CN109498625B - Pharmaceutical composition for treating chronic obstructive pulmonary disease and preparation method thereof - Google Patents
Pharmaceutical composition for treating chronic obstructive pulmonary disease and preparation method thereof Download PDFInfo
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- CN109498625B CN109498625B CN201811643129.9A CN201811643129A CN109498625B CN 109498625 B CN109498625 B CN 109498625B CN 201811643129 A CN201811643129 A CN 201811643129A CN 109498625 B CN109498625 B CN 109498625B
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- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4375—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
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Abstract
The invention relates to a pharmaceutical composition for treating chronic obstructive pulmonary disease and a preparation method thereof, wherein the pharmaceutical composition takes xanthenedione and optional glucocorticoid as active ingredients, and can be administered through gastrointestinal tract or inhaled after being added with pharmaceutically acceptable carriers. The combination of xanthethidione, xanthethidione and glucocorticoid can effectively improve the lung function of chronic obstructive pulmonary diseases and relieve the clinical symptoms of the chronic obstructive pulmonary diseases, wherein the combination of xanthethidione and glucocorticoid can remarkably reduce the effective dose of glucocorticoid while maintaining similar treatment effect, thereby remarkably reducing the side effect of glucocorticoid.
Description
Technical Field
The invention belongs to the field of medicines, and particularly relates to a pharmaceutical composition for treating chronic obstructive pulmonary disease and a preparation method thereof.
Background
Chronic Obstructive Pulmonary Disease (COPD), referred to as Chronic obstructive pulmonary disease (Chronic obstructive pulmonary disease), is a general term for a disease with persistent airway obstruction, and clinical symptoms of Chronic obstructive pulmonary disease mainly include Chronic cough, expectoration, chest distress, short breath or dyspnea, etc., can be further developed into pulmonary heart disease and respiratory failure, and has the characteristics of high disability rate and mortality rate. At present, the exact causes of chronic obstructive pulmonary disease are still unclear, but pulmonary dysplasia, smoking, dust inhalation, air pollution, irritant inhalation, respiratory infection, nutrient imbalance, climate mutation and the like are all related to the occurrence of chronic obstructive pulmonary disease. Epidemiological research shows that the incidence rate of the chronic obstructive pulmonary disease in people over 40 years old reaches 6% -10%, the incidence rate of the chronic obstructive pulmonary disease in people over 40 years old in China exceeds 8%, and the number of patients dying of the chronic obstructive pulmonary disease in China per year exceeds 100 ten thousand. Has become one of the diseases seriously affecting the health of human body.
For the treatment of chronic obstructive pulmonary disease, attention is mainly focused on administration of bronchodilators, inhalation or systemic administration of glucocorticoids, or symptomatic administration of antitussive, expectorant, anti-infective, etc. The administration of large amounts of glucocorticoids, while relieving the clinical symptoms of the chronic obstructive pulmonary disease to some extent, has severe side effects such as central obesity, elevated blood glucose, gastric ulcer, hypertension, acne, hirsutism, glaucoma, cataracts, etc., the presence of these large amounts of side effects severely limits the long-term, high-volume use of glucocorticoids in the treatment of chronic obstructive pulmonary disease.
Xanthatin dione (xanthhiazone) is a thiazine compound found in xanthium, has an antiarrhythmic effect through modern pharmacological research, and can be used for preventing and treating cardiovascular diseases. Chinese patent applications 201711420139 and 201810458324 both disclose that xanthium thiazine dione can be used for preventing and treating rheumatism and rheumatoid arthritis, but the treatment effect of xanthium thiazine dione on chronic obstructive pulmonary disease is not reported yet.
The invention aims to provide a pharmaceutical composition for treating chronic obstructive pulmonary disease and a preparation method thereof, wherein the pharmaceutical composition takes xanthium thiazine diketone and optional glucocorticoid as active ingredients.
Disclosure of Invention
The invention aims to provide a pharmaceutical composition for treating chronic obstructive pulmonary disease and a preparation method thereof.
In one aspect, the invention provides a pharmaceutical composition for treating chronic obstructive pulmonary disease, which comprises xanthenedione and optionally glucocorticoid as active ingredients.
Preferably, the pharmaceutical composition takes xanthethidione as the only active ingredient.
The pharmaceutical composition can be administered via the gastrointestinal tract or by inhalation, and preferably the pharmaceutical dosage form for gastrointestinal administration is selected from the group consisting of: tablets, capsules, granules, solutions, electuary, pills, powders and the like; the pharmaceutical dosage form for inhalation administration is selected from: aerosol, spray or powder inhalation.
The content of the xanthatinedione in the pharmaceutical composition accounts for 1-99%, preferably 3-80%, more preferably 5-50%, and most preferably 10% of the total weight of the pharmaceutical composition.
Preferably, the pharmaceutical composition further comprises a glucocorticoid;
preferably, the weight ratio of the xanthiundione to the glucocorticoid is 3-10: 1;
more preferably, the weight ratio of the xanthiumcinethione to the glucocorticoid is 4-8: 1;
most preferably, the weight ratio of the xanthethidione to the glucocorticoid is 6: 1.
Preferably, the glucocorticoid is selected from the group consisting of: prednisone, prednisolone, hydrocortisone, dexamethasone, betamethasone, etc. and pharmaceutically acceptable salts thereof;
more preferably, the glucocorticoid is selected from the group consisting of: prednisone, prednisolone, hydrocortisone, and the like, and pharmaceutically acceptable salts thereof;
most preferably, the glucocorticoid is selected from prednisolone and pharmaceutically acceptable salts thereof.
The content sum of the xanthium thiazine diketone and the glucocorticoid in the pharmaceutical composition accounts for 1-99% of the total weight of the pharmaceutical composition, preferably 3-80%, more preferably 5-50%, and most preferably 10%.
It is a further object of the invention to provide the use of xanthethidione for the preparation of a pharmaceutical combination for the treatment of chronic obstructive pulmonary disease.
The invention also provides application of the combination of xanthatinedione and glucocorticoid in preparing a pharmaceutical composition for treating chronic obstructive pulmonary disease.
Preferably, the weight ratio of the xanthiundione to the glucocorticoid is 3-10: 1;
more preferably, the weight ratio of the xanthiumcinethione to the glucocorticoid is 4-8: 1;
most preferably, the weight ratio of the xanthethidione to the glucocorticoid is 6: 1.
Preferably, the glucocorticoid is selected from the group consisting of: prednisone, prednisolone, hydrocortisone, dexamethasone, betamethasone, etc. and pharmaceutically acceptable salts thereof;
more preferably, the glucocorticoid is selected from the group consisting of: prednisone, prednisolone, hydrocortisone, and the like, and pharmaceutically acceptable salts thereof;
most preferably, the glucocorticoid is selected from prednisolone and pharmaceutically acceptable salts thereof.
Still another object of the present invention is to provide a method for preparing a pharmaceutical composition for treating chronic obstructive pulmonary disease, comprising the steps of:
(1) preparing and crushing: weighing xanthatinedione and optional glucocorticoid according to the amount, and crushing the xanthatinedione and optional glucocorticoid to D90Weighing xanthatin diketone and optional lactose 5-10 times of the total weight of glucocorticoid, and pulverizing to obtain D904 μm particles are ready for use;
(2) mixing: uniformly mixing the particles obtained in the step (1) to obtain mixture particles;
(3) preparation: and (3) packaging the mixed particles obtained in the step (2) into a dry powder inhaler or adding pharmaceutically acceptable auxiliary materials to prepare the gastrointestinal tract administration pharmaceutical composition.
Preferably, in the step (1), 9 times of lactose is weighed based on the total weight of the xanthenedione and the optional glucocorticoid.
The invention has the beneficial effects
The invention discovers the treatment effect of the xanthatine dione on the chronic obstructive pulmonary disease for the first time, can effectively improve the pulmonary function of the chronic obstructive pulmonary disease, and can obviously reduce the effective dose of the glucocorticoid while maintaining similar treatment effect when being used together with the glucocorticoid, thereby avoiding various side effects of the glucocorticoid to the maximum extent while effectively treating the chronic obstructive pulmonary disease, and being beneficial to the long-term treatment and application of the glucocorticoid.
Detailed Description
The present invention is described in more detail below to facilitate an understanding of the present invention.
Example 1: dry powder inhalant for treating chronic obstructive pulmonary disease
70mg of xanthatinedione and 630mg of lactose, and the preparation method comprises the following steps:
(1) preparing and crushing: weighing xanthatinedione according to the amount, and crushing the xanthatinedione into powderD90Weighing lactose 9 times of the total weight of xanthil thiazine diketone, and pulverizing to D904 μm particles are ready for use;
(2) mixing: uniformly mixing the particles obtained in the step (1) to obtain mixture particles;
(3) preparation: and (3) packaging the mixed particles obtained in the step (2) into a dry powder inhaler to obtain the dry powder inhaler for treating the chronic obstructive pulmonary disease.
Example 2: dry powder inhalant for treating chronic obstructive pulmonary disease
60mg of xanthatinedione, 10mg of prednisolone acetate and 630mg of lactose, and is prepared according to the following steps:
(1) preparing and crushing: weighing xanthatinedione and prednisolone acetate according to the amount, and respectively crushing the xanthatinedione and prednisolone acetate to D90Weighing lactose 9 times of the total weight of xanthil thiazine dione and prednisolone acetate, and pulverizing to D904 μm particles are ready for use;
(2) mixing: uniformly mixing the particles obtained in the step (1) to obtain mixture particles;
(3) preparation: and (3) packaging the mixed particles obtained in the step (2) into a dry powder inhaler to obtain the dry powder inhaler for treating the chronic obstructive pulmonary disease.
Example 3: dry powder inhalant for treating chronic obstructive pulmonary disease
The xanthatinedione preparation is prepared from 30mg of xanthatinedione, 10mg of prednisolone acetate and 400mg of lactose according to the following steps:
(1) preparing and crushing: weighing xanthatinedione and prednisolone acetate according to the amount, and respectively crushing the xanthatinedione and prednisolone acetate to D90Weighing lactose 10 times of the total weight of xanthil thiazine dione and prednisolone acetate, and pulverizing to D904 μm particles are ready for use;
(2) mixing: uniformly mixing the particles obtained in the step (1) to obtain mixture particles;
(3) preparation: and (3) packaging the mixed particles obtained in the step (2) into a dry powder inhaler to obtain the dry powder inhaler for treating the chronic obstructive pulmonary disease.
Example 4: dry powder inhalant for treating chronic obstructive pulmonary disease
100mg of xanthatinedione, 10mg of prednisolone acetate and 550mg of lactose, and is prepared according to the following steps:
(1) preparing and crushing: weighing xanthatinedione and prednisolone acetate according to the amount, and respectively crushing the xanthatinedione and prednisolone acetate to D90Weighing lactose 5 times of the total weight of xanthil thiazine dione and prednisolone acetate, and pulverizing to D904 μm particles are ready for use;
(2) mixing: uniformly mixing the particles obtained in the step (1) to obtain mixture particles;
(3) preparation: and (3) packaging the mixed particles obtained in the step (2) into a dry powder inhaler to obtain the dry powder inhaler for treating the chronic obstructive pulmonary disease.
Example 5: tablet for treating chronic obstructive pulmonary disease
120mg of xanthenedione, 20mg of prednisolone acetate, 1260mg of lactose, 70mg of hydroxypropyl cellulose, 56mg of croscarmellose sodium and a proper amount of magnesium stearate, and the preparation method comprises the following steps:
(1) preparing and crushing: weighing xanthatinedione and prednisolone acetate according to the amount, and respectively crushing the xanthatinedione and prednisolone acetate to D90Weighing lactose 9 times of the total weight of xanthil thiazine dione and prednisolone acetate, and pulverizing to D904 μm particles are ready for use;
(2) mixing: uniformly mixing the particles obtained in the step (1) to obtain mixture particles;
(3) preparation: and (3) adding hydroxypropyl cellulose and croscarmellose sodium into the mixed granules obtained in the step (2), uniformly mixing, granulating by a wet method, adding magnesium stearate after finishing granules, uniformly mixing, and tabletting to obtain the tablet for treating the chronic obstructive pulmonary disease.
Effect example 1: the influence of the pharmaceutical composition on the lung function of chronic obstructive pulmonary disease rats
1.1 Experimental drugs:
xanthium thiazine dione, 70 mg;
prednisolone acetate, 70 mg;
xanthethidione: prednisolone acetate 1: 1, 70 mg;
xanthethidione: prednisolone acetate 6: 1, 70 mg;
xanthethidione: prednisolone acetate 20: 1, 70mg, which is prepared into dry powder inhalant according to the method of example 1.
1.2 Experimental methods
35 male SD rats with the age of six weeks and the weight of 190-210g are randomly divided into a normal group, a model group, a xanthium thiazine diketone group, a prednisolone acetate group, a mixed group 1, a mixed group 2 and a mixed group 3, wherein after 5 rats in each group are adaptively raised for 1d, the rats are placed in a closed box which is internally and independently divided into 5 parts and mutually ventilated, wherein each divided part is provided with one rat, the closed box comprises an air inlet and an air outlet, the air inlet is provided with a cigarette fixing clamp and can be used for fixing 1-5 cigarettes at a time, and the air outlet is provided with an exhaust fan and can be used for sucking cigarette smoke into the closed box. On days 1-7 of the start of the experiment, rats in each group except the normal group smoked twice a day with 10min intervals, 3 cigarettes each time, and smoked for 30min each time. The normal group follows the same procedure, but no cigarettes are provided at the air inlet.
On 8 th to 14 th days after the experiment, the rats in each group respectively inhale each experimental drug twice a day, with an interval of 30min and 10min each time, wherein the experimental drug is sprayed into the air inlet 1 time every 1min, and simultaneously the exhaust fan 2S is started. Wherein the blank group of drugs uses an equal amount of lactose instead of the active ingredient.
After the last administration for 30min on the 14 th day of the experiment, the Forced Vital Capacity (FVC) and the forced expiratory volume (FEV0.3) of the rat are measured by using an animal respiratory function instrument, and the ratio of the forced expiratory volume (FEV0.3/FVC) in the 0.3 th second to the forced vital capacity (FEV0.3) is calculated, and the specific experiment results are shown in Table 1.
1.3 results of the experiment
And (3) performing data analysis by using a multi-factor variance analysis module of statistical software SPSS, wherein P is less than 0.05 to indicate that the difference has statistical significance.
TABLE 1 Effect of the pharmaceutical compositions on Chronic obstructive pulmonary disease Lung function
Delta. DELTA.P < 0.01 in comparison with the normal group; p < 0.05, P < 0.01 compared to model group.
The experimental results in table 1 show that after 7 days of smoking, compared with the normal group, the ratio of forced vital capacity, 0.3 second forced expiratory volume and 0.3 second forced expiratory volume to the forced vital capacity of the model group rats is obviously low, and has significant difference, which indicates that the chronic obstructive pulmonary disease modeling of the rats is successful. Compared with a model group, the forced vital capacity, the 0.3-second forced expiratory volume and the ratio of the 0.3-second forced expiratory volume to the forced vital capacity of 1-3 groups of rats are improved, and the results show that the 1-3 groups of the xanthenedione, the acetate prednisolone and the mixture of the xanthenedione and the acetate prednisolone have the effect of improving the lung function of chronic obstructive pulmonary diseases, wherein the 2-effect of the mixture of the acetate prednisolone, the xanthenedione and the acetate prednisolone is particularly the most excellent. The weight ratio of the xanthethidione to the prednisolone acetate in the mixture 2 group of the xanthethidione and the prednisolone acetate is 6: 1, namely the application amount of the prednisolone acetate is one sixth of that of a rat in the separate prednisolone acetate group, and after the application amount of the prednisolone acetate is obviously reduced, the effect similar to that of the separate prednisolone acetate with 6 times of dosage is obtained by combining the xanthethidione and the prednisolone acetate, so that the application amount of the glucocorticoid in the treatment of the chronic obstructive pulmonary disease is favorably reduced, the side effect of the glucocorticoid in the treatment process can be obviously reduced while the clinical symptoms of the chronic obstructive pulmonary disease are effectively relieved, and the long-term clinical treatment of the chronic obstructive pulmonary disease is suitable.
The foregoing describes preferred embodiments of the present invention, but is not intended to limit the invention thereto. Modifications and variations of the embodiments disclosed herein may be made by those skilled in the art without departing from the scope and spirit of the invention.
Claims (7)
1. A pharmaceutical composition for treating chronic obstructive pulmonary disease is characterized in that xanthium thiazine diketone and glucocorticoid are used as active ingredients,
the weight ratio of the xanthium thiazine diketone to the glucocorticoid is 6: 1, and the glucocorticoid is prednisolone acetate.
2. The pharmaceutical composition for treating chronic obstructive pulmonary disease according to claim 1, wherein the sum of the contents of xanthenedione and glucocorticoid in the pharmaceutical composition is 1-99% of the total weight of the pharmaceutical composition.
3. The pharmaceutical composition for treating chronic obstructive pulmonary disease according to claim 2, wherein the sum of the contents of xanthenedione and glucocorticoid in the pharmaceutical composition is 3-80% of the total weight of the pharmaceutical composition.
4. The pharmaceutical composition for treating chronic obstructive pulmonary disease according to claim 3, wherein the sum of the contents of xanthenedione and glucocorticoid in the pharmaceutical composition is 5-50% of the total weight of the pharmaceutical composition.
5. The pharmaceutical composition for treating chronic obstructive pulmonary disease according to claim 4, wherein the sum of the contents of xanthenedione and glucocorticoid in the pharmaceutical composition is 10% of the total weight of the pharmaceutical composition.
6. A pharmaceutical composition for the treatment of chronic obstructive pulmonary disease according to any one of claims 1 to 5, wherein the pharmaceutical composition is administered parenterally or by inhalation, in a pharmaceutical dosage form selected from the group consisting of: tablets, capsules, granules, solutions, granules, pills, powders; the pharmaceutical dosage form for inhalation administration is selected from: aerosol, spray or powder inhalation.
7. The application of the combination of xanthium thiazine dione and glucocorticoid in preparing a pharmaceutical composition for treating chronic obstructive pulmonary disease is characterized in that the weight ratio of xanthium thiazine dione to glucocorticoid is 6: 1, and the glucocorticoid is prednisolone acetate.
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| CN108283643A (en) * | 2017-12-25 | 2018-07-17 | 中国人民解放军第二军医大学 | A kind of thiazadione class compound prepare prevent or the drug for the treatment of rheumatoid arthritis in application |
| CN108514568A (en) * | 2018-05-14 | 2018-09-11 | 黑龙江中医药大学 | The preparation method and its medical usage of thiazides compounds in the achene of Siberian cocklebur |
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| PT1713473E (en) * | 2004-02-06 | 2013-05-13 | Meda Pharma Gmbh & Co Kg | The combination of anticholinergics and glucocorticoids for the long-term treatment of asthma and copd |
| GB0415789D0 (en) * | 2004-07-15 | 2004-08-18 | Astrazeneca Ab | Novel combination |
| CN101797258A (en) * | 2009-02-06 | 2010-08-11 | 莫始平 | Medicine composition containing oral glucocorticoid and oral bronchodilator |
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| CN108283643A (en) * | 2017-12-25 | 2018-07-17 | 中国人民解放军第二军医大学 | A kind of thiazadione class compound prepare prevent or the drug for the treatment of rheumatoid arthritis in application |
| CN108514568A (en) * | 2018-05-14 | 2018-09-11 | 黑龙江中医药大学 | The preparation method and its medical usage of thiazides compounds in the achene of Siberian cocklebur |
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| 苍耳子的化学成分和临床应用研究进展;崔秀荣等;《现代药物与临床》;20121130;第27卷(第6期);第614-618页 * |
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