A kind of silver yellow Neulized inhalation pharmaceutical solutions and preparation method thereof
Technical field
The present invention relates to a kind of silver yellow Neulized inhalation pharmaceutical solutions and preparation method thereof, belong to galenic pharmacy field.
Background technology
Silver yellow is a kind of classical Chinese patent drug, and main component is Honegsukle flower P.E and scutelloside, has heat-clearing, removing toxic substances,
The effect of relieving sore-throat.For the infection of the upper respiratory tract, acute tonsillitis, pharyngitis.Existing silver yellow preparation has granule, tablet, glue
Wafer, oral liquid, parenteral solution, dripping pill, lozenge, soft capsule etc..Because its curative effect is clear and definite, it is deep by numerous doctors, suffer from both sides and welcome, be
The Typical Representative of traditional heat-clearing and detoxifying herb.
Due to Conventional oral dosage forms, work slower, usage amount is larger.And parenteral solution is relatively rapid-action, but parenteral solution is given
Adverse reactions of patients generation after medicine is more, and security is poor, while parenteral solution administration has medicine-feeding part pain, and patient complies with
Property poor.The commercialized product of Neulized inhalation pharmaceutical solutions is relatively fewer at present, predominantly imported product.Clinically with note
It is more to penetrate the situation of liquid application Neulized inhalation, but does not have the application method of specification in specification, it is hidden to there is safety in use
Suffer from.
It is high it is an object of the invention to provide a kind of bioavilability, lesions position is directly acted on, it is rapid-action, it is safer
Effective silver yellow Neulized inhalation pharmaceutical solutions.
The content of the invention
The present invention solves the technical problem of provide it is a kind of safely, effectively, the silver yellow Neulized inhalation of good quality use
Pharmaceutical solutions;Present invention also offers the preparation method of said preparation.
The present invention is achieved by the following technical solutions:
A kind of silver yellow Neulized inhalation pharmaceutical solutions, including:
(1)Silver yellow active ingredient;
(2)Isotonic agent and solvent;
Wherein, isotonic agent refers to inorganic salts isotonic agent or carbohydrate isotonic agent;Each system of silver yellow Neulized inhalation pharmaceutical solutions
The amount of the isotonic agent containing inorganic salts is 0.2-0.9% in agent unit, or each preparation unit of silver yellow Neulized inhalation pharmaceutical solutions
In the amount of the isotonic agent containing carbohydrate be 1-9%.
Silver yellow Neulized inhalation is prepared obtaining with pharmaceutical solutions:
12.5 parts in terms of chlorogenic acid of Honegsukle flower P.E, 20 parts in terms of scutelloside sterling of Baical Skullcap root P.E
Two kinds of extracts are weighed according to above-mentioned parts by weight, respectively plus after water for injection and the appropriate dissolving of 8% sodium hydroxide solution, are mixed
Close, inject water to about 980ml, adjust pH value to 7.2 with 8% sodium hydroxide solution, add activated carbon appropriate, put and add in water-bath
Heat 1 hour, lets cool, and filters, produces silver yellow active ingredient solution;The solution adds appropriate isotonic agent, adds to the full amount of water for injection,
PH value is adjusted, ultrafiltration, embedding, sterilizing, produces pharmaceutical solutions of the invention.
Wherein, Honegsukle flower P.E is prepared:Honeysuckle is added water to cook secondary, 1 hour first time, second
Filter by several times within 45 minutes, filtrate, which merges, is concentrated under reduced pressure into every ml equivalent to honeysuckle 2g, adds 20% milk of lime, regulation pH value to
12-13, stir evenly, stand, filtration discards filtrate, and precipitation plus 2 times of amount ethanol stir evenly, cross No. 4 sieves, pH is adjusted with 50% sulfuric acid solution
Value is stirred evenly, filtered, filtrate is neutralized to pH6.5-7.0 with 40% sodium hydroxide solution, filters, filtrate decompression is condensed into thick to 3-4
Paste, dry, produce, this product should be not less than 18% containing chlorogenic acid;
Radix scutellariae is prepared:Radix scutellariae is added water to cook it is secondary, 1 hour every time, filtration, merging filtrate, with salt acid for adjusting pH
Value 80 DEG C of insulations, separates out scutelloside cohesion, filtration, discards filtrate, sediment adds suitable quantity of water to stir evenly, with 40% hydrogen-oxygen to 1-2
Change sodium dissolving, regulation pH value adds equivalent ethanol to 7, then with salt acid for adjusting pH value to 1-2, is heated to 80 DEG C, analyses scutelloside
Go out, filter, precipitate after being washed with a small amount of 50% ethanol, then with 5 times of amount ethanol washings, dry, produce, this product should not containing scutelloside
Less than 92.0%.
Inorganic salts isotonic agent is one kind in sodium chloride, magnesium chloride, calcium chloride;Carbohydrate isotonic agent be glucose, fructose,
One kind in mannitol;It is preferred that sodium chloride.
The pH value of aerosol inhalation solution is 3.5-8.0;Preferable ph is 5.0-7.5.
Neulized inhalation is with 0.2-1.0 times that the daily crude drug amount of solution is the daily crude drug amount of YINHUANG ZHUSHEYE;It is it is preferred that daily
Crude drug amount is 0.5-0.9 times of the daily crude drug amount of YINHUANG ZHUSHEYE.
It is straight with atomised form with ultrasonic atomizer or air compression type atomizer by gained aerosol inhalation solution preparation
Connect suction respiratory system.
Silver yellow Neulized inhalation pharmaceutical solutions of the present invention has heat-clearing, removing toxic substances, the effect of relieving sore-throat, can be used for controlling
Treat the infection of the upper respiratory tract, acute tonsillitis, pharyngitis etc..
It is an advantage of the present invention to provide a kind of novel form better than YINHUANG ZHUSHEYE, said preparation refers to that medicine is dissolved in conjunction
In suitable medium, by means of atomizer with aerosol form, oral or nasal inhalation delivery to respiratory tract or lung, through service portion is administered
Position, reduce distribution of the medicine in other histoorgans, the drug concentration of local lesion is high, and for drug administration by injection, atomization is inhaled
The treatment total effective rate for entering administering mode greatly improves, and has the characteristics of safe and effective, bioavilability is high, toxic side effect is small,
Thus have a clear superiority.
Pharmaceutical solutions prepared by the present invention compensate for the blank on domestic market, can prevent due to a lack of Inhalation in Treating
Special preparation medicine, and it is substituted for Inhalation in Treating and caused safety risks using YINHUANG ZHUSHEYE.And the present invention
The pharmaceutical solutions of preparation is to aim at Neulized inhalation to be designed with patient, is supported the use with atomizer, convenient using process, is noted with silver yellow
Liquid phase ratio is penetrated, method of administration is different, and dosage is reduced, and security improves.Parenteral solution repeat administration can be avoided to patient simultaneously
Caused by damage, increase the compliance of patient, for inconvenient drug administration by injection and the children being administered orally be it is a kind of well to
Medicine approach.
Beneficial effects of the present invention are further illustrated below by way of test example:
The infant of patient diagnosis children's upper respiratory tract infection 135,1~3 years old age, the course of disease are less than 7 days, and clinical manifestation is difference
Heating, the cough of degree.Agematched infant is divided into observation group 1, observation group 2 and control according to medical sequencing
Group, every group 45, three groups of infants have comparativity in terms of sex, age and the state of an illness, and therapeutic effect easily compares.
The silver yellow Neulized inhalation that observation group 1 gives embodiment 1 carries out atomization inspiration treatment with pharmaceutical solutions, and observation group 2 gives
Atomization inspiration treatment is carried out with pharmaceutical solutions with the silver yellow Neulized inhalation of embodiment 2, control group gives YINHUANG ZHUSHEYE(Yaan three
Nine pharmaceutcal corporation, Ltds)Carry out intramuscular injection treatment.Three groups of the course for the treatment of is 3 days.
Criterion of therapeutical effect:(1)It is effective:Without cough or only slight cough, no heating, congestion of throat are disappeared;(2)Effectively:Treatment 3
Its above clinical symptoms and pharyngeal sign are clearly better;(3)It is invalid:After treatment 3 days, clinical symptoms and pharyngeal sign without taking a turn for the better or
Aggravate, no alleviation of generating heat.Specifically it see the table below:
Three groups for the treatment of children's upper respiratory tract infection curative effects of table compare [n(%)]
Group |
It is effective |
Effectively |
It is invalid |
Total effective rate |
Observation group 1 |
5(11.1) |
13(28.9) |
27(60.0) |
40.0 |
Observation group 2 |
19(42.2) |
16(36.6) |
10(22.2) |
77.8 |
Control group |
7(15.6) |
15(33.3) |
23(51.1) |
48.9 |
Thus table can be seen that observation group 1, observation group 2 and control group has therapeutic action to the infection of the upper respiratory tract, wherein observing
The therapeutic effect of group 2 is significantly better than control group(P<0.05).
Equally, observation group 2 is also significantly better than YINHUANG ZHUSHEYE in the effect for the treatment of pharyngitis, acute tonsillitis etc..
Embodiment,
The dosage of material is not limited to word used in material used in the production process and preparation of following pharmaceutical preparation embodiment or preparation
Statement, all formulation methods containing pharmaceutical composition provided by the invention, belongs to protection scope of the present invention.
Embodiment 1
(1)The preparation of silver yellow extract:
The preparation of Honegsukle flower P.E:Honeysuckle is added water to cook to secondary, 1 hour first time, filtered by several times within second 45 minutes,
Filtrate, which merges, is concentrated under reduced pressure into every ml equivalent to honeysuckle 2g, adds 20% milk of lime, regulation pH value to 12-13, stirs evenly, stands,
Filtration, filtrate is discarded, precipitation plus 2 times of amount ethanol stir evenly, and cross No. 4 sieves, adjust pH value to 3-4 with 50% sulfuric acid solution, stir evenly, filter
To cross, filtrate is neutralized to pH6.5-7.0 with 40% sodium hydroxide solution, and filtration, filtrate decompression is condensed into paste, dries, produces,
This product should be not less than 18% containing chlorogenic acid;
The preparation of Baical Skullcap root P.E:Radix scutellariae is added water to cook it is secondary, 1 hour every time, filtration, merging filtrate, with salt acid for adjusting pH
Value 80 DEG C of insulations, separates out scutelloside cohesion, filtration, discards filtrate, sediment adds suitable quantity of water to stir evenly, with 40% hydrogen-oxygen to 1-2
Change sodium dissolving, regulation pH value adds equivalent ethanol to 7.0, then with salt acid for adjusting pH value to 1-2, is heated to 80 DEG C, analyses scutelloside
Go out, filter, precipitate after being washed with a small amount of 50% ethanol, then with 5 times of amount ethanol washings, dry, produce, this product should not containing scutelloside
Less than 92.0%.
(2)The preparation of silver yellow Neulized inhalation solution:
Honegsukle flower P.E 3.75g in terms of chlorogenic acid
Baical Skullcap root P.E 6g in terms of scutelloside sterling
Magnesium chloride 9g
Purified water adds to 1000ml
Two kinds of extracts are weighed by recipe quantity, respectively plus after water for injection and the appropriate dissolving of 8% sodium hydroxide solution, are mixed, filling
Penetrate with water to about 980ml, adjust pH value to 7.2 with 8% sodium hydroxide solution, add activated carbon appropriate, put and heated 1 hour in water-bath,
Let cool, filter, 9g magnesium chlorides are added in filtrate, inject water to 1000ml, regulation pH value to 6.0, ultrafiltration, embedding, sterilize,
Produce the pharmaceutical solutions of the present invention.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 2
(1)The preparation of silver yellow extract:With embodiment 1.
(2)The preparation of silver yellow Neulized inhalation solution:
Honegsukle flower P.E 8.75g in terms of chlorogenic acid
Baical Skullcap root P.E 14g in terms of scutelloside sterling
Sodium chloride 5g
Purified water adds to 1000ml
Two kinds of extracts are weighed by recipe quantity, respectively plus after water for injection and the appropriate dissolving of 8% sodium hydroxide solution, are mixed, filling
Penetrate with water to about 980ml, adjust pH value to 7.2 with 8% sodium hydroxide solution, add activated carbon appropriate, put and heated 1 hour in water-bath,
Let cool, filter, 5g sodium chloride is added in filtrate, inject water to 1000ml, regulation pH value to 7.3, ultrafiltration, embedding, sterilize,
Produce the pharmaceutical solutions of the present invention.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 3
(1)The preparation of silver yellow extract:With embodiment 1.
(2)The preparation of silver yellow Neulized inhalation solution:
Honegsukle flower P.E 6.25g in terms of chlorogenic acid
Baical Skullcap root P.E 10g in terms of scutelloside sterling
Calcium chloride 4g
Purified water adds to 1000ml
Two kinds of extracts are weighed by recipe quantity, respectively plus after water for injection and the appropriate dissolving of 8% sodium hydroxide solution, are mixed, filling
Penetrate with water to about 980ml, adjust pH value to 7.2 with 8% sodium hydroxide solution, add activated carbon appropriate, put and heated 1 hour in water-bath,
Let cool, filter, 4g calcium chloride is added in filtrate, inject water to 1000ml, regulation pH value to 3.5, ultrafiltration, embedding, sterilize,
Produce the pharmaceutical solutions of the present invention.
By gained aerosol inhalation solution preparation, after being atomized with air compression type atomizer, it is directly sucked in and is exhaled with atomised form
Desorption system.
Embodiment 4
(1)The preparation of silver yellow extract:With embodiment 1.
(2)The preparation of silver yellow Neulized inhalation solution:
Honegsukle flower P.E 11.25g in terms of chlorogenic acid
Baical Skullcap root P.E 18g in terms of scutelloside sterling
Glucose 10g
Purified water adds to 1000ml
Two kinds of extracts are weighed by recipe quantity, respectively plus after water for injection and the appropriate dissolving of 8% sodium hydroxide solution, are mixed, filling
Penetrate with water to about 980ml, adjust pH value to 7.2 with 8% sodium hydroxide solution, add activated carbon appropriate, put and heated 1 hour in water-bath,
Let cool, filter, 10g glucose is added in filtrate, inject water to 1000ml, regulation pH value ultrafiltration, embedding, is gone out to 7.5
Bacterium, produce the pharmaceutical solutions of the present invention.
By gained aerosol inhalation solution preparation, after being atomized with air compression type atomizer, it is directly sucked in and is exhaled with atomised form
Desorption system.
Embodiment 5
(1)The preparation of silver yellow extract:With embodiment 1.
(2)The preparation of silver yellow Neulized inhalation solution:
Honegsukle flower P.E 2.5g in terms of chlorogenic acid
Baical Skullcap root P.E 4g in terms of scutelloside sterling
Fructose 90g
Purified water adds to 1000ml
Two kinds of extracts are weighed by recipe quantity, respectively plus after water for injection and the appropriate dissolving of 8% sodium hydroxide solution, are mixed, filling
Penetrate with water to about 980ml, adjust pH value to 7.2 with 8% sodium hydroxide solution, add activated carbon appropriate, put and heated 1 hour in water-bath,
Let cool, filter, 90g fructose is added in filtrate, inject water to 1000ml, regulation pH value to 5.0, ultrafiltration, embedding, sterilize,
Produce the pharmaceutical solutions of the present invention.
By gained aerosol inhalation solution preparation, after being atomized with air compression type atomizer, it is directly sucked in and is exhaled with atomised form
Desorption system.
Embodiment 6
(1)The preparation of silver yellow extract:With embodiment 1.
(2)The preparation of silver yellow Neulized inhalation solution:
Honegsukle flower P.E 12.5g in terms of chlorogenic acid
Baical Skullcap root P.E 20g in terms of scutelloside sterling
Sodium chloride 2g
Purified water adds to 1000ml
Two kinds of extracts are weighed by recipe quantity, respectively plus after water for injection and the appropriate dissolving of 8% sodium hydroxide solution, are mixed, filling
Penetrate with water to about 980ml, adjust pH value to 7.2 with 8% sodium hydroxide solution, add activated carbon appropriate, put and heated 1 hour in water-bath,
Let cool, filter, 2g sodium chloride is added in filtrate, inject water to 1000ml, regulation pH value to 8.0, ultrafiltration, embedding, sterilize,
Produce the pharmaceutical solutions of the present invention.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 7
(1)The preparation of silver yellow extract:With embodiment 1.
(2)The preparation of silver yellow Neulized inhalation solution:
Honegsukle flower P.E 10g in terms of chlorogenic acid
Baical Skullcap root P.E 16g in terms of scutelloside sterling
Mannitol 30g
Purified water adds to 1000ml
Two kinds of extracts are weighed by recipe quantity, respectively plus after water for injection and the appropriate dissolving of 8% sodium hydroxide solution, are mixed, filling
Penetrate with water to about 980ml, adjust pH value to 7.2 with 8% sodium hydroxide solution, add activated carbon appropriate, put and heated 1 hour in water-bath,
Let cool, filter, 30g mannitol is added in filtrate, inject water to 1000ml, regulation pH value ultrafiltration, embedding, is gone out to 4.5
Bacterium, produce the pharmaceutical solutions of the present invention.
By gained aerosol inhalation solution preparation, after being atomized with air compression type atomizer, it is directly sucked in and is exhaled with atomised form
Desorption system.
Embodiment 8
(1)The preparation of silver yellow extract:Preparation method is the same as embodiment 1.
(2)The preparation of silver yellow Neulized inhalation solution:
Honegsukle flower P.E 7.5g in terms of chlorogenic acid
Baical Skullcap root P.E 12g in terms of scutelloside sterling
Glucose 50g
Purified water adds to 1000ml
Two kinds of extracts are weighed by recipe quantity, respectively plus after water for injection and the appropriate dissolving of 8% sodium hydroxide solution, are mixed, filling
Penetrate with water to about 980ml, adjust pH value to 7.2 with 8% sodium hydroxide solution, add activated carbon appropriate, put and heated 1 hour in water-bath,
Let cool, filter, 50g glucose is added in filtrate, inject water to 1000ml, regulation pH value ultrafiltration, embedding, is gone out to 5.5
Bacterium, produce the pharmaceutical solutions of the present invention.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 9
(1)The preparation of silver yellow extract:Preparation method is the same as embodiment 1.
(2)The preparation of silver yellow Neulized inhalation solution:
Honegsukle flower P.E 5g in terms of chlorogenic acid
Baical Skullcap root P.E 8g in terms of scutelloside sterling
Fructose 70g
Purified water adds to 1000ml
Two kinds of extracts are weighed by recipe quantity, respectively plus after water for injection and the appropriate dissolving of 8% sodium hydroxide solution, are mixed, filling
Penetrate with water to about 980ml, adjust pH value to 7.2 with 8% sodium hydroxide solution, add activated carbon appropriate, put and heated 1 hour in water-bath,
Let cool, filter, 70g fructose is added in filtrate, inject water to 1000ml, regulation pH value to 6.5, ultrafiltration, embedding, sterilize,
Produce the pharmaceutical solutions of the present invention.
By gained aerosol inhalation solution preparation, after being atomized with air compression type atomizer, it is directly sucked in and is exhaled with atomised form
Desorption system.
Embodiment 10
(1)The preparation of silver yellow extract:Preparation method is the same as embodiment 1.
(2)The preparation of silver yellow Neulized inhalation solution:
Honegsukle flower P.E 6.25g in terms of chlorogenic acid
Baical Skullcap root P.E 10g in terms of scutelloside sterling
Sodium chloride 7g
Purified water adds to 1000ml
Two kinds of extracts are weighed by recipe quantity, respectively plus after water for injection and the appropriate dissolving of 8% sodium hydroxide solution, are mixed, filling
Penetrate with water to about 980ml, adjust pH value to 7.2 with 8% sodium hydroxide solution, add activated carbon appropriate, put and heated 1 hour in water-bath,
Let cool, filter, 7g sodium chloride is added in filtrate, inject water to 1000ml, regulation pH value to 7, ultrafiltration, embedding, sterilize, i.e.,
Obtain pharmaceutical solutions of the invention.
By gained aerosol inhalation solution preparation, after being atomized with air compression type atomizer, it is directly sucked in and is exhaled with atomised form
Desorption system.