0.01-0.1 part of folic acid compound.
2. The traditional Chinese medicine composition according to claim 1, wherein in the traditional Chinese medicine composition, 20-25 parts of angelica sinensis, 10-13 parts of dried orange peel, 10-15 parts of astragalus membranaceus, 10-12 parts of polygonatum sibiricum and 8-12 parts of medlar; preferably, the traditional Chinese medicine composition also comprises 0.1-1 part of sodium chloride.
3. The traditional Chinese medicine composition according to claim 1, which comprises the following components in parts by weight: 25 parts of angelica, 10 parts of dried orange peel, 12 parts of astragalus, 10 parts of rhizoma polygonati, 10 parts of medlar, 12 parts of red dates, 5 parts of hawthorn, 5 parts of lemon, 0.5 part of iron nutrition enhancer, 0.05 part of folic acid compound and 0.5 part of sodium chloride.
4. The Chinese medicinal composition according to claim 1, wherein the iron nutrition enhancer is one or more selected from the group consisting of ferrous lactate, ferrous gluconate, ferric citrate, ferric ammonium citrate and ferrous fumarate.
5. The Chinese medicinal composition according to claim 1, wherein the folic acid compounds are one or more of folic acid, leucovorin, L-methyl folic acid, pharmaceutically acceptable salts of folic acid, active metabolites of folic acid or pharmaceutically acceptable salts of folic acid, and substances capable of metabolizing and/or generating folic acid in vivo.
6. The method for preparing a Chinese medicinal composition according to any one of claims 1 to 5, comprising the steps of:
(1) extracting radix Angelicae sinensis, pericarpium Citri Tangerinae, fructus Lycii, fructus Citri Limoniae and sodium chloride with water under reflux, filtering, concentrating the medicinal liquid, and centrifuging to remove impurities to obtain extract 1;
(2) soaking radix astragali, rhizoma Polygonati, fructus Jujubae and fructus crataegi in water, decocting, filtering to obtain total decoction, concentrating, filtering, cooling the filtrate to room temperature, and concentrating under reduced pressure to obtain extract 2;
(3) spray drying the extract 1 and the extract 2, preparing into extract powder, adding folic acid compounds and iron nutrition enhancer, mixing well to obtain a mixture, mixing the mixture with a pharmaceutically acceptable carrier, and preparing into a preparation.
7. The preparation method of the Chinese medicinal composition according to claim 6, wherein the volume of the water added in the step (1) is 8-15ml/g of the total weight of the added medicaments, the extraction times are 2-3 times, and each time lasts for 1-2 h; the relative density of the concentrated solution is 1.05-1.20 when the concentrated solution is cooled to room temperature.
8. The preparation method of the traditional Chinese medicine composition according to claim 6, wherein the water is added in the step (2) for decocting three times, the ratio of the volume of the water added in the first decoction to the total weight of the added medicines is 10-13ml/g, the soaking time is 1.2-1.8h, and the first decoction time is 1.2-1.8 h; the water adding amount of the second decoction is 6-8ml/g of the total weight of the medicine, the soaking time is 0.5-1h, and the decoction time is 1-2 h; the water adding amount of the third decoction is 6-8ml/g of the total weight of the medicine, and the decoction time is 0.5-1 h.
9. The method for preparing a Chinese medicinal composition according to claim 6, wherein the concentration in step (2) is a reduced pressure concentration, and the relative density is 1.03-1.10 when the concentration is carried out to 35 ℃; and concentrating under reduced pressure again until the relative density is 1.10-1.30.
10. Use of the Chinese medicinal composition of any one of claims 1-5 in the preparation of a medicament for treating anemia.
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