CN112957350A - A herba Houttuyniae aerosol inhalation solution and its preparation method - Google Patents

A herba Houttuyniae aerosol inhalation solution and its preparation method Download PDF

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CN112957350A
CN112957350A CN202110140294.8A CN202110140294A CN112957350A CN 112957350 A CN112957350 A CN 112957350A CN 202110140294 A CN202110140294 A CN 202110140294A CN 112957350 A CN112957350 A CN 112957350A
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houttuynia cordata
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张保献
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Shenwei Pharmaceutical Group Co Ltd
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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Abstract

The invention relates to a houttuynia cordata solution preparation for atomization and inhalation, belonging to the field of pharmaceutics. A solution preparation for atomizing and inhaling houttuynia cordata comprises (1) effective components of houttuynia cordata; (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 houttuynia cordata injection, reduces the dosage and improves the safety.

Description

A herba Houttuyniae aerosol inhalation solution and its preparation method
Technical Field
The invention relates to a houttuynia cordata solution preparation for atomization and inhalation and a preparation method thereof, belonging to the field of pharmaceutics.
Background
The houttuynia cordata injection has the effects of clearing heat, detoxifying and promoting diuresis, and is mainly suitable for lung abscess, phlegm heat cough, leucorrhea, urinary tract infection, carbuncle furuncle and the like. However, in recent years, with the increase of the population for clinical medication, the adverse reaction reports are increasing, so that the research and development of novel medicaments with definite curative effect and rapid effect have important practical significance.
Disclosure of Invention
The invention mainly solves the technical problem of providing a safe, effective and excellent-quality houttuynia cordata atomizing inhalation solution preparation; the invention also provides a preparation method of the preparation.
The invention is realized by the following technical scheme:
a solution formulation for the aerosol inhalation of houttuynia cordata comprising:
(1) effective component of herba Houttuyniae;
(2) isotonic agents and solvents;
buffers may also be added.
Wherein the mass ratio of the effective component of the houttuynia cordata to the isotonic agent is 1:1-1: 5.
The active ingredients are prepared by the following steps:
steam distilling 2000g of fresh houttuynia cordata, collecting 200ml of primary distillate, redistilling, collecting 1000ml of secondary distillate, and properly concentrating 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 dosage of the atomized inhalation solution is 0.1-0.8 times of the dosage of the houttuynia cordata injection; the preferable dosage is 0.3-0.6 times of the dosage of the houttuynia cordata injection.
The houttuynia cordata solution preparation for atomization and inhalation can be used for treating lung abscess, phlegm heat cough and the like.
The invention has the advantages that the invention provides a new formulation which is superior to the houttuynia cordata injection, the formulation 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, and can be directly absorbed from the mucosa of the airway and the lung, the administration mode can directly deliver the effective components to the focus, and the invention has the advantages of safety, effectiveness, high bioavailability, low dose and quick and effective treatment, thereby having obvious advantages.
The solution preparation prepared by the invention makes up for the blank of 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 houttuynia cordata 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 houttuynia cordata 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 phlegm-heat cough 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 normal saline for intravenous injection; the positive control group is given with the houttuynia cordata injection for intravenous injection; the first, second, third and fourth drug groups are respectively administered with the houttuynia cordata atomized inhalation solution (the dosage is respectively 0.1 time, 0.3 time, 0.6 time and 0.8 time of the houttuynia cordata injection), and are continuously administered for 5 days, and the cure rate, the adverse reaction incidence rate and the drug peak concentration in lung tissues and blood after the last administration of the drug are observed. In particular, see the following table:
table conditions after treatment of each group
Figure BDA0002928498300000021
Therefore, each drug group has a better treatment effect on the phlegm-heat cough 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 on treating other indications is also obviously better than that of the houttuynia injection.
The houttuynia cordata atomization inhalation solution has the treatment effect obviously superior to that of houttuynia cordata injection, fills up the blank of the special houttuynia cordata atomization inhalation solution in the domestic market at present, greatly reduces the dosage compared with the houttuynia cordata injection, is 0.1-0.8 times, preferably 0.3-0.6 times of the houttuynia cordata injection, changes the administration route and reduces the occurrence of adverse reactions, and therefore, the houttuynia cordata atomization 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:
steam distilling 2000g of fresh houttuynia cordata, collecting 200ml of primary distillate, redistilling, collecting 1000ml of secondary distillate, and properly concentrating to obtain the effective component of the invention.
(2) Preparation of a solution for houttuynia cordata aerosol inhalation:
Figure BDA0002928498300000031
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 4.5-6.5, adding a proper amount of water for injection, filling and sealing to obtain the compound disodium hydrogen phosphate injection.
Example 2
(1) Preparation of active ingredients: the same as in example 1.
(2) Preparation of a solution for houttuynia cordata aerosol inhalation:
Figure BDA0002928498300000032
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 4.0-6.0, adding a proper amount of water for injection, filling and sealing to obtain the compound disodium hydrogen phosphate injection.
Example 3
(1) Preparation of active ingredients: the same as in example 1.
(2) Preparation of a solution for houttuynia cordata aerosol inhalation:
Figure BDA0002928498300000041
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 a proper amount of water for injection, filling and sealing to obtain the compound disodium hydrogen phosphate injection.
Example 4
(1) Preparation of active ingredients: the same as in example 1.
(2) Preparation of a solution for houttuynia cordata aerosol inhalation:
Figure BDA0002928498300000042
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 5.0-7.0, adding a proper amount of water for injection, filling and sealing to obtain the compound disodium hydrogen phosphate injection.
Example 5
(1) Preparation of active ingredients: the same as in example 1.
(2) Preparation of a solution for houttuynia cordata aerosol inhalation:
Figure BDA0002928498300000043
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 adding an appropriate amount of sodium citrate and an appropriate amount of water for injection to prepare a solution of 0.2mol/L, slowly adding the solution into the solution 3 while stirring, adjusting the pH value to 3.0-5.0, adding an appropriate amount of water for injection, filling and sealing to obtain the product.
Example 6
(1) Preparation of active ingredients: the same as in example 1.
(2) Preparation of a solution for houttuynia cordata aerosol inhalation:
Figure BDA0002928498300000051
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 a proper amount of water for injection, filling and sealing to obtain the compound disodium hydrogen phosphate injection.
Example 7
(1) Preparation of active ingredients: the same as in example 1.
(2) Preparation of a solution for houttuynia cordata aerosol inhalation:
Figure BDA0002928498300000052
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 6.5-8.5, adding an appropriate amount of water for injection, filling and sealing to obtain the product.
Example 8
(1) Preparation of active ingredients: the same as in example 1.
(2) Preparation of a solution for houttuynia cordata aerosol inhalation:
Figure BDA0002928498300000053
Figure BDA0002928498300000061
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 5.5-7.5, adding a proper amount of water for injection, filling and sealing to obtain the compound disodium hydrogen phosphate injection.
Example 9
(1) Preparation of active ingredients: the same as in example 1.
(2) Preparation of a solution for houttuynia cordata aerosol inhalation:
Figure BDA0002928498300000062
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 6.0-8.0, adding a proper amount of water for injection, filling and sealing to obtain the compound disodium hydrogen phosphate injection.
Example 10
(1) Preparation of active ingredients: the same as in example 1.
(2) Preparation of a solution for houttuynia cordata aerosol inhalation:
Figure BDA0002928498300000063
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 7.5-8.5, adding a proper amount of water for injection, filling and sealing to obtain the compound disodium hydrogen phosphate injection.
Example 11
(1) Preparation of active ingredients: the same as in example 1.
(2) Preparation of a solution for houttuynia cordata aerosol inhalation:
Figure BDA0002928498300000071
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 0.2mol/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 6.0-7.0, adding a proper amount of water for injection, filling and sealing to obtain the compound disodium hydrogen phosphate injection.

Claims (9)

1. A solution preparation for atomizing and inhaling houttuynia cordata is characterized by comprising (1) effective components of houttuynia cordata; (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:
steam distilling 2000g of fresh houttuynia cordata, collecting 200ml of primary distillate, redistilling, collecting 1000ml of secondary distillate, and properly concentrating to obtain the effective component of the invention.
3. The formulation of claim 1, wherein the isotonicity agent is one of sodium chloride, potassium chloride, magnesium chloride, calcium chloride, glucose, xylitol, and sorbitol.
4. The formulation of claim 1, further comprising a buffer.
5. The formulation of claim 4, 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.
6. The formulation of claim 1, wherein the pH of the solution for nebulization and inhalation is from 3.0 to 8.5.
7. The formulation of claim 6, wherein the pH of the solution for nebulization and inhalation is from 4.0 to 7.0.
8. 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 solution of houttuynia cordata.
9. The formulation of claim 8, wherein the amount of the solution for inhalation is 0.3 to 0.6 times the amount of the injection solution of houttuynia cordata.
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