CN102552380A - Novel traditional Chinese medicine for treating hypoleucocytosis caused by radiotherapy and chemotherapy for treating cancers and preparation method thereof - Google Patents
Novel traditional Chinese medicine for treating hypoleucocytosis caused by radiotherapy and chemotherapy for treating cancers and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a novel traditional Chinese medicine for treating hypoleucocytosis caused by radiotherapy and chemotherapy for treating cancers and a preparation method thereof, and also discloses pharmacological effects and clinical application of the novel traditional Chinese medicine. The novel traditional Chinese medicine provided by the invention comprises pearl ginseng and astragalus mongholicus. The preparation method of the novel traditional Chinese medicine comprises the following steps of adding water into pearl ginseng and astragalus mongholicus, respectively carrying out decoction extraction, merging the extract, carrying out concentration, carrying out alcohol precipitation, standing, recovering ethanol of supernate, carrying out condensation, and mixing the concentrated solution and one or more pharmaceutically acceptable carriers/auxiliary materials to obtain an oral solution, wherein the oral solution is the novel traditional Chinese medicine. The oral solution named as a pearl ginseng-astragalus mongholicus oral solution has active components of total saponins and plant polysaccharides, wherein the total saponins comprise ginsenoside Ro, panax japonicus saponin IVa and astragaloside IV. The oral solution can be utilized for treating diseases of hypoleucocytosis, lusterless complexion, mental and physical fatigue, palpitaition, shortness of breath, insomnia, dry throat and inappetence after radiotherapy and chemotherapy for treating cancers.
Description
Technical field
The invention belongs to medical technical field, relate to a kind of treatment because of leukopenia new Chinese medicine and method for preparing due to the carcinosis radiotherapy and chemotherapy.
Background technology
Tumor is one of disease of serious threat human health and life, in China's tumor very high sickness rate is arranged also, because of the dead number of malignant tumor accounts for 17.9% of the total death toll in the whole nation, is the second largest cause of death.From present clinical anti-tumor method, mainly comprise: the Comprehensive Treatment of operative treatment, chemotherapy, radiotherapy, immunotherapy, gene therapy, Chinese medicine and multiple therapy methods.Operative treatment wherein, chemotherapy and radiotherapy have been brought into play important effect as the main method and the means of clinical treatment to aspects such as the misery of removing the patient, the life that prolongs the patient and raising life qualities.But leukopenia, immunologic function degression appear in tumor patient after chemotherapy, radiotherapy, other infectious disease of Chang Jifa; Tcm clinical practice shows as lusterless complexion, shortness of breath and palpitation, spiritlessness and weakness, insomnia, dry pharynx, poor appetite etc., often makes the putting of tumor, chemotherapy receives very big restriction or compelled stopping.
The inventor is according to phase. and state's medical science and modern medicine are theoretical; Unique theoretical system in conjunction with the doctor of Pennisetum centrasiaticum Tzvel too " seven because of seven methods " and " four beams, eight posts "; Combine with differential diagnosis of diseases dialectical, think malignant tumor, start from the medicine gram and cut down usefulness because of the leukopenia due to the chemotherapy; Or hinder its gas earlier, impairment of QI must reach in cloudy blood; Or hinder its cloudy blood earlier, cloudy blood trouble void must reach in gas.Impairment caused by overstrain is deficient, the internal organs function is weak, insufficiency of generating and transforming QI and blood.Utilize modern analytical technique and pharmacological research method; Shaanxi " too white seven medicines " and the effective site of classical folk prescription, proved recipe and secret recipe are analyzed, screened; To drug effect dependency and safety carry out standard, the systematic research evaluation, develop " treatment because of carcinosis radiotherapy and chemotherapy due to leukopenia Chinese medicine oral liquid ".The side uses the Rhizoma Panacis Majoris of supplementing QI and nourishing YIN, hemopoietic to be monarch drug, and its sweet in the mouth, hardship and cold nature is the article of mending are clearly gone into the gas of edema caused by disorder of QI benefit strengthening spleen and lung; Walk Liver Channel and go into blood system and the yin nourishing hemopoietic; More use the Radix Astragali, sweet temperature compensation gas is supporing yang, with the source of abundant hemopoietic, changes and gives birth to cloudy blood, so-called " tangible blood is born in invisible gas ".Two medicines share, Yin grows while yang is generating, supplementing QI and nourishing YIN, the prosperous hemopoietic of gas.
Rhizoma Panacis Majoris is the dry beading rhizome of Araliaceae Rhizoma Panacis Majoris [Panax.japonicus C.A.Mey.var.major (Buck.) C.Y.Wu et K.M.Feng] or Rhizoma Panacis bipinnatifidi [Panax jap Onicus C.A.Mey.var.bipinnatifidus (Seem.) C.Y.Wu et K.M.Feng].Mainly be distributed in provinces such as China Shaanxi, Sichuan, Hubei, Yunnan.Have tonifying the lung, yin nourishing, active, hemostatic effect, be used for gas and attach that two void, dysphoria with smothery sensation are thirsty, cough due to consumptive disease, injury from falling down, arthralgia, hemoptysis, haematemesis, traumatic hemorrhage etc.Its aerial parts is practised and is claimed Rhizoma panacis majoris or Hanzhong Rhizoma panacis majoris, has effects such as heat-clearing and toxic substances removing, strengthening by means of tonics.Modern medicine study proves; T cell propagation effect under the Rhizoma Panacis Majoris total saponins is induced PHA and ConA has tangible potentiation; Induce human liver cancer cell SMMC-7721 apoptosis, have effects such as certain antitumor, human body immunity improving function, anti peroxidation of lipid and antalgic and sedative.The Radix Astragali is the root of pulse family Astragalus Radix Astragali Astragalus membranaceus (Fisch.) Bunge and astragalus mongholicus Bge A.mongholicus Bunge.Compendium of Material Medica record " can control the disease of all weakness of QI blood deficiency "; " Radix Astragali complement sun fills space between skin and muscles to Jing-Yue Complete Works, and flourish muscles and bones is controlled impairment caused by overstrain, longue meat.Modern medicine finds that the Radix Astragali can increase body's immunity, increases cellular metabolism, regulates dna replication dna and RNA and proteinic synthetic, heart tonifying, the pharmacological action of blood pressure lowering, auxiliary anticancer therapy.
Summary of the invention
The objective of the invention is to overcome the defective that exists in the prior art, provide treatment because of leukopenia new Chinese medicine and method for preparing due to the carcinosis radiotherapy and chemotherapy.
Its technical scheme is:
A kind of treatment is because of leukopenia new Chinese medicine due to the carcinosis radiotherapy and chemotherapy, and its composition and weight proportion thereof are: Rhizoma Panacis Majoris 10%-90%, Radix Astragali 90%-10%.
Said composition and weight proportion thereof are: Rhizoma Panacis Majoris 25%-75%, Radix Astragali 75%-25%.
Said composition and weight proportion thereof are: Rhizoma Panacis Majoris 25%, the Radix Astragali 75%.
The effective site of new Chinese medicine according to the invention is total saponins and vegetable polysaccharides, and main activated saponin composition is ginsenoside Ro, Rhizoma Panacis Japonici saponin IVa and astragaloside etc.
A kind of method for preparing of above-mentioned new Chinese medicine comprises the steps:
1) extracts: with Rhizoma Panacis Majoris, the fragmentation of Radix Astragali raw medicinal material, broken material is used water extraction, obtain extracting solution;
2) concentrate: collect the step 1) extracting solution, filter, will filtrate concentrates;
3) precipitate with ethanol: with step 2) concentrated solution adds ethanol, leaves standstill;
4) reclaim ethanol: with step 3) precipitate with ethanol supernatant liquid filtering, filtrate recycling ethanol is to most;
5) dosing: the concentrated solution of step 4) is added correctives, antiseptic and purified water, filtration sterilization, encapsulation.
Step 1) is said to be specially broken material with water extraction, with 5-40 times of water heating extraction 1-3 time, and each 1-3 hour, to filter, filtrating merges.
Step 2) in filtrate decompression is concentrated, obtain concentrated solution, the concentrated solution ratio is 1: 0.5-1: 1.5, and promptly every milliliter of concentrated solution contains crude drug 0.5-1.5 gram.
Add ethanol in the step 3) to containing alcohol amount 20-40%, left standstill 24 hours.
Alcohol deposit fluid is filtered in the step 4), and decompression recycling ethanol is not to there being the alcohol flavor, and concentrated medicament makes every milliliter to contain crude drug 05-1.5 gram.
Further preferably, add the water of 8 times of amounts of medical material in the step 1), each 2h carries 2 times altogether.
Step 2) 1 of concentrating under reduced pressure extracting solution to crude drug times of amount.
Step 3) adds 95% ethanol makes determining alcohol to 30% in the medicinal liquid.
Step 4) is evaporated to every milliliter and contains crude drug 1.0g.
Correctives described in the step 5) is: sucrose.
Antiseptic described in the step 5) is: sodium sorbate.
Compared with prior art, beneficial effect of the present invention is:
1, prescription is formed simply, and active ingredient is clear and definite.
2, clinical efficacy is definite.Confirm that through the clinical observations in nearly ten years and correlational study carcinosis radiotherapy and chemotherapy is taken this oral liquid simultaneously, rising white total effective rate is 75%; Take this oral liquid after the leukopenia, total effective rate is 88.93%; With matched group significant difference is arranged relatively; There is not " knock-on " phenomenon.This oral liquid of pharmacological evaluation prompting can induce the HL-60 cell differentiation, improves the sensitivity of 5-FU, chemicotherapy is had attenuation, synergism, the scalable function, improves bone marrow depression, promotes the growth of hematopoietic stem cell, the absolute value of leukocyte increasing.
3, preparation technology is simple, with low cost, does not have harmful poisonous reagent and uses.
4, this liquid oral medicine is the main pharmacodynamics composition with Rhizoma Panacis Japonici saponin IVa, ginsenoside Ro, stable content.Meet new Chinese medicine " three little, triple effect, five convenience " requirement.
The specific embodiment
Below in conjunction with specific embodiment method of the present invention is done explanation in further detail.
Embodiment 1: 1000mL is an example with production oral liquid product of the present invention, and its preparation method is:
1) extract: get Rhizoma Panacis Majoris 100g, Radix Astragali 300g, crude drug is broken, with 8 times of water heating extraction 2 times, each 2 hours, filters the filtrating merging;
2) concentrate: filtrate decompression is concentrated, obtain concentrated solution, the concentrated solution ratio is 1: 0.25, and promptly every milliliter of concentrated solution contains crude drug 0.25 gram;
3) precipitate with ethanol: slowly add ethanol in the concentrated solution,, left standstill 24 hours to containing alcohol amount 30%;
4) reclaim ethanol: get the precipitate with ethanol supernatant, filter, decompression recycling ethanol is not to there being the alcohol flavor, and it is 1: 1 that medicinal liquid concentrates ratio, and promptly every milliliter contains crude drug 1.0 grams;
5) dosing: 1. get sucrose 150 grams, process simple syrup as correctives
2. getting 1.5 sodium sorbates is dissolved in the purified water and encapsulates as antiseptic.
3. the concentrated solution that obtains of step 4) adds correctives and antiseptic mixing, adds purified water to 1000ml, and filtration, sterilization, embedding promptly get oral liquid of the present invention.
Specification: every bottle of 10mL.
Usage and dosage: once oral 10ml, 3 times on the one, one after each meal.
Embodiment 2: 1000mL is an example with production oral liquid product of the present invention, and its preparation method is:
1) extract: get Rhizoma Panacis Majoris 100g, Radix Astragali 300g, crude drug is broken, with 5 times of water heating extraction 3 times, each 1 hour, filters the filtrating merging;
2) concentrate: filtrate decompression is concentrated, obtain concentrated solution, the concentrated solution ratio is 1: 0.5, and promptly every milliliter of concentrated solution contains crude drug 0.5 gram;
3) precipitate with ethanol: slowly add ethanol in the concentrated solution,, left standstill 24 hours to containing alcohol amount 40%;
4) reclaim ethanol: get the precipitate with ethanol supernatant, filter, decompression recycling ethanol is not to there being the alcohol flavor, and it is 1: 0.5 that medicinal liquid concentrates ratio, and promptly every milliliter contains crude drug 0.5 gram;
5) dosing: 1. get sucrose 150 grams, process simple syrup as correctives
2. getting 1.5 sodium sorbates is dissolved in the purified water and encapsulates as antiseptic.
3. the concentrated solution that obtains of step 4) adds correctives and antiseptic mixing, adds purified water to 1000ml, and filtration, sterilization, embedding promptly get oral liquid of the present invention.
Specification: every bottle of 10mL.
Usage and dosage: once oral 10ml, 3 times on the one, one after each meal.
Embodiment 3: 1000mL is an example with production oral liquid product of the present invention, and its preparation method is:
1) extract: get Rhizoma Panacis Majoris 100g, Radix Astragali 300g, crude drug is broken, with 40 times of water heating extraction 1 time, each 3 hours, filters the filtrating merging;
2) concentrate: filtrate decompression is concentrated, obtain concentrated solution, the concentrated solution ratio is 1: 1.5, and promptly every milliliter of concentrated solution contains crude drug 1.5 grams;
3) precipitate with ethanol: slowly add ethanol in the concentrated solution,, left standstill 24 hours to containing alcohol amount 20%;
4) reclaim ethanol: get the precipitate with ethanol supernatant, filter, decompression recycling ethanol is not to there being the alcohol flavor, and it is 1: 1.5 that medicinal liquid concentrates ratio, and promptly every milliliter contains crude drug 15 grams;
5) dosing: 1. get sucrose 150 grams, process simple syrup as correctives;
2. getting 1.5 sodium sorbates is dissolved in the purified water and encapsulates as antiseptic.
3. the concentrated solution that obtains of step 4) adds correctives and antiseptic mixing, adds purified water to 1000ml, and filtration, sterilization, embedding promptly get oral liquid of the present invention.
Specification: every bottle of 10mL.
Usage and dosage: once oral 10ml, 3 times on the one, one after each meal.
Oral liquid pharmacodynamic experiment of the present invention
Pharmacodynamic experiment receive the reagent thing, by of the step of preparation process preparation of ShanXi Chinese Medicine Academy Chemistry for Chinese Traditional Medicine laboratory by oral liquid of the present invention.Face with preceding concentrate and be mixed with Cmax and contain raw medicinal herbs 2g/ml, supply to irritate stomach (ig) administrable.4 ℃ of following refrigerators are preserved subsequent use.
Acute toxicity testing
1. prerun
Get 9 of mices, body weight 18 ± 2g, fasting is 6 hours before the administration, divides 3 groups, and dosage is respectively 0.3ml/10g, 0.2ml/10g, 0.1ml/10g; Irritate stomach 1 time in the 24h, observe the mice ordinary circumstance after the administration.See the mice activity freely, it is normal to take food, drink water, and stool is the wet particle shape.Do not have 1 in 3 dosage mice 72h and extremely do not have obvious toxic reaction yet, point out these article to be difficult to measure LD50, so select to do mtd test.
2. receive most the test of reagent thing amount greatly
Get 40 of mices, male and female half and half, body weight 18 ± 2g; Fasting 6h before the administration is mixed with 1 perfusion in the Cmax oral liquid 24h to concentrate, and dosage is 0.4ml/10g; Observe a week, itemized record mice behavioral activity, state, diet, defecation and hair color, secretions etc. continuously.
3. experimental result
40 mice outward appearance sign no abnormality seens, activity freely, the feed, drinking-water all normal, feces is the wet particle shape; Fur is bright and clean, and mouth, nose, eye and Anal cleaning do not have secretions, observes a week continuously; Body weight has increase, and 20 mices of administration group as a result all survive, and do not have obvious toxic reaction; Dissect finding: thoracic cavity, abdominal cavity no abnormality seen liquid, intestinal tube is not seen flatulence, important organs such as the heart, liver, spleen, lung, kidney are not seen color, paramophia; No petechia or other pathological change; The gastric mucosa color is ruddy, no ulcer; Postmortem is no abnormal.
Oral liquid of the present invention does not measure LD50 for mouse stomach, observes 7d with after the administration in the maximum administration volume of the Cmax 24h 1 time, none death of mice as a result, and its maximum tolerated dose is 80g/kg, is 400 times of clinical people's consumption (0.2g/kg).
4. experiment conclusion
Oral liquid of the present invention does not have obvious acute toxicity effect.
Influence to leukocyte count and immune organ
1. experimental technique
Get 50 mices, be divided into 5 groups at random, 10 every group.Be dose groups (2.4g/kg) and oral liquid small dose group (1.2g/kg) in the heavy dose of group of normal control group, cyclophosphamide group and oral liquid (4.8g/kg), the oral liquid.The 3d that conforms irritates stomach and gives normal group and cyclophosphamide group mice normal saline 20ml/kg, and experiment beginning first three day, except that the normal control group, other respectively organizes lumbar injection 100mg/kg cyclophosphamide, manufacturing immunocompromised model.The administration group gives the corresponding dosage medicine, successive administration 7d.Behind the last administration 24h, adopt eye socket to pluck the eyeball blood taking method, count leukocyte count with blood cell counting plate.Put to death animal then, cut open and get thymus and spleen, filter paper is inhaled and is removed surperficial residual blood, on precision balance, claims its weight in wet base immediately, calculates the organ weights index, carries out the t check analysis between group, and the result sees table 1.
Annotate: compare with model group: * P<0.05; * P<0.01
2 experimental results
2.1 influence to leukocyte count
Experimental result by table 1 can be found out: compare with the normal control group, the leukocyte count of cyclophosphamide group significantly reduces (P<0.01), and significant difference is arranged, and explains with the cyclophosphamide modeling and sets up; Compare with the cyclophosphamide group; Little, the middle dose groups leukocyte count of ginseng increasing white blood cell oral liquid significantly increases (P<0.05); Significant difference is arranged, and big or middle dosage has stronger significant difference (P<0.01), and experimental result explanation oral liquid of the present invention has the effect of stronger leukocyte increasing number.
2.2 influence to immune organ
Immune organ is the organization that animal is carried out immunologic function, and their development condition directly has influence on the height of immunity of organisms.Wherein thymus, spleen play an important role in influencing immune factor.Experimental result by table 1 can be found out: compare with the normal control group; The index and spleen index of cyclophosphamide group significantly reduces (P<0.05); Significant difference is arranged, explain with the cyclophosphamide modeling index and spleen index is reduced, the big or middle dose groups index and spleen index of oral liquid of the present invention significantly increases (P<0.05); Compare with the cyclophosphamide group, significant difference is arranged.Oral liquid is heavy dose of, and thymus index and model group relatively have significant difference (P<0.05),
3 experiment conclusion
Oral liquid of the present invention can improve the immunity of immune organ.
The influence of oral liquid carbon clearance experiment of the present invention
1 experimental technique
Get 50 mices, be divided into 5 groups at random, 10 every group.Be dose groups (2.4g/kg) and oral liquid small dose group (1.2g/kg) in the heavy dose of group of normal control group, cyclophosphamide group and oral liquid (4.8g/kg), the oral liquid.The 3d that conforms irritates stomach and gives normal group and cyclophosphamide group mice normal saline 20ml/kg, and experiment beginning first three day, except that the normal control group, other respectively organizes lumbar injection 100mg/kg cyclophosphamide, manufacturing immunocompromised model.The administration group gives the corresponding dosage medicine, successive administration 7d.India ink is with 10 times of diluted for use of normal saline, and after the last administration, each caudal vein is annotated the people and diluted india ink 10ml/kg body weight, in injection back 1min and 6min mouse orbit blood sampling 25ul, adds people 0.1%Na
2CO
3Shake up among the solution 2ml, 600nm absorbing wavelength place colorimetric on spectrophotometer is calculated phagocytic index and is engulfed the coefficient correction phagocytic index.Photometry density (OD value); K=logOD1-logOD2/t2-t1; A=K1/3 * body weight/(liver weight+spleen is heavy).Carry out the t check analysis between group, the result sees table 2.
The influence
of table 2 carbon clearance experiment
Annotate: compare with model group: * P<0.05; * P<0.01
2. experimental result
Experimental result by table 2 can be found out: compare with the normal control group, K, a of cyclophosphamide group significantly reduces (P<0.05) has significant difference, explains with the cyclophosphamide modeling and sets up; Compare with the cyclophosphamide group, the value of dose groups K, a significantly increases (P<0.05) in the oral liquid.
3. experiment conclusion
Dose groups can strengthen phagocytic index and engulf coefficient in the oral liquid of the present invention, proofreaies and correct phagocytic index.
Also can comprise some conventional liq excipient substances in the oral liquid of the present invention: purified water, Mel, aspartame, Pulvis Talci, magnesium stearate, sodium benzoate, potassium sorbate, p-Hydroxybenzoate etc.Any type of simple transformation, equivalence replacement all fall into protection scope of the present invention.
Claims (9)
1. a treatment is characterized in that its composition and weight proportion thereof are: Rhizoma Panacis Majoris 10%-90%, Radix Astragali 90%-10% because of leukopenia new Chinese medicine due to the carcinosis radiotherapy and chemotherapy.
2. treatment according to claim 1 is characterized in that said composition and weight proportion thereof are: Rhizoma Panacis Majoris 25%-75%, Radix Astragali 75%-25% because of leukopenia new Chinese medicine due to the carcinosis radiotherapy and chemotherapy.
3. treatment according to claim 2 is characterized in that said composition and weight proportion thereof are: Rhizoma Panacis Majoris 25%, the Radix Astragali 75% because of leukopenia new Chinese medicine due to the carcinosis radiotherapy and chemotherapy.
4. treatment according to claim 1 is characterized in that because of leukopenia new Chinese medicine due to the carcinosis radiotherapy and chemotherapy effective site is total saponins and vegetable polysaccharides, and main activated saponin composition is ginsenoside Ro, Rhizoma Panacis Japonici saponin IVa and astragaloside.
5. the method for preparing of each said new Chinese medicine of claim 1-4 is characterized in that, comprises the steps:
1) extracts: with Rhizoma Panacis Majoris, the fragmentation of Radix Astragali raw medicinal material, broken material is used water extraction, obtain extracting solution;
2) concentrate: collect the step 1) extracting solution, filter, will filtrate concentrates;
3) precipitate with ethanol: with step 2) concentrated solution adds ethanol, leaves standstill;
4) reclaim ethanol: with step 3) precipitate with ethanol supernatant liquid filtering, filtrate recycling ethanol is to most;
5) dosing: the concentrated solution of step 4) is added correctives, antiseptic and purified water, filtration sterilization, encapsulation.
6. method according to claim 5 is characterized in that,
Step 1) is said to be specially broken material with water extraction, with 5-40 times of water heating extraction 1-3 time, and each 1-3 hour, to filter, filtrating merges.
Step 2) in filtrate decompression is concentrated, obtain concentrated solution, the concentrated solution ratio is 1: 0.5-1: 1.5, and promptly every milliliter of concentrated solution contains crude drug 0.5-1.5 gram.
Add ethanol in the step 3) to containing alcohol amount 20%-40%, left standstill 24 hours.
Alcohol deposit fluid is filtered in the step 4), and decompression recycling ethanol is not to there being the alcohol flavor, and concentrated medicament makes every milliliter to contain crude drug 0.5-1.5 gram.
7. method according to claim 6 is characterized in that,
The water that adds 8 times of amounts of medical material in the step 1), each 2h carries 2 times altogether.
Step 2) 1 of concentrating under reduced pressure extracting solution to crude drug times of amount.
Step 3) adds 95% ethanol makes determining alcohol to 30% in the medicinal liquid.
Step 4) is evaporated to every milliliter and contains crude drug 1g.
8. method according to claim 6 is characterized in that the correctives described in the step 5) is: sucrose.
9. method according to claim 6 is characterized in that the antiseptic described in the step 5) is: sodium sorbate.
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