CN107789340B - Solution preparation for andrographis paniculata aerosol inhalation and preparation method thereof - Google Patents
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Abstract
The invention relates to a solution preparation for andrographis paniculata aerosol inhalation, and belongs to the field of pharmaceutics. A solution preparation for atomizing and inhaling herba Andrographitis comprises (1) effective components of herba Andrographitis; (2) isotonic agent and solvent. 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 atomized by an ultrasonic atomizer or an air compression type atomizer and then directly inhaled into a respiratory system in an atomization mode, is convenient and fast in use process, has different administration ways compared with common andrographis herb oral liquid, reduces the dosage, takes effect quickly, improves the safety, and can better play the role of treating upper respiratory tract infection, sore throat, cough with lung heat and the like.
Description
Technical Field
The invention relates to a solution preparation for andrographis paniculata aerosol inhalation and a preparation method thereof, belonging to the field of pharmaceutics.
Background
Herba Andrographitis is also called Happy, WANGBIXIANCAO, Sizhibang, etc., and has bitter and cold properties, and has effects of clearing away heat and toxic materials, cooling blood and stopping bleeding. The main component of herba Andrographitis is andrographolide, has effects of clearing heat and detoxicating, and can be used for treating upper respiratory infection, laryngopharynx swelling and pain, lung heat cough, etc. Due to the good treatment efficacy, the common andrographis herbs are developed into common dosage forms such as tablets, capsules, injections, soft capsules, dropping pills and the like, and are well popularized and applied.
The traditional oral preparation has large dosage, can not directly act on the affected part, needs the first pass effect of the liver, enters a circulatory system to act on the affected part, has slow effect, and limits the medication of patients to a certain extent. The injection needs to pass through a circulating system and acts on the affected part, so that the distribution of the medicine in other tissues is more, the toxic and side effects of the medicine are increased, and the problems of pain at the administration part and poor patient compliance exist in the administration of the injection. The aerosol inhalation solution preparation can be directly acted on the affected part as a respiratory tract or lung administration preparation, can improve the administration concentration of the respiratory tract or the lung, has quick response, avoids the first pass effect of the liver, reduces the administration dosage of the medicament, improves the bioavailability of the medicament, reduces the distribution of the medicament in other tissues and reduces side effects. Currently, the solution preparations for aerosol inhalation are relatively few products on the market, mainly imported products. Clinically, the aerosol inhalation is frequently applied to injection, but the specification does not have a standard use method, so that the safety hazard exists in the use aspect.
The invention aims to provide a solution preparation for andrographis paniculata aerosol inhalation, which has high bioavailability, is directly acted on a focus part, has quick response and is safer and more effective.
Disclosure of Invention
The invention mainly solves the technical problem of providing a safe, effective and excellent-quality andrographis paniculata solution preparation for aerosol inhalation; the invention also provides a preparation method of the preparation.
The invention is realized by the following technical scheme:
an andrographis paniculata solution formulation for aerosol inhalation comprising:
(1) ethanol extract of Andrographis paniculata Nees;
(2) isotonic agents and solvents;
(3) a cosolvent;
wherein the isotonic agent is inorganic salt isotonic agent or saccharide isotonic agent; the amount of the isotonic agent of inorganic salts in each preparation unit of the andrographis paniculata solution preparation for aerosol inhalation is 0.2-0.9%, or the amount of the isotonic agent of saccharides in each preparation unit of the andrographis paniculata solution preparation for aerosol inhalation is 1-10%.
The solution preparation for andrographis paniculata aerosol inhalation is prepared by the following steps:
10 portions of andrographis paniculata ethanol extract
Weighing the andrographis paniculata ethanol extract according to the weight parts, adding water for injection and a proper amount of cosolvent, stirring or grinding, adding half amount of water for injection under stirring or grinding to dissolve the water, adding a proper amount of activated carbon, fully stirring, boiling for 30min, cooling to room temperature, refrigerating for 24h, filtering, adding water for injection to 980ml, adding a proper amount of isotonic agent, adding water for injection to full amount, adjusting the pH value, ultrafiltering, encapsulating, and sterilizing to obtain the solution preparation of the invention.
Wherein, the andrographis paniculata ethanol extract is prepared by the following steps: extracting folium Andrographis with 20 times of 90% ethanol by hot dipping for 3 times, each time for 4h, mixing extractive solutions, filtering, recovering ethanol from filtrate to 1:1.5, adding 5-6% active carbon, heating and refluxing for 30min, filtering while hot, washing filter residue with appropriate amount of ethanol, mixing filtrates, adding 3 times of ethanol, stirring, standing for 24h, filtering, recovering ethanol from filtrate, and making into fluid extract.
The inorganic salt isotonic agent is one of sodium chloride, magnesium chloride and calcium chloride; the saccharide isoosmotic agent is one of glucose, fructose and mannitol; sodium chloride is preferred.
The cosolvent is one of hydroxypropyl-beta-cyclodextrin, tween 80, polyethylene glycol-400 and propylene glycol.
The pH value of the atomized inhalation solution is 3.0-8.5; preferably, the pH is 5.0 to 8.0.
The daily crude drug amount of the solution for atomization and inhalation is 0.1-1.0 time of that of the andrographis paniculata injection; the preferable dosage is 0.3-1.0 times of daily crude drug of herba Andrographitis injection.
The resulting aerosolized inhalation solution formulation is directly inhaled into the respiratory system in an aerosolized form using an ultrasonic nebulizer or an air compression nebulizer.
The andrographis paniculata solution preparation for aerosol inhalation has the effects of clearing heat and removing toxicity, and can be used for treating upper respiratory tract infection, sore throat, lung heat cough and the like.
The invention has the advantages that the invention provides a new formulation which is superior to andrographis paniculata injection, the formulation is that the medicament is dissolved in a proper medium, and is delivered to respiratory tract or lung by oral or nasal inhalation in an aerosol form by an atomizer, the medicament is delivered to the action part directly, the distribution of the medicament in other tissues and organs is reduced, the medicament concentration of local focuses is high, compared with oral administration, the total treatment effective rate of an aerosol inhalation administration mode is greatly improved, and the invention has the characteristics of safety, effectiveness, high bioavailability and small toxic and side effect, thereby having obvious advantages.
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 andrographis paniculata injection, reduces the dosage and improves the safety. Meanwhile, the first pass effect of liver passing required by injection administration can be avoided, the injury to patients can be avoided, the compliance of the patients can be increased, and the oral administration preparation is a good administration route for children who are inconvenient to take orally.
The beneficial effects of the present invention are further illustrated by the following test examples:
150 patients with upper respiratory tract infection are diagnosed in an outpatient clinic, the age is 14-60 years, the course of the disease is less than 7 days, and the clinical manifestations are fever and cough with different degrees. Patients with similar ages are divided into an observation group 1, an observation group 2 and a control group according to the sequence of the treatment, each group comprises 50 patients, the three groups of patients have comparability in sex, age and disease condition, and the treatment effect is easy to compare.
The observation group 1 was administered with the solution preparation for inhalation of andrographis paniculata of example 1 for aerosol inhalation therapy, the observation group 2 was administered with the solution preparation for inhalation of andrographis paniculata of example 2 for aerosol inhalation therapy, and the control group was administered with injection therapy of andrographis paniculata injection (Zhejiang Connbei pharmaceutical Co., Ltd.). The treatment course of three groups is 3 days.
The curative effect standard is as follows: (1) the effect is shown: no or only slight cough, no fever, and pharyngeal congestion resolved; (2) the method has the following advantages: the treatment of the clinical symptoms and the pharyngeal physical signs for more than 3 days is obviously improved; (3) and (4) invalidation: after 3 days of treatment, the clinical symptoms and the pharyngeal physical signs are not improved or aggravated, and the fever is not relieved. In particular, see the following table:
comparison of efficacy of the three groups of patients in treating upper respiratory tract infection [ n (%) ]
| Group of | Show effect | Is effective | Invalidation | Total effective rate |
| Observation group 1 | 7（14.0） | 14（28.0） | 29（58.0） | 42.0 |
| Observation group 2 | 15（30.0） | 22（44.0） | 13（26.0） | 74.0 |
| Control group | 9（18.0） | 16（32.0） | 25（50.0） | 50.0 |
As can be seen from the table, the observation group 1, the observation group 2 and the control group all have treatment effects on the upper respiratory tract infection, wherein the treatment effect of the observation group 2 is significantly better than that of the control group (P < 0.05).
Similarly, the effect of observation group 2 on treating cough with lung heat, sore throat, etc. is also obviously superior to that of andrographis paniculata injection.
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) Preparing an andrographis paniculata ethanol extract:
extracting folium Andrographis with 20 times of 90% ethanol by hot dipping for 3 times, each time for 4h, mixing the extractive solutions, filtering, recovering ethanol from the filtrate to 1:1.5, adding 5-6% active carbon, heating and refluxing for 30min, filtering while hot, washing the filter residue with appropriate amount of ethanol, mixing the filtrates, adding 3 times of ethanol, stirring, standing for 24h, filtering, recovering ethanol from the filtrate, and making into fluid extract.
(2) Preparation of solution for andrographis paniculata aerosol inhalation:
andrographis paniculata Nees ethanol extract 4g
Sodium chloride 9g
Proper amount of beta-cyclodextrin
Adding water for injection to 1000ml
Weighing the andrographis paniculata ethanol extract according to the prescription amount, adding 30ml of aqueous solution containing a proper amount of beta-cyclodextrin, grinding to paste, adding half amount of water for injection, stirring to dissolve, adding activated carbon, fully stirring, boiling for 30min, cooling to room temperature, filtering when refrigerating for 24h, adding water for injection to 980ml, adding 9g of sodium chloride to dissolve, adding water for injection to 1000ml, adjusting the pH to 6.5, ultrafiltering, encapsulating and sterilizing to obtain the solution preparation of the invention.
The resulting aerosolized inhalation solution formulation is aerosolized using an ultrasonic nebulizer and then directly inhaled into the respiratory system in an aerosolized form.
Example 2
(1) Preparing an andrographis paniculata ethanol extract: the same as in example 1.
(2) Preparation of solution for andrographis paniculata aerosol inhalation:
andrographis paniculata Nees ethanol extract 7g
6g of sodium chloride
Proper amount of hydroxypropyl-beta-cyclodextrin
Adding water for injection to 1000ml
Weighing the andrographis paniculata ethanol extract according to the prescription amount, adding 40ml of aqueous solution containing a proper amount of hydroxypropyl-beta-cyclodextrin, grinding to paste, adding half amount of water for injection, stirring to dissolve, adding activated carbon, fully stirring, boiling for 30min, cooling to room temperature, refrigerating for 24h, filtering, adding water for injection to 980ml, adding 6g of sodium chloride, dissolving, adding water for injection to 1000ml, adjusting the pH to 7.0, performing ultrafiltration, filling and sealing, and sterilizing to obtain the solution preparation.
The resulting aerosolized inhalation solution formulation is aerosolized using an ultrasonic nebulizer and then directly inhaled into the respiratory system in an aerosolized form.
Example 3
(1) Preparing an andrographis paniculata ethanol extract: the same as in example 1.
(2) Preparation of solution for andrographis paniculata aerosol inhalation:
andrographis paniculata Nees ethanol extract 3g
Glucose 100g
Proper amount of hydroxypropyl-beta-cyclodextrin
Adding water for injection to 1000ml
Weighing the andrographis paniculata ethanol extract according to the prescription amount, adding 10ml of aqueous solution containing a proper amount of hydroxypropyl-beta-cyclodextrin, grinding to paste, adding half amount of water for injection, stirring to dissolve, adding activated carbon, fully stirring, boiling for 30min, cooling to room temperature, refrigerating for 24h, filtering, adding water for injection to 980ml, adding 100g of glucose, dissolving, adding water for injection to 1000ml, adjusting the pH to 3.0, performing ultrafiltration, filling and sealing, and sterilizing to obtain the solution preparation.
The resulting aerosolized inhalation solution formulation is aerosolized using an ultrasonic nebulizer and then directly inhaled into the respiratory system in an aerosolized form.
Example 4
(1) Preparing an andrographis paniculata ethanol extract: the same as in example 1.
(2) Preparation of solution for andrographis paniculata aerosol inhalation:
andrographis paniculata Nees ethanol extract 1g
Fructose 80g
Proper amount of beta-cyclodextrin
Adding water for injection to 1000ml
Weighing the andrographis paniculata ethanol extract according to the prescription amount, adding 20ml of aqueous solution containing a proper amount of beta-cyclodextrin, grinding to paste, adding half amount of water for injection, stirring to dissolve, adding activated carbon, fully stirring, boiling for 30min, cooling to room temperature, refrigerating for 24h, filtering, adding water for injection to 980ml, adding 80g of fructose to dissolve, adding water for injection to 1000ml, adjusting the pH to 3.5, ultrafiltering, filling and sealing, and sterilizing to obtain the solution preparation.
The resulting aerosolized inhalation solution formulation is aerosolized using an air compression nebulizer and then directly inhaled into the respiratory system in an aerosolized form.
Example 5
(1) Preparing an andrographis paniculata ethanol extract: the same as in example 1.
(2) Preparation of solution for andrographis paniculata aerosol inhalation:
andrographis paniculata Nees ethanol extract 8g
Mannitol 20g
Proper amount of propylene glycol
Adding water for injection to 1000ml
Weighing the andrographis paniculata ethanol extract according to the prescription amount, adding a proper amount of aqueous solution of propylene glycol, stirring, adding half amount of water for injection under stirring for dissolving, adding activated carbon, fully stirring, boiling for 30min, cooling to room temperature, refrigerating for 24h, filtering, adding water for injection to 980ml, adding 20g of mannitol for dissolving, adding water for injection to 1000ml, adjusting the pH value to 5.0, ultrafiltering, encapsulating and sterilizing to obtain the solution preparation of the invention.
The resulting aerosolized inhalation solution formulation is aerosolized using an air compression nebulizer and then directly inhaled into the respiratory system in an aerosolized form.
Example 6
(1) Preparing an andrographis paniculata ethanol extract: the same as in example 1.
(2) Preparation of solution for andrographis paniculata aerosol inhalation:
andrographis paniculata Nees ethanol extract 5g
Magnesium chloride 2g
Appropriate amount of Tween 80
Adding water for injection to 1000ml
Weighing the andrographis paniculata ethanol extract according to the prescription amount, adding a proper amount of Tween 80 aqueous solution, stirring, adding half amount of water for injection under stirring for dissolving, adding activated carbon, fully stirring, boiling for 30min, cooling to room temperature, refrigerating for 24h, filtering, adding water for injection to 980ml, adding 2g of magnesium chloride for dissolving, adding water for injection to 1000ml, adjusting the pH value to 7.5, ultrafiltering, encapsulating and sterilizing to obtain the solution preparation of the invention.
The resulting aerosolized inhalation solution formulation is aerosolized using an air compression nebulizer and then directly inhaled into the respiratory system in an aerosolized form.
Example 7
(1) Preparing an andrographis paniculata ethanol extract: the same as in example 1.
(2) Preparation of solution for andrographis paniculata aerosol inhalation:
andrographis paniculata Nees ethanol extract 10g
Glucose 10g
Appropriate amount of polyethylene glycol-400
Adding water for injection to 1000ml
Weighing the andrographis paniculata ethanol extract according to the prescription amount, adding a proper amount of polyethylene glycol-400 aqueous solution, stirring, adding half amount of injection water under stirring for dissolving, adding activated carbon, fully stirring, boiling for 30min, cooling to room temperature, refrigerating for 24h, filtering, adding injection water to 980ml, adding 10g of glucose, dissolving, adding injection water to 1000ml, adjusting the pH to 8.5, ultrafiltering, encapsulating and sterilizing to obtain the solution preparation of the invention.
The resulting aerosolized inhalation solution formulation is aerosolized using an air compression nebulizer and then directly inhaled into the respiratory system in an aerosolized form.
Example 8
(1) Preparing an andrographis paniculata ethanol extract: the same as in example 1.
(2) Preparation of solution for andrographis paniculata aerosol inhalation:
andrographis paniculata Nees ethanol extract 2g
Fructose 50g
Proper amount of propylene glycol
Adding water for injection to 1000ml
Weighing the andrographis paniculata ethanol extract according to the prescription amount, adding 30ml of aqueous solution containing a proper amount of propylene glycol, adding half amount of water for injection under grinding for dissolving, adding activated carbon, fully stirring, boiling for 30min, cooling to room temperature, refrigerating for 24h, filtering, adding water for injection to 980ml, adding 50g of fructose for dissolving, adding water for injection to 1000ml, adjusting the pH to 8.0, ultrafiltering, encapsulating and sterilizing to obtain the solution preparation of the invention.
The resulting aerosolized inhalation solution formulation is aerosolized using an air compression nebulizer and then directly inhaled into the respiratory system in an aerosolized form.
Example 9
(1) Preparing an andrographis paniculata ethanol extract: the same as in example 1.
(2) Preparation of solution for andrographis paniculata aerosol inhalation:
andrographis paniculata Nees ethanol extract 6g
Magnesium chloride 4g
Proper amount of hydroxypropyl-beta-cyclodextrin
Adding water for injection to 1000ml
Weighing the andrographis paniculata ethanol extract according to the prescription amount, adding 30ml of aqueous solution containing a proper amount of hydroxypropyl-beta-cyclodextrin, adding half of water for injection under grinding for dissolving, adding active carbon, fully stirring, boiling for 30min, cooling to room temperature, refrigerating for 24h, filtering, adding water for injection to 980ml, adding 4g of magnesium chloride for dissolving, adding water for injection to 1000ml, adjusting the pH to 6.0, ultrafiltering, filling and sealing, and sterilizing to obtain the solution preparation of the invention.
The resulting aerosolized inhalation solution formulation is aerosolized using an air compression nebulizer and then directly inhaled into the respiratory system in an aerosolized form.
Example 10
(1) Preparing an andrographis paniculata ethanol extract: the same as in example 1.
(2) Preparation of solution for andrographis paniculata aerosol inhalation:
andrographis paniculata Nees ethanol extract 9g
Calcium chloride 8g
Appropriate amount of Tween 80
Adding water for injection to 1000ml
Weighing the andrographis paniculata ethanol extract according to the prescription amount, adding 30ml of aqueous solution containing a proper amount of tween 80, adding half amount of water for injection under grinding for dissolving, adding activated carbon, fully stirring, boiling for 30min, cooling to room temperature, refrigerating for 24h, filtering, adding water for injection to 980ml, adding 8g of calcium chloride for dissolving, adding water for injection to 1000ml, adjusting the pH to 4.0, ultrafiltering, encapsulating and sterilizing to obtain the solution preparation of the invention.
The resulting aerosolized inhalation solution formulation is aerosolized using an air compression nebulizer and then directly inhaled into the respiratory system in an aerosolized form.
Claims (4)
1. An andrographis paniculata solution formulation for aerosol inhalation, wherein the formulation comprises:
the preparation method comprises weighing the ethanol extract of herba Andrographitis according to the prescription amount, adding 40ml of aqueous solution containing appropriate amount of hydroxypropyl-beta-cyclodextrin, grinding to paste, adding half amount of water for injection, stirring for dissolving, adding activated carbon, stirring thoroughly, boiling for 30min, cooling to room temperature, refrigerating for 24h, filtering, adding water for injection to 980ml, adding 6g of sodium chloride, dissolving, adding water for injection to 1000ml, adjusting pH to 7.0, ultrafiltering, bottling, and sterilizing to obtain the final product;
the preparation method of the andrographis paniculata ethanol extract comprises the following steps:
extracting folium Andrographis with 20 times of 90% ethanol by hot dipping for 3 times, each time for 4h, mixing extractive solutions, filtering, recovering ethanol from filtrate to 1:1.5, adding 5-6% active carbon, heating and refluxing for 30min, filtering while hot, washing filter residue with appropriate amount of ethanol, mixing filtrates, adding 3 times of ethanol, stirring, standing for 24h, filtering, recovering ethanol from filtrate, and making into fluid extract.
2. The formulation of claim 1, wherein the daily dose of the solution for aerosolization for inhalation is 0.1-1.0 times the daily dose of the injection of Andrographis paniculata Nees.
3. The formulation of claim 2, wherein the daily dose of the solution for aerosolization for inhalation is 0.3-1.0 times the daily dose of the injection of Andrographis paniculata Nees.
4. The formulation of claim 1, wherein: the resulting aerosolized inhalation solution formulation is directly inhaled into the respiratory system in an aerosolized form using an ultrasonic nebulizer or an air compression nebulizer.
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