CN115475209A

CN115475209A - Pharmaceutical composition, preparation and application thereof

Info

Publication number: CN115475209A
Application number: CN202211229959.3A
Authority: CN
Inventors: 李庭玉
Original assignee: Individual
Current assignee: Individual
Priority date: 2022-10-09
Filing date: 2022-10-09
Publication date: 2022-12-16

Abstract

The invention relates to a pharmaceutical composition, a preparation and an application thereof, which are characterized by comprising the following components in parts by weight: 60 parts of spreading hedyotis herb, 20 parts of fritillaria, 10 parts of codonopsis pilosula and 10 parts of costus root. The application of the pharmaceutical composition in preparing a medicament for treating pneumonia. Through reasonable selection of the active ingredients and the content thereof of the traditional Chinese medicines and the synergistic effect of the active ingredients of various traditional Chinese medicines, the traditional Chinese medicine composition can effectively treat the pneumonia, the treatment principle is to strengthen the body resistance and eliminate the pathogenic factors, and tonify deficiency and purge excess, and the treatment method embodies tonifying qi and blood, soothing the liver and relieving depression, and promoting blood circulation and removing blood stasis.

Description

Pharmaceutical composition, preparation and application thereof

Technical Field

The invention belongs to the field of medicines, and particularly relates to a pharmaceutical composition, a preparation and an application thereof, in particular to a pharmaceutical composition for treating pneumonia, a preparation and an application thereof.

Background

Pneumonia refers to inflammation of the terminal airways, alveoli and lung interstitium, and may be caused by disease microorganisms, physicochemical factors, immune injury, allergy and drugs. Bacterial pneumonia is the most common pneumonia and is also one of the most common infectious diseases. Pneumonia in daily life mainly refers to pneumonia caused by bacterial infection, and the pneumonia is also the most common pneumonia.

Before the application of antibiotics, bacterial pneumonia threatens the health of children and old people greatly, anti-infection treatment is the most important link of pneumonia treatment, and the occurrence and development of antibiotics once obviously reduce the death rate of pneumonia. Due to the wide application of antibiotics in recent years, the pneumococcus generates drug resistance to various drugs, which brings difficulty to treatment, and therefore, a pharmaceutical composition, a preparation and an application thereof are provided.

Disclosure of Invention

Aiming at the defects in the prior art, the invention aims to provide a pharmaceutical composition, a preparation and an application thereof.

The technical scheme of the invention is as follows: the pharmaceutical composition is characterized by comprising the following components in parts by weight: 55-65 parts of oldenlandia diffusa, 15-25 parts of fritillaria, 5-15 parts of codonopsis pilosula and 5-15 parts of saussurea lappa.

Preferably, the pharmaceutical composition is characterized by comprising the following components in parts by weight: 60 parts of spreading hedyotis herb, 20 parts of fritillaria, 10 parts of codonopsis pilosula and 10 parts of costus root.

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

The preparation method of the preparation of the pharmaceutical composition is characterized by comprising the following steps of: soaking in water, decocting twice, mixing decoctions, filtering, concentrating into soft extract, drying, pulverizing into fine powder, adding pharmaceutically acceptable adjuvants, mixing, and making into preparation.

The invention also relates to application of the traditional Chinese medicine composition in preparing a medicine for treating pneumonia.

The invention also relates to application of the preparation of the traditional Chinese medicine composition in preparing a medicine for treating pneumonia.

The medicine used in the invention: oldenlandia (academic name: hedyotis diffusa) is selected from herba Hedyotidis Diffusae, anti-inflammatory agent of herba Hedyotidis Diffusae, herba Menispermi, herba Hedyotidis Diffusae, herba sauropris, and herba Hedyotidis Diffusae; is a year-old and scattered herbal medicine with a height of 15-50cm. Slender root, branch, white flower. The stem is somewhat square or flat cylindrical, smooth and hairless, with multiple branches emanating from the base. Spring in flowering phase. The seeds are brown yellow, fine and have 3 edges and corners. Its patent medicine is bitter and bland in taste and cold in nature. The main effects are clearing away heat and toxic material, relieving pain and dissipating stagnation, and promoting urination and removing dampness. It is especially good at treating various types of inflammation. In clinical practice, the compatibility of the oldenlandia diffusa is proper, which can cure various diseases.

Bulbus Fritillariae Cirrhosae (with its scientific name: fritillaria spp.) is a generic name for perennial herbs in the genus of Fritillaria in the family of Liliaceae. The bulbs are deeply buried in the soil, and the bulbs are externally provided with the bulb skins; the stem is upright without branching, and one part is positioned underground; the basal leaves have long stems; the stem leaves are grown in pairs, in rotation or in scattering; flowers are bigger or slightly smaller, usually bell-shaped, nodding, and are symmetrical in radiation, and single top or multiple top flowers are arranged into a general inflorescence or an umbrella-shaped inflorescence; the capsule has 6 edges, fins are usually arranged on the edges, and the chamber back is cracked; seeds were mostly flat with narrow wings at the edges. The medicinal material fritillaria is the dry bulb of fritillaria, has a long use history in China, is usually used for clearing heat and moistening lung, and reducing phlegm and relieving cough, and has important medicinal and economic values, so that fritillaria becomes an important income source for the masses in the producing areas.

Codonopsis pilosula (the scientific name: codonopsis pilosula (Franch.) Nannf.) of Campanulaceae, perennial herb with milk. The stem base has a plurality of nodular stem marks, the root is very big and is in a spindle shape or spindle shape cylinder shape, the stem is wound, sterile or the tip of the stem is attached with flowers, yellow green or yellow white, the leaves are grown on the main stem and the side branches, the leaf stalk has short and loose bristles, the leaves are in an oval shape or a narrow oval shape, the edge of the leaf stalk has wavy blunt sawteeth, the upper green and the lower gray green, the flower grows on the branch end and grows with or nearly grows with the leaf stalk, the upper part of the flower crown is in a broad bell shape, the lobe is in a regular triangle shape, the anther is long, the seeds are in a majority, in an oval shape, and the flower can bear fruits in 7-10 months. Codonopsis pilosula, radix Codonopsis is neutral in nature, sweet in flavor and slightly sour. It enters spleen and lung meridians. Tonify qi, strengthen spleen and nourish lung. Can be used for treating spleen and lung deficiency, short breath, palpitation, anorexia, loose stool, asthma, cough, internal heat, and diabetes. Suitable for people with weak constitution, deficiency of qi and blood, sallow complexion and weak constitution after illness and delivery. Radix codonopsitis is a commonly used traditional tonifying medicine in China, and the radix codonopsitis produced in Shanxi Shandangshen area is used as a superior product in ancient times, so that the radix codonopsitis has the effects of tonifying middle-jiao and Qi, and tonifying spleen and lung. Radix Codonopsis has effects of enhancing immunity, dilating blood vessel, lowering blood pressure, improving microcirculation, and improving hemopoiesis function. In addition, the composition has an effect of improving leucocyte reduction caused by chemotherapy and radiotherapy.

Saussurea lappa (scientific name: saussurea costus (falc.) Lipech.) is a perennial big herb of Saussurea of Compositae, and can reach 2 m in height. The main root is thick, the stem is upright and has edges, the basal leaf has a long wing handle, the wing handle is in a crenulate shape and is shallowly split, the leaf is in a heart shape or a halberd shape and is triangular, and the margin is arranged at the tooth edge. The upper lobe is tapered, triangular or oval, with no or short wing handle; the head-shaped inflorescence grows stem tips or branch tips singly, and the stem tips are integrated with dense fascicular chamber inflorescences. The involucre is hemispherical and black, the outer layer of the involucre is long triangular, the top end is short needle-pricked to form a soft bone, the middle layer is needle-shaped or elliptical, and all the involucre are upright. Flowers are dark purple, lean fruits are light brown, trigone, and flowers and fruits come out in 7 months. Radix aucklandiae: is pungent and bitter in taste and warm in nature, has the effects of promoting qi circulation, relieving pain, warming the middle-jiao and regulating the stomach, and is mainly used for treating chest and abdomen distending pain, emesis, diarrhea and dysentery with tenesmus. The radix aucklandiae has effects of invigorating spleen, regulating stomach function, regulating qi, resolving stagnation, relieving pain, and preventing miscarriage. Is a Chinese medicinal variety collected in the pharmacopoeia of the people's republic of China, the calendar edition.

The traditional Chinese medicine composition conforms to the compatibility principle of 'monarch, minister, assistant and guide', the pneumonia is located in the lung, but the liver governs smoothing flow of qi, the spleen governs transporting and transforming water dampness, and the kidney governs steaming and transforming water, so the traditional Chinese medicine composition is closely related to the liver, the spleen and the kidney. The main effects are clearing away heat and toxic material, relieving pain and dissipating stagnation, promoting urination and removing dampness, and can help the lung qi to disperse and descend. The fritillary and the codonopsis pilosula are ministerial drugs, and the fritillary clears heat and moistens lung, and eliminates phlegm and stops cough; codonopsis pilosula, mild in nature, sweet in taste and slightly sour; it enters spleen and lung meridians. Tonify middle-jiao and Qi, invigorate spleen and benefit lung. Can be used for treating spleen and lung deficiency, short breath, palpitation, anorexia, loose stool, dyspnea due to deficiency, cough, internal heat, and thirst. The two ministerial drugs are cold and help the monarch to remove heat and dissipate stagnation, eliminate dampness and relieve pain, and eliminate carbuncle and remove blood stasis; both herbs enter lung and spleen meridians, and have qi-tonifying effect. The lung governs qi of the whole body, and is warm in nature to help monarch and mediate the middle warmer to eliminate dampness, warm and dispel the turbid, and disperse and transform qi movement to relieve dragging pain caused by complicated cold and pathogenic heat, the fritillaria is a common phlegm-resolving medicament in clinic, and the pharmacological effects of the fritillaria comprise relieving cough and reducing phlegm, relaxing bronchial smooth muscle, regulating water passage to promote diuresis, relieving pain, resisting inflammation, reducing blood pressure, activating blood circulation to dissipate blood stasis, resisting ulcer, reversing bacterial drug resistance and the like, and the effects of soothing liver and strengthening spleen, regulating qi movement and relieving cold nature of various medicaments are enhanced. The codonopsis pilosula has the effects of tonifying middle-jiao and Qi, tonifying lung qi, strengthening spleen and middle-jiao, and nourishing and transforming the spleen and the stomach; invigorating qi and ascending, tonifying lung qi and strengthening yang to strengthen superficies, and combining the two herbs can strengthen the action of invigorating qi. Radix aucklandiae, radix aucklandiae: the saussurea lappa Clarke has the effects of promoting qi circulation, relieving pain, warming middle-jiao and regulating stomach, and the saussurea lappa Clarke has the effects of assisting monarch in strengthening spleen and regulating stomach, regulating qi, resolving stagnation and relieving pain. The kidney is the lung, dryness of kidney water can cause the lung to be scorched, the lung likes to clear and relieve, dislike congestion, like moistening and dislike dryness, aster is moistening lung, and inula root is used for clearing lung heat, so as to prevent ginseng from tonifying qi and warming property. The whole formula has the effects of expelling cold and dampness, treating both qi and blood, dispersing the liver and spleen, and making qi in the lower energizer pivot, gasifying and transporting, excreting pathogenic heat, and resolving cold and dampness, so that the chronic aeipathia is slow. All the herbs are neutral in nature, cold-damp without preference, and are beneficial but violent without affecting the spleen and spleen, so they have excellent clinical effect.

The traditional Chinese medicine composition is prepared according to the monarch, minister, assistant and guide theory and the medicine-to-medicine compatibility theory of the traditional Chinese medicine, the medicines are combined, the synergy is realized, the functions of clearing away heat and toxic materials, promoting blood circulation to remove blood stasis, nourishing lung and kidney, and tonifying qi and spleen are realized, the treatment is both temporary and permanent, the acute and chronic injuries are reduced, the treatment sensitivity is increased to a certain extent, the local control rate is improved, and the effect is obtained for treating the pneumonia.

The beneficial effects of the invention are: the Chinese medicinal materials are mainly derived from natural medicines and processed products thereof, including plant medicines, animal medicines, mineral medicines and partial chemical and biological medicines. Because the traditional Chinese medicines are mostly plant medicines, the Chinese medicine treatment has the advantage of small side effect by utilizing the traditional Chinese medicine, the preparation method is simple, the prepared combined medicine has no toxic or side effect, has small irritation after long-term use, and has the effects of antibiosis and antiphlogosis; the adopted anti-inflammatory antibacterial agent has the advantages of wide application range, exact curative effect, safety, reliability, no drug dependence and no side effect, and can achieve the effect of treating both symptoms and root causes.

Detailed Description

The technical solutions in the present invention will be described clearly and completely with reference to the following embodiments of the present invention, and it should be understood that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Example 1: a pharmaceutical composition comprises the following components in parts by weight: 55 parts of oldenlandia diffusa, 15 parts of fritillaria, 5 parts of codonopsis pilosula and 5 parts of costus root.

Example 2: a pharmaceutical composition comprises the following components in parts by weight: 60 parts of oldenlandia diffusa, 20 parts of fritillaria, 10 parts of codonopsis pilosula and 10 parts of costus root.

Example 3: a pharmaceutical composition comprises the following components in parts by weight: 65 parts of oldenlandia diffusa, 25 parts of fritillaria, 15 parts of codonopsis pilosula and 15 parts of costus root.

Example 4: a preparation of a pharmaceutical composition is prepared by taking the pharmaceutical composition of any one of the embodiments 1-3, 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 5: 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 1-3;

(2) Mixing all decoction pieces, soaking in 12 times of water for 60min, decocting for 1.5 hr, filtering, adding 10 times of water into the residue, decocting for 1.5 hr, filtering, mixing the decoctions, standing, filtering to remove precipitate, concentrating to relative density of 1.30-1.35 (50 deg.C), and filtering to obtain soft extract;

(3) Drying the above soft extract, pulverizing, and collecting dry extract powder;

(4) Adding dextrin and starch into the above dry extract powder according to dry extract powder, adjuvant (1);

(5) And subpackaging the granules into plastic bags and carrying out external packaging.

In the embodiment, the raw materials are processed by a water extraction method to prepare the granules, and the granules are absorbed quickly like decoction, are stable compared with liquid dosage forms, are convenient to take and have better patient compliance.

According to the preparation of the pharmaceutical composition, the traditional Chinese medicine active ingredients and the content thereof are reasonably selected, and the traditional Chinese medicine active ingredients are synergistic, so that the traditional Chinese medicine composition can effectively treat the pneumonia, and the treatment principle is to strengthen the body resistance and eliminate the pathogenic factor, supplement deficiency and purge excess, and embody qi and blood tonifying, liver soothing and depression relieving, blood circulation promoting and blood stasis removing on the treatment method. With the therapeutic principles of strengthening body resistance to eliminate pathogenic factors, tonifying deficiency and reducing excess, and the therapeutic methods of soothing liver and relieving depression, promoting blood circulation and removing blood stasis, and invigorating qi and blood, and can also promote apoptosis. In addition, the Chinese medicinal composition has the effects of improving clinical symptoms of patients, improving the life quality of the patients, regulating functions, improving the physique and preventing pneumonia.

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

1. Research method

Patients meeting the pneumonia inclusion standard within nearly 8 years are selected, the pharmaceutical composition is used for treatment, and the clinical curative effect and adverse reaction of the patients are observed.

2. Study object

Patients with pneumonia.

3. Diagnostic criteria

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

4. Standard of Western diagnosis

Patients with pneumonia.

5. Traditional Chinese medicine syndrome diagnosis standard

Clinically, it is manifested as increased respiration, cough and auscultation with abnormal respiration.

6. Inclusion criteria

1. Meets the western medicine diagnosis standard of pneumonia and the traditional Chinese medicine syndrome diagnosis standard.

2. The age is 18-85 years.

3. No other medications were used.

7. Exclusion criteria

1. Pregnant women, lactating women, are prepared during or near term pregnancy.

2. Patients with serious diseases such as heart, liver, kidney and hematopoietic system are also known.

3. Patients with mental diseases.

4. Allergic constitution or people who are allergic to various drugs.

5. In recent years, similar drugs are used for treatment, such as those with related or antagonistic action, which makes the curative effect of the drugs difficult to judge.

8. Medicine for use and method of administration

The medicine used is the granules prepared by the preparation method of the medicine composition according to the embodiment 1-3. The dosage of the specific drugs in the pharmaceutical composition can be adjusted within the scope of the invention according to different clinical symptoms of patients. The reference amount is 5-6 g each time.

The taking method comprises the following steps: the preparation is administered 3 times daily, and 1 month is a course of treatment.

9. Criteria for therapeutic effect

1. And (3) healing: the main symptoms disappear after treatment, and the disease does not relapse within 1 month after the medicine is stopped.

2. The effect is shown: the main symptoms disappear or are obviously relieved after treatment.

3. The method has the following advantages: the main symptoms are relieved after treatment.

4. And (4) invalidation: the major symptoms are not reduced or are aggravated after treatment.

10. Summary of clinical effects

The observation shows that the patients are treated within 8 years for 500 cases, wherein 142 cases are clinically cured, 284 cases are obviously effective, 67 cases are effective, and 7 cases are ineffective.

11. Adverse reaction

Clinical application shows no toxic side effect and untoward effect.

12. Typical cases

1. Patients are in 42 years old and have a diagnosis for pneumonia, and the patients have chest distress. The granules prepared by the pharmaceutical composition of the embodiment 1 are orally taken for 3 times a day, the dosage is 5-6 g each time, and after 1 month of treatment course, patients do not feel uncomfortable and are rechecked to be normal.

2. The patient ran a certain number, male, 33 years old, new pool, dry part, enrshi city; the granules prepared by orally taking the pharmaceutical composition of example 2 are examined in a trio hospital in 2017 to diagnose pneumonia, the dosage is 3 times per day, 5-6 g is used, and after 1 month of treatment course, patients do not feel uncomfortable and are rechecked to be normal.

3. A patient is a certain woman in the field, the year of 69, temple people in Enshi city, and farmers; the granules prepared by orally taking the pharmaceutical composition of the embodiment 2 are examined in a trio hospital in 2017 and diagnosed as pneumonia, the dosage of the granules is 5-6 g every 3 times a day, and after 1 month of treatment course, patients do not feel uncomfortable and are rechecked to be normal.

4. Old man, 85 years old, en city red-earthman, farmer; the pneumonia is diagnosed in a hospital in a trimethyl department in 2020, the granules prepared by orally taking the pharmaceutical composition of the embodiment 3 are taken 3 times a day, the dosage is 5-6 g, after 1 month of treatment course, patients do not feel uncomfortable, the reexamination is normal, and all the life and daily life are normal and healthy.

5. The teacher dedicates a festival person to a certain city, male, 48 years old, chongqing city; pneumonia was diagnosed in 2016 in a triot of hospitals, with symptoms of pain and insomnia; the granules prepared by taking the pharmaceutical composition of the embodiment 2 are taken 3 times a day, the dosage is 5-6 g each time, after 1 month of treatment course, the pain in day and night disappears, and after 6 years, the symptoms do not relapse, and the life is normal and healthy.

6. In seikaganfu, male, 59 years old, en shi city, mountain top, examined in his hospital in 2017, was diagnosed with pneumonia and had symptoms of cough and pain; after the granules prepared from the pharmaceutical composition in the embodiment 2 are taken 3 times a day, the dosage is 5-6 g each time, cough disappears after 1 month of treatment course, and the symptoms do not relapse after 5 years, so that the life is normal and healthy.

7. Tian Yi Gui, female, 56 years old, building official store, peasant; the patient was diagnosed with pneumonia and had cough and pain symptoms by examination in his hospital in 2020; the granules prepared by taking the pharmaceutical composition of the embodiment 3 are taken 3 times a day, the dosage is 5-6 g each time, after 1 month of treatment course, cough disappears, the symptoms do not relapse, and the life is normal and healthy.

8. The medicine is suitable for farmers in certain countryside, male, and 59 years old, farmers are in home for farmers for a long time, cough is interrupted for more than 4 months, low fever is 1 week, dry cough is the main part, a little white and sticky sputum is coughed, bloody sputum is not seen, chest distress and shortness of breath are avoided, fever is avoided, night sweat is avoided, chest pain is avoided, after self-administration of the medicine for resisting infection and relieving cough, symptoms are better changed, and because the symptoms are lighter and unaccepted, low fever appears before 1 week before raining, fluctuates at about 37.8 ℃, and the weight is reduced by 6kg in more than 2 months. There was a history of smoking for 15 years, about 10 cigarettes/day. Chinese medicine diagnosis at the time of treatment: deficiency of both qi and yin and combination of phlegm and blood stasis. After the traditional Chinese medicine decoction of the embodiment 2 is orally taken for 1 treatment course in an outpatient department, the symptoms of fever and cough of a patient are obviously improved, and after 2 treatment courses, the focus is stable by rechecking CT.

The above typical cases show that the pharmaceutical composition of the present invention can achieve the technical effects of the present invention without limiting the present invention in any way. The typical cases are only partial cases observed in clinic, the used pharmaceutical composition is also only partial pharmaceutical composition, and in actual clinical use, the dosage of the specific drug in the pharmaceutical composition can be adjusted correspondingly within the scope of the invention according to different clinical symptoms of patients.

It should be noted that, in this document, relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

In the description of the present invention, it should be noted that the terms "upper", "lower", "inner", "outer", "front", "rear", "both ends", "one end", "the other end", etc., indicate orientations or positional relationships only for convenience of description and simplification of description, but do not indicate or imply that the device or element referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and thus should not be construed as limiting the present invention.

Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.

Claims

1. The pharmaceutical composition is characterized by comprising the following components in parts by weight: 55-65 parts of oldenlandia diffusa, 15-25 parts of fritillaria, 5-15 parts of codonopsis pilosula and 5-15 parts of saussurea lappa.

2. The pharmaceutical composition according to claim 1, comprising the following components in parts by weight: 60 parts of spreading hedyotis herb, 20 parts of fritillaria, 10 parts of codonopsis pilosula and 10 parts of costus root.

3. The preparation of the pharmaceutical composition of claim 1 or 2, wherein the preparation of the pharmaceutical composition is prepared by adding pharmaceutically acceptable auxiliary materials into the pharmaceutical composition.

4. A method of preparing a formulation of the pharmaceutical composition of claim 3, comprising the steps of: soaking in water, decocting twice, mixing decoctions, filtering, concentrating into soft extract, drying, pulverizing into fine powder, adding pharmaceutically acceptable adjuvants, mixing, and making into preparation.

5. Use of a pharmaceutical composition according to claim 1 or 2 for the manufacture of a medicament for the treatment of pneumonia.

6. Use of a formulation of a pharmaceutical composition according to claim 3 for the manufacture of a medicament for the treatment of pneumonia.