CN113648381A - Traditional Chinese medicine composition for bronchiectasis and preparation method thereof - Google Patents
Traditional Chinese medicine composition for bronchiectasis and preparation method thereof Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicine composition, which comprises the following raw material medicines in parts by weight: 10-30 parts of codonopsis pilosula, 15-45 parts of radix astragali preparata, 5-15 parts of radix bupleuri, 5-15 parts of radix peucedani, 3-9 parts of coptis chinensis, 5-15 parts of dark plum, 15-45 parts of houttuynia cordata, 5-15 parts of rhizoma bletillae, 15-45 parts of semen coicis, 5-15 parts of platycodon grandiflorum and 3-9 parts of radix glycyrrhizae preparata. The invention also provides a preparation method and pharmaceutical application of the traditional Chinese medicine composition. The traditional Chinese medicine composition can effectively inhibit pseudomonas aeruginosa and treat bronchiectasis caused by pseudomonas aeruginosa colonization.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, relates to a traditional Chinese medicine composition for treating bronchiectasis and a preparation method thereof, and particularly relates to a traditional Chinese medicine composition preparation for treating bronchiectasis caused by pseudomonas aeruginosa colonization and a preparation method thereof.
Background
Bronchiectasis (broncheectasis, abbreviated as "Bronchiectasis") is a common structural lung disease, which is caused by repeated suppurative infection caused by multiple reasons, repeated injury and/or blockage of small and medium sized tracheas, destruction of bronchial wall structures, and abnormal and continuous Bronchiectasis, and is clinically manifested by persistent or recurrent cough and expectoration, sometimes accompanied by hemoptysis. The bronchiectasis has long course and irreversible lesion, and the repeated infection, especially the extensive bronchiectasis can seriously damage the lung tissue and function of a patient, can cause respiratory dysfunction and chronic pulmonary heart disease, seriously influences the life quality of the patient and causes heavy social and economic burden.
Pseudomonas Aeruginosa (PA) is a common non-zymobacter clinically, and has the characteristics of easy field planting, easy variation and multiple drug resistance. PA is the most common pathogenic microorganism of patients with the branch expansion disease, and researches show that the toxicity factor cyanide can seriously damage the lung function of the patients, the positivity of the toxicity factor exoU or pldA gene is an important risk factor of acute exacerbation of the patients with the branch expansion disease, and PA colonization is closely related to the inflammation level, the lung function damage, the disease deterioration, the life quality reduction and the death rate increase of the patients with the branch expansion disease. The current scoring system for evaluating the severity of bronchiectasis, such as the Bronchiectasis Severity Index (BSI), the FACED score and the E-FACED score, takes PA as one of the important factors for evaluating the risk and prognosis of the bronchiectasis. Therefore, it is important to effectively eliminate PA colonization. Research shows that the macrolide drugs are effective on PA, and long-term low-dose oral administration of macrolide antibiotics can reduce the acute exacerbation risk of patients with the bronchiectasis, delay the decline of lung function and improve the quality of life, so that the macrolide antibiotics are recommended as first-line drugs. However, bacterial resistance, dysbacteriosis, adverse reactions of digestive system, circulatory system and skin, and the like caused by long-term use of macrolide drugs are not negligible.
The branch and enlargement syndrome is mainly treated in the category of pulmonary abscess in traditional Chinese medicine. Clinical practice shows that PA colonized and expanded patients mostly show cough, expectoration, yellow white or green color, and symptoms such as hypodynamia, anorexia, emaciation and the like, and the patients are mainly characterized by deficiency of lung and spleen qi, phlegm heat accumulating in lung and disease property with deficiency and excess mixed together; and practice proves that the traditional Chinese medicine has obvious clinical curative effect on improving symptoms such as cough and expectoration caused by bronchiectasis. Therefore, the development of a medicament for treating PA colonization branch disease, which has no toxic or side effect and good treatment effect, is an urgent problem to be solved.
Disclosure of Invention
In order to solve the problems in the prior art, the invention provides, in a first aspect, a traditional Chinese medicine composition, wherein pharmaceutically active materials of the traditional Chinese medicine composition comprise:
radix Codonopsis, radix astragali Preparata, bupleuri radix, radix Peucedani, Coptidis rhizoma, mume fructus, herba Houttuyniae, rhizoma Bletillae, Coicis semen, radix Platycodi and radix Glycyrrhizae Preparata.
In some embodiments, the raw material medicines of the traditional Chinese medicine composition comprise, by weight: 10-30 parts of codonopsis pilosula, 15-45 parts of radix astragali preparata, 5-15 parts of radix bupleuri, 5-15 parts of radix peucedani, 3-9 parts of coptis chinensis, 5-15 parts of dark plum, 15-45 parts of houttuynia cordata, 5-15 parts of rhizoma bletillae, 15-45 parts of semen coicis, 5-15 parts of platycodon grandiflorum and 3-9 parts of radix glycyrrhizae preparata.
In some embodiments, the raw material medicines of the traditional Chinese medicine composition comprise, by weight: 20 parts of codonopsis pilosula, 30 parts of radix astragali preparata, 10 parts of radix bupleuri, 10 parts of radix peucedani, 6 parts of coptis chinensis, 10 parts of dark plum, 30 parts of houttuynia cordata, 10 parts of rhizoma bletillae, 30 parts of semen coicis, 10 parts of platycodon grandiflorum and 6 parts of radix glycyrrhizae preparata.
In some embodiments, the Chinese medicinal composition further comprises pharmaceutically acceptable excipients.
In some embodiments, the pharmaceutically acceptable excipient comprises at least one of a disintegrant, a lubricant, and a binder.
In some embodiments, the binder is dextrin.
In some embodiments, the adjuvant is 15-35 parts by weight of the raw materials of the Chinese medicinal composition.
In some embodiments, the pharmaceutical composition is in the form of decoction or granules.
The second aspect of the present invention provides a method for preparing the Chinese medicinal composition of the first aspect of the present invention, wherein the method comprises: is prepared from radix Codonopsis, radix astragali Preparata, bupleuri radix, radix Peucedani, Coptidis rhizoma, mume fructus, herba Houttuyniae, rhizoma Bletillae, Coicis semen, radix Platycodi, and radix Glycyrrhizae Preparata.
In some embodiments, the method comprises the steps of:
s1: preparing radix Codonopsis, radix astragali Preparata, bupleuri radix, radix Peucedani, Coptidis rhizoma, mume fructus, herba Houttuyniae, rhizoma Bletillae, Coicis semen, radix Platycodi, and radix Glycyrrhizae Preparata into decoction filtrate mixture;
s2: concentrating the decoction filtrate mixture into fluid extract.
In some embodiments, the method further comprises the steps of:
s3: and mixing the clear paste with auxiliary materials to obtain the traditional Chinese medicine composition.
In some embodiments, in step S1, decocting a mixture of codonopsis pilosula, astragalus membranaceus preparata, bupleurum, peucedanum root, coptis chinensis, dark plum, houttuynia cordata, bletilla striata, coix seed, platycodon grandiflorum, and radix glycyrrhizae preparata, and discarding residues to obtain the decoction filtrate mixture; or
Decocting radix Codonopsis, radix astragali Preparata, bupleuri radix, radix Peucedani, Coptidis rhizoma, mume fructus, herba Houttuyniae, rhizoma Bletillae, Coicis semen, radix Platycodi, and radix Glycyrrhizae Preparata respectively, discarding residues, and mixing all decoctions to obtain the decoction filtrate mixture.
In some embodiments, in step S1, the water used for decoction is 5-10 times the weight of the bulk drug.
In some embodiments, in step S1, the decoction time is 0.5-2 hours.
In some embodiments, in step S1, the decoction filtrate mixture is a mixture of multiple decoctions, and the residue after the previous decoction is removed in the next decoction, wherein the number of times of decoction is 1-5.
In some embodiments, in step S2, the concentration is performed at 55-65 ℃.
In some embodiments, in step S2, the decoction filtrate mixture is concentrated to a density of 1.15-1.20g/cm3The clear paste is obtained.
In some embodiments, in step S2, the fluid extract is prepared into granules.
In a third aspect, the present invention provides the use of the composition of the first aspect or the method of the second aspect in the preparation of a medicament for treating, preventing, slowing or controlling bronchiectasis.
In a fourth aspect, the present invention provides a use of the Chinese medicinal composition of the first aspect or the preparation method of the second aspect in preparing a preparation for inhibiting or killing pseudomonas aeruginosa.
In a fifth aspect, the present invention provides the use of the Chinese medicinal composition of the first aspect of the present invention or the preparation method of the second aspect of the present invention in the preparation of a preparation for treating, preventing, alleviating or controlling diseases capable of being treated, prevented, alleviated or controlled by inhibiting or killing pseudomonas aeruginosa.
In a sixth aspect, the invention provides the use of a composition according to the first aspect of the invention or a method according to the second aspect of the invention in the preparation of a formulation for treating, preventing, slowing or controlling bronchiectasis colonized by pseudomonas aeruginosa.
The pharmaceutical composition of the invention comprises the following components by weight:
codonopsis pilosula (codonopsis radix): sweet and neutral. It enters spleen and lung meridians. Tonify middle-jiao and Qi, invigorate spleen and benefit lung.
Radix astragali Preparata (ASTRAGALI RADIX PRAEPARATA CUM MELLE): sweet and warm. It enters lung and spleen meridians. Tonify qi, strengthen superficies, induce diuresis, expel pus, heal wound and promote tissue regeneration.
BUPLEURI RADIX (BUPLEURI RADIX): bitter and slightly cold. It enters liver and gallbladder meridians. Harmonize exterior and interior, soothe liver and raise yang.
Peucedanum root (PEUCEDANI RADIX): bitter, pungent and slightly cold. It enters lung meridian. Dispel wind and clear heat, direct qi downward and resolve phlegm.
Coptis chinensis (COPTIDIS RHIZOMA): bitter and cold. It enters heart, spleen, stomach, liver, gallbladder and large intestine meridians. Clear heat and dry dampness, purge fire and remove toxicity.
Dark plum (MUME frutus): sour, astringent and neutral. It enters liver, spleen, lung and large intestine meridians. Astringe lung, astringe intestine, promote fluid production and relieve ascaris.
Houttuynia cordata (HOUTTUYNIAE HERBA): pungent and slightly cold. It enters lung meridian. Clearing away heat and toxic material, curing abscess and discharging pus, inducing diuresis and treating stranguria.
RHIZOMA Bletillae (BLETILLAE RHIZOMA): bitter, sweet, astringent and slightly cold. It enters lung, liver and stomach meridians. Astringe to stop bleeding, resolve swelling and promote tissue regeneration.
Coix seed (COICIS SEMEN): sweet, bland and cool. It enters spleen, stomach and lung meridians. To invigorate the spleen, remove dampness, remove arthralgia, check diarrhea, clear heat and expel thick.
Platycodon grandiflorum (PLATYCODONIS RADIX): bitter, pungent and even. It enters lung meridian. Disperse lung qi, relieve sore throat, dispel phlegm, and expel pus.
Prepared licorice (Glycyrrhizae RADIX ET RHIZOMA PRAEPARATA CUM MELLE): sweet and neutral. It enters heart, lung, spleen and stomach meridians. Tonify spleen and stomach, replenish qi and recover pulse.
The medicinal parts, properties and processing methods of the raw material medicaments are disclosed in the 'Chinese pharmacopoeia' 2020 edition.
Bronchiectasis is mainly treated in the category of pulmonary abscess in traditional Chinese medicine. Clinical practice shows that patients with the branch and dilation syndrome mostly have symptoms of cough, expectoration, yellow white or green color, weakness, anorexia, emaciation and the like, and the disease property is mainly caused by mixed deficiency and excess, so that the common pathogenesis of patients with the branch and dilation syndrome of PA (polyamide) is that lung-spleen qi is deficient, and phlegm-heat is accumulated in the lung. Phlegm-heat contradicts with spleen deficiency, the lung-spleen deficiency is aggravated by excessive phlegm-heat, and the phlegm-heat is restrained by excess lung-spleen, which is consistent with the fact that fire and original qi do not stand simultaneously, and one prevails and the other is negative, which is suggested by Lidongyuan, namely, the original qi of spleen and stomach is insufficient, the yin fire is hidden, and the phlegm-heat stagnates the lung. The deficiency of lung and spleen qi often reduces the immune function of the body, weakens the anti-pathogenic capability, causes yin fire (including airway colonization bacteria, chronic inflammatory reaction and the like) to be suffered, and if the primordial qi is sufficient, the yin fire converges internally, forming the attack pattern of bronchiectasis with vital qi deficiency and pathogenic attachment, pathogenic trend excess and pathogenic decline. Therefore, the treatment of patients with PA colonisation and expansion diseases should pay attention to lung and spleen tonifying to treat the root, and simultaneously clear lung and resolve phlegm, and relieve the symptoms of soreness and bitterness and purging pathogenic fire.
The invention exerts the characteristics of ' simple and convenient use, low price, simple administration and clear conception of the traditional Chinese medicine according to the treatment concept of ' simultaneous treatment of principal and subordinate symptoms and combined administration of reinforcement and purgation ', and has the functions of tonifying lung and spleen, clearing lung and eliminating phlegm.
The prescription takes the astragalus, the codonopsis pilosula and the honey-fried licorice root as main medicines, and the three medicines are all sweet and warm, can tonify primordial qi and can purge fire. The original Baoyuan decoction of Wei Zhi Shi of the later generation also comprises radix codonopsitis, radix astragali and radix glycyrrhizae preparata, which are used for greatly tonifying primordial qi to treat all the syndromes of primordial qi deficiency, and the Kouyanbo is recorded as: "the formula Huang Qi strengthens exterior, ren Shen strengthens interior, gan Cao harmonizes middle energizer, and three qi are enough to treat the exterior syndrome, just as summarized in Yi Zong Yi Ji Bing Xin Fa Jue: all qi deficiency and vitality securing soups, Qiwei Shen and Neihuo, all in the middle of the herb. For vomiting yellow-green phlegm and yellow-purulent phlegm, modified Qian Mei san is used. Chai qian mei lian san is originated from yuandai satu (rui zhu tang experiential prescription, xu meng door), the current famous medical profession snow (jin kui yan jie): 'Chailian Liansan' is the only treatment for cough due to overstrain wind and green phlegm. The symptoms are consistent and the effects are like sound. In the prescription, dark plum is sour in taste and can nourish yin, and the Shen nong Ben Cao Jing indicates that dark plum has the effects of removing dead muscles and malignant flesh and has the functions of removing putrefaction and promoting granulation on the putrefaction and congestion of flesh caused by local damage of airways of a bronchiectasis disease; the coptis, the houttuynia and the coix seed clear away internal yin fire, resolve phlegm and remove turbidity; peucedanum root, radix Peucedani purges lung and lowers qi, and clears phlegm and relieves cough; the platycodon grandiflorum has the effects of dispersing lung qi, relieving cough, eliminating phlegm and expelling pus; bupleurum root, radix bupleuri, semen Euphorbiae Lathyridis, radix bupleuri, radix bupleuri, radix cortex Phellodendri cortex Radicis, radix bupleuri, radix bupleuri, radix bupleuri, radix bupleuri, radix bupleuri, radix bupleuri, radix bupleuri, radix. Yin fire is hidden inside without discharging outside, when fire is stagnated and pathogenic factors are helped to go out, the radix peucedani and the radix bupleuri are wind-evil, the radix bupleuri mainly ascends, the radix peucedani mainly descends, and the two are used together to ascend and descend, so the Chinese herbal medicine has the effects of promoting aging to cause novelty, dissolving phlegm and dispelling turbidity, and opening lung to stop cough. For instance, it is recorded in Ben Cao Hui Yan that it is good at entering lung meridian and damaged lung lobe is caused by heat accumulation and blood stasis, so it can be taken after grinding for a day to consolidate and astringe lung, seal and fill up damaged lung, resolve carbuncle swelling, remove ulcer and dead muscle, clean pus and blood, and has the wonderful effect of relieving old and promoting tissue regeneration.
FIG. 1 is a schematic representation of the composition of the present invention.
The invention has the following composition characteristics: based on the basic pathogenesis that fire and original qi are not compatible, one prevails and the other is negative, and the relationship of qi and fire is disordered, namely, the original qi of the spleen and the stomach is insufficient, the yin fire is hidden, phlegm is coagulated and accumulated, and phlegm-heat stagnates in the lung, the spleen-tonifying lung-clearing decoction is prepared for treating the PA permanent planting bronchiectasis patients. (1) In the formula, the codonopsis pilosula, the radix astragali preparata and the honey-fried licorice root are used as main medicines, and aim at the deficiency of the spleen and the stomach and the internal generation of yin fire to strengthen the original qi of the spleen and the stomach, consolidate the constitution, defend evil and reduce phlegm; (2) radix bupleuri, radix peucedani, coptis, dark plum, houttuynia cordata, semen coicis and platycodon grandiflorum are used as ministerial drugs, and the effects of benefiting yin and purging fire, clearing lung and eliminating phlegm and expelling pus are achieved; (3) rhizoma Bletillae has effects of removing necrotic tissue, promoting granulation, astringing lung, and sealing and filling up damaged tissue, aiming at the pathogenesis characteristics of heat congestion and blood stasis and lung collateral injury of patients. The whole formula can supplement primordial qi, purge yin fire, eliminate phlegm and heat, and tightly fasten pathogenesis, so that fire and primordial qi reach a coordinated state.
The invention has the following beneficial effects:
the invention exerts the characteristics of ' simple and convenient use, low price, simple administration and clear conception of the traditional Chinese medicine according to the treatment concept of ' simultaneous treatment of principal and subordinate symptoms and combined administration of reinforcement and purgation ', and has the functions of tonifying lung and spleen, clearing lung and eliminating phlegm. The traditional Chinese medicine composition can effectively treat the bronchiectasis caused by the pseudomonas aeruginosa planting, can effectively reduce the acute exacerbation times of patients, improves symptoms and further improves the life quality.
The long-term oral administration of macrolide antibiotics for treating the bronchiectasis colonized by the pseudomonas aeruginosa has a plurality of adverse reactions, and the research and development of a medicament which has no toxic or side effect and good treatment effect and is used for treating the bronchiectasis colonized by the pseudomonas aeruginosa is urgently needed. The composition has therapeutic effect on patients without branch and enlargement symptom complicated with PA colonization, and syndrome differentiation of lung and spleen qi deficiency and phlegm heat accumulation in lung.
Drawings
FIG. 1 shows a composition 1.
Figure 2 is a comprehensive report form of patient 1 prior to treatment.
Figure 3 is a comprehensive report sheet after treatment of patient 1.
Figure 4 is a comprehensive report form before treatment for patient 2.
Figure 5 is a comprehensive report sheet after treatment of patient 2.
Figure 6 is a comprehensive report form of patient 3 prior to treatment.
Figure 7 is a comprehensive report sheet after treatment of patient 3.
FIG. 8 is a test report sheet for sputum culture test of P.aeruginosa for patient 4 prior to treatment.
FIG. 9 is a test report sheet for sputum culture test of P.aeruginosa after patient 4 treatment.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, embodiments of the present invention will be described in detail with reference to the accompanying drawings.
Example 1: a Chinese medicinal composition
Each dose of the traditional Chinese medicine composition consists of the following medicinal materials in parts by weight:
20g of codonopsis pilosula, 30g of radix astragali preparata, 10g of radix bupleuri, 10g of radix peucedani, 6g of coptis chinensis, 10g of dark plum, 30g of houttuynia cordata, 10g of rhizoma bletillae, 30g of semen coicis, 10g of platycodon grandiflorum and 6g of radix glycyrrhizae preparata.
The preparation method comprises the following steps: mixing the eleven traditional Chinese medicine decoction pieces according to the weight proportion of the formula, adding water with the weight 6-8 times of the total weight of the medicinal materials, decocting for 1.5 hours, adding the water with the same weight, decocting the decoction dregs obtained after the first decoction, mixing the decoction obtained by the two decoctions, filtering the decoction with gauze to obtain filtrate, heating the filtrate at 60 ℃ and concentrating the filtrate until the density is 1.15-1.20g/cm3The mass of the clear paste is about 50 g. Adding dextrin 25g into the above fluid extract, and granulating with granulating equipment. Thus, composition 1 was obtained.
Test example 1: clinical observations
(I) the subject
The clinical test is carried out on patients collected in the department of pulmonary diseases of western aster hospital of Chinese academy of science, and different treatment schemes are respectively carried out on the patients who simultaneously accord with the western medicine diagnosis standard of PA permanent planting bronchiectasis and the traditional Chinese medicine lung-spleen qi deficiency and phlegm-heat lung accumulation syndrome by randomly dividing the patients into an observation group and a control group. A total of 60 cases meeting the following criteria were counted, and 31 were observed and 29 were controlled.
Diagnostic criteria:
standard of Western diagnosis
(1) The diagnosis standard of the bronchiectasis is made according to the consensus of the adult bronchiectasis diagnosis and treatment experts (2012 edition) made by the consensus writing group of the adult bronchiectasis diagnosis and treatment experts: chest high resolution CT is the primary means of diagnosing bronchiectasis. According to the past medical history, clinical manifestations, physical signs and laboratory examinations. Stationary phase standard: the patient has no fever, hemoptysis, dyspnea and shortness of breath and other general symptoms. Acute exacerbation criteria: the patient has symptoms of cough, increased or altered sputum, increased purulent sputum and/or general symptoms of asthma, shortness of breath, hemoptysis and fever. PA field planting: in the last 3 months, the pseudomonas aeruginosa is found by sputum culture.
(2) Syndrome diagnosis standard of traditional Chinese medicine
The method is formulated according to the Chinese traditional medicine society 2008 formulated "diagnosis and treatment guidelines for common diseases in internal medicine of traditional Chinese medicine-part of traditional Chinese medicine syndrome": cough, purulent sputum with bluish green color, short breath, tiredness, hypodynamia, poor appetite, spontaneous sweating, yellow complexion, red or pale red tongue with thin or greasy coating, wiry or slippery pulse.
Case inclusion criteria
(1) Patients who meet the diagnostic standard of PA colonized bronchiectasis;
(2) age 18-70 years;
(3) the traditional Chinese medicine distinguishes the syndrome that the lung and spleen are deficient and phlegm-heat is accumulated in the lung;
(4) patients who have had at least acute exacerbations of 1 in the past 1 year;
(5) willing to follow the physician's diagnosis, treatment schedule and sign informed consent.
Criteria for case exclusion
(1) Those who do not meet the above-mentioned criteria of Western diagnosis and Chinese medicine syndrome differentiation;
(2) pregnant or lactating women;
(3) history of chronic alcohol abuse or drug abuse or any factor affecting compliance;
(4) the compliance during the screening period is poor;
(5) combined with primary diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic systems;
(6) dysfunction of liver and kidney: liver function index (such as ALT or AST) is more than one time higher than upper limit of normal value or renal function abnormal person, such as BUN or Cr abnormal person;
(7) psychotic patients;
(8) allergic constitution and people allergic to the medicine;
(9) those who have been treated with other similar drugs;
(10) other clinical treatment patients have participated in within 1 month.
(II) methods of treatment
Observation group (one group): composition 1 prepared in example 1 was orally administered. One dose every other day. Stop the drug for 24 weeks.
Control group (two groups): azithromycin tablets (0.25 g/tablet, national Standard: H10960167, Peucedanum pharmaceuticals, Inc.) are administered orally at a dose of 0.5g every other day for 1 time. Stop the drug for 24 weeks.
Observation index
(1) Number of acute exacerbations
The number of acute exacerbations during the period of taking the medicine (12 weeks, 24 weeks) and the follow-up period of 24 weeks was counted.
(2) Quality of life (san Jose respiratory questionnaire) score
Baseline and 3 times were recorded 12 weeks after dosing and 24 weeks after dosing, respectively.
The individual scores and total score changes of the main clinical symptoms and signs of the patients are observed.
The quality of life of the patients is comprehensively evaluated according to the literature by applying the holy george rating scale:
the method has the following advantages: the score of holy georgette is reduced by more than 4 points after treatment compared with that before treatment;
and (3) stabilizing: the fluctuation before and after the holy george score treatment is less than or equal to 4 points;
deterioration: the score of Shengqiaozhi is increased by more than 4 points after treatment compared with that before treatment.
The integral changes of symptom expression, activity limitation and psychological condition parts of two groups of patients before and after treatment are compared and processed statistically.
(3) The curative effect of the syndrome of traditional Chinese medicine
Reference is made to the guiding principle of clinical development of new Chinese medicines published by the publishing society of Chinese medical science and technology in 2002 and the standard of curative effect of diagnosis of Chinese medical disorders published by the State administration of Chinese medicine.
The clinical cure is as follows: the symptoms disappear after treatment, and the symptom score is reduced by more than or equal to 95 percent.
The effect is shown: the total integral of symptoms after treatment is reduced by more than or equal to 70 percent and less than 95 percent.
The method has the following advantages: the total integral of symptoms after treatment is reduced by more than or equal to 30 percent and less than 70 percent.
And (4) invalidation: after treatment, symptoms did not improve or worsen, and the total score decreased by < 30%.
Note: the calculation formula (nimodipine method) is [ (pre-treatment integral-post-treatment integral)/pre-treatment integral ]. 100%.
(4) Pulmonary function
Lung function before and after treatment in each group was compared separately: change in the 1 st second forced expiratory volume to the expected percentage of FEV 1% pred, one second rate FEV 1/FVC; the changes in lung function before and after treatment between the two groups were compared and statistically processed.
(5) Index of inflammation
Changes in blood inflammatory markers (CRP, ESR) before and after treatment were compared and statistically processed.
(6) Sputum culture
Statistical method
The distribution of the metering data conforming to normal adopts t test and paired t test; and the method of adopting rank sum test and the like is not in accordance with normal distribution. The counting data is checked by chi-square method. The statistical significance was judged by a P value of less than 0.05.
(III) therapeutic results
(1) The number of acute exacerbations in both groups of patients was compared as shown in table 1.
Table 1 comparison of acute exacerbations in two groups of patients (times,
)
note: comparison with control group after treatment*P＜0.05。
As can be seen from Table 1, after taking the traditional Chinese medicine composition of example 1 of the invention, the number of acute exacerbations of patients in composition 1 group after 24 weeks of administration and 24 weeks of withdrawal follow-up is less than that of patients in azithromycin group, which shows that composition 1 has an effect of reducing the number of acute exacerbations of patients with PA colonization and proliferation.
(2) The quality of life (san. george's respiratory questionnaire) scores before and after treatment were compared between the two groups of patients as shown in table 2.
Table 2 quality of life (san george respiratory questionnaire) score comparisons (score,
)
note: comparison with this group before treatment▲P＜0.05。
As can be seen from table 2, after taking the traditional Chinese medicine composition of example 1 of the present invention, the total score of the quality of life (saint george's respiratory questionnaire) score and the symptom score of the patients in composition 1 group were significantly reduced after 24 weeks of taking the composition, compared with those before treatment, which indicates that composition 1 has significant effects in improving the symptoms and quality of life of the patients.
(3) The therapeutic effects of the two groups of patients are shown in Table 3.
TABLE 3 two groups of patients with syndrome of traditional Chinese medicine for comparison of therapeutic effect [ case, (%) ]
Note: the observed group and the control group have the curative effect comparison after 12 weeks and 24 weeks of treatment, and P is less than 0.05.
As can be seen from Table 3, after the traditional Chinese medicine composition disclosed by the embodiment 1 of the invention is taken, the curative effect of the traditional Chinese medicine syndrome of the patient in the composition 1 group is obviously better than that of the patient in the azithromycin group after the patient takes the traditional Chinese medicine composition for 12 and 24 weeks, which shows that the composition 1 has the effect of improving the traditional Chinese medicine syndrome of the patient.
(4) Lung function (FEV 1% pred, FEV1/FVC) was compared before and after treatment in both groups of patients, as shown in Table 4. FEV 1% pred is commonly written as FEV1 in patient reports.
TABLE 4 comparison of pulmonary function (%, x + -s) before and after treatment (FEV 1% pred, FEV1/FVC) in two groups of patients
Note: p values were >0.05 in both the observation and control groups at 12 weeks, 24 weeks post-treatment and pre-treatment.
In the patients with composition 1, both FEV 1% pred and FEV1/FVC showed an improved trend in lung function compared to those before treatment. (see Table 4). The results of three patients with significant improvement in lung function (FEV 1% pred and FEV1/FVC) are shown in FIGS. 2-7, where FIGS. 2 and 3 are the combined report form before and after treatment for patient 1, FIGS. 4 and 5 are the combined report form before and after treatment for patient 2, and FIGS. 6 and 7 are the combined report form before and after treatment for patient 3.
(5) Composition 1 group patients were compared before and after treatment for inflammation indices as shown in table 5.
TABLE 5 comparison of serum CRP, ESR treatment before and after treatment in two groups of patients
Note: comparison with this group before treatment▲P＜0.05。
As can be seen from table 5, after taking the traditional Chinese medicine composition of example 1 of the present invention, serum CRP and ESR of patients in composition 1 group were significantly reduced after taking the composition for 24 weeks, compared with those before treatment, which indicates that composition 1 has significant effect in improving the inflammation level of patients.
(6) Sputum culture
After the traditional Chinese medicine composition disclosed by the embodiment 1 of the invention is taken, the cough and sputum amount of part of patients is obviously reduced, and certain influence is brought to the sputum specimen collection and sputum culture results in the follow-up period. However, sputum culture results turned negative during follow-up visits in some patients, indicating that composition 1 has a significant effect in reducing sputum secretion and controls bronchodilation to some extent by inhibiting P.aeruginosa.
The sputum culture of the patients after treatment is changed from positive to negative by pseudomonas aeruginosa, and the results are compared and shown in figures 8-9, which are the test report sheets for testing pseudomonas aeruginosa by sputum culture of the patients 4 before and after treatment.
In conclusion, the composition can control pseudomonas aeruginosa to a certain extent, so that the acute exacerbation frequency of patients with pseudomonas aeruginosa colonization and proliferation disorders can be effectively reduced, and the symptoms and the life quality can be improved.
It will be appreciated by those skilled in the art that the invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The embodiments disclosed above are therefore to be considered in all respects as illustrative and not restrictive. All changes which come within the scope of or equivalence to the invention are intended to be embraced therein.
Claims (10)
1. A traditional Chinese medicine composition, wherein the pharmaceutically active materials of the traditional Chinese medicine composition comprise:
radix Codonopsis, radix astragali Preparata, bupleuri radix, radix Peucedani, Coptidis rhizoma, mume fructus, herba Houttuyniae, rhizoma Bletillae, Coicis semen, radix Platycodi and radix Glycyrrhizae Preparata.
2. The traditional Chinese medicine composition of claim 1, wherein the raw materials of the traditional Chinese medicine composition comprise, in parts by weight: 10-30 parts of codonopsis pilosula, 15-45 parts of radix astragali preparata, 5-15 parts of radix bupleuri, 5-15 parts of radix peucedani, 3-9 parts of coptis chinensis, 5-15 parts of dark plum, 15-45 parts of houttuynia cordata, 5-15 parts of rhizoma bletillae, 15-45 parts of semen coicis, 5-15 parts of platycodon grandiflorum and 3-9 parts of radix glycyrrhizae preparata;
preferably, the traditional Chinese medicine composition comprises the following raw material medicines in parts by weight: 20 parts of codonopsis pilosula, 30 parts of radix astragali preparata, 10 parts of radix bupleuri, 10 parts of radix peucedani, 6 parts of coptis chinensis, 10 parts of dark plum, 30 parts of houttuynia cordata, 10 parts of rhizoma bletillae, 30 parts of semen coicis, 10 parts of platycodon grandiflorum and 6 parts of radix glycyrrhizae preparata.
3. The traditional Chinese medicine composition of claim 1, further comprising pharmaceutically acceptable excipients;
preferably, the pharmaceutically acceptable excipients include at least one of a disintegrant, a lubricant, and a binder;
preferably, the binder is dextrin;
preferably, the auxiliary materials account for 15-35 parts by weight of the raw material medicines of the traditional Chinese medicine composition;
preferably, the dosage form of the pharmaceutical composition is decoction or granules.
4. A method of preparing the traditional Chinese medicine composition of any one of claims 1-3, the method comprising: is prepared from radix Codonopsis, radix astragali Preparata, bupleuri radix, radix Peucedani, Coptidis rhizoma, mume fructus, herba Houttuyniae, rhizoma Bletillae, Coicis semen, radix Platycodi, and radix Glycyrrhizae Preparata.
5. The method of claim 4, wherein the method comprises the steps of:
s1: preparing radix Codonopsis, radix astragali Preparata, bupleuri radix, radix Peucedani, Coptidis rhizoma, mume fructus, herba Houttuyniae, rhizoma Bletillae, Coicis semen, radix Platycodi, and radix Glycyrrhizae Preparata into decoction filtrate mixture;
s2: concentrating the decoction filtrate mixture into clear paste;
preferably, the method further comprises the steps of:
s3: and mixing the clear paste with auxiliary materials to obtain the traditional Chinese medicine composition.
6. The method of claim 5, wherein in step S1, the mixture of codonopsis pilosula, radix astragali preparata, radix bupleuri, radix peucedani, coptis chinensis, dark plum, houttuynia cordata, rhizoma bletillae, semen coicis, platycodon grandiflorum, and radix glycyrrhizae preparata is decocted, and the residue is discarded to obtain the decoction filtrate mixture; or
Decocting radix Codonopsis, radix astragali Preparata, bupleuri radix, radix Peucedani, Coptidis rhizoma, mume fructus, herba Houttuyniae, rhizoma Bletillae, Coicis semen, radix Platycodi, and radix Glycyrrhizae Preparata respectively, discarding residues, and mixing all decoctions to obtain the decoction filtrate mixture;
preferably, in step S1, the amount of water used for decoction is 5-10 times of the weight of the raw material medicine;
preferably, in step S1, the decoction time is 0.5-2 hours;
preferably, in step S1, the decoction filtrate mixture is a mixture of multiple decoctions, and the residue after the previous decoction is removed in the next decoction is decocted for 1-5 times;
preferably, in step S2, the concentration is performed at 55-65 ℃;
preferably, in step S2, the decoction filtrate mixture is concentrated to a density of 1.15-1.20g/cm3The clear paste is obtained;
preferably, in step S2, the fluid extract is prepared into granules.
7. Use of the traditional Chinese medicine composition of any one of claims 1-3 or the preparation method of any one of claims 4-6 in the preparation of a formulation for treating, preventing, slowing or controlling bronchodilation.
8. Use of the traditional Chinese medicine composition of any one of claims 1 to 3 or the preparation method of any one of claims 4 to 6 in the preparation of a preparation for inhibiting or killing pseudomonas aeruginosa.
9. Use of the traditional Chinese medicine composition of any one of claims 1-3 or the preparation method of any one of claims 4-6 in the preparation of a formulation capable of treating, preventing, alleviating or controlling a disease capable of being treated, prevented, slowed down or controlled by inhibiting or killing pseudomonas aeruginosa.
10. Use of the traditional Chinese medicine composition of any one of claims 1-3 or the preparation method of any one of claims 4-6 in the preparation of a formulation for treating, preventing, slowing or controlling pseudomonas aeruginosa colonizing bronchiectasis.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102327525A (en) * | 2011-10-13 | 2012-01-25 | 上海中医药大学附属岳阳中西医结合医院 | Chinese medicinal composition for treating bronchiectasis |
| CN102961643A (en) * | 2012-11-10 | 2013-03-13 | 成都绿迪科技有限公司 | Traditional Chinese medicine preparation for treating bronchiectasis |
-
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102327525A (en) * | 2011-10-13 | 2012-01-25 | 上海中医药大学附属岳阳中西医结合医院 | Chinese medicinal composition for treating bronchiectasis |
| CN102961643A (en) * | 2012-11-10 | 2013-03-13 | 成都绿迪科技有限公司 | Traditional Chinese medicine preparation for treating bronchiectasis |
Non-Patent Citations (3)
| Title |
|---|
| 徐波等: "苗青自拟补中柴前连梅汤治疗支气管扩张症稳定期经验", 《中华中医药杂志》 * |
| 樊长征等: "补中柴前连梅煎对支气管扩张症大鼠模型肺气管组织病理学的影响", 《世界中医药》 * |
| 秦雪梅: "柴胡梅连汤加减治疗慢性支气管炎32例", 《内蒙古中医药》 * |
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Application publication date: 20211116 |