CN100361681C - Medicine for treating thrombocytopenia and anemia and its prepn process and quality control method - Google Patents
Medicine for treating thrombocytopenia and anemia and its prepn process and quality control method Download PDFInfo
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Abstract
The present invention is medicine for treating thrombocytopenia and anemia and its preparation process and quality control method, and belongs to the field of Chinese medicine technology. The medicine is prepared with donkey-hide gelatin 3.5-6.5 weight portions, astragalus root 140-260 weight portions, angelica 105-195 weight portions, date 70-130 weight portions and antler gelatin 10.5-19.5 weight portions. It has the functions of invigorating qi, nourishing blood, and benefiting kidney and spleen, and is used in treating thrombocytopenia and anemia. It has also certain curative effect on leucopenia caused by radiotherapy and chemotherapy.
Description
Technical field
The invention belongs to a kind of Chinese medicine and preparation method thereof and method of quality control.
Background technology
The leukopenia that causes behind thrombocytopenia, anemia and the chemicotherapy is a clinical common diseases, therefore study a kind of efficient, nontoxic medicine, it is extremely important just to seem, it is to the quality of improving the people's livelihood, increase work efficiency, promoting the well-being of mankind has very important significance.
This just requires us to produce high-quality product, but the initial quality control method is for to carry out assay with dual wavelength thin layer chromatography method to astragaloside in this product Radix Astragali, and its measurement result is not accurate especially.We improve the method for quality control of said preparation, and product is carried out effective quality control.
Summary of the invention
The invention provides a kind of medicine for the treatment of thrombocytopenia, anemia and preparation method thereof and method of quality control.
Selecting Colla Corii Asini in the side for use is monarch drug, and nature and flavor are sweet flat, are tonifying blood and arresting bleeding, the YIN nourishing key medicine.Compendium of Material Medica: " treat and spit blood, epistaxis, hemorrhoidal hamorrhage dysentery.Woman's blood pain, blood depletion, irregular menstruation, loss of fecundity, metrorrhagia, leukorrhagia, tire all diseases in preceding puerperal." minister is with Radix Angelicae Sinensis, sweet, Xin Wen has and enriches blood, hemostasis, analgesic effect." the Jing Yue's complete work book on Chinese herbal medicine is just ": " Radix Angelicae Sinensis, its sweet in the mouth and weighing is so specially can enrich blood; Its gas is light and hot, again can promoting the circulation of blood.Invigorating middle warmer has, in the row benefit is arranged, the gas medicine in the sincere blood, and also the panacea in the blood is also." the monarch and his subjects' two medicines must join, and can strengthen the power of enriching blood, and can strengthen the merit of promoting the circulation of blood again.Mend and oiliness, promoting the circulation of blood does not stagnate, and is just right, can treat the disease of various blood deficiency.Assistant is with the Radix Astragali, and sweet tepor both had been apt to invigorating the spleen and replenishing QI, and kind again YANG invigorating is lifted and fallen into, and is the key medicine of tonifying Qi and lifting yang; Fructus Jujubae, Gan Wen, invigorating the spleen and replenishing QI, nourishing blood to tranquillize the mind relaxes the property of medicine, and two medicines match, and mend all deficient deficiencies, and strong taste strengthen source of generating QI and blood, and assist a ruler in governing a country monarch-minister drug, and strongly invigorating QI and blood can be treated various deficient diseases.Assistant is with Colla cornus cervi, and kidney-Yang invigorating fills blood, the spermatogenesis marrow, and warm muscles and bones, and be the guide of group's medicine, then just be so incensed that multiple, make the disease recovery from illness.All medicines share, and play benefiting qi and nourishing blood altogether, and kidney tonifying helps the function of spleen.
The consumption of drug component of the present invention is also groped to sum up to draw through the inventor in a large number, and each amounts of components is for all having better curative effect in following weight range:
3.5～6.5 parts in Colla Corii Asini, 140～260 parts of the Radixs Astragali, 105～195 parts of Radix Angelicae Sinensis, 70～130 parts in Fructus Jujubae, 10.5～19.5 parts of Colla cornus cervis.
Be preferably:
5 parts in Colla Corii Asini, 200 parts of the Radixs Astragali, 150 parts of Radix Angelicae Sinensis, 100 parts in Fructus Jujubae, 15 parts of Colla cornus cervis.
The preparation method of medicine activity component of the present invention is as follows:
1) get the above five tastes, Radix Angelicae Sinensis extracts volatile oil with the way of distillation, and is standby;
2) get Radix Angelicae Sinensis medicinal residues, the Radix Astragali and Fructus Jujubae three flavor medicines and decoct with water twice, be respectively 3,2 hours, amount of water is respectively 5 times, 3 times, filter, merging filtrate, being concentrated into relative density is 1.23～1.28 (20 ℃ of surveys) clear paste, adds ethanol and makes determining alcohol reach 65%, fully stir, static 24 hours, filter filtrate recycling ethanol, get herbal extracts such as Radix Angelicae Sinensis, standby;
3) Colla Corii Asini, that Colla cornus cervi adds water is an amount of, the heating molten, standby;
4) add correctives, add 1) following Radix Angelicae Sinensis volatile oil, 2) following herbal extract, 3 such as Radix Angelicae Sinensis) down Colla Corii Asini and Colla cornus cervi molten liquid and antiseptic, stir, add water to 1000ml, mixing filters, and packing promptly gets oral liquid.
The active component of medicine of the present invention can add various conventional adjuvant required when preparing different dosage form, be prepared into any common formulations as disintegrating agent, lubricant, binding agent, correctives, excipient etc. with the method for Chinese medicinal of routine, as pill, powder, tablet, granule, capsule, oral liquid, syrup etc.
Method of quality control of the present invention is:
Chromatographic condition and system suitability test: with the octadecylsilane chemically bonded silica is filler; 30～40: 60～70 acetonitriles-water is mobile phase; Evaporative light scattering detector.Number of theoretical plate calculates with the astragaloside peak should be not less than 3000.
The preparation of reference substance solution: it is an amount of that precision takes by weighing the astragaloside reference substance, adds methanol and make the solution that every 1ml contains 0.5mg, promptly.
The preparation of need testing solution: get this product 25～50ml, use water saturation n-butanol extraction 5 times, each 25～50ml merges ammonia solution thorough washing 3 times of n-butyl alcohol liquid, each 30ml discards ammonia solution, n-butyl alcohol liquid evaporate to dryness, and residue adds water 10ml, heating for dissolving is put coldly, passes through D
101Macroporous adsorptive resins, (internal diameter 1.5cm, long 12cm) with water 100ml eluting, discards water liquid.Reuse 40% ethanol 100ml eluting discards 40% ethanol elution, continues with 70% ethanol 100ml eluting, collects the eluent evaporate to dryness, with dissolve with methanol and be transferred in the 5ml measuring bottle, and be diluted to scale, shake up, filter with 0.40～0.50 μ m microporous filter membrane, collect subsequent filtrate, promptly.
Algoscopy: accurate reference substance solution 5～10 μ l, 15～20 μ l of drawing, need testing solution 10～20 μ l inject chromatograph of liquid, measure, and calculate with the two points external standard method logarithmic equation, promptly.
The every ml of this product contains the Radix Astragali with astragaloside (C
41H
68O
14) meter, must not be less than 13～22 μ g.
A kind of embodiment of method of quality control of the present invention is:
Chromatographic condition and system suitability test: with the octadecylsilane chemically bonded silica is filler; 32: 68 acetonitrile-water is mobile phase; Evaporative light scattering detector.Number of theoretical plate calculates with the astragaloside peak should be not less than 3000.
The preparation of reference substance solution: it is an amount of that precision takes by weighing the astragaloside reference substance, adds methanol and make the solution that every 1ml contains 0.5mg, promptly.
The preparation of need testing solution: get this product 25ml, with water saturation n-butanol extraction 5 times, each 25ml merges n-butyl alcohol liquid with ammonia solution thorough washing 3 times, and each 30ml discards ammonia solution, n-butyl alcohol liquid evaporate to dryness, and residue adds water 10ml, and heating for dissolving is put coldly, passes through D
101Macroporous adsorptive resins, (internal diameter 1.5cm, long 12cm) with water 100ml eluting, discards water liquid.Reuse 40% ethanol 100ml eluting discards 40% ethanol elution, continues with 70% ethanol 100ml eluting, collects the eluent evaporate to dryness, with dissolve with methanol and be transferred in the 5ml measuring bottle, and be diluted to scale, shake up, filter with 0.45 μ m microporous filter membrane, collect subsequent filtrate, promptly.
Algoscopy: accurate reference substance solution 5 μ l, the 15 μ l of drawing, need testing solution 20 μ l inject chromatograph of liquid, measure, and calculate with the two points external standard method logarithmic equation, promptly.
The every ml of this product contains the Radix Astragali with astragaloside (C
41H
68O
14) meter, must not be less than 15 μ g.
The present invention has benefiting qi and nourishing blood, and kidney tonifying helps the effect of spleen.Be used for deficiency of both QI and blood, metrostaxis, a little less than the body weakness with emaciation, thrombocytopenia and anemia have certain therapeutical effect to the leukopenia that causes behind the radiation and chemotherapy.Determined curative effect, side effect are little.Drug usage consumption of the present invention: oral, calculate 4.7g/ time 2 times on the one with the crude drug amount.
The specific embodiment
Below further set forth the beneficial effect of medicine of the present invention by testing example, these test the pharmacodynamics test that examples have comprised medicine of the present invention (hereinafter to be referred as YANGXUEYIN KOUFUYE).
Test example 1 YANGXUEYIN KOUFUYE pharmacodynamic study
1, experiment material
1.1 animal: Kunming mouse, body weight 18～24g, Wistar rat 150～200g body weight, the male and female dual-purpose, all available from laboratory animal room of preclinical medicine institute of Jilin University, the quality certification number is SCXK-2002-005.
1.2 be subjected to the reagent thing:
1.2.1 YANGXUEYIN KOUFUYE is provided by Jilin Aodong Liyuan Pharmaceutical Industry Co., Ltd., every 10ml contains crude drug 4.7g, lot number: 020410.Time spent is made into the suspension of respective concentration with distilled water, for gastric infusion.
1.2.2 beneficial blood rubber capsule is produced lot number: 020303 by Aodong, Jilin Zhuhai pharmaceutcal corporation, Ltd.Time spent is made into the suspension of respective concentration with distilled water, for gastric infusion.
1.3 reagent: cyclophosphamide, produce lot number: 000205 by Hualian Pharmaceutical Co., Ltd., Shanghai.Time spent is made into desired concn for gastric infusion with normal saline.
1.4 experimental apparatus:
1.4.1
60Co radiation: chamber, applied chemistry institute cobalt source, Changchun.
1.4.2 micro-electronics Libra: day island proper Tianjin AEG-220.
1.4.3 spectrophotometer: 752 types.Shanghai analytical tool factory.
1.5 statistical procedures: data represent with mean plus-minus standard deviation, the significance test of group difference with the t-check (
).
2, method and result:
2.1, to the influence of mice hemorrhagic anemia
Get 60 of mices, divide equally six groups at random, be respectively normal control group (20ml water/kg), model group, positive control drug benefit blood rubber capsule 3g/kg and YANGXUEYIN KOUFUYE 4.88,2.44,1.22g/kg group, successive administration 10 days, cause the mice hemorrhagic anemia respectively at 1 hour socket of the eye venesection 0.5ml after the administration in the 3rd, 5 day, 1 hour socket of the eye vein is got blood after the last administration, measures hemoglobin and RBC number, the results are shown in Table 1.
Table 1. YANGXUEYIN KOUFUYE is to the influence of mice hemorrhagic anemia
| Group | Dosage (g/kg) | Number of animals | HB(g/L) | RBC(×10 12/L) |
| Matched group model group benefit blood rubber capsule YANGXUEYIN KOUFUYE | 3 4.88 2.44 1.22 | 10 10 10 10 10 10 | 121.4±6.88 ** 90.7±5.47 97.8±8.39 △ 108.2±7.30 △△ 97.7±6.78 △ 95.5±4.50 △ | 7.66±0.59 ** 5.42±0.50 5.98±0.92 △△ 6.48±0.54 △△ 6.22±0.53 △△ 6.28±0.53 △△ |
Compare * * P＜0.01 with matched group, compare △ P＜0.05, △ △ P＜0.01 with model group
The result shows that beneficial blood rubber capsule 3g/kg and YANGXUEYIN KOUFUYE 4.88,2.44,1.22g crude drug/kg organize all can significantly raise losing blood property blood deficiency mice peripheral hemoglobin and blood content and RBC number.
2.2, to the influence of rat hemorrhagic anemia
Get 40 rats, male and female half and half, body weight 180～220g, respectively organize rat before the experiment and all measure content of hemoglobin and counting RBC number to cut the blood sampling of tail method, take its whole body to contain blood volume 1/4 blood according to rat body weight from heart and cause the rat hemorrhagic anemia, be divided into after 30 hours and divide equally four groups at random, be respectively positive control drug benefit blood rubber capsule 2.1g/kg and YANGXUEYIN KOUFUYE 3.4,1.7,0.85g/kg group, each is taken a blood sample once after 5,10 days in administration, measure content of hemoglobin and counting RBC number, carry out own control relatively, result such as table 2.
Table 2, YANGXUEYIN KOUFUYE are to the influence of hemorrhagic anemia rat hemoglobin and RBC number
Own control compares * * P＜0.01 before and after the n=10 administration
The result shows that YANGXUEYIN KOUFUYE 3.4,1.7,0.85g crude drug/kg organize all can significantly raise losing blood property blood deficiency rat peripheral hemoglobin and blood content and RBC number.
2.3, to the influence of caused by cyclophosphamide mice syndrome of deficiency of blood
Choose 60 of mices, body weight 18～22g, be divided into six groups at random, (20ml water/kg), model control group, positive control drug benefit blood rubber capsule 3g/kg group, YANGXUEYIN KOUFUYE 4.88,2.44,1.22g crude drug/kg organize to be respectively the normal control group, each organized the mice successive administration after 10 days, in administration the 6th day except that the normal control group, each Mus is all irritated stomach and gives cyclophosphamide 70mg/kg once, after the last administration 2 hours, socket of the eye venous blood collection counting leukocyte, erythrocyte, content of hemoglobin, result such as table 3.
Table 3 YANGXUEYIN KOUFUYE is to the influence of caused by cyclophosphamide mice anemia
| Group | Dosage | Number of animals | WBC/mm 3 | RBC ten thousand/mm 3 | Hb g/％ |
| Normal control group model matched group benefit blood rubber capsule YANGXUEYIN KOUFUYE | 3 4.88 2.44 1.22 | 10 10 10 10 10 10 | 5430±460 ** 3500±410 4650±840 5180±410 ** 6130±150 ** 4270±180 | 627.0±18.4 **476.8±20.6 △△599.0±9.0 **654.0±30.6 **712.0±26.1 **602.0±37.1 ** | 9.6±0.27 ** 7.86±0.39 △△ 9.0±0.27 * 9.56±0.33 ** 9.85±0.28 ** 9.65±0.31 ** |
Administration group and model group type group be * p＜0.05 relatively, * * p＜0.01, model group type group and normal control group △ △ p＜0.01
The result shows that beneficial blood rubber capsule 3g/kg group and YANGXUEYIN KOUFUYE 4.88,2.44,1.22g crude drug/kg group all have the rising effect of highly significant to erythrocyte, leukocyte and hematoblastic minimizing in the caused by cyclophosphamide mice peripheral blood.
2.4, to the influence of anemia due to the mice radiation injury
Get 60 of mices, divide equally six groups at random, be respectively normal control group (20ml water/kg), model group, positive control drug benefit blood rubber capsule 3g/kg and YANGXUEYIN KOUFUYE 4.88,2.44,1.22g crude drug/kg group, behind the successive administration 3 days, except that the normal control group, all with Philips deep X ray one subtotal body irradiation, irradiation source is apart from mice centre distance 40cm, exposure rate 8.51 * 10 for each Mus
-5C/kg/ minute (33 human relations/minute), Continuous irradiation 14 minutes, accumulated dose are 4Gy.Continue administration 6 days, after the last administration, put to death animal in 1 hour, get blood, measure peripheral hemoglobin and blood content, numeration erythrocyte, leukocyte and platelet count.The results are shown in Table 4.
Table 4 YANGXUEYIN KOUFUYE is to the influence of anemia due to the mice radiation injury
| Group | Dosage | Hb(g/L) | RBC(×10 12/L) | WBC(×10 9/L) | PLt(×10 9/L) |
| Matched group model group benefit blood rubber capsule YANGXUEYIN KOUFUYE | 3 4.88 2.44 1.22 | 108.4±8.78 89.4±9.06 ** 91.0±8.81 93.6±5.89 90.8±8.84 87.3±7.53 | 7.50±0.05 5.84±0.42 ** 8.58±0.80 △△ 8.44±0.62 △ 6.38±0.89 6.48±0.45 | 10.96±1.23 1.02±0.29 ** 0.64±0.18 1.34±0.30 △△ 1.34±0.58 0.82±0.23 | 399±58 142±20 ** 142±29 146±31 170±43 146±35 |
Compare * * P＜0.01 with matched group, compare △ P＜0.05, △ △ P＜0.01 with model group
The result shows, beneficial blood rubber capsule 3g/kg and YANGXUEYIN KOUFUYE 4.88g crude drug/kg group can significantly raise after the x-ray bombardment erythrocyte and leukocyte count in the mice peripheral hemogram.Though hemoglobin and platelet are had certain rising trend, not statistically significant.
2.5, to the influence of rat hypoferric anemia
Get 60 of rats, be divided into six groups at random, be respectively matched group, model group, positive control drug benefit blood rubber capsule 2.1g/kg and YANGXUEYIN KOUFUYE 3.4,1.7,0.85g crude drug/kg group, except that the normal control group, all the other each groups are all hanged down ferrum feedstuff (corn starch 54%, milk powder 40%, Oleum Glycines 5%, Sal 1%) 10 days, about 10 of blood-letting every other day, played positive control drug benefit blood rubber capsule 2.1g/kg and YANGXUEYIN KOUFUYE 3.4 on the 11st day, 1.7,0.85g/kg the group administration, continuous 7 days, except that the normal control group, all the other each groups continue the low ferrum feedstuff of feed simultaneously.Put to death animal after 1 hour after the last administration, get hematometry hemoglobin and RBC number, and measure iron content in the blood, the results are shown in Table 5.
Table 5 YANGXUEYIN KOUFUYE is to the influence of rat hypoferric anemia
| Group | Dosage (g/kg) | Number of animals | Hb(g/L) | RBC(×10 12/L) | Fe(μg/ml) |
| Matched group model group benefit blood rubber capsule YANGXUEYIN KOUFUYE | 2.1 3.4 1.7 0.85 | 10 10 10 10 10 10 | 118.0±6.28 91.0±4.05 ** 98.75±5.75 △ 96.38±8.03 95.0±7.27 99.5±7.67 | 7.28±0.49 5.64±0.35 ** 6.34±0.47 △△ 6.28±0.72 △ 6.29±0.64 △ 6.55±0.74 △△ | 4.40±1.28 2.50±0.30 ** 3.06±0.45 △ 3.29±1.22 3.16±0.71 △ 2.95±0.77 |
Compare * * P＜0.01 with matched group
Compare △ P＜0.05, △ △ P＜0.01 with model group
The result shows, benefit blood rubber capsule 2.1g/kg and YANGXUEYIN KOUFUYE 3.4,1.7,0.85g/kg organize RBC number in the hypoferric anemia rat peripheral blood that all can significantly raise, and beneficial blood rubber capsule 2.1g/kg and YANGXUEYIN KOUFUYE 1.7g crude drug/kg group also can improve iron content in the blood.
2.6, to the influence of cyclophosphamide syndrome of deficiency of blood model mice bone marrow nucleated cell quantity
Get 60 of mices, body weight 18～22g, be divided into six groups at random, be respectively normal control group (20ml water/kg), model control group, positive control drug benefit blood rubber capsule 3g/kg group, YANGXUEYIN KOUFUYE 4.88,2.44,1.22g crude drug/kg group, each organized the mice successive administration after 10 days, in administration the 6th day except that the normal control group, each Mus is all irritated stomach and gives cyclophosphamide 70mg/kg once, after the last administration 2 hours, draw neck to put to death mice, get one of its femur, in 10ml 3% acetate solution, count nucleated cell sum in the full femoral cavity with whole nucleated cell in the 3% acetate solution flushing femur.Observe the protective effect of YANGXUEYIN KOUFUYE, the results are shown in Table 6 hemopoietic function of bone marrow.
Table 6 YANGXUEYIN KOUFUYE is to the influence of cyclophosphamide syndrome of deficiency of blood model mice bone marrow nucleated cell quantity
| Group | Dosage (g/kg) | Number of animals | Nucleated cell sum in the full femoral cavity |
| Matched group model group benefit blood is given birth to YANGXUEYIN KOUFUYE | 3 4.88 2.44 1.22 | 10 10 10 10 10 10 | 14,760,000±762,481.3 ** 9,640,000±818,019.3 △△ 12,400,000±1,470,676.3 **△△ 14,522,220±691,772.6 ** 13,420,000±782,275.9 **△△ 12,985,000±1,012,356.4 **△△ |
Compare * * p＜0.01 with model group type group, with normal control group △ △ P＜0.01
The result shows that beneficial blood gives birth to the 3g/kg group and YANGXUEYIN KOUFUYE 4.88,2.44,1.22g crude drug/kg group all can obviously increase bone marrow nucleated cell quantity.
2.7, YANGXUEYIN KOUFUYE is to the influence of mice swimming time
Get 50 mices, body weight 20～22g, be divided into five groups at random, be respectively normal control group, positive control drug benefit blood rubber capsule 3g/kg, YANGXUEYIN KOUFUYE 4.88g, 2.44,1.22g crude drug/kg group, successive administration 10 days, after the last administration 1 hour, put into depth of water 35cm, water temperature be in 29 ± 1 ℃ of baths with mice sink under water dead non-rising be observation index, write down the time-to-live of each Mus, the results are shown in Table 7.
Table 7 YANGXUEYIN KOUFUYE is to the influence of mice swimming time
| Group | Dosage (g/kg) | Number of animals (only) | Swimming time (hour) | P |
| Normal control group benefit blood rubber capsule YANGXUEYIN KOUFUYE | 3 4.88 2.44 1.22 | 10 10 10 10 10 | 1.779±0.143 1.956±0.256 4.805±0.646 4.28±0.641 3.76±0.581 | P＜0.01 P＜0.01 P＜0.01 |
The result shows that YANGXUEYIN KOUFUYE 4.88g, 2.44,1.22g crude drug/kg group all can obviously prolong the mice time-to-live.
2.8, YANGXUEYIN KOUFUYE is to the influence of mice reticuloendothelial system phagocytic function
Get 50 of mices, male and female half and half, be divided into five groups at random, every group 10, be respectively the normal control group, positive control drug benefit blood rubber capsule 3g/kg, YANGXUEYIN KOUFUYE 4.88g, 2.44,1.22g crude drug/kg group, successive administration 7 days, by tail vein injection india ink 0.1ml/10g body weight, when injection 2 minutes and 15 minutes, mice socket of the eye venous plexus is got blood 0.025ml in 1 hour each Mus of last administration, add among the 5% sodium carbonate liquor 5ml, shake up, survey the OD value with 752 type spectrophotometer 600nm places, and put to death animal immediately, cut open and get liver, spleen is weighed, the calculating K value, the α value.The results are shown in Table 8.
Table 8 YANGXUEYIN KOUFUYE is to the influence of mice reticuloendothelial system phagocytic function
Compare * * P＜0.01 * P＜0.05 with matched group
The result shows that beneficial blood rubber capsule 3g/kg and YANGXUEYIN KOUFUYE 4.88g, 2.44,1.22g crude drug/kg group can obviously improve the phagocytic function of mononuclear phagocyte.
Experimental result shows, the content of hemoglobin that YANGXUEYIN KOUFUYE causes for hemorrhagic anemia, hypoferric anemia, chemical injury and radiation injury reduces and RBC number minimizing tool improves significantly, can alleviate the inhibitory action of cyclophosphamide, show that it has the effect of significant QI invigorating and blood producing, the living marrow of the kidney invigorating hemopoietic function of bone marrow; Obviously improve the phagocytic function of mononuclear phagocyte in the mice reticuloendothelial system, prolong mice and continue swimming time, show the effect that it has health invigorating, improves immunologic function.Above-mentioned experimental result may be one of clinical pharmacological basis that is used for the treatment of anemia benefiting qi and nourishing blood, health invigorating, allaying tiredness.
Come further to set forth the preparation method of medicine of the present invention by the following examples.
The preparation of embodiment 1 medicine oral liquid of the present invention
It is made by following crude drug:
Colla Corii Asini 5g, Radix Astragali 200g, Radix Angelicae Sinensis 150g, Fructus Jujubae 100g, Colla cornus cervi 15g.
1) get Radix Angelicae Sinensis and extract volatile oil with the way of distillation, standby;
2) getting Radix Angelicae Sinensis medicinal residues, the Radix Astragali and Fructus Jujubae three flavor medicines decocts with water twice, be respectively 3,2 hours, amount of water is respectively 5 times, 3 times, filters, merging filtrate, being concentrated into relative density is 1.23～1.28 (20 ℃ of surveys) clear paste, adds ethanol and makes determining alcohol reach 65%, fully stirs, static 24 hours, filter, filtrate recycling ethanol gets herbal extracts such as Radix Angelicae Sinensis.Herbal extracts such as Radix Angelicae Sinensis add water to 250ml, add Radix Angelicae Sinensis volatile oil, and mixing is standby;
3) Colla Corii Asini, that Colla cornus cervi adds water is an amount of, the heating molten, standby;
4) 200g or 400g sucrose are made simple syrup, add 1) following Radix Angelicae Sinensis volatile oil, add 2) following herbal extract such as Radix Angelicae Sinensis, and 3) down Colla Corii Asini and Colla cornus cervi molten liquid and antiseptic, stir, add water to 1000ml, mixing filters, and packing promptly gets oral liquid.
The preparation of embodiment 2 medicine capsules of the present invention
It is made by following crude drug:
Colla Corii Asini 3.5g, Radix Astragali 140g, Radix Angelicae Sinensis 105g, Fructus Jujubae 70g, Colla cornus cervi 10.5g.
1) get the above five tastes, Radix Angelicae Sinensis extracts volatile oil with the way of distillation, the beta-schardinger dextrin-of 8 times of amounts of gained volatile oil, put in the suitable glass container, add the water of 6 times of amounts of beta-schardinger dextrin-, on the magnetic force heating stirrer, constant temperature is stirred to 30 ℃, gets above-mentioned volatile oil, after diluting with dehydrated alcohol in 1: 1 ratio, splash in the beta-schardinger dextrin-solution, constant temperature stirred 3 hours, put 4 ℃ of refrigerator and cooled and hid sucking filtration 24 hours, 40 ℃ of dryings 4 hours, standby;
2) get Radix Angelicae Sinensis medicinal residues, the Radix Astragali, Fructus Jujubae three flavor medicines and decoct with water twice, be respectively 3,2 hours, amount of water is respectively 5 times, 3 times, filter, merging filtrate, being concentrated into relative density is 1.23～1.28 (20 ℃ of surveys) clear paste, adds ethanol and makes determining alcohol reach 65%, fully stir, static 24 hours, filter filtrate recycling ethanol, be concentrated into relative density and be 1.30～1.40 thick pastes, standby;
3) Colla Corii Asini, Colla cornus cervi are ground into fine powder, and be standby;
4) with 2) the gained thick paste adds 3) described in fine powder, mixing, 60 ℃～80 ℃ are dry down, add 1) described in volatile oil beta cyclodextrin inclusion complex;
5) with 4) pulverizing of gained active component, to granulate, drying incapsulates, and obtains capsule.
The preparation of embodiment 3 medicinal granules of the present invention
It is made by following crude drug:
Colla Corii Asini 6.5g, Radix Astragali 260g, Radix Angelicae Sinensis 195g, Fructus Jujubae 130g, Colla cornus cervi 19.5g.
1) step of preparation active substance is with 1 of embodiment 2)～4),
2) with 1) pulverizing of gained active component, to granulate, drying obtains granule.
The preparation of embodiment 4 medicinal tablets of the present invention
It is made by following crude drug:
Colla Corii Asini 5g, Radix Astragali 200g, Radix Angelicae Sinensis 150g, Fructus Jujubae 100g, Colla cornus cervi 15g.
1) step of preparation active substance is with 1 of embodiment 2)～4).
2) with 2) pulverizing of gained active component, granulate, drying, tabletting obtains tablet.
Embodiment 5 method of quality control:
Chromatographic condition and system suitability test: with the octadecylsilane chemically bonded silica is filler; 32: 68 acetonitrile-water is mobile phase; Evaporative light scattering detector.Number of theoretical plate calculates with the astragaloside peak should be not less than 3000.
The preparation of reference substance solution: it is an amount of that precision takes by weighing the astragaloside reference substance, adds methanol and make the solution that every 1ml contains 0.5mg, promptly.
The preparation of need testing solution: get the oral liquid 25ml of the embodiment of the invention 1, use water saturation n-butanol extraction 5 times, each 25ml merges ammonia solution thorough washing 3 times of n-butyl alcohol liquid, each 30ml discards ammonia solution, n-butyl alcohol liquid evaporate to dryness, and residue adds water 10ml, heating for dissolving is put coldly, passes through D
101Macroporous adsorptive resins, (internal diameter 1.5cm, long 12cm) with water 100ml eluting, discards water liquid.Reuse 40% ethanol 100ml eluting discards 40% ethanol elution, continues with 70% ethanol 100ml eluting, collects the eluent evaporate to dryness, with dissolve with methanol and be transferred in the 5ml measuring bottle, and be diluted to scale, shake up, filter with 0.45 μ m microporous filter membrane, collect subsequent filtrate, promptly.
Algoscopy: accurate reference substance solution 5 μ l, the 15 μ l of drawing, need testing solution 20 μ l inject chromatograph of liquid, measure, and calculate with the two points external standard method logarithmic equation, promptly.
The every ml of this product contains the Radix Astragali with astragaloside (C
41H
68O
14) meter, must not be less than 15 μ g.
Embodiment 6 method of quality control:
Chromatographic condition and system suitability test: with the octadecylsilane chemically bonded silica is filler; 30: 70 acetonitrile-water is mobile phase; Evaporative light scattering detector.Number of theoretical plate calculates with the astragaloside peak should be not less than 3000.
The preparation of reference substance solution: it is an amount of that precision takes by weighing the astragaloside reference substance, adds methanol and make the solution that every 1ml contains 0.5mg, promptly.
The preparation of need testing solution: get the oral liquid 50ml of the embodiment of the invention 1, use water saturation n-butanol extraction 5 times, each 50ml merges ammonia solution thorough washing 3 times of n-butyl alcohol liquid, each 30ml discards ammonia solution, n-butyl alcohol liquid evaporate to dryness, and residue adds water 10ml, heating for dissolving is put coldly, passes through D
101Macroporous adsorptive resins, (internal diameter 1.5cm, long 12cm) with water 100ml eluting, discards water liquid.Reuse 40% ethanol 100ml eluting discards 40% ethanol elution, continues with 70% ethanol 100ml eluting, collects the eluent evaporate to dryness, with dissolve with methanol and be transferred in the 5ml measuring bottle, and be diluted to scale, shake up, filter with 0.40 μ m microporous filter membrane, collect subsequent filtrate, promptly.
Algoscopy: accurate reference substance solution 8 μ l, the 17 μ l of drawing, need testing solution 10 μ l inject chromatograph of liquid, measure, and calculate with the two points external standard method logarithmic equation, promptly.
The every ml of this product contains the Radix Astragali with astragaloside (C
41H
68O
14) meter, must not be less than 13 μ g.
Embodiment 7 method of quality control
Chromatographic condition and system suitability test: with the octadecylsilane chemically bonded silica is filler; 40: 60 acetonitrile-water is mobile phase; Evaporative light scattering detector.Number of theoretical plate calculates with the astragaloside peak should be not less than 3000.
The preparation of reference substance solution: it is an amount of that precision takes by weighing the astragaloside reference substance, adds methanol and make the solution that every 1ml contains 0.5mg, promptly.
The preparation of need testing solution: get the oral liquid 40ml of the embodiment of the invention 1, use water saturation n-butanol extraction 5 times, each 40ml merges ammonia solution thorough washing 3 times of n-butyl alcohol liquid, each 30ml discards ammonia solution, n-butyl alcohol liquid evaporate to dryness, and residue adds water 10ml, heating for dissolving is put coldly, passes through D
101Macroporous adsorptive resins, (internal diameter 1.5cm, long 12cm) with water 100ml eluting, discards water liquid.Reuse 40% ethanol 100ml eluting discards 40% ethanol elution, continues with 70% ethanol 100ml eluting, collects the eluent evaporate to dryness, with dissolve with methanol and be transferred in the 5ml measuring bottle, and be diluted to scale, shake up, filter with 0.50 μ m microporous filter membrane, collect subsequent filtrate, promptly.
Algoscopy: accurate reference substance solution 10 μ l, the 20 μ l of drawing, need testing solution 15 μ l inject chromatograph of liquid, measure, and calculate with the two points external standard method logarithmic equation, promptly.
The every ml of this product contains the Radix Astragali with astragaloside (C
41H
68O
14) meter, must not be less than 22 μ g.
Claims (6)
1. medicine for the treatment of thrombocytopenia, anemia, it is characterized in that: it is made by following bulk drugs:
3.5～6.5 parts in Colla Corii Asini, 140～260 parts of the Radixs Astragali, 105～195 parts of Radix Angelicae Sinensis, 70～130 parts in Fructus Jujubae, 10.5～19.5 parts of Colla cornus cervis.
2. the medicine of treatment thrombocytopenia according to claim 1, anemia is characterized in that: it is made by following bulk drugs:
5 parts in Colla Corii Asini, 200 parts of the Radixs Astragali, 150 parts of Radix Angelicae Sinensis, 100 parts in Fructus Jujubae, 15 parts of Colla cornus cervis.
3. the preparation method of the medicine of treatment thrombocytopenia according to claim 1 and 2, anemia is characterized in that the preparation method of the active component of this medicine is:
1) get the above five tastes, Radix Angelicae Sinensis extracts volatile oil with the way of distillation, and is standby;
2) get Radix Angelicae Sinensis medicinal residues, the Radix Astragali and Fructus Jujubae three flavor medicines and decoct with water twice, be respectively 3,2 hours, amount of water is respectively 5 times, 3 times, filter, merging filtrate is surveyed in the time of 20 ℃, be concentrated into relative density and be 1.23～1.28 clear paste, add ethanol and make determining alcohol reach 65%, fully stir static 24 hours, filter, filtrate recycling ethanol gets herbal extracts such as Radix Angelicae Sinensis, and is standby;
3) Colla Corii Asini, that Colla cornus cervi adds water is an amount of, the heating molten, standby.
4. the preparation method of the oral liquid of treatment thrombocytopenia according to claim 1 and 2, anemia is characterized in that: comprise the following steps:
1) get the above five tastes, Radix Angelicae Sinensis extracts volatile oil with the way of distillation, and is standby;
2) get Radix Angelicae Sinensis medicinal residues, the Radix Astragali and Fructus Jujubae three flavor medicines and decoct with water twice, be respectively 3,2 hours, amount of water is respectively 5 times, 3 times, filter, merging filtrate is surveyed in the time of 20 ℃, be concentrated into relative density and be 1.23～1.28 clear paste, add ethanol and make determining alcohol reach 65%, fully stir static 24 hours, filter, filtrate recycling ethanol gets herbal extracts such as Radix Angelicae Sinensis, and is standby;
3) Colla Corii Asini, that Colla cornus cervi adds water is an amount of, the heating molten, standby;
4) add correctives, add 1) following Radix Angelicae Sinensis volatile oil, 2) following herbal extract, 3 such as Radix Angelicae Sinensis) down Colla Corii Asini and Colla cornus cervi molten liquid and antiseptic, stir, add water to 1000ml, mixing filters, packing.
5. the method for quality control of the oral liquid of treatment thrombocytopenia according to claim 4, anemia is characterized in that content assaying method is:
Chromatographic condition and system suitability test: with the octadecylsilane chemically bonded silica is filler; 30～40: 60～70 acetonitrile-waters are mobile phase; Evaporative light scattering detector; Number of theoretical plate calculates with the astragaloside peak should be not less than 3000;
The preparation of reference substance solution: it is an amount of that precision takes by weighing the astragaloside reference substance, adds methanol and make the solution that every 1ml contains 0.5mg, promptly;
The preparation of need testing solution: get this oral liquid 25～50ml, use water saturation n-butanol extraction 5 times, each 25～50ml merges ammonia solution thorough washing 3 times of n-butyl alcohol liquid, each 30ml discards ammonia solution, n-butyl alcohol liquid evaporate to dryness, and residue adds water 10ml, heating for dissolving is put coldly, passes through D
101Macroporous adsorptive resins, its internal diameter 1.5cm, long 12cm with water 100ml eluting, discard water liquid; Reuse 40% ethanol 100ml eluting discards 40% ethanol elution, continues with 70% ethanol 100ml eluting, collects the eluent evaporate to dryness, with dissolve with methanol and be transferred in the 5ml measuring bottle, and be diluted to scale, shake up, filter with 0.40～0.50 μ m microporous filter membrane, collect subsequent filtrate, promptly;
Algoscopy; Accurate reference substance solution 5～10 μ l, 15～20 μ l of drawing, need testing solution 10～20 μ l inject chromatograph of liquid, measure, and calculate with the two points external standard method logarithmic equation, promptly;
The every ml of this product contains the Radix Astragali with astragaloside C
41H
68O
14Meter must not be less than 13～22 μ g.
6. the method for quality control of the oral liquid of treatment thrombocytopenia as claimed in claim 5, anemia is characterized in that content assaying method is:
Chromatographic condition and system suitability test: with the octadecylsilane chemically bonded silica is filler; 32: 68 acetonitrile-waters are mobile phase; Evaporative light scattering detector; Number of theoretical plate calculates with the astragaloside peak should be not less than 3000;
The preparation of reference substance solution: it is an amount of that precision takes by weighing the astragaloside reference substance, adds methanol and make the solution that every 1ml contains 0.5mg, promptly;
The preparation of need testing solution: get this oral liquid 25ml, use water saturation n-butanol extraction 5 times, each 25ml merges ammonia solution thorough washing 3 times of n-butyl alcohol liquid, each 30ml discards ammonia solution, n-butyl alcohol liquid evaporate to dryness, and residue adds water 10ml, heating for dissolving is put coldly, passes through D
101Macroporous adsorptive resins, this macroporous adsorptive resins internal diameter 1.5cm, long 12cm with water 100ml eluting, discards water liquid; Reuse 40% ethanol 100ml eluting discards 40% ethanol elution, continues with 70% ethanol 100ml eluting, collects the eluent evaporate to dryness, with dissolve with methanol and be transferred in the 5ml measuring bottle, and be diluted to scale, shake up, filter with 0.45 μ m microporous filter membrane, collect subsequent filtrate, promptly;
Algoscopy: accurate reference substance solution 5 μ l, the 15 μ l of drawing, need testing solution 20 μ l inject chromatograph of liquid, measure, and calculate with the two points external standard method logarithmic equation, promptly;
The every ml of this product contains the Radix Astragali with astragaloside C
41H
68O
14Meter must not be less than 15 μ g.
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| CNB2006100171725A CN100361681C (en) | 2006-09-14 | 2006-09-14 | Medicine for treating thrombocytopenia and anemia and its prepn process and quality control method |
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| CN101234172B (en) * | 2008-02-02 | 2010-06-30 | 李顺清 | Method of preparing Chinese medicine for treating qi-deficiency type metrorrhagia |
| CN105982158A (en) * | 2016-06-13 | 2016-10-05 | 国药药材健康产业新疆有限公司 | Health maintenance porridge for improving anemia and application thereof in preparation of other foods |
| CN110840949A (en) * | 2019-12-05 | 2020-02-28 | 福建省南平市人民医院（福建省南平市中医院） | Shengbai oral liquid and preparation method thereof |
| CN115025153A (en) * | 2022-06-15 | 2022-09-09 | 中科健康产业集团股份有限公司 | Natural pharmaceutical composition for nourishing blood and enriching blood |
| CN117398400B (en) * | 2023-12-15 | 2024-03-15 | 吉林敖东集团力源制药股份有限公司 | Pharmaceutical composition for treating anemia |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1075881A (en) * | 1992-12-15 | 1993-09-08 | 吉林省敦化市制药厂 | Blood nourishing decoction |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1075881A (en) * | 1992-12-15 | 1993-09-08 | 吉林省敦化市制药厂 | Blood nourishing decoction |
Non-Patent Citations (1)
| Title |
|---|
| 中华人民共和国卫生部药品标准 中药成方制剂 第18册. 190，药典委员会. 1998 * |
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