CN102380042B - Dendrobium traditional Chinese medicine composition, preparation method and application thereof - Google Patents
Dendrobium traditional Chinese medicine composition, preparation method and application thereof Download PDFInfo
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- CN102380042B CN102380042B CN201110330667.4A CN201110330667A CN102380042B CN 102380042 B CN102380042 B CN 102380042B CN 201110330667 A CN201110330667 A CN 201110330667A CN 102380042 B CN102380042 B CN 102380042B
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Abstract
The invention discloses a dendrobium traditional Chinese medicine composition, a preparation method and application thereof. The dendrobium traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 1-2 parts of dendrobium, 1-3 parts of turtle shell and 1-2 parts of pseudo-ginseng. The preparation method comprises the following steps: respectively micro-pulverizing the raw materials to 10-60 thousand meshes, evenly mixing, and processing into an oral solid preparation. The dendrobium traditional Chinese medicine composition can be used for treating aplastic anemia, and has obvious effect. The traditional Chinese medicine composition has the effects of nourishing yin and suppressing hyperactive yang, tonifying the kidney, regenerating the marrow, promoting blood circulation and nourishing the blood, and is safe and effective. Compared with common pulverization, the preparation method disclosed by the invention can greatly enhance the absorption availability of rare medicinal herbs, and effectively reduce the dosage. Compared with a common decoction method, the preparation method disclosed by the invention can overcome the defects of high time and labor consumption and low extraction rate due to long-time decoction, effectively lower the production cost and enhance the drug effect.
Description
One, technical field
The present invention relates to a kind of Chinese medicine composition, Its Preparation Method And Use, specifically a kind of Herba Dendrobii Chinese medicine composition, Its Preparation Method And Use.
Two, background technology
Aplastic anemia (Aplastic anemia, AA) is called for short aplastic anemia, is a kind of more serious disease of hematopoietic system that pancytopenia, marrow hematopoiesis function failure be feature of take.Abroad in Recent Years annual morbidity is 2,/10 ten thousand people, and domestic annual morbidity is 7.4/10 ten thousand people, and wherein acute aplastic anemia is 1.4/10 ten thousand people, and along with the increase of human work, variety of life and some paathogenic factors, morbidity has the trend rising year by year.Severe aplastic anemia disease progression is fast, and mortality rate is high, and in 1 year, mortality rate reaches more than 90%, and human health in serious threat.The cause of disease of aplastic anemia is still not exclusively clear so far, but most relevant with known medicine, chemical substance, physical factor and viral infection etc.Aplastic anemia treatment is at present mainly androgen, immunomodulating, hemopoietic and hematopoietic stem cell transplantation, and clinical therapeutic efficacy is undesirable.Single employing androgen in treating chronic aplastic anemia effective percentage is 40% left and right, antithymocyte globulin (ATG) or antilymphocyte globulin (ALG) treatment acute aplastic anemia curative effect are 40%-50%, cyclosporin A (CSA) treatment chronic aplastic anemia effective percentage is 50% left and right, said medicine side effect is many, it is desirable that curative effect is owed, and is problem demanding prompt solution in aplastic anemia treatment.The multiple complications wherein occurring in Hemopoietic Stem Cell Transplantation acute aplastic anemia process, as infection, hemorrhage, serious graft versus host disease (GVHD), immunologic reconstitution difficulty etc., has a strong impact on curative effect and patients ' life quality.
The domestic preferentially scheme for chronic aplastic anemia treatment is androgen+Chinese medicine+immunosuppressant, has obtained certain curative effect, so develop safe, effective, quality controllable new Chinese medicine, for aplastic anemia, has positive therapeutical effect.
Treatment by Chinese herbs aplastic anemia more and more receives publicity because of its multicomponent, multiple location, many target spots.Chronic aplastic anemia belongs to the categories such as Chinese medicine " asthenia ", " blood disorder ".Since the fifties, Chinese traditional treatment aplastic anemia is divided into three phases substantially, before the sixties, take invigorating the heart and spleen or invigorating QI and blood as main; The seventies is spleen reinforcing kidney or invigorating the liver and kidney on the basis of front method; Since the eighties, almost all take the kidney invigorating as main, or double filling blood, or double spleen reinforcing, or double invigorating blood circulation, or the removing toxic substances of holding concurrently, or hold concurrently and conciliate; Since the nineties, on the medicine typing opinion basis of controlling, according to state of an illness weight, dialectical Stages is proposed, formed more through proved recipe, but mainly with simple decoction be main from pharmacy, medicine according to the development of new drug standardization is few in number, mainly contain in the market the Chinese medicines such as FUFANG ZAOFAN WAN, XUEBAO capsule, but technique is simple, dosage form is backward, flavour of a drug have, reach tens of tastes, active substance is indefinite, and Quality Control is with low content of technology, patient takes inconvenience, compliance is poor, is difficult to guarantee product curative effect, affects clinical use.
Three, summary of the invention
The present invention aims to provide a kind of Herba Dendrobii Chinese medicine composition, Its Preparation Method And Use, and according to Chinese medical theory system and modern medicine study achievement, selecting the Herba Dendrobii that is described as " first of nine large Herba mesonae chinensis " is monarch drug, and enriching yin and nourishing kidney, keep fit to consolidate; Take Carapax Et Plastrum Testudinis as ministerial drug, nourishing YIN for suppressing the hyperactive YANG, kidney tonifying bone strengthening, the reinforcing the heart of nourishing blood; The rare Chinese medicine Radix Notoginseng of take helps source of generating QI and blood to make as helping, blood circulation promoting and blood stasis dispelling, and blood stops blooding, promoting tissue regeneration by removing blood stasis.
Technical solution problem of the present invention adopts following technical scheme:
The feature of Herba Dendrobii Chinese medicine composition of the present invention is that its raw material is configured to by mass fraction: Herba Dendrobii 1-2 part, Carapax Et Plastrum Testudinis 1-3 part, Radix Notoginseng 1-2 part; Described Herba Dendrobii is selected from Herba Dendrobii, Herba Dendrobii or dendrobium moniliformeSweet.
Preferred: 1 part of Herba Dendrobii, 2 parts of Carapax Et Plastrum Testudiniss, 1 part of Radix Notoginseng.
The feature of the preparation method of Herba Dendrobii Chinese medicine composition of the present invention is to operate according to the following steps: by each raw material mix homogeneously after micronizing to order number is 1-6 ten thousand orders respectively, be processed into oral solid formulation.
Described oral solid formulation is granule, tablet, powder, pill or hard capsule and other pharmaceutically acceptable oral solid formulations.
The application of described Herba Dendrobii Chinese medicine composition in treatment aplastic anemia.
The present invention adopts the bioavailability that can greatly improve famous and precious medicine after micronizing, effectively reduces taking dose.In Herba Dendrobii, main effective ingredient is polysaccharide, and as adopted decocting method, each extraction time is longer, and at least more than 4 hours, and extraction time is no less than 3 times, and cost and energy consumption are all higher.Three kinds of medical materials in raw material of the present invention adopt conventional pulverizing, and bioavailability is low, and dose is larger.Through the above-mentioned Chinese medicine composition of evidence, after modern crafts processing, can stimulate Bone Morrow Hematopoietic Progenitor Cells growth, improve bone marrow microenvironment, enhancing body non-specific immunity, thus recover hemopoietic function of bone marrow, safe and effective to aplastic anemia treatment.
Four, the specific embodiment
Embodiment 1: hard capsule
1, raw material: 125 grams of Herba Dendrobiis, 250 grams of Carapax Et Plastrum Testudiniss, 125 grams of Radix Notoginseng.
2, method for making: above three tastes after micronizing, mix with 5g microcrystalline Cellulose respectively, incapsulate, and make 1000, obtain.
3, character: this product is hard capsule, content is tan powder, feeble QI, mildly bitter flavor.
4, specification: every fills 0.5 gram.
5, usage and consumption: oral.One time 4,2 times on the one.
Embodiment 2: granule
1, raw material: 166.7 grams of Herba Dendrobiis, 333.3 grams of Carapax Et Plastrum Testudiniss, 166.7 grams of Radix Notoginseng.
2, method for making: above three tastes after micronizing, mix with 1111g dextrin, 222.2g Icing Sugar respectively, granulation, dry, make 1000g, obtain.
3, character: this product is granule, content is tan granule, feeble QI, sweet, the micro-hardship of taste.
4, specification: every packed 3 grams
5, usage and consumption: oral.One time 1 bag, 2 times on the one.
Embodiment 3: tablet
1, raw material: 83.3 grams of Herba Dendrobiis, 166.7 grams of Carapax Et Plastrum Testudiniss, 83.3 grams of Radix Notoginseng.
2, method for making: above three tastes after micronizing, mix with 15g dextrin respectively, granulation, dry, add 1.7g magnesium stearate, be pressed into 1000, sugar coating or film-coat, obtain.
3, character: this product is coated tablet or Film coated tablets, removes aobvious sepia after coating; Feeble QI, mildly bitter flavor.
4, specification: every of film-coat is heavy 0.35 gram, coated tablet (0.35 gram of plate core weight)
5, usage and consumption: oral.One time 4,3 times on the one.
Embodiment 4: powder
1, raw material: 125 grams of Herba Dendrobiis, 250 grams of Carapax Et Plastrum Testudiniss, 125 grams of Radix Notoginseng.
2, method for making: above three tastes after micronizing, mix respectively, pack in vial and get final product.
3, character: this product is tan powder or easy loose piece, feeble QI, mildly bitter flavor.
4, specification: every bottled 4 grams.
5, usage and consumption: oral.One time 2 grams, 2 times on the one.
Embodiment 5: pill
1, raw material: 166.7 grams of Herba Dendrobiis, 333.3 grams of Carapax Et Plastrum Testudiniss, 166.7 grams of Radix Notoginseng.
2, method for making: above three tastes after micronizing, mix respectively, every 100g powder adds refined honey 40-60g and appropriate water, and pill is dry, makes water-honeyed pill.
3, character: this product is tan water-honeyed pill; Mildly bitter flavor.
4, usage and consumption: oral.3g of water-honeyed pill, 2 times on the one.
The medical material adopting in compositions of the present invention and medicine, by checking under < < Chinese Pharmacopoeia > > version in 2010 and provincial standard respective items, all meets the requirements.
Compositions of the present invention and medicine are according to < < Chinese Pharmacopoeia > > version appendix VIB thin layer chromatography qualitative identification in 2010, can identify respectively dendrophnol, cholesterol, arasaponin R1, prove that this compound contains the three taste medical materials such as Herba Dendrobii, Carapax Et Plastrum Testudinis, Radix Notoginseng.
In the present composition and medicine, arsenic salt and heavy metal detect: press < < Chinese Pharmacopoeia > > version appendix IXE, IXF item purgation in 2010 and check, result is all in claimed range.
Limit test of microbe in the present composition and medicine: press < < Chinese Pharmacopoeia > > version appendix XIIIC item purgation in 2010 and check, result is all up to specification:
Antibacterial≤10000cfu/g, yeast and mold≤100cfu/g, coliform≤100/g, escherichia coli do not detect.
For safety and the effectiveness of proof Chinese medicine composition of the present invention, inventor carries out animal safety test and pharmacodynamic experiment research with the Herba Dendrobii Chinese medicinal composition capsules agent of embodiment 1 preparation, and experimental result is as follows:
Capsule acute oral toxicity test
(1) experiment purpose: the LD that cannot measure mouse stomach through trial test
50therefore, carry out maximum dosage-feeding test.
(2) materials and methods:
1, capsule 's content is mixed with to 0.25g/mL and two concentration of 0.5g/mL with distilled water.
2, animal: Kunming mouse, body weight 18-22g, male and female half and half.
3, experimental technique: learn from else's experience and raise 40 of one week N/R mices, male and female half and half, are divided into two groups, 20 every group.Before experiment, water 12h is can't help in animal fasting, and gavage of per os gives animal subject, volume 0.4mL/10g, and administration concentration is respectively 0.25g/mL and 0.5g/mL.
4, observation index: after administration, continue fasting 2h, observe diet, feces, skin, mucosa, breathing, heart beating and active situation in animal seven days.If there is abnormal timely record, if there is death, postmortem immediately, while finding that there is macroscopic pathological change, does pathological section.
(3) result of the test:
After mice oral capsule, activity slightly reduces, and recovers normal after 1 hour., all there are not abnormal conditions in diet, feces, skin, mucosa, breathing, heart beating and active situation in seven days, more without dead, occurs.0.5g/mL has been the maximum administration concentration of said preparation, and 0.4mL/10g has been maximum administration volume, therefore the oral maximum dosage-feeding of this medicine is greater than 20g crude drug/kg.
(4) conclusion:
According to sampling test result, dosage is 20g crude drug/kg when (this dosage is equivalent to 299 times of quantity), and mice is without poisoning symptom, also without dead.According to study of tcm new drug guide the acute toxicity tests evaluation criterion, this capsule Oral toxicity is for substantially nontoxic.
The pharmacodynamics test of capsule to Induced Aplastic Anemia Mice
(1) experiment material
1, laboratory animal and grouping
BALB/c mouse, is provided credit number by Hebei province's Experimental Animal Center: SYXK (Ji) 2008-0026, and body weight 20 ± 2g, male and female half and half,, are divided into 4 groups (Normal group, irradiation control group, positive drug group, experimental grouies) at random by totally 52.
2, Experimental agents
Capsule is provided by Sheng Nong biotech inc, Anhui, specification: 0.5g * 100, lot number: 20110612.Positive control drug: FUFANG ZAOFAN WAN (Haoqijun Pharm Mfg., Co., Ltd, Shanxi, specification: 0.2g * 72 ball, lot number: 20110638).
(2) experimental technique
1, modeling method
Except Normal group, all the other 3 groups give
60co irradiates, and dosage is 450 rads, prepares animal model of aplastic anemia.
2, medication
Once, capsule dosage is 0.6g/kg body weight to experimental group gavage every day, and once, dosage is 0.8g/kg body weight to positive drug group gavage every day, and other each group gives equivalent normal saline, successive administration 14 days.
3, observation index
3.1 general signs.
Blood routine examination is carried out in 3.2 test the 7th, 14 days blood samplings.
After 3.3 execution mices, collect blood and measure IL-2, IL-6 content.
3.4 adopt mouse-anti Mus cell surface molecule monoclonal antibody, indirect immune labeled fluorescence spectrometry bone marrow CD4
+, CD8
+, CD34
+.
3.5 get bone marrow smear observation of cell hypertrophy situation.
3.6 check bone marrow nucleated cell quantity.
4, statistical method
Experimental data is added and subtracted standard deviation with average
represent, between each group, relatively adopt the T inspection statistics method between two sample averages.
(3) experimental result
1, warp
60the mice that Co irradiates, loses weight, poor appetite, and hair has some setbacks, slowly movable, and routine blood test shows aplastic anemia model success.The situations such as experimental mice started to lose weight from the 4th day, poor appetite, and hair has some setbacks, movable slow change to some extent.
2, blood routine examination result is carried out in test blood sampling in the 7th, 14 days, in Table 1.
Table 1 blood routine examination result
Note: * p < 0.05, * * p < 0.01, * * * p < 0.001 and Normal group comparison
△p < 0.05,
△ △p < 0.01,
△ △ △p < 0.001 and irradiation control group comparison
zerop < 0.05,
00p < 0.01, with the comparison of positive drug group
3, plasma IL-2, IL-6 measurement result (ng/mL), in Table 2.
Table 2 plasma IL-2, IL-6 measurement result (ng/mL)
Note:
△p < 0.05, with irradiation control group comparison
4, bone marrow CD4
+, CD8
+, CD34
+measurement result, in Table 3.
Table 3 bone marrow CD4
+, CD8
+, CD34
+measurement result
Note: * p < 0.05, * * p < 0.01, * * * p < 0.001 and Normal group comparison
△p < 0.05, with irradiation control group comparison
5, bone marrow smear is observed situation and matched group comparison, and two administration group bone marrow smears are showed no remarkable difference.
6, bone marrow nucleated cell volume check result, in Table 4.
Table 4 bone marrow nucleated cell is counted check result
Note: * p < 0.001 and Normal group comparison
△p < 0.001 and irradiation control group comparison
(4) conclusion
This capsule is to the treatment of Induced Aplastic Anemia Mice gavage after 7 days and 14 days, and platelet and hemoglobin significantly raise compared with positive drug group, treat after 7 and 14 days platelet, hemoglobin, plasma IL-2, IL-6, bone marrow CD34
+, bone marrow nucleated cell number all compared with irradiation control group have that significance changes, bone marrow smear morphology is without significant change.This traditional Chinese medicine composition for treating aplastic anemia is evident in efficacy, its mechanism of action and stimulation marrow hemopoietic stem cells, and it is relevant that raising Hemopoietic factor level is recovered the functions such as hemopoietic.
Claims (4)
1. a Herba Dendrobii Chinese medicine composition that is used for the treatment of aplastic anemia, is characterized in that its raw material is configured to by mass fraction: Herba Dendrobii 1-2 part, Carapax Et Plastrum Testudinis 1-3 part, Radix Notoginseng 1-2 part; Described Herba Dendrobii is selected from Herba Dendrobii, Herba Dendrobii or dendrobium moniliformeSweet;
Described Herba Dendrobii Chinese medicine composition be by each raw material respectively after micronizing to order number is 1-6 ten thousand orders mix homogeneously and be processed into oral solid formulation after the Herba Dendrobii Chinese medicine composition that obtains.
2. Herba Dendrobii Chinese medicine composition according to claim 1, is characterized in that its raw material is configured to by mass fraction: 1 part of Herba Dendrobii, 2 parts of Carapax Et Plastrum Testudiniss, 1 part of Radix Notoginseng.
3. a preparation method for the Herba Dendrobii Chinese medicine composition described in claim 1 or 2, is characterized in that operating according to the following steps: by each raw material mix homogeneously after micronizing to order number is 1-6 ten thousand orders respectively, be processed into oral solid formulation.
4. preparation method according to claim 3, is characterized in that: described oral solid formulation is granule, tablet, powder, pill or hard capsule.
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Owner name: JIUXIANZUN HERBA DENDROBII CO., LTD. Free format text: FORMER NAME: ANHUI SHENGNONG BIOTECHNOLOGY TECHNOLOGY CO., LTD. |
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Address after: Two road 237000 Lu'an Province Economic Development Zone No. 88 North Anhui Patentee after: JIUXIANZUN HUOSHAN DENDROBIUM CO., LTD. Address before: 237000 Anhui province Lu'an Gaocheng road Yangtze Seiko Industrial Park wonderful wall color aluminum office building Patentee before: Anhui Shengnong Biotechnology Technology Co., Ltd. |