CN1751700A - Novel administration route of isatis root injection for relieving internal heat, and prepn. technique and application thereof - Google Patents
Novel administration route of isatis root injection for relieving internal heat, and prepn. technique and application thereof Download PDFInfo
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- CN1751700A CN1751700A CN 200510087741 CN200510087741A CN1751700A CN 1751700 A CN1751700 A CN 1751700A CN 200510087741 CN200510087741 CN 200510087741 CN 200510087741 A CN200510087741 A CN 200510087741A CN 1751700 A CN1751700 A CN 1751700A
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Abstract
A Chinese medicine in the form of injection for treating non-icteric hepatitis, upper respiratary tract infection and infantile pneumonia by intravenous injection is prepared from south isatis root through extracting by purified water, depositing in alcohol, cyclic purifying, adding the water for injection and excipient, stirring, filter, regulating pH=6.5, millipore membrane filtering, and conventional steps.
Description
Technical field:
The present invention relates to new route of administration of Chinese medicine Baphicacanthus cusia detoxicating injection and preparation technology thereof, new indication.
Technical background:
China is the district occurred frequently of viral hepatitis, and the crowd that 8%-10% arranged approximately is hepatitis B virus carriers, is about 1.3 hundred million people, wherein has 3,000 ten thousand people to suffer from chronic hepatitis approximately, and it is about about 1,400,000 that average year is sent out case load, and is annual because of hepatitis about 300,000 people that die that die of illness.Hepatitis C virus carrier 0.38 hundred million people, add the hepatitis of other types, nearly 200,000,000 people of total number of persons that suffer from hepatitis, estimate every year due to illness virus hepatitis cause direct economic loss 30,000,000,000～50,000,000,000 RMB, caused heavy financial burden for patient family and society.
Medicine for hepatitis mainly comprises nucleotide analogs such as alpha-interferon, vidarabine, vidarabine phosphate, lamivudine, famciclovir at present.Although these medicines have the obvious suppression effect to multiple hepatitis virus, through after the long-term treatment, variation and drug resistance may appear in virus, need multiple medication combined application, increase the weight of patient's Liver and kidney and drain burden.And Chinese medicine has incomparable superiority aspect the treatment of viral hepatitis.
The Chinese medicine preparation kind of treatment viral hepatitis is a lot, Baphicacanthus cusia detoxifcation injection is to have heat-clearing and toxic substances removing, the Rhizoma Et Radix Baphicacanthis Cusiae of anti-inflammation function processes through extracting, can obviously reduce capillary permeability, the inflammation-inhibiting mediator discharges, increase the phagocytic function of macrophage, significantly raise immunity has significant function for protecting liver and reducing enzyme activity to chronic hepatic injury.Be widely used in treatment non-icteric type chronic hepatitis clinically and belong to syndrome of dampness-heat of liver and gallbladder, effect is remarkable.
But Baphicacanthus cusia detoxifcation injection adopts the intramuscular injection method aspect clinical practice, absorbs by tissue, and speed is slower, and dosage is less, and this administrated method limits its clinical practice.Therefore, at this problem, we have developed the intravenously administrable approach, have both increased clinical effective dose, can comparatively fast absorb again, have increased new indication, make clinical practice more convenient, can be patient's service better.
Summary of the invention:
The invention provides new route of administration of a kind of new Chinese medicine Baphicacanthus cusia detoxicating injection and new indication thereof.
New route of administration involved in the present invention, the blue detoxicating injection of fingerboard is used for multiple intravenously administrables such as intravenous drip, intravenous injection.
New indication involved in the present invention, the blue detoxicating injection of fingerboard is used for upper respiratory tract infection, infantile pneumonia etc.
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).
The above extraction, refining may further comprise the steps to raw material of Chinese medicine:
A: the preparation of extract: get Rhizoma Et Radix Baphicacanthis Cusiae, be ground into coarse powder, add purified water dipping 30 minutes, decoct secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.12～1.18 (80 ℃), adds ethanol and makes and contain the alcohol amount and reach 65%, stir evenly, left standstill 48 hours, and filtered, behind the filtrate recycling ethanol, put 4～10 ℃ of cold preservations 8 hours, filter, filtrate is regulated pH value to 8～9 with ammonia, puts 4～10 ℃ of cold preservations 8 hours, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.05～1.10 (50 ℃), adds injection water 200ml and pluronic F-68, medicinal charcoal stirs, heated and boiled 30 minutes, be chilled to 40 ℃, filter filtrate for later use.
B: the activated feedstock that the extract that obtains with above step is used as injection makes injection through the galenic pharmacy routine techniques;
Wherein:
(1) it is as follows to penetrate the preparation process of liquid: add the injection water to ormal weight, regulate pH value to 6.5 with 20% sodium hydroxide solution, put 4～10 ℃ of cold preservations more than 6 hours, filter repeatedly to clear and bright, embedding is sterilized, promptly.
(2) preparation process of lyophilized powder is as follows: add an amount of excipient, add the injection water to ormal weight, regulate pH value to 6.5 with 20% sodium hydroxide solution, put 4～10 ℃ of cold preservations more than 6 hours, filter repeatedly to clear and bright, the filtrate fill in the cillin bottle of 10ml, every bottled 2～3ml.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: add an amount of excipient, add the injection water to ormal weight, regulate pH value to 6.5 with 20% sodium hydroxide solution, put 4～10 ℃ of cold preservations more than 6 hours, filter to clear and bright repeatedly, 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: with above-mentioned extract obtained adjusting pH value, filter with microporous filter membrane (0.2 μ m), filtrate is evaporated under aseptic condition in right amount, embedding, and sterilization, promptly.
The preparation process of (5) 5% glucose injections is as follows: with an amount of glucose of above-mentioned extract obtained adding, stir, add the injection water to ormal weight, regulate pH value to 6.5 with 20% sodium hydroxide solution, put 4～10 ℃ of cold preservations more than 6 hours, filter repeatedly to clear and bright, embedding, sterilization, promptly.
The preparation process of (6) 0.9% sodium chloride injections is as follows: with an amount of sodium chloride of above-mentioned extract obtained adding, stir, add the injection water to ormal weight, regulate pH value to 6.5 with 20% sodium hydroxide solution, put 4～10 ℃ of cold preservations more than 6 hours, filter to clear and bright embedding repeatedly, 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.
Extract drugs composition in the Baphicacanthus cusia detoxicating preparation of the present invention, its shared percentage by weight in preparation can be 01～99.9%, all the other are the medicine acceptable carrier.Baphicacanthus cusia detoxicating injection of the present invention exists with unit dosage form, as every of injection, every bottle of the powder pin etc.
Baphicacanthus cusia detoxicating injection 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.
Baphicacanthus cusia detoxifcation ejection preparation of the present invention as injection, can be drawn 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:
In order to prove that Baphicacanthus cusia detoxifcation injection changes the Clinical feasibility of route of administration, we have carried out preclinical pharmaceutical research to this medicine, to compare intramuscular injection and two kinds of route of administration of intravenous injection in difference aspect the pharmacodynamics.
1. the antiinflammatory action mice is 30, body weight 18～20g, and male and female are regardless of, and divide equally three groups at random.Blank group intravenous injection normal saline, positive controls intramuscular injection Rhizoma Et Radix Baphicacanthis Cusiae injection 2ml/ are only; Experimental group tail vein injection Rhizoma Et Radix Baphicacanthis Cusiae injection 2ml/ only, behind the administration 45min, with the dimethylbenzene cotton balls by touching mouse right ear 5min, put to death animal behind the 15min, with diameter 7mm card punch the mice ears are downcut with the position homalographic, torsion balance is weighed, it is heavy heavily to deduct left auricle with the auris dextra sheet, as the swelling degree, the comparable group differences calculates inhibitory rate of intumesce (%).
The results are shown in Table 1.
The influence of table 1 pair Mice Auricle dimethylbenzene inflammation
| Group | The Mus number | Dosage (ml/g) | Auricle swelling degree (mg) | Inhibitory rate of intumesce (%) |
| NS positive controls experimental group | 10 10 10 | -- 0.1 0.1 | 5.20±1.14 3.70±1.25 3.40±1.51 | 28.85 30.77 |
Two groups and NS comparison, P＜0.05; Experimental group and positive controls compare, △ P＜0.05
By in the table as can be seen, experimental group and positive controls relatively have significant difference, illustrate that intravenously administrable can obviously increase the antiinflammatory curative effect with respect to intramuscular administration.
2. the immunological enhancement mice is 30, male and female are regardless of, body weight 18～19g, divide equally 3 groups at random, each organizes rat every day by table 2 dosed administration, NS group and positive controls intramuscular injection administration, experimental group tail intravenously administrable, successive administration 14d, 2h after the last administration, every Mus lumbar injection 5% chicken red blood cell 1ml, animal takes off cervical vertebra execution behind the 12h, with distilled water flushing for several times, collect flushing liquor, adjust volume to 10ml, centrifugal (3000rpm) 5min, under oily mirror, count 100 of macrophages for every, calculate its phagocytic percentage and engulf lot number, the results are shown in Table 2.
The influence of table 2 pair Turnover of Mouse Peritoneal Macrophages phagocytic function
| Group | The Mus number | Dosage (g/kg) | Phagocytic percentage (%) | Phagocytic index |
| NS experimental group positive controls | 10 10 10 | -- 0.1 0.1 | 32.5±3.0 63.9±7.2 53.2±6.2 | 0.35±0.05 0.80±0.12 0.58±0.23 |
Two groups and NS comparison, P＜0.05; Experimental group and positive controls compare, △ P＜0.05
The influence of 3 pairs of carbon tetrachloride chronic hepatic injuries
30 of rats, male and female half and half, body weight 150～160g divides equally 3 groups at random, injects 10% carbon tetrachloride solution 5ml/kg by rat intramuscular, 2 times weekly, continuous 2 months, causes carbon tetrachloride chronic hepatic injury animal model.After the moulding 1 month, each organizes rat every day by table 3 dosed administration, NS group and positive controls intramuscular injection administration, and experimental group tail intravenously administrable,
The influence of table 5 pair carbon tetrachloride chronic hepatic injury model biochemical indicator
| Group | The Mus number | Dosage | SGPT | T-BIL | TP | ALB | GLB |
| The positive group of NS experimental group | 10 10 10 | -- 0.1 0.1 | 437.7±43.9 146.3±66.9 187.5±70.3 | 2.28±0.69 1.17+0.21 1.25±0.17 | 66.4±2.44 70.1±2.51 67.1±4.00 | 34.2±1.63 36.0±1.5 33.4±1.9 | 32.2±1.41 34.2+1.56 33.7±2.4 |
Two groups and NS comparison, P＜0.05; Experimental group and positive controls compare, △ P＜0.05
4 toxicologic studies
Acute toxicity test shows that mouse tail vein injection Baphicacanthus cusia detoxifcation injection fails to measure LD
50
Long term toxicity test
80 of mices are divided four groups, are basic, normal, high three dosage groups and a blank group by 5 times of amounts of clinical dosage, 10 times of amounts, 20 times of amounts, every day tail vein injection once, connect and to annotate 90d.
Pass through long term toxicity test, 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, remove administration treated animal weight increase, spleen weight is not seen other significant changes outside increasing comparatively fast than matched group; 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.
Clinically at present, its main route of administration is intramuscular injection.We are by changing route of administration, compare with original administering mode, find that intravenously administrable can obviously improve this medicine xylol induced mice auricle inflammation remarkable inhibitory action is arranged, significantly improve the phagocytic function of Turnover of Mouse Peritoneal Macrophages, strengthen the mouse cell immunologic function, have significant function for protecting liver and reducing enzyme activity also obviously to increase rat chronic hepatic injury due to the carbon tetrachloride.And after changing route of administration, this medicine still has higher safety.Above experimental result all shows: intravenously administrable is compared with intramuscular administration, and the former is safer, more effective.
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:
Prescription: Rhizoma Et Radix Baphicacanthis Cusiae 500g pluronic F-68 4g active carbon 0.5g
Make 1000ml
Preparation method:
Get Rhizoma Et Radix Baphicacanthis Cusiae, be ground into coarse powder, add purified water dipping 30 minutes, decoct secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.12～1.18 (80 ℃), add ethanol and make and contain alcohol amount and reach 65%, stir evenly, left standstill 48 hours, filter, behind the filtrate recycling ethanol, put 4～10 ℃ of cold preservations 8 hours, filter, filtrate is regulated pH value to 8～9 with ammonia, puts 4～10 ℃ of cold preservations 8 hours, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.05～1.10 (50 ℃), adds injection water 200ml and pluronic F-68, medicinal charcoal, stir, heated and boiled 30 minutes is chilled to 40 ℃, filter, add the injection water to ormal weight, regulate pH value to 6.5, put 4～10 ℃ of cold preservations more than 6 hours with 20% sodium hydroxide solution, filter repeatedly to clear and bright, embedding, sterilization, promptly.
Embodiment 2:
The preparation method of lyophilized powder of the present invention:
Prescription: Rhizoma Et Radix Baphicacanthis Cusiae 1000g pluronic F-68 8g
Active carbon 0.5g dextran-40 70g
Make 1000
Preparation method:
Get Rhizoma Et Radix Baphicacanthis Cusiae, be ground into coarse powder, add purified water dipping 30 minutes, decoct secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.12～1.18 (80 ℃), adding ethanol makes and contains alcohol amount and reach 65%, stir evenly, left standstill 48 hours, filter, behind the filtrate recycling ethanol, put 4～10 ℃ of cold preservations 8 hours, filter, filtrate is regulated pH value to 8～9 with ammonia, put 4～10 ℃ of cold preservations 8 hours, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.05～1.10 (50 ℃), adds injection water 200ml and pluronic F-68, the dextran of recipe quantity excipient, medicinal charcoal, stir, heated and boiled 30 minutes is chilled to 40 ℃, filters, add the injection water to ormal weight, regulate pH value to 6.5 with 20% sodium hydroxide solution, put 4～10 ℃ of cold preservations more than 6 hours, filter repeatedly to clear and bright, the filtrate fill in the cillin bottle of 10ml, every bottled 2～3ml.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;
Embodiment 3:
The preparation method of sterilized powder of the present invention:
Prescription: Rhizoma Et Radix Baphicacanthis Cusiae 1000g pluronic F-68 8g
Active carbon 0.5g mannitol 200g
Make 1000 bottles
Preparation method:
Get Rhizoma Et Radix Baphicacanthis Cusiae, be ground into coarse powder, add purified water dipping 30 minutes, decoct secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.12～1.18 (80 ℃), add ethanol and make and contain alcohol amount and reach 65%, stir evenly, left standstill 48 hours, filter, behind the filtrate recycling ethanol, put 4～10 ℃ of cold preservations 8 hours, filter, filtrate is regulated pH value to 8～9 with ammonia, puts 4～10 ℃ of cold preservations 8 hours, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.05～1.10 (50 ℃), adds injection water 200ml and pluronic F-68, the mannitol of recipe quantity excipient, medicinal charcoal stirs, heated and boiled 30 minutes, be chilled to 40 ℃, filter, add the injection water to ormal weight, regulate pH value to 6.5 with 20% sodium hydroxide solution, put 4～10 ℃ cold good more than 6 hours, filter repeatedly to clear and bright, filtrate is sprayed with the spray drying tower under the aseptic condition, make sterilized powder, packing, labeling, promptly;
Embodiment 4:
The preparation method of concentrated solution for injection of the present invention:
Prescription: Rhizoma Et Radix Baphicacanthis Cusiae 1500g pluronic F-68 12g active carbon 0.5g
Make 1000ml
Preparation method:
Get Rhizoma Et Radix Baphicacanthis Cusiae, be ground into coarse powder, add purified water dipping 30 minutes, decoct secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.12～1.18 (80 ℃), add ethanol and make and contain alcohol amount and reach 65%, stir evenly, left standstill 48 hours, filter, behind the filtrate recycling ethanol, put 4～10 ℃ of cold preservations 8 hours, filter, filtrate is regulated pH value to 8～9 with ammonia, puts 4～10 ℃ of cold preservations 8 hours, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.05～1.10 (50 ℃), adds injection water 200ml and pluronic F-68, medicinal charcoal, stir, heated and boiled 30 minutes is chilled to 40 ℃, filters, with above-mentioned extract obtained adjusting pH value, filter with microporous filter membrane (0.2 μ m), filtrate is evaporated under aseptic condition in right amount, embedding, sterilization, promptly.
Embodiment 5:
The preparation method of the present invention's 5% glucose injection:
Prescription: Rhizoma Et Radix Baphicacanthis Cusiae 500g pluronic F-68 4g
Active carbon 0.5g glucose 50g
Make 1000ml
Preparation method:
Get Rhizoma Et Radix Baphicacanthis Cusiae, be ground into coarse powder, add purified water dipping 30 minutes, decoct secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.12～1.18 (80 ℃), add ethanol and make and contain alcohol amount and reach 65%, stir evenly, left standstill 48 hours, filter, behind the filtrate recycling ethanol, put 4～10 ℃ of cold preservations 8 hours, filter, filtrate is regulated pH value to 8～9 with ammonia, puts 4～10 ℃ of cold preservations 8 hours, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.05～1.10 (50 ℃), adds injection water 200ml and pluronic F-68, medicinal charcoal stirs, heated and boiled 30 minutes, be chilled to 40 ℃, filter, add the recipe quantity glucose, stir, add the injection water to ormal weight, regulate pH value to 6.5, put 4～10 ℃ of cold preservations more than 6 hours with 20% sodium hydroxide solution, filter repeatedly to clear and bright, embedding, sterilization, promptly.
Embodiment 6:
The preparation method of the present invention's 0.9% sodium chloride injection:
Prescription: Rhizoma Et Radix Baphicacanthis Cusiae 500g pluronic F-68 4g
Active carbon 0.5g sodium chloride 9g
Make 1000ml
Preparation method:
Get Rhizoma Et Radix Baphicacanthis Cusiae, be ground into coarse powder, add purified water dipping 30 minutes, decoct secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.12～1.18 (80 ℃), add ethanol and make and contain alcohol amount and reach 65%, stir evenly, left standstill 48 hours, filter, behind the filtrate recycling ethanol, put 4～10 ℃ of cold preservations 8 hours, filter, filtrate is regulated pH value to 8～9 with ammonia, put 4～10 ℃ cold good 8 hours, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.05～1.10 (50 ℃), adds injection water 200ml and pluronic F-68, medicinal charcoal stirs, heated and boiled 30 minutes, be chilled to 40 ℃, filter, add recipe quantity sodium chloride, stir, add the injection water to ormal weight, regulate pH value to 6.5, put 4～10 ℃ of cold preservations more than 6 hours with 20% sodium hydroxide solution, filter repeatedly to clear and bright, embedding, sterilization, promptly.
Claims (8)
1. a new Baphicacanthus cusia detoxicating injection is characterized in that being formed for the raw material processing and preparing by Rhizoma Et Radix Baphicacanthis Cusiae.
2. the new route of administration of claim 1, the blue detoxicating injection of fingerboard is used for multiple intravenously administrables such as intravenous drip, intravenous injection.
3. the new indication of claim 1 refers to upper respiratory tract infection, infantile pneumonia etc.
4. the new preparation type of claim 2 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).
5. can contain excipient in the described preparation of claim 4, excipient is selected from: mannitol, dextran, glycine, lactose etc.
6. the described preparation type of claim 4 in preparation process, can add an amount of solubilizing agent in case of necessity, and solubilizing agent is selected from poloxamer 188 (F-68), tween 80, EL (polyoxyethylene castor oil).Preferred poloxamer 188.
7. the preparation method of any one injection of claim 1-6 is characterized in that, the process following steps:
A: the preparation of extract:
Get Rhizoma Et Radix Baphicacanthis Cusiae, be ground into coarse powder, add purified water dipping 30 minutes, decoct secondary, 1.5 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate is concentrated into the clear paste that relative density is 1.12～1.18 (80 ℃), add ethanol and make and contain alcohol amount and reach 65%, stir evenly, left standstill 48 hours, filter, behind the filtrate recycling ethanol, put 4～10 ℃ of cold preservations 8 hours, filter, filtrate is regulated pH value to 8～9 with ammonia, puts 4～1 ℃ of cold preservations 8 hours, filter, filtrate decompression is concentrated into the clear paste that relative density is 1.05～1.10 (50 ℃), adds injection water 200ml and pluronic F-68, medicinal charcoal stirs, heated and boiled 30 minutes, be chilled to 40 ℃, filter filtrate for later use.
B: the activated feedstock that the extract that obtains with above step is used as injection makes injection through the galenic pharmacy routine techniques.
8. the preparation method of claim 7 is characterized in that,
Wherein:
(1) preparation process of injection is as follows: add the injection water to ormal weight, regulate pH value to 6.5, put 4～10 ℃ of cold preservations more than 6 hours, filter repeatedly to clear and bright with 20% sodium hydroxide solution, and embedding, sterilization, promptly.
(2) preparation process of lyophilized powder is as follows: add an amount of excipient, add the injection water to ormal weight, regulate pH value to 6.5 with 20% sodium hydroxide solution, put 4～10 ℃ of cold preservations more than 6 hours, filter repeatedly to clear and bright, the filtrate fill in the cillin bottle of 10ml, every bottled 2～3ml.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: add an amount of excipient, add the injection water to ormal weight, regulate pH value to 6.5 with 20% sodium hydroxide solution, put 4～10 ℃ of cold preservations more than 6 hours, filter to clear and bright repeatedly, 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: with above-mentioned extract obtained adjusting pH value, filter with microporous filter membrane (0.2 μ m), filtrate is evaporated under aseptic condition in right amount, embedding, and sterilization, promptly.
The preparation process of (5) 5% glucose injections is as follows: with an amount of glucose of above-mentioned extract obtained adding, stir, add the injection water to ormal weight, regulate pH value to 6.5 with 20% sodium hydroxide solution, put 4～10 ℃ of cold preservations more than 6 hours, filter repeatedly to clear and bright, embedding, sterilization, promptly.
The preparation process of (6) 0.9% sodium chloride injections is as follows: with an amount of sodium chloride of above-mentioned extract obtained adding, stir, add the injection water to ormal weight, regulate pH value to 6.5 with 20% sodium hydroxide solution, put 4～10 ℃ of cold preservations more than 6 hours, filter to clear and bright embedding repeatedly, sterilization, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510087741 CN1751700A (en) | 2005-08-08 | 2005-08-08 | Novel administration route of isatis root injection for relieving internal heat, and prepn. technique and application thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510087741 CN1751700A (en) | 2005-08-08 | 2005-08-08 | Novel administration route of isatis root injection for relieving internal heat, and prepn. technique and application thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1751700A true CN1751700A (en) | 2006-03-29 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510087741 Pending CN1751700A (en) | 2005-08-08 | 2005-08-08 | Novel administration route of isatis root injection for relieving internal heat, and prepn. technique and application thereof |
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| CN (1) | CN1751700A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102872171A (en) * | 2012-10-30 | 2013-01-16 | 湖北天圣康迪制药有限公司 | Method for preparing radix isatidis injection |
-
2005
- 2005-08-08 CN CN 200510087741 patent/CN1751700A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102872171A (en) * | 2012-10-30 | 2013-01-16 | 湖北天圣康迪制药有限公司 | Method for preparing radix isatidis injection |
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