CN101181440A - Chinese medicine composition for curing hemopathy as well as preparation method and usage thereof - Google Patents
Chinese medicine composition for curing hemopathy as well as preparation method and usage thereof Download PDFInfo
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Abstract
The invention relates to a Chinese traditional medicine composition for curing hematonosis. The invention is produced by the following Chinese traditional medicine raw materials: green tangerine peel, shizandra, scurfpea fruit, saffron, senega root, mint, gynura segetum, ginseng, radix pseudostellariae and almond. The invention also relates to the production method of the combination and the use used for producing the drug curing hematonosis. The product of the invention has obvious curing effect on hematonosis and improves the nutrition state of patients suffering hematonosis.
Description
Technical field
The present invention relates to the colourless transparent liquid of process distillation extraction from natural Chinese medicinal herb, regeneration with boosting qi and nourishing yin, vital energy regualting and blood circulation-promoting, promotion hematopoietic function recovery, activated bone marrow hematopoietic stem cell, be used for the treatment of hemopathic Chinese medicine compositions such as aplastic anemia, leukemia, thrombocytopenic purpura and preparation method thereof, also relate to the application of said composition in the anti-hematopathy medicine of preparation.
Background technology
Hematopathy also is called disease of hematopoietic system, comprises being primary in disease of hematopoietic system (being primary in myeloid tissue etc. as leukemia) and mainly involving disease of hematopoietic system (as iron deficiency anemia etc.).Hematopathy can be former, and wherein great majority are pernicious changes of congenital hemopoietic function defective or bone marrow composition.Also can be secondary, the disease of other system such as malnutrition, Developmental and Metabolic Disorder and physical chemical factor etc. also can cause untoward reaction to the bone marrow system, and blood or bone marrow composition have obviously changer, also belong to hemopathic category.Disease in the blood system is refractory disease mostly, and morbidity is latent attacks, the condition of illness concealment, even ill, patient Chang Buneng oneself examines and knows, how seeks medical advice because of other diseases or is found during health examination.
Adopting the means of Chinese medicine to treat the hematopathy disease, is a channel extremely leaved for development, and this is because therefore Chinese medicine characteristics such as to have the property of medicine gentle, applied widely are having its original effect aspect treating hematopathy.
Summary of the invention
An object of the present invention is to provide the hemopathic Chinese medicine composition of a kind of treatment, said composition is prepared from by the raw material of Chinese medicine of following weight ratio:
Pericarpium Citri Reticulatae Viride 40 80 Fructus Schisandrae Chinensis 30-70 Fructus Psoraleae 30-70 Stigma Croci 5-15
Radix Polygalae 80-120 Herba Menthae 30-70 Radix Notoginseng 10-50 Radix Ginseng 80-120
Radix Pseudostellariae 30-70 Semen Armeniacae Amarum 10-50.
Preferably, said composition is prepared from by the raw material of Chinese medicine of following weight ratio:
Pericarpium Citri Reticulatae Viride 50-70 Fructus Schisandrae Chinensis 40-60 Fructus Psoraleae 40-60 Stigma Croci 8-12
Radix Polygalae 90-110 Herba Menthae 40-60 Radix Notoginseng 20-40 Radix Ginseng 90-110
Radix Pseudostellariae 40-60 Semen Armeniacae Amarum 20-40.
Most preferably, said composition is prepared from by the raw material of Chinese medicine of following weight ratio:
Pericarpium Citri Reticulatae Viride 60 Fructus Schisandrae Chinensis 50 Fructus Psoraleaes 50 Stigma Crocis 10
Radix Polygalae 100 Herba Menthaes 50 Radix Notoginseng 30 Radix Ginsengs 100
Radix Pseudostellariae 50 Semen Armeniacae Amarums 30.
Chinese medicine composition of the present invention can be made various types of pharmaceutical preparatioies according to actual needs, for example makes oral liquid or injection, and is preferred but be not limited to oral liquid.In order to prepare these preparations, can in compositions of the present invention, add conventional pharmaceutically acceptable auxiliaries as required, selection for adjuvant, those skilled in the art can carry out according to the requirement of dosage form, when for example preparing oral liquid, in the present composition, can add sweeting agent, flavoring agent and antiseptic.For the concrete selection of adjuvant, the present invention's specific restriction useless.
Another object of the present invention provides a kind of preparation method of the present composition, this method comprise clean, dry and above ten flavor raw material of Chinese medicine are ground into coarse powder, cross No. two and sieve, put into the extraction pot of band distillator, add water 5-10 and doubly measure, soaked 2-5 hour, stir 2-5 time therebetween, each 10-20 minute, heating extraction 1-3 hour, it was an amount of to collect distillate, and cold preservation was placed 8-12 hour down, precipitation is filtered.
Subsequently, can preparation of compositions of the present invention be become various dosage forms according to the ordinary skill in the art.For example get filtrate, can add flavoring agent and/or antiseptic if desired, regulate pH value to 7.0, and adjust total amount with sodium hydroxide, embedding, sterilization, packing promptly gets oral liquid of the present invention.
The present invention adopts the preparation technology of the way of distillation, and the volatile ingredient straight run distillation in Radix Ginseng and all the other the 9 flavor medical materials is come out promptly, and technology is simple.So in fact the present invention is exactly the aqueous solution of various volatile ingredients.Preferably described water is distilled water.
Need to prove that method of the present invention is a kind of preferable preparation technique but is not limited to this.Product by the inventive method preparation has good stability.
For many years, adopt Chinese medicine composition of the present invention, particularly the oral liquid treatment hematopathy obtains better curative effect, does not see any toxic and side effects.
Qi depression to blood stasis is the disease of assisting based on deficiency of both QI and YIN because hematopathy is one, is monarch so adopt with Radix Ginseng, Radix Polygalae qi-supplementing, blood-engendering in the side, and Fructus Schisandrae Chinensis, the cloudy blood of Fructus Psoraleae the liver and the kidney tonifying are minister, and Herba Menthae, Pericarpium Citri Reticulatae Viride are regulated the flow of vital energy, and Stigma Croci is invigorated blood circulation and is assistant.Again and Fructus Schisandrae Chinensis, Semen Armeniacae Amarum, Radix Ginseng, Herba Menthae allocate the heart mutually into, and the row motive helps the heart, to promote the operation of blood; Radix Ginseng, Radix Polygalae, Herba Menthae dispersing and lowering lung-QI and towards hundred arteries and veins, Radix Pseudostellariae, Fructus Schisandrae Chinensis, Fructus Psoraleae invigorating the liver and kidney are with promoting generation of vital essence and blood, Radix Ginseng, Fructus Schisandrae Chinensis, spleen reinforcing circulation of qi promoting coordinate hemopoietic, promoting the circulation of blood, system blood to help system blood mutually, and the Radix Notoginseng convergence is with hemostasis.All medicines are harmonious, and reach supplementing QI and nourishing YIN jointly, vital energy regualting and blood circulation-promoting, and marrow is added in the kidney invigorating, the effect of hemopoietic.
[composition] Radix Ginseng, Fructus Schisandrae Chinensis, Stigma Croci etc.
[character] this product is an achromaticity and clarification liquid, gas perfume (or spice), bitter in the mouth.
The regeneration of [function cures mainly] boosting qi and nourishing yin, vital energy regualting and blood circulation-promoting, promotion hematopoietic function recovery, activated bone marrow hematopoietic stem cell is used for the treatment of hematopathys such as aplastic anemia, leukemia, thrombocytopenic purpura.
[usage and dosage] oral 10-30 milliliter, 2-3 time on the one or follow the doctor's advice.
Idol has dizzy sense after [untoward reaction] medication.
[points for attention] 1, period in a medicine are forbidden share with other Chinese medicine.2, period in a medicine is forbidden share with antiallergic agent.3, pungent, the seafood food of period in a medicine fasting.4, as taking other medicines, please Ref Dr or pharmacist before use this product.
For this reason, another object of the present invention provides the application of a kind of present composition in hematopathy medicines such as preparation treatment aplastic anemia, leukemia, thrombocytopenic purpura.
Description of drawings
Accompanying drawing 1 is preparation technology's flow chart of oral liquid of the Chinese medicine composition of invention.
The specific embodiment
Embodiment 1
Oral liquid:
Clean, dry raw material of Chinese medicine and consumption:
Pericarpium Citri Reticulatae Viride 60, Fructus Schisandrae Chinensis 50, Fructus Psoraleae 50, Stigma Croci 10, Radix Polygalae 100, Herba Menthae 50, Radix Notoginseng 30, Radix Ginseng 100, Radix Pseudostellariae 50, Semen Armeniacae Amarum 30.
Method for making: above ten flavor raw material of Chinese medicine are ground into coarse powder, cross sieve No. two, put into the extraction pot of band distillator, add water 1600ml, soaked 2 hours, and stirred therebetween 3 times, each 10 minutes, heating extraction 1 hour, the collection distillate is an amount of, and cold preservation was placed 8-12 hour down, and precipitation filters.
Get filtrate, regulate pH value to 7.0, and adjust total amount to 1000ml with sodium hydroxide.Embedding, sterilization, packing, promptly.
Character: this product is an achromaticity and clarification liquid; Gas perfume (or spice), puckery, little hardship.
Differentiate: get this product 200ml, put in the round-bottomed flask, connect condensing tube (should be short and small) heating and be distilled to about 1 minute of boiling, when treating that crystallization appears in the condensing tube inwall, withdraw thermal source immediately, collect agglomerative crystallization on distillate (about 2-3ml) and the condensing tube inwall.
(1) it is an amount of to take by weighing the crystallization of separating out, and adds ethanol and makes dissolving, and make the solution that every 1ml contains 2.5mg, as need testing solution.According to ultraviolet-visible spectrophotometer method (appendix VA of Chinese Pharmacopoeia version in 2005) test, be blank with ethanol.Measure absorption curve between wavelength 230-350nm, its absorption curve should be consistent with the absorption curve of Radix Ginseng reference substance solution (1ml contains 2.5ml), at wavelength 289 ± 1nm place one maximum absorption band should be arranged.
(2) getting this product distillate, according to ultraviolet visible spectrophotometry (appendix VA of Chinese Pharmacopoeia version in 2005) test, is blank with water.Wavelength place at wavelength 250-350nm measures absorption curve, at 277 ± 1nm place, a maximum absorption band should be arranged.
Check: relative density should be not less than 0.9 (an appendix VII of Chinese Pharmacopoeia version in 2005 A).
PH value should be 5.5-7.5 (an appendix VII of Chinese Pharmacopoeia version in 2005 G).
Other should meet every regulation relevant under the mixture item (appendix IJ of Chinese Pharmacopoeia version in 2005).
Usage and consumption: oral, a 10-30 milliliter, 2-3 time on the one, or follow the doctor's advice.
Embodiment 2
Oral liquid:
Clean, dry raw material of Chinese medicine and consumption:
Pericarpium Citri Reticulatae Viride 40, Fructus Schisandrae Chinensis 30, Fructus Psoraleae 30, Stigma Croci 5, Radix Polygalae 80, Herba Menthae 30, Radix Notoginseng 10, Radix Ginseng 80, Radix Pseudostellariae 30, Semen Armeniacae Amarum 10.
Method for making: above ten flavor raw material of Chinese medicine are ground into coarse powder, cross sieve No. two, put into the extraction pot of band distillator, add water 1600ml, soaked 2 hours, and stirred therebetween 3 times, each 10 minutes, heating extraction 1 hour, the collection distillate is an amount of, and cold preservation was placed 8-12 hour down, and precipitation filters.
Get filtrate, add an amount of sucrose dissolved, regulate pH value to 7.0, and adjust total amount to 1000ml with sodium hydroxide.Embedding, sterilization, packing, promptly.
Embodiment 3
Oral liquid:
Clean, dry raw material of Chinese medicine and consumption:
Pericarpium Citri Reticulatae Viride 80, Fructus Schisandrae Chinensis 70, Fructus Psoraleae 70, Stigma Croci 15, Radix Polygalae 120, Herba Menthae 70, Radix Notoginseng 50, Radix Ginseng 120, Radix Pseudostellariae 70, Semen Armeniacae Amarum 50.
Method for making: above ten flavor raw material of Chinese medicine are ground into coarse powder, cross sieve No. two, put into the extraction pot of band distillator, add water 1600ml, soaked 2 hours, and stirred therebetween 3 times, each 10 minutes, heating extraction 1 hour, the collection distillate is an amount of, and cold preservation was placed 8-12 hour down, and precipitation filters.
Get filtrate, add an amount of sucrose dissolved, regulate pH value to 7.0, and adjust total amount to 1000ml with sodium hydroxide.Embedding, sterilization, packing, promptly.
Embodiment 4
Injection:
Clean, dry raw material of Chinese medicine and consumption:
Pericarpium Citri Reticulatae Viride 50, Fructus Schisandrae Chinensis 40, Fructus Psoraleae 40, Stigma Croci 8, Radix Polygalae 90, Herba Menthae 40, Radix Notoginseng 20, Radix Ginseng 90, Radix Pseudostellariae 40, Semen Armeniacae Amarum 20.
Method for making: above ten flavor raw material of Chinese medicine are ground into coarse powder, cross sieve No. two, put into the extraction pot of band distillator, add water 1600ml, soaked 2 hours, and stirred therebetween 3 times, each 10 minutes, heating extraction 1 hour, the collection distillate is an amount of, and cold preservation was placed 8-12 hour down, and precipitation filters.
Get filtrate, regulate pH value to 7.0, and adjust total amount to 1000ml with sodium hydroxide.Embedding, sterilization, packing, promptly.
Embodiment 5
Clinical trial:
Patients such as the oral liquid treatment chronic aplastic anemia of the application of the invention embodiment 1, hematopathy totally 35 examples prove the curative effect of Chinese medicine composition of the present invention.
The material method:
Case is selected: totally 35 examples are divided into two groups at random.25 examples are used the oral liquid of the embodiment of the invention 1, are the oral liquid group of Chinese medicine composition of the present invention; 10 examples are used the oral liquid mixed type of Chinese medicine composition of the present invention, are the oral liquid combined group of Chinese medicine composition of the present invention.Select 5 examples to make positive control in addition, be matched group.
The oral liquid group of Chinese medicine composition of the present invention, male 13 examples, women 12 examples, the age is 18～66 years old, average 42 years old.Chronic aplastic anemia 6 examples wherein, acute leukemia 8 examples (anxious grain 7 examples, anxious 1 example of drenching), MDS 5 examples (RA 2 examples, RAEB 3 examples), ITP2 example, mixed type anemia 4 examples.The mixed type group, chronic aplastic anemia 2 examples, acute leukemia 4 examples (anxious grain 3 examples, anxious 1 example of drenching), MDS 2 examples (RA 1 example, RAEB 1 example), ITP 2 examples.Matched group, male 3 examples, women 2 examples, 21～58 years old age (average 38 years old), chronic aplastic anemia 2 examples, acute leukemia 2 examples (being anxious grain), MDS 1 example.
Diagnosis and curative effect determinate standard:
Three groups of hematopathy patients all confirm through hemogram, bone marrow smear or groupization dyeing.
Criterion of therapeutical effect:
Produce effects---leukocyte (WBC) raises＞2.0 * 10
9/ L, hemoglobin (Hb) is increased to more than the 110g/L, and platelet (PTS) is increased to 100 * 10
9More than/the L.
Effectively---leukocyte raises 0.5～2.0 * 10
9Between/the L, more than the hemoglobin rising＞20g/L, platelet raises＞20 * 10
9More than/the L.
Invalid---hemogram does not have obvious improvement or more preceding descender after the medication.
Therapeutic Method:
The oral liquid group of Chinese medicine composition of the present invention: every day 2 times, each 1,7 is a course of treatment, intermittently begins for second course of treatment after 2～3 days, uses 2-3 the course of treatment.
The oral liquid combined group of Chinese medicine composition of the present invention: every day 2 times, each 1,7 is a course of treatment, intermittently begins for second course of treatment after 2～3 days, uses 2-3 the course of treatment.It is oral to shake up the back when taking.
Matched group: do not take the oral liquid of Chinese medicine composition of the present invention, only with the conventional therapy medicine for the treatment of chronic aplastic anemia, acute leukemia or MDS.
The result:
One, curative effect: the oral liquid group of Chinese medicine composition of the present invention: produce effects 7 examples, effective 15 examples, total effective rate 88% (22 example), invalid 3 examples.Wherein use oral liquid treatment chronic aplastic anemia 6 examples of Chinese medicine composition of the present invention, produce effects 2 examples, effective 3 examples, invalid 1 example, effective percentage 83%; Treatment MDS 5 examples, produce effects 1 example, effective 4 examples, effective percentage 100%; Treatment mixed type anemia 2 examples, produce effects 1 example, effective 1 example, effective percentage 100%; Treatment acute leukemia 8 examples, produce effects 2 examples, effective 4 examples, invalid 2 examples, effective percentage 75%.Treatment ITP2 example is effectively.The oral liquid mixed type group of Chinese medicine composition of the present invention: produce effects 1 example, effective 7 examples, total effective rate 80% (8 example), invalid 2 examples.Matched group: produce effects 1 example, effective 2 examples, total effective rate 60% (3 example), invalid 2 examples.
Two, hemogram situation of change before and after the treatment: (opinion) as following table 1, table 2
Three, toxic and side effects: the patient all checks liver, renal function.Use in the oral liquid treatment process of Chinese medicine composition of the present invention, liver, renal function injury appear in none example.ALT increased before 2 example treatments were arranged, and 1 routine ALT recovers normal behind the oral liquid treatment of Chinese medicine composition of the present invention, anaphylaxis such as no erythra in the treatment.
Hemogram changes (x) before and after the oral liquid group 25 example treatments of table 1, Chinese medicine composition of the present invention
| Chronic aplastic anemia n=6 | Acute leukemia n=8 | MDS n＝5 | ITP n＝2 | Mixed type anemia n=4 | ||
| Hb g/L | Before | 66 | 72.6 | 67 | 122.5 | 71 |
| After | 85 | 85.3 | 88.8 | 124.5 | 77.5 | |
| WBC ×10 9/L | Before | 3.1 | 5 | 4.1 | 5.1 | 2.4 |
| After | 3.9 | 5.2 | 4.5 | 6.1 | 3.6 | |
| PTC ×10 9/L | Before | 68.8 | 82.5 | 90.1 | 55 | 79.5 |
| After | 76.1 | 94.8 | 92 | 72 | 86 | |
Hemogram changes (x) before and after the oral liquid combined group 10 example treatments of table 2, Chinese medicine composition of the present invention
| Chronic aplastic anemia n=2 | Acute leukemia n=4 | MDS n＝2 | ITP n＝2 | ||
| Hb g/L | Before | 51 | 79.5 | 71.5 | 90 |
| After | 62.5 | 85.5 | 82.5 | 91 | |
| WBC ×10 9/L | Before | 3.0 | 3.1 | 7.6 | 6.6 |
| After | 3.6 | 3.9 | 7.2 | 6.9 | |
| PTC ×10 9/L | Before | 72.5 | 54 | 60.5 | 31 |
| After | 71 | 70 | 74.5 | 34 | |
Discuss: the oral liquid of Chinese medicine composition of the present invention is a kind of pure Chinese medicinal preparation, it is the colourless transparent liquid of process distillation extraction from natural Chinese medicinal herb, have the regeneration of boosting qi and nourishing yin, vital energy regualting and blood circulation-promoting, promotion hematopoietic function recovery, activated bone marrow hematopoietic stem cell, be used for the treatment of hematopathys such as aplastic anemia, leukemia, thrombocytopenic purpura.
By observing hematopathy patient's 35 examples with the oral liquid treatment of Chinese medicine composition of the present invention.Take and effectively to improve blood cell count, hemoglobin, leukocyte, platelet behind this medicine in various degree raising is all arranged.The oral liquid group total effective rate 88% of Chinese medicine composition of the present invention, the oral liquid mixed type group total effective rate 80% of Chinese medicine composition of the present invention.Cooperate original therapeutic scheme can improve hemopathic remission rate.To the pancytopenia that causes after the leukemia combined chemotherapy, can improve leukocyte and platelet count rapidly after the oral liquid through adding Chinese medicine composition of the present invention, reduced hemorrhage and the infection complication, thereby improved remission rate.To ITP, mixed type anemia, data shows also certain curative effect, but due to illness routine less, and its curative effect waits further to observe to inquire into.
Clinical test results shows, the oral liquid of Chinese medicine composition of the present invention has the characteristics rapid-action, that curative effect is high, he can be used for multiple hemopathic hemogram abnormity in clinical practice, as aplastic anemia, leukemia, MPS, ITP, mixed type anemia etc., the oral liquid of Chinese medicine composition of the present invention is safe in utilization, have no side effect.
Embodiment 6
Model case exemplifies:
Case one: king XX, woman, 35 years old.Patient 1986 once caused anemia because of diarrhoea clothes chloromycetin, and the back is hospitalized to have a thorough examination, is diagnosed as aplastic anemia, long-term treatment and poor effect.Check hematochrome 4 gram %, leukocyte 2,000/mm
3, platelet 50,000/mm
3The symptom pale complexion, dizziness headache, order is stuck with paste tinnitus, and heart beating is breathed hard, spiritlessness and weakness, soreness of waist and knee joint, the difficult dreaminess of sleeping, forgetful being afraid of cold, afternoon low grade fever, dryness of the mouth and throat, half congealed during stool, yellow urine, the slight edema of lower limb, extremity skin has petechia, pale tongue, tongue is greasy in vain, and stringy,thready and rapid pulse is unable.The oral liquid of taking Chinese medicine composition of the present invention is after 2 weeks, and all diseases disappear, hemogram blood test pigment 12 gram %, leukocyte 6,000/mm
3, platelet 150,000/mm
3All normal.Hale and hearty, resume work.
Case two: Guo XX, man, 14 years old, student.The patient went to a doctor in July, 1988, and symptom is a pale complexion, and expression in the eyes is dull, and is dizzy refreshing tired, deficiency of QI with disinclination to talk, and indigestion and loss of appetite, gingiva is hemorrhage constantly, existing purpura when subcutaneous, extremity are not warm, and it is half congealed partially to defecate, and a little less than pulse condition was slow, thin lingual fur, light red tongue were not flourish.Check hemoglobin 5 gram %, erythrocyte 2,200,000/mm
3, platelet 5.8 ten thousand/mm
3The oral liquid of taking Chinese medicine composition of the present invention is after 5 weeks, and hemogram checking hemoglobin 15 restrains %, erythrocyte 6,600,000/mm
3, platelet 17.4 ten thousand/mm
3, all normal.Complexion is moist gradually, and spirit takes a turn for the better, and has recovered normal study, after follow up a case by regular visits to 2 years gun-hos.
Case three: all XX, man, 15 years old.The patient intermittently generated heat 3 months, and pale complexion is the anemia looks, the enlargement of neck superficial lymph knot, and skeleton does not have tenderness, and the liver spleen does not touch and is diagnosed as acute myeloblastic leukemia after inspection.Check hematochrome 4.2 gram %, erythrocyte 2,230,000/mm
3, leukocyte 37,500/mm
3, platelet 150,000/mm
3Leukocyte differential count: juvenile cell 19%.Bone marrow smear: myelosis is obviously active.One week of the oral liquid back state of an illness of taking Chinese medicine composition of the present invention begins to take a turn for the better, and hematochrome has risen to 7.5 gram %.To second week, do not see juvenile cell in the tip blood, no hemorrhage and infection.To the 3rd all hematochrome 14.5 gram %, erythrocyte 4,700,000/mm
3, leukocyte 8,600/mm
3, platelet 200,000/mm
3Disease is alleviated substantially, continues to take 3 week of the oral liquid back hemogram checking of Chinese medicine composition of the present invention, and it is normal that the bone marrow smear inspection has all recovered.After follow up a case by regular visits to 3 years gun-hos.
Embodiment 7
Acute toxicity test:
The oral liquid of Chinese medicine composition of the present invention is a kind of pure Chinese medicinal preparation, it is the colourless transparent liquid of process distillation extraction from natural Chinese medicinal herb, have the regeneration of boosting qi and nourishing yin, vital energy regualting and blood circulation-promoting, promotion hematopoietic function recovery, activated bone marrow hematopoietic stem cell, be used for the treatment of hematopathys such as aplastic anemia, leukemia, thrombocytopenic purpura.
Therefore, this medicine has been carried out acute toxicity test in mice, its acute toxicity test is reported as follows:
Choose 20 of NIH kind mices, ♀ ♂ half and half, body weight is 23.52 ± 2.20g (X ± S), press the dosage gastric infusion of 40ml/kg, one day twice, observed no abnormal phenomenon seven, do not have deadly, body weight increases to 27.57 ± 2.61g, and (X ± S) is than increasing weight 17.22% before the administration.
The oral liquid clinical medicine dose of Chinese medicine composition of the present invention is 5mL * 2=10ml every day, become body weight for humans by 60kg, then Cheng Ren oral dose is 10mL/60kg=0.167ml/kg, and mice dosage every day is 40 * 2=80ml/kg, and quite the 80/0.167=480 of people's consumption doubly.
The oral liquid formulations of Chinese medicine composition of the present invention is oral peace bottle, selects 10 of NIH kind mices, and with the dosage tail vein injection of every of 0.5mL, 8-10 at the uniform velocity injects second, observes 72 hours, and no abnormal phenomenon does not have dead.
Result of the test shows: the oral liquid toxicity of Chinese medicine composition of the present invention is less.
Embodiment 8
Long term toxicity test:
The oral liquid of Chinese medicine composition of the present invention is a kind of pure Chinese medicinal preparation, it is the colourless transparent liquid of process distillation extraction from natural Chinese medicinal herb, regeneration with boosting qi and nourishing yin, vital energy regualting and blood circulation-promoting, promotion hematopoietic function recovery, activated bone marrow hematopoietic stem cell, be used for the treatment of hematopathys such as aplastic anemia, leukemia, thrombocytopenic purpura, test report is as follows:
Material and method
60 of the Wistar rats of experimental animal: 7-8 health in age in week, male and female half and half are provided by Shanxi Medical College's Experimental Animal Center.Observe a week before the test, adopt randomized blocks that rat is divided into three groups, 20 every group, male and female half and half, sub-cage rearing.Periodic logging rats eating amount is freely drunk water.Claim body weight weekly one time.
Tried thing and dosage: " oral liquid of Chinese medicine composition of the present invention " is the plurality of Chinese distillation extraction, the supernatant liquid of purification.
The dosage group is the requirement by acute toxicity testing result and new Chinese medicine toxicologic study guide, establishes two dosage groups of height and a matched group.High dose is 1200g/kg, is equivalent to 70 times of clinical application amount, and low dose group is 500g/kg, is equivalent to bright 30 times of clinical application.
Route of administration and method: adopt administration by gavage.Irritate body of stomach long-pending by body weight 1% wait not even depth administration of capacity.Every day 1 time, 6 days weekly, amounted to for 8 weeks.Press weekly body weight change during the administration and adjust dosage.
Observation index:
Ordinary circumstance: observe the outward appearance sign every day, behavioral activity, urine excrement situation, food-intake.Weigh weekly to observe and change.
Hematological examination: get 10 rats (male and female half and half) at random for every group, before administration, the 4th week and the 8th week after the administration, get blood at the tail vein, erythrocyte, leukocyte are tested by " national Clinical Laboratory rule of operation " requirement with indexs such as classification, platelet, reticulocyte and content of hemoglobin.
Blood biochemical is learned and checked: test proceeded to for the 4th week and the 8th week, in the blood vessel blood sampling of thigh portion, measured serum alanine transaminase (ALT), total bilirubin (T--BIL), blood urea nitrogen (BUN) and creatinine (CRE) four indices.
Rat is dissected and histopathologic examination: experiment finishes, get 10 rats (male and female half and half) for every group, thigh portion blood vessel sacrificed by exsanguination, the conventional dissection, observe the mode of appearance of each internal organs, color etc., and internal organs such as the heart, liver, spleen, lung, kidney, brain are weighed, calculate the percentage ratio of itself and body weight, i.e. organ coefficient.The pathology method is handled routinely then, the histopathologic examination of doing the heart, liver, spleen, lung, kidney, brain and femur.
Statistical procedures: adopt T check and F check.Data machine are as calculated handled.
The result:
General state and body weight change: during the administration, each treated animal general state, movable normal, the no abnormality seen reaction.Administration group and matched group food-intake are close substantially.Administration group and matched group body weight gain trend basically identical illustrate that long term administration do not have obvious influence to growth of animal.Male Mus or each administration group weight gain value of female Mus are compared no significant difference (P＞0.05) with matched group.
Hematological indices: rat hemogram check result is listed in table 3,4,5.Find out by table 3 and table 4, " oral liquid of Chinese medicine composition of the present invention " height, end dosage group erythrocyte, leukocyte and classification, platelet and content of hemoglobin be 4 week and 8 weeks before administration, after the administration, compare with matched group, P＞0.05 illustrates that medicine does not have obvious influence to above-mentioned each index.
Blood biochemical is learned index: test proceeded to for the 4th week and the 8th week, in the blood vessel blood sampling of thigh portion, measured serum alanine transaminase (ALT), total bilirubin (T--BIL), and blood urea nitrogen (BUN) and creatinine (CRE) four indices the results are shown in table 5.
Organ weights: each organizes organ weights such as the heart, liver, spleen, lung, kidney, brain and organ coefficient is listed in table 6.
Histopathologic examination: off-test, rat is dissected, and does not find the obvious change of organs such as the heart, liver, spleen, lung, kidney, brain.Histopathologic examination does not find that pathological change is arranged yet, and shows that long term administration do not have obvious damage to each organs and tissues.
Brief summary:
Continuous 8 weeks pour into " oral liquid of Chinese medicine composition of the present invention " to rat oral, and dosage is 70 times and 30 times of clinical consumption, and the rat general state is good, no abnormal performance, and each organizes bodyweight difference does not have significance, and the rat normal growth is not had obvious influence.
Continuous 8 all administrations, the rat reticulocyte significantly increases (table 4), learns other indexs of liquid and changes not significantly (table 6), illustrate " oral liquid of Chinese medicine composition of the present invention " but hemopoietic function improvement." oral liquid of Chinese medicine composition of the present invention " the long term toxicity test result show, finds no pathological change (table 3).
Above result of the test shows, " oral liquid of Chinese medicine composition of the present invention " life-time service, and no overt toxicity is safe Chinese medicine preparation.
Table 3, " oral liquid of Chinese medicine composition of the present invention " long term toxicity test hemogram result (X ± S)
| Matched group | Low dose group | High dose group | P | ||
| Before the administration | Number of animals (only) | 10 | 10 | 10 | |
| Erythrocyte ( *10/L) | 70.5±1.54 | 6.87±0.76 | 6.46±1.22 | ＞0.05 | |
| Leukocyte ( *10/L) | 16.03±5.43 | 15.07±4.25 | 18.00±2.82 | ＞0.05 | |
| Hemoglobin (g/L) | 141.28±14.94 | 145.12±10.84 | 140.23±5.81 | ＞0.05 | |
| Platelet ( *10/L) | 769.20±176.10 | 734.10±165.77 | 614.30±243.57 | ＞0.05 | |
| Around after the administration | Number of animals (only) | 10 | 10 | 10 | |
| Erythrocyte ( *10/L) | 8.03±1.26 | 8.07±0.31 | 7.66±1.10 | ＞0.05 | |
| Leukocyte ( *10/L) | 19.96±2.84 | 19.72±3.57 | 19.42±2.09 | ＞0.05 | |
| Hemoglobin (g/L) | 140.93±14.47 | 150.37±6.99 | 123.79±44.67 | ＞0.05 | |
| Platelet ( *10/L) | 668.00±137.78 | 667.20±156.38 | 601.44±129.53 | ＞0.05 | |
| 8 weeks after the administration | Number of animals (only) | 10 | 10 | 10 | |
| Erythrocyte ( *10/L) | 7.62±1.15 | 7.43±1.83 | 7.09±1.32 | ＞0.05 | |
| Leukocyte ( *10/L) | 19.23±3.69 | 16.81±1.99 | 19.67±3.49 | ＞0.05 | |
| Hemoglobin (g/L) | 154.96±12.40 | 147.22±13.03 | 144.54±9.57 | ＞0.05 | |
| Platelet ( *10/L) | 747.30±111.48 | 680.80±163.92 | 763.33±111.09 | ＞0.05 |
Table 4, " oral liquid of Chinese medicine composition of the present invention " are to the influence of reticulocyte (%, X ± S)
| Group | Number of animals | Before the administration | 4 weeks after the administration | 8 weeks after the administration | P |
| Contrast | 10 | 2.05±1.13 | 1.40±0.69 | 2.18±1.34 | |
| Low dosage | 10 | 1.93±1.17 | 2.13±1.07 | 6.75±1.35 | ＜0.01 |
| High dose | 10 | 2.11±1.12 | 2.21±0.91 | 7.07±1.91 | ＜0.01 |
| P | ＞0.05 | ＞0.05 | ＞0.05 |
Table 5, differential blood count result (%, X ± S)
| Matched group | Low dose group | High dose group | ||
| Before the administration | Neutrophilic leukocyte | 16.70±6.23 | 9.40±5.20 | 15.33±4.74 |
| Lymphocyte | 82.30±6.23 | 90.20±5.00 | 83.22±3.79 | |
| Mononuclear cell | 0.90±0.70 | 0.40±0.80 | 0.00 | |
| Eosinophil leucocyte | 0.10±0.30 | 0.00 | 0.30±0.40 | |
| 4 weeks after the administration | Neutrophilic leukocyte | 16.40±8.20 | 13.70±5.27 | 17.56±6.09 |
| Lymphocyte | 83.10±8.57 | 86.10±5.28 | 82.33±0.85 | |
| Mononuclear cell | 0.30±0.30 | 0.00 | 0.00 | |
| Eosinophil leucocyte | 0.20±0.20 | 0.00 | 0.10±0.20 | |
| 8 weeks after the administration | Neutrophilic leukocyte | 18.90±11.45 | 9.70±3.35 | 13.89±9.91 |
| Lymphocyte | 80.30±11.39 | 89.70±3.41 | 85.22±0.51 | |
| Mononuclear cell | 0.30±0.90 | 0.10±0.10 | 0.00 | |
| Eosinophil leucocyte | 0.50±0.60 | 0.50±0.60 | 0.90±0.90 | |
Table 6, blood biochemical are learned index determining result (X ± S)
| 4 weeks after the administration | 8 weeks after the administration | |||||||
| ALT | I-BIL | BUN | Cre | ALT | I-BIL | BUN | Cre | |
| Ka Menshi unit | mg/dl | mg/dl | mg/dl | Ka Menshi unit | mg/dl | mg/dl | mg/dl | |
| Contrast | 35±16 | 0.24±0.1 5 | 14.79±3.09 | 2.20±0.46 | 38±23 | 0.25±0.18 | 16.98±8.21 | 1.58±0.70 |
| Low dosage | 35±13 | 0.17±0.1 5 | 16.64±2.23 | 2.67±0.97 | 40±19 | 0.11±0.07 | 16.20±3.15 | 1.75±0.29 |
| High dose | 34±15 | 0.23±0.2 5 | 15.73±2.40 | 2.81±0.88 | 42±20 | 0.12±0.11 | 15.40±2.13 | 2.00±0.44 |
Table 7, respectively organize relatively (X ± S) of organ coefficient
| Matched group | Low dose group | High dose group | P | ||
| The dirty heart of device | Weight (gram) | 0.94±0.12 | 0.89±0.08 | 0.92±0.09 | ＞0.05 |
| Coefficient | 0.37±0.05 | 0.37±0.03 | 0.37±0.03 | ||
| Liver | Weight (gram) | 9.67±1.58 | 9.27±1.89 | 9.31±1.12 | ＞0.05 |
| Coefficient | 3.78±0.54 | 3.37±0.37 | 3.77±0.20 | ||
| Spleen | Weight (gram) | 0.86±0.14 | 0.82±0.15 | 0.86±0.16 | ＞0.05 |
| Coefficient | 0.34±0.08 | 0.34±0.08 | 0.33±0.06 | ||
| Lung | Weight (gram) | 1.27±0.28 | 1.15±0.14 | 1.14±0.10 | ＞0.05 |
| Coefficient | 0.49±0.07 | 0.47±0.04 | 0.46±0.05 | ||
| Kidney | Weight (gram) | 1.79±0.23 | 1.70±0.25 | 1.70±0.24 | ＞0.05 |
| Coefficient | 0.70±0.07 | 0.69±0.04 | 0.68±0.05 | ||
| Brain | Weight (gram) | 1.57±0.08 | 1.56±0.11 | 1.58±0.08 | ＞0.05 |
| Coefficient | 0.62±0.11 | 0.65±0.12 | 0.64±0.09 |
Embodiment 9
The stability of product of the present invention: carry out repeatedly stability test at various products of the present invention.Test comprises that high temperature quickens and room temperature is placed.Show that all product of the present invention has good stability.The oral liquid that shows product embodiments 1 of the present invention in the table 8 is at the steadiness of placing 18 months.
More than embodiments of the invention are had been described in detail, but described content only is preferred embodiment of the present invention, can not be considered to be used to limit practical range of the present invention.All equalizations of doing according to the present patent application scope change and improve etc., all should still belong within the patent covering scope of the present invention.
The stable experimental data of the oral liquid clinical medicine of table 8, Chinese medicine composition of the present invention
| The sample lot number investigation time is investigated project | 20050212 | |||||||
| Of that month 2005.3.10 | January 2005.4.10 | February 2005.5.10 | March 2005.6.10 | June 2005.9.10 | December 2006.3.10 | Ten August 2006.9.10 | ||
| Appearance character | Achromaticity and clarification liquid | Achromaticity and clarification liquid | Achromaticity and clarification liquid | Achromaticity and clarification liquid | Achromaticity and clarification liquid | Achromaticity and clarification liquid | Achromaticity and clarification liquid | |
| Differentiate | (1) | It is up to specification to be positive reaction | It is up to specification to be positive reaction | It is up to specification to be positive reaction | It is up to specification to be positive reaction | It is up to specification to be positive reaction | It is up to specification to be positive reaction | It is up to specification to be positive reaction |
| (2) | It is up to specification to be positive reaction | It is up to specification to be positive reaction | It is up to specification to be positive reaction | It is up to specification to be positive reaction | It is up to specification to be positive reaction | It is up to specification to be positive reaction | It is up to specification to be positive reaction | |
| Routine examination | PH | 5.8 | 5.8 | 5.8 | 5.8 | 5.8 | 5.8 | 5.8 |
| Other | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | |
| Health examination | Assorted bacterium | ＜10/9 | ＜10/9 | ＜10/9 | ＜10/9 | ＜10/9 | ＜10/9 | ＜10/9 |
| Mycete | ＜10/9 | ＜10/9 | ＜10/9 | ＜10/9 | ＜10/9 | ＜10/9 | ＜10/9 | |
| Large intestine | Do not detect | Do not detect | Do not detect | Do not detect | Do not detect | Do not detect | Do not detect | |
| Demodicid mite lives | Do not detect | Do not detect | Do not detect | Do not detect | Do not detect | Do not detect | Do not detect | |
Claims (6)
1. treat hemopathic Chinese medicine composition for one kind, it is characterized in that: said composition is prepared from by the raw material of Chinese medicine of following weight ratio:
Pericarpium Citri Reticulatae Viride 40-80 Fructus Schisandrae Chinensis 30-70 Fructus Psoraleae 30-70 Stigma Croci 5-15
Radix Polygalae 80-120 Herba Menthae 30-70 Radix Notoginseng 10-50 Radix Ginseng 80-120
Radix Pseudostellariae 30-70 Semen Armeniacae Amarum 10-50.
2. the hemopathic Chinese medicine composition of a kind of treatment according to claim 1 is characterized in that: said composition is that the raw material of Chinese medicine by following weight ratio is prepared from:
Pericarpium Citri Reticulatae Viride 50-70 Fructus Schisandrae Chinensis 40-60 Fructus Psoraleae 40-60 Stigma Croci 8-12
Radix Polygalae 90-110 Herba Menthae 40-60 Radix Notoginseng 20-40 Radix Ginseng 90-110
Radix Pseudostellariae 40-60 Semen Armeniacae Amarum 20-40.
3. the hemopathic Chinese medicine composition of a kind of treatment according to claim 1 and 2 is characterized in that: said composition is that the raw material of Chinese medicine by following weight ratio is prepared from:
Pericarpium Citri Reticulatae Viride 60 Fructus Schisandrae Chinensis 50 Fructus Psoraleaes 50 Stigma Crocis 10
Radix Polygalae 100 Herba Menthaes 50 Radix Notoginseng 30 Radix Ginsengs 100
Radix Pseudostellariae 50 Semen Armeniacae Amarums 30.
4. treat hemopathic Chinese medicine composition for described any one group according to claim 1-3, it is characterized in that: described compositions is oral liquid or injection.
5. according to the described any one group of preparation method for the treatment of hemopathic Chinese medicine composition of claim 1-3, it is characterized in that: this method comprise with described ten flavor raw material of Chinese medicine clean, crushed after being dried becomes coarse powder, crosses sieve No. two, put into the extraction pot of band distillator, add water 5-10 and doubly measure, soaked 2-5 hour, stir 2-5 time therebetween, each 10-20 minute, heating extraction 1-3 hour, it was an amount of to collect distillate, and cold preservation was placed 8-12 hour down, precipitation is filtered.
6. a kind of preparation method for the treatment of hemopathic Chinese medicine composition according to claim 5 is characterized in that: further filtrate regulated pH value to 7.0 with sodium hydroxide, and adjusts total amount, and embedding, sterilization, packing promptly gets oral liquid.
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| CN103071041A (en) * | 2013-02-06 | 2013-05-01 | 孙彩霞 | Chinese medicinal preparation for treating anemia and preparation method |
| CN105362887A (en) * | 2015-12-02 | 2016-03-02 | 钊桂英 | Prescription for treating leukemia and preparation method |
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| CN1061846C (en) * | 1997-07-30 | 2001-02-14 | 黄碧有 | Traditional Chinese medicine prescription for tonifying the kidney reinforcing the spleen and nourishing the blood and preparation process |
| CN1255361A (en) * | 1999-09-10 | 2000-06-07 | 刘福明 | Multifunctional health-care wine |
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| CN103071041A (en) * | 2013-02-06 | 2013-05-01 | 孙彩霞 | Chinese medicinal preparation for treating anemia and preparation method |
| CN103071041B (en) * | 2013-02-06 | 2014-07-16 | 孙彩霞 | Chinese medicinal preparation for treating anemia and preparation method |
| CN105362887A (en) * | 2015-12-02 | 2016-03-02 | 钊桂英 | Prescription for treating leukemia and preparation method |
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