CN1799612A - Novel drug administering route of 'Qu Gan Re' injection, its preparation process and novel indications - Google Patents
Novel drug administering route of 'Qu Gan Re' injection, its preparation process and novel indications Download PDFInfo
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Abstract
The invention relates to a novel drug administering route of 'Qu Gan Re' injection, its preparation process and novel indications, wherein the injection is prepared from the following raw materials: reed rhizome, sweet wormwood, bamboo leaves, thorowax root, gypsum, water for injection, activated charcoal, and pharmaceutically acceptable excipient, the injection can be made into the forms of concentrated solution, freeze-dried powder, or asepsis powder.
Description
Technical field:
The present invention relates to new route of administration of Chinese medicine preparation QUGANRE ZHUSHEJI and preparation technology thereof, new indication.
Technical background:
Acute upper respiratory tract infection is a usual diseases of childhood, and clinical have symptoms such as heating, pharyngalgia, headache more, and severe patient can cause hyperpyrexia convulsion, and this also is the common clinical manifestation of hyperpyrexia that upper respiratory tract infection causes.Acute respiratory infection is a kind of common infectious disease, all can fall ill throughout the year in of all ages, the sex of falling ill, occupation, area, see with children's more, all can fall ill for each person every year for several times, severe patient can cause pneumonia, tracheitis and bronchitis etc., has brought great inconvenience to the patient.
At present, the Chinese medicine and western medicine of the hyperpyrexia that treatment upper respiratory tract infection causes is a lot, but how many Western medicine has some side effect.Chinese medicine has certain characteristic aspect the treatment hyperpyrexia, utilize heat-clearing and toxic substances removing, relieving the exterior syndrome by diaphoresis method treatment hyperpyrexia that certain effect is arranged, if but emphasize the removing summer-heat interior-heat in the treatment simply, then can injure the human righteousness, it is empty to increase the weight of losing of healthy energy, and clinical treatment should be the Therapeutic Principle with the giving consideration to both the exterior and interior.
Cold fever eliminating injection contains Chinese medicines such as Rhizoma Phragmitis, Herba Artemisiae Annuae, Folium Bambusae, Radix Bupleuri, Gypsum Fibrosum, and wherein the Rhizoma Phragmitis bitter cold is apt to clearing away lung-heat; Folium Bambusae, Radix Bupleuri are bitter cool, and the merit of reconciling superficies and interior is arranged, and are the key medicine that heating is induced sweat, and treatment common cold, influenza heating effect are better; The bitter little suffering of Herba Artemisiae Annuae has the merit of clearing away summer-heat; Gypsum Fibrosum is hot cold for controlling the key medicine of edema caused by disorder of QI heat syndrome.All medicine compatibilities can be played and defend that gas is ruled together, the merit of relieving exterior-interior syndrome.Multinomial clinical observation shows that the treatment group general curative effect of use cold fever eliminating injection is close with the matched group that uses injection of Radix Bupleuri, but its effect aspect improvement heating, elimination pharyngeal hyperemia is better, and does not see obvious toxic-side effects, is worth clinical practice.
But cold fever eliminating injection adopts the intramuscular injection method aspect clinical practice, absorbs by tissue, and speed is slower, dosage is less, and has both increased patient's misery, also can cause the injection site scleroma, even swell and ache, secondary infection, often having an injection also causes " hip contracture " easily.This administrated method significantly limits its clinical practice.Therefore, at this problem, we have developed the intravenously administrable approach, have overcome to absorb shortcoming slow, that onset time is long.Both increased clinical effective dose, and can comparatively fast absorb again, blood drug level is higher, has improved bioavailability, has increased new indication, and more convenient for clinical practice, more preferably the patient serves.
Summary of the invention:
The invention provides compound recipe Radix Notoginseng injection, prepare by the following weight proportion raw material:
50～200 parts in 62.5～250 parts of Gypsum Fibrosum of 125～500 parts of HERBA BUPLEURI of 125～500 portions of Herba Artemisiae Annuaes of Rhizoma Arundinis Donacis.
Preferably:
100 parts in 125 parts of Gypsum Fibrosum of 250 parts of HERBA BUPLEURI of 250 portions of Herba Artemisiae Annuaes of Rhizoma Arundinis Donacis.
After the raw material of Chinese medicine to said ratio extracts, makes with extra care, obtains purified extract, add the suitable medicinal ejection preparation that suitable excipient is made again.
QUGANRE ZHUSHEJI involved in the present invention is mainly used in multiple intravenously administrables such as intravenous drip, intravenous injection.
New indication of the present invention refers to all kinds of febrile diseases that caused by multiple infection comprise diseases such as influenza, pneumonia, bronchitis, acute nephritis, acute enteritis, epidemic hemorrhagic fever, chickenpox, parotitis, hyperpyrexia convulsion.
Preparation type involved in the present invention comprises small-volume injection (injection, concentrated solution for injection), bulk capacity injection (5% glucose injection, 0.9% sodium chloride injection) and specific type injection dosage forms such as (lyophilized powder, sterilized powders).Wherein:
(1) preparation process of injection is as follows: get Herba Artemisiae Annuae, HERBA BUPLEURI is distilled with the way of distillation, collect distillate 930ml, medicinal residues are abandoned it; Other gets Rhizoma Arundinis Donacis, Gypsum Fibrosum decocts with water three times, and collecting decoction filters, filtrate is concentrated in right amount, handle secondary with ethanol precipitation, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 80% for the second time, leave standstill, filter, reclaim and wave most ethanol, it is an amount of to add the injection water, add active carbon and boil in right amount, sucking filtration is to clear and bright; Benzyl alcohol 3ml, pluronic F-68 5ml are added in the distillate, and mixing merges with above-mentioned medicinal liquid again, regulates pH value, adds the injection water to 1000ml, fine straining, and embedding, sterilization, promptly.
(2) preparation process of lyophilized powder is as follows: get Herba Artemisiae Annuae, HERBA BUPLEURI is distilled with the way of distillation, collect distillate 930ml, medicinal residues are abandoned it, with gained volatile oil and HP-enclose; Other gets Rhizoma Arundinis Donacis, Gypsum Fibrosum decocts with water three times, and collecting decoction filters, filtrate is concentrated in right amount, handle secondary with ethanol precipitation, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 80% for the second time, leave standstill, filter, reclaim and wave most ethanol, it is an amount of to add the injection water, add active carbon and boil in right amount, sucking filtration is to clear and bright; Benzyl alcohol 3ml, pluronic F-68 5ml are added in the clathrate, and mixing merges with above-mentioned medicinal liquid again, regulate pH value, add the injection water to 1000ml, fine straining, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, the filtrate fill in the cillin bottle of 20ml, every bottled 7ml.And be placed in the freeze drying box pre-freeze evacuation after 3～5 hours.Condensation temperature remains unchanged, and after 24 hours, unpacks, and makes dried frozen aquatic products, and gland is sealed with wax, labeling, promptly;
(3) preparation process of sterilized powder is as follows: get Herba Artemisiae Annuae, HERBA BUPLEURI is distilled with the way of distillation, collect distillate 930ml, medicinal residues are abandoned it, with gained volatile oil and HP-enclose; Other gets Rhizoma Arundinis Donacis, Gypsum Fibrosum decocts with water three times, and collecting decoction filters, filtrate is concentrated in right amount, handle secondary with ethanol precipitation, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 80% for the second time, leave standstill, filter, reclaim and wave most ethanol, it is an amount of to add the injection water, add active carbon and boil in right amount, sucking filtration is to clear and bright; Benzyl alcohol 3ml, pluronic F-68 5ml are added in the clathrate, mixing merges with above-mentioned medicinal liquid again, regulates pH value, add the injection water to 1000ml, fine straining, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate is sprayed with the spray drying tower under the aseptic condition, make sterilized powder, packing, labeling, promptly;
(4) preparation process of concentrated solution for injection is as follows: get Herba Artemisiae Annuae, HERBA BUPLEURI is distilled with the way of distillation, collect distillate 930ml, medicinal residues are abandoned it, with gained volatile oil and HP-enclose; Other gets Rhizoma Arundinis Donacis, Gypsum Fibrosum decocts with water three times, and collecting decoction filters, filtrate is concentrated in right amount, handle secondary with ethanol precipitation, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 80% for the second time, leave standstill, filter, reclaim and wave most ethanol, it is an amount of to add the injection water, add active carbon and boil in right amount, sucking filtration is to clear and bright; Benzyl alcohol 3ml, pluronic F-68 5ml are added in the clathrate, and mixing merges with above-mentioned medicinal liquid again, regulates pH value, add the injection water to 1000ml, fine straining, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate is evaporated under aseptic condition in right amount, embedding, sterilization, promptly.
The preparation process of (5) 5% glucose injections is as follows: get Herba Artemisiae Annuae, HERBA BUPLEURI is distilled with the way of distillation, collect distillate 930ml, medicinal residues are abandoned it; Other gets Rhizoma Arundinis Donacis, Gypsum Fibrosum decocts with water three times, and collecting decoction filters, filtrate is concentrated in right amount, handle secondary with ethanol precipitation, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 80% for the second time, leave standstill, filter, reclaim and wave most ethanol, it is an amount of to add the injection water, add active carbon and boil in right amount, sucking filtration is to clear and bright; Benzyl alcohol 3ml, pluronic F-685ml, an amount of glucose are added in the distillate, and mixing merges with above-mentioned medicinal liquid again, regulates pH value, adds the injection water to 1000ml, fine straining, and embedding, sterilization, promptly.
The preparation process of (6) 0.9% sodium chloride injections is as follows: get Herba Artemisiae Annuae, HERBA BUPLEURI is distilled with the way of distillation, collect distillate 930ml, medicinal residues are abandoned it; Other gets Rhizoma Arundinis Donacis, Gypsum Fibrosum decocts with water three times, and collecting decoction filters, filtrate is concentrated in right amount, handle secondary with ethanol precipitation, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 80% for the second time, leave standstill, filter, reclaim and wave most ethanol, it is an amount of to add the injection water, add active carbon and boil in right amount, sucking filtration is to clear and bright; Benzyl alcohol 3ml, pluronic F-685ml, an amount of sodium chloride are added in the distillate, and mixing merges with above-mentioned medicinal liquid again, regulates pH value, adds the injection water to 1000ml, fine straining, and embedding, sterilization, promptly.
During more than prescription was formed, the weight of raw material of Chinese medicine medicine was calculated with crude drug, and per 1 part can be 1 gram, also can be kilogram or ton, if be unit with gram, this prescription composition can be made into 1000 doses of pharmaceutical preparatioies.Described 1000 doses of fingers, the final drug preparation of making, as 1000 of injection, freeze-dried powder is 1000 bottles, each consumption is 1～3 (or bottle).
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The extract drugs composition that goes in the sensible heat preparation of the present invention, its shared percentage by weight in preparation can be 0.1～99.9%, all the other are the medicine acceptable carrier.QUGANRE ZHUSHEJI of the present invention exists with unit dosage form, as every of injection, every bottle of the powder pin etc.
QUGANRE ZHUSHEJI of the present invention, the liquid unit dosage forms of preparation contains active substance of the present invention and sterile carrier.According to carrier and concentration, this chemical compound can be suspended or dissolving.The preparation of solution is normally by being dissolved in active substance in a kind of carrier filter-sterilized before it is packed into a kind of suitable bottle or ampoule, sealing then.For example a kind of local anesthetic of adjuvant, antiseptic and buffer agent also can be dissolved in this carrier.In order to improve its stability, can be after the bottle of packing into that this compositions is freezing, and under vacuum, water is removed.
The present invention removes the sensible heat ejection preparation, as injection, can draw 1～3 with disposable syringe in use, adopts intramuscular injection, and after also pharmaceutical liquid can being diluted with 0.9% normal saline, 10～40ml, intravenous injection was slowly injected in 5～8 minutes; Also can be diluted in 0.9% sodium chloride injection or 5% glucose injection, 250～500ml, vein splashes into.For lyophilized injectable powder, can adopt the said method administration with after the sterilized water for injection dissolving.
Following data declaration beneficial effect of the present invention by experiment:
For the whether equivalence of the curative effect that proves new route of administration and original this medicine approach, or be any more effective, we have done preclinical zoopery, and concrete grammar and result are as follows:
One, the influence of the hyperpyrexia effect that endotoxin is caused
(1) material and method
1, laboratory animal: the healthy common white rabbit of choosing body weight 1.8～2.5kg (male and female dual-purpose).
2, escherichia coli endotoxin: provided by the biological study of Ministry of Public Health Changchun.Be made into 15ug/ml solution with normal saline.
3, experimental procedure: choose 30 of animals, be divided at random: 10 of normal group, 10 of matched groups.10 of experimental grouies.Wherein two groups of every the animals in back are injected endotoxin liquid 3ml once by auricular vein, and the physiological saline solution of normal group injection same dose once.Before the injection endotoxin behind 2h and the injection endotoxin, every of experimental group through auricular vein inject cold fever eliminating injection 5ml/kg each once, matched group through the cold fever eliminating injection of intramuscular injection Isodose each once.
4, observation index:
(1) body temperature: three groups of laboratory animals are respectively at experiment before measurement anus Wen Sanci, and averaging is basal body temperature.Survey the anus temperature once per half an hour behind the injection endotoxin, and it is poor as body temperature to deduct basal body temperature with surveyed body temperature.
(2) symptom and sign: the ear of all animals before and after the observation experiment, skin, conjunctiva, tongue, thirsty drink, the situation of change of mind and general body state etc.
(2) result and analysis
1, sings and symptoms
Control animals is beginning heating about 30 minutes to 1 hour behind the counteracting toxic substances, and occur alarmming hair, shakes, roll up, refusing to eat, heart rate is accelerated, the eye conjunctiva is not seen hyperemia, and body of the tongue does not have change, to about 2 hours, alarm hair, shake, roll up and fade away, and heating is more obvious, and heart rate is faster, rapid breathing, frequent drinking-water, but auricle and subcutaneously do not see hemorrhage speckle, sanity.The above-mentioned performance of experimental group animal is lighter.The normal group animal does not see above-mentioned performance.
2, body temperature changes
Basal body temperature before the experiment of (1) three treated animal sees Table 1.
The comparison of basal body temperature before the experiment of table 1 three treated animals (℃)
| Group | Quantity | Basal body temperature |
| Normal group matched group experimental group | 10 10 10 | 39.05 38.79 38.89 |
Body temperature does not have significant difference (P＞0.05) all in normal range between each group before the experiment of three treated animals.
(2) heating effect
The heating effect observation index is heating peak net added value (AT); 2.5 hour body temperature effect index (TRI2.5 means the area value between 2.5 hours heating curves and its body temperature baseline); The mean body temperature response curve.
A, three treated animal AT change: see Table 2.
The comparison of table 2 four treated animal AT
| Group | Quantity | AT |
| Normal group matched group experimental group | 10 10 10 | 0.008 1.372 0.574 |
Annotate: the AT of each treated animal relatively is T＜0.01 in twos
The variation of B, three treated animal TRI2.5: see Table 3.
The comparison of table 3 four treated animal TRI2.5
| Group | Quantity | AT |
| Normal group matched group experimental group | 10 10 10 | 0.008 1.372 0.574 |
Annotate: the TRI2.5 of each treated animal relatively is T＜0.01 in twos
C, the average heating curve of three treated animals are seen accompanying drawing:
By table 1,2,3 and accompanying drawing in as seen, matched group, experimental group body temperature behind counteracting toxic substances all has rising, matched group is up to 1.37 ℃, 0.57 ℃ of experimental group, normal group rises minimum, the intravenously administrable experimental group takes second place, matched group is the highest.This medicine group curative effect of vein is described significantly better than the muscle administration, also better for the heat clearing away effect.
Two, to the therapeutical effect of viral pneumonia
50 of healthy mices are divided into the virazole matched group at random, go sensible heat intramuscular injection group, quiet notes group, model control group and normal control group, and 10 every group, male and female half and half.
Get 10 times of LD
50Amount (10TCLD
50) collunarium infecting mouse pulmonary, the normal control group sucks normal saline, 30 μ l/ only infect back 2h, give every mice respectively and go sensible heat intramuscular injection group, quiet notes group, 25mg/kg, virazole 25mg/kg, im, model control group, normal control group all give the 0.5ml normal saline, successive administration 5d, twice of every day.Begin to observe continuously 15d from administration.Write down death toll and death time behind the mouse infection influenza virus every day, calculate dead protective rate as follows and prolong vital rates with the dead sum of every treated animal in 15 days, and with lot number medicine repeated experiments once.Dead protective rate (%)-(matched group mortality rate-experimental group mortality rate) * 100% prolongs vital rates (%)-(experimental group on average life number of days-matched group on average life number of days)/(matched group is life number of days on average) * 100%.
The result shows; intramuscular injection or quiet notes QUGANRE ZHUSHEJI all can reduce the animal dead rate after the mouse infection virus; average life order number prolongs along with this pharmaceutical quantities increases, and effect increases, and the model control group animal obviously becomes thin behind 4d; dyspnea; beginning is dead, compares with model control group, and QUGANRE ZHUSHEJI all can significantly reduce animal dead rate (P＜0.05); the most obvious with quiet notes, but dead protective rate is lower than virazole.
Three, toxicity:
Acute toxicity test shows that the mouse tail vein injection cold fever eliminating injection is not measured LD
50
Long term toxicity test: mice group, every day tail vein injection once, connect and annotate 90d, the result, administration group mice and control group mice movable, search for food, drinking-water, body weight and multinomial observation indexs such as substantial viscera pathologic finding and histopathology detect, result of the test is not all found any toxicity; Hemogram and hepatic and renal function index and the equal no significant difference of matched group.
The blood vessel irritation of this medicine, allergy and hemolytic test all are negative.
In sum, cold fever eliminating injection is a kind of heat and toxic materials clearing away medicine preferably, treatment to various infection, noninfectious fever has the important clinical meaning, and changing original intramuscular administration is intravenously administrable, can obviously increase its clinical efficacy, not have tangible toxicity in addition, prolonged application safety, therefore, being worth clinical further applies.
The specific embodiment:
Further specify the present invention by the following examples, include but not limited to the following example.
Embodiment 1:
The preparation method of injection of the present invention:
The preparation process of injection is as follows: get Herba Artemisiae Annuae 250g, HERBA BUPLEURI 125g and distill with the way of distillation, collect distillate 930ml, medicinal residues are abandoned it; Other gets Rhizoma Arundinis Donacis 250g, Gypsum Fibrosum 100g and decocts with water three times, and collecting decoction filters, filtrate is concentrated in right amount, handle secondary with ethanol precipitation, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 80% for the second time, leave standstill, filter, reclaim and wave most ethanol, it is an amount of to add the injection water, add active carbon and boil in right amount, sucking filtration is to clear and bright; Benzyl alcohol 3ml, pluronic F-68 5ml are added in the distillate, and mixing merges with above-mentioned medicinal liquid again, regulates pH value, adds the injection water to 1000ml, fine straining, and embedding, sterilization promptly gets 500 (2ml/ props up).
Embodiment 2:
The preparation method of lyophilized injectable powder of the present invention:
Get Herba Artemisiae Annuae 250g, HERBA BUPLEURI 125g and distill with the way of distillation, collect distillate 930ml, medicinal residues are abandoned it, with gained volatile oil and HP-enclose; Other gets Rhizoma Arundinis Donacis 250g, Gypsum Fibrosum 100g and decocts with water three times, and collecting decoction filters, filtrate is concentrated in right amount, handle secondary with ethanol precipitation, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 80% for the second time, leave standstill, filter, reclaim and wave most ethanol, it is an amount of to add the injection water, add active carbon and boil in right amount, sucking filtration is to clear and bright; Benzyl alcohol 3ml, pluronic F-68 5ml are added in the clathrate, and mixing merges with above-mentioned medicinal liquid again, regulate pH value, add the injection water to nearly full dose, fine straining, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, the filtrate fill in the cillin bottle of 20ml, every bottled 5ml.And be placed in the freeze drying box pre-freeze evacuation after 3～5 hours.Condensation temperature remains unchanged, and after 24 hours, unpacks, and makes dried frozen aquatic products, and gland is sealed with wax, and labeling promptly gets 500 bottles (400mg/ props up).
Embodiment 3
The preparation method of sterilized powder:
Get Herba Artemisiae Annuae 250g, HERBA BUPLEURI 125g and distill with the way of distillation, collect distillate 930ml, medicinal residues are abandoned it, with gained volatile oil and HP-enclose; Other gets Rhizoma Arundinis Donacis 250g, Gypsum Fibrosum 100g and decocts with water three times, and collecting decoction filters, filtrate is concentrated in right amount, handle secondary with ethanol precipitation, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 80% for the second time, leave standstill, filter, reclaim and wave most ethanol, it is an amount of to add the injection water, add active carbon and boil in right amount, sucking filtration is to clear and bright; Benzyl alcohol 3ml, pluronic F-6g 5ml are added in the clathrate, mixing merges with above-mentioned medicinal liquid again, regulates pH value, add the injection water to ormal weight, fine straining, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate is sprayed with the spray drying tower under the aseptic condition, make sterilized powder, packing, labeling promptly gets 1000 bottles (100mg/ props up).
Embodiment 4
The preparation process of concentrated solution for injection is as follows:
Get Herba Artemisiae Annuae 250g, HERBA BUPLEURI 125g and distill with the way of distillation, collect distillate 930ml, medicinal residues are abandoned it, with gained volatile oil and HP-enclose; Other gets Rhizoma Arundinis Donacis 250g, Gypsum Fibrosum 100g and decocts with water three times, and collecting decoction filters, filtrate is concentrated in right amount, handle secondary with ethanol precipitation, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 80% for the second time, leave standstill, filter, reclaim and wave most ethanol, it is an amount of to add the injection water, add active carbon and boil in right amount, sucking filtration is to clear and bright; Benzyl alcohol 3ml, pluronic F-68 5ml are added in the clathrate, mixing, merge with above-mentioned medicinal liquid again, regulate pH value, add the injection water to ormal weight, fine straining, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate is evaporated to 600ml under aseptic condition, embedding, sterilization promptly gets 300 (2ml/ props up).
Embodiment 5
The preparation process of 5% glucose injection is as follows:
Get Herba Artemisiae Annuae 250g, HERBA BUPLEURI 125g and distill with the way of distillation, collect distillate 930ml, medicinal residues are abandoned it; Other gets Rhizoma Arundinis Donacis 250g, Gypsum Fibrosum 100g and decocts with water three times, and collecting decoction filters, filtrate is concentrated in right amount, handle secondary with ethanol precipitation, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 80% for the second time, leave standstill, filter, reclaim and wave most ethanol, it is an amount of to add the injection water, add active carbon and boil in right amount, sucking filtration is to clear and bright; Benzyl alcohol 3ml, pluronic F-68 5ml, an amount of glucose are added in the distillate, and mixing merges with above-mentioned medicinal liquid again, regulates pH value, adds the injection water to 1000ml, fine straining, and embedding, sterilization, promptly.
Embodiment 6
The preparation process of 0.9% sodium chloride injection is as follows: get Herba Artemisiae Annuae 250g, HERBA BUPLEURI 125g and distill with the way of distillation, collect distillate 930ml, medicinal residues are abandoned it; Other gets Rhizoma Arundinis Donacis 250g, Gypsum Fibrosum 100g and decocts with water three times, and collecting decoction filters, filtrate is concentrated in right amount, handle secondary with ethanol precipitation, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 80% for the second time, leave standstill, filter, reclaim and wave most ethanol, it is an amount of to add the injection water, add active carbon and boil in right amount, sucking filtration is to clear and bright; Benzyl alcohol 3ml, pluronic F-68 5ml, an amount of sodium chloride are added in the distillate, and mixing merges with above-mentioned medicinal liquid again, regulates pH value, adds the injection water to 1000ml, fine straining, and embedding, sterilization, promptly.
Claims (6)
1. QUGANRE ZHUSHEJI is characterized in that being made by the following weight proportion raw material:
50～200 parts in 62.5～250 parts of Gypsum Fibrosum of 125～500 parts of HERBA BUPLEURI of 125～500 portions of Herba Artemisiae Annuaes of Rhizoma Arundinis Donacis.
2. the injection of claim 1 is characterized in that, is made by the following weight proportion raw material:
100 parts in 125 parts of Gypsum Fibrosum of 250 parts of HERBA BUPLEURI of 250 portions of Herba Artemisiae Annuaes of Rhizoma Arundinis Donacis.
3. the ejection preparation of claim 2, it is characterized in that, be small-volume injection (injection, concentrated solution for injection), bulk capacity injection (5% glucose injection, 0.9% sodium chloride injection) and specific type injection dosage forms such as (freeze-dried powder, sterilized powders).
4. the new route of administration of claim 2 refers to that QUGANRE ZHUSHEJI is used for multiple intravenously administrables such as intravenous drip, intravenous injection.
5. the new indication of claim 2 refers to all kinds of febrile diseases that caused by various bacteria, viral infection comprise diseases such as influenza, pneumonia, bronchitis, acute nephritis, acute enteritis, epidemic hemorrhagic fever, chickenpox, parotitis, hyperpyrexia convulsion.
6. the method for making of claim 1-5 is characterized in that:
Wherein:
(1) preparation process of injection is as follows: get Herba Artemisiae Annuae, HERBA BUPLEURI is distilled with the way of distillation, collect distillate 930ml, medicinal residues are abandoned it; Other gets Rhizoma Arundinis Donacis, Gypsum Fibrosum decocts with water three times, and collecting decoction filters, filtrate is concentrated in right amount, handle secondary with ethanol precipitation, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 80% for the second time, leave standstill, filter, reclaim and wave most ethanol, it is an amount of to add the injection water, add active carbon and boil in right amount, sucking filtration is to clear and bright; Benzyl alcohol 3ml, pluronic F-685ml are added in the distillate, and mixing merges with above-mentioned medicinal liquid again, regulates pH value, adds the injection water to 1000ml, fine straining, and embedding, sterilization, promptly.
(2) preparation process of lyophilized powder is as follows: get Herba Artemisiae Annuae, HERBA BUPLEURI is distilled with the way of distillation, collect distillate 930ml, medicinal residues are abandoned it, with gained volatile oil and HP-enclose; Other gets Rhizoma Arundinis Donacis, Gypsum Fibrosum decocts with water three times, and collecting decoction filters, filtrate is concentrated in right amount, handle secondary with ethanol precipitation, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 80% for the second time, leave standstill, filter, reclaim and wave most ethanol, it is an amount of to add the injection water, add active carbon and boil in right amount, sucking filtration is to clear and bright; Benzyl alcohol 3ml, pluronic F-685ml are added in the clathrate, and mixing merges with above-mentioned medicinal liquid again, regulate pH value, add the injection water to 1000ml, fine straining, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, the filtrate fill in the cillin bottle of 20ml, every bottled 5ml.And be placed in the freeze drying box pre-freeze evacuation after 3～5 hours.Condensation temperature remains unchanged, and after 24 hours, unpacks, and makes dried frozen aquatic products, and gland is sealed with wax, labeling, promptly;
(3) preparation process of sterilized powder is as follows: get Herba Artemisiae Annuae, HERBA BUPLEURI is distilled with the way of distillation, collect distillate 930ml, medicinal residues are abandoned it, with gained volatile oil and HP-enclose; Other gets Rhizoma Arundinis Donacis, Gypsum Fibrosum decocts with water three times, and collecting decoction filters, filtrate is concentrated in right amount, handle secondary with ethanol precipitation, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 80% for the second time, leave standstill, filter, reclaim and wave most ethanol, it is an amount of to add the injection water, add active carbon and boil in right amount, sucking filtration is to clear and bright; Benzyl alcohol 3ml, pluronic F-68 5ml are added in the clathrate, mixing merges with above-mentioned medicinal liquid again, regulates pH value, add the injection water to 1000ml, fine straining, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate is sprayed with the spray drying tower under the aseptic condition, make sterilized powder, packing, labeling, promptly;
(4) preparation process of concentrated solution for injection is as follows: get Herba Artemisiae Annuae, HERBA BUPLEURI is distilled with the way of distillation, collect distillate 930ml, medicinal residues are abandoned it, with gained volatile oil and HP-enclose; Other gets Rhizoma Arundinis Donacis, Gypsum Fibrosum decocts with water three times, and collecting decoction filters, filtrate is concentrated in right amount, handle secondary with ethanol precipitation, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 80% for the second time, leave standstill, filter, reclaim and wave most ethanol, it is an amount of to add the injection water, add active carbon and boil in right amount, sucking filtration is to clear and bright; Benzyl alcohol 3ml, pluronic F-68 5ml are added in the clathrate, and mixing merges with above-mentioned medicinal liquid again, regulates pH value, add the injection water to 1000ml, fine straining, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate is evaporated under aseptic condition in right amount, embedding, sterilization, promptly.
The preparation process of (5) 5% glucose injections is as follows: get Herba Artemisiae Annuae, HERBA BUPLEURI is distilled with the way of distillation, collect distillate 930ml, medicinal residues are abandoned it; Other gets Rhizoma Arundinis Donacis, Gypsum Fibrosum decocts with water three times, and collecting decoction filters, filtrate is concentrated in right amount, handle secondary with ethanol precipitation, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 80% for the second time, leave standstill, filter, reclaim and wave most ethanol, it is an amount of to add the injection water, add active carbon and boil in right amount, sucking filtration is to clear and bright; Benzyl alcohol 3ml, pluronic F-685ml, an amount of glucose are added in the distillate, and mixing merges with above-mentioned medicinal liquid again, regulates pH value, adds the injection water to 1000ml, fine straining, and embedding, sterilization, promptly.
The preparation process of (6) 0.9% sodium chloride injections is as follows: get Herba Artemisiae Annuae, HERBA BUPLEURI is distilled with the way of distillation, collect distillate 930ml, medicinal residues are abandoned it; Other gets Rhizoma Arundinis Donacis, Gypsum Fibrosum decocts with water three times, and collecting decoction filters, filtrate is concentrated in right amount, handle secondary with ethanol precipitation, make for the first time that to contain the alcohol amount be 70%, make that to contain the alcohol amount be 80% for the second time, leave standstill, filter, reclaim and wave most ethanol, it is an amount of to add the injection water, add active carbon and boil in right amount, sucking filtration is to clear and bright; Benzyl alcohol 3ml, pluronic F-685ml, an amount of sodium chloride are added in the distillate, and mixing merges with above-mentioned medicinal liquid again, regulates pH value, adds the injection water to 1000ml, fine straining, and embedding, sterilization, promptly.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200510087738 CN1799612A (en) | 2005-08-08 | 2005-08-08 | Novel drug administering route of 'Qu Gan Re' injection, its preparation process and novel indications |
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| CN 200510087738 CN1799612A (en) | 2005-08-08 | 2005-08-08 | Novel drug administering route of 'Qu Gan Re' injection, its preparation process and novel indications |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104510763A (en) * | 2013-12-26 | 2015-04-15 | 唐桂益 | Application of Artemisia carvifolia in preparation of gastrointestinal disease treatment drugs |
| CN108143957A (en) * | 2018-01-19 | 2018-06-12 | 河北晟和生物科技有限公司 | A kind of Chinese medicine composition for treating neurological disorders |
-
2005
- 2005-08-08 CN CN 200510087738 patent/CN1799612A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104510763A (en) * | 2013-12-26 | 2015-04-15 | 唐桂益 | Application of Artemisia carvifolia in preparation of gastrointestinal disease treatment drugs |
| CN108143957A (en) * | 2018-01-19 | 2018-06-12 | 河北晟和生物科技有限公司 | A kind of Chinese medicine composition for treating neurological disorders |
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