Patents of beclomethasone propionate suspension

Preface—

In the middle of winter, the temperature in most parts of the country has dropped below freezing point, and the winter solstice is coming. Parents are afraid of their children "staying at home" and catching a cold. However, they can't stop catching a cold, having a fever, coughing, wheezing and, alas, tears. ...

A few days ago, a 3-year-old child in the ward just recovered from severe pneumonia. A few days later, the mother took the child to the clinic. Let me see. Isn't this the little guy who was infected with Klebsiella pneumoniae the other day? This disease can make mom and dad suffer a lot.

Mother said: "The baby has been discharged from the hospital for a few days, and everything is not bad, except that he has an endless cough and seems to have phlegm in his throat." Is it not good enough? "

Dad said: "The doctor told me that the child is too young to use cough medicine casually, saying that coughing is a kind of protection, but people say that atomizing inhalation has many side effects."

At present, pediatricians at home and abroad have repeatedly suggested that children under 2 years old and before 6 years old should not take cough medicine and cold medicine (at least before 2 years old); Just as children should not abuse antibiotics to prevent flora imbalance. As a result, parents have been worried, what should children do if they cough and have phlegm?

Parents' questions:

In fact, for many years, the theory of aerosol inhalation therapy has been reversed for a long time and debated endlessly. Which aspect is more reliable?

Can't children cough and atomize quickly? Parents take their children to see a doctor, and the doctor will probably let them do atomized inhalation. Is the effect of atomization treatment so "divine"?

Recently, it has been circulated on the Internet that atomization inhalation is mostly the function of hormones. Who dares to use hormones? What obesity, buffalo back, long beard, infection? Who doesn't "stay away" from this side effect?

The adverse reactions of atomized inhalation are not less than that of infusion, and the mucosa absorbs drugs quickly. Are the side effects of drugs also possessed? Can I use any medicine when inhaling by atomization? Can antibiotics be used Oh, now that information is so developed, anyone looking for "Du Niang" will have an answer, but it is not clear whether it is accurate or not.

Authoritative guidance:

In fact, atomization therapy is not a "new therapy", nor is it derived from intravenous infusion therapy because of people's convenience. As early as 1950s, atomization therapy was used as an auxiliary treatment for respiratory diseases in British medical research, and it has been carried out in China for 20 to 30 years.

In order to further standardize and rationally use children's medication and ensure the safety of children's medication, the National Children's Medical Center and the editorial board of China Journal of Practical Pediatrics have organized experts to discuss in recent years, and have successively formulated a number of clinical guidelines and * * * knowledge related to aerosol inhalation therapy, among which the most authoritative ones are "Guidelines for Rational Drug Use for Children's Asthmatic Diseases" and * * Expert Knowledge on Rational Drug Use for Aerosol Inhalation Therapy (20 19 Edition). This provides authoritative guidance for our aerosol inhalation and provides guarantee and medication standard for children's aerosol treatment. As long as the medication guide is strictly grasped, the atomization inhalation treatment is safe and reliable.

What is atomized inhalation:

Atomization inhalation is to dissolve and disperse drugs and sterilized water into inhalable droplets (droplets or particles with a diameter of several microns) in a professional atomization device, and these droplets are inhaled by children and deposited in the respiratory tract and/or lungs, thus achieving the effect of local treatment of respiratory tract.

This function is:

Atomization inhalation makes drugs directly act on respiratory mucosa, achieving direct curative effect. Atomized inhalation has the characteristics of high safety, simple operation, flexible dosage adjustment and convenient application, and has no special requirements for the compliance of children's treatment. It is especially suitable for pediatric children, so it has been widely used in pediatrics. It has been widely used in the adjuvant treatment of children's bronchial asthma, acute laryngitis, bronchiolitis, bronchopneumonia and other diseases.

Therefore, we can understand that our respiratory tract is connected with the outside world, and atomization inhalation is to make full use of the openness of the respiratory tract and add some treated and inhalable droplets containing drugs to the air that children breathe, so as to achieve the effects of relieving airway spasm, diminishing inflammation, humidifying and thinning phlegm.

First of all, it should be emphasized that the routes of administration and therapeutic purposes between them are different. Aerosol inhalation is more used as an auxiliary treatment for respiratory diseases. Therefore, the scope of medication may not be as wide as intravenous infusion. Intravenous infusion is a method to deal with a large number of liquids, electrolytes, drugs, etc. Enter various organs of the body through intravenous routes.

In recent years, the scientific research department has continuously improved the driving device of atomization inhalation, increased the types of drugs used in atomization, and gradually enhanced the safety. At present, it is mainly used for laryngitis, bronchitis, bronchiolitis and pneumonia in children. The effect of relieving asthma and resolving phlegm is obvious.

1. Atomization inhalation is convenient, fast and non-invasive;

The atomization inhalation operation is simple. Ultrasonic atomization device can be selected at home, and air compression pump or oxygen-driven atomization device can be selected at hospital. Generally, it can be operated without special professional training. However, infusion must be completed by professional medical staff, and the aseptic operation technology is strict, which is impossible for ordinary people to operate.

Atomization inhalation is a non-invasive operation, and children are not alert, so the compliance of treatment is better than intravenous infusion. Venous puncture is an invasive operation, and children cry when they see needles, and they are unwilling to infusion.

2, the local atomization drug takes effect quickly;

Atomization inhalation is that drugs directly act on respiratory mucosa without being transported through systemic blood circulation, so drugs take effect quickly, especially bronchodilators and anti-inflammatory glucocorticoids.

3. The adverse reaction of drugs is very small:

Because atomization inhalation directly acts on respiratory mucosa, mainly local medication, the dosage of atomization therapy is far less than that of systemic medication, that is, intravenous infusion, especially the dosage of glucocorticoid is less than that of110 of infusion or oral dosage, so the medication safety is better than that of infusion, and the adverse reactions are relatively few. Intravenous infusion is transported through the whole body blood, and its blood dose and concentration are large, and its drug half-life is long; Therefore, it will increase the burden of children's liver and kidney function.

At the same time, despite strict aseptic technology, the probability of blood transfusion reaction is inevitable. Thermogenic substances (allergy, agglutination, antigen, etc.). ) in liquid, children will suddenly have high fever, chills, skin allergies and other hypersensitivity reactions, and severe anaphylactic shock will occur, which is life-threatening. This is the biggest harm of intravenous infusion.

1, inhaled glucocorticoid: It is the strongest local anti-inflammatory drug in the airway known by experts at present, and is mainly used for the treatment of airway inflammation with high reactivity, such as bronchial asthma. Commonly used and recommended inhaled sex hormone suspensions are budesonide, beclomethasone dipropionate and fluticasone propionate.

The World Health Organization and China Pediatric Society have designated budesonide as the only recommended list of essential drugs for children with asthma, which is currently applicable to children under 12 years old. However, fluticasone propionate is only suitable for the treatment of acute attack of mild and moderate asthma in 4-year-old children 16.

2.β2 receptor agonists: these drugs are the most commonly used bronchodilators in clinic, which are characterized by rapid onset and short maintenance time; As a short-term medication for bronchial asthma, it usually lasts for 4-6 hours. Mainly used to relieve bronchospasm and stenosis, can be used as needed, and takes effect within a few minutes. Generally, this medicine is used in combination with hormones, which has a synergistic effect. Terbutaline and salbutamol are commonly used as atomized preparations of β2 receptor agonists.

3. Cholinergic M receptor antagonist: It has bronchiectasis and is mainly used for wheezing, coughing and excessive phlegm in children. The drug takes effect slowly, but lasts longer than β2 receptor agonist, so it is often used in combination with salbutamol, which can complement each other and is mainly used for combined inhalation during acute asthma attack. The main atomizing drug is ipratropium bromide.

4. expectorants: These drugs can dilute sputum, reduce viscosity and make it easy to cough up, or accelerate the ciliary movement of respiratory mucosa and improve the transportation function of sputum. It mainly promotes the discharge of sputum accumulated in the lumen of respiratory tract, reduces the stimulation to respiratory mucosa, indirectly plays the role of relieving cough and asthma, and is also conducive to controlling secondary infection. At present, there are two kinds of atomized inhalation expectorants in China, acetylcysteine solution and ambroxol hydrochloride solution.

However, after clinical drug investigation, not all drugs and diseases can be inhaled by atomization. Under normal circumstances, the application and administration of atomized inhalation should be guided by doctors, and there will be different diagnosis and treatment schemes according to individual differences. Any treatment and drug should not be abused at will.

1, dexamethasone, α-chymotrypsin, antibiotics and antiviral drugs (interferon and ribavirin), Chinese patent medicine injection, etc. Especially for children who are highly allergic to antibiotics, even if there is skin allergy test, there is still the risk of allergy when drugs are absorbed through skin and mucosa. Traditional Chinese medicine preparations, due to the complex types of drugs, the side effects of drugs have not been confirmed, and there are hidden dangers in drug use.

2. Although the clinical application of ambroxol injection has been reported in China, there is no description of the safety evaluation of atomized inhalation at present. In version 20 18, it is listed as a drug list outside the instructions, and atomized inhalation is not recommended. Therefore, for safety reasons, out-of-range use is not recommended. Children often choose acetylcysteine atomized solution for inhalation.

1 first of all, the atomization device should be cleaned and disinfected, so that one person can use it and disinfect it, especially the masks, distillers and pipes for inhalation.

2. When doing inhalation therapy, teach children to keep calm and take a deep breath slowly, so as to facilitate the deposition of drug particles in the respiratory tract, especially in the bronchi and alveoli, and try to achieve better absorption of drugs.

3, the child should use various methods to make the child breathe as smoothly as possible, crying will affect the therapeutic effect, because the drug particles mainly transport the drug to the oropharynx through the inertia of airflow.

4. The mask suitable for children's age should be attached to the face as comfortably and tightly as possible, so that the drug particles can be inhaled evenly and not sprayed into the eyes.

5, aerosol inhalation, parents should pay attention to observe the child's breathing, cough, expectoration, if the child is upset and crying, stop aerosol inhalation, or consult a doctor. Give medicine or wash your face after treatment to reduce the absorption of medicine in other parts. Rinse your mouth or drink water at the same time to avoid drug residue in the oropharynx.

6. Atomized inhalation is also a medical behavior, especially if it is a prescription drug. Parents must correctly apply atomized inhalation under the guidance of doctors according to the needs of their illness.