CN109908294B - Pharmaceutical composition for treating stable stage of bronchiectasis and preparation method and application thereof - Google Patents
Pharmaceutical composition for treating stable stage of bronchiectasis and preparation method and application thereof Download PDFInfo
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Abstract
The invention provides a pharmaceutical composition for treating stable stage of bronchiectasis, which is a preparation prepared from the following raw material medicines in parts by weight: 20-40 parts of codonopsis pilosula, 10-20 parts of poria cocos, 10-20 parts of rhizoma pinellinae praeparata, 10-20 parts of pericarpium citri reticulatae, 10-20 parts of bran-fried bighead atractylodes rhizome, 10-20 parts of fructus amomi, 5-15 parts of elecampane, 5-15 parts of raw liquorice, 20-40 parts of Chinese yam, 20-40 parts of semen coicis, 5-15 parts of wine-processed scutellaria baicalensis, 20-40 parts of radix astragali preparata, 5-15 parts of schisandra chinensis, 10-30 parts of lily, 10-20 parts of moutan bark and 10-20 parts of radix rehmanniae recen. The pharmaceutical composition provided by the invention has a precise and appropriate formula, can relieve the clinical symptoms and signs of patients in the stable stage of the bronchiectasis, slows down the disease progress, has good safety, no toxic or side effect and convenient use, and provides a new medicine choice for clinically treating the stable stage of the bronchiectasis.
Description
Technical Field
The invention relates to the field of traditional Chinese medicines, and in particular relates to a pharmaceutical composition for treating a stable stage of bronchiectasis, and a preparation method and application thereof.
Background
Bronchiectasis is a pathological and persistent dilation of the bronchial tree caused by various reasons, resulting in chronic inflammation of the airways with repeated purulent infection, and clinically manifested as persistent or repeated cough, expectoration and other symptoms. The stable stage (also called remission stage) of bronchiectasis refers to the stable symptoms of cough, expectoration and the like, and is not in the clinical exacerbation stage. In recent years, the disease has gradually increased prevalence rate, is a common disease in respiratory department, and is treated by antibiotics because of acute exacerbation caused by infection; even in the stationary phase (also called as remission phase), patients continue to have cough and expectoration, or chronic symptoms such as hypodynamia, anorexia, emaciation and the like. In addition, chronic obstructive pulmonary disease, chronic pulmonary heart disease and the like can be complicated in the later period of the disease, and the quality of life of patients is seriously influenced. Therefore, it is important to treat the bronchiectasis in the stable phase to prevent the acute exacerbation and complications.
However, no effective treatment scheme is available in western medicine at present for the stable stage of the bronchiectasis. The traditional Chinese medicine for treating the stable stage of the bronchiectasis has obvious advantages, and can improve the clinical symptoms and signs of patients, improve the life quality and slow down the disease progress. At present, no report on the treatment of stable stage of bronchiectasis is found in codonopsis pilosula, poria cocos, rhizoma pinellinae praeparata, pericarpium citri reticulatae, bran-fried bighead atractylodes rhizome, fructus amomi, elecampane, raw liquorice, Chinese yam, semen coicis, wine-processed scutellaria baicalensis, radix astragali preparata, schisandra chinensis, lily, moutan bark and radix rehmanniae.
Disclosure of Invention
In order to solve the technical problems, the invention provides a pharmaceutical composition for treating the stable stage of the bronchiectasis, which is a preparation prepared from the following raw material medicines in parts by weight:
20-40 parts of codonopsis pilosula, 10-20 parts of poria cocos, 10-20 parts of rhizoma pinellinae praeparata, 10-20 parts of pericarpium citri reticulatae, 10-20 parts of bran-fried bighead atractylodes rhizome, 10-20 parts of fructus amomi, 5-15 parts of elecampane, 5-15 parts of raw liquorice, 20-40 parts of Chinese yam, 20-40 parts of semen coicis, 5-15 parts of wine-processed scutellaria baicalensis, 20-40 parts of radix astragali preparata, 5-15 parts of schisandra chinensis, 10-30 parts of lily, 10-20 parts of moutan bark and 10-20 parts of radix rehmanniae recen.
Further, the pharmaceutical composition is a preparation prepared from the following raw material medicines in parts by weight:
30 parts of codonopsis pilosula, 15 parts of poria cocos, 15 parts of rhizoma pinellinae praeparata, 15 parts of pericarpium citri reticulatae, 15 parts of bran-fried bighead atractylodes rhizome, 15 parts of fructus amomi, 10 parts of elecampane, 10 parts of raw liquorice, 30 parts of Chinese yam, 30 parts of semen coicis, 10 parts of wine-processed scutellaria baicalensis, 30 parts of radix astragali preparata, 10 parts of schisandra chinensis, 20 parts of lily, 15 parts of moutan bark and 15 parts of radix rehmanniae recen.
Furthermore, the radix astragali Preparata is radix astragali Preparata with honey, and the rhizoma Dioscoreae is rhizoma Dioscoreae parched with bran.
Further, the Poria cocos is dried sclerotium of Poria cos (Schw.) Wolf, a fungus of Polyporaceae.
Furthermore, the pharmaceutical composition is a preparation prepared by taking the medicinal powder of the raw material medicines, the water or organic solvent extract of the raw material medicines as active ingredients and adding pharmaceutically acceptable auxiliary materials according to the weight ratio.
Further, the formulation is an oral formulation.
Further, the oral preparation is decoction, oral liquid, granules, capsules, tablets and powder.
The invention also provides a preparation method of the pharmaceutical composition, which comprises the following steps:
(1) weighing the raw materials in a weight ratio;
(2) the raw materials are directly pulverized, or the raw materials are decocted with water or extracted by an organic solvent, the extract is concentrated, and pharmaceutically acceptable auxiliary materials are added to prepare the preparation.
The invention also provides application of the pharmaceutical composition in preparing a medicament for treating the stable stage of the bronchiectasis.
In traditional Chinese medicine, bronchiectasis belongs to the categories of cough and hemoptysis, and the disease is caused by insufficient healthy qi and repeated affection of exogenous pathogenic factors or internal retention of phlegm and dampness due to qi deficiency of spleen and lung and failure of body fluid transportation and application, so that the disease is caused by obstruction of airway. The disease has the pathogenesis characteristics of deficiency and excess of origin and deficiency and excess inclusion, mainly takes deficiency of both lung and spleen as the origin, invasion of exogenous pathogenic factors as the index, repeated attack of disease condition, prolonged difficult healing, gradual loss of vital qi, phlegm dampness generation, qi reversal and blood stasis, so clinical treatment focuses more on strengthening the vital qi and consolidating the foundation in the remission stage, and aims to supplement earth and generate gold, reduce phlegm and expel pus, dissipate blood stasis and cool blood, astringe lung and relieve cough.
In the use formula, the codonopsis pilosula is sweet in nature, enters spleen and lung channels, and can tonify spleen and lung qi; the spleen is the source of phlegm generation, while Poria cocos in the formula treats both principal and secondary aspects by inducing diuresis with bland excretion and removing dampness, and treats both principal and secondary aspects by strengthening spleen and removing dampness and banking up earth and generating gold, and both are monarch drugs. Rhizoma pinelliae preparata eliminates dampness and phlegm and also has the function of relieving cough, dried orange peel promotes qi circulation, eliminates dampness and phlegm, disperses and lowers lung qi, and is used for treating cough caused by damp phlegm together with rhizoma pinelliae, rhizoma atractylodis macrocephalae stir-fried with bran, radix astragali preparata and semen coicis have the functions of tonifying qi and strengthening spleen, eliminating dampness, promoting diuresis and discharging pus, Chinese yam has the functions of tonifying spleen and lung qi and benefiting spleen and lung yin, and the traditional Chinese medicines are used for assisting radix codonopsitis and poria cocos, strengthening earth and promoting generation of gold, eliminating phlegm, promoting diuresis and discharging pus, and are used as ministerial medicines together. Fructus amomi and elecampane have the functions of promoting qi circulation and eliminating dampness, so that the whole formula is tonifying without stagnation; the lung is the body of deficiency-clearing, the nature is good for clearing and moistening, and the lung is cool in nature, so the cold herbs are used for nourishing the lung, so the wine scutellaria baicalensis is used for clearing lung heat and drying dampness, the lily is used for nourishing yin and moistening lung, relieving cough and eliminating phlegm, the rehmannia root is used for clearing heat and cooling blood, stopping bleeding, nourishing yin and promoting the production of body fluid, the schisandra chinensis is used for astringing lung to relieve cough and tonifying qi, and the cortex moutan is used for clearing heat, cooling blood and dissipating blood stasis as adjuvant drugs because lung collaterals injury and qi reversal and blood stasis are all the time in the disease. Licorice root, radix Glycyrrhizae is also used as an adjuvant drug, and has the actions of tonifying qi, regulating the middle warmer, and harmonizing the effects of the other drugs. The medicines are used together to play the effects of reinforcing earth and generating gold, reducing phlegm and expelling pus, dissipating blood stasis and cooling blood, astringing lung and relieving cough, and treat the stable stage of the bronchiectasis.
The pharmaceutical composition provided by the invention has a precise and appropriate formula, can relieve the clinical symptoms and signs of patients in the stable stage of the bronchiectasis, slows down the disease progress, has good safety, no toxic or side effect and convenient use, and provides a new medicine choice for clinically treating the stable stage of the bronchiectasis.
Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.
The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.
Detailed Description
The raw materials and equipment used in the embodiment of the present invention are known products and obtained by purchasing commercially available products.
Example 1 preparation of a pharmaceutical composition of the invention
Prescription: 30g of codonopsis pilosula, 15g of poria cocos, 15g of rhizoma pinellinae praeparata, 15g of dried orange peel, 15g of bran-fried bighead atractylodes rhizome, 15g of fructus amomi, 10g of elecampane, 10g of raw liquorice, 30g of Chinese yam, 30g of semen coicis, 10g of wine-processed scutellaria baicalensis, 30g of radix astragali preparata, 10g of schisandra chinensis, 20g of lily, 15g of moutan bark and 15g of radix rehmanniae recen.
The preparation method comprises the following steps: according to the formula, firstly, codonopsis pilosula, poria cocos, rhizoma pinellinae praeparata, dried orange peel, bran-fried bighead atractylodes rhizome, raw liquorice, Chinese yam, coix seed, wine-processed scutellaria baicalensis, roasted astragalus mongholicus, schisandra chinensis, lily, moutan bark and raw rehmannia root are placed into a casserole, and 2500ml of water is added to soak the materials for 0.5 hour. Boiling with strong fire (strong fire) for 1-1.5 hours, adding fructus Amomi and radix aucklandiae, further boiling with slow fire for 10-15 minutes, pouring the boiled liquid medicine into a clean container, and pouring about 150-200ml of liquid medicine. Adding 1500ml of water into the residue, boiling with strong fire for 0.5 hr, boiling with slow fire (slow fire) to obtain 200ml of residue 150-.
Example 2 preparation of a pharmaceutical composition of the invention
Prescription: 20g of codonopsis pilosula, 10g of poria cocos, 10g of rhizoma pinellinae praeparata, 10g of dried orange peel, 10g of bran-fried bighead atractylodes rhizome, 10g of fructus amomi, 5g of elecampane, 5g of raw liquorice, 20g of Chinese yam, 20g of semen coicis, 5g of wine-processed scutellaria baicalensis, 20g of radix astragali preparata, 5g of schisandra chinensis, 10g of lily, 10g of moutan bark and 10g of radix rehmanniae recen.
The preparation method comprises the following steps: the same as in example 1.
Example 3 preparation of a pharmaceutical composition of the invention
Prescription: 40g of codonopsis pilosula, 20g of poria cocos, 20g of rhizoma pinellinae praeparata, 20g of dried orange peel, 20g of bran-fried bighead atractylodes rhizome, 20g of fructus amomi, 15g of elecampane, 15g of raw liquorice, 40g of Chinese yam, 40g of coix seed, 15g of wine-processed scutellaria baicalensis, 40g of radix astragali preparata, 15g of schisandra chinensis, 30g of lily, 20g of moutan bark and 20g of radix rehmanniae recen.
The preparation method comprises the following steps: the same as in example 1.
The advantageous effects of the present invention are described below by way of test examples.
Test example 1 study on the treatment of the stable phase of bronchiectasis with the pharmaceutical composition of the present invention
1. Case data
Test groups: a total of 12 patients, 9 males and 3 females, with a mean age of 52.2 ± 11.3 years;
control group: a total of 13 patients, 9 males and 4 females, with a mean age of 50.7 ± 12.7 years;
the patients in two groups have no obvious difference in age, disease course, disease condition and the like (P is more than 0.05).
2. Diagnostic criteria
According to the seventh edition of the internal medicine and the clinical diagnosis and treatment guidelines: the diagnosis standard in the respiratory pathology brochure has medical histories of long-term chronic cough with a large amount of purulent sputum, repeated hemoptysis, repeated infection of the lung and the like, auscultation of locally audible, fixed and lasting humdrum noise of the lung is performed by using a stethoscope, and preliminary clinical diagnosis can be performed by combining the existing medical histories of respiratory tract infection and the like which induce bronchiectasis; the bronchiectasis can be clearly diagnosed by combining with the lung CT with the bronchiectasis image. The stable stage of bronchiectasis is stable or almost disappeared symptoms such as cough, phlegm and asthma, and is not in clinical exacerbation at least 6 weeks before study.
3. Method of treatment
(1) The administration method comprises the following steps: in the control group, 13 patients orally took ambroxol hydrochloride tablets (Musultan) (Shanghai Boringer Yiger pharmaceutical Co., Ltd.) 60mg at a time and 3 times a day after meals. In a test group, 12 patients take the medicine prepared in the example 1 orally, 100-150 ml/time and 3 times/day. The treatment course is 3 months.
4. Determination of therapeutic effect
The clinical efficacy judgment standard is as follows: the clinical curative effect is judged according to the guiding principle of clinical research of new traditional Chinese medicines. And (3) clinical control: the main clinical symptoms are improved, and the sign integral rate of the clinical symptoms is more than 80 percent; the effect is shown: the integral of the clinical symptom sign is lower than that of clinical control, and the integral rate of the clinical symptom sign is 51-80%; the method has the following advantages: the clinical symptom sign integral rate is 20-50%; and (4) invalidation: the clinical symptoms and signs are not obviously improved or aggravated, and the integral rate of the clinical symptoms and signs is less than 20 percent.
5. Statistical method
By adopting SPSS19.0 statistical analysis software, the difference is statistically significant when P is less than 0.05.
6. Therapeutic effects
The clinical effects of the two groups were compared and are shown in Table 1. The total effective rate is the sum of clinical control rate, obvious effective rate and effective rate.
Table 1: two groups of clinical efficacy comparison [ n (%) ]
| Group of | Number of examples | Clinical control | Show effect | Is effective | Invalidation | Total effective rate |
| Control group | 13 | 2(15) | 4(31) | 3(23) | 4(31) | 69 |
| Test group | 12 | 3(25) | 4(33) | 3(25) | 2(17) | 83 |
As shown in Table 1, the total effective rates of the control group and the test group are 69% and 83%, respectively, and the comparison difference between the groups has statistical significance (P is less than 0.05). The test results show that: after the pharmaceutical composition is taken, the clinical symptom sign of a patient in the stable stage of the bronchiectasis is obviously improved, and the pharmaceutical composition has obvious curative effect on the stable stage of the bronchiectasis.
7. Adverse reaction
The test group of the composition has no serious adverse reaction.
In conclusion, the pharmaceutical composition provided by the invention has a precise and appropriate formula, can relieve the clinical symptoms and signs of patients in the stable stage of the bronchiectasis, slows down the disease progress, has good safety, no toxic or side effect and convenient use, and provides a new medicine selection for clinically treating the stable stage of the bronchiectasis.
Claims (8)
1. A pharmaceutical composition for reinforcing earth to generate gold, reducing phlegm and expelling pus, removing blood stasis and cooling blood, astringing lung and relieving cough and treating stable stage of bronchiectasis is characterized in that: the preparation is prepared from the following raw material medicines in parts by weight:
30 parts of codonopsis pilosula, 15 parts of poria cocos, 15 parts of rhizoma pinellinae praeparata, 15 parts of pericarpium citri reticulatae, 15 parts of bran-fried bighead atractylodes rhizome, 15 parts of fructus amomi, 10 parts of elecampane, 10 parts of raw liquorice, 30 parts of Chinese yam, 30 parts of semen coicis, 10 parts of wine-processed scutellaria baicalensis, 30 parts of radix astragali preparata, 10 parts of schisandra chinensis, 20 parts of lily, 15 parts of moutan bark and 15 parts of radix rehmanniae recen.
2. The pharmaceutical composition of claim 1, wherein: the radix astragali Preparata is honey-fried radix astragali, and the rhizoma Dioscoreae is bran-fried rhizoma Dioscoreae.
3. The pharmaceutical composition of claim 1, wherein: the Poria is dried sclerotium of Wolf of Poria cocos (Schw.) belonging to Polyporaceae.
4. The pharmaceutical composition according to any one of claims 1 to 3, wherein: the preparation is prepared by taking medicinal powder of raw material medicines, water or organic solvent extract of the raw material medicines as active ingredients and adding pharmaceutically acceptable auxiliary materials.
5. The pharmaceutical composition of claim 4, wherein: the preparation is an oral preparation.
6. The pharmaceutical composition of claim 5, wherein: the oral preparation is decoction, oral liquid, granule, capsule, tablet, or powder.
7. A method of preparing a pharmaceutical composition according to any one of claims 1 to 6, wherein: it comprises the following steps:
(1) weighing the raw materials in a weight ratio;
(2) the raw materials are directly pulverized, or the raw materials are decocted with water or extracted by an organic solvent, the extract is concentrated, and pharmaceutically acceptable auxiliary materials are added to prepare the preparation.
8. Use of a pharmaceutical composition according to any one of claims 1 to 6 in the manufacture of a medicament for the treatment of the stable phase of bronchiectasis.
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Non-Patent Citations (2)
| Title |
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| 治疗支气管扩张咯血验方;牛银平等;《中医药学刊》;19990831;第18卷(第4期);第28页，尤其是第28页右栏倒数两段 * |
| 香砂六君丸临床应用解析;本刊编辑部;《中国社区医师》;20100319;第26卷(第11期);第14页，尤其是第14页最左栏第1段和最右栏第2段 * |
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