A kind of fresh bamboo sap Neulized inhalation pharmaceutical solutions and preparation method thereof
Technical field
The present invention relates to a kind of fresh bamboo sap Neulized inhalation pharmaceutical solutions and preparation method thereof, belongs to galenic pharmacy field.
Background technique
As soon as cough is ancient disease, there is the special piece of cough to discuss in medical literature Huangdi's Internal Classics before 2,000 years, and
The mechanism of cough can be made us by discussing the vital organs of the human body all, and the basic pathogenesis clearly coughed is Lung Qi upward reversal.According to doctor trained in Western medicine theory, cough
Coughing is one of most common symptom of respiratory disease, is also possible to independent disease, and a kind of protectiveness for belonging to human body is exhaled
Absorption/reflection movement.Though can effectively clear the secretion in respiratory tract by cough reflex or enter the foreign matter of air flue, cough
There is its unfavorable one side, such as a long time, frequently, acutely coughing influences work, rests, or even causes laryngalgia, hoarse voice and respiratory muscle pain,
Acutely cough can lead to hemorrhage in respiratory tract.
Fresh bamboo sap is a kind of traditional Chinese medicine ingredient for extracting from bamboo, medical value with higher, early in " herbal guiding principle
Mesh " in just it is on the books: fresh bamboo sap, smell is sweet, nontoxic, cures mainly sudden and violent apoplexy, wandering arthritis, in the heart big blood, have apparent antibechic, eliminating the phlegm
And other effects.It is also recorded as Chinese medicine issues drug standards Chinese medicine first in portion in 1992.Modern study and analysis shows,
Contain the plurality of active ingredients including guaiacol and tyrosine in fresh bamboo sap, wherein tyrosine accounts for amino in fresh bamboo sap
Sour total content exceedes 50%.In addition, further including having the ingredients such as gluconic acid, salicylic acid, phenol, germanium, silicon in fresh bamboo sap.Test table
Bright, it is a kind of more common Chinese medicine that fresh bamboo sap, which has comparable therapeutic effect to cough and bronchitis, is had biggish
Medicinal and economic value.Fresh bamboo juice extraction process is disclosed in the prior art, and " fresh bamboo sap extracts work to China's authorization patent of invention
Skill " (ZL201010501441.1), which is disclosed, obtains fresh bamboo sap product by boiling, initial filter, refined filtration, separation and disinfection.
Fog inhalation therapy is the critical treatment means of respiratory system related disease, is clinically more widely answered
With can directly act on patient part, breathing can be improved compared with the traditional approach such as oral, intramuscular injection and intravenously administrable
The administration concentration of road or lung, it is rapid-action, and said preparation avoids the first pass effect of liver, reduces the dosage of drug, mentions
High drug bioavailability, and drug is reduced in the distribution of its hetero-organization, side effect is reduced, is widely applied both at home and abroad.At present
Neulized inhalation is relatively fewer with the product that pharmaceutical solutions list, predominantly imported product.Fresh bamboo sap is peroral dosage form, in town
Cough, eliminating the phlegm etc. have good curative effect, but because of the dosage form for not being suitable for, it are made preferably to play effect.
Summary of the invention
The invention mainly solves the technical problem of providing one kind safely, effectively, the fresh bamboo sap Neulized inhalation of good quality
Use pharmaceutical solutions;The present invention also provides the preparation methods of said preparation.
The present invention is achieved by the following technical solutions:
A kind of fresh bamboo sap Neulized inhalation pharmaceutical solutions, comprising: fresh bamboo sap effective component, isotonic agent and solvent are described fresh
Bamboo juice effective component is prepared by fresh bamboo sap stoste.
Fresh bamboo sap stoste of the present invention can pass through commercially available acquisition.
It is currently preferred to be: in 1L pharmaceutical solutions, the amount using fresh bamboo sap stoste be 100-1000ml (such as 200ml,
300ml, 400ml, 500ml, 600ml, 700ml etc.), preferably 200-800ml.
Isotonic agent of the present invention refers to inorganic salts isotonic agent or carbohydrate isotonic agent.Wherein, inorganic salts isotonic agent is
Sodium chloride;Carbohydrate isotonic agent is one or both of glucose, mannitol mixture;It is preferred that sodium chloride.
Fresh bamboo sap Neulized inhalation pharmaceutical solutions of the present invention, it is described inorganic in every liter of Neulized inhalation solution
The quality of salt isotonic agent is 2-10g (such as 2g, 3g, 4.5g, 5g, 6g, 7g, 8.5g, 9%g, 10g), preferably 3-8g, or every
Rise in the Neulized inhalation solution, the quality of the carbohydrate isotonic agent be 10-100g (such as 10g, 20g, 30g, 40g, 45g,
60g, 75g, 80g, 90g, 100g), preferably 20-80g.
The solvent of Neulized inhalation solution of the present invention selects water for injection.
PH adjusting agent can also be added in Neulized inhalation solution of the present invention, and the pH value of Neulized inhalation solution is
5.0-8.0 (such as 5.0,5.5,6.0,6.5,7.0,7.5,8.0);Preferable ph is 6.0-7.5.
In the present invention, gained aerosol inhalation solution preparation is made with ultrasonic atomizer or air compression type atomizer
Fresh bamboo sap Neulized inhalation is directly sucked in respiratory system with solution with atomised form, directly acts on lesions position, rapid-action, more pacifies
It is complete effective.
The present invention also provides a kind of preparation methods of fresh bamboo sap Neulized inhalation pharmaceutical solutions, including use fresh bamboo sap former
Liquid prepares fresh bamboo sap effective component step, and prepares fresh bamboo sap atomization using the fresh bamboo sap effective component of preparation and isotonic agent and inhale
Enter and use pharmaceutical solutions step, it is specific the preparation method is as follows:
Step 1 weighs fresh bamboo sap stoste by above-mentioned parts by weight, boils, and lets cool standing, and filtration obtains medical fluid I;Medical fluid I adds
Enter the first solvent, stir evenly, refrigerate, take supernatant, filter, recycle the first solvent, appropriate solvent is added, stirs evenly, refrigerates, take supernatant
Liquid obtains medical fluid II;II decolorization of medical fluid is to get fresh bamboo sap effective component solution;
Fresh bamboo sap effective component solution obtained in step 1 is added appropriate isotonic agent, solvent, adjusts pH by step 2
Value, ultrafiltration, encapsulating sterilize to get pharmaceutical solutions of the invention.
In the above preparation method, as a preferred implementation manner, in said step 1, the boiling time is
15-60min;It is preferred that the boiling time is 30min.
In the above preparation method, as a preferred implementation manner, in said step 1, the time of repose is
12-48h;It is preferred that the time of repose is for 24 hours.
In the above preparation method, as a preferred implementation manner, in said step 1, first solvent is second
Alcohol.
In the above preparation method, as a preferred implementation manner, in said step 1, the filtrate is added first
Solvent processing are as follows: ethyl alcohol, which is added, in medical fluid I makes alcohol content reach 60%-90%, stirs evenly, and stands, and refrigeration takes supernatant, filters, filter
Liquid recycles alcoholic solvent to no alcohol taste;It is preferred that the addition ethyl alcohol makes alcohol content reach 75%.
In the above preparation method, as a preferred implementation manner, in said step 1, the cold preservation time is
12-48h;It is preferred that the cold preservation time is for 24 hours.
In the above preparation method, as a preferred implementation manner, in said step 1, the decolorization are as follows:
The medical fluid II plus active carbon are boiled into 15-60min, let cool, is filtered to get fresh bamboo sap effective component solution;It is preferred that described add
Active carbon boiling time is 30min.
In the above preparation method, as a preferred implementation manner, in the step 2, the isotonic agent is chlorination
One of sodium, glucose, mannitol are both glucose, mannitol mixture.
In the above preparation method, as a preferred implementation manner, in the step 2, the pH adjusting agent is
One of sodium hydroxide, sodium bicarbonate, sodium carbonate.
In the above preparation method, as a preferred implementation manner, in the step 2, the ultrafiltration technology is selected
Ultrafiltration pressure 10-30psi (such as 10psi, 20psi, 30psi), ultrafiltration flow velocity 40-80ml/min (such as 40ml/min,
50ml/min, 60ml/min, 70ml/min, 80ml/min) carry out ultrafiltration;It is preferred that the ultrafiltration pressure is 20psi, the ultrafiltration
Flow velocity 60ml/min.
In the above preparation method, as a preferred implementation manner, in the step 2, the ultrafiltration technology is selected
Ultrafiltration membrane be 5KD poly (ether-sulfone) ultrafiltration membrane, 10KD poly (ether-sulfone) ultrafiltration membrane, 5KD cellulosic ultrafiltration membrane, 10KD cellulosic ultrafiltration membrane;
It is preferred that the ultrafiltration membrane is 5KD poly (ether-sulfone) ultrafiltration membrane, 5KD cellulosic ultrafiltration membrane.
In the above preparation method, as a preferred implementation manner, in the step 1 or two, the solvent is note
It penetrates and uses water.
Furthermore the present invention also provides a kind of above-mentioned fresh bamboo sap Neulized inhalation pharmaceutical solutions in preparation treatment antibechic, dispels
Phlegm, the application in the drug of respiratory tract infection.
Compared with prior art, the present invention has the following technical effect that
1, fresh bamboo sap Neulized inhalation solution provided by the invention can quickly form aerosol by atomizer, be formed
Aerosol can be by direct snap action at sufferer, and the drug for acting on affected part can quickly be absorbed action;Not only make
It is few with dosage and rapid-action, good effect, without other toxic side effects.
2, it is an advantage of the present invention to provide a kind of novel form better than fresh bamboo sap mixture, said preparation refers to that drug is dissolved in
In suitable media, borrows atomizer with aerosol form, oral or nasal inhalation delivery to respiratory tract or lung, through service portion is administered
Position reduces drug in the distribution of other histoorgans, and the drug concentration of local lesion is high, and for being relatively administered orally, atomization is inhaled
The treatment total effective rate for entering administration mode greatly improves, and has safely and effectively, the feature that bioavilability is high, toxic side effect is small,
Thus have a clear superiority.
3, pharmaceutical solutions prepared by the present invention compensate for the blank on domestic market, and solution prepared by the present invention
Preparation is to aim at Neulized inhalation to be designed with patient, is matched with atomizer, and use process is convenient, compared with fresh bamboo sap mixture,
Administration route is different, and dosage is reduced, and the safety is improved.It can avoid the first pass effect needed for oral administration by liver simultaneously,
It is damaged to caused by patient, increases the compliance of patient, be a kind of administration way well for the children for being inconvenient to be administered orally
Diameter.
Specific embodiment
The dosage of substance used in substance used in the production process and preparation of following pharmaceutical preparation embodiment or preparation is not limited to
Character express, all formulation methods containing pharmaceutical composition provided by the invention, all belongs to the scope of protection of the present invention.
Embodiment 1
Fresh bamboo sap Neulized inhalation pharmaceutical solutions:
Fresh bamboo sap stoste 400ml
Sodium chloride 9g
Water for injection adds to 1000ml
Fresh bamboo sap stoste is weighed by weight, boils 30min, lets cool standing for 24 hours, and filtration obtains medical fluid I;Second is added in medical fluid I
Alcohol makes alcohol content 75%, stirs evenly, and refrigerates 12h, takes supernatant, filters, filtrate recycling ethanol to no alcohol taste, adds water for injection suitable
Amount, stirs evenly, and refrigerates 36h, takes supernatant, obtain medical fluid II;Medical fluid II plus active carbon boil 30min, let cool, and filter, add injection
9g sodium chloride is added to 980ml in water, and dissolution adds to the full amount of water for injection, and adjusts pH value to 6.5, with 5KD poly (ether-sulfone) ultrafiltration membrane,
Be 20psi in ultrafiltration pressure, ultrafiltration under conditions of the ultrafiltration flow velocity 60ml/min, gained filtrate encapsulating, sterilizing to get.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 2
Fresh bamboo sap Neulized inhalation pharmaceutical solutions:
Fresh bamboo sap stoste 600ml
Sodium chloride 6g
Water for injection adds to 1000ml
Fresh bamboo sap stoste is weighed by weight, boils 15min, lets cool and stands 48h, and filtration obtains medical fluid I;Second is added in medical fluid I
Alcohol makes alcohol content 85%, stirs evenly, and refrigeration for 24 hours, takes supernatant, filters, filtrate recycling ethanol to no alcohol taste, adds water for injection suitable
Amount, stirs evenly, and refrigeration for 24 hours, takes supernatant, obtains medical fluid II;Medical fluid II plus active carbon boil 30min, let cool, and filter, add injection
To 980ml 6g sodium chloride is added, dissolution injects water to 1000ml, and adding sodium hydroxide adjusts pH to 7.0, poly- with 10KD in water
Ether sulfone ultrafiltration membrane is 30psi in ultrafiltration pressure, and ultrafiltration under conditions of the ultrafiltration flow velocity 80ml/min, gained filtrate encapsulating is gone out
Bacterium to get.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 3
Fresh bamboo sap Neulized inhalation pharmaceutical solutions:
Fresh bamboo sap stoste 300ml
Glucose 100g
Water for injection adds to 1000ml
Fresh bamboo sap stoste is weighed by weight, boils 25min, lets cool standing for 24 hours, and filtration obtains medical fluid I;Medical fluid I is added third
Alcohol makes alcohol content 85%, stirs evenly, and refrigeration for 24 hours, takes supernatant, filters, and filtrate recycles propyl alcohol to no alcohol taste, adds water for injection suitable
Amount, stirs evenly, and refrigerates 12h, takes supernatant, obtain medical fluid II;Medical fluid II plus active carbon boil 30min, let cool, and filter, add injection
To 980ml 100g glucose is added, dissolution injects water to 1000ml, adds sodium bicarbonate to adjust pH to 5.0, uses 5KD in water
Poly (ether-sulfone) ultrafiltration membrane is 20psi in ultrafiltration pressure, ultrafiltration under conditions of the ultrafiltration flow velocity 60ml/min, gained filtrate encapsulating,
Sterilizing to get.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 4
Fresh bamboo sap Neulized inhalation pharmaceutical solutions:
Fresh bamboo sap stoste 100ml
Mannitol 80g
Water for injection adds to 1000ml
Fresh bamboo sap stoste is weighed by weight, boils 35min, lets cool and stands 12h, and filtration obtains medical fluid I;Second is added in medical fluid I
Alcohol makes alcohol content 75%, stirs evenly, and stands, and refrigerates 20h, takes supernatant, filters, and filtrate recycling ethanol to no alcohol taste, filling is penetrated
It with appropriate amount of water, stirs evenly, refrigerates 36h, take supernatant, obtain medical fluid II;Medical fluid II plus active carbon boil 30min, let cool, and filter, add
Water for injection to 980ml, addition 80g mannitol, dissolution injects water to 1000ml, sodium bicarbonate is added to adjust pH to 5.5,
It is 10psi, ultrafiltration under conditions of the ultrafiltration flow velocity 40ml/min, gained filtrate in ultrafiltration pressure with 5KD cellulosic ultrafiltration membrane
Encapsulating, sterilizing to get.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 5
Fresh bamboo sap Neulized inhalation pharmaceutical solutions:
Fresh bamboo sap stoste 200ml
Glucose and mannitol mixture 45g
Water for injection adds to 1000ml
Fresh bamboo sap stoste is weighed by weight, boils 60min, lets cool and stands 18h, and filtration obtains medical fluid I;Medical fluid I is added third
Alcohol makes alcohol content 70%, stirs evenly, and refrigerates 48h, takes supernatant, filters, and filtrate recycles propyl alcohol to no alcohol taste, adds water for injection suitable
Amount, stirs evenly, and refrigerates 40h, takes supernatant, obtain medical fluid II;Medical fluid II plus active carbon boil 30min, let cool, and filter, add injection
To 980ml 50g glucose and mannitol mixture is added, dissolution injects water to 1000ml, and sodium carbonate is added to adjust pH in water
It is 10psi, ultrafiltration under conditions of the ultrafiltration flow velocity 50ml/min, institute in ultrafiltration pressure with 5KD cellulosic ultrafiltration membrane to 8.0
Filtrate encapsulating, sterilizing to get.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 6
Fresh bamboo sap Neulized inhalation pharmaceutical solutions:
Fresh bamboo sap stoste 500ml
Sodium chloride 2g
Water for injection adds to 1000ml
Fresh bamboo sap stoste is weighed by weight, boils 45min, lets cool standing for 24 hours, and filtration obtains medical fluid I;Second is added in medical fluid I
Alcohol makes alcohol content 90%, stirs evenly, and refrigerates 12h, takes supernatant, filters, filtrate recycling ethanol to no alcohol taste, adds water for injection suitable
Amount, stirs evenly, and refrigerates 30h, takes supernatant, obtain medical fluid II;Medical fluid II plus active carbon boil 30min, let cool, and filter, add injection
To 980ml 2g sodium chloride is added, dissolution injects water to 1000ml, adjusts pH to 7.5, ultrafiltration, and encapsulating sterilizes, i.e., in water
?.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 7
Fresh bamboo sap Neulized inhalation pharmaceutical solutions:
Fresh bamboo sap stoste 1000ml
Glucose 10g
Water for injection adds to 1000ml
Fresh bamboo sap stoste is weighed by weight, boils 15min, lets cool and stands 36h, and filtration obtains medical fluid I;Second is added in medical fluid I
Alcohol makes alcohol content 60%, stirs evenly, and refrigerates 12h, takes supernatant, filters, filtrate recycling ethanol to no alcohol taste, adds water for injection suitable
Amount, stirs evenly, and refrigerates 48h, takes supernatant, obtain medical fluid II;Medical fluid II plus active carbon boil 30min, let cool, and filter, add injection
To 980ml 10g glucose is added, dissolution injects water to 1000ml, adjusts pH to 8.0, ultrafiltration, and encapsulating sterilizes, i.e., in water
Obtain pharmaceutical solutions of the invention.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 8
Fresh bamboo sap Neulized inhalation pharmaceutical solutions:
Fresh bamboo sap stoste 800ml
Mannitol 20g
Water for injection adds to 1000ml
Fresh bamboo sap stoste is weighed by weight, boils 45min, lets cool and stands 40h, and filtration obtains medical fluid I;First is added in medical fluid I
Alcohol makes alcohol content 65%, stirs evenly, and refrigerates 18h, takes supernatant, filters, and filtrate recycles methanol to no alcohol taste, adds water for injection suitable
Amount, stirs evenly, and refrigerates 30h, takes supernatant, obtain medical fluid II;Medical fluid II plus active carbon boil 30min, let cool, and filter, add injection
To 980ml 20g mannitol is added, dissolution injects water to 1000ml, pH to 7.0 is adjusted, with 10KD cellulose ultrafiltration in water
Film is 10psi in ultrafiltration pressure, ultrafiltration under conditions of the ultrafiltration flow velocity 70ml/min, gained filtrate encapsulating, sterilizing to get.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 9
Fresh bamboo sap Neulized inhalation pharmaceutical solutions:
Fresh bamboo sap stoste 700ml
Sodium chloride 4.5g
Water for injection adds to 1000ml
Fresh bamboo sap stoste is weighed by weight, boils 30min, lets cool and stands 20h, and filtration obtains medical fluid I;First is added in medical fluid I
Alcohol makes alcohol content 60%, stirs evenly, and refrigerates 36h, takes supernatant, filters, and filtrate recycles methanol to no alcohol taste, adds water for injection suitable
Amount, stirs evenly, and refrigerates 12h, takes supernatant, obtain medical fluid II;Medical fluid II plus active carbon boil 30min, let cool, and filter, add injection
To 980ml 4g sodium chloride is added, dissolution injects water to 1000ml, adjusts pH to 6.0, ultrafiltration, and encapsulating sterilizes, i.e., in water
?.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 10
Fresh bamboo sap Neulized inhalation pharmaceutical solutions:
Fresh bamboo sap stoste 900ml
Sodium chloride 8.5g
Water for injection adds to 1000ml
Fresh bamboo sap stoste is weighed by weight, boils 45min, lets cool and stands 18h, and filtration obtains medical fluid I;Second is added in medical fluid I
Alcohol makes alcohol content 80%, stirs evenly, and refrigerates 20h, takes supernatant, filters, filtrate recycling ethanol to no alcohol taste, adds water for injection suitable
Amount, stirs evenly, and refrigerates 48h, takes supernatant, obtain medical fluid II;Medical fluid II plus active carbon boil 30min, let cool, and filter, add injection
To 980ml 8g sodium chloride is added, dissolution injects water to 1000ml, adjusts pH to 4.0, ultrafiltration, and encapsulating sterilizes, i.e., in water
?.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Beneficial effects of the present invention are further illustrated below by way of test example:
Patient diagnosis Patients With Respiratory Tract Infection 40, the age 14~60 years old, for the course of disease less than 7 days, clinical manifestation was different journeys
Cough, abundant expectoration, the shortness of breath of degree.Agematched patient is divided into observation group 1, observation group 2, observation according to medical sequencing
Group 3 and control group, every group 10, four groups of patients are comparable in terms of gender, age and the state of an illness, and therapeutic effect easily compares
Compared with.
The fresh bamboo sap atomization that embodiment 1, embodiment 5, embodiment 8 are given respectively by observation group 1, observation group 2, observation group 3 is inhaled
Enter and carry out atomization inspiration treatment with pharmaceutical solutions, control group give fresh bamboo sap mixture (Jiangxi Yaodu Zhangshu Pharmaceutical Co., Ltd) into
Row oral medication.Four groups of the course for the treatment of is 3 days.
Criterion of therapeutical effect: (1) effective: no cough or only slight cough, no phlegm, shortness of breath disappear;(2) effectively: treatment 3 days or more
Clinical symptoms and pharyngeal sign are clearly better;(3) invalid: after treatment 3 days, clinical symptoms and pharyngeal sign without improvement or are aggravated,
Shortness of breath is without alleviation.Specifically it see the table below:
Two groups for the treatment of coughs of table, abundant expectoration, shortness of breath curative effect compare [n (%)]
Thus table, which can be seen that observation group 1, observation group 2, observation group 3 and control group, has treatment to make respiratory tract infection
With wherein the therapeutic effect of observation group 3 is significantly better than control group (P < 0.05).
Equally, observation group 3 treat antibechic, in terms of effect be also significantly better than fresh bamboo sap mixture.