CN102258595B - Traditional Chinese medicine composition for treating tuberculosis, preparation and application thereof - Google Patents
Traditional Chinese medicine composition for treating tuberculosis, preparation and application thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating the tuberculosis, a preparation and application thereof. The traditional Chinese medicine composition comprises the following materials in parts by weight: 5-25 parts of Panax pseudoginseng, 2-22 parts of ripterospermum affine and 2-20 parts of hairyvein agrimony. The traditional Chinese medicine composition has the effects of nourishing yin, clearing away the lung heat and calming blood, can be used for treating the tuberculosis, and especially is suitable for treating the drug-resistant tuberculosis caused by yin deficiency, lung heat and meridian injury.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition and its production and use, particularly a kind of Chinese medicine composition for the treatment of resistant tuberculosis and its production and use.
Background technology
As everyone knows, the tulase drug resistance is to cause the major reason of tuberculotherapy failure.Resistant tuberculosis can be divided into two kinds according to the difference that it produces reason: primary drug resistance and acquired drug-resistance.The drug resistance kind is more, and cure rate is lower, and more certainly, relapse rate is not higher for late result.Because drug resistance patient's treatment mortality is high, causes drug resistance source of infection long-term existence, has increased the propagation chance of Resistant strain, also brought great threat for public health.
At present, still take chemotherapy as main, but its effectiveness remains further to be improved for the treatment of resistant tuberculosis.Chinese medicine emphasizes that dialectical opinion is controlled, the disease combination, and at the characteristic and advantage that oneself is arranged aspect the treatment resistant tuberculosis, but the application of present stage Chinese medicine compound aspect resistant tuberculosis is very few, can say, the Advantages of TCM of resistant tuberculosis treatment is demanded exploitation urgently.
Summary of the invention
The object of the invention is to provide a kind of Chinese medicine composition lungy for the treatment of; Another object of the present invention is to provide the preparation method of this Chinese medicine composition; The 3rd purpose of the present invention is to provide the purposes of this Chinese medicine composition.
The present invention seeks to by following technical solution, A, B, C, D realize:
Option A:
The Chinese medicine composition of a kind of Cure of depression of the present invention, its crude drug consists of (weight ratio):
Rhizoma panacis majoris 5-25 weight portion, Herba Tripterospermi 2-22 weight portion, Herba Agrimoniae 2-20 weight portion.
The crude drug composition of Chinese medicine composition of the present invention is preferably: Rhizoma panacis majoris 10-20 weight portion, Herba Tripterospermi 5-12 weight portion, Herba Agrimoniae 5-12 weight portion.
The crude drug composition of Chinese medicine composition of the present invention is preferably: Rhizoma panacis majoris 6 weight portions, Herba Tripterospermi 21 weight portions, Herba Agrimoniae 3 weight portions.
The crude drug composition of Chinese medicine composition of the present invention is preferably: Rhizoma panacis majoris 24 weight portions, Herba Tripterospermi 3 weight portions, Herba Agrimoniae 18 weight portions.
The crude drug composition of Chinese medicine composition of the present invention is preferably: Rhizoma panacis majoris 15 weight portions, Herba Tripterospermi 6 weight portions, Herba Agrimoniae 18 weight portions.
The crude drug composition of Chinese medicine composition of the present invention is preferably: Rhizoma panacis majoris 24 weight portions, Herba Tripterospermi 12 weight portions, Herba Agrimoniae 9 weight portions.
The crude drug composition of Chinese medicine composition of the present invention is preferably: Rhizoma panacis majoris 15 weight portions, Herba Tripterospermi 12 weight portions, Herba Agrimoniae 9 weight portions.
The invention described above traditional Chinese medicinal composition raw materials adds conventional adjuvant, according to common process, makes the dosage form of clinical acceptance, includes but not limited to capsule, granule, single herbal concentrate-granule, pill, tablet, oral liquid or lyophilized injectable powder.The preferred single herbal concentrate-granule of Chinese medicine composition dosage form of the present invention.
The preparation method of Chinese medicine composition of the present invention is: Rhizoma panacis majoris ethanol extraction, alcohol extract purification by macroporous resin; Herba Tripterospermi, Herba Agrimoniae merge ethanol extraction, alcohol extract purification by macroporous resin; Add conventional adjuvant, according to a conventional method, make the dosage form of clinical acceptance, include but not limited to capsule, granule, single herbal concentrate-granule, pill, tablet, oral liquid or lyophilized injectable powder.
In the preparation method of Chinese medicine composition of the present invention, the preparation method of Rhizoma panacis majoris is preferably: add 3-8 and doubly measure (volume is doubly measured) 40-60% ethanol, reflux, extract, 1-3 time 1-3h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.1-1.0 weight portion crude drug/ml, upper low pole macroporous resin, static adsorption 0.1-1.0 hour, the post blade diameter length ratio is 6-18: 1, with distilled water flush away impurity, use the 30%-85% ethanol elution, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain.
In the preparation method of Chinese medicine composition of the present invention, the preparation method of Rhizoma panacis majoris is preferably: add 50% ethanol of 6 times of amounts, reflux, extract, 2 times 2h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.5 weight portion crude drug/ml, with AB-8 macroporous resin on the 3BV/h flow velocity, static adsorption 0.5 hour, the post blade diameter length ratio is 12: 1, with 5BV distilled water flush away impurity, collects 16BV 60% ethanol elution, elution flow rate is 2BV/h, the eluent concentrating under reduced pressure, is drying to obtain.
In the preparation method of Chinese medicine composition of the present invention, the preparation method of Herba Tripterospermi, Herba Agrimoniae is preferably: Herba Tripterospermi, Herba Agrimoniae add 4-15 and doubly measure 20-60% ethanol, and reflux, extract, 1-3 time 1-3h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.1-0.3 weight portion crude drug/ml, upper low pole macroporous resin, static adsorption 0.1-1.0 hour, the post blade diameter length ratio is 6-18: 1, with distilled water flush away impurity, 40-85% ethanol elution, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain.
In the preparation method of Chinese medicine composition of the present invention, the preparation method of Herba Tripterospermi, Herba Agrimoniae is preferably: Herba Tripterospermi, Herba Agrimoniae add 40% ethanol of 10 times of amounts, and reflux, extract, 2 times 2h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.2 weight portion crude drug/ml, with AB-8 macroporous resin on the 3BV/h flow velocity, static adsorption 0.5 hour, post blade diameter length ratio are 12: 1, with 5BV distilled water flush away impurity, 70% ethanol elution, collect 5BV 70% ethanol elution, elution flow rate is 3BV/h, the eluent concentrating under reduced pressure, is drying to obtain.
The object of the invention by following technical solution B realizes:
The crude drug of Chinese medicine composition of the present invention consists of: Rhizoma panacis majoris 5-25 weight portion, Herba Tripterospermi 2-22 weight portion, Herba Agrimoniae 2-20 weight portion, Radix Rhodiolae 1-12 weight portion.
The crude drug composition of Chinese medicine composition of the present invention is preferably: Rhizoma panacis majoris 10-20 weight portion, Herba Tripterospermi 5-12 weight portion, Herba Agrimoniae 5-12 weight portion, Radix Rhodiolae 4-9 weight portion.
The crude drug composition of Chinese medicine composition of the present invention is preferably: Rhizoma panacis majoris 6 weight portions, Herba Tripterospermi 21 weight portions, Herba Agrimoniae 3 weight portions, Radix Rhodiolae 11 weight portions.
The crude drug composition of Chinese medicine composition of the present invention is preferably: Rhizoma panacis majoris 24 weight portions, Herba Tripterospermi 3 weight portions, Herba Agrimoniae 18 weight portions, Radix Rhodiolae 3 weight portions.
The crude drug composition of Chinese medicine composition of the present invention is preferably: Rhizoma panacis majoris 15 weight portions, Herba Tripterospermi 6 weight portions, Herba Agrimoniae 18 weight portions, Radix Rhodiolae 6 weight portions.
The crude drug composition of Chinese medicine composition of the present invention is preferably: Rhizoma panacis majoris 24 weight portions, Herba Tripterospermi 12 weight portions, Herba Agrimoniae 9 weight portions, Radix Rhodiolae 3 weight portions.
The crude drug composition of Chinese medicine composition of the present invention is preferably: Rhizoma panacis majoris 15 weight portions, Herba Tripterospermi 12 weight portions, Herba Agrimoniae 9 weight portions, Radix Rhodiolae 6 weight portions.
The invention described above traditional Chinese medicinal composition raw materials adds conventional adjuvant, according to common process, makes the dosage form of clinical acceptance, includes but not limited to capsule, granule, single herbal concentrate-granule, pill, tablet, oral liquid or lyophilized injectable powder.The preferred single herbal concentrate-granule of Chinese medicine composition dosage form of the present invention.
The preparation method of Chinese medicine composition of the present invention is: Rhizoma panacis majoris ethanol extraction, alcohol extract purification by macroporous resin; Herba Tripterospermi, Herba Agrimoniae merge ethanol extraction, alcohol extract purification by macroporous resin; The Radix Rhodiolae water boiling and extraction, water extraction liquid macroporous resin is refining; Add conventional adjuvant, according to a conventional method, make the dosage form of clinical acceptance, include but not limited to capsule, granule, single herbal concentrate-granule, pill, tablet, oral liquid or lyophilized injectable powder.
In the preparation method of Chinese medicine composition of the present invention, the preparation method of Rhizoma panacis majoris is preferably: add 40-60% ethanol, reflux, extract, 1-3 time 1-3h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.1-1.0g crude drug/ml, upper low pole macroporous resin, static adsorption 0.1-1.0 hour, the post blade diameter length ratio is 6-18: 1, with distilled water flush away impurity, use the 30%-85% ethanol elution, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain.
In the preparation method of Chinese medicine composition of the present invention, the preparation method of Rhizoma panacis majoris is preferably: add 50% ethanol of 6 times of amounts, reflux, extract, 2 times 2h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.5g crude drug/ml, with AB-8 macroporous resin on the 3BV/h flow velocity, static adsorption 0.5 hour, the post blade diameter length ratio is 12: 1, with 5BV distilled water flush away impurity, collects 16BV 60% ethanol elution, elution flow rate is 2BV/h, the eluent concentrating under reduced pressure, is drying to obtain.
In the preparation method of Chinese medicine composition of the present invention, the preparation method of Herba Tripterospermi, Herba Agrimoniae is preferably: Herba Tripterospermi, Herba Agrimoniae add 20-60% ethanol, and reflux, extract, 1-3 time 1-3h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.1-0.3g crude drug/ml, upper low pole macroporous resin, static adsorption 0.1-1.0 hour, the post blade diameter length ratio is 6-18: 1, with distilled water flush away impurity, 40-85% ethanol elution, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain.
In the preparation method of Chinese medicine composition of the present invention, the preparation method of Herba Tripterospermi, Herba Agrimoniae is preferably: Herba Tripterospermi, Herba Agrimoniae add 40% ethanol of 10 times of amounts, and reflux, extract, 2 times 2h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.2g crude drug/ml, with AB-8 macroporous resin on the 3BV/h flow velocity, static adsorption 0.5 hour, post blade diameter length ratio are 12: 1, with 5BV distilled water flush away impurity, 70% ethanol elution, collect 5BV 70% ethanol elution, elution flow rate is 3BV/h, the eluent concentrating under reduced pressure, is drying to obtain.
In the preparation method of Chinese medicine composition of the present invention, the preparation method of Radix Rhodiolae is preferably: add 4-15 times of water gaging, reflux, extract, 2-4 time 1-3h/ time, gets water extraction liquid; Water extraction liquid adds the aqueous solution that water is mixed with 0.1-0.3g crude drug/ml, loading macroporous resin, static adsorption 0.1-1.0 hour, the post blade diameter length ratio is 6-18: 1, with distilled water flush away impurity, 20-60% ethanol elution, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain.
In the preparation method of Chinese medicine composition of the present invention, the preparation method of Radix Rhodiolae is preferably: add the water of 8 times of amounts, reflux, extract, 3 times 2h/ time, gets water extraction liquid; Water extraction liquid adds the aqueous solution that water is mixed with 0.2g crude drug/ml, with 3BV/h flow velocity loading HPD-100 macroporous resin, static adsorption 0.5 hour, the post blade diameter length ratio is 12: 1, with 5BV distilled water flush away impurity, collect 5BV 30% ethanol elution, elution flow rate is 2BV/h, the eluent concentrating under reduced pressure, is drying to obtain.
The object of the invention by following technical solution C realizes:
Scheme C:
The crude drug of Chinese medicine composition of the present invention consists of: Rhizoma panacis majoris extract 5-25 weight portion, Herba Tripterospermi extract 2-22 weight portion, Herba Agrimoniae extract 2-20 weight portion, Radix Rhodiolae extract 1-12 weight portion.
The crude drug composition of Chinese medicine composition of the present invention is preferably: Rhizoma panacis majoris extract 6 weight portions, Herba Tripterospermi extract 21 weight portions, Herba Agrimoniae extract 3 weight portions, Radix Rhodiolae extract 11 weight portions.
The crude drug composition of Chinese medicine composition of the present invention is preferably: Rhizoma panacis majoris extract 24 weight portions, Herba Tripterospermi extract 3 weight portions, Herba Agrimoniae extract 18 weight portions, Radix Rhodiolae extract 3 weight portions.
The crude drug composition of Chinese medicine composition of the present invention is preferably: Rhizoma panacis majoris extract 15 weight portions, Herba Tripterospermi extract 6 weight portions, Herba Agrimoniae extract 18 weight portions, Radix Rhodiolae extract 6 weight portions.
The crude drug composition of Chinese medicine composition of the present invention is preferably: Rhizoma panacis majoris extract 24 weight portions, Herba Tripterospermi extract 12 weight portions, Herba Agrimoniae extract 9 weight portions, Radix Rhodiolae extract 3 weight portions.
The said extracted thing adds conventional adjuvant, according to common process, makes the dosage form of clinical acceptance, includes but not limited to capsule, granule, single herbal concentrate-granule, pill, tablet, oral liquid or lyophilized injectable powder.
Extract described in the scheme C can be by commercially available purchase, or by the prior art preparation, preferably adopts following conventional method preparation:
Above-mentioned common process water extracting method can for: each 10-30 doubly measures, and extracts 1-3 hour at every turn 1-4 time;
Above-mentioned common process alcohol extraction method can for: 30-80% ethanol, 4-15 doubly measured, extract respectively 1-3 hour;
The described macroporous resin column method of crossing is: extracting solution filters, and filtrate is by macroporous resin, first with the ethanol elution of 4-6 times of water gaging or 20% following concentration, eluent is abandoned or adopted, and with adding 1-10 times of eluting of 50-80% ethanol, collects eluent again, decompression recycling ethanol gets purification liquid to without the alcohol flavor.
The preparation method of Chinese medicine composition of the present invention is: the Rhizoma panacis majoris ethanol extraction, and the alcohol extract purification by macroporous resin gets the Rhizoma panacis majoris extract; Herba Tripterospermi, Herba Agrimoniae merge ethanol extraction, and the alcohol extract purification by macroporous resin gets Herba Tripterospermi extract, Herba Agrimoniae extract; The Radix Rhodiolae water boiling and extraction, water extraction liquid macroporous resin is refining, gets Radix Rhodiolae extract; Add conventional adjuvant, according to a conventional method, make the dosage form of clinical acceptance, include but not limited to capsule, granule, single herbal concentrate-granule, pill, tablet, oral liquid or lyophilized injectable powder.
The preparation method of the described extract of scheme C is more preferably:
The preparation method of described Rhizoma panacis majoris extract is preferably: Rhizoma panacis majoris adds 4-8 and doubly measures (volume is doubly measured) 40-60% ethanol, and reflux, extract, 1-3 time 1-3h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.1-1.0g crude drug/ml, upper low pole macroporous resin, static adsorption 0.1-1.0 hour, the post blade diameter length ratio is 6-18: 1, with distilled water flush away impurity, use the 30%-85% ethanol elution, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain.
The preparation method of described Rhizoma panacis majoris extract is preferably: add 50% ethanol of 6 times of amounts, reflux, extract, 2 times 2h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.5g crude drug/ml, with AB-8 macroporous resin on the 3BV/h flow velocity, static adsorption 0.5 hour, the post blade diameter length ratio is 12: 1, with 5BV distilled water flush away impurity, collects 16BV 60% ethanol elution, elution flow rate is 2BV/h, the eluent concentrating under reduced pressure, is drying to obtain.
The preparation method of described Herba Tripterospermi, Herba Agrimoniae extract is preferably: Herba Tripterospermi, Herba Agrimoniae add 20-60% ethanol, and reflux, extract, 1-3 time 1-3h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.1-0.3g crude drug/ml, upper low pole macroporous resin, static adsorption 0.1-1.0 hour, the post blade diameter length ratio is 6-18: 1, with distilled water flush away impurity, 40-85% ethanol elution, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain.
The preparation method of described Herba Tripterospermi, Herba Agrimoniae extract is preferably: Herba Tripterospermi, Herba Agrimoniae add 40% ethanol of 10 times of amounts, and reflux, extract, 2 times 2h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.2g crude drug/ml, with AB-8 macroporous resin on the 3BV/h flow velocity, static adsorption 0.5 hour, post blade diameter length ratio are 12: 1, with 5BV distilled water flush away impurity, 70% ethanol elution, collect 5BV 70% ethanol elution, elution flow rate is 3BV/h, the eluent concentrating under reduced pressure, is drying to obtain.
The preparation method of described Radix Rhodiolae extract is preferably: add entry, reflux, extract, 2-4 time 1-3h/ time, gets water extraction liquid; Water extraction liquid adds the aqueous solution that water is mixed with 0.1-0.3g crude drug/ml, loading macroporous resin, static adsorption 0.1-1.0 hour, the post blade diameter length ratio is 6-18: 1, with distilled water flush away impurity, 20-60% ethanol elution, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain.
The preparation method of described Radix Rhodiolae extract is preferably: add the water of 8 times of amounts, reflux, extract, 3 times 2h/ time, gets water extraction liquid; Water extraction liquid adds the aqueous solution that water is mixed with 0.2g crude drug/ml, with 3BV/h flow velocity loading HPD-100 macroporous resin, static adsorption 0.5 hour, the post blade diameter length ratio is 12: 1, with 5BV distilled water flush away impurity, collect 5BV 30% ethanol elution, elution flow rate is 2BV/h, the eluent concentrating under reduced pressure, is drying to obtain.
Described g crude drug/ml refers to the weight of suitable crude drug and the ratio of liquor capacity.
Drug tolerance pulmonary tuberculosis is because of due to deficiency of YIN lung-heat network hinders, and belongs to the card that clinical deficiency in origin is the master; Chinese medicine composition among the present invention program A, B, the C is established for deficiency of YIN lung-heat, and the deficiency of YIN is not grown, the unclear then lung of lung-heat network is difficult peaceful; The nourishing YIN and clearing away lung-heat calming blood is its basic treatment rule, uses this side, has embodied the basic principle of differential diagnosis of diseases and dialectical combination and " treatment must aim at the pathogenesis of disease ".Full policy is treated etiology and pathogenesis essence, and outstanding effect is concentrated one's efforts grand.Rhizoma panacis majoris (has another name called Rhizoma Panacis Majoris in the side, dry rhizome for Araliaceae Rhizoma Panacis Majoris Panax japonicus C.A.Mey.var.major (Burk.) A.Y.Wu et K.M.Feng or Rhizoma Panacis bipinnatifidi Panaxjaponicus C.A.Mey.var.bipinna tifidus (Weem.) C.Y.Wu et K.M.Feng), cold in nature, bitter in the mouth, sweet, return liver, lung, stomach warp, effect with yin nourishing, lung heat clearing, dissipating blood stasis, hemostasis, "
Bencao Congxin" " tonifying the lung, pathogenic fire reducing.The lung-heat person should it.", being used for deficiency of both QI and YIN, dysphoria with smothery sensation is thirsty, cough due to consumptive disease, injury from falling down, arthralgia, hemoptysis is spitted blood, and traumatic hemorrhage is monarch drug in the side.Herba Tripterospermi (has another name called HUDIECAO, be gentianaceae plant Tripterospermum affine Tripterspermumchinense (Migo) H.Smith (the young tender herb of T.affine auct.non (Wall.) H.Smith), acrid in the mouth, cold in nature, merit is apt to clearing away lung-heat to relieve cough, detoxifcation; Be used for the treatment of the cough due to lung-heat, pulmonary tuberculosis spitting of blood, lung abscess, nephritis, carbuncle sore furuncle and phyma.Herba Agrimoniae (being the dry aerial parts of rosaceous plant Agrimony Agrimonia pilosa wing edeb.), property is flat, bitter in the mouth, puckery, GUIXIN, lung meridian, the puckery convergence, the function astringing to arrest bleeding has tonify deficiency, strong effect concurrently.Herba Tripterospermi, Herba Agrimoniae two medicines are the merit of additional strong Rhizoma panacis majoris nourishing YIN and clearing away lung-heat hemostasis altogether, is all the ministerial drug mutual reinforcement between for using.Radix Rhodiolae (being dry root and the rhizome of crassulaceae plants Radix Rhodiolae Rhodiolacrenulata (Hook.f.et Thoms) H.Ohba) property is flat, and sweet in the mouth, hardship are returned lung, heart channel, have benefiting QI for activating blood circulation, the effect of promoting blood circulation and relievining asthma.Be used for blood stasis due to qi deficiency, obstruction of qi in the chest and cardialgia, asthenia asthma is adjuvant in the side.
Chinese medicine composition nourishing YIN and clearing away lung-heat calming blood among the present invention program A, B, the C can be used for treating resistant tuberculosis, especially be suitable for treatment deficiency of YIN lung-heat network hinder due to resistant tuberculosis.
Clinical and experimental study proves: the bacterial strain to H37RV, anti-SM, anti-RFP, anti-RFP+INH when the present invention program A, B, the external high concentration of C preparation all has obvious sterilization or bacteriostasis; External all have obvious sterilization or bacteriostasis to common growth of microorganism, and its inhibitory action to bacillus is better than coccus; Can prolong the pulmonary tuberculosis death time; Alleviate lungs tuberculosis (cheesy necrosis and epithelioid cell hypertrophy), the tuberculosis effect is better; Can obviously increase the cell number of secretion specific antibody, strengthen delayed hypersensitivity intensity, the mixed lymphocyte reaction of abnormal shape and the phagocytic function of macrophage, reduce activity, helper T lymphocyte percentage rate and the TH/TS ratio of interleukin II; Ear swelling due to foot swelling due to the Ovum Gallus domesticus album, the Fructus Crotonis mixture there is certain inhibitory action; Fervescence has reducing effect due to the induced by endotoxin; The fervescence that yeast is caused has reducing effect; Can reduce the number of elements that acetic acid causes the mouse writhing reaction; Capsule of the present invention has significant anti-mycobacterium tuberculosis, broad-spectrum antiseptic and immunoregulation effect, and simultaneously this medicine heating that tubercule bacillus is caused and inflammation and pain etc. also tool have a better role.
Following experimental example and embodiment are used for further specifying the present invention but are not limited to the present invention.
The specific embodiment
The experiment of experimental example 1 clinical efficacy
1, object of study:
64 examples are outpatient service person, all meet the drug Resistant Pulmonary Tuberculosis diagnostic criteria; Adopt random district prescription method, be divided into treatment group and matched group.
Treatment group 64 examples, male 30 examples, women 34 examples; Minimum 21 years old of age, maximum 70 years old;
Matched group 64 examples, male 31 examples, women 33 examples; Minimum 20 years old of age, maximum 69 years old;
Two groups of case Baseline Datas are learned processing by statistics, there was no significant difference (P＞0.05).
2, Therapeutic Method
Treatment group: Rhizoma panacis majoris 15 gram, Herba Tripterospermi 12 grams, Herba Agrimoniae 9 grams, Radix Rhodiolae 6 grams, exempt to fry in shallow oil 1 dose of granule (embodiment 1) every day, minute sooner or later two inferior to decoction being taken warmly after meal.
Matched group: alone anti-consumptive disease treatment; All cases are according in the past medication history selection whole body antituberculosis drugs thing, mainly select pasiniazid (Dipasic, be called for short D), rifapentine (being called for short L), Levofloxacin (being called for short 0), pyrazinamide (being called for short Z), amikacin (being called for short A) etc., scheme is 3DL10ZA/18DL10Z.
The course for the treatment of: 8 weeks
3, curative effect index and observational technique
All carry out expectorant inspection, liver function, chest X ray or C T before the treatment and check, check per month expectorant inspection and liver, renal function during the treatment, the 4th, 8 week checked chest C T or X-ray film in the treatment, carries out front and back to being compared to the evaluation criterion of curative effect with this.The evaluation methodology of C-XF focus is by the standard of Society of Tuberculosis of China's revision in 1992.
Tcm clinical practice symptom scalar quantization, 5 grades of methods of marking that adopted 0～4 minute quantize scoring.
4, curative effect determinate standard
Clinical cure: clinical symptoms and physical signs of lung disappear, and the chest films showed pathological changes all absorbs or without activeness, the expectorant bacterium is negative (or the moon turns continuously) continuously.
Produce effects: symptom and physical signs of lung disappear substantially, and rabat shows that focus absorbs or basic absorption 3 feminine genders of expectorant smear.
Effectively: sings and symptoms is clearly better, and rabat shows that focus partially absorbs, 3 feminine genders of expectorant smear.
Invalid: symptom is without taking a turn for the better or slightly take a favorable turn or sb.'s illness took a turn for the worse, and focus is unchanged or enlarge expectorant smear lasting masculin or repeatedly positive.
5, data processing method
Measurement data is all with mean+SD
SPSS 11.0 statistical softwares are adopted in expression, according to data character, adopt corresponding statistical method.
6, therapeutic outcome
Table 1 liang group Comparison of therapeutic table [n (%)]
Annotate: two groups of Comparison of therapeutic are analyzed P＜0.01 through Ridit
The result: 64 examples meet diagnosis to be had the patient who asks to use the embodiment of the invention 1 described single herbal concentrate-granule to cooperate anti-consumptive disease to treat for 8 weeks, cure 38 examples, produce effects 13 examples, and 11 examples that take a turn for the better, invalid 2 examples, total effective rate is 96.88%.Relatively there were significant differences for treatment group and matched group curative effect, and treatment group treatment (drug resistance) pulmonary tuberculosis is evident in efficacy, and curative effect is better than matched group.
Following experimental example 2-9 all adopts the embodiment of the invention 2 described capsules.
The experiment in vitro of 2 pairs of substance of medicines-resistant branched tubercle bacillus of experimental example and common microorganism
Select H37RV standard bacterium (ATCC:27294); Single anti-streptomycin (SM); Dan Naili secondary flat (RFP); Single anti-isoniazid (INH); Anti-RFP+INH; Provide by CDC.Prepare on request Soviet Union's general formula culture medium and the Russell medium of improvement.The preparation Tong Shi of Soviet Union medium base liquid, every of test tube packing adds 20ml.Capsule decocting liquid of the present invention is diluted to a series of gradients, is respectively every milliliter of 100mg (former concentration), 50mg, 25mg, 125mg, 6.25mg, 3.125mg autoclaving; Join under gnotobasis in the Tong Shi of the Soviet Union culture medium, every adds 0.2ml.The concentration of positive control drug RFP is respectively every milliliter of 500 μ g, 250 μ g, 125 μ g, 62.5 μ g, 31.25 μ g, 15.62 μ g.Operation:
1. take by weighing respectively 1m g H37RV, anti-INH, anti-RFP, anti-SM, the bacterium colony of anti-INH+RFP grinds with bacteria grinder, adds the bacteria suspension that normal saline dilution becomes every 1m g/m l, draw accurately concentration take the sterilization suction pipe and enter to contain 6 kinds of variable concentrations pastille culture medium as the bacterium liquid 0.1m l kind of 1m g/ml, inoculate simultaneously 0.1ml in the culture medium that does not contain medicine as blank.Repeat 2 times.2. after above-mentioned all culture medium all place 37 ℃ of incubators to hatch for 2 weeks, draw 0.1m l transferred species in the modified Russell medium inclined-plane for every.Observed result around 37 ℃ of cultivations.(-: has no the tulase growth; +: bacterium colony accounts for 1/4 of inclined-plane; ++: bacterium colony accounts for 1/2 of inclined-plane; +++more than: colony growth is in whole inclined-plane).
Select 6 kinds of bacterium, 56 strain bacterial strains, type strain: staphylococcus aureus 26112 (ATCC25923), escherichia coli 4413 (ATCC25922), Pseudomonas aeruginosa 10211 (ATCC27853), Bacillus proteus 49027, beta hemolytic streptococcus 32210 each 1 strain.Clinical separation strain: staphylococcus aureus, escherichia coli, bacillus pyocyaneus, each 9 strain of Bacillus proteus, streptococcus 7 strains of B family, klebsiella pneumoniae 8 strains; It is 3g/mL (3g refers to the crude drug amount of corresponding capsule of the present invention in every ml solution) that maximum concentration adopts capsule 's content solution concentration of the present invention, and remaining concentration adopts doubling dilution.
The result shows:
During the external high concentration of capsule of the present invention the bacterial strain of H37RV, anti-SM, anti-RFP, anti-RFP+INH all there are obvious sterilization or bacteriostasis.When capsule in high dose of the present invention and middle dosage H37RV, anti-SM, anti-RFP, anti-RFP+INH there are preferably tuberculosis effect, particularly common Resistance Mycobacterium Tuberculosis are had preferably fungistatic effect.
The common microorganism MIC of capsule In Vitro Anti of the present invention, MBC measure, and common growth of microorganism is all had obvious sterilization or bacteriostasis, and its inhibitory action to bacillus is better than coccus.
Anti-clinical separation M. tuberculosis mycobacteria experiment in experimental example 3 bodies
Set up ICR mice tuberculosis model infection bacteria species and bacterium amount; At first measuring clinical separation M. tuberculosis mycobacteria sensitive strain half survival time ST50 (time of fifty percentsurvival) is 15d, selects this strain infection ICR mice, every mouse tail vein injection 1mg bacterium amount; Route of infection: get that well-grown clinical separation M. tuberculosis mycobacteria sensitive strain is prepared into bacterial suspension with bacteria grinder on the modified Russell medium, be diluted to desired concn: 5mg/mL with the sterile saline (NS) that contains 0.05% Tween 80 again, every mouse tail vein injection 0.2mL (1mg bacterium amount, approximately 107CFU).
With ICR mice random packet, every group 20, male and female half and half, be divided into Normal group, the blank matched group of model, capsule high dose group of the present invention [(6.0g/ (kg.d)], middle dosage group [3.0g/ (kg.d)], low dose group [1.5g/ (kg.d)], rifampicin group [0.06g/ (kg.d)]; Infect administration on the same day in setting up model, the blank matched group of Normal group and model gives equivalent NS; Every mice is pressed 0.25mL/10g body weight ig, and drug dose is by 10 times of calculating of adult's (60kg) consumption; Gastric infusion, 1 time/d, continuous 4 weeks.
Result of study shows:
Capsule of the present invention prolongs 3d on the impact of death time, ST50 and the survival rate of mice tuberculosis model: middle dosage group ICR mice ST50 (ST50=18d) with the blank matched group of model (ST50=15d) contrast.
Capsule of the present invention is examined the impact of pathological change on the coagulation of YIN-cold in ZANG-organ of ICR mouse lung: HE dyeing, the high power microscope check pathological section, nuclear pathological changes (cheesy necrosis and epithelioid cell hypertrophy) is compared with model control group the trend of alleviating is all arranged from high dose group to the coagulation of YIN-cold in ZANG-organ of low dose group mouse lung, the pulmonary tuberculosis pathology of dosage medication group mice changes the gentlyest in the capsule of the present invention, shows that the tuberculosis effect of middle dosage medication group is relatively better.
Experimental example 4 adopts isotope method to detect in vivo and in vitro the phagocytic function experiment of humoral immunization, cellular immunization and macrophage in conjunction with monoclonal antibody
The result shows: capsule of the present invention can obviously increase the cell number of mice secretion specific antibody, strengthen delayed hypersensitivity intensity, the mixed lymphocyte reaction of special-shaped mice and the phagocytic function of macrophage, reduce activity, helper T lymphocyte percentage rate and the TH/TS ratio of interleukin II; The high, medium and low dosage group of capsule of the present invention and model group more all have significant difference (P＜0.05-0.01).
Experimental example 5 capsules of the present invention to rat paw edema, Fructus Crotonis mixture induced mice ear swelling due to the Ovum Gallus domesticus album have certain inhibitory action (P＜0.05-0.01).
The large ear rabbit fervescence has reducing effect due to the experimental example 6 capsule induced by endotoxins of the present invention, after the pyrogenicity 2 and 3 hours, with model group relatively, the high, medium and low dosage treated animal of capsule administration of the present invention body temperature obviously reduces, and has statistical significance (P＜0.05-0.01).
The rat temperature that experimental example 7 capsules of the present invention cause yeast raise have reducing effect, the high, medium and low dosage group of administration and model group more all have significant difference (P＜0.05-0.01).
Experimental example 8 capsules of the present invention can reduce the number of elements that acetic acid causes the mouse writhing reaction.
Testing 2-8 proves, capsule of the present invention has significant anti-mycobacterium tuberculosis, broad-spectrum antiseptic and immunoregulation effect, points out simultaneously this medicine that heating and the tools such as inflammation and pain that tubercule bacillus causes are had a better role.
Experimental example 9 acute toxicity tests
Laboratory observation capsule of the present invention is to the Acute Toxicity of mice, with toxicity and the safety of understanding this preparation.
Give mice this product 5g/kg gavage, mice does not occur poisoning and is dead, therefore can't measure LD50.Give mice capsule 18g/kg of the present invention (being equivalent to crude drug amount 155g/kg, 45% suspension 0.4ml/10g) by maximum dosage-feeding method ig, administration in a day 2 times, to mice without the overt toxicity effect, approximately behave 358 times of clinical usual amounts of its maximum dosage-feeding.
The result shows, animal activity reacts as usual freely behind the capsule gastric infusion of the present invention, and the growth of viewing duration mouse hair is normal, eupnea, and the skin glossiness is good, ingests, to take the photograph water normal, and stool, urine is normal.Mice Body mass penalty in the 14d, front 21.16g ± 0.55g is increased to 35.16g ± 1.34g by test, and the 48h animal is without death, and 2 all rear all animals are healthy the survival all.Mice was put to death in the cervical vertebra dislocation when experiment finished, perusal main organs color and morphological change after dissecting, and the main organs such as the heart, liver, spleen, lung, kidney, stomach, intestinal are showed no abnormal change as a result.Experimental result shows that capsule mouse stomach administration maximum dosage-feeding every day of the present invention is 155g crude drug/kg, is equivalent to 358 times of clinical application amount, has no acute toxic reaction.
Following embodiment all can realize the effect of above-mentioned experimental example
The specific embodiment
Embodiment 1: single herbal concentrate-granule
Rhizoma panacis majoris 15g, Herba Tripterospermi 12g, Herba Agrimoniae 9g, Radix Rhodiolae 6g
The above-mentioned crude drug decoction pieces that meets concocted specification, through routine extract, concentrated, separate, dry, granulate, packing, make single herbal concentrate-granule.
Embodiment 2 capsules
Rhizoma panacis majoris 150g, Herba Tripterospermi 120g, Herba Agrimoniae 90g, Radix Rhodiolae 60g
Rhizoma panacis majoris adds 50% ethanol of 6 times of amounts, and reflux, extract, 2 times 2h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.5g crude drug/ml, with 3BV/h flow velocity loading AB-8 macroporous resin, static adsorption 0.5 hour, post blade diameter length ratio are 12: 1, with 5BV distilled water flush away impurity, 60% ethanol elution, collect the 16BV60% ethanol elution, elution flow rate is 2BV/h, the eluent concentrating under reduced pressure, is drying to obtain the Rhizoma panacis majoris extract;
Herba Tripterospermi, Herba Agrimoniae add 40% ethanol of 10 times of amounts, and reflux, extract, 2 times 2h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.2g crude drug/ml, with 3BV/h flow velocity loading AB-8 macroporous resin, static adsorption 0.5 hour, post blade diameter length ratio are 12: 1, with 5BV distilled water flush away impurity, 70% ethanol elution, collect 5BV 70% ethanol elution, elution flow rate is 3BV/h, the eluent concentrating under reduced pressure, is drying to obtain Herba Tripterospermi, Herba Agrimoniae extract;
Radix Rhodiolae adds the water of 8 times of amounts, and reflux, extract, 3 times 2h/ time, gets water extraction liquid; Water extraction liquid adds the aqueous solution that water is mixed with 0.2g crude drug/ml, with 3BV/h flow velocity loading HPD-100 macroporous resin, static adsorption 0.5 hour, the post blade diameter length ratio is 12: 1, with 5BV distilled water flush away impurity, 30% ethanol elution is collected 5BV 30% ethanol elution, elution flow rate is 2BV/h, the eluent concentrating under reduced pressure, is drying to obtain Radix Rhodiolae extract;
Above extract according to common process, adds conventional adjuvant, makes 90 of capsules, and day is taken each three three times.
Embodiment 3: single herbal concentrate-granule
Rhizoma panacis majoris 24g, Herba Tripterospermi 12g, Herba Agrimoniae 9g
The above-mentioned crude drug decoction pieces that meets concocted specification, through the modern pharmaceutical technology extract, concentrated, separate, dry, granulate, packing, make single herbal concentrate-granule.
Embodiment 4: oral liquid
Rhizoma panacis majoris 6g, Herba Tripterospermi 21g, Herba Agrimoniae 3g
The above-mentioned raw materials medicine according to common process, adds conventional adjuvant, makes oral liquid.
Embodiment 5: tablet
Rhizoma panacis majoris 24g, Herba Tripterospermi 3g, Herba Agrimoniae 18g
The above-mentioned raw materials medicine, Rhizoma panacis majoris ethanol extraction, alcohol extract purification by macroporous resin; Herba Tripterospermi, Herba Agrimoniae merge ethanol extraction, alcohol extract purification by macroporous resin; Add conventional adjuvant, according to a conventional method, make tablet.
Embodiment 6: pill
Rhizoma panacis majoris 15g, Herba Tripterospermi 12g, Herba Agrimoniae 9g
Rhizoma panacis majoris adds 50% ethanol of 6 times of amounts, and reflux, extract, 2 times 2h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.5g crude drug/ml, with 3BV/h flow velocity loading AB-8 macroporous resin, static adsorption 0.5 hour, the post blade diameter length ratio is 12: 1, with 5BV distilled water flush away impurity, collects 16BV 60% ethanol elution, elution flow rate is 2BV/h, the eluent concentrating under reduced pressure, is drying to obtain Rhizoma panacis majoris ginseng saponins extract;
Herba Tripterospermi, Herba Agrimoniae add 40% ethanol of 10 times of amounts, and reflux, extract, 2 times 2h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.2g crude drug/ml, with 3BV/h flow velocity loading AB-8 macroporous resin, static adsorption 0.5 hour, the post blade diameter length ratio is 12: 1, with 5BV distilled water flush away impurity, collects 5BV 70% ethanol elution, elution flow rate is 3BV/h, the eluent concentrating under reduced pressure, is drying to obtain the total phenolic acid of Herba Tripterospermi and lactone extract, Herba Agrimoniae flavone extract;
Above extract according to common process, adds conventional adjuvant, makes pill.
Embodiment 7: single herbal concentrate-granule
Rhizoma panacis majoris 24g, Herba Tripterospermi 12g, Herba Agrimoniae 9g, Radix Rhodiolae 6g
The Rhizoma panacis majoris ethanol extraction, the alcohol extract purification by macroporous resin; Herba Tripterospermi, Herba Agrimoniae merge ethanol extraction, alcohol extract purification by macroporous resin; The Radix Rhodiolae water boiling and extraction, water extraction liquid macroporous resin is refining; Add conventional adjuvant, according to a conventional method, make single herbal concentrate-granule.
Embodiment 8: pill
Rhizoma panacis majoris 6g, Herba Tripterospermi 21g, Herba Agrimoniae 3g, Radix Rhodiolae 11g
The above-mentioned raw materials medicine according to common process, adds conventional adjuvant, makes pill.
Embodiment 9: tablet
Rhizoma panacis majoris 24g, Herba Tripterospermi 3g, Herba Agrimoniae 18g, Radix Rhodiolae 3g
Rhizoma panacis majoris adds 40% ethanol, and reflux, extract, 3 times 1h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, adds the aqueous solution that water is mixed with 0.2g crude drug/ml, the loading macroporous resin, static adsorption 0.9 hour, post blade diameter length ratio are 7: 1, with distilled water flush away impurity, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain the Rhizoma panacis majoris extract;
Herba Tripterospermi, Herba Agrimoniae add 60% ethanol, and reflux, extract, 1 time 3h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, adds the aqueous solution that water is mixed with 0.2g crude drug/ml, the loading macroporous resin, static adsorption 0.9 hour, post blade diameter length ratio are 8: 1, with distilled water flush away impurity, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain Herba Tripterospermi, Herba Agrimoniae extract;
Radix Rhodiolae adds entry, and reflux, extract, 4 times 1h/ time, gets water extraction liquid; Water extraction liquid adds the aqueous solution that water is mixed with 0.3g crude drug/ml, the loading macroporous resin, and static adsorption 0.2 hour, the post blade diameter length ratio is 17: 1, with distilled water flush away impurity, collects ethanol elution, the eluent concentrating under reduced pressure, is drying to obtain Radix Rhodiolae extract;
The above-mentioned raw materials medicine adds conventional adjuvant, according to a conventional method, makes tablet.
Embodiment 10: capsule
Rhizoma panacis majoris 15g, Herba Tripterospermi 12g, Herba Agrimoniae 9g, Radix Rhodiolae 6g
Rhizoma panacis majoris adds 50% ethanol of 6 times of amounts, and reflux, extract, 2 times 2h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.5g crude drug/ml, with 3BV/h flow velocity loading AB-8 macroporous resin, static adsorption 0.5 hour, the post blade diameter length ratio is 12: 1, with 5BV distilled water flush away impurity, collects 16BV 60% ethanol elution, elution flow rate is 2BV/h, the eluent concentrating under reduced pressure, is drying to obtain Rhizoma panacis majoris ginseng saponins extract;
Herba Tripterospermi, Herba Agrimoniae add 60% ethanol, and reflux, extract, 1 time 3h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, adds the aqueous solution that water is mixed with 0.2g crude drug/ml, the loading macroporous resin, static adsorption 0.9 hour, post blade diameter length ratio are 8: 1, with distilled water flush away impurity, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain Herba Tripterospermi, Herba Agrimoniae extract;
Radix Rhodiolae adds entry, and reflux, extract, 4 times 1h/ time, gets water extraction liquid; Water extraction liquid adds the aqueous solution that water is mixed with 0.3g crude drug/ml, the loading macroporous resin, and static adsorption 0.2 hour, the post blade diameter length ratio is 17: 1, with distilled water flush away impurity, collects ethanol elution, the eluent concentrating under reduced pressure, is drying to obtain Radix Rhodiolae extract;
Above four class extracts according to common process, add conventional adjuvant, make capsule.
Embodiment 11: single herbal concentrate-granule
Rhizoma panacis majoris saponins extract 24g, the total phenolic acid of Herba Tripterospermi and lactone extract 12g, Herba Agrimoniae flavone extract 9g, Flavonoids in Rhodiola class extract 6g
The Rhizoma panacis majoris ethanol extraction, the alcohol extract purification by macroporous resin gets Rhizoma panacis majoris saponins extract; Herba Tripterospermi, Herba Agrimoniae merge ethanol extraction, and the alcohol extract purification by macroporous resin gets the total phenolic acid of Herba Tripterospermi and lactone extract, Herba Agrimoniae flavone extract; The Radix Rhodiolae water boiling and extraction, water extraction liquid macroporous resin is refining, gets Flavonoids in Rhodiola class extract; Add conventional adjuvant, according to a conventional method, make single herbal concentrate-granule.
Embodiment 12: pill
Rhizoma panacis majoris saponins extract 6g, the total phenolic acid of Herba Tripterospermi and lactone extract 21g, Herba Agrimoniae flavone extract 3g, Flavonoids in Rhodiola class extract 11g
The above-mentioned raw materials medicine according to common process, adds conventional adjuvant, makes pill.
Embodiment 13: tablet
Rhizoma panacis majoris saponins extract 24g, the total phenolic acid of Herba Tripterospermi and lactone extract 3g, Herba Agrimoniae flavone extract 18g, Flavonoids in Rhodiola class extract 3g
Rhizoma panacis majoris adds 40% ethanol, and reflux, extract, 3 times 1h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, adds the aqueous solution that water is mixed with 0.2g crude drug/ml, the loading macroporous resin, static adsorption 0.9 hour, post blade diameter length ratio are 7: 1, with distilled water flush away impurity, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain Rhizoma panacis majoris saponins extract;
Herba Tripterospermi, Herba Agrimoniae add 60% ethanol, and reflux, extract, 1 time 3h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.2g crude drug/ml, the loading macroporous resin, static adsorption 0.9 hour, the post blade diameter length ratio is 8: 1, with distilled water flush away impurity, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain the total phenolic acid of Herba Tripterospermi and lactone extract, Herba Agrimoniae flavone extract;
Radix Rhodiolae adds entry, and reflux, extract, 4 times 1h/ time, gets water extraction liquid; Water extraction liquid adds the aqueous solution that water is mixed with 0.3g crude drug/ml, the loading macroporous resin, and static adsorption 0.2 hour, the post blade diameter length ratio is 17: 1, with distilled water flush away impurity, collects ethanol elution, the eluent concentrating under reduced pressure, is drying to obtain Flavonoids in Rhodiola class extract;
The above-mentioned raw materials medicine adds conventional adjuvant, according to a conventional method, makes tablet.
Embodiment 14: capsule
Rhizoma panacis majoris saponins extract 15g, the total phenolic acid of Herba Tripterospermi and lactone extract 12g, Herba Agrimoniae 9g, Flavonoids in Rhodiola class extract 6g
Rhizoma panacis majoris adds 50% ethanol of 6 times of amounts, and reflux, extract, 2 times 2h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.5g crude drug/ml, with 3BV/h flow velocity loading AB-8 macroporous resin, static adsorption 0.5 hour, the post blade diameter length ratio is 12: 1, with 5BV distilled water flush away impurity, collects 16BV 60% ethanol elution, elution flow rate is 2BV/h, the eluent concentrating under reduced pressure, is drying to obtain Rhizoma panacis majoris ginseng saponins extract;
Herba Tripterospermi, Herba Agrimoniae add 60% ethanol, and reflux, extract, 1 time 3h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.2g crude drug/ml, the loading macroporous resin, static adsorption 0.9 hour, the post blade diameter length ratio is 8: 1, with distilled water flush away impurity, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain the total phenolic acid of Herba Tripterospermi and lactone extract, Herba Agrimoniae flavone extract;
Radix Rhodiolae adds entry, and reflux, extract, 4 times, gets water extraction liquid 1 h/ time; Water extraction liquid adds the aqueous solution that water is mixed with 0.3g crude drug/ml, the loading macroporous resin, and static adsorption 0.2 hour, the post blade diameter length ratio is 17: 1, with distilled water flush away impurity, collects ethanol elution, the eluent concentrating under reduced pressure, is drying to obtain Flavonoids in Rhodiola class extract;
Above four class extracts according to common process, add conventional adjuvant, make capsule.
Embodiment 15: single herbal concentrate-granule
Rhizoma panacis majoris saponins extract 15g, the total phenolic acid of Herba Tripterospermi and lactone extract 12g, Herba Agrimoniae 9g, Flavonoids in Rhodiola class extract 6g
Rhizoma panacis majoris adds 50% ethanol of 6 times of amounts, and reflux, extract, 2 times 2h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.5g crude drug/ml, with 3BV/h flow velocity loading AB-8 macroporous resin, static adsorption 0.5 hour, the post blade diameter length ratio is 12: 1, with 5BV distilled water flush away impurity, collects 16BV 60% ethanol elution, elution flow rate is 2BV/h, the eluent concentrating under reduced pressure, is drying to obtain Rhizoma panacis majoris ginseng saponins extract;
Herba Tripterospermi, Herba Agrimoniae add 40% ethanol of 10 times of amounts, and reflux, extract, 2 times 2h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, is drying to obtain Herba Tripterospermi extract, Herba Agrimoniae extract;
Radix Rhodiolae adds the water of 8 times of amounts, and reflux, extract, 3 times 2h/ time, gets water extraction liquid; Be drying to obtain Radix Rhodiolae extract; Above four class extracts according to common process, add conventional adjuvant, make single herbal concentrate-granule.
Claims (10)
1. a treatment Chinese medicine composition lungy is characterized in that the crude drug of this Chinese medicine composition consists of: Rhizoma panacis majoris 5-25 weight portion, Herba Tripterospermi 2-22 weight portion, Herba Agrimoniae 2-20 weight portion.
2. a treatment Chinese medicine composition lungy is characterized in that the crude drug of this Chinese medicine composition consists of: Rhizoma panacis majoris 5-25 weight portion, Herba Tripterospermi 2-22 weight portion, Herba Agrimoniae 2-20 weight portion, Radix Rhodiolae 1-12 weight portion.
3. Chinese medicine composition as claimed in claim 2 is characterized in that the crude drug of this Chinese medicine composition consists of: Rhizoma panacis majoris 6 weight portions, Herba Tripterospermi 21 weight portions, Herba Agrimoniae 3 weight portions, Radix Rhodiolae 11 weight portions; Rhizoma panacis majoris 24 weight portions, Herba Tripterospermi 3 weight portions, Herba Agrimoniae 18 weight portions, Radix Rhodiolae 3 weight portions; Rhizoma panacis majoris 15 weight portions, Herba Tripterospermi 6 weight portions, Herba Agrimoniae 18 weight portions, Radix Rhodiolae 6 weight portions; Rhizoma panacis majoris 24 weight portions, Herba Tripterospermi 12 weight portions, Herba Agrimoniae 9 weight portions, Radix Rhodiolae 3 weight portions; Perhaps Rhizoma panacis majoris 15 weight portions, Herba Tripterospermi 12 weight portions, Herba Agrimoniae 9 weight portions, Radix Rhodiolae 6 weight portions.
4. such as the preparation method of the arbitrary described Chinese medicine composition of claim 2-3, it is characterized in that the method is: Rhizoma panacis majoris ethanol extraction, alcohol extract purification by macroporous resin; Herba Tripterospermi, Herba Agrimoniae merge ethanol extraction, alcohol extract purification by macroporous resin; The Radix Rhodiolae water boiling and extraction, water extraction liquid purification by macroporous resin; Add conventional adjuvant, according to a conventional method, make the dosage form of clinical acceptance, include but not limited to capsule, granule, pill, tablet, oral liquid or lyophilized injectable powder.
5. the preparation method of Chinese medicine composition as claimed in claim 4 is characterized in that the preparation method of Rhizoma panacis majoris in the method is: add 40-60% ethanol, reflux, extract, 1-3 time 1-3h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.1-1.0 weight portion crude drug/ml, upper low pole macroporous resin, static adsorption 0.1-1.0 hour, the post blade diameter length ratio is 6-18: 1, with distilled water flush away impurity, use the 30%-85% ethanol elution, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain.
6. preparation method as claimed in claim 4 is characterized in that the preparation method of Herba Tripterospermi in the method, Herba Agrimoniae is: Herba Tripterospermi, Herba Agrimoniae add 20-60% ethanol, and reflux, extract, 1-3 time 1-3h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.1-0.3 weight portion crude drug/ml, upper low pole macroporous resin, static adsorption 0.1-1.0 hour, the post blade diameter length ratio is 6-18: 1, with distilled water flush away impurity, 40-85% ethanol elution, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain.
7. the preparation method of Chinese medicine composition as claimed in claim 4, it is characterized in that the preparation method of Radix Rhodiolae in the method is: Radix Rhodiolae adds entry, and reflux, extract, 2-4 time 1-3h/ time, gets water extraction liquid; Water extraction liquid adds the aqueous solution that water is mixed with 0.1-0.3g crude drug/ml, upper macroporous resin, static adsorption 0.1-1.0 hour, the post blade diameter length ratio is 6-18: 1, with distilled water flush away impurity, 20-60% ethanol elution, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain.
8. the preparation method of Chinese medicine composition as claimed in claim 4 is characterized in that the method is:
Rhizoma panacis majoris adds 3-8 and doubly measures 40-60% ethanol, and reflux, extract, 1-3 time 1-3h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.1-1.0 weight portion crude drug/ml, upper low pole macroporous resin, static adsorption 0.1-1.0 hour, the post blade diameter length ratio is 6-18: 1, with distilled water flush away impurity, use the 30%-85% ethanol elution, collect ethanol elution, eluent concentrating under reduced pressure, the dry extract that gets;
Herba Tripterospermi, Herba Agrimoniae add the 20-60% ethanol that 4-15 doubly measures, and reflux, extract, 1-3 time 1-3h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.1-0.3 weight portion crude drug/ml, upper low pole macroporous resin, static adsorption 0.1-1.0 hour, the post blade diameter length ratio is 6-18: 1, with distilled water flush away impurity, 40-85% ethanol elution, collect ethanol elution, eluent concentrating under reduced pressure, the dry extract that gets;
Radix Rhodiolae adds 4-15 times of water gaging, and reflux, extract, 2-4 time 1-3h/ time, gets water extraction liquid; Water extraction liquid adds the aqueous solution that water is mixed with 0.1-0.3g crude drug/ml, upper macroporous resin, static adsorption 0.1-1.0 hour, the post blade diameter length ratio is 6-18: 1, with distilled water flush away impurity, 20-60% ethanol elution, collect ethanol elution, eluent concentrating under reduced pressure, the dry extract that gets;
Mix above extract, add conventional adjuvant, according to a conventional method, make the dosage form of clinical acceptance, include but not limited to capsule, granule, pill, tablet, oral liquid or lyophilized injectable powder.
9. such as the application of the arbitrary described Chinese medicine composition of claim 1-3 in preparation treatment resistant tuberculosis medicine.
10. a treatment Chinese medicine composition lungy is characterized in that the crude drug of this Chinese medicine composition consists of: Rhizoma panacis majoris extract 5-25 weight portion, Herba Tripterospermi extract 2-22 weight portion, Herba Agrimoniae extract 2-20 weight portion, Radix Rhodiolae extract 1-12 weight portion;
Described Rhizoma panacis majoris extract is to prepare by the following method: Rhizoma panacis majoris adds 3-8 and doubly measures 40-60% ethanol, and reflux, extract, 1-3 time 1-3h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.1-1.0 weight portion crude drug/ml, upper low pole macroporous resin, static adsorption 0.1-1.0 hour, the post blade diameter length ratio is 6-18: 1, with distilled water flush away impurity, use the 30%-85% ethanol elution, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain;
Described Herba Tripterospermi, Herba Agrimoniae extract are to prepare by the following method: Herba Tripterospermi, Herba Agrimoniae add the 20-60% ethanol that 4-15 doubly measures, and reflux, extract, 1-3 time 1-3h/ time, gets alcohol extract; Alcohol extract is evaporated to without the alcohol flavor, add the aqueous solution that water is mixed with 0.1-0.3 weight portion crude drug/ml, upper low pole macroporous resin, static adsorption 0.1-1.0 hour, the post blade diameter length ratio is 6-18: 1, with distilled water flush away impurity, 40-85% ethanol elution, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain;
Described Radix Rhodiolae extract is to prepare by the following method: Radix Rhodiolae adds 4-15 times of water gaging, and reflux, extract, 2-4 time 1-3h/ time, gets water extraction liquid; Water extraction liquid adds the aqueous solution that water is mixed with 0.1-0.3g crude drug/ml, upper macroporous resin, static adsorption 0.1-1.0 hour, the post blade diameter length ratio is 6-18: 1, with distilled water flush away impurity, 20-60% ethanol elution, collect ethanol elution, the eluent concentrating under reduced pressure, be drying to obtain.
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| CN1128662A (en) * | 1995-02-11 | 1996-08-14 | 晚霞工程组织委员会 | Oral liquid for curing cancer and prepn. method thereof |
| CN1256131A (en) * | 1998-10-30 | 2000-06-14 | 邓钦文 | Chinese herbal medicine for treating pulmonary tuberculosis |
| CN101049484A (en) * | 2007-05-14 | 2007-10-10 | 郝来勤 | Strong effective Chinese traditional medicine for treating lung cancer and other various cancers |
| CN101564460A (en) * | 2008-04-24 | 2009-10-28 | 北京以岭药业有限公司 | Application of Chinese medicinal composition in preparing medicament for treating chronic obstructive pulmonary disease |
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2010
- 2010-05-27 CN CN 201010183565 patent/CN102258595B/en not_active Expired - Fee Related
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1128662A (en) * | 1995-02-11 | 1996-08-14 | 晚霞工程组织委员会 | Oral liquid for curing cancer and prepn. method thereof |
| CN1256131A (en) * | 1998-10-30 | 2000-06-14 | 邓钦文 | Chinese herbal medicine for treating pulmonary tuberculosis |
| CN101049484A (en) * | 2007-05-14 | 2007-10-10 | 郝来勤 | Strong effective Chinese traditional medicine for treating lung cancer and other various cancers |
| CN101564460A (en) * | 2008-04-24 | 2009-10-28 | 北京以岭药业有限公司 | Application of Chinese medicinal composition in preparing medicament for treating chronic obstructive pulmonary disease |
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