CN1306848A - Chinese medicine preparation for preventing and treating leucocytopenia and its preparation process - Google Patents
Chinese medicine preparation for preventing and treating leucocytopenia and its preparation process Download PDFInfo
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Abstract
The Chinese medicine preparation consists of Chinese angelica, Astragalus membranaceus, Codonopsis Pilosulae, Lycium chinense, privet fruit and other 5 to 7 kinds of Chinese medicinal materials. It has the functions of invigorating spleen, benefiting kidney, invigorating vital energy and creating blood, and it is used to treat leucocytopenia caused by chemotherapy, radiotherapy and other reason and may be also used as tonic.
Description
The invention belongs to the field of Chinese medicines, relate to the Chinese medicine preparation and the preparation technology thereof that treat leukopenia.
When human body peripheral blood numeration of leukocyte continues to be lower than 4 * 10
9During/L, be called leukopenia.Its cause of disease has secondary causes such as chemical, radioactivity, infectivity.This disease shows as: lusterless complexion or sallow, have a dizzy spell, weak, low grade fever night sweat, feel sick, inappetence, immunity of organisms lowly, is easily caught a cold and bring out multiple disease, has a strong impact on people's quality of life and health level.This disease Western medicine commonly used such as batilol, leucogen, adenine phosphate treatment, effect is not ideal, and its effective percentage only was 44.26～66.70% (Chen Huizhen etc., Chinese Chinese and western medicine magazine, in December, 1992 third phases; Zhu Yi etc., journal of shanghai Chinese medicine, in December, 1992; Wang Hai etc., Beijing traditional Chinese medical science, the second phase in 1992).Use hormone, lithium salts treatment, though curative effect has raising, side effect is bigger.Use treatments such as imported medicine SHENGBAINENG, curative effect is better, but costs an arm and a leg.Carry out determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs and use Chinese medical theory, often obtain good effect.
The purpose of this invention is to provide a kind of Chinese medicine preparation and preparation technology who prevents and treats leukopenia, this Chinese medicine preparation effective percentage height has no side effect.
The Chinese medicine of preventing and treating leukopenia of the present invention is characterized in that it being to be made by following parts by weight of traditional Chinese medicines raw material: Radix Angelicae Sinensis 9～12, the Radix Astragali 9～30, Radix Codonopsis or Radix Ginseng 9～15, Fructus Lycii 9～15, Fructus Ligustri Lucidi 9～15, Caulis Spatholobi or Colla Corii Asini 10～30, Pericarpium Citri Reticulatae 6～10, Fructus Jujubae 9～12, Radix Glycyrrhizae 6～12.
Described raw material of Chinese medicine preferably also comprises 1～3 kind in Radix Rehmanniae Preparata 10～30, Poria 9～15, the Fructus Hordei Germinatus 6～15.
Prescription of the present invention is a monarch drug with Radix Angelicae Sinensis, the Radix Astragali, when being classified as the key medicine of enriching blood, and sweet in the mouth, suffering, warm in nature, can enrich blood and can promoting the circulation of blood and the leucogen; The Radix Astragali, sweet temperature QI invigorating, the yang invigorating consolidating superficial resistance, two medicine mutual reinforcements between are usefulness, help the QI and blood alternate altogether.Radix Codonopsis, QI invigorating, promoting the production of body fluid nourishes blood kind controls interior deficiencyly, and to help the power of Radix Astragali QI invigorating, the gas of big spleen reinforcing lung is as a means of the source of hemopoietic; Radix Rehmanniae Preparata, Caulis Spatholobi will product for enriching blood, the Radix Rehmanniae Preparata nourishing YIN and benefiting blood, and spermatogenesis is mended marrow, and Caulis Spatholobi can be enriched blood and can promoting the circulation of blood, and tonify without causing stagnation to help the merit of Chinese angelica blood supplementing, more uses Fructus Lycii, Fructus Ligustri Lucidi prosperous with the smart sufficient blood of nourishing kidney the liver benefiting; Five medicines are enrich blood power work of minister, and assistant is with in the Poria spleen invigorating benefit, Fructus Hordei Germinatus, Pericarpium Citri Reticulatae help digestion regulate the flow of vital energy in case heavily mend grow greasy; Fructus Jujubae is gone into the blood system invigorating the heart and spleen, and be good at and seek, the Radix Glycyrrhizae invigorating the spleen and replenishing QI, and can coordinating the actions of various ingredients in a prescription, two medicines bring out the best in each other for making.All medicines share the merit of holding benefiting qi and nourishing blood, tonifying speen and tonifying kidney altogether.
Radix Codonopsis of the present invention can substitute with Radix Ginseng, and Caulis Spatholobi can substitute with Colla Corii Asini.
The above each raw material of Chinese medicine can be made acceptable various dosage forms on the Chinese medicine, and the present invention introduces a kind of oral liquid formulation.
The technology of preparation oral liquid is as follows: each raw material of Chinese medicine decocts with water, decoction liquor after filtration, concentrate and to obtain the brown concentrated solution, it is that 55～70% ethanol carries out cold preservation that the brown concentrated solution adds concentration, the cold preservation after-filtration, reclaim ethanol, obtain brownish red water liquid, promptly obtain oral liquid through cold preservation, filtration, adjustment capacity again.
Described refrigerated storage temperature is 2～10 ℃.
The effective ingredient of each raw material of Chinese medicine mostly is water soluble ingredient, therefore be that to extract water-soluble substances to greatest extent be guarantee the preparation curative effect basic to solvent with water, each raw material of Chinese medicine adopts decocting to boil three times mode, each amount of water is respectively 8,6,6 times of raw material of Chinese medicine gross weight, and each decocting time is 1～1.5 hour.Behind the medical filtration, contain a large amount of water, boil off part water so concentrate earlier, the weight of concentrated solution can be 2 times of raw material of Chinese medicine gross weight.When boiling,, removes decocting so employing adds the cold preservation of low concentration alcohol with concentrated solution because of having proposed invalid components such as a large amount of macromole phenols, resin simultaneously.Many effective ingredient of considering all medicines are polysaccharide, though high concentration alcohol can make the clarity of medicinal liquid better, but can cause polysaccharide to lose, therefore adopt low concentration alcohol cold preservation (more than 48 hours) filtering and impurity removing matter, reclaim behind the ethanol the deimpurity method of cold preservation once more, both guaranteed clarity, preserved effective ingredient again to greatest extent, make the quality of the pharmaceutical preparations stable, curative effect is reliable.The adjustment capacity is to make the weight of filtrate identical with the gross weight of raw material of Chinese medicine at last.
Function of the present invention with cure mainly: tonifying speen and tonifying kidney, qi-supplementing, blood-engendering, be used to prevent and treat the leukopenia that causes because of chemotherapy, radiotherapy or other multiple reasons, also can be used as tonic invigorator and take.With the oral liquid is example, one time 10～20 milliliters, twice of every day.Chemotherapy, radiotherapy or contact may cause that taking this medicine before the situation such as leukopenic factor can play the leukopenic effect of prevention.The patient who suffers from leukopenia there is therapeutical effect.
Advantage of the present invention:
1, the present invention is a pure Chinese medicinal preparation, does not contain any additives, taking convenience, moderate cost.
2, through toxicologic study, safety has no side effect.
3, pharmacodynamic study proves: (1) can significantly resist the leukopenia that cyclophosphamide (CTX) causes, relatively leukocyte increasing; (2) can improve the active degree of medullary cell, promote the new life of bone marrow nucleated cell, have the protection medullary cell, promote the effect of bone marrow hematogenesis; (3) can safeguard the histiocytic integrity of liver spleen, increase the liver Kupffer, the splenic lymphonodules number obviously be increased, tunicle lower limb district leucocyte hyperplasia.Illustrate that said preparation can protect liver spleen histiocyte, immunity that again can enhancing body can also promote the generation of extramedullary hemopoiesis kitchen range; (4) can increase the weight of thymus and spleen, effect with enhancing human body immunity power; (5) has appetitive effect.
4, show through clinical research: have the effect of tonifying speen and tonifying kidney, qi-supplementing, blood-engendering, can improve quantity of leucocyte, improve the clinical symptoms of leukopenia, have obvious curative effects for the leukopenia that causes because of occupational factor, chemotherapy and other reasons.Effective percentage can reach more than 81%.
The drug inspection that the oral liquid sample that the present invention is made carries out is reported as follows:
Inspection item: standard code assay
Character should be brown liquid, and sweet in the mouth is a brown liquid, sweet in the mouth
Discriminating should detect astragaloside and detect astragaloside
Check:
PH value 4.0～5.0 4.5
Relative density should be not less than 1.060 1.074
Bacterial population must not be crossed 100/milliliter less than 10/milliliter
Mycete and yeast count must not be crossed 100/milliliter less than 10/milliliter
Escherichia coli must not detect
The demodicid mite that lives must not detect
Assay contains Radix Angelicae Sinensis in ferulic acid, should be no less than 12.3 μ g/ml
10μg/ml
Below be the experiment of anxious poison experiment and leukogenic effect effect:
One, experiment material:
Animal: Kunming kind white mice, body weight 20+2g is provided by the Chinese Academy of Medical Sciences animal center of breeding.
Medicine: oral liquid 10ml bottle of the present invention, every milliliter contains crude drug 1g, faces with preceding to concentrate or be diluted to desired concn with water recently distilled.Cyclophosphamide (CTX) 200mg/ bottle, Shanghai No.12 Pharmaceutical Factory produces, lot number: 921203, face with preceding with physiological saline solution and be diluted to desired concn.
Two. experimental technique and result
(1) acute toxicity test (maximum tolerance determination):
Get 80 white mice and be divided into 4 groups at random, 20 every group, male and female half and half.Use the oral liquid of the present invention of variable concentrations to irritate stomach 3 times in one day respectively, observed in detail 7 days, and the response situation of record mice.The multiple that calculates total dosage and be equivalent to intend recommending clinical application the results are shown in Table 1.
Table 1. oral medicine liquid tolerance test of the present invention situation (n=20)
| The other g/kg.d of group dosage | Suitable clinical application multiple | Response situation | Dead number of elements | The Liver and kidney pathological change |
| ????1????100???? ????2????180???? ????3????240??? ????4????330??? | ????100?? ????180?? ????240?? ????330?? | Nothing only second day stool is few rare | ????0 ????0 ????0 ????0 | Do not have |
This test Cmax maximal dose is used 330g/kg.d, and this dosage is equivalent to 330 times of clinical application, and experimental animal is all survived, none death.Illustrate that experimental animal is very big to the dosis tolerata of this medicine, LD
50Can't measure, the drug safety of said preparation is reliable.
(2). rise test in vain:
Get 78 of male mices, be divided into 6 groups at random, 13 every group, get blood from the tail point, the artificial numeration of leukocyte of microscopically, leukocyte count there was no significant difference between group.Day by day give institute's reagent thing then, irritate stomach every day twice, wherein matched group and CTX group is irritated stomach with normal saline and is handled (0.5ml), administration the 4th day, give lumbar injection CTX 100mg/Kg.d by the mice ABW, continue administration again after four days, leukocyte count is surveyed in blood sampling, the result learns processing by statistics, sees Table 2.
Table 2. oral liquid of the present invention (various dose) is to leukocytic shadow (n=13)
| Group | Dosage g/kgd | Leukocyte count (* 10 9/L) ????x±s | Compare with the CTX group |
| Contrast CTX the present invention+CTX | ????0.1 ????5.0 ????25.0 ????50.0 ????80.0 | ?8.1730±2.6708?? ?2.9654±1.3993?? ?3.6269±1.4719 ?5.2269±1.9108?? ?5.4385±1.4692?? ?5.8731±2.1120 | ?P＜0.001 ?p＜0.01 ?p＜0.001 ?p＜0.001 |
Table 2 as seen, oral liquid of the present invention is in the toxicity of antagonism CTX, hemopoietic function protecting, relative leukocyte increasing has the effect of highly significant, and strengthens with the increase of dosage.The dose-effect regression equation is between produce effects dosage group: Y=4.9011+0.0125X r=0.9896
(3). immunologic function and appetite test:
Get 30 of male mices, be divided into three groups at random, every group 10, matched group and CTX group are with normal saline twice filling every day stomach (0.5ml/ time), and reagent group dosage is irritated stomach at twice with 25g/kg.d, continuous 12 days, four, eight days respectively to CTX group and reagent group lumbar injection CTX (100mg/kg) each once, the quantitative foodstuff of twice input every day, and write down the situation of suffering from indigestion of each treated animal; The 13 day eye socket sacrificed by exsanguination cutd open and got spleen, thymus is weighed, and the result learns processing by statistics, sees Table 3.
Table 3. oral liquid of the present invention is to the influence (n=10) of spleen, thymic weight and appetite
| Group | The heavy mg of spleen (x ± s) | The heavy mg of thymus (x ± s) | The amount of suffering from indigestion g (x ± s) |
| Matched group CTX organizes SBY+CTX | ?102.2±+51.9 *?64.0±17.1 ?111.0±43.8 * | 73.3±15.0 ***16.0±12.6 28.0±12.3 * | 3.91±3.51 **9.41±5.54 3.89±4.25 * |
Annotate: compare with the CTX group: * P＜0.05 * * P＜0.01 * * * P＜0.001
As shown in Table 3, oral liquid of the present invention has significant antagonism for the immunosuppressive action of CTX, can increase thymic weight relatively, and the human body immunity improving ability is offset the appetite that CTX causes and descended, and increases spleen and heavily reaches and receive appetite, illustrates that its spleen reinforcing effect is definite.
Three. discuss
This experiment confirm oral liquid of the present invention can significantly resist toxic and side effects such as the immunosuppressant, gastrointestinal reaction of CTX, and leukocyte increasing promotes hemopoietic function relatively, and human body immunity improving power promotes appetite.So can think that said preparation has the effect that tonifying speen and tonifying kidney, QI invigorating rise blood, and said preparation is safe.Therefore, can be used for preventing and treating the leukopenia that chemotherapy, radiotherapy and other reasons cause, be particularly useful for the patient of asthenia of both the spleen and kidney, insufficiency of vital energy and blood, also can be used as tonic invigorator and take.
Below be the experiment of oral liquid of the present invention to cell substitution function and liver spleen tissue influence:
Oral liquid of the present invention can significantly resist toxic and side effects such as the immunosuppressive action, gastrointestinal reaction of CTX, and leukocyte increasing improves body and exempts from the ability that presses down relatively, promotes appetite, has the effect of tonifying speen and tonifying kidney, qi-supplementing, blood-engendering.For further inquiring into the pharmacological action of oral liquid of the present invention, we have carried out following experiment again.
One. experiment material
Animal: Kunming kind white mice, male, body weight 20 ± 2g is provided by the Chinese Academy of Medical Sciences animal center of breeding.
Medicine: oral liquid of the present invention (SBY), the 10ml/ bottle, every milliliter contains crude drug 1g; Cyclophosphamide (CTX), the 200mg bottle, Shanghai No.12 Pharmaceutical Factory produces, lot number: 921203, face with preceding and be diluted to desired concn with normal saline.
Two. method and result
(1). the cell substitution function test:
Get 36 of mices, be divided into four groups at random, 9 every group.1, uses normal saline for 2 groups, 3, irritate stomach with SBY for 4 groups, every day twice, each 0.5ml/20g (being equivalent to crude drug 25g/Kg.d), successive administration 13 days, 2,3 groups in administration in the 8th, nine, ten days, every day lumbar injection CTX once, dosage is 120mg/kg, last administration was after 1 hour at the 13 day, the mice dislocation of cervical vertebra is put to death, cut open and get a femur and go out the bone marrow inner cell with 3% acetate solution 10ml, microscopically is manually counted the bone marrow nucleated cell number; Get another root femur and make bone marrow smear, Wright's staining is examined under a microscope the medullary cell active degree, hypertrophy bad note-1, active proliferation note 1, obviously active note 2; The above results is learned processing by statistics, sees Table 4.
(2). to the influence of liver spleen tissue:
Experimental technique cuts open behind the execution mice and gets the liver spleen with " cell substitution functional experiment ", the formalin fixed with 10%, and section statining is examined under a microscope, and the results are shown in Table 5.
When the Cheng Shi histology pointed out that the animal bone marrow hemopoietic function is suppressed, its liver spleen was organized and is still had an extramedullary hemopoiesis function, and the grain of mice spleen is that hemopoietic focus generates the position near splenic capsule, girder or splenic lymphonodules place that wrecks; The liver Kupffer Cell has endocytosis, participates in effects such as lipoprotein metabolism, immunne response, antitumor.By table 5 as seen, oral liquid of the present invention has protective effect to the liver spleen, can promote the hypertrophy of Kupffer Cell and the extramedullary hemopoiesis of liver spleen, can obviously improve the quantity of splenic lymphonodules.Binding immunoassay function and appetite test can prove further that said preparation has the effect that promotes extramedullary hemopoiesis, human body immunity improving power.
Table 4. oral liquid of the present invention is to the influence (n=9) of medullary cell
Group bone marrow nucleated cell counting (* 10
7) active degree
x±s?????????????????x±s
Matched group 1.8128 ± 0.3643* 0.3331 ± 1.000
CTX group 1.3694 ± 0.2700 0.5556 ± 0.8819
SBY+CTX group 1.8806 ± 0.3060** 1.5556 ± 1.0138*#
SBY group 2.1141 ± 0.4542*** 2.0000 ± 0***### annotates: compare with the CTX group: * p＜0.05 * * p＜0.01 * * * p＜0.001
Compare with matched group: #p＜0.05 ### p＜0.001
Table 5. oral liquid of the present invention is to the influence of Mouse Liver spleen tissue
| Group | Hepatic tissue | The spleen tissue |
| Matched group | The cell marshalling, no abnormal change; See a small amount of extramedullary hemopoiesis kitchen range. | 32 of lymphatic nodules (x), tunicle lower limb district leucocyte hyperplasia. |
| The CTX group | Cell arrangement disorder, cloudy swelling, cavity sample become, the sense of wax sample, and lobules of liver structure major part is destroyed, portal area biliary ductuli hypertrophy. | 19 of lymphatic nodules (x), tunicle lower limb district leukopenia. |
| CTX+SBY group | The disorder of cell aligning part, cloudy swelling, cavity sample become, the sense of wax sample, and part lobules of liver structure still keeps.Sinus hepaticus is slightly expanded, the slight hypertrophy of Kupffer Cell, the slight hypertrophy of portal area biliary ductuli. | 33 of lymphatic nodules (x), the slight hypertrophy of tunicle lower limb district leukocyte. |
| The SBY group | The cell marshalling, no abnormal change, the lobules of liver structure keeps, the sinus hepaticus expansion, the Kupffer Cell hypertrophy, the slight hypertrophy of portal area biliary ductuli, tool extramedullary hemopoiesis kitchen range. | The lymphatic nodule showed increased reaches 54 (x), a tunicle lower limb district leucocyte hyperplasia. |
Three. discuss
The bone marrow depression that this experiment confirm oral liquid of the present invention can resist CTX increases the bone marrow nucleated cell number and the raising of active degree, improves the hemopoietic function of hemocyte, promotes that bone marrow hematogenesis has remarkable effect; Also can improve splenic lymphonodules quantity, promote the hypertrophy of Kupffer Cell, strengthen the extramedullary hemopoiesis function of liver spleen tissue.The effect that leukocyte count, enhancing human body immunity power in the said preparation rising blood are described is definite.Prove that also said preparation can resist the damage of CTX to liver, has certain liver protection function.Exchanging fat, antitumor also seemingly has certain meaning, is still waiting further research.
Below sum up for oral liquid treatment leukopenia clinical observation on the therapeutic effect of the present invention:
We use this medicine the leukopenia patient that a variety of causes causes have been carried out clinical observation on the therapeutic effect.Clinical case 149 examples of finishing, matched group 50 examples wherein all having tangible curative effect aspect the improvement of symptom and the rising of leukocyte count purpose, obtain promising result through this medicine of clinical observation, now are summarized as follows:
One, data and method
(1) case source
Experimenter's 149 examples, test group (oral liquid of the present invention) 99 examples, male 56 examples, women 43 examples, age 16-70 year (average 40.82 ± 12.97); Matched group 50 examples, male 32 examples, women 18 examples, age 24-69 year (average 42.82 ± 14.06).
(2) case standard
1. include the case standard in
Meet primary disease diagnosis and continuous 3 WBC＜4.0 * 10 of hemogram checking
9/ L person.
2. get rid of the case standard
(1) age is below 16 one full year of life or more than 70 one full year of life, trimester of pregnancy or women breast-feeding their children.
(2) be associated with serious primary disease such as cardiovascular, liver, kidney, psychotic.
(3) do not meet the standard of including in, do not take medicine in accordance with regulations, or data is not difficult to carry out therapeutic evaluation person entirely.
(3) research method
1. case grouping: be divided into test group and matched group at random by 2: 1, test group 99 examples, matched group 50 examples.
2. clinical observation on the therapeutic effect: 1-2 the course of treatment of observing time (be one month 1 course of treatment).The oral oral liquid of the present invention of test group, every day 2 times, each 2 (10ml/ props up).The oral batilol of matched group (100mg/ time, 3 times/day) and leucogen's (20mg/ time, 3 times/day).Write down clinical symptoms change simultaneously.
(4) observation index: adopt the table record method of observing
1. safety observation: (1) general health check-up project; (2) blood, urine routine test; (3) heart, liver, kidney function test.
2. health giving quality observation: (1) detailed medical history-taking observes the symptoms and sign; (2) hemogram (leukocyte and classification, hemoglobin, platelet etc.) is checked; (3) liver, kidney function test.
(5) curative effect determinate standard:
Produce effects: clinical symptoms is significantly improved, and leukocyte rises to 4.0 * 10
9More than/the L, follow up a case by regular visits to three months stable disease or keep progressive person.
Effectively: clinical symptoms has certain improvement, and leukocyte raises 1.0 * 10
9More than/the L, but still be lower than 4.0 * 10
9/ L.
Invalid: symptom, hemogram can not reach the responder after fully treating.
Two, result
1. oral liquid of the present invention is to the influence (table 6) of quantity of leucocyte
2. oral liquid of the present invention is to the influence (table 7) of platelet counts
3. oral liquid of the present invention is to the influence (table 8) of amount of hemoglobin
4. oral liquid of the present invention is to the influence (table 9) of erythrocyte number
5. oral liquid clinical observation on the therapeutic effect table of the present invention (table 10)
6. oral liquid clinicing symptom observation table of the present invention (table 11)
7. (branch is sick plants) hemocyte and hemoglobin change list (table 12) before and after the treatment group medication
8. (branch is sick plants) clinical observation on the therapeutic effect table (table 13) before and after the treatment group medication
Table 6: leukocyte change list before and after the medication
| Before the medication | After the medication | The t value | ????P | |
| The matched group test group | ?3144.86±486.20 ?3286.94±392.07 | ?4264.6±1310.98 ?5012.93±1246.02 | -5.77 -13.14 | ＜0.001 ＜0.001 |
Table 7: platelet change list before and after the medication
| Before the medication | After the medication | The t value | ??????P | |
| The matched group test group | ????176.3±59.9 ????188.3±64.9 | ????191.5±67.8 ????204.9±63.4 | ????-1.19?? ????-1.81?? | ????＞0.05 ????＜0.05 |
Table 8: hemoglobin change list before and after the medication
| Before the medication | After the medication | The t value | ???????P | |
| The matched group test group | ?125.68±17.37 ?123.83±16.17 | ????129.56±18.45 ????129.86±17.22 | ????-1.08 ????-2.48 | ????＞0.05 ????＜0.05 |
Table 9: change of red blood cell table before and after the medication
| Before the medication | After the medication | The t value | ???????P | |
| The matched group test group | ??3.91±0.52 ??3.71±0.61 | ????4.00±0.50 ????3.90±0.54 | ????-0.90?? ????-2.27??? | ????＞0.05 ????＜0.05 |
Table 10: oral liquid clinical observation on the therapeutic effect table of the present invention
| Produce effects | Effectively | Invalid | Obvious effective rate | Effective percentage | ????x 2 | ????p | |
| The matched group test group | ????22 ????79 | ????0 ????2 | ????28 ????18 | ????44.00％ ????79.80％ | ????44.00％ ????81.82％ | ????20.53 | ＜0.001 |
Table 11: clinical symptoms change table before and after the medication
| Symptom | Matched group | The treatment group | ????X 2 | ??????P | ||
| Effective routine number | Invalid routine number | Effective routine number | Invalid routine number | |||
| The dizzy cardiopalmus sleep of headache and dizzy is weak | ????3 ????18 ????2 ????12 ????15 | ????7 ????15 ????9 ????10 ????18 | ????18 ????50 ????17 ????40 ????62 | ????3 ????11 ????4 ????15 ????14 | ????7.24 ????6.74 ????11.79 ????1.61 ????12.79 | ????＜0.01 ????＜0.01 ????＜0.01 ????＞0.05 ????＜0.01 |
Table 12: (branch is sick plants) hemocyte and hemoglobin change list before and after the medication of treatment group
| Paathogenic factor | Classification | Before the medication | After the medication | ??????T | ???P |
| Other factors of occupational factor n=54 Radiotherapy chemotherapy factor n=27 n=18 (wherein CAA 8 examples) | Leucocyte blood platelet hemoglobin red blood cell leucocyte blood platelet hemoglobin red blood cell leucocyte blood platelet hemoglobin red blood cell | ?3476.97±262.98 ?203.57±36.82 ?131.22±7.27 ???3.75±0.36 ?3024.07±367.52 ?184.63±49.25 ?119.81±12.64 ???3.95±1.45 ?2988.89±552.95???? ???119.39±69.96??? ???103.07±23.75 ????3.22±1.06 | ?5086.67±1091.30 ??209.75±40.07 ??135.83±10.54 ????3.81±0.31 ?5255.56±1344.60 ??232.37±69.27 ??127.44±14.11 ????4.15±0.46 ?4455.56±1418.04 ??135.28±62.39 ??115.27±28.39 ????3.62±0.94 | -10.54??? -0.82???? -2.62???? -1.93???? -8.32???? -2.92???? -2.09???? -1.547??? -4.08????? -0.72????? -1.28 -1.15 | ＜0.001 ＞0.05 ＜0.05 ＜0.05 ＜0.001 ＜0.01 ＜0.05 ＞0.05 ＜0.001 ＞0.05 ＞0.05 ＞0.05 |
Table 13: (branch is sick plants) clinical observation on the therapeutic effect table before and after the medication of treatment group
| Paathogenic factor | Produce effects | Effectively | Invalid | Obvious effective rate | Effective percentage |
| Occupational factor n=54 is put, other factors of chemotherapy factor n=27 n=18 (wherein CAA 8 examples, effective 2 examples) matched group | ????46 ????24 ????9 ????22 | ????0 ????0 ????2 ????0 | ????8 ????3 ????7 ????28 | ?85.19％ ?88.89％ ?50.00％ ?44.00％ | ????85.19％ ????88.89％ ????61.11％ ????44.00％ |
Three, discuss:
This result of study prompting oral liquid of the present invention is having significant clinical meaning aspect the treatment leukopenia, and clinical effectiveness is supported the Basic Experiment Study result, that is: energy leukocyte increasing quantity promotes the body hemopoietic function.Also show simultaneously: oral liquid of the present invention has the effect that tonifying speen and tonifying kidney, QI invigorating rise blood, can significantly improve the clinical symptoms of leukopenia and improve peripheral leukocytes quantity, the leukopenia that chemotherapy, radiotherapy and other reasons are caused has obvious curative effects.Do not find any toxic and side effects in the whole clinical experiment.
1. test group (taking oral liquid of the present invention) is respectively 81.82% and 44.00% (seeing Table 10) with the effective percentage of matched group (taking shark glycol, leucogen) treatment leukopenia, two groups are carried out X 2 test utmost point significant difference (p＜0.001) are arranged, and promptly the test group clinical efficacy obviously is better than matched group.Matched group curative effect similar to the curative effect of bibliographical information (bibliographical information take shark glycol, leucogen clinical efficacy be 44.26%-66.70%).
2. clinical effectiveness shows that oral liquid of the present invention all has obvious rising effect (to see Table 6 to leukopenia patient's leukocyte, erythrocyte, hemoglobin and platelet, 7,8,9), there were significant differences (leukocyte p＜0.001, other are p＜0.05) in treatment anteroposterior diameter T check; Matched group only has obvious rising effect (p＜0.001) to leukocyte, and other hemocytees and hemoglobin are not had obvious improvement effect (p＞0.05).This with the zoopery result in oral liquid of the present invention can improve the outer hematopoietic function of marrow internal medullary mass and conform to.
3. zoopery confirms that said preparation has relative leukocyte increasing, promotes hematopoietic function, and human body immunity improving power promotes functions such as appetite.Clinical confirmation oral liquid of the present invention can obviously improve the clinical symptoms (seeing Table 11) of leukopenia, the improvement of weak, dizzy, the insomnia that the leukopenia patient is occurred, cardiopalmus, headache symptom obviously is better than matched group (being p＜0.01 through X 2 test), to the improvement situation similar to matched group (through X 2 test p＞0.05) of sleeping.
4. oral liquid of the present invention to occupational factor, put, leukopenia that chemotherapy factor and other factors cause all has tangible rising effect (T check p＜0.001 before and after the treatment).Its effective percentage is respectively 85.19%, 88.89% and 61.11% (seeing Table 13).The hemoglobin and the erythrocyte number of said preparation leukopenia that occupational factor is caused also have tangible rising effect (T check p＜0.05 before and after the treatment) in addition; To put, the platelet (p＜0.01) of patients undergoing chemotherapy, hemoglobin (p＜0.05) have the rising effect; And to occupational factor patient's platelet (p＞0.05), put, the erythrocyte (p＞0.05) of patients undergoing chemotherapy do not have obviously influence, and is obvious to other factors patient dialogue impact cell, to other influences less (seeing Table 12).Prompting may cause the bone marrow depression characteristics different relevant with different factors.Await further discussion.
5. oral liquid of the present invention is general to chronic aplastic anemia anemia (CAA) patient's clinical effectiveness, but has therapeutic value.Observe in the treatment group among the 8 routine CAA patients, effective 2 examples, it is all invalid that matched group is observed 4 examples.
6. in this clinical trial, any toxicity does not all appear in all patients that use oral liquid of the present invention, and is safe in utilization.
Following examples are parts by weight.
Embodiment one: Radix Angelicae Sinensis 12, the Radix Astragali 30, Radix Codonopsis 12, Fructus Lycii 12, Fructus Ligustri Lucidi 12, Caulis Spatholobi 15, Pericarpium Citri Reticulatae 10, Fructus Jujubae 10, Radix Glycyrrhizae 6, Radix Rehmanniae Preparata 15, Poria 12, Fructus Hordei Germinatus 10.
Getting each medicinal decocting boils three times, each amount of water is respectively 8,6,6 times of raw material of Chinese medicine gross weight, the each decoction 1 hour, merge medicinal liquid, filter, filtrate is decocting and concentrating in steam-jacked kettle, concentrated solution is 2 times of raw material of Chinese medicine gross weight, add concentration then and be 60% ethanol and carried out cold preservation 48 hours, filter then, reclaim ethanol, obtain brownish red water liquid, through cold preservation 24～48 hours, filtration, filtrate adds the distilled water adjustment capacity that newly boils to the medicinal liquid weight identical with the raw material of Chinese medicine gross weight again, and embedding, sterilization promptly obtain oral liquid of the present invention.
Embodiment two: Radix Angelicae Sinensis 9, the Radix Astragali 20, Radix Codonopsis 15, Fructus Lycii 15, Fructus Ligustri Lucidi 9, Caulis Spatholobi 10, Pericarpium Citri Reticulatae 6, Fructus Jujubae 9, Radix Glycyrrhizae 8, Radix Rehmanniae Preparata 25, Poria 15, Fructus Hordei Germinatus 6.
Embodiment three:
Radix Angelicae Sinensis 10, the Radix Astragali 9, Radix Codonopsis 9, Fructus Lycii 9, Fructus Ligustri Lucidi 15, Caulis Spatholobi 25, Pericarpium Citri Reticulatae 8, Fructus Jujubae 12, Radix Glycyrrhizae 12, Radix Rehmanniae Preparata 30, Poria 9, Fructus Hordei Germinatus 12.
Embodiment four:
Radix Angelicae Sinensis 11, the Radix Astragali 15, Radix Codonopsis 11, Fructus Lycii 13, Fructus Ligustri Lucidi 13, Caulis Spatholobi 30, Pericarpium Citri Reticulatae 7, Fructus Jujubae 11, Radix Glycyrrhizae 10, Radix Rehmanniae Preparata 10, Poria 13, Fructus Hordei Germinatus 8.
Embodiment five:
Radix Angelicae Sinensis 12, the Radix Astragali 30, Radix Codonopsis 12, Fructus Lycii 12, Fructus Ligustri Lucidi 12, Caulis Spatholobi 15, Pericarpium Citri Reticulatae 10, Fructus Jujubae 10, Radix Glycyrrhizae 6.
Embodiment six:
Radix Angelicae Sinensis 11, the Radix Astragali 15, Radix Codonopsis 11, Fructus Lycii 9, Fructus Ligustri Lucidi 15, Caulis Spatholobi 25, Pericarpium Citri Reticulatae 8, Fructus Jujubae 12, Radix Glycyrrhizae 12, Radix Rehmanniae Preparata 30.
Embodiment seven:
Radix Angelicae Sinensis 10, the Radix Astragali 30, Radix Codonopsis 12, Fructus Lycii 9, Fructus Ligustri Lucidi 15, Caulis Spatholobi 15, Pericarpium Citri Reticulatae 6, Fructus Jujubae 10, Radix Glycyrrhizae 12, Poria 15, Fructus Hordei Germinatus 15.
Embodiment eight:
Radix Angelicae Sinensis 9, the Radix Astragali 20, Radix Codonopsis 9, Fructus Lycii 15, Fructus Ligustri Lucidi 13, Caulis Spatholobi 25, Pericarpium Citri Reticulatae 10, Fructus Jujubae 10, Radix Glycyrrhizae 6, Radix Rehmanniae Preparata 15, Fructus Hordei Germinatus 10.
Claims (6)
1, a kind of Chinese medicine preparation of preventing and treating leukopenia is characterized in that it being to be made by following parts by weight of traditional Chinese medicines raw material: Radix Angelicae Sinensis 9～12, the Radix Astragali 9～30, Radix Codonopsis or Radix Ginseng 9～15, Fructus Lycii 9～15, Fructus Ligustri Lucidi 9～15, Caulis Spatholobi or Colla Corii Asini 10～30, Pericarpium Citri Reticulatae 6～10, Fructus Jujubae 9～12, Radix Glycyrrhizae 6～12.
2, the Chinese medicine preparation of preventing and treating leukopenia according to claim 1 is characterized in that raw material of Chinese medicine also comprises 1～3 kind in Radix Rehmanniae Preparata 10～30, Poria 9～15, the Fructus Hordei Germinatus 6～15.
3, the Chinese medicine preparation of preventing and treating leukopenia according to claim 1 and 2 is characterized in that being oral liquid formulation.
4, a kind of claim 1 or 2 described technologies of preventing and treating the Chinese medicine oral liquid of leukopenia of preparing, it is characterized in that through following technology: each raw material of Chinese medicine decocting boils, decoction liquor after filtration, concentrate and to obtain the brown concentrated solution, it is that 55～70% ethanol carries out cold preservation that the brown concentrated solution adds concentration, the cold preservation after-filtration, reclaim ethanol, obtain brownish red water liquid, promptly obtain oral liquid through cold preservation, filtration, adjustment capacity again.
5, technology according to claim 4 is characterized in that described refrigerated storage temperature is 2～10 ℃.
6, technology according to claim 4 is characterized in that each raw material of Chinese medicine decocting boils three times, and each amount of water is respectively 8,6,6 times of raw material of Chinese medicine gross weight, and each decocting time is 1～1.5 hour.
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