CN103830592A - Capsule for partner treatment on pulmonary tuberculosis and preparation method thereof - Google Patents

Abstract

The invention discloses a capsule for partner treatment on pulmonary tuberculosis and a preparation method of the capsule, for solving the problem of treating senile pulmonary tuberculosis. The capsule is characterized in that the preparation method comprises the following steps: (1) respectively distilling fragrant sarcococca ruscifolia, bark of himalayan coralbean, tetrapanax papyriferum, sowthistle-leaf ixeris seedling, cinnamomum cassia and crude ficus pumila powder by using steam so as to extract essential oil, collecting and mixing the essential oil and the medicine residues for later use; (2) uniformly mixing loranthus parasiticus, Chinese ladiestresses root, anchusa officinalis, Chinese honey locust, chick shells, mulberry seeds and the medicine residues in the step 1, performing water extract and alcohol precipitate, and drying the supernate to obtain a primary material; and (3) spraying the essential oil into the primary material, screening by using a sieve of 60 meshes, and filling into the capsule. Clinical experiments show that the capsule for treating senile pulmonary tuberculosis has the characteristics of good curative effect and high security, and is worthy of clinical application and popularization.

Description

A kind of capsule for pulmonary tuberculosis partner treatment and preparation method thereof

Technical field

The present invention relates to the field of Chinese medicines, be specifically related to a kind of capsule for pulmonary tuberculosis partner treatment and preparation method thereof.

Background technology

Senile pulmonary tuberculosis disease (senile pulmonary tuberculosis, SPT) is a class lungy.Tuberculosis is in China's the 50's of 20th century, and along with the development of the antituberculous chemotherapy such as streptomycin, isoniazid technology, epidemic situation obviously declines.But after 20th century 10 years, incidence of tuberculosis had again rise trend, and especially the sickness rate of SPT obviously increases, and the factor that this kind increases is: 1. Endogenous relapse; 2. pathological changes delay; 3. recurrence; 4. resistance against diseases is low the geratic period, and repeated multiple times tulase is invaded and falls ill.

SPT performance is not true to type more, and asymptomatic person is up to 26%, with relatively atypical symptom of between twenty and fifty patient, insidious onset, General Symptoms shows as master, and respiratory symptom is slight, the anemia that shows as usual, become thin, loss of appetite, drowsiness etc., heating, night sweat symptom occurrence probability are showing lower than middle-young patients, and the hypoproteinemia that easily occurs together, low sodium hypokalemia, simultaneously chronic fibrotic cavitys type and hematogenous disseminated pulmonary tuberculosis number of patients showed increased.

The traditional Chinese medical science is " pulmonary tuberculosis " with respect to phthisical name of disease, after the evil poison of pathogenesis sense consumptive disease worm, and struggle between vital QI and pathogen before this, then impairment of YIN causes hyperactivity of fire caused by deficiency of YIN, very the cloudy consumption wound of gas or deficiency of both YIN and YANG.But due to the intervention of doctor trained in Western medicine antituberculotics, serious interference nature process lungy, but the anti-consumptive disease of the current traditional Chinese medical science coordinates isoniazid Therapeutic Method also to fall aspect asthenic fire in the parasite killing nourishing YIN of being based on traditional pulmonary tuberculosis, cause the stack of effect deadness, and the side effect that can not resist doctor trained in Western medicine antitubercular agent deposits yields.And SPT tuberculosis toxicity is also not obvious, and heating, night sweat symptom occurrence probability are showing lower than middle-young patients.But existing anti-consumptive disease Fang Qing falls asthenic fire ignores impairment of dispersing and descending function of the lung, lung network is obstructed, or the product of go up greatly YIN nourishing cause that water is capable not to be transported, and expectorant is turbid multiple and be condensed in lung network, becomes and gives birth to his disease.

How to coordinate existing doctor trained in Western medicine antituberculotics, the special product of performance traditional Chinese medical science two-ways regulation, taking doctor trained in Western medicine antituberculous chemotherapy medicine as basis, by using Chinese medicine, play on the one hand auxiliary tuberculosis, reduce drug resistance (quite a few SPT is the resistant tuberculosis patient of delay), can alleviate again on the other hand the toxic and side effects of antituberculotics, become the new direction of the anti-consumptive disease of the combination of Chinese and Western medicine.

Summary of the invention

Technical assignment of the present invention is for above the deficiencies in the prior art, and capsule for pulmonary tuberculosis partner treatment that a kind of curative effect is affirmed and side effect is little and preparation method thereof is provided.

The technical scheme that the present invention solves its technical problem is: the sick ancillary drug of a kind of senile pulmonary tuberculosis, is characterized in that being prepared from by the crude drug of following weight proportion: 10 ~ 30 parts, delicate fragrance osmanthus, 6 ~ 12 parts of Radix seu Herba Spiranthis Lanceae, 3 ~ 10 parts of Folium Fumicis Dentatis, 6 ~ 12 parts, Fructus Gleditsia, go back 3 ~ 10 parts, bobbin, 6 ~ 12 parts of Ovum Gallus domesticus crustas, 6 ~ 12 parts of Cortex erythrinaes, 6 ~ 12 parts of Caulis fici pumilae (Fructus Fici Pumilae)s, 6 ~ 12 parts of Fructus cinnamomi immaturus, 1 ~ 5 part of Herba Ixeritis Sonchifoliae, 3 ~ 10 parts of Fructus Mori, 10 ~ 25 parts of Herba Taxillis.

Chinese medicine of the present invention can be prepared from by following method:

(1) by Cortex erythrinae, Radix seu Herba Spiranthis Lanceae, go back bobbin, Ovum Gallus domesticus crusta, Fructus cinnamomi immaturus, Caulis fici pumilae (Fructus Fici Pumilae) coarse powder respectively with vapor distillation extract volatile oil, and collect after mixing for standby use, medicinal residues are for subsequent use;

(2) medicinal residues in delicate fragrance osmanthus, Herba Taxilli, Folium Fumicis Dentati, Fructus Gleditsia, Herba Ixeritis Sonchifoliae, Fructus Mori and step 1 are mixed and add 5 times of water yields, decoct with water 2 times, each 1 hour, collecting decoction, left standstill; Then toward 95% the ethanol that adds 3 ~ 4 times of medicinal liquids in decocting liquid, leave standstill 15 minutes, then with 3000rpm/min centrifugal 20 minutes, get supernatant, spraying is dry, draws just material;

(3) gained volatile oil in step 1 is sprayed in the first material of step 2 gained, mix, cross 60 mesh sieves, encapsulated forming.

Wherein said: delicate fragrance osmanthus is Buxaceae Sarcococca plant delicate fragrance osmanthus Sarcococca ruscifolia Stapf root.Nature and flavor are pungent, bitter, flat.Merit can regulating QI to relieve pain, dispelling, collateral-activating.

Radix seu Herba Spiranthis Lanceae, for the orchid family Spiranthes plant Radix seu Herba Spiranthis Lanceae Spiranthes australis (R. Brown.) Lindl., with root, all herbal medicine.Nature and flavor are sweet, light, flat.Merit can enriching yin boost qi, removing pathogenic heat from blood and toxic substance from the body.

Folium Fumicis Dentati is the leaf of polygonaceae plant rumex dentatus Rumex dentatus L..Nature and flavor hardship; Cold in nature.Merit can heat-clearing and toxic substances removing; Killing parasites for relieving itching.

Fructus Gleditsia is the fruit of leguminous plant Fructus Gleditsia Gleditsia sinensis Lam..Nature and flavor are pungent, temperature.Return lung; Large intestine channel.Merit can expelling phlegm for arresting cough; Have one's ideas straightened out to lead to and close; Parasite killing eliminating stagnation.

Also bobbin is the fruit of orchid Rhizoma Gastrodiae Gastrodia elata Bl..Sweet in the mouth; Cold in nature.Merit can tonify deficiency subduing the wind syndrome.

Ovum Gallus domesticus crusta is the hard coat of the ovum of the chicken Gallus gallus domesticus Brisson of Phasianidae animal man.Nature and flavor are lightly seasoned; Property is put down.Return stomach; Kidney channel.Merit can restrain; Antacid; Bone strengthening; Hemostasis; Improving eyesight.

Cortex erythrinae is bark or the root bark of pulse family Erythrinae Arborescentis Erythrina indica Lam..Nature and flavor hardship, flat.Return liver, kidney channel.Merit can wind-damp dispelling, channels sootheing and network vessel quickening.Wind-damp dispelling, the meridian dredging, parasite killing.

Caulis fici pumilae (Fructus Fici Pumilae) is stem, the leaf of moraceae plants Caulis fici pumilae (Fructus Fici Pumilae) Ficus pumila L..Sour in the mouth, cool in nature.Merit can expelling wind and removing dampness; Promoting blood circulation to remove obstruction in the collateral; Removing toxic substances and promoting subsidence of swelling.

Fructus cinnamomi immaturus is the tender fruit of children of canella Cortex Cinnamomi.Gas fragrance, taste is micro-sweet.Nature and flavor Wen Xingan, returns stomach warp.Merit can warming spleen and stomach for dispelling cold.

Herba Ixeritis Sonchifoliae, for wild gutweed platymiscium Herba Ixeritis Sonchifoliae Ixeris sonchifolia (Bunge) Hance of Compositae, with all herbal medicine.Nature and flavor hardship, pungent, flat.Merit can heat-clearing and toxic substances removing, evacuation of pus, pain relieving.

Fructus Mori is the dry fruit ear of moraceae plants Mulberry Morus alba L..Nature and flavor are sweet, sour, cold.GUIXIN, liver, kidney channel.The merit YIN nourishing of can enriching blood, promotes the production of body fluid and moisturizes.

Herba Taxilli, for Herba Taxilli is the dry stem and branch with leaf of Loranthaceae plant Herba Taxilli Taxillus chinensis (DC.) Danser.Nature and flavor bitter, sweet, flat.Return liver, kidney channel.Merit can tonifying the lung kidney, bone and muscle strengthening, wind-damp dispelling, antiabortive unit.

Composition principle: the traditional Chinese medical science is " pulmonary tuberculosis " with respect to phthisical name of disease, after the evil poison of pathogenesis sense consumptive disease worm, struggle between vital QI and pathogen before this, then impairment of YIN causes hyperactivity of fire caused by deficiency of YIN, very the cloudy consumption wound of gas or deficiency of both YIN and YANG.But due to the intervention of doctor trained in Western medicine antituberculotics, serious interference nature process lungy, but the anti-consumptive disease of the current traditional Chinese medical science coordinates isoniazid Therapeutic Method also to fall aspect asthenic fire in the parasite killing nourishing YIN of being based on traditional pulmonary tuberculosis, cause the stack of effect deadness, and the side effect that can not resist doctor trained in Western medicine antitubercular agent deposits yields.And SPT tuberculosis toxicity is also not obvious, and heating, night sweat symptom occurrence probability are showing lower than middle-young patients.But existing anti-consumptive disease Fang Qing falls asthenic fire ignores impairment of dispersing and descending function of the lung, lung network is obstructed, or the product of go up greatly YIN nourishing cause that water is capable not to be transported, and expectorant is turbid multiple and be condensed in lung network, becomes and gives birth to his disease.Inventor for many years clinical experience and pharmaceutical research result shows, dredging collateral eliminating phlegm dissipating blood stasis, and delicate fragrance osmanthus, the right use of Radix seu Herba Spiranthis Lanceae medicine are the core places for the treatment of senile pulmonary tuberculosis disease.

Compared with prior art, the present invention has following characteristics:

1, prescription uniqueness: get delicate fragrance osmanthus, Radix seu Herba Spiranthis Lanceae in side for monarch, described delicate fragrance osmanthus and the two combination of Radix seu Herba Spiranthis Lanceae can lung heat clearing networks, sharp blood vessels, regulating menstruation is regulated the flow of vital energy, and its feature is that Papillary can remove pathogenic wind in lung network.Inventor's laboratory pharmacological research shows: heavy dose of delicate fragrance osmanthus decoct rat oral gavage (1000mg/kg), can resist the rat liver homogenate lipid peroxidation of FeC12-vitamin C-ADP mixture induction, and malonaldehyde (MDA) content is declined; The rats'liver infringement that isoniazid is caused has inhibitory action.So the two coordinates except can effectively removing pathogenic wind in lung network, alleviate outside respiratory symptom, also have and the effect of nourishing liver.And to the experimental tuberculosis of mice, Radix seu Herba Spiranthis Lanceae can make pulmonary lesion alleviate to some extent.

2, in side, get Folium Fumicis Dentati, Fructus Gleditsia, go back bobbin, Ovum Gallus domesticus crusta is minister: the reciprocal causation of the senile tuberculosis expectorant stasis of blood, Yi Shengta becomes, therefore choose Folium Fumicis Dentati removing toxic substances dissipating blood stasis; Monarch drug dredging collateral power is strong, and the turbid effect deficiency of eliminating the phlegm, therefore get Fructus Gleditsia expectorant powder junction; Also among bobbin and we, there is the merit of open-minded deficiency-phlegm.Ovum Gallus domesticus crusta water extract has and reduces the effect of oozing out for the experimental tuberculosis of mice.

3, supplementary drug thing: Cortex erythrinae treatment of arthritis and promoting collateral and channels, and contribute to the capable lung qi of dredging collateral; Caulis fici pumilae (Fructus Fici Pumilae) helps Folium Fumicis Dentati removing toxic substances dissipating blood stasis, and Caulis fici pumilae (Fructus Fici Pumilae), Folium Fumicis Dentati mixing water decoct be to having inhibitory action with the mouse pulmonary fibrosis that in Bleomycin A5 trachea prepared by administration, and these two medicine dissipating blood stasis are but without the anxiety of moving blood.Fructus Mori, Herba Taxilli help goes back bobbin tonifying the lung kidney, vital base and primordial QI consolidating; Fructus cinnamomi immaturus warming middle-JIAO, one sideization cold-phlegm, also has the balanced property of medicine on the other hand, prevents cold and cool meaning too.

4, get Herba Ixeritis Sonchifoliae using corrigent, get the meaning of its convergence.Modern pharmacological research shows: the analgesia of Herba Ixeritis Sonchifoliae tool, spasmolytic effect, the content of its analgesic effect and total flavones is also not parallel, and has certain antiinflammatory action.

5, medicine material consumption of the present invention is to grope in a large number to sum up through inventor to draw: delicate fragrance osmanthus dosage is heavier, and there is the merit of replenishing blood and nourishing liver this dosage below; Herba Ixeritis Sonchifoliae dosage is less, gets the meaning of its spasmolytic, and can not hold too entirely, produces the anxiety of hemoptysis.

Detailed description of the invention

Below in conjunction with practical situation, the specific embodiment of the present invention is elaborated.

Embodiment 1, crude drug weight proportion: 20 parts, delicate fragrance osmanthus, 10 parts of Radix seu Herba Spiranthis Lanceae, 6 parts of Folium Fumicis Dentatis, 10 parts, Fructus Gleditsia, go back 6 parts, bobbin, 10 parts of Ovum Gallus domesticus crustas, 10 parts of Cortex erythrinaes, 10 parts of Caulis fici pumilae (Fructus Fici Pumilae)s, 10 parts of Fructus cinnamomi immaturus, 2 parts of Herba Ixeritis Sonchifoliaes, 6 parts of Fructus Mori, 20 parts of Herba Taxillis.

The preparation method of embodiment 1 is: by delicate fragrance osmanthus, Radix seu Herba Spiranthis Lanceae, Folium Fumicis Dentati, Fructus Gleditsia, go back bobbin, Ovum Gallus domesticus crusta, Cortex erythrinae, Caulis fici pumilae (Fructus Fici Pumilae), Fructus cinnamomi immaturus, Herba Ixeritis Sonchifoliae, Fructus Mori, Herba Taxilli mixing and water adding and decoct, after 30 minutes, get filtrate, medicinal residues add water to continue to decoct after 20 minutes and get filtrate, twice filtrate merges, and is divided into two parts of morning and evenings to take.

Embodiment 2, crude drug weight proportion: 10 parts, delicate fragrance osmanthus, 6 parts of Radix seu Herba Spiranthis Lanceae, 3 parts of Folium Fumicis Dentatis, 6 parts, Fructus Gleditsia, go back 3 parts, bobbin, 6 parts of Ovum Gallus domesticus crustas, 6 parts of Cortex erythrinaes, 6 parts of Caulis fici pumilae (Fructus Fici Pumilae)s, 6 parts of Fructus cinnamomi immaturus, 1 part of Herba Ixeritis Sonchifoliae, 3 parts of Fructus Mori, 10 parts of Herba Taxillis.

Embodiment 3, crude drug weight proportion: 20 parts, delicate fragrance osmanthus, 10 parts of Radix seu Herba Spiranthis Lanceae, 6 parts of Folium Fumicis Dentatis, 10 parts, Fructus Gleditsia, go back 6 parts, bobbin, 10 parts of Ovum Gallus domesticus crustas, 10 parts of Cortex erythrinaes, 10 parts of Caulis fici pumilae (Fructus Fici Pumilae)s, 10 parts of Fructus cinnamomi immaturus, 2 parts of Herba Ixeritis Sonchifoliaes, 6 parts of Fructus Mori, 20 parts of Herba Taxillis.

Embodiment 4, crude drug weight proportion: 30 parts, delicate fragrance osmanthus, 12 parts of Radix seu Herba Spiranthis Lanceae, 10 parts of Folium Fumicis Dentatis, 12 parts, Fructus Gleditsia, go back 10 parts, bobbin, 12 parts of Ovum Gallus domesticus crustas, 12 parts of Cortex erythrinaes, 12 parts of Caulis fici pumilae (Fructus Fici Pumilae)s, 12 parts of Fructus cinnamomi immaturus, 5 parts of Herba Ixeritis Sonchifoliaes, 10 parts of Fructus Mori, 25 parts of Herba Taxillis.

The Chinese medicine of embodiment 2 ~ 4 can be prepared from by following method:

(1) by delicate fragrance osmanthus, Cortex erythrinae, go back bobbin, Herba Ixeritis Sonchifoliae, Fructus cinnamomi immaturus, Caulis fici pumilae (Fructus Fici Pumilae) coarse powder respectively with vapor distillation extract volatile oil, and collect after mixing for standby use, medicinal residues are for subsequent use;

(2) medicinal residues in Herba Taxilli, Radix seu Herba Spiranthis Lanceae, Folium Fumicis Dentati, Fructus Gleditsia, Ovum Gallus domesticus crusta, Fructus Mori and step 1 are mixed and add 5 times of water yields, decoct with water 2 times, each 1 hour, collecting decoction, left standstill; Then toward 95% the ethanol that adds 3 ~ 4 times of medicinal liquids in decocting liquid, leave standstill 15 minutes, then with 3000rpm/min centrifugal 20 minutes, get supernatant, spraying is dry, draws just material;

(3) gained volatile oil in step 1 is sprayed in the first material of step 2 gained, mix, cross 60 mesh sieves, encapsulated forming.

Can set every capsules is 0.5g.

Effective combination of said medicine, coordinates mutually, effectively reach the object for the treatment of senile pulmonary tuberculosis disease, and side effect is less.The above results is that clinical data fully proves, interrelated data is as follows.

1 object and method.

1.1 object.

1.1.1 case selection: in January, 2010 ~ 2013 are diagnosed as consumptive's 150 examples that the age is greater than 60 years old year January, gets rid of and deposits serious heart hepatorenal disease, diabetes, pneumoconiosis and disease of immune system.60 ~ 78 years old age, male 97 examples, female's 53 examples.150 routine patients are divided into matched group 50 examples, decoction group 50 examples and Capsules group 50 examples.Just control 112 examples, control again 38 examples.Before three groups of patient treatments, in sex, age, the course of disease, classification, the state of an illness, compare, difference not statistically significant (P>0.05), has comparability.

1.1.2 diagnosis basis: foundation " phthisical clinical criteria and therapeutic scheme " 1. clinical manifestation: heating, cough continue more than 2 weeks, or pant etc.; 2. chest X-ray has pulmonary tuberculosis performance; 3. sputum, gastric juice or bronchoalveolar lavage fluid tubercule bacillus smear or cultivation are positive; 4. pathologic inspection meets pulmonary tuberculosis feature.Have the 1. with the 2., and the 3. or 4. item person.

1.2 method.

1.2.1 Therapeutic Method: matched group is just controlled patient's the first two months strengthening phase employing isoniazid, rifapentine, pyrazinamide and ethambutol therapeutic alliance, control again patient's the first two months and adopt isoniazid, rifapentine, pyrazinamide, ethambutol and combined with levofloxacin treatment, rear consolidation, adopts isoniazid, rifapentine, ethambutol treatment.Decoction group and Capsules group are on the treatment basis of matched group, and decoction group adds with gained decoction oral in the embodiment of the present invention 1,2 times/d, after one month, use gained capsule oral in embodiment 3 instead, Capsules group adds with gained capsule oral in the embodiment of the present invention 3,2g/ time, 2 times/d.It within 6 months, is a course for the treatment of.Treat and carry out efficacy evaluation in 6 months later, as do not reach clinical cure and carry out the treatment of second course for the treatment of.

1.2.2 the standard of curative effect evaluation: 1. X-ray focus changes situation: it more than 1/2 is effective that focus absorbs, less than 1/2 is effectively, without changing or worsening as invalid.2. sputum conversion situation: Sputum inspection is taked smear 3 times, total negative is that the moon turns.

1.2.3 statistical analysis: SPSS 13.0 carries out statistical analysis.Enumeration data χ ²inspection.

2 results.

2.1 sputum conversion situation comparisons: matched group negative conversion rate is 58%(29/50), decoction group is 82%(41/50), Capsules group is 84%(42/50).Three groups of comparisons, decoction group and Capsules group are apparently higher than matched group (P<0.05).

2.2 focus absorbing state comparisons: as following table;

Group	Number of cases	Effective	Effectively	Invalid	Total effective rate
						Matched group	50	10(20%)	14(28%)	26(52%)	48%
Decoction group	50	20(40%)	21(42%)	9(18%)	82%
						Capsules group	50	19(38%)	21(42%)	10(20%)	80%

Three groups of comparisons, decoction group and Capsules group total effective rate are apparently higher than matched group (P<0.05).

2.3 3 groups of adverse reactions of patients incidence rates comparison: after treatment, matched group has 42% patient to occur untoward reaction, wherein abnormal liver function 17 examples; Decoction group has 18% patient to occur untoward reaction, wherein abnormal liver function 6 examples; Capsules group has 20% patient to occur untoward reaction, wherein abnormal liver function 6 examples.Three groups of comparisons, decoction group and Capsules group adverse reaction rate, hepar damnification incidence rate is starkly lower than matched group (P<0.05).

3. conclusion.

This result of study shows, take decoction group of the present invention and Capsules group total effective rate apparently higher than matched group, and untoward reaction is starkly lower than matched group, illustrate that pharmaceutical composition prepared by the inventive method has at treatment senile pulmonary tuberculosis that effect is clear and definite, untoward reaction is light, the higher advantage of safety aspect sick.

Claims (1)

1. capsule for pulmonary tuberculosis partner treatment and preparation method thereof, is characterized in that, crude drug comprises delicate fragrance osmanthus, Radix seu Herba Spiranthis Lanceae, Folium Fumicis Dentati, Fructus Gleditsia, goes back bobbin, Ovum Gallus domesticus crusta, Cortex erythrinae, Caulis fici pumilae (Fructus Fici Pumilae), Fructus cinnamomi immaturus, Herba Ixeritis Sonchifoliae, Fructus Mori, Herba Taxilli; Formed by following steps:

(1) by delicate fragrance osmanthus, Cortex erythrinae, go back bobbin, Herba Ixeritis Sonchifoliae, Fructus cinnamomi immaturus, Caulis fici pumilae (Fructus Fici Pumilae) coarse powder respectively with vapor distillation extract volatile oil, and collect after mixing for standby use, medicinal residues are for subsequent use;

(2) medicinal residues in Herba Taxilli, Radix seu Herba Spiranthis Lanceae, Folium Fumicis Dentati, Fructus Gleditsia, Ovum Gallus domesticus crusta, Fructus Mori and step 1 are mixed and add 5 times of water yields, decoct with water 2 times, each 1 hour, collecting decoction, left standstill; Then toward 95% the ethanol that adds 3 ~ 4 times of medicinal liquids in decocting liquid, leave standstill 15 minutes, then with 3000rpm/min centrifugal 20 minutes, get supernatant, spraying is dry, draws just material;

(3) gained volatile oil in step 1 is sprayed in the first material of step 2 gained, mix, cross 60 mesh sieves, encapsulated forming.