CN114344380A - Asthma-relieving aerosol inhalation solution preparation and preparation method thereof - Google Patents

Asthma-relieving aerosol inhalation solution preparation and preparation method thereof Download PDF

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CN114344380A
CN114344380A CN202111478588.8A CN202111478588A CN114344380A CN 114344380 A CN114344380 A CN 114344380A CN 202111478588 A CN202111478588 A CN 202111478588A CN 114344380 A CN114344380 A CN 114344380A
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solution
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张保献
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Shenwei Pharmaceutical Group Co Ltd
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Abstract

The invention relates to an asthma-relieving aerosol inhalation solution preparation, and belongs to the field of pharmaceutics. An aerosol inhalation solution preparation of antiasthmatic comprises (1) effective components of antiasthmatic; (2) isotonic agent and solvent, and buffer solution. The solution preparation prepared by the invention makes up the blank of the current domestic market, is specially designed for patients for atomization and inhalation, is matched with an atomizer for use, is convenient to use, has different administration routes compared with the antiasthmatic injection, reduces the dosage and improves the safety.

Description

Asthma-relieving aerosol inhalation solution preparation and preparation method thereof
The present application is a divisional application of the Chinese patent application 201610112777.6.
Technical Field
The invention relates to an asthma-relieving aerosol inhalation solution preparation and a preparation method thereof, belonging to the field of pharmaceutics.
Background
The antiasthmatic injection has the effects of dispersing lung qi, relieving asthma, eliminating phlegm and relieving cough, and can be used for treating asthma, cough, chest distress and excessive phlegm caused by turbid phlegm obstructing lung and lung qi loss; patients with bronchial asthma and asthmatic bronchitis with the above syndromes.
In recent years, with the increase of clinical medication population, adverse reaction reports are increasing, so that a safer dosage form is urgently needed to be developed, the adverse reaction is reduced, and the clinical medication safety is improved.
Disclosure of Invention
The invention mainly solves the technical problem of providing a safe, effective and excellent-quality solution preparation for asthma-relieving aerosol inhalation; the invention also provides a preparation method of the preparation.
The invention is realized by the following technical scheme:
an anti-asthmatic solution formulation for aerosol inhalation comprising:
(1) effective components of antiasthmatic;
(2) isotonic agents and solvents;
buffers may also be added.
Wherein the mass ratio of the effective components to the isotonic agent is 1:1-1: 5.
The active ingredients are prepared by the following steps:
5-15 parts of ephedra, 1-10 parts of flos lonicerae, 5-15 parts of bitter almond and 5-25 parts of fructus forsythiae
Weighing the four medicines according to the weight parts, adding water, decocting for two times, the first time lasts for 1 hour, the second time lasts for 0.5 hour, combining the decoctions, filtering, concentrating the filtrate to a proper amount, precipitating with ethanol twice, refrigerating the first solution at 4 ℃ for 24 hours at the second time for 24 hours, filtering, and concentrating the filtrate to a proper amount to obtain the effective component of the invention.
The active ingredient is preferably prepared by:
6-10 parts of ephedra, 3-5 parts of datura flower, 7-12 parts of bitter almond and 8-20 parts of weeping forsythia capsule
Weighing the four medicines according to the weight parts, adding water, decocting for two times, the first time lasts for 1 hour, the second time lasts for 0.5 hour, combining the decoctions, filtering, concentrating the filtrate to a proper amount, precipitating with ethanol twice, refrigerating the first solution at 4 ℃ for 24 hours at the second time for 24 hours, filtering, and concentrating the filtrate to a proper amount to obtain the effective component of the invention.
The isotonic agent is one of sodium chloride, potassium chloride, magnesium chloride, calcium chloride, glucose, xylitol, and sorbitol.
The buffer solution is one of citric acid-sodium citrate, citric acid-disodium hydrogen phosphate, potassium dihydrogen phosphate-disodium hydrogen phosphate, citric acid-sodium hydroxide, and citric acid-disodium hydrogen phosphate.
The pH of the aerosolized inhalation solution is from 3.0 to 8.5; preferably the pH is 4.0-7.0.
The amount of the atomized inhalation solution is 0.1-0.8 times of the amount of the antiasthmatic injection; the preferred dosage is 0.3-0.6 times of the dosage of the antiasthmatic injection.
The solution preparation for the aerosol inhalation of the antiasthmatic provided by the invention can be used for treating bronchial asthma, asthmatic bronchitis and the like.
The invention has the advantages that the invention provides a new preparation form which is superior to the antiasthmatic injection, the preparation is directly inhaled from the respiratory tract, is locally aggregated into higher concentration, directly acts on a receptor or a target receptor on the surface of the airway to play a role, can be directly absorbed from the mucous membrane of the airway and the lung, can directly deliver the effective components to the focus of infection by the administration mode, is safe and effective, has high bioavailability, can realize low dose and quick and effective treatment, and has obvious advantages.
The solution preparation prepared by the invention makes up the blank in the current domestic market, can avoid the potential safety hazard caused by the lack of special preparation medicines for inhalation therapy and the use of the antiasthmatic injection for replacing the inhalation therapy. The solution preparation prepared by the invention is specially designed for patients for atomization and inhalation, is matched with an atomizer for use, is convenient and fast in use process, has different administration routes compared with the antiasthmatic injection, reduces the dosage and improves the safety.
The beneficial effects of the present invention are further illustrated by the following test examples:
preparing 60 bronchial asthma rat models, randomly dividing the models into a normal control group, a positive control group, a drug group I, a drug group II, a drug group III and a drug group IV, wherein each group comprises 10 rats, and the normal control group is administered with the same amount of physiological saline for intravenous injection; the positive control group is given with the intravenous injection of the antiasthmatic injection; the first, second, third and fourth drug groups are respectively administered with the aerosol inhalation solution of the antiasthmatic drug (the dosage is respectively 0.1 time, 0.3 time, 0.6 time and 0.8 time of the antiasthmatic injection), and are continuously administered for 5 days, and the cure rate, the incidence of adverse reaction and the drug peak concentration in lung tissues and blood after the treatment are observed. In particular, see the following table:
table conditions after treatment of each group
Figure BDA0003394195450000021
Therefore, each drug group has a better treatment effect on bronchial asthma rats, wherein the treatment effects of the drug groups II, III and IV are obviously better than those of the positive control group, and no adverse reaction occurs.
In conclusion, the medicine group has small dosage and less adverse reaction, the medicine is mainly gathered in the lung to form higher concentration, the medicine effect components can directly act on the focus, the bioavailability is high, and the low-dosage quick and effective treatment is realized, so the medicine has obvious advantages.
Similarly, the effect of the medicine group in treating asthmatic bronchitis and the like is obviously superior to that of the antiasthmatic injection.
The therapeutic effect of the asthma-relieving medicine aerosol inhalation solution is obviously superior to that of asthma-relieving injection, the blank of the asthma-relieving medicine aerosol inhalation solution in the domestic market at present is filled, compared with the asthma-relieving medicine injection, the using dosage is greatly reduced and is 0.1-0.8 time, preferably 0.3-0.6 time of the asthma-relieving medicine injection, the administration route is changed, and the occurrence of adverse reaction is reduced, so that the asthma-relieving medicine aerosol inhalation solution has creative and prominent substantive characteristics and remarkable progress.
Detailed Description
The preparation process and the materials used in the preparation or the dosage of the materials used in the preparation in the following pharmaceutical preparation examples are not limited to the words, and all the preparation methods containing the pharmaceutical composition provided by the present invention are within the protection scope of the present invention.
Example 1
(1) Preparation of active ingredients:
8 parts of ephedra, 4 parts of datura flower, 10 parts of bitter apricot kernel and 15 parts of weeping forsythia capsule
Weighing the four medicines according to the weight parts, adding water, decocting for two times, the first time lasts for 1 hour, the second time lasts for 0.5 hour, combining the decoctions, filtering, concentrating the filtrate to a proper amount, precipitating with ethanol twice, refrigerating the first solution at 4 ℃ for 24 hours at the second time for 24 hours, filtering, and concentrating the filtrate to a proper amount to obtain the effective component of the invention.
(2) Preparation of a solution for aerosol inhalation of anti-asthmatic:
Figure BDA0003394195450000031
weighing the effective components according to the prescription amount, adding a proper amount of water for injection, and uniformly stirring to obtain a solution 1; adding appropriate amount of water for injection into sodium chloride and citric acid, and stirring to dissolve to obtain solution 2; mixing the solution 1 and the solution 2, and uniformly stirring to obtain a solution 3; and preparing a solution of 0.4mol/L by adding a proper amount of disodium hydrogen phosphate and a proper amount of water for injection, slowly adding the solution into the solution 3 while stirring, adjusting the pH value to 5.0-7.0, adding 1000ml of water for injection, filling and sealing to obtain the compound disodium hydrogen phosphate injection.
Example 2
(1) Preparation of active ingredients:
6 parts of ephedra, 5 parts of datura flower, 7 parts of bitter apricot seed and 20 parts of forsythia
Weighing the four medicines according to the weight parts, adding water, decocting for two times, the first time lasts for 1 hour, the second time lasts for 0.5 hour, combining the decoctions, filtering, concentrating the filtrate to a proper amount, precipitating with ethanol twice, refrigerating the first solution at 4 ℃ for 24 hours at the second time for 24 hours, filtering, and concentrating the filtrate to a proper amount to obtain the effective component of the invention.
(2) Preparation of a solution for aerosol inhalation of anti-asthmatic:
Figure BDA0003394195450000041
weighing the effective components according to the prescription amount, adding a proper amount of water for injection, and uniformly stirring to obtain a solution 1; taking sodium chloride, adding a proper amount of water for injection, and stirring to dissolve to obtain a solution 2; mixing the solution 1 and the solution 2, and uniformly stirring to obtain a solution 3; and preparing a solution of 0.4mol/L by adding a proper amount of disodium hydrogen phosphate and a proper amount of water for injection, slowly adding the solution into the solution 3 while stirring, adjusting the pH value to 4.0-7.0, adding 1000ml of water for injection, filling and sealing to obtain the compound disodium hydrogen phosphate injection.
Example 3
(1) Preparation of active ingredients:
10 parts of ephedra, 3 parts of datura flower, 12 parts of bitter apricot kernel and 8 parts of forsythia
Weighing the four medicines according to the weight parts, adding water, decocting for two times, the first time lasts for 1 hour, the second time lasts for 0.5 hour, combining the decoctions, filtering, concentrating the filtrate to a proper amount, precipitating with ethanol twice, refrigerating the first solution at 4 ℃ for 24 hours at the second time for 24 hours, filtering, and concentrating the filtrate to a proper amount to obtain the effective component of the invention.
(2) Preparation of a solution for aerosol inhalation of anti-asthmatic:
Figure BDA0003394195450000042
weighing the effective components according to the prescription amount, adding a proper amount of water for injection, and uniformly stirring to obtain a solution 1; adding a proper amount of water for injection into magnesium chloride and citric acid, and stirring to dissolve to obtain a solution 2; mixing the solution 1 and the solution 2, and uniformly stirring to obtain a solution 3; and preparing a solution of 0.2mol/L by adding a proper amount of disodium hydrogen phosphate and a proper amount of water for injection, slowly adding the solution into the solution 3 while stirring, adjusting the pH value to 5.0-6.0, adding 1000ml of water for injection, filling and sealing to obtain the compound disodium hydrogen phosphate injection.
Example 4
(1) Preparation of active ingredients:
10 parts of ephedra, 5 parts of datura flower, 10 parts of bitter apricot kernel and 15 parts of forsythia
Weighing the four medicines according to the weight parts, adding water, decocting for two times, the first time lasts for 1 hour, the second time lasts for 0.5 hour, combining the decoctions, filtering, concentrating the filtrate to a proper amount, precipitating with ethanol twice, refrigerating the first solution at 4 ℃ for 24 hours at the second time for 24 hours, filtering, and concentrating the filtrate to a proper amount to obtain the effective component of the invention.
(2) Preparation of a solution for aerosol inhalation of anti-asthmatic:
Figure BDA0003394195450000051
weighing the effective components according to the prescription amount, adding a proper amount of water for injection, and uniformly stirring to obtain a solution 1; adding appropriate amount of water for injection into calcium chloride and citric acid, and stirring to dissolve to obtain solution 2; mixing the solution 1 and the solution 2, and uniformly stirring to obtain a solution 3; and preparing a solution of 0.4mol/L by adding a proper amount of disodium hydrogen phosphate and a proper amount of water for injection, slowly adding the solution into the solution 3 while stirring, adjusting the pH value to 5.0-6.5, adding 1000ml of water for injection, filling and sealing to obtain the compound disodium hydrogen phosphate injection.
Example 5
(1) Preparation of active ingredients:
5 parts of ephedra, 10 parts of datura flower, 5 parts of bitter apricot kernel and 25 parts of weeping forsythia capsule
Weighing the four medicines according to the weight parts, adding water, decocting for two times, the first time lasts for 1 hour, the second time lasts for 0.5 hour, combining the decoctions, filtering, concentrating the filtrate to a proper amount, precipitating with ethanol twice, refrigerating the first solution at 4 ℃ for 24 hours at the second time for 24 hours, filtering, and concentrating the filtrate to a proper amount to obtain the effective component of the invention.
(2) Preparation of a solution for aerosol inhalation of anti-asthmatic:
Figure BDA0003394195450000052
weighing the effective components according to the prescription amount, adding a proper amount of water for injection, and uniformly stirring to obtain a solution 1; adding appropriate amount of water for injection into sodium chloride and citric acid, and stirring to dissolve to obtain solution 2; mixing the solution 1 and the solution 2, and uniformly stirring to obtain a solution 3; and preparing a solution of 0.4mol/L by adding an appropriate amount of water for injection into an appropriate amount of sodium citrate, slowly adding the solution into the solution 3 while stirring, adjusting the pH value to 6.0-7.0, adding 1000ml of water for injection, filling and sealing to obtain the sodium citrate injection.
Example 6
(1) Preparation of active ingredients:
ephedra 15 parts, datura flower 1 part, bitter apricot seed 15 parts, capsule of weeping forsythia 5 parts
Weighing the four medicines according to the weight parts, adding water, decocting for two times, the first time lasts for 1 hour, the second time lasts for 0.5 hour, combining the decoctions, filtering, concentrating the filtrate to a proper amount, precipitating with ethanol twice, refrigerating the first solution at 4 ℃ for 24 hours at the second time for 24 hours, filtering, and concentrating the filtrate to a proper amount to obtain the effective component of the invention.
(2) Preparation of a solution for aerosol inhalation of anti-asthmatic:
Figure BDA0003394195450000061
weighing the effective components according to the prescription amount, adding a proper amount of water for injection, and uniformly stirring to obtain a solution 1; adding appropriate amount of water for injection into glucose and citric acid, and stirring to dissolve to obtain solution 2; mixing the solution 1 and the solution 2, and uniformly stirring to obtain a solution 3; and preparing a solution of 0.4mol/L by adding a proper amount of disodium hydrogen phosphate and a proper amount of water for injection, slowly adding the solution into the solution 3 while stirring, adjusting the pH value to 4.5-5.5, adding 1000ml of water for injection, filling and sealing to obtain the compound disodium hydrogen phosphate injection.
Example 7
(1) Preparation of active ingredients:
12 parts of ephedra, 8 parts of datura flower, 8 parts of bitter apricot seed and 12 parts of forsythia
Weighing the four medicines according to the weight parts, adding water, decocting for two times, the first time lasts for 1 hour, the second time lasts for 0.5 hour, combining the decoctions, filtering, concentrating the filtrate to a proper amount, precipitating with ethanol twice, refrigerating the first solution at 4 ℃ for 24 hours at the second time for 24 hours, filtering, and concentrating the filtrate to a proper amount to obtain the effective component of the invention.
(2) Preparation of a solution for aerosol inhalation of anti-asthmatic:
Figure BDA0003394195450000062
weighing the effective components according to the prescription amount, adding a proper amount of water for injection, and uniformly stirring to obtain a solution 1; adding appropriate amount of water for injection into xylitol and citric acid, and stirring to dissolve to obtain solution 2; mixing the solution 1 and the solution 2, and uniformly stirring to obtain a solution 3; and adding an appropriate amount of sodium hydroxide and an appropriate amount of water for injection to prepare a solution of 0.1mol/L, slowly adding into the solution 3 while stirring, adjusting the pH value to 3.0-5.0, adding 1000ml of water for injection, filling and sealing to obtain the product.
Example 8
(1) Preparation of active ingredients:
9 parts of ephedra, 6 parts of datura flower, 9 parts of bitter apricot seed and 16 parts of forsythia
Weighing the four medicines according to the weight parts, adding water, decocting for two times, the first time lasts for 1 hour, the second time lasts for 0.5 hour, combining the decoctions, filtering, concentrating the filtrate to a proper amount, precipitating with ethanol twice, refrigerating the first solution at 4 ℃ for 24 hours at the second time for 24 hours, filtering, and concentrating the filtrate to a proper amount to obtain the effective component of the invention.
(2) Preparation of a solution for aerosol inhalation of anti-asthmatic:
Figure BDA0003394195450000071
weighing the effective components according to the prescription amount, adding a proper amount of water for injection, and uniformly stirring to obtain a solution 1; taking sodium chloride and potassium dihydrogen phosphate, adding a proper amount of water for injection, and stirring to dissolve to obtain a solution 2; mixing the solution 1 and the solution 2, and uniformly stirring to obtain a solution 3; and preparing a solution of 0.4mol/L by adding a proper amount of disodium hydrogen phosphate and a proper amount of water for injection, slowly adding the solution into the solution 3 while stirring, adjusting the pH value to 7.5-8.5, adding 1000ml of water for injection, filling and sealing to obtain the compound disodium hydrogen phosphate injection.
Example 9
(1) Preparation of active ingredients:
ephedra 7 parts, datura flower 7 parts, bitter apricot seed 11 parts, capsule of weeping forsythia 18 parts
Weighing the four medicines according to the weight parts, adding water, decocting for two times, the first time lasts for 1 hour, the second time lasts for 0.5 hour, combining the decoctions, filtering, concentrating the filtrate to a proper amount, precipitating with ethanol twice, refrigerating the first solution at 4 ℃ for 24 hours at the second time for 24 hours, filtering, and concentrating the filtrate to a proper amount to obtain the effective component of the invention.
(2) Preparation of a solution for aerosol inhalation of anti-asthmatic:
Figure BDA0003394195450000072
Figure BDA0003394195450000081
weighing the effective components according to the prescription amount, adding a proper amount of water for injection, and uniformly stirring to obtain a solution 1; adding appropriate amount of water for injection into sorbitol and citric acid, and stirring to dissolve to obtain solution 2; mixing the solution 1 and the solution 2, and uniformly stirring to obtain a solution 3; and preparing a solution of 0.2mol/L by adding a proper amount of disodium hydrogen phosphate and a proper amount of water for injection, slowly adding the solution into the solution 3 while stirring, adjusting the pH value to 5.0-6.0, adding 1000ml of water for injection, filling and sealing to obtain the compound disodium hydrogen phosphate injection.
Example 10
(1) Preparation of active ingredients:
ephedra 8 parts, datura flower 4 parts, bitter apricot seed 8 parts, capsule of weeping forsythia 12 parts
Weighing the four medicines according to the weight parts, adding water, decocting for two times, the first time lasts for 1 hour, the second time lasts for 0.5 hour, combining the decoctions, filtering, concentrating the filtrate to a proper amount, precipitating with ethanol twice, refrigerating the first solution at 4 ℃ for 24 hours at the second time for 24 hours, filtering, and concentrating the filtrate to a proper amount to obtain the effective component of the invention.
(2) Preparation of a solution for aerosol inhalation of anti-asthmatic:
Figure BDA0003394195450000082
weighing the effective components according to the prescription amount, adding a proper amount of water for injection, and uniformly stirring to obtain a solution 1; adding appropriate amount of water for injection into sodium chloride and citric acid, and stirring to dissolve to obtain solution 2; mixing the solution 1 and the solution 2, and uniformly stirring to obtain a solution 3; and preparing a solution of 0.2mol/L by adding a proper amount of disodium hydrogen phosphate and a proper amount of water for injection, slowly adding the solution into the solution 3 while stirring, adjusting the pH value to 5.0-6.5, adding 1000ml of water for injection, filling and sealing to obtain the compound disodium hydrogen phosphate injection.
Example 11
(1) Preparation of active ingredients:
8 parts of ephedra, 4 parts of datura flower, 10 parts of bitter apricot kernel and 15 parts of weeping forsythia capsule
Weighing the four medicines according to the weight parts, adding water, decocting for two times, the first time lasts for 1 hour, the second time lasts for 0.5 hour, combining the decoctions, filtering, concentrating the filtrate to a proper amount, precipitating with ethanol twice, refrigerating the first solution at 4 ℃ for 24 hours at the second time for 24 hours, filtering, and concentrating the filtrate to a proper amount to obtain the effective component of the invention.
(2) Preparation of a solution for aerosol inhalation of anti-asthmatic:
Figure BDA0003394195450000083
Figure BDA0003394195450000091
weighing the effective components according to the prescription amount, adding a proper amount of water for injection, and uniformly stirring to obtain a solution 1; adding a proper amount of water for injection into magnesium chloride, and stirring to dissolve the magnesium chloride to obtain a solution 2; mixing the solution 1 and the solution 2, and uniformly stirring to obtain a solution 3; and preparing a solution of 0.4mol/L by adding a proper amount of disodium hydrogen phosphate and a proper amount of water for injection, slowly adding the solution into the solution 3 while stirring, adjusting the pH value to 6.5-8.5, adding 1000ml of water for injection, filling and sealing to obtain the compound disodium hydrogen phosphate injection.

Claims (10)

1. An antiasthmatic solution for aerosol inhalation, which comprises (1) an effective component of antiasthmatic; (2) isotonic agents and solvents;
wherein the mass ratio of the effective components to the isotonic agent is 1:1-1: 5.
2. The formulation according to claim 1, wherein the active ingredient is prepared by:
5-15 parts of ephedra, 1-10 parts of flos lonicerae, 5-15 parts of bitter almond and 5-25 parts of fructus forsythiae
Weighing the four medicines according to the weight parts, adding water, decocting for two times, the first time lasts for 1 hour, the second time lasts for 0.5 hour, combining the decoctions, filtering, concentrating the filtrate to a proper amount, precipitating with ethanol twice, refrigerating the first solution at 4 ℃ for 24 hours at the second time for 24 hours, filtering, and concentrating the filtrate to a proper amount to obtain the effective component of the invention.
3. The formulation according to claim 2, characterized in that the active principle is prepared by:
6-10 parts of ephedra, 3-5 parts of datura flower, 7-12 parts of bitter almond and 8-20 parts of weeping forsythia capsule
Weighing the four medicines according to the weight parts, adding water, decocting for two times, the first time lasts for 1 hour, the second time lasts for 0.5 hour, combining the decoctions, filtering, concentrating the filtrate to a proper amount, precipitating with ethanol twice, refrigerating the first solution at 4 ℃ for 24 hours at the second time for 24 hours, filtering, and concentrating the filtrate to a proper amount to obtain the effective component of the invention.
4. The formulation of claim 1, wherein the isotonicity agent is one of sodium chloride, potassium chloride, magnesium chloride, calcium chloride, glucose, xylitol, and sorbitol.
5. The formulation of claim 1, further comprising a buffer.
6. The formulation of claim 5, wherein the buffer is one of citric acid-sodium citrate, citric acid-disodium hydrogen phosphate, potassium dihydrogen phosphate-disodium hydrogen phosphate, citric acid-sodium hydroxide, and citric acid-disodium hydrogen phosphate.
7. The formulation of claim 1, wherein the pH of the solution for nebulization and inhalation is from 3.0 to 8.5.
8. The formulation of claim 7, wherein the pH of the solution for nebulization and inhalation is from 4.0 to 7.0.
9. The formulation of claim 1, wherein the amount of the solution for inhalation is 0.1 to 0.8 times the amount of the injection of antiasthmatic.
10. The formulation of claim 9, wherein the amount of the solution for inhalation is 0.3 to 0.6 times the amount of the injection of antiasthmatic.
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