WO2020135475A1 - 一种治疗呼吸系统疾病的中药组合物及其制备方法和应用 - Google Patents

一种治疗呼吸系统疾病的中药组合物及其制备方法和应用 Download PDF

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WO2020135475A1
WO2020135475A1 PCT/CN2019/128179 CN2019128179W WO2020135475A1 WO 2020135475 A1 WO2020135475 A1 WO 2020135475A1 CN 2019128179 W CN2019128179 W CN 2019128179W WO 2020135475 A1 WO2020135475 A1 WO 2020135475A1
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chinese medicine
medicine composition
traditional chinese
treatment
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陈刚
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北京梅林科技有限公司
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/90—Smilacaceae (Catbrier family), e.g. greenbrier or sarsaparilla
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232—Angelica
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/236—Ligusticum (licorice-root)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/26—Aristolochiaceae (Birthwort family), e.g. heartleaf
    • A61K36/268—Asarum (wild ginger)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/56—Loganiaceae (Logania family), e.g. trumpetflower or pinkroot
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/714—Aconitum (monkshood)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/716—Clematis (leather flower)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/80—Scrophulariaceae (Figwort family)
    • A61K36/804—Rehmannia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
    • A61K36/8884—Arisaema, e.g. Jack in the pulpit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/14—Antitussive agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/10—Antioedematous agents; Diuretics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH

Definitions

  • the present application belongs to the field of traditional Chinese medicine preparations, and specifically relates to a traditional Chinese medicine composition for treating respiratory diseases and a preparation method thereof.
  • Respiratory disease is a common and frequently-occurring disease.
  • the main lesions are trachea, bronchus, lungs and chest cavity.
  • cough, chest pain, and affected breathing are more frequent.
  • dyspnea, hypoxia, and death caused by respiratory failure Furthermore, due to air pollution, smoking, aging population and other factors, the incidence and mortality of chronic obstructive pulmonary disease (COPD), asthma, bronchitis, hydrothorax and other diseases at home and abroad have increased.
  • COPD chronic obstructive pulmonary disease
  • asthma is a heterogeneous disease, which is more common in children or youth. It is often accompanied by allergic diseases such as allergic rhinitis and urticaria and family history.
  • the clinical manifestation is paroxysmal wheezing, which is a chronic cough, Sputum, shortness of breath, and dyspnea are the main symptoms. It is a common disease characterized by incomplete airway reversible airflow limitation.
  • Common asthma symptoms are the syndrome of drinking cold outside, drinking phlegm and blocking lung, and phlegm-heat syndrome. , Wind phlegm blocking lung syndrome and so on.
  • Chronic bronchitis is a chronic non-specific inflammation of the trachea, bronchi and surrounding tissues caused by infection or non-infection. It is clinically characterized by a chronic course of cough, expectoration, or wheezing and repeated attacks. It is a hazard to human health. The larger respiratory system is common and frequent. Common symptoms of chronic bronchitis in traditional Chinese medicine are phlegm-heat accumulation lung syndrome, phlegm obstruction lung syndrome, spleen-pulmonary deficiency syndrome, Fei Shen Qi deficiency syndrome, lung and kidney Yang deficiency syndrome, wind and cold attack lung syndrome, etc. It is long and prone to repeated attacks. It is often accompanied by obstructive emphysema, pulmonary hypertension, and pulmonary heart disease. If it is associated with irreversible airway obstruction, it is chronic obstructive pulmonary disease (COPD).
  • COPD chronic obstructive pulmonary disease
  • Chronic obstructive pulmonary disease is a respiratory disease characterized by incompletely reversible airflow limitation. It has the characteristics of slow progression, repeated attacks, and progressive exacerbation.
  • the common symptoms of chronic bronchitis in traditional Chinese medicine are Phlegm turbid obstruction lung syndrome, phlegm-heat syndrome lung syndrome, phlegm stasis lung syndrome, spleen deficiency lung heat syndrome, etc., the syndrome is mostly phlegm, heat, deficiency and qi deficiency, the disease is mostly in the lung, kidney, spleen .
  • sputum is a pathological product caused by dysfunction of human organs and metabolic disorders of water.
  • the production of sputum is mostly related to lung, spleen, and kidney. If it is said that "the spleen is the source of phlegm”, phlegm stagnation in the throat will cause itching, causing coughing.
  • Phlegm obstruction airway (trachea, bronchus, etc.) will also affect the expulsion of lung gas, resulting in cough, asthma, chest tightness, etc.
  • phlegm obstruction is a Chinese medicine factor that causes and aggravates the lung syndrome, and is also The key to the treatment of respiratory diseases is that the respiratory diseases of patients in the exacerbation stage are often accompanied by phlegm obstruction lung syndrome.
  • the treatment of respiratory diseases with symptoms of phlegm obstruction lung syndrome is also more difficult, but the current Chinese medicines for phlegm obstruction
  • the treatment effect of respiratory diseases of obstructive lung syndrome is not ideal.
  • Chinese patent CN1048160C discloses a method for producing asthma medicine.
  • the combined medicines include seaweed, coriander, twig, red peony, ephedra, baibei, and Tiannanxing.
  • auxiliary materials to suppress Formed into tablets, it is also used to treat a variety of respiratory diseases, namely asthma, bronchitis, tuberculosis, correct asthma, bronchitis, cold and heat mixed asthma can calm the cold and heat, relieve the symptoms of phlegm, relieve cough, relieve lungs Panting.
  • the effect of asthma in patients with exacerbation of phlegm and obstructive lung syndrome is not ideal.
  • the combined medicine for treating COPD disclosed in Chinese Patent CN102188689A is composed of fourteen traditional Chinese medicines such as Codonopsis, Rhubarb, Radix Scutellaria, Stir-fried Turquoise, Stir-fried Atractylodes, etc. It is soaked, decoction, and then filtered to obtain the filtrate, and the liquid is extracted with ethanol Formulations or supplementary materials are used to prepare tablets, pills or capsules. This combination is mainly used to treat COPD in patients with spleen deficiency and lung heat syndrome, but it is also unsatisfactory for COPD patients with exacerbated phlegm.
  • the purpose of the present application is to provide a traditional Chinese medicine composition for treating respiratory diseases, its preparation method and application, which can effectively treat respiratory diseases, and is especially suitable for respiratory diseases with symptoms of phlegm and obstructive lung syndrome.
  • the present application provides a traditional Chinese medicine composition for treating respiratory diseases, which includes the following parts by weight of raw material medicines: 10-30 parts of Chuanwu, 5-15 parts of Maqianzi, 2-10 parts of Shengdi, Nanxing 2-10 servings, Chuanxiong 2-10 servings, Clematis 1-5 servings, Duhuo 1-5 servings, Poria cocos 1-5 servings, Angelica 1-5 servings, Asarum 1-5 servings, and borneol 0.5-1 Copies.
  • API Including the following parts by weight of API: 30 parts of Chuanwu, 15 parts of Macaroni, 10 parts of Nanxing, 10 parts of Shengdi, 10 parts of Chuanxiong, 5 parts of clematis, 5 parts of Duhuo, 5 parts of Poria cocos, 5 parts of angelica, 5 parts of Asarum and 1 part of Borneol.
  • the traditional Chinese medicine composition is added with conventional auxiliary materials according to a conventional process to make a clinically acceptable external preparation.
  • the present application provides an external preparation prepared by using the above-mentioned traditional Chinese medicine composition and adding conventional auxiliary materials according to a conventional process.
  • the external preparations include sprays, liniments, ointments, tinctures, wet compresses, pastes, lotions, or plasters.
  • the present application provides a method for preparing the above-mentioned traditional Chinese medicine composition for treating respiratory diseases.
  • the method includes the following steps:
  • the present application provides another method for preparing the above-mentioned traditional Chinese medicine composition for treating respiratory diseases.
  • the method includes the following steps:
  • the method includes the following steps:
  • step (c) the permeating liquid of the above-mentioned traditional Chinese medicine composition is taken, finely filtered using an ultrafiltration membrane, the permeated liquid is collected, a carrier made of a non-woven fabric is immersed in the fine filtrate, and sealed and packaged in pieces to obtain a wet compress.
  • the present application provides an application of the above-mentioned traditional Chinese medicine composition in the preparation of the traditional Chinese medicine composition in the preparation of medicine for treating chronic obstructive pulmonary disease, chronic bronchitis, asthma, and pleural effusion.
  • the present invention also provides a method for treating chronic obstructive pulmonary disease, chronic bronchitis, asthma, and pleural effusion, characterized in that the method comprises administering the traditional Chinese medicine composition and/or the compound to a subject in need The traditional Chinese medicine composition prepared by the method.
  • the treatment symptom belongs to chronic obstructive pulmonary disease, chronic bronchitis, asthma, and pleural effusion, especially the treatment symptom belongs to cold phlegm obstruction lung syndrome.
  • the traditional Chinese medicine composition for the treatment of respiratory diseases described in this application can be selected from Chuanwu, Nanxing, Duhuo, Clematis, Poria, Asarum, or sexual temperature, or hot sex, or both.
  • one cold and many temperatures, both cold and warm, but mainly Xinxin so it has the effect of dispelling wind and dispelling cold, dissipating phlegm and relieving lungs; at the same time, it is accompanied by Xinwen Zhichuanxiong to exercise Qi and blood, and smooth the whole body Qi machine At the same time, it can also relieve wind and pain; in addition, it has the effects of clearing heat and cooling blood, nourishing yin and replenishing cold.
  • the total effective rate in 6 courses is 95.31%, 95%, and 98.57%, and in 4-8 courses.
  • the total effective rate of pleural effusion is 95%, and the total effective rate of chronic obstructive pulmonary disease, chronic bronchitis and asthma is 100%, especially for cold phlegm and obstructive lung syndrome. .
  • Preparation method (a) According to the selected weight parts, Chuanwu, Chuanzizi, Habitat, Nanxing, Chuanxiong, Clematis, Duhuo, Poria, Angelica and Asarum are crushed and mixed or mixed Crush to get medicine powder;
  • the Chinese medicine composition is applied to the skin of the patient, or used together with the "transdermal drug delivery instrument” disclosed in the utility model patent publication CN1303717A, and the Chinese medicine composition is placed in the "transdermal drug delivery instrument" In the pad, apply the applicator to the patient's skin, turn on the heating element, and act for more than 20 minutes at a time.
  • Shengchuanwu 30g Shengmaqinzi, Shengnanxing 10g, Shengdi 10g, Chuanxiong 10g, Clematis 5g, Duhuo 5g, Poria cocos 5g, Angelica 5g, Asarum 5g and Borneol 1g.
  • Preparation method (a) According to the selected parts by weight, take the raw Chuanwu, Shengmaqianzi, Shengdi, Shengnanxing, Chuanxiong, Clematis, Duhuo, Poria, Angelica and Asarum, crushed and mixed or mixed Crush to get medicine powder;
  • the Chinese medicine composition is applied to the skin of the patient, or used together with the "transdermal drug delivery instrument” disclosed in the utility model patent publication CN1303717A, and the Chinese medicine composition is placed in the "transdermal drug delivery instrument" In the pad, apply the applicator to the patient's skin, turn on the heating element, and act for more than 20 minutes at a time.
  • Preparation method (a) According to the selected parts by weight, Chuanwu, Chuanzizi, Habitat, Nanxing, Chuanxiong, Clematis, Duhuo, Poria, Angelica, Asarum and Borneol are crushed and mixed separately. Get medicine powder
  • Preparation method (a) According to the selected parts by weight, take Chuanwu, Chuanzizi, Habitat, Nanxing, Chuanxiong, Clematis, Duhuo, Poria, Angelica and Asarum, decoction with water twice. Add 12 times the weight of the drug at a time, decoction for 1.5 hours, add 10 times the amount of water for the second time, decoction for 1 hour, filter, combine the filtrates, let stand overnight, take the supernatant and concentrate to 60°C relative density is 1.20 extract;
  • Shengchuanwu 10g Shengmaqinzi, Shengnanxing 2g, Shengdi 10g, Chuanxiong 10g, Clematis 3g, Duhuo 3g, Poria cocos 5g, Angelica 3g, Asarum 1g and Borneol 0.5g.
  • Preparation method (a) According to the selected parts by weight, take the raw Chuanwu, Shengmaqianzi, Shengdi, Shengnanxing, Chuanxiong, Clematis, Duhuo, Poria, Angelica and Asarum, crushed and mixed or mixed Crush to get medicine powder;
  • Preparation method (a) According to the selected parts by weight, Chuanwu, Shengma Qianzi, Habitat, Shengnanxing, Chuanxiong, Clematis, Duhuo, Poria, Angelica and Asarum, decoction twice with water, the first Add 12 times the weight of the drug at a time and cook for 1.5 hours, and add 10 times the amount of water for the second time, cook for 1 hour, filter, and combine the filtrate;
  • Shengchuanwu 30g Shengmaqinzi 12g, Shengnanxing 10g, Shengdi 8g, Chuanxiong 8g, Clematis 5g, Duhuo 5g, Poria cocos 4g, Angelica 5g, Asarum 3.5g and Borneol 0.5g.
  • Preparation method (a) According to the selected parts by weight, take the raw Chuanwu, Shengmaqianzi, Shengdi, Shengnanxing, Chuanxiong, Clematis, Duhuo, Poria, Angelica and Asarum, crushed and mixed or mixed Crush to get medicine powder;
  • Shengchuanwu 30g Shengmaqinzi 5g, Shengnanxing 10g, Shengdi 2g, Chuanxiong 10g, Clematis 1g, Duhuo 5g, Poria cocos 1g, Angelica 5g, Asarum 1g and Borneol 1g.
  • Preparation method (a) According to the selected parts by weight, take the raw Chuanwu, Shengmaqianzi, Shengdi, Shengnanxing, Chuanxiong, Clematis, Duhuo, Poria, Angelica and Asarum, crushed and mixed or mixed Crush to get medicine powder;
  • Shengchuanwu 10g Shengmaqinzi, Shengnanxing 2g, Shengdi 10g, Chuanxiong 2g, Clematis 5g, Duhuo 1g, Poria cocos 5g, Angelica 1g, Asarum 5g and Borneol 0.5g.
  • Preparation method (a) Mix the raw powder of each raw material uniformly to obtain powder;
  • Test drug the wet compress prepared in Example 1.
  • Excipient does not include the traditional Chinese medicine composition of the present application, but only contains the formulation auxiliary material of Example 1.
  • mice Forty ICR mice were taken. Male and female half, body weight 18-22g, randomly divided into 4 groups, 10 in each group, namely the excipient group, the test drug high (1.2g/kg), medium (0.6g/kg), low (0.3g /kg) dose group. Hair removal was performed on the back of the mouse, with an area of 2 ⁇ 2 cm. The drug was applied to the hair removal site and fixed with gauze wrapped with breathable tape. According to the above-mentioned administration dosage, the administration area of different dosages is different, and the administration is once a day for 5 consecutive days. One hour after the last administration, the mice were placed one by one into the YLS-8A multifunctional cough and asthma inducer.
  • the tested drugs 0.3, 0.6, 1.2g/kg are equivalent to 0.5, 1, 2 times of the clinical equivalent equivalent dose.
  • the external smear administration can significantly prolong the incubation period of mice caused by concentrated ammonia and reduce cough caused by concentrated ammonia Times. It is suggested that the drug is administered externally and has obvious antitussive effect.
  • Test drug the wet compress prepared in Example 2.
  • Excipient does not contain the traditional Chinese medicine composition of the present application, but only contains the preparation auxiliary material of Example 2.
  • mice weighing 18-22g were randomly divided into 4 groups, namely the excipient group, the test drug high-dose group (1.2g/kg,), the medium-dose group (0.6g/kg), and the low-dose group (0.3 g/kg), 10 animals per group. Hair removal was performed on the back of the mouse, with an area of 2 ⁇ 2 cm. The drug was applied to the hair removal site and fixed with gauze wrapped with breathable tape. According to the above-mentioned administration dosage, the administration area of different dosages is different, and the administration is once a day for 7 consecutive days. One hour after the last administration, xylene was applied to the right ear of each group of mice, 40 ⁇ l each, without any treatment on the left ear.
  • Clinical data Clinical observations were made on 64 patients with chronic obstructive pulmonary disease, including 20 cases of phlegm obstructive lung syndrome in chronic obstructive lung and 44 other symptoms.
  • Method of administration Take the wet compress prepared in Example 1 with a transdermal drug delivery device, and apply 1 patch at a time to each action site at the Dazhui, Feixu and adjacent parts (equivalent to 2.5g of raw medicinal materials) , A course of treatment every 12 days, 2 times a day.
  • the above-mentioned 64 patients were treated with the Chinese medicine composition prepared in Example 1 of this application by the transdermal drug delivery device.
  • the treatment results of the 64 patients with COPD were observed.
  • the total number of 64 patients The efficiency is 84.38%, of which the total efficiency of COPD is 96.9%, and the total effective rate of 64 patients in 6 courses of treatment is 95.31%.
  • the total effective rate is 100%.
  • Toxic and side effects during the treatment, the patient's skin will not have the side effects of rash and ulceration. After the treatment, the hematuria routine, stool, heart, liver and kidney functions have not been found to be abnormal. Three months after discontinuation of the drug, the above cases were revisited, and there were no relapsed patients.
  • the traditional Chinese medicine composition described in this application has a significant therapeutic effect in the treatment of respiratory diseases, etc.
  • the total effective rate within a course of treatment can reach 84.38%, short-term administration can relieve symptoms in time, and the cure rate within 6 courses It can be up to 95.31%.
  • the long-term medication cure rate is high, especially the chronic obstructive pulmonary disease cure rate of phlegm obstruction lung syndrome can reach 100%, short treatment course, fast effect, low recurrence rate, and no toxic side effects.
  • Clinical data Clinical observations were made on 40 patients with asthma, including 10 cases of phlegm obstructing lung syndrome and 30 cases of other symptoms.
  • the wet compress prepared in Example 2 is used in combination with a transdermal drug delivery device.
  • the drug acts on Dazhui, Fengmen, and bilateral Feishu points.
  • Each action site is administered with 1 patch (equivalent to 2.5g Raw medicinal herbs), a course of treatment every 12 days, 2 times a day.
  • Example 2 of this application Use the Chinese medicine composition prepared in Example 2 of this application to administer the above-mentioned 40 patients with a transdermal drug delivery device. Observe the treatment results. Within 3 courses, the total effective rate of 40 patients was 90%, of which phlegm obstruction The total effective rate of asthma in lung syndrome is 100%. In 6 courses, the total effective rate of 40 patients is 95%. Among them, the total effective rate of asthma with syndrome of phlegm obstruction is 100%.
  • Toxic and side effects during the treatment, the patient's skin will not have the side effects of rash and ulceration. After the treatment, the hematuria routine, stool, heart, liver and kidney functions have not been found to be abnormal. Three months after discontinuation of the drug, the above cases were revisited, and there were no relapsed patients.
  • the traditional Chinese medicine composition described in this application has a significant therapeutic effect in the treatment of asthma.
  • the total effective rate can reach 90%.
  • Short-term administration can relieve symptoms in time, and the cure rate can reach up to 6 courses 95%, the long-term medication cure rate is high, especially the asthma cure rate of phlegm obstruction lung syndrome can reach 100%, short treatment course, quick effect, low recurrence rate, and no toxic side effects.
  • Diagnostic criteria refer to "Practical Internal Medicine” to formulate diagnostic criteria: patients with long-term cough, sputum, and asthma, lasting more than 2 years, lasting more than 3 months per year; long-term repeated attacks and remissions alternate; lungs can smell dry, Wet rales; Chest radiographs have chronic bronchitis symptoms.
  • the diagnostic criteria of TCM refer to "Internal Medicine of Traditional Chinese Medicine” (New Century National College of Traditional Chinese Medicine).
  • the "phlegm and obstructive lung syndrome” in asthma syndrome cough, white sticky Phlegm, phlegm in Houzhong, chest tightness such as suffocation, difficulty breathing, even open mouth and raise shoulders, can not lie down, pale tongue, greasy tongue coating, slippery pulse string.
  • Clinical cure basic control of cough, expectoration, wheezing and other main symptoms, stable condition for more than 1 year without recurrence; significant effect: cough, cough The main symptoms of phlegm, wheezing, etc. were obviously stabilized, and the number and degree of attacks were significantly reduced; effective: the main symptoms of cough, sputum, wheezing, etc.
  • cure rate number of cured cases / total number of cases
  • marked efficiency marked number of effective cases / total number of cases
  • effective effective number of cases / total number of cases
  • Total effective rate cure rate + apparent efficiency + effective rate.
  • the wet compress prepared in Example 4 is used in combination with a transdermal drug delivery device.
  • the drug acts on Dazhui, Shuangfeixian, and the lower part of Shuangfeixue.
  • Each action site is administered 1 patch at a time (equivalent to 2.5g Raw medicinal herbs), a course of treatment every 12 days, 2 times a day.
  • the above-mentioned 70 patients were treated with the Chinese medicine composition prepared in Example 4 of the present application by the transdermal drug delivery device.
  • the observation results showed that within 3 courses, the cure rate + significant efficiency was 80% and the effective rate was 10%.
  • the significant efficiency of chronic bronchitis with obstructive pulmonary syndrome is 90% and the effective rate is 5.7%; the total effective rate is 68.57% in 6 courses, and the total effective rate of chronic bronchitis with phlegm and obstructive lung syndrome is 100% .
  • Toxic and side effects during the treatment, the patient's skin will not have the side effects of rash and ulceration. After the treatment, the hematuria routine, stool, heart, liver and kidney functions have not been found to be abnormal. Three months after discontinuation of the drug, the above cases were revisited, and there were no relapsed patients.
  • the traditional Chinese medicine composition described in this application has a significant therapeutic effect in the treatment of chronic bronchitis.
  • the marked effect can reach 80% in 3 courses, short-term administration can relieve symptoms in time, and the total effective rate in 6 courses can reach 98.57%.
  • the long-term medication has a high effective rate, especially the total effective rate of chronic bronchitis with phlegm and obstructive lung syndrome, which has a short course of treatment, quick results, low recurrence rate, and no toxic and side effects.
  • Clinical data 20 patients with malignant lung cancer pleural effusion were clinically observed, confirmed by B-ultrasound or CT examination, and confirmed by histopathological and/or cytological diagnosis.
  • Chest X-ray examination can show high-density shadows of rib diaphragm angle dull, high outside and low inside; Ultrasound examination shows dark liquid areas of pleural cavity, CT examination shows crescent-shaped density shadows of the lower back of the thoracic cavity running along the inner edge of the rib cage . Ultrasound examination and CT examination can confirm the diagnosis. Thoracic puncture withdrawn fluid, pleural effusion examination routine, biochemical, immunology and cytology. It can be clearly as exudate or leakage, which is helpful for the diagnosis of the cause.
  • Method of administration Take the patch prepared in Example 7 and apply it to Dazhui, Shuangfeixian, and lower part of Shuangfeixue, 1 patch per day (equivalent to 2g of raw medicinal materials) per day, a course of treatment every 12 days, 2 per day Times.
  • the above-mentioned 20 patients were treated with the Chinese medicine composition prepared in Example 7 of the present application by the transdermal drug delivery device.
  • the observation results showed that in 4-8 courses, 16 cases were cured + markedly effective cases, and 3 cases were effective cases.
  • the invalid case was 1 case, the cure rate + significant efficiency was 80%, the effective rate was 15%, and the total effective rate was 95%.
  • Toxic and side effects during the treatment, the patient's skin will not have the side effects of rash and ulceration. After the treatment, the hematuria routine, stool, heart, liver and kidney functions have not been found to be abnormal. Three months after discontinuation of the drug, the above cases were revisited, and there were no relapsed patients.
  • the traditional Chinese medicine composition described in this application has a significant therapeutic effect in the treatment of pleural effusion, and the total effective rate can reach 95% in 4-8 treatment courses, with good curative effect, short treatment course, fast effect, low recurrence rate, and non-toxic side effect.
  • Diagnosis of traditional Chinese medicine cough, deficiency of lung and kidney qi.
  • the drug acts on the Dazhui, Shuangfeixi, and Dazhui points, and one patch (equivalent to 2.5 g of raw medicinal materials) is administered at once for each action site.
  • Example 2 The oral anti-inflammatory and antiasthmatic drugs did not work well. . Laboratory examination: Allergen allergen skin prick test report conclusion: pollen allergy, dust mite allergy, fur allergy. Western medicine diagnosis: Asthmatic bronchitis, Chinese medicine diagnosis: Kidney deficiency pneumonia cough (wind-heat type).
  • the wet compress prepared in Example 2 was used in combination with a transdermal drug delivery device. The drugs acted on Dazhui, Fengmen, and Bifeifeishu. Each treatment had 4 sites, and each site was given 1 patch at a time (equivalent to 2.5 g raw medicinal herbs), once a day, 12 times as a course of treatment, rest for 2-3 days after 12 times of treatment, continue the next course of treatment. The symptoms of wheezing were alleviated on the day of treatment, and the child continued coughing without wheezing the next day. After the third treatment, the child's symptoms disappeared.
  • Example 4 Laboratory examination: X-ray, chest radiograph showing thickening of both lungs.
  • Example 4 Use the wet compress as described in Example 4 in combination with a transdermal drug delivery device.
  • the drug acts on bilateral Feishu points.
  • Each action site is administered 1 patch at a time (equivalent to 2.5g of raw medicinal materials).
  • Contact dermatitis occurred during the treatment, which is considered to be allergy to drug contact. After 3 weeks of treatment, there was occasional cough and no sputum. After 4 weeks of treatment, he recovered.

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Abstract

一种治疗呼吸系统疾病的中药组合物，包括如下重量份的原料药：川乌10‑30份、马钱子5‑15份、生地2‑10份、南星2‑10份、川芎2‑10份、威灵仙1‑5份、独活1‑5份、土茯苓1‑5份、当归1‑5份、细辛1‑5份和冰片0.5‑1份，该中药组合物在治疗慢阻肺、慢性支气管炎、哮喘、胸腔积水等方面具有显著的治疗效果，见效快，费用低，无不良反应，使用方便。

Description

一种治疗呼吸系统疾病的中药组合物及其制备方法和应用
交叉引用
本申请要求在2018年12月25日提交中国专利局、申请号为201811591459.8、名称为“一种治疗呼吸系统疾病的中药组合物及其制备方法和应用”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请属于中药制剂领域，具体涉及一种治疗呼吸系统疾病的中药组合物及其制备方法。
背景技术
呼吸系统疾病是一种常见病、多发病，主要病变在气管、支气管、肺部及胸腔，病变轻者多咳嗽、胸痛、呼吸受影响，重者呼吸困难、缺氧，设置呼吸衰竭而致死，更因空气污染、吸烟、人口老龄化及其他因素，使国内外的慢性阻塞性肺病(COPD)、哮喘、支气管炎、胸腔积水等疾病的发病率、死亡率有增无减。
其中，哮喘是一种异质性疾病，多见于儿童或青年时期发病，常伴有过敏性鼻炎、荨麻疹等过敏性疾病以及家族史，临床表现为发作性喘息，是一种以慢性咳嗽、咳痰、气短和呼吸困难为主要症状，以气道不完全可逆性气流受限为特征的常见性疾病，常见的哮喘症候为外寒内饮证、痰浊阻肺证、痰热壅肺证、风痰阻肺证等。
慢性支气管炎是由于感染或者非感染引起的气管、支气管及其周围组织的慢性非特异性炎症，临床以咳嗽、咯痰或伴有喘息及反复发作的慢性病程为特征，是一种对人类健康危害较大的呼吸系统常见病、多发病。常见的慢性支气管炎中医症候为痰热蕴肺证、痰浊阻肺证、脾肺两虚证、费肾气虚证、肺肾阳虚证、风寒袭肺证等，由于慢性支气管炎的病程较长，易反复发作，常伴有阻塞性肺气肿、肺动脉高压、肺源性心脏病等，如合并不可逆性气道 阻塞，则呈慢性阻塞性肺疾病(COPD)。
慢性阻塞性肺疾病，简称慢阻肺，是一种以不完全可逆性气流受限为特征的呼吸系统疾病，具有缓慢进展，反复发作，进行性加重的特点，常见的慢性支气管炎中医症候为痰浊阻肺证、痰热壅肺证、痰瘀痹肺证、脾虚肺热证等，证素病性属实多为痰、热、虚性多为气虚，病位多在肺、肾、脾。
呼吸系统疾病最常见的症状为“咳、痰、喘”，中医理论认为痰是由于人体脏腑功能失常，水液代谢障碍而形成的病理产物，痰的产生多与肺、脾、肾有关。如有“脾为生痰之源”之说，痰浊滞于咽喉则局部发痒，引发咳嗽不止。痰阻气道(气管、支气管等)更会影响肺气的宣通肃降，而导致咳嗽、气喘、胸闷等症，所以说痰浊阻肺是肺系各证产生并加重的中药因素，也是治疗呼吸系统疾病的关键所在，通常加重期患者的呼吸系统疾病多伴有痰浊阻肺证，症候为痰浊阻肺证的呼吸系统疾病的治疗难度也较大，但是目前的中药对于痰浊阻肺证的呼吸系统疾病的治疗效果并不理想。
中国专利CN1048160C所公开的治疗哮喘药物生产方法，组合药物包括海藻、芫花、桂枝、赤芍、麻黄、百部、天南星等共十六位药物，煎煮得药液后，加入辅料，压制成片，同时用于治疗多种呼吸系统疾病，即治哮喘、支气管炎、肺结核，对正虚邪实、寒热错杂的哮喘病症能使寒热平调、解表蠲饮、祛痰止咳、宣肺平喘。而对于加重期患者痰浊阻肺证哮喘的效果并不理想。中国专利CN102188689A所公开的治疗慢阻肺的组合药物，由党参、制大黄、黄芩、炒青礞石、炒白术等十四味中药组成，浸泡、煎煮，然后过滤得到滤液，乙醇提取得到液体制剂或者添加辅料制得片剂、丸剂或者胶囊剂，该种组合药物主要治疗脾虚肺热证的慢阻肺，而对于加重期患者痰浊阻肺证的慢阻肺效果也不理想。
发明内容
为此，本申请的目的在于提供一种治疗呼吸系统疾病的中药组合物及其制备方法和应用，能够有效地治疗呼吸系统疾病，尤其适用于症候为痰浊阻肺证的呼吸系统疾病。
为解决上述技术问题，本申请提供了一种治疗呼吸系统疾病的中药组合物，包括如下重量份的原料药：川乌10-30份、马钱子5-15份、生地2-10份、南星2-10份、川芎2-10份、威灵仙1-5份、独活1-5份、土茯苓1-5份、当归1-5份、细辛1-5份和冰片0.5-1份。
包括如下重量份的原料药：川乌30份、马钱子15份、南星10份、生地10份、川芎10份、威灵仙5份、独活5份、土茯苓5份、当归5份、细辛5份和冰片1份。
所述中药组合物按照常规工艺加入常规辅料制成临床上可接受的外用制剂。
本申请提供了一种采用上述的中药组合物加入常规辅料按照常规工艺制备得到的外用制剂。
所述外用制剂包括喷剂、搽剂、软膏剂、酊剂、湿敷剂、糊剂、洗剂或贴膏剂。
本申请提供了一种制备上述的治疗呼吸系统疾病的中药组合物的方法，该方法包括如下步骤：
(a)按照选定的重量份数取川乌、马钱子、生地、南星、川芎、威灵仙、独活、土茯苓、当归和细辛，分别粉碎后混合或混合后粉碎，得到药粉，备用；
(b)取上述药粉，然后加入常规辅料、冰片按照常规工艺制成临床上可接受的喷剂、搽剂、软膏剂、酊剂、湿敷剂、糊剂、洗剂或贴膏剂。
本申请提供了另一种制备上述的治疗呼吸系统疾病的中药组合物的方法，该方法包括如下步骤：
(a)按照选定的重量份数取川乌、马钱子、生地、南星、川芎、威灵仙、独活、土茯苓、当归和细辛，分别粉碎后混合或混合后粉碎，备用；
(b)取上述药粉，加入适量的50-95vt％乙醇浸泡，然后以50％-95vt％乙醇为溶剂渗漉，收集渗漉液，将冰片加入适量50-95vt％乙醇完全溶解，加入至 上述渗漉液中，混合均匀，得到中药组合物渗漉液；
(c)取上述中药组合物渗漉液，加入常规辅料按照常规工艺制成临床上可接受的喷剂、搽剂、膏剂、酊剂、湿敷剂、糊剂、洗剂或贴剂。
该方法包括如下步骤：
步骤(c)中，取上述中药组合物渗漉液，使用超滤膜精滤，收集透过液，将无纺布制成载体浸入到精滤液中，分片密封包装，得湿敷剂。
本申请提供了一种上述中药组合物在制备的中药组合物在制备治疗慢阻肺、慢性支气管炎、哮喘、胸腔积水的药物中的应用。
所述的中药组合物在制备治疗症候属于痰浊阻肺证的慢阻肺、慢性支气管炎、哮喘、胸腔积水的药物中的应用，尤其是在制备治疗症候属于寒痰浊阻肺证的应用。
本发明还提供了一种治疗慢阻肺、慢性支气管炎、哮喘、胸腔积水的方法，其特征在于，所述方法包括向有需要的受试者施用所述的中药组合物和/或所述的方法制备的中药组合物。
优选地，治疗症候属于痰浊阻肺证的慢阻肺、慢性支气管炎、哮喘、胸腔积水，尤其是治疗症候属于寒痰浊阻肺证。
本申请所述的治疗呼吸系统疾病的中药组合物，通过选用川乌、南星、独活、威灵仙、土茯苓、细辛，或性温，或性大热，或兼辛香走窜沟通表里，一寒多温，寒温兼顾，但以辛温为主，故具有祛风散寒，化痰通肺络之效；同时配以辛温之川芎，以行气血，通畅全身气机，同时还可祛风止痛；此外生地甘苦寒，还具有清热凉血、养阴生津的作用，可作为佐制药，防治大量热药伤阴致燥；当归补血活血，一方面活血化瘀，另一方面防止大量热药耗伤气血而补血滋阴；细辛辛香走窜，能引药由里达表，冰片有芳香开窍、止痛消炎的功效，能引药由表达里，如此一表一里，如同肺之宣降一呼一吸，以畅达肺之气机。因此其具有温经通络、行气化痰的作用。故其对于呼吸类疾病如慢阻肺、哮喘、慢性支气管炎在1-3个疗程即可显效，6个疗程内总有 效率分别为95.31％、95％和98.57％，4-8个疗程内，胸腔积水的总有效率为95％，而病辩证为痰浊阻肺证的慢阻肺、慢性支气管炎和哮喘的总有效率为100％，尤其是寒痰浊阻肺证效果更佳。
具体实施方式
实施例1
制川乌30g、制马钱子15g、制南星10g、生地10g、川芎10g、威灵仙5g、独活5g、土茯苓5g、当归5g、细辛5g和冰片1g。
制法：(a)按照选定重量份数取制川乌、制马钱子、生地、制南星、川芎、威灵仙、独活、土茯苓、当归和细辛，分别粉碎后混合或混合后粉碎，得到药粉；
(b)取上述药粉，加入50vt％乙醇浸渍，然后以75vt％乙醇为溶剂渗漉，收集渗漉液，将冰片加入适量75vt％乙醇完全溶解，加入至上述渗漉液中，混合均匀，得到中药组合物渗漉液；
(c)取上述中药组合物渗漉液，使用超滤膜精滤，收集透过液，将无纺布制成载体浸入到精滤液中，分片密封包装。
使用方法：该中药组合物贴敷于患者皮肤上，或者与公开号为CN1303717A实用新型专利公开的“经皮给药仪”共同使用，将该中药组合物放入“经皮给药仪”药垫中，将敷贴盘贴敷于患者皮肤上，开启电热元件，一次作用20min以上。
实施例2
生川乌30g、生马钱子15g、生南星10g、生地10g、川芎10g、威灵仙5g、独活5g、土茯苓5g、当归5g、细辛5g和冰片1g。
制法：(a)按照选定重量份数取生川乌、生马钱子、生地、生南星、川芎、威灵仙、独活、土茯苓、当归和细辛，分别粉碎后混合或混合后粉碎，得到药粉；
(b)取上述药粉，加入50vt％乙醇浸渍，然后以75vt％乙醇为溶剂渗漉， 收集渗漉液，将冰片加入适量75vt％乙醇完全溶解，加入至上述渗漉液中，混合均匀，得到中药组合物渗漉液；
(c)取上述中药组合物渗漉液，使用超滤膜精滤，收集透过液，将无纺布制成载体浸入到精滤液中，分片密封包装。
使用方法：该中药组合物贴敷于患者皮肤上，或者与公开号为CN1303717A实用新型专利公开的“经皮给药仪”共同使用，将该中药组合物放入“经皮给药仪”药垫中，将敷贴盘贴敷于患者皮肤上，开启电热元件，一次作用20min以上。
实施例3
制川乌30g、制马钱子10g、制南星5g、生地2g、川芎5g、威灵仙5g、独活1g、土茯苓3g、当归5g、细辛5g和冰片0.5g。
制法：(a)按照选定重量份数取制川乌、制马钱子、生地、制南星、川芎、威灵仙、独活、土茯苓、当归、细辛和冰片，分别粉碎后混合，得到药粉；
(b)取上述药粉，加入常规辅料按照常规工艺制成临床上可接受的软膏剂。
使用方法：该中药组合物涂抹于患者皮肤上。
实施例4
制川乌20g、制马钱子15g、制南星10g、生地6g、川芎10g、威灵仙2g、独活5g、土茯苓1g、当归3g、细辛3g和冰片1g。
制法：(a)按照选定重量份数取制川乌、制马钱子、生地、制南星、川芎、威灵仙、独活、土茯苓、当归和细辛，加水煎煮二次，第一次加12倍药物重量的水，煎煮1.5小时，第二次加10倍量水，煎煮1小时，滤过，合并滤液，静置过夜，取上清液浓缩至60℃相对密度为1.20的浸膏；
(b)取上述浸膏，加入保湿剂和蒸馏水，将冰片加入适量50vt％乙醇完全溶解，加入至上述溶液中，混合均匀，然后分装于无纺布载体中，得到湿敷剂。使用方法：同实施例1。
实施例5
生川乌10g、生马钱子5g、生南星2g、生地10g、川芎10g、威灵仙3g、独活3g、土茯苓5g、当归3g、细辛1g和冰片0.5g。
制法：(a)按照选定重量份数取生川乌、生马钱子、生地、生南星、川芎、威灵仙、独活、土茯苓、当归和细辛，分别粉碎后混合或混合后粉碎，得到药粉；
(b)取上述药粉，加入适量的75vt％乙醇浸泡，然后以75vt％乙醇为溶剂渗漉，收集渗漉液；
(c)取上述渗漉液，过滤，浓缩，加入适量的保湿剂和乙醇或蒸馏水，将冰片加入适量75vt％乙醇完全溶解，加入至上述溶液中，混合均匀，过滤，得到喷剂。
使用方法：喷于患处。
实施例6
制川乌20g、生马钱子15g、生南星10g、生地10g、川芎10g、威灵仙5g、独活5g、土茯苓5g、当归5g、细辛5g和冰片0.5g。
制法：(a)按照选定重量份数取制川乌、生马钱子、生地、生南星、川芎、威灵仙、独活、土茯苓、当归和细辛，加水煎煮二次，第一次加12倍药物重量的水，煎煮1.5小时，第二次加10倍量水，煎煮1小时，滤过，合并滤液；
(b)将冰片加入适量50vt％乙醇完全溶解，加入至上述溶液中，混合均匀，过滤，得到洗剂。
使用方法：加热外洗或者药浴。
实施例7
生川乌30g、生马钱子12g、生南星10g、生地8g、川芎8g、威灵仙5g、独活5g、土茯苓4g、当归5g、细辛3.5g和冰片0.5g。
制法：(a)按照选定重量份数取生川乌、生马钱子、生地、生南星、川 芎、威灵仙、独活、土茯苓、当归和细辛，分别粉碎后混合或混合后粉碎，得到药粉；
(b)取上述药粉，加入适量的50vt％乙醇浸泡，然后以75vt％乙醇为溶剂渗漉，收集渗漉液，将冰片加入适量95vt％乙醇完全溶解，加入至上述渗漉液中，混合均匀，得到中药组合物渗漉液；
(c)取上述渗漉液，浓缩，加入常规辅料，按照常规工艺制成临床上可接受的贴膏剂。
使用方法：贴于患处，每个部位每天1贴。
实施例8
生川乌30g、生马钱子5g、生南星10g、生地2g、川芎10g、威灵仙1g、独活5g、土茯苓1g、当归5g、细辛1g和冰片1g。
制法：(a)按照选定重量份数取生川乌、生马钱子、生地、生南星、川芎、威灵仙、独活、土茯苓、当归和细辛，分别粉碎后混合或混合后粉碎，得到药粉；
(b)取上述药粉，加入75vt％乙醇浸渍，然后以50vt％乙醇为溶剂渗漉，收集渗漉液，将冰片加入适量50vt％乙醇完全溶解，加入至上述渗漉液中，混合均匀，得到中药组合物渗漉液；
(c)取上述中药组合物渗漉液，使用超滤膜精滤，收集透过液，将无纺布制成载体浸入到精滤液中，分片密封包装，得湿敷剂。
使用方法：同实施例1。
实施例9
生川乌10g、生马钱子15g、生南星2g、生地10g、川芎2g、威灵仙5g、独活1g、土茯苓5g、当归1g、细辛5g和冰片0.5g。
制法：(a)将各原料药粉粹，混合均匀，得到药粉；
(b)取上述药粉，加入95vt％乙醇浸渍，然后以95vt％乙醇为溶剂渗漉，收集渗漉液，将冰片加入适量50vt％乙醇完全溶解，加入至上述渗漉液中，混 合均匀，得到中药组合物渗漉液；
(c)取上述渗漉液，加入常规辅料，按照常规工艺制成临床上可接受的湿敷剂。
使用方法：同实施例1。
一、本申请中药组合物对小鼠浓氨水引咳试验
1.药品
受试药物：按实施例1制备的湿敷剂。
赋形剂：不包含本申请中药组合物，仅包含实施例1制剂辅料。
2.实验方法
取ICR小鼠40只。雌雄各半，体质量18-22g，随机分为4组，每组10只，即赋形剂组，受试药物高(1.2g/kg)、中(0.6g/kg)、低(0.3g/kg)剂量组。小鼠背部除毛，面积2×2cm，将药物贴敷于除毛部位，用纱布包裹透气胶带固定。按上述给药剂量给药，不同剂量给药面积不同，每天给药1次，连续5天。末次给药后1h将小鼠逐只放入YLS-8A多功能诱咳引喘仪。以多功能诱咳引喘仪喷人28％浓氨水30s引咳，喷雾终止后立即取出小鼠。记录2min内小鼠的咳嗽次数(腹肌收缩或缩胸，同时张大嘴，有时可有咳声者，计为“有咳嗽”)。个别动物在试验中出现死亡或休克，判为咳嗽阳性。末次药1h后进行小鼠氨水引咳试验，并计算引起半数小鼠咳嗽次数及潜伏期。
受试药物对浓氨水引咳试验的影响见表1。与赋形剂组比较，祛风消痰高、中剂量组浓氨水致咳的潜伏期显著延长(P<0.05)；低剂量对小鼠致咳的潜伏期影响不明显(P<0.05)；受试药物高、中剂量组浓氨水致咳的次数显著减少(P<0.05)；低剂量组小鼠致咳的次数变化不明显(P>0.05)。
受试药物0.3、0.6、1.2g/kg相当于临床拟用等效剂量的0.5、1、2倍，外部涂抹给药能够可显著性延长小鼠浓氨水致咳的潜伏期和减少浓氨水致咳的次数。提示该药物外用给药并具有明显的镇咳作用。
表1 受试药物对浓氨水致咳试验的影响
Figure PCTCN2019128179-appb-000001
组别 剂量 潜伏期 咳嗽次数
  g/kg (s) (次)
赋形剂组 1.2 32.8±10.6 25.3±12.2
高剂量组 1.2 47.2±14.4* 13.2±7.6*
中剂量组 0.6 43.8±10.2* 14.5±6.4*
低剂量组 0.3 41.1±12.5 18.7±8.2
注： *与赋形剂组比较p<0.05
二、本申请中药组合物对二甲苯致小鼠耳肿胀的影响
1.药品
受试药物：按实施例2制备的湿敷剂。
赋形剂：不包含本申请中药组合物，仅包含实施例2制剂辅料。
2.实验方法
取体重18-22g雄性小鼠，随机分为4组，即赋形剂组、受试药物高剂量组(1.2g/kg，)、中剂量组(0.6g/kg)、小剂量组(0.3g/kg)，每组10只。小鼠背部除毛，面积2×2cm，将药物贴敷于除毛部位，用纱布包裹透气胶带固定。按上述给药剂量给药，不同剂量给药面积不同，每天给药1次，连续7d。末次给药后1小时，将二甲苯涂于各组小鼠右耳，每只40μl，左耳不做任何处理。20min后处死动物，剪下双耳用8mm的打孔器将双耳相同部位的等面积打下，精密天平称重，以左右耳片重之差值为肿胀度，计算抑制率，比较组间差异。试验数据以
Figure PCTCN2019128179-appb-000002
表示。所有数据均用
Figure PCTCN2019128179-appb-000003
表示，按单因素方差分析进行统计分析。
结果显示：受试药物高、中剂量组可明显抑制二甲苯所致小鼠的耳肿胀。提示本品对小鼠非特异性急性炎症模型具有明显的抑制作用，结果见表2。
表2 活血通络酊对二甲苯致小鼠耳肿胀的影响
Figure PCTCN2019128179-appb-000004
Figure PCTCN2019128179-appb-000005
注： *与赋形剂组比较p<0.05；* *与赋形剂组比较p<0.01
二、临床观察
1、慢性阻塞性肺
1.1临床病例
1.1.1临床资料：对64例患有慢性阻塞性肺的患者进行临床观察，其中慢性阻塞性肺中的痰浊阻肺证病例20例，其他症候病例44例。
1.1.2诊断标准：全部病例均符合《慢性阻塞性肺疾病诊疗指南》(2007年修订版)中的诊断标准；中医诊断标准参照《中医内科学》(新世纪全国高等中医药院校规划教材)喘证中“痰浊阻肺证”：咳嗽，咯白黏痰，侯中痰鸣，胸闷如窒，呼吸困难，甚则张口抬肩，不能平卧，舌质淡、舌苔白腻，脉弦滑，并排除肺结核、支气管扩张、哮喘、肺癌等其他心肺疾病者。
1.1.3临床治疗效果的评价标准为：根据2002年《中药新药临床研究指导原则》，选取咳嗽、咯痰、气喘、鼻翼煽动、胸膈满闷5个常见症状作为观察指标，按照症状和体征的严重程度分为“无、轻、中、重”4个等级，并分别相应以“0分、1分、2分、3分”计算来量化积分，在治疗前和治疗后分别评价1次，前后比较分析。参照《中医药新药临床研究指导原则》拟定。临床控制：(1)临床治愈：临床症状、体征消失或者基本消失，症候积分减少≥95％；(2)显效：临床症状、体征明显改善，症候积分减少≥70％；(3)有效：临床症状、体征消失均有好转，症候积分减少≥30％；(4)无效：临床症状、体征消无明显改善，甚或加重，症候积分不足30％，治愈率＝治愈例数/总例数，显效率＝显效例数/总例数，有效率＝有效例数/总例数，总有效率＝治愈率+显效率+有效率。
给药方法：取实施例1制备的湿敷剂配合经皮给药仪给药，在大椎穴、肺腧穴及相邻部位，每个作用部位一次给药1贴(相当于2.5g生药材)，每12天一疗程，每天2次。
1.2治疗结果
使用本申请实施例1制备的中药组合物经皮给药仪给药治疗上述64例病 患，观察所述64例患者的慢阻肺的治疗结果，1个疗程内，64例病患的总效率为84.38％，其中痰浊阻肺证的慢阻肺的总效率为96.9％，6个疗程内，64例病患者的总有效率为95.31％，其中痰浊阻肺证的慢阻肺的总有效率为100％。
毒副作用：在治疗过程中，患者皮肤不会出现红疹、溃烂的副作用，在治疗结束后，复查血尿常规、大便、心、肝和肾功能未发现异常改变。停药3个月后对上述病例进行回访，无复发患者。
1.3结论
(1)本申请所述的中药组合物在治疗呼吸系统疾病等方面具有显著的治疗效果，1个疗程内总有效率可达84.38％，短期给药可及时缓解症状，6个疗程内治愈率可达95.31％，长期用药治愈率高，尤其是痰浊阻肺证的慢阻肺治愈率可达100％，疗程短，见效快，复发率低，且无毒副作用。
2、哮喘
2.1临床病例
2.1.1临床资料：对40例患有哮喘的患者进行临床观察，其中痰浊阻肺证病例10例，其他症候病例30例。
2.1.2诊断标准：全部病例均符合《中西医临床呼吸病学》(中国中医药出版社)中哮喘的诊断标准和其中哮喘“痰浊阻肺证”的诊断标准；并排除肺结核、支气管扩张、慢阻肺、肺癌等其他心肺疾病者。
2.1.3临床治疗效果的评价标准为：根据2002年《中药新药临床研究指导原则》，临床治疗效果的评价标准为：根据《实用内科学》拟定疗效评定标准，临床治愈：咳嗽、咯痰、喘息、哮鸣音等主要症状、体征基本消失；显效：咳嗽、咯痰、喘息等主要症状明显转为稳定，发作次数及程度明显减轻；有效：咳嗽、咯痰、喘息等主要症状有所好转，但病情不稳定，发作次数和程度较以前减轻；无效：咳嗽、咯痰、喘息等主要症状无好转，发作次数及程度无改善，治愈率＝治愈例数/总例数，显效率＝显效例数/总例数，有效率＝ 有效例数/总例数，总有效率＝治愈率+显效率+有效率。
给药方法：取实施例2制备的湿敷剂配合经皮给药仪给药，药物作用于大椎穴、风门、双侧肺俞穴，每个作用部位一次给药1贴(相当于2.5g生药材)，每12天一疗程，每天2次。
2.2治疗结果
使用本申请实施例2制备的中药组合物经皮给药仪给药治疗上述40例病患，观察治疗结果，3个疗程内，40例病患的总有效率为90％，其中痰浊阻肺证的哮喘的总有效率为100％，6个疗程内，40例病患的总有效率为95％，其中症候为痰浊阻肺证的哮喘的总有效率为100％。
毒副作用：在治疗过程中，患者皮肤不会出现红疹、溃烂的副作用，在治疗结束后，复查血尿常规、大便、心、肝和肾功能未发现异常改变。停药3个月后对上述病例进行回访，无复发患者。
2.3结论
(1)本申请所述的中药组合物在治疗哮喘中具有显著的治疗效果，3个疗程内，总有效率可达90％，短期给药可及时缓解症状，6个疗程内治愈率可达95％，长期用药治愈率高，尤其是痰浊阻肺证的哮喘治愈率可达100％，疗程短，见效快，复发率低，且无毒副作用。
3、慢性支气管炎
3.1临床病例
3.1.1临床资料：对70例患有慢性支气管炎的患者进行临床观察，其中症候为痰浊阻肺证的慢性支气管炎病例为50例，其他症候病例为20例。
3.1.2诊断标准：参照《实用内科学》制定诊断标准：患者长期咳嗽、咯痰、气喘，持续2年以上，每年持续3个月以上；长期反复发作与缓解交替；肺部可闻干、湿性啰音；胸片检查有慢性支气管炎症象，中医诊断标准参照《中医内科学》(新世纪全国高等中医药院校规划教材)喘证中“痰浊阻肺证”：咳嗽，咯白黏痰，侯中痰鸣，胸闷如窒，呼吸困难，甚则张口抬肩， 不能平卧，舌质淡、舌苔白腻，脉弦滑。排出肺结核、支气管扩张、哮喘、肺癌等痰浊阻肺证的其他心肺疾病者。
3.1.3临床治疗效果的评价标准为：根据《实用内科学》拟定疗效评定标准，临床治愈：咳嗽、咯痰、喘息等主要症状基本控制，病情稳定1年以上无复发；显效：咳嗽、咯痰、喘息等主要症状明显转为稳定，发作次数及程度明显减轻；有效：咳嗽、咯痰、喘息等主要症状有所好转，但病情不稳定，发作次数和程度较以前减轻；无效：咳嗽、咯痰、喘息等主要症状无好转，发作次数及程度无改善，治愈率＝治愈例数/总例数，显效率＝显效例数/总例数，有效率＝有效例数/总例数，总有效率＝治愈率+显效率+有效率。
给药方法：取实施例4制备的湿敷剂配合经皮给药仪给药，药物作用于大椎、双肺腧穴、双肺腧穴下部，每个作用部位一次给药1贴(相当于2.5g生药材)，每12天一疗程，每天2次。
3.2治疗结果
使用本申请实施例4制备的中药组合物经皮给药仪给药治疗上述70例病患，观察结果，3个疗程内，治愈率+显效率为80％，有效率10％，其中痰浊阻肺证的慢性支气管炎的显效率为90％，有效率5.7％；6个疗程内，总有效率为98.57％，其中症候为痰浊阻肺证的慢性支气管炎的总有效率为100％。
毒副作用：在治疗过程中，患者皮肤不会出现红疹、溃烂的副作用，在治疗结束后，复查血尿常规、大便、心、肝和肾功能未发现异常改变。停药3个月后对上述病例进行回访，无复发患者。
3.3结论
本申请所述的中药组合物在治疗慢性支气管炎中具有显著的治疗效果，3个疗程内显效可达80％，短期给药可及时缓解症状，6个疗程内总有效率可达98.57％，长期用药有效率高，尤其是痰浊阻肺证的慢性支气管炎的总有效率可达100％，疗程短，见效快，复发率低，且无毒副作用。
4、胸腔积水
4.1临床病例
4.1.1临床资料：对20例患有恶性肺癌胸腔积液的患者进行临床观察，由B超或CT检查确诊，并均经病理组织学和/或细胞学诊断证实。
4.1.2诊断标准：胸闷、胸痛、气促。胸腔积液量少时可无阳性体征，积液量多时患侧呼吸运动减弱，语颤消失，叩诊浊音或实音，呼吸音减弱或消失，气管、纵隔、心脏移向健侧。胸部X线检查可示肋膈角变钝、外高内低的高密度影；超声波检查示胸腔液性暗区，CT检查示胸腔下后部沿胸廓内缘走行的新月形承样密度影。超声检查和CT检查可以确定诊断。胸腔穿刺抽出液体，胸水检查常规、生化、免疫学和细胞学。可明确为渗出液或漏出液，有助于病因诊断。
4.1.3临床治疗效果的评价标准为：临床治愈：治疗后通过B超检查胸腔积液完全消失并持续4周以上；显效：胸腔积液减少一半以上并持续4周；有效：胸腔积液减少少于一半或者维持于原水平；无效：胸腔积液较原来增多，治愈率＝治愈例数/总例数，显效率＝显效例数/总例数，有效率＝有效例数/总例数，总有效率＝治愈率+显效率+有效率。
给药方法：取实施例7制备的贴膏剂，贴于大椎、双肺腧穴、双肺腧穴下部，每个部位每天给药1贴(相当于2g生药材)，每12天一疗程，每天2次。
4.2治疗结果
使用本申请实施例7制备的中药组合物经皮给药仪给药治疗上述20例病患，观察结果，4-8个疗程内，其中治愈例+显效例为16例，有效例为3例，无效例为1例，治愈率+显效率为80％，有效率为15％，总有效率为95％。
毒副作用：在治疗过程中，患者皮肤不会出现红疹、溃烂的副作用，在治疗结束后，复查血尿常规、大便、心、肝和肾功能未发现异常改变。停药3个月后对上述病例进行回访，无复发患者。
4.3结论
本申请所述的中药组合物在治疗胸腔积水中具有显著的治疗效果，4-8个疗程内总有效率可达到95％，疗效好，疗程短，见效快，复发率低，且无毒副作用。
典型病案举例：
张某，男，67岁，于2017年06月就诊，患者近50年烟龄，5年前开始晨起咳嗽，咳痰，近期咳嗽加重，痰无法咳出，体力劳动时有气短现象，慢性胃炎半年、反流性食管炎1年。体格检查：T：36.7，BP：125/75mmHg，两肺呼吸音减低，呼气延长，平静呼吸时可闻干性啰音，两肺底或其他肺野可闻湿啰音；心音遥远，剑突部心音较清晰响亮。实验室检查：肺功能提示慢阻肺Ⅰ级。中医诊断：咳嗽、肺肾气虚型。用实施例1所述湿敷剂结合经皮给药仪给药，药物作用于大椎穴、双肺腧穴、大椎穴下部，每个作用部位一次给药1贴(相当于2.5g生药材)。每次治疗4个部位，每日治疗一次，12天为一个疗程。治疗第3天后咳嗽明显减轻，但是仍然觉得嗓子眼有痰；继续治疗至2个疗程结束，患者咳嗽、咳痰症状消失，体力劳动过长时偶有气短现象，一般体力劳动均能胜任。
王某，男，9岁，于2011年11月就诊，患儿过敏体质，以肺炎喘嗽2年，一周内加重，曾在当地医院住院治疗。患儿呈阵发性咳嗽，干咳，少痰伴喘息，T36.6C、P89次/分、R28次/分，咽部充血，两肺呼吸音粗。中医给于止咳平喘，西医给于抗炎，对症治疗效果不佳。现病史：患儿以反复喘嗽，粉尘螨，花粉及皮毛过敏曾在当地医院住院治疗，出院后受凉即咳嗽喘息并反复发作，口服消炎平喘药效果不佳，患儿咳喘夜间睡眠差。实验室检查：变态反应室过敏原皮肤点刺实验报告结论：花粉过敏、粉尘螨过敏、皮毛过敏。西医诊断：喘息性支气管炎，中医诊断：肾虚肺炎喘嗽(风热型)。取实施例2制备的湿敷剂配合经皮给药仪给药，药物作用于大椎、风门、双侧肺俞，每次治疗4个部位，每个作用部位一次给药1贴(相当于2.5g生药材)，每日治疗一次，12次为一疗程，治疗12次后休息2-3天，继续下一疗程的治疗。治疗当天喘息症状即减轻，第二天继续治疗患儿偶有咳嗽无喘。第三次治疗 后患儿自觉症状消失。
杨某，男，40岁，于2006年06月就诊，慢性支气管炎，10余年前受凉后咳嗽，咳痰经治疗痊愈，但每稍受凉就发作并持续很长时间，咳嗽反复发作，口服中药，静脉注射抗生素，疗效均不佳，迁延月余，15天前由于受凉、劳累出现咳嗽，吐白痰，右侧头跳痛，舌质红，苔黄腻，脉浮数。体格检查：T：36.7，BP：125/75mmHg，咽腔充血，双肺听诊呼吸音粗，未闻及干湿性啰音。实验室检查：X线，胸部正位片示双肺纹理增粗。西医诊断：慢性支气管炎。中医诊断：咳嗽、痰热郁肺型。用实施例4所述湿敷剂结合经皮给药仪给药，药物作用于大椎穴、双侧肺俞穴，每个作用部位一次给药1贴(相当于2.5g生药材)，每次治疗4个部位，每日治疗一次，12次为一疗程，治疗12次后休息2-3天。治疗第4天咳嗽减轻，继续巩固治疗1个疗程痊愈。感冒后咳嗽偶用少量抗生素即愈。
张某，男，10岁，于2016年02月就诊，北京市东城区，病史：一月前无明显原因出现咳嗽、咳痰，就诊于北京某三甲医院，查CT诊断为“肺炎”，使用阿奇霉素抗菌治疗2周，仍咳嗽。体格检查：咽红，扁桃体Ⅰ度肿大。双肺呼吸音清，未闻及干湿啰音。实验室检查：全血细胞分析 +CRP：白细胞计数9.17×109/L，中性粒细胞比率14.4％，噬酸粒细胞百分比4.5％。西医诊断：肺炎。中医诊断：风热犯肺。用实施例4所述湿敷剂结合经皮给药仪给药，药物作用于双侧肺俞穴，每个作用部位一次给药1贴(相当于2.5g生药材)，每周治疗2-3次，治疗2周后，自觉咳嗽频率较前好转50％，但仍不时有黄痰咳出。治疗过程中出现一次接触性皮炎，考虑为药物接触过敏。治疗3周后，偶有咳嗽，无痰。治疗4周后，痊愈。
祝先生，男，80岁，于2016年09月就诊，主诉：胸腔积液10余年，近期咳嗽咳痰20天，加重伴胸闷气促5天，现病史：胸闷气促，活动后加重，咳嗽咳痰，痰黄粘腻，四肢乏力，易出虚汗，纳可，夜寐安，脉细弦滑，舌暗。体格检查：心率116次/分；双下肺叩诊浊音，右侧呼吸音减弱，左肺可闻及散在湿性啰音。实验室检查：胸部正侧位片：右侧中等量胸腔积液，伴 右下肺压迫性肺不张；左侧少量胸腔积液。西医诊断：胸水。中医诊断：咳嗽、肺肾气虚型。用实施例7所述贴膏剂，贴于大椎、双肺腧穴、双肺腧穴下部，每个部位每天给药1贴(相当于2g生药材)，每日治疗两次，每次治疗4个部位，12天为一个疗程，建议治疗12个疗程以上，治疗第7天后感觉咳嗽、喘憋好转，四肢乏力情况有改善；患者家住4楼，原来每爬一层楼梯需要休息5分钟左右时间，治疗2疗程后，患者爬楼中间只需要休息一次即可上楼，咳嗽、咳痰症状消失，喘憋有明显改善；治疗三疗程后，复查CT显示，胸腔积液有明显减少。
显然，上述实施例仅仅是为清楚地说明所作的举例，而并非对实施方式的限定。对于所属领域的普通技术人员来说，在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本申请创造的保护范围之中。

Claims (12)

  1. 一种治疗呼吸系统疾病的中药组合物，其特征在于，包括如下重量份的原料药：川乌10-30份、马钱子5-15份、生地2-10份、南星2-10份、川芎2-10份、威灵仙1-5份、独活1-5份、土茯苓1-5份、当归1-5份、细辛1-5份和冰片0.5-1份。
  2. 根据权利要求1所述的治疗呼吸系统疾病的中药组合物，其特征在于，包括如下重量份的原料药：川乌30份、马钱子15份、南星10份、生地10份、川芎10份、威灵仙5份、独活5份、土茯苓5份、当归5份、细辛5份和冰片1份。
  3. 根据权利要求1或2所述的治疗呼吸系统疾病的中药组合物，其特征在于，所述中药组合物按照常规工艺加入常规辅料制成临床上可接受的外用制剂。
  4. 采用权利要求1-3任一所述的中药组合物加入常规辅料按照常规工艺制备得到的外用制剂。
  5. 根据权利要求4所述的外用制剂，其特征在于，所述外用制剂包括喷剂、搽剂、软膏剂、酊剂、湿敷剂、糊剂、洗剂或贴膏剂。
  6. 一种制备如权利要求1-3任一所述的治疗呼吸系统疾病的中药组合物的方法，其特征在于，该方法包括如下步骤：
    (a)按照选定的重量份数取川乌、马钱子、生地、南星、川芎、威灵仙、独活、土茯苓、当归和细辛，分别粉碎后混合或混合后粉碎，得到药粉，备用；
    (b)取上述药粉，然后加入常规辅料、冰片按照常规工艺制成临床上可接受的喷剂、搽剂、膏剂、酊剂、湿敷剂、糊剂、洗剂或贴剂。
  7. 一种制备如权利要求1-3任一所述的治疗呼吸系统疾病的中药组合物的方法，其特征在于，该方法包括如下步骤：
    (a)按照选定的重量份数取川乌、马钱子、生地、南星、川芎、威灵仙、独活、土茯苓、当归和细辛，分别粉碎后混合或混合后粉碎，得到药粉，备用；
    (b)取上述药粉，加入适量的50-95vt％乙醇浸泡，然后以50-95vt％乙醇为溶剂渗漉，收集渗漉液，将冰片加入适量50-95vt％乙醇完全溶解，加入至上述渗漉液中，混合均匀，得到中药组合物渗漉液；
    (c)取上述中药组合物渗漉液，加入常规辅料按照常规工艺制成临床上可接受的喷剂、搽剂、软膏剂、酊剂、湿敷剂、糊剂、洗剂或贴膏剂。
  8. 根据权利要求7所述的治疗呼吸系统疾病的药物的制备方法，其特征在于，
    步骤(c)中，取上述中药组合物渗漉液，使用超滤膜精滤，收集透过液，将无纺布制成载体浸入到精滤液中，分片密封包装，得湿敷剂。
  9. 权利要求1-3任一所述的中药组合物、权利要求6-8任一所述的方法制备的中药组合物在制备治疗慢阻肺、慢性支气管炎、哮喘、胸腔积水的药物中的应用。
  10. 根据权利要求9所述的应用，其特征在于，权利要求1-3任一所述的中药组合物、权利要求6-8任一所述的方法制备的中药组合物在制备治疗症候属于痰浊阻肺证的慢阻肺、慢性支气管炎、哮喘、胸腔积水的药物中的应用，尤其是在制备治疗症候属于寒痰浊阻肺证的应用。
  11. 一种治疗慢阻肺、慢性支气管炎、哮喘、胸腔积水的方法，其特征在于，所述方法包括向有需要的受试者施用权利要求1-3任一所述的中药组合物和/或权利要求6-8任一所述的方法制备的中药组合物。
  12. 根据权利要求11所述的方法，其特征在于，治疗症候属于痰浊阻肺证的慢阻肺、慢性支气管炎、哮喘、胸腔积水，尤其是治疗症候属于寒痰浊阻肺证。
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