CN103479798A - Traditional Chinese medicine for resisting mycobacterium trberculosis and preparation method thereof - Google Patents
Traditional Chinese medicine for resisting mycobacterium trberculosis and preparation method thereof Download PDFInfo
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- CN103479798A CN103479798A CN201210193211.2A CN201210193211A CN103479798A CN 103479798 A CN103479798 A CN 103479798A CN 201210193211 A CN201210193211 A CN 201210193211A CN 103479798 A CN103479798 A CN 103479798A
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- tuberculosis
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Abstract
The invention provides a traditional Chinese medicine prepared from callicarpa nudiflora. The traditional Chinese medicine has an effect of resisting mycobacterium trberculosis. At the same time, a preparation method of the traditional Chinese medicine is also disclosed.
Description
Technical field
The present invention relates to the medicine of anti-mycobacterium tuberculosis, is Chinese medicine of a kind of anti-mycobacterium tuberculosis and preparation method thereof specifically.
Background technology
The communicable disease that has caused by tubercule bacillus is tuberculosis, and tuberculosis can be involved a plurality of internal organs of whole body, but the most common with pulmonary tuberculosis.The anti-mycobacterium tuberculosis medicine of extensive use at present has isoniazid, rifampicin, pyrazinamide, ethambutol and streptomycin, rifapentine etc., the patient develops immunity to drugs and drug resistance because treatment time is long, and there is the side effect to the damage of liver, kidney etc., treatment for the outer tuberculosis (as bone tuberculosis, tuberculous meningitis) of lung, usually with chemotherapy or operative treatment, the state of an illness easily repeatedly, even will be carried out the amputation treatment, to the patient, brings the body and mind misery.For overcoming the problems referred to above, the invention provides a kind of Chinese medicine that a kind of medicine time is short, expense is lower, cure rate is high.Contemporary Chinese medicine 16 24 phases of volume in 2009 " dispersible tablet of naked flower beautyberry leaf and Western medicine share pharmacology analysis and the clinical efficacy for the treatment of hemoptysis of pulmonary tuberculosis " have put down in writing dispersible tablet of naked flower beautyberry leaf and hemorrhage share the hemoptysis of pulmonary tuberculosis for the treatment of various degree except massive hemoptysis all than alone hemorrhage good effect, shorten the course for the treatment of of stopping blooding, alleviate disease.Health professional education 22 11 phases of volume in 2004 " therapeutic alliance of Callicarpa nudiflora sheet is controlled again tuberculosis and observed " have been put down in writing the Callicarpa nudiflora sheet and combine and control again pulmonary tuberculosis, can increase the synergism of chemotherapeutic agent, reduce toxic and side effects.The report that Callicarpa nudiflora anti-mycobacterium tuberculosis effect is in vivo and in vitro not yet arranged at present.
Summary of the invention
The object of the present invention is to provide a kind of Chinese medicine of anti-mycobacterium tuberculosis, another object of the present invention is to provide its preparation method of this Chinese medicine.
Purpose of the present invention is achieved through the following technical solutions:
A kind of Chinese medicine for anti-mycobacterium tuberculosis, this Chinese medicine is prepared from by Callicarpa nudiflora.
The preparation method of a kind of Chinese medicine for anti-mycobacterium tuberculosis of the present invention, include but not limited to following two kinds.
Method one: comprise the steps:
(1) get fresh or dry Callicarpa nudiflora, add water or 50 ~ 90% alcoholic solvents to extract, the 1-20 that the consumption of solvent is the raw material dose doubly measures, and after extracting, filters, and obtains filtrate;
(2) step (1) gained filtrate being condensed into to relative density is 1.03 ~ 1.35(60 ℃) clear paste or fluid extract;
(3) gained clear paste or fluid extract and pharmaceutically acceptable adjuvant are prepared into to preparation.
Method two: comprise the steps:
(1) get the Callicarpa nudiflora of fresh state, through squeezing, obtain pressed liquor and press residue, pressed liquor filters, and obtains liquor B, and remaining press residue adds water or 50 ~ 90% alcoholic solvents, and the consumption of solvent is doubly measured for the 1-20 of the squeezing quantity of slag, after extracting, filters, and obtains liquor C;
(2) it is 1.03 ~ 1.35(60 ℃ that filtrate liquor B or C or BC merged is condensed into relative density) clear paste or fluid extract;
(3) step (2) gained clear paste or fluid extract and pharmaceutically acceptable adjuvant are prepared into to preparation.
In above-mentioned two kinds of methods, gained clear paste or fluid extract are further refining, then are prepared into preparation with pharmaceutically acceptable adjuvant.
In method one and two, alcoholic solvent includes but not limited to methanol, ethanol, propanol; Described process for purification includes but not limited to precipitate with ethanol, macroporous resin separation and purification, flocculate and clarify, membrance separation; Described extraction step can extract one and arrive repeatedly, preferably 1-3 time; The 2-8 that the consumption of described extraction solvent is preferably crude drug or the squeezing quantity of slag doubly measures.
Squeezing step described in method two can adopt and add the water that 0.5-3 doubly measures and squeezed, and the water that preferably 0.5-1.5 doubly measures is squeezed.
Doubly amount described in the present invention is the multiple of weight.
The Chinese medicine that is used for the treatment of tuberculosis of the present invention can be for the administration form: aerosol, spray, injectable powder, injection, capsule, tablet, granule, syrup.
The Chinese medicine that is used for the treatment of tuberculosis of the present invention, be used for the treatment of the outer tuberculosis of pulmonary tuberculosis and lung, the outer tuberculosis of described lung comprises bone tuberculosis, tuberculous meningitis, lymphoid tuberculosis, tuberculous peritonitis, tuberculosis of intestine, renal tuberculosis, tuberculosis of epididymis, genito-urinary tuberculosis, bone tuberculosis, tuberculosis of skin, eye tuberculosis, otorhinolaryngology tuberculosis, tuberculosis of tongue.
By following pharmacodynamics test, observe the effectiveness of Chinese medicine composition of the present invention:
(1), experimentation
1. prepared and autoclaving by Callicarpa nudiflora stock solution:
Get Callicarpa nudiflora and put in extraction pot, add 8 times of water extraction twice, 2 hours for the first time, 1 hour for the second time, collecting decoction, filtering, be condensed into relative density was 1.16～1.20(60 ℃) fluid extract, spray drying, obtain the Callicarpa nudiflora dry extract.
Above-mentioned Callicarpa nudiflora dry extract water is dissolved into to 121 ℃ of Callicarpa nudiflora stock solution (being equivalent to crude drug concentration 300mg/ml) high pressure steam sterilizations 20 minutes.
2. the dilution of Callicarpa nudiflora stock solution and streptomycin: with physiological saline solution, by the dilution of Callicarpa nudiflora stock solution, be 1/2,1/4,1/8,1/16,1/32,1/64,1/160 of stock solution, each concentration preparation 10 pipe, every pipe 9.8ml.With physiological saline solution, streptomycin being diluted to concentration is 4000 μ g/ml, 200 μ g/ml, 20 μ g/ml, 2 μ g/ml.Each concentration preparation 10 pipe, every pipe 9.8ml.
3. the preparation of Callicarpa nudiflora pastille culture medium and streptomycin pastille culture medium: Callicarpa nudiflora stock solution is joined in neutral modified Russell medium, make it concentration and be respectively 1/2,1/4,1/8,1/16,1/32,1/64,1/80 of stock solution.Each concentration packing 10 pipe; Streptomycin solution (4000 μ g/ml) is joined to neutrality have been changed in Russell medium, make it concentration and be respectively 2000 μ g/ml(1/2), 1000 μ g/ml(1/4), 500 μ g/ml(1/8), 250 μ g/ml1/ (1/16), 125 μ g/ml(1/32), 4 μ g/ml, each concentration packing 10 pipes., containing the some pipes of neutral modified Russell medium of any medicine, every pipe 8ml, in 85 ℃ of sterilizings of constant temp. steam coagulater 50 minutes in preparation simultaneously.
4. sterility test: modified Russell medium sterility test 3 days for the experiment that will prepare.Find no the culture medium of pollution, can continue next step experiment.
5. bacterium solution preparation: choose the Mycobacterium tuberculosis H37Rv type strain cultivated 3 weeks, clinical separation strain two strains and (number 14506 for to INH, RFP, EMB, RFT, PAS, OFLX, KM, AMK, CPM, THI321 sensitivity, to SM10, SM100 drug resistance; Number 14374 couples of SM, INH, RFP, EMB, RFT, PAS, OFLX, KM, AMK, CPM, THI321 sensitivity) the mill bacterium, be mixed with 0.5 Maxwell unit (1mg/ml) bacteria suspension.
6. inoculation:
Method one: by H37Rv, 14506, the 14374 bacteria suspension 1:100 of bacterial strain 0.5 Maxwell unit (1mg/ml) dilutions, be inoculated in respectively in Callicarpa nudiflora pastille culture medium, streptomycin pastille culture medium and control tube every pipe 0.1ml, each concentration inoculation 2 pipe.
Method two: H37Rv, 16045,17437 bacterial strain 0.5 Maxwell unit (1mg/ml) bacteria suspensions are added in Callicarpa nudiflora, streptomycin dilution tube and control tube to every pipe 0.2ml, each concentration 2 pipe, in 37 ℃ of calorstats, place 24 hours, after 24 hours, in the aseptic centrifuge tube of packing into, the centrifugal 20min of 3000xg places, remove supernatant, precipitation adds the 10ml physiological saline solution, shakes up, and is inoculated in respectively in neutral modified Russell medium, every pipe 0.1ml, each concentration inoculation 2 pipe.
7. cultivate: the culture medium of having inoculated is positioned over to 37 ℃ of constant incubators and cultivates 4 weeks observed results.
(2), experimental result:
Method one: Absolute concentration method
Table 1. mycobacterium tuberculosis is containing Callicarpa nudiflora modified Russell medium growing state (clump count):
Table 2. mycobacterium tuberculosis is containing growing state (clump count) on the streptomycin modified Russell medium:
In above-mentioned table 1 and table 2, clump count is less than 100, with actual clump count counting, 100 be labeled as 1+, and cover inclined-plane 1/2 and be expressed as 2+, cover inclined-plane 3/4 and be expressed as 3+.
Method two: medicine and mycobacterium tuberculosis effect 24 hours:
Table 3. Callicarpa nudiflora medicine and mycobacterium tuberculosis effect after 24 hours on modified Russell medium growing state (clump count):
Table 4. streptomycin and mycobacterium tuberculosis effect after 24 hours on modified Russell medium growing state (clump count):
In above-mentioned table 3 and table 4, clump count is less than 100, with actual clump count counting, 100 be labeled as 1+, and cover inclined-plane 1/2 and be expressed as 2+, cover inclined-plane 3/4 and be expressed as 3+.
(3), interpretation
Callicarpa nudiflora has obvious bacteriostasis to mycobacterium tuberculosis, the 1/16(that the MIC that direct effect method (method two) records is the Callicarpa nudiflora original liquid concentration is 18.75mg/ml), the 1/2(that the MIC that Absolute concentration method (method one) records is the Callicarpa nudiflora original liquid concentration is 150mg/ml);
Beneficial effect of the present invention: Chinese medicine of the present invention has stronger anti-mycobacterium tuberculosis effect, has stronger anti-drug resistance, high-efficiency low-toxicity.
The specific embodiment
embodiment 1 injection
prescription:
Callicarpa nudiflora (aquatic foods, leaf and twig, the rate 33.2% of giving money as a gift) 500g sodium chloride 7g tween 80 5g water for injection adds to 1000ml
method for making:
Callicarpa nudiflora adds 1.5 times of water gagings and is broken into homogenate, and squeezing filters, and it is 1.03 ~ 1.10(60 ℃ that pressed liquor is concentrated into relative density), add ethanol and reach 50% to containing the alcohol amount, stir cold preservation, precipitation, filtration, filtrate recycling ethanol, be concentrated into 500ml, then add ethanol to containing the alcohol amount, reaching 80%, cold preservation 24 hours, filter, filtrate recycling ethanol, to without the alcohol flavor, merges with distillate, filter, add sodium chloride, tween 80, stirring and dissolving, inject water to 1000ml, uses G
3sintered glass funnel filters, and sterilizing, obtain.
embodiment 2 aerosols
prescription:
Callicarpa nudiflora 800g(aquatic foods, leaf and twig, the rate 33.2% of giving money as a gift) the appropriate appropriate amount of ethanol of dichlorodifluoromethane
method for making:
Callicarpa nudiflora adds 0.5 times of water gaging and is broken into homogenate, and squeezing filters, obtain pressed liquor, remaining press residue adds 1 times of amount 50% ethanol extraction 1 time, after extracting, filters, obtain filtrate, filtrate and pressed liquor merge, and being concentrated into relative density is 1.15 ~ 1.35(60 ℃), merge with pressed liquor, add ethanol and extremely containing the alcohol amount, reach 75%, precipitation, filtration, filtrate recycling ethanol, to without alcohol, distinguishing the flavor of adding distil water to 1000ml, mixes, and filters, be sub-packed in the aerosol pressure vessel, be pressed into dichlorodifluoromethane, obtain.
embodiment 3 sprays
prescription:
Callicarpa nudiflora 1000g (aquatic foods, leaf and twig, the rate 33.2% of giving money as a gift) nipalgin 0.25 g
method for making:
Callicarpa nudiflora adds 3 times of water and is broken into homogenate, and squeezing filters, it is 1.03 ~ 1.06(60 ℃ that pressed liquor is concentrated into relative density) clear paste, remaining press residue adds 5 times of amount 90% ethanol extractions 1 time, after extracting, filters, filtrate, it is 1.03 ~ 1.06(60 ℃ that filtrate is concentrated into relative density) clear paste, with pressed liquor gained clear paste, merge, add nipalgin, dissolve, filter, adding distil water is to 1000ml, be sub-packed in aerosol apparatus, obtain.
embodiment 4 injectable powder
prescription:
Callicarpa nudiflora 600g
method for making:
Get Callicarpa nudiflora and add 2 times of water gagings decoctions 2 times, each 2 hours, filter, filtrate is concentrated into relative density to 1.05 ~ 1.10(60 ℃), cross the polystyrene type macroporous adsorptive resins, discard effluent, the water washing cylinder of 6 times of column volumes, discard cleaning mixture, 80% ethanol elution, collect eluent, reclaim ethanol, being evaporated to relative density is 1.20 ~ 1.25(60 ℃), lyophilization, obtain.
embodiment 5 capsules
prescription:
Callicarpa nudiflora 1000g starch 75g lactose 75g micropowder silica gel 4g magnesium stearate 2.5g
method for making:
Callicarpa nudiflora adds 20 times of decoctings and boils 2 times, and each 2 hours, filter, it was 1.20 ~ 1.35(60 ℃ that filtrate is concentrated into relative density), add starch, lactose, ethanol soft material processed, granulate, drying, granulate, add micropowder silica gel, magnesium stearate, mixes, and filling, and get final product.
embodiment 6 bran slurry agent
prescription:
Callicarpa nudiflora 1000g sucrose 650g ploughs sour potassium 2.5g in mountain
method for making:
Callicarpa nudiflora adds 5 times of amount 90% ethanol and decocts 2 times, within each 2 hours, filters, and filtrate recycling ethanol is to nothing alcohol flavor, being concentrated into relative density is 1.03 ~ 1.10(60 ℃) clear paste, sucrose adds water boil, after dissolving, filters, be condensed into syrup, merge with clear paste, mix, boil, let cool, add mountain to plough sour potassium and dissolve, mix, with distilled water diluting, to 1000ml, obtain.
embodiment 7 tablets
prescription:
Callicarpa nudiflora 1000g starch 80g lactose 60g magnesium stearate 2.5g
method for making:
Callicarpa nudiflora adds 8 times of water gagings and decocts 2 times, and each 2 hours, filter, it was 1.20 ~ 1.35(60 ℃ that filtrate is concentrated into relative density), add starch, lactose, ethanol soft material processed, granulation, drying, granulate, add micropowder silica gel, magnesium stearate, mixes, and tabletting, and get final product.
embodiment 8 granules
prescription:
Callicarpa nudiflora 1000g starch 80g, lactose 60g
method for making:
Callicarpa nudiflora adds 2 times of amount 50% ethanol and decocts 2 times, within each 2 hours, filters, and filtrate recycling ethanol is to nothing alcohol flavor, and being concentrated into relative density is 1.20 ~ 1.35(60 ℃), add starch, lactose, ethanol soft material processed, granulate, drying, granulate, obtain.
embodiment 9 granules
prescription:
Callicarpa nudiflora 1000g starch 80g, lactose 60g
method for making:
Callicarpa nudiflora adds 1 times of amount 80% ethanol and decocts 2 times, within each 2 hours, filters, and filtrate recycling ethanol is to nothing alcohol flavor, and being concentrated into relative density is 1.20 ~ 1.35(60 ℃), add starch, lactose, ethanol soft material processed, granulate, drying, granulate, obtain.
Claims (6)
1. the Chinese medicine for anti-mycobacterium tuberculosis, is characterized in that this Chinese medicine is prepared from by Callicarpa nudiflora.
2. the preparation method of a kind of Chinese medicine for anti-mycobacterium tuberculosis claimed in claim 1, is characterized in that comprising the steps:
(1) get fresh or dry Callicarpa nudiflora, add water or 50 ~ 90% alcoholic solvents to extract, the 1-20 that the consumption of solvent is the raw material dose doubly measures, and after extracting, filters, and obtains filtrate;
(2) step (1) gained filtrate being condensed into to relative density is 1.03 ~ 1.35(60 ℃) clear paste or fluid extract;
(3) gained clear paste or fluid extract and pharmaceutically acceptable adjuvant are prepared into to preparation.
3. the preparation method of a kind of Chinese medicine for anti-mycobacterium tuberculosis according to claim 1, is characterized in that, comprises the steps:
(1) get the Callicarpa nudiflora of fresh state, through squeezing, obtain pressed liquor and press residue, pressed liquor filters, and obtains liquor B, and remaining press residue adds water or 50 ~ 90% alcoholic solvents, and the consumption of solvent is doubly measured for the 1-20 of the squeezing quantity of slag, after extracting, filters, and obtains liquor C;
(2) it is 1.03 ~ 1.35(60 ℃ that filtrate liquor B or C or BC merged is condensed into relative density) clear paste or fluid extract;
(3) step (2) gained clear paste or fluid extract and pharmaceutically acceptable adjuvant are prepared into to preparation.
4. according to the preparation method of the described a kind of Chinese medicine for anti-mycobacterium tuberculosis of claim 2 or 3, it is characterized in that, gained clear paste or fluid extract are further refining, then are prepared into preparation with pharmaceutically acceptable adjuvant.
5. the Chinese medicine for anti-mycobacterium tuberculosis according to claim 1, is characterized in that described Chinese medicine can be for the administration form: aerosol, spray, injectable powder, injection, capsule, tablet, granule, syrup.
6. the Chinese medicine for anti-mycobacterium tuberculosis claimed in claim 1, it is characterized in that being used for the treatment of the pulmonary tuberculosis and the outer tuberculosis of lung that are caused by tubercule bacillus, the outer tuberculosis of described lung comprises bone tuberculosis, tuberculous meningitis, lymphoid tuberculosis, tuberculous peritonitis, tuberculosis of intestine, renal tuberculosis, tuberculosis of epididymis, genito-urinary tuberculosis, bone tuberculosis, tuberculosis of skin, eye tuberculosis, otorhinolaryngology tuberculosis, tuberculosis of tongue.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103505566A (en) * | 2012-06-15 | 2014-01-15 | 九芝堂股份有限公司 | Chinese herbal compound resisting mycobacterium tuberculosis and preparation method |
| CN106266264A (en) * | 2015-06-10 | 2017-01-04 | 九芝堂股份有限公司 | A kind of pharmaceutical composition of anti-mycobacterium tuberculosis and preparation method thereof |
| CN106266265A (en) * | 2015-06-10 | 2017-01-04 | 九芝堂股份有限公司 | A kind of Callicarpa nudiflora Chinese medicine composition and its production and use |
| CN106266263A (en) * | 2015-06-10 | 2017-01-04 | 九芝堂股份有限公司 | A kind of Chinese medicine composition and its production and use |
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| CN1814048A (en) * | 2005-12-02 | 2006-08-09 | 杨文龙 | Chinese medicine liquid capsule of Folium callicarpae Nudiflorae, preparing method and quality control method |
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2012
- 2012-06-13 CN CN201210193211.2A patent/CN103479798B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1814048A (en) * | 2005-12-02 | 2006-08-09 | 杨文龙 | Chinese medicine liquid capsule of Folium callicarpae Nudiflorae, preparing method and quality control method |
Non-Patent Citations (2)
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| 杨远姗: "裸花紫珠片的临床应用进展", 《临床合理用药》 * |
| 湖南医药工业研究所技术情报研究室: "《中草药制剂新产品展品简介》", 30 November 1977 * |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103505566A (en) * | 2012-06-15 | 2014-01-15 | 九芝堂股份有限公司 | Chinese herbal compound resisting mycobacterium tuberculosis and preparation method |
| CN103505566B (en) * | 2012-06-15 | 2018-06-08 | 九芝堂股份有限公司 | A kind of anti-mycobacterium tuberculosis Chinese medicine compound prescription and preparation method |
| CN106266264A (en) * | 2015-06-10 | 2017-01-04 | 九芝堂股份有限公司 | A kind of pharmaceutical composition of anti-mycobacterium tuberculosis and preparation method thereof |
| CN106266265A (en) * | 2015-06-10 | 2017-01-04 | 九芝堂股份有限公司 | A kind of Callicarpa nudiflora Chinese medicine composition and its production and use |
| CN106266263A (en) * | 2015-06-10 | 2017-01-04 | 九芝堂股份有限公司 | A kind of Chinese medicine composition and its production and use |
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