CN115252748B

CN115252748B - Pharmaceutical composition for treating pulmonary nodules and preparation and application thereof

Info

Publication number: CN115252748B
Application number: CN202211151563.1A
Authority: CN
Inventors: 李树清
Original assignee: Yunnan Qiongyue Enterprise Management Co ltd
Current assignee: Yunnan Qiongyue Enterprise Management Co ltd
Priority date: 2022-09-21
Filing date: 2022-09-21
Publication date: 2023-01-20
Anticipated expiration: 2042-09-21
Also published as: CN115252748A

Abstract

The invention discloses a pharmaceutical composition for treating pulmonary nodules, a preparation and an application thereof, wherein the pharmaceutical composition comprises the following components in parts by weight: 10-30 parts of roasted astragalus membranaceus, 10-30 parts of bran-fried bighead atractylodes rhizome, 10-30 parts of bran-fried semen coicis, 5-20 parts of rhizoma pinellinae praeparata, 10-30 parts of radix ranunculi ternati, 5-20g of fried mustard seed, 10-30 parts of lance asiabell root, 10-30 parts of wild buckwheat rhizome, 10-30 parts of fried semen lepidii, 5-20 parts of fried stiff silkworm, 10-30 parts of vinegar rhizoma sparganii, 5-20 parts of vinegar curcuma zedoary, 10-30 parts of earthworm, 5-20 parts of periostracum cicada and 10-30 parts of platycodon grandiflorum. The pharmaceutical composition can be added with pharmaceutically acceptable auxiliary materials to prepare a preparation. The pharmaceutical composition and the preparation can be used for treating pulmonary nodules.

Description

Pharmaceutical composition for treating pulmonary nodules and preparation and application thereof

Technical Field

The invention belongs to the field of medicines, and particularly relates to a pharmaceutical composition for treating pulmonary nodules, and a preparation and application thereof.

Background

In recent years, the incidence rate of pulmonary sarcoidosis tends to increase year by year, and with the development of imaging and the popularization of CT scanning technology, the detection rate of pulmonary sarcoidosis is greatly increased, and pulmonary sarcoidosis becomes a common disease and frequently encountered disease. The lung nodule is a focal circular dense image with various sizes, clear or fuzzy edges and a diameter less than or equal to 3cm on a lung image. Symptoms and signs vary depending on how urgent and how many organs are involved in the onset of the disease. Early stage of intrathoracic sarcoidosis often has no obvious symptoms or signs. Cough, a small amount of sputum and occasional hemoptysis can occur; it has the effects of asthenia, fever, night sweat, anorexia, and weight loss. Chest tightness, shortness of breath and even cyanosis can appear when the pathological changes are extensive. It can aggravate the disease due to complicated infection, emphysema, bronchiectasis, pulmonary heart disease, etc. The follow-up study shows that: a small nodule develops for decades and twenty years and is possibly malignant to cancer, in recent years, the death rate of lung cancer rapidly rises along with the influence of smoking and various environmental factors, and the small nodule already occupies the first cause of death of various cancers, and the early-stage traditional Chinese medicine treatment has positive significance for eliminating and controlling the development of pulmonary sarcoidosis and reducing the occurrence or malignant change of lung tumor. The traditional Chinese medicine has rich experience in treating the disease, has rich treatment methods and higher curative effect, is combined with disease differentiation and syndrome differentiation of modern traditional Chinese medicine, explores a plurality of new treatment schemes and prescriptions, and shows unique advantages clinically.

The nomenclature of lung accumulation diseases is first found in "nan Jing", and later doctors of all ages discuss symptoms and treatment methods of lung accumulation diseases, but at present, the named lung accumulation diseases in China are lung tumors or lung cancers. Since a significant fraction of early lung cancer is characterized by pulmonary nodules, and malignant nodules account for perhaps about 30% of the pulmonary nodules, many oncologists have classified pulmonary nodules as precancerous lesion management. The traditional Chinese medicine considers that the tumor is an unbalanced disease formed by imbalance of qi and blood in a human body, and although the disease is induced or activated by various internal and external factors, the most critical pathogenesis is the imbalance of qi activity of the human body, and body fluid is not generated by the generation of body fluid. Firstly, the deficiency of vital qi at local or whole part of a human body is caused by various reasons, so that the gasification of the human body is disordered, the running of water and dampness is blocked, phlegm is generated due to aggregation, phlegm and dampness are combined, blood circulation is not smooth to generate stasis, a part of the human body is cemented into a block, the aggregation is performed to form a tumor, and the tumor is worsened to finally form the cancer.

The formation mechanism of pulmonary nodules is also the disturbance of qi activity of human body, the lung fails to descend due to the fact that patients feel smoking and drinking, or are polluted by the environment, or life is irregular, and the like, and the lung is disordered and has abnormal functions of the smooth and regulated water channel, moisture accumulates to form phlegm, phlegm and turbidity are combined, qi and blood are blocked, and the blood is cemented to form stasis and is left in the lung collaterals to form lung accumulation (small tumors or pulmonary nodules).

"nourishing healthy qi and removing the product by itself" and "eliminating the pathogenic factors and then keeping healthy qi" are important treatment methods in traditional Chinese medicine. In the pathogenesis of lung stagnation, phlegm stasis is not only a pathological product of the functional disorder of lung and viscera due to invasion of pathogenic toxin, but also a pathogenic factor causing the internal deficiency of vital qi and the intersection and agglomeration of pathogenic toxin. Therefore, phlegm stasis is the whole disease process of lung disease. The "Binzhengdu Biao Ben (Binzheng and Ju Bing) of Yi Zong (medical Zong) is characterized by: the accumulation of qi is also indicated by deficiency of healthy qi and pathogenic qi. "indicating that lung accumulation is caused by deficiency and excess caused by deficiency, it is a disease of general deficiency and local excess. Clinically, patients with symptoms of spleen, stomach and lung, such as cough, expectoration, short breath, asthma, mental fatigue, hypodynamia, inappetence, abdominal distension, loose stool or edema of face and limbs. The tongue is pale with white and slippery coating and the pulse is deep and thready. The syndrome differentiation includes spleen-lung qi deficiency, phlegm stagnation, qi stagnation, and stagnation of toxic stasis. The treatment method needs to use the methods of invigorating spleen, replenishing qi, nourishing lung, eliminating phlegm, removing blood stasis, removing food retention, etc. Strengthening healthy qi to eliminate pathogenic factors should be the basic therapeutic principle.

Disclosure of Invention

Aiming at the defects in the prior art, the invention aims to provide a pharmaceutical composition for treating pulmonary nodules, and a preparation and application thereof. The pharmaceutical composition can be used for treating pulmonary nodules, and particularly has a good treatment effect on lung retention diseases caused by spleen-lung qi deficiency and phlegm accumulation.

The purpose of the invention is realized by the following technical scheme: the pharmaceutical composition for treating pulmonary nodules comprises the following components in parts by weight: 10-30 parts of roasted astragalus membranaceus, 10-30 parts of bran-fried bighead atractylodes rhizome, 10-30 parts of bran-fried semen coicis, 5-20 parts of rhizoma pinellinae praeparata, 10-30 parts of radix ranunculi ternati, 5-20 parts of fried semen brassicae, 10-30 parts of lance asiabell root, 10-30 parts of wild buckwheat rhizome, 10-30 parts of fried semen lepidii, 5-20 parts of fried stiff silkworm, 10-30 parts of vinegar rhizoma sparganii, 5-20 parts of vinegar rhizoma zedoariae, 10-30 parts of lumbricus, 5-20 parts of periostracum cicadae and 10-30 parts of platycodon grandiflorum.

Preferably, the composition comprises the following components in parts by weight: 20-30 parts of roasted astragalus membranaceus, 10-20 parts of bran-fried bighead atractylodes rhizome, 20-30 parts of bran-fried semen coicis, 5-15 parts of rhizoma pinellinae praeparata, 20-30 parts of radix ranunculi ternati, 5-15 parts of fried semen brassicae, 20-30 parts of lance asiabell root, 20-30 parts of wild buckwheat rhizome, 10-20 parts of fried semen lepidii, 5-15 parts of fried stiff silkworm, 10-20 parts of vinegar rhizoma sparganii, 5-15 parts of vinegar rhizoma zedoariae, 10-20 parts of lumbricus, 5-15 parts of periostracum cicadae and 10-20 parts of platycodon grandiflorum.

Preferably, the composition comprises the following components in parts by weight: 25-30 parts of roasted astragalus membranaceus, 10-15 parts of bran-fried bighead atractylodes rhizome, 25-30 parts of bran-fried semen coicis, 5-10 parts of rhizoma pinellinae praeparata, 25-30 parts of radix ranunculi ternati, 5-10 parts of fried semen brassicae, 25-30 parts of lance asiabell root, 25-30 parts of wild buckwheat rhizome, 10-15 parts of fried semen lepidii, 5-10 parts of fried stiff silkworm, 10-15 parts of vinegar rhizoma sparganii, 5-10 parts of vinegar curcuma zedoary, 10-15 parts of earthworm, 5-10 parts of periostracum cicada and 10-15 parts of platycodon grandiflorum.

The pharmaceutical composition also comprises 6-10 parts of blackberrylily rhizome, 15-30 parts of dandelion and 15-30 parts of Chinese violet.

The medicine composition also comprises 15-30 parts of pumice, 6-10 parts of pangolin and 15-30 parts of ligusticum wallichii.

The pharmaceutical composition also comprises 15-30 parts of bletilla striata and 5-10 parts of centipedes.

The pharmaceutical composition also comprises 10-15 parts of edible tulip, 6-10 parts of airpotato yam rhizome, 15-30 parts of spreading hedyotis herb and 10-15 parts of rhizoma paridis.

The pharmaceutical composition also comprises 10-20 parts of selfheal, 10-18 parts of thunberg fritillary bulb and 15-30 parts of raw oyster.

The pharmaceutical composition also comprises 10-20 parts of radix curcumae, 15-30 parts of dandelion, 6-10 parts of pangolin scales, 15-30 parts of loofah sponge, 10-15 parts of beautiful sweetgum fruit and 10-15 parts of spina gleditsiae.

The pharmaceutical composition also comprises 15-30 parts of Chinese actinidia root, 15-30 parts of herba patriniae, and 15-30 parts of barbed skullcap herb.

The preparation of the pharmaceutical composition is prepared by adding pharmaceutically acceptable auxiliary materials into the pharmaceutical composition.

Preferably, the formulation is in the form of a decoction, granules, capsules or pills prepared according to conventional methods.

A preparation method of a pharmaceutical composition preparation for treating pulmonary nodules comprises the following steps:

(1) Mixing Atractylodis rhizoma parched with bran, coicis semen parched with bran, rhizoma Pinelliae Preparata, semen Brassicae Junceae preparata, bombyx Batryticatus preparata, periostracum Cicadae, and radix Platycodi, pulverizing, and sieving; the medicine contains volatile components which need to be prepared for use at present;

(2) Decocting radix astragali Preparata, radix Ranunculi Ternati, radix Rapanae Thomasianae, rhizoma Fagopyri Dibotryis, semen Lepidii preparata, rhizoma Sparganii, curcumae rhizoma and Lumbricus with 10 times of water for 1.5 hr, filtering, mixing decoctions, concentrating at 60 deg.C to obtain soft extract with relative density of 1.30 + -0.02, adding the above medicinal powder, mixing, drying at 60-80 deg.C, pulverizing, and sieving. Adjusting the total amount with appropriate amount of starch, and mixing;

(3) Making pills with 60-80% alcohol, drying at 60-80 deg.C, polishing and making into pill.

The application of the pharmaceutical composition in preparing a medicament for treating pulmonary nodules.

The preparation of the pharmaceutical composition is applied to the preparation of drugs for treating pulmonary nodules.

The invention has the beneficial effects that: the invention uses astragalus root as monarch drug, which can invigorate qi and spleen, replenish qi and strengthen exterior; through tonifying lung qi, filling qi and blood to dredge meridians and collaterals, the channels and collaterals are dredged to eliminate dampness, phlegm and stasis. The fried largehead atractylodes rhizome, the fried coix seed and the rhizoma pinellinae praeparata are taken as ministerial drugs together for tonifying qi and strengthening spleen, and eliminating dampness and phlegm; the astragalus membranaceus is used for assisting the astragalus membranaceus to achieve the purposes of nourishing the lung and removing stasis. The rest nine medicines are used as adjuvant medicines, and the ternate buttercup root, the fried white mustard seed and the lance asiabell root are used for warming lung and reducing phlegm, supplementing qi and nourishing yin, and dredging collaterals and dissipating stagnation; the therapeutic principle of "the phlegm-fluid-drinking syndrome should be treated with warm herbs" is followed. Uses wild buckwheat rhizome, semen lepidii and stiff silkworm to clear away heat and toxic material, dispel stasis, relieve asthma, reduce phlegm and remove food retention; then, the common burreed rhizome, the zedoary and the earthworm are used for promoting qi circulation and removing blood stasis, and removing food retention and dredging collaterals; the three groups of nine medicines respectively play their own roles of eliminating phlegm, removing blood stasis and removing accumulation, and the two medicines enter lung meridian together by taking the cicada slough and the platycodon root as guiding medicines, so that the effects of guiding the medicines into the meridian and dredging the lung meridian are achieved. Has the effects of invigorating spleen, invigorating qi, nourishing lung, eliminating phlegm, removing blood stasis and removing food retention. The formula for nourishing lung and removing accumulation consists of fifteen traditional Chinese medicines, conforms to the ancient system of Huangdi's internal channel and Zhizhen important theory, adopts the big system of monarch, minister, sanzhuojiu and adds two conductant drugs.

Radix astragali Preparata: sweet and warm. Enter lung and spleen meridians, and tonify qi and strengthen middle energizer. Can be used for treating qi deficiency, asthenia, anorexia, and loose stool. The main components of the astragalus root are flavonoid, saponins, polysaccharide and the like, and the astragalus root has pharmacological actions of regulating immunity, protecting cardiovascular system and nervous system and the like.

Frying the bighead atractylodes rhizome: bitter, sweet and warm. It enters spleen and stomach meridians. Invigorate spleen, replenish qi, dry dampness, induce diuresis, arrest sweating, and prevent abortion. Can be used for treating spleen deficiency, anorexia, abdominal distention, diarrhea, phlegm retention, dizziness, palpitation, edema, spontaneous perspiration, and threatened abortion. The main active ingredients in the rhizoma atractylodis macrocephalae comprise volatile oil, lactone, polysaccharide and the like, and have pharmacological effects of regulating immunity, promoting urination, resisting tumors and the like.

Coix seed: sweet, bland and cool. It enters spleen, stomach and lung meridians. Induce diuresis and drain dampness, invigorate spleen to arrest diarrhea, remove arthralgia, expel pus, remove toxicity and dissipate nodulation. Can be used for treating edema, loempe, dysuria, spleen deficiency, diarrhea, damp arthralgia, spasm, pulmonary abscess, intestinal abscess, wart, and cancer. The coix seed mainly comprises polysaccharide, fatty acid, lipid and the like as active ingredients, and modern pharmacological research shows that triglyceride components in the coix seed have an anti-tumor effect.

Rhizoma pinelliae preparata: pungent and warm. It enters spleen, stomach and lung meridians. Dry dampness and resolve phlegm. Can be used for treating cough and asthma due to excessive phlegm, dizziness and palpitation due to phlegm and fluid retention, dizziness due to wind-phlegm, phlegm syncope and headache. The rhizoma Pinelliae Preparata contains alkaloid and beta-sitosterol as main active ingredients, and has pharmacological effects of resisting tumor, relieving cough, and resisting inflammation.

Radix ranunculi ternati: sweet, pungent and warm. It enters liver and lung meridians. Resolve phlegm and dissipate nodulation, remove toxicity and relieve swelling. Can be used for treating scrofula, subcutaneous nodule, furuncle, toxic swelling, and snake and insect bite. The main active ingredients of the radix ranunculi ternati comprise volatile oil, lactones, sterols and the like, and the radix ranunculi ternati has pharmacological effects of resisting tumors, tuberculosis, regulating immune functions and the like.

Stir-frying mustard seeds: pungent and warm. It enters lung meridian. Warm lung, eliminate phlegm, promote qi circulation, dissipate nodulation, dredge collaterals and alleviate pain. Can be used for treating cough due to cold phlegm, distending pain in chest and hypochondrium, phlegm stagnation in channels and collaterals, numbness and pain of joints, phlegm dampness, multiple abscess, and deep-rooted carbuncle of yin type. The main active component of the stir-fried mustard seed is alkaloid, and the stir-fried mustard seed has pharmacological effects of relieving cough, easing pain and the like.

And (3) lance asiabell: tonify qi, nourish yin, remove toxicity, relieve swelling, expel pus, and promote lactation. It can be used for treating listlessness, dizziness, headache, pulmonary abscess, acute mastitis, intestinal abscess, skin sore, furuncle, toxic swelling, tonsillitis, lymphoid tuberculosis, puerperal hypogalactia, leucorrhea, and venomous snake bite. The main active ingredient of the lance asiabell root is flavonoid, and the lance asiabell root has pharmacological actions such as sedation, analgesia and the like.

Wild buckwheat rhizome: clear heat and remove toxicity, expel pus and remove stasis. It can be used for treating pulmonary abscess, cough due to lung heat, lymphoid tuberculosis, sore, furuncle, and sore throat. The main active component of the lance asiabell is flavonoid, and the pharmaceutical effects of sedation, analgesia and the like are about. The main active ingredients in the wild buckwheat rhizome comprise flavonoids, steroids, terpenoids, lignans and the like, and the wild buckwheat rhizome has various pharmacological actions such as diabetes treatment, tumor inhibition, cancer resistance, oxidation resistance, bacteria resistance and the like.

Semen lepidii: purge lung, relieve dyspnea, induce diuresis to alleviate edema. It can be used for treating edema, pleural effusion, hydrops, and dysuria. The semen Lepidii contains isothiocyanate and its glycosides and flavonoids as main active ingredients, wherein thiocyanic acid and its glucosinolates are common components of plants of Brassicaceae, and have effects of relieving cough and asthma.

Stiff silkworm: extinguish wind and stop spasm, dispel wind and alleviate pain, resolve phlegm and dissipate nodulation. Is mainly used for treating convulsion and convulsion caused by acute and chronic infantile convulsion, epilepsy, tetanus and the like; wind attacking meridians and causing facial distortion; headache due to wind-heat, conjunctival congestion, pharyngalgia, rubella and pruritus; scrofula and subcutaneous nodule. The main chemical components in the batryticated silkworm include protein, polypeptide, amino acid, etc. Has anticoagulant, antithrombotic, and microcirculation promoting effects.

Three-edge: break blood and move qi, resolve food stagnation and alleviate pain. Can be used for treating blood qi and heart pain, food stagnation, abdominal distention and pain, amenorrhea due to blood stagnation, dysmenorrhea, abdominal mass, and traumatic injury. The rhizoma Sparganii contains volatile oil, flavonoids, organic acids, saponins, phenylpropanoids and alkaloids as main active ingredients, and has anticoagulant, antithrombotic, analgesic and antiinflammatory effects.

Zedoary turmeric: move qi and break blood, resolve food stagnation and alleviate pain. Can be used for treating blood qi and heart pain, food stagnation, abdominal distention and pain, blood stagnation amenorrhea, dysmenorrhea, abdominal mass, and traumatic injury. Mainly contains two components of volatile oil and diphenyl heptane, and has pharmacological effects of resisting tumor, protecting liver, and promoting blood coagulation.

Earthworm: clear heat and stop endogenous wind, dredge collaterals, relieve asthma, induce diuresis and lower blood pressure. Is mainly used for treating high fever fright epilepsy and mania; qi deficiency, blood stagnation, hemiplegia; arthralgia syndrome, arthralgia and difficulty in flexion and extension; asthma with lung heat; dysuria due to accumulation of heat in the bladder or anuresis; dizziness, headache; traumatic injury; abscess, swelling and sore, etc. The main components of Lumbricus include amino acids, nucleosides, dipeptide compounds, etc., and have pharmacological effects of resisting inflammation, relieving pain, eliminating phlegm, and relieving cough.

Cicada slough: disperse wind-heat, relieve sore throat and produce sound, promote eruption, improve vision and remove nebula, extinguish wind and stop convulsion. It is mainly used for wind-heat type common cold, early epidemic febrile disease, hoarseness, measles without adequate eruption, pruritus, conjunctival congestion, nebula, acute and chronic infantile convulsion, tetanus, etc. The main active components in the cicada slough comprise chitin, protein, amino acid and trace elements required by human body, and have pharmacological effects of resisting convulsion, tranquilizing and relieving pain, relieving cough, eliminating phlegm and the like. Cloud in the chapter of "endowment of drug Property of the pearl sac": "it has four functions: relieve sore throat, remove nasal obstruction; benefiting diaphragm qi and removing lung abscess; yellow millet of various herbs and yellow millet of lung. The method comprises the following steps: disperse lung qi, dispel phlegm, relieve sore throat and expel pus. Can be used for treating cough with excessive phlegm and chest distress; swollen and sore throat, aphonia; lung abscess with pus discharge. The main active ingredients in the platycodon root comprise platycodin, flavonoid and the like, and have pharmacological effects of resisting tumors, oxidation, bacteria and inflammation and the like. The pharmaceutical composition can be added with pharmaceutically acceptable auxiliary materials to prepare preparations such as granules, tablets, powder, pills and the like. The whole formula has the effects of invigorating spleen, tonifying qi, nourishing lung, eliminating phlegm, removing blood stasis and removing stasis.

Detailed Description

The present invention will be further described with reference to the following examples, but the present invention is not limited to these examples.

Example 1

A pharmaceutical composition comprising the following components: 30g of roasted astragalus membranaceus, 15g of bran-fried bighead atractylodes rhizome, 30g of bran-fried semen coicis, 10g of rhizoma pinellinae praeparata, 30g of radix ranunculi ternati, 10g of fried semen brassicae, 30g of lance asiabell root, 30g of wild buckwheat rhizome, 10g of fried semen lepidii, 10g of fried stiff silkworm, 10g of vinegar rhizoma sparganii, 10g of vinegar rhizoma zedoariae, 10g of earthworm, 5g of periostracum cicada and 10g of platycodon grandiflorum.

Example 2

A pharmaceutical composition comprising the following components: 20g of radix astragali preparata, 15g of rhizoma atractylodis macrocephalae stir-fried with bran, 20g of semen coicis stir-fried with bran, 5g of rhizoma pinellinae praeparata, 20g of radix ranunculi ternati, 5g of semen brassicae preparata, 20g of lance asiabell root, 20g of wild buckwheat rhizome, 15g of semen lepidii preparata, 5g of fried stiff silkworm, 15g of rhizoma sparganii with vinegar, 15g of rhizoma zedoariae with vinegar, 15g of earthworm, 10g of periostracum cicada and 15g of platycodon grandiflorum.

Example 3

A pharmaceutical composition comprising the following components: 15g of roasted astragalus membranaceus, 10g of bran-fried bighead atractylodes rhizome, 15g of bran-fried semen coicis, 9g of rhizoma pinellinae praeparata, 10g of radix ranunculi ternati, 15g of fried semen brassicae, 15g of lance asiabell root, 10g of wild buckwheat rhizome, 15g of fried semen lepidii, 15g of fried stiff silkworm, 20g of vinegar rhizoma sparganii, 20g of vinegar rhizoma zedoariae, 15g of earthworm, 15g of periostracum cicada and 10g of platycodon grandiflorum.

Example 4

A pharmaceutical composition comprising the following components: 30g of roasted astragalus membranaceus, 15g of bran-fried bighead atractylodes rhizome, 15g of bran-fried semen coicis, 10g of rhizoma pinellinae praeparata, 15g of radix ranunculi ternati, 9g of fried semen brassicae, 10g of lance asiabell root, 15g of wild buckwheat rhizome, 10g of fried semen lepidii, 6g of fried stiff silkworm, 10g of vinegar rhizoma sparganii, 9g of vinegar rhizoma zedoariae, 10g of earthworm, 15g of periostracum cicada and 10g of platycodon grandiflorum.

Example 5

A pharmaceutical composition comprising the following components: 20g of roasted astragalus membranaceus, 10g of bran-fried bighead atractylodes rhizome, 10g of bran-fried semen coicis, 10g of rhizoma pinellinae praeparata, 20g of radix ranunculi ternati, 10g of fried semen brassicae, 20g of lance asiabell root, 20g of wild buckwheat rhizome, 10g of fried semen lepidii, 8g of fried stiff silkworm, 10g of vinegar rhizoma sparganii, 6g of vinegar rhizoma zedoariae, 10g of earthworm, 10g of periostracum cicada and 15g of platycodon grandiflorum.

Example 6

A pharmaceutical composition comprising the following components: 10g of roasted astragalus membranaceus, 15g of bran-fried bighead atractylodes rhizome, 15g of bran-fried semen coicis, 5g of rhizoma pinellinae praeparata, 10g of ternate buttercup root, 5g of fried mustard seed, 10g of lance asiabell root, 10g of wild buckwheat rhizome, 10g of fried pepperweed seed, 5g of fried stiff silkworm, 10g of vinegar rhizoma sparganii, 5g of vinegar curcuma zedoary, 10g of earthworm, 5g of cicada slough and 10g of platycodon grandiflorum.

Example 7

A preparation of a pharmaceutical composition is prepared by taking the pharmaceutical composition of any one of embodiments 1-6, soaking in water, decocting twice, mixing decoctions, filtering, concentrating into thick paste, drying, pulverizing into fine powder, adding an appropriate amount of dextrin, starch or other suitable adjuvants, mixing well, and making into tablet, powder, pill, etc.

Example 8

A pharmaceutical composition comprises 6g of blackberrykiky rhizome, 15g of dandelion and 15g of Chinese violet, and the rest is the same as in example 3.

Example 9

A pharmaceutical composition comprises 8g of blackberrykiky rhizome, 20g of dandelion and 25 g of Chinese violet, and the rest is the same as in example 2.

Example 10

A pharmaceutical composition comprises 10g of blackberrykiky rhizome, 30g of dandelion and 30g of Chinese violet, and the rest is the same as in example 1.

Example 11

A pharmaceutical composition comprises Pumex 15g, squama Manis 6g, rhizoma Ligustici Chuanxiong 15g, and the rest is the same as example 3.

Example 12

A pharmaceutical composition comprises pumice 25 g, pangolin scales 8g, and Chuanxiong rhizome 25 g, as in example 2.

Example 13

A pharmaceutical composition comprises Pumex 30g, squama Manis 10g, rhizoma Ligustici Chuanxiong 30g, and the rest of the same as example 1.

Example 14

A pharmaceutical composition comprises rhizoma Bletillae 15g, scolopendra 2 strips (6 g), the remainder being as in example 3.

Example 15

A pharmaceutical composition comprises 30g of rhizoma bletillae and 3 centipedes (9 g), and the rest is the same as example 1.

Example 16

A pharmaceutical composition comprises 15g of edible tulip, 10g of airpotato yam rhizome, 30g of oldenlandia diffusa, 15g of rhizoma paridis, and the rest is the same as example 1.

Example 17

A pharmaceutical composition comprises 12 g of edible tulip, 8g of airpotato yam rhizome, 25 g of oldenlandia diffusa, 12 g of rhizoma paridis, and the rest is the same as example 2.

Example 18

A pharmaceutical composition comprises 10g of edible tulip, 6g of airpotato yam rhizome, 15g of oldenlandia diffusa, 10g of rhizoma paridis, and the rest is the same as example 3.

Example 19

A formulation of a pharmaceutical composition, prepared according to the following steps:

(1) Weighing the traditional Chinese medicine decoction pieces according to the proportion of the pharmaceutical composition in any one of the embodiments 1 to 6;

(2) Mixing Atractylodis rhizoma parched with bran, coicis semen parched with bran, rhizoma Pinelliae Preparata, semen Brassicae Junceae preparata, bombyx Batryticatus preparata, periostracum Cicadae, and radix Platycodi, pulverizing, and sieving; the medicine contains volatile components which need to be prepared at present;

(3) Decocting eight ingredients of radix astragali preparata, radix ranunculi ternati, lance asiabell root, wild buckwheat rhizome, fried semen lepidii, vinegar rhizoma sparganii, vinegar rhizoma zedoariae, earthworm and the like twice with water, adding water with the weight 10 times of that of the raw material medicines each time, decocting for 1.5 hours, filtering, combining the decoctions, concentrating into thick paste with the relative density of 1.30 +/-0.02 at 60 ℃, adding the medicinal powder, mixing uniformly, drying at 60-80 ℃, crushing and sieving. Adjusting the total amount with appropriate amount of starch, and mixing;

(3) Making 60-80% alcohol into pills, drying at 60-80 deg.C, polishing and making into pill.

Application example-the pharmaceutical composition according to the invention is used for the treatment of pulmonary nodules.

1. Research method

Patients meeting the standard for bringing the lung accumulation disease (pulmonary sarcoidosis) in nearly five years are selected, and the pharmaceutical composition is used for treating and observing the clinical curative effect and the adverse reaction of the patients.

2. Study object

Lung qi deficiency syndrome type lung stagnation patients.

3. Diagnostic criteria

Refer to the guideline for clinical research of new Chinese medicine (1993 version).

4. Standard of Western diagnosis

(1) Lung CT scan report: pulmonary nodules.

(2) Pulmonary nodules are less than 1.0cm, have no ground glass shadow, have no burrs on the edges, and are mostly inflammatory nodules or benign nodules.

(3) Pulmonary nodules greater than 1.0cm, frosted glass shadows, irregular edges, burrs, and high vigilance to the mischievous potential.

5. Traditional Chinese medicine syndrome diagnosis standard

The diagnosis standard of spleen-lung qi deficiency syndrome:

cough with expectoration, shortness of breath and dyspnea, mental fatigue, hypodynamia, inappetence, abdominal distension and loose stool, or edema of the face and limbs, pale tongue with white and smooth coating, deep and thready pulse. The above symptoms of lung, spleen and stomach are more than 3, and the corresponding pulse and tongue, so the syndrome of spleen-lung qi deficiency can be diagnosed.

6. Inclusion criteria

1. Those who meet the diagnostic criteria of Western medicine pulmonary sarcoidosis;

2. those who meet the diagnosis standard of the spleen-lung qi deficiency syndrome of lung accumulation disease in traditional Chinese medicine;

3. the age is 18-80 years old, and male and female are not limited;

4. examination by CT scan report: pulmonary nodule patients with 0.1 cm-1.0 cm are found on one side or two sides of the lung.

7. Exclusion criteria

1. Those who do not meet the criteria for diagnosing lung disease (pulmonary nodules) in the traditional Chinese and Western medicine;

2. lung cancer, pulmonary tuberculosis, lymphoma, metastatic malignant tumor of pulmonary portal, and other granulomatous diseases;

3. those aged 18 years, or over 80 years;

4. serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system are combined;

5. psychotic patients;

6. those who are allergic to the study drug;

7. if the drug is not in accordance with the inclusion criteria, the drug is not administered according to the regulations, and the efficacy or safety of the drug cannot be judged.

8. Method of administration

1. The medicine is taken with warm water, 5g for one time, 3 times a day, and 3 months are a treatment course.

2. Spicy, spicy and dry food should not be taken during taking.

3. Other drugs were discontinued during the treatment period.

9. Criteria for therapeutic effect

1. And (3) healing: clinically, the symptoms of spleen-lung qi deficiency disappear, and the lung nodules disappear.

2. The effect is shown: clinical symptoms of qi deficiency of spleen and lung are eliminated, lung nodules are reduced, and the frosted glass shadow and/or burrs disappear.

3. The method has the following advantages: the clinical symptoms of the deficiency of spleen-lung qi are relieved or eliminated, and lung nodules are not enlarged, and glass shadows and/or burrs are not enlarged.

4. And (4) invalidation: after the treatment is finished, the clinical symptoms of spleen-lung qi deficiency are not improved, the lung nodules continue to increase, and the ground glass shadow and/or burrs are not changed or continue to increase.

10. Summary of clinical effects

121 effective cases were observed in the study. 46 male patients and 76 female patients; 30 cases aged 18 to 40 years, 63 cases aged 41 to 60 years, and 29 cases aged 60 or older. All 121 patients underwent pulmonary CT examination: there are 121 pulmonary nodules, 39 with nodules smaller than 0.5cm, 82 with nodules ranging from 0.5cm to 1.0cm, and 1 with nodules larger than 1.0 cm.

In 121 patients with the pulmonary disease (pulmonary sarcoidosis) treated by the pharmaceutical composition, one treatment course (3 months) is observed, 37 patients are cured (30.57%), 7 patients with obvious effect (5.79%), 70 patients with the effect (57.85%) and 7 patients with the effect (5.79%). After the treatment (3 months) is finished, the total treatment effective rate of 121 patients is 94.21%, and the clinical research observation items are shown in a statistical table:

statistical table analysis: (1) Female patients are more than male patients because most male patients cannot adhere to the treatment, and the treatment staff are automatically quitted and interrupted. (2) The number of people with pulmonary nodules of 0.5-1.0 cm is large, and the nodules are large when general patients receive examination, so that the treatment can be carried out as early as possible, and the cure possibility is high.

11. Adverse reaction

The clinical application shows that the medicine has no toxic side effect and adverse reaction.

12. Typical cases

1. Zhang a certain time, female, 34 years old, patient will see a doctor for repeated cough for more than 1 month, patient will feel cough before 1 month, and phlegm is abundant. Then the doctor visits the local three hospitals, and the CT examination of the chest shows that: the double lung is scattered on tiny nodules, the nodule boundaries are clear, the two lung is mainly located in the posterior basal segment of the right lung inferior lobe, the maximum diameter is about 4mm, no substantial lesion image is seen in the rest lung, the lobes and the segments on the two sides are unobstructed, and no swollen lymph node is seen in each tissue gap in the mediastinum. The symptoms are as follows: cough with profuse sputum, yellow and thick complexion, lassitude, loss of appetite, poor sleep, normal stool and urine, pale tongue with white and slippery coating, deep and thready pulse. After a patient insists on taking for a course of treatment, the symptoms of cough and profuse sputum are obviously improved, and the patient reviews chest CT shows that: the texture of the two lungs is clear, and no obvious nodules or substantive pathological changes are seen.

2. The patient is high, male, 42 years old, the patient has intermittent cough and asthma for more than 3 months, the patient is hospitalized for cough and asthma 3 months ago, and chest CT shows that: the external basal segment of the right inferior lobe of the lung is ground into a vitreous shadow and a nodule shadow which is about 4 multiplied by 2mm, the main artery window in the mediastinum shows a lymph node shadow, no substantial lesion shadow is seen in the lung, and the lobes and the bronchial tubes on the two sides are unobstructed. The symptoms are as follows: cough and dyspnea, yellow sputum, chest distress, mental fatigue, poor appetite, lusterless complexion, abdominal distension, edema of complexion, low voice, no speaking desire, poor sleep, pale tongue with white and slippery coating, and deep and thready pulse. After a patient takes the medicine for one treatment course, the cough and asthma of the patient obviously improve the symptoms of expectoration, the mental fatigue and the hypodynamia and the inappetence of the patient are relieved, and the chest CT is reviewed: the texture of the double lungs is clear, no obvious nodules and substantive pathological changes are seen, the cough symptom is obviously improved, the mental fatigue and the hypodynamia are caused, and the inappetence symptom is relieved.

3. Zhangzhi, female, age 39, cough for 1 month, aggravated 1 week, no obvious coughing cause before 1 month, CT in chest: the veins of both lungs are clear, the anterior segment of the superior lobe of the left lung and the anterior basal segment of the inferior lobe of the right lung are two pieces of 3X 2mm, and the boundaries of the solid nodules are clear. The symptoms are as follows: cough, white sputum, poor appetite, loose stool, hypodynamia, pale tongue with white and slippery coating, and deep and thready pulse. After a patient takes one treatment course, the patient has the symptoms of cough, expectoration, inappetence, loose stool and hypodynamia relieved, and the chest CT is reviewed as follows: the texture of the two lungs is clear, and no obvious nodules and substantive pathological changes are seen.

4. Patient Wangzhi, male, 51 years old, patient had paroxysmal cough for more than 1 year. The patient has no obvious reason before 1 year, cough with chest pain, paroxysmal, obvious at night, little white foamy sputum, and obviously reduced weight loss compared with the prior art, the patient is diagnosed with 'double lower lung infection' in local hospitals, acid-fast bacillus (++++) is found in sputum smear examination, the symptom is reduced after anti-tuberculosis treatment, and the re-examination of chest tablets shows a few fiber proliferation focuses on the right upper lung. 15g of common bletilla pseudobulb and 2 centipedes (6 g) are added on the basis of the traditional Chinese medicine composition, after a patient takes the traditional Chinese medicine composition for one treatment course, the symptoms are obviously improved, and the right upper lung fibroproliferative focus is obviously reduced.

5. The patient Zhao Zhi, female, age 45, repeated paroxysmal cough for half a year, aggravated for 1 week. The patient found nodules in the lungs during a physical examination half a year ago, and the upper lobes of both lungs were scattered on the tiny nodules, with a diameter of about 2-3mm. Mammary gland ultrasonography: small lymph nodes can be seen in the right breast, and the patient can take antibiotics for treatment by self, the symptoms are repeated, and the symptoms are as follows: cough, chest distress, shortness of breath, hypodynamia, inappetence, lusterless complexion, pale tongue with white and slippery coating, deep and thready pulse. 10g of radix curcumae, 15g of dandelion, 6g of pangolin scales, 15g of loofah sponge, 10g of beautiful sweetgum fruit and 10g of Chinese honeylocust spine are added on the basis of the traditional Chinese medicine preparation, and a patient takes the traditional Chinese medicine preparation for a course of treatment. Cough, chest distress, shortness of breath and hypodynamia are better. And (3) reviewing CT (computed tomography) table: no obvious nodules and substantial lesion shadows were seen, breast ultrasound showed: no obvious abnormality was seen in both breasts.

6. The above cases are only partial cases observed in clinic, the used pharmaceutical composition is also only partial pharmaceutical composition, and the dosage of the specific drug in the pharmaceutical composition can be arbitrarily selected within the scope of the present invention according to different clinical symptoms of patients in actual clinical use.

7. In clinic, the prescription can be adjusted and added or subtracted according to different patients:

(1) For patients with inflammatory nodules, rhizoma Belamcandae 6-10 g, herba Taraxaci 15-30 g, herba Violae 15-30 g, and radix astragali Preparata and SHANHAI snail can be added. Atractylodis rhizoma and Coicis semen are modified into raw materials.

(2) For benign tubercle, adding Pumex 15-30 g, squama Manis 6-10 g, and rhizoma Ligustici Chuanxiong 15-30 g.

(3) If the tuberculous tubercle is concerned, 15-30 g of bletilla striata and 5-10 parts of centipede can be added.

(4) For patients with malignant change or lung cancer after surgery, 10-15 g of edible tulip, 6-10 g of airpotato yam rhizome, 15-30 g of oldenlandia diffusa and 10-15 g of rhizoma paridis can be added.

(5) If thyroid nodule is complicated, 10-20 g of selfheal, 10-18 g of thunberg fritillary bulb and 15-30 g of raw oyster can be added.

(6) For the complicated breast nodules, 10-20 g of radix curcumae, 15-30 g of dandelion, 6-10 g of pangolin scales, 15-30 g of loofah sponge, 10-15 g of beautiful sweetgum fruit and 10-15 g of Chinese honeylocust spine can be added.

(7) For patients with hysteromyoma and cyst, 15-30 g of radix Actinidiae chinensis, 30g of rhizoma Curcumae, 15-30 g of herba Patriniae and 15-30 g of herba Scutellariae Barbatae can be added.

Claims

1. The pharmaceutical composition for treating pulmonary nodules is characterized by comprising the following components in parts by weight: 10-30 parts of roasted astragalus membranaceus, 10-30 parts of bran-fried bighead atractylodes rhizome, 10-30 parts of bran-fried semen coicis, 5-20 parts of rhizoma pinellinae praeparata, 10-30 parts of radix ranunculi ternati, 5-20 parts of fried semen brassicae, 10-30 parts of lance asiabell root, 10-30 parts of wild buckwheat rhizome, 10-30 parts of fried semen lepidii, 5-20 parts of fried stiff silkworm, 10-30 parts of vinegar rhizoma sparganii, 5-20 parts of vinegar rhizoma zedoariae, 10-30 parts of lumbricus, 5-20 parts of periostracum cicadae and 10-30 parts of platycodon grandiflorum.

2. A pharmaceutical composition for treating pulmonary nodules is characterized in that 6-10 parts of blackberrylily rhizome, 15-30 parts of dandelion and 15-30 parts of Chinese violet are added on the basis of the pharmaceutical composition of claim 1.

3. A pharmaceutical composition for treating pulmonary nodules, characterized in that on the basis of the pharmaceutical composition of claim 1, 15-30 parts of pumice, 6-10 parts of pangolin scales and 15-30 parts of hemlock parsley are also added.

4. A pharmaceutical composition for treating pulmonary nodules, which is characterized in that 15-30 parts of bletilla striata and 5-10 parts of centipede are added on the basis of the pharmaceutical composition of claim 1.

5. The pharmaceutical composition for treating pulmonary nodules is characterized in that 10-15 parts of Indian iphigenia bulb, 6-10 parts of airpotato yam rhizome, 15-30 parts of spreading hedyotis herb and 10-15 parts of rhizoma paridis are added on the pharmaceutical composition of claim 1.

6. A preparation of the pharmaceutical composition of claim 1, wherein the pharmaceutical composition is formulated with pharmaceutically acceptable excipients.

7. The preparation of pharmaceutical composition according to claim 6, wherein the preparation is in the form of decoction, granule, capsule or pill prepared according to conventional methods.

8. A method of preparing a formulation of a pharmaceutical composition according to claim 6, comprising the steps of:

(1) Mixing Atractylodis rhizoma parched with bran, coicis semen parched with bran, rhizoma Pinelliae Preparata, semen Brassicae Junceae preparata, bombyx Batryticatus preparata, periostracum Cicadae, and radix Platycodi, pulverizing, and sieving; because the medicine contains volatile components;

(2) Decocting radix astragali Preparata, radix Ranunculi Ternati, radix Codonopsis Lanceolatae, rhizoma Fagopyri Dibotryis, parched semen Lepidii, rhizoma Sparganii processed with vinegar, curcumae rhizoma processed with vinegar, and Lumbricus with water 10 times of the weight of the raw materials for each time, decocting for 1.5 hr, filtering, mixing decoctions, concentrating at 60 deg.C to obtain soft extract with relative density of 1.30 + -0.02, adding the above medicinal powder, mixing, drying at 60-80 deg.C, pulverizing, sieving, adjusting total amount with appropriate amount of starch, and mixing;

9. Use of a pharmaceutical composition according to any one of claims 1 to 5 in the manufacture of a medicament for the treatment of pulmonary nodules.

10. Use of a formulation of the pharmaceutical composition of any one of claims 6 to 7 in the preparation of a medicament for treating pulmonary nodules.