CN1730014A - Novel drug administration route of semen armeniacae amarum injection, its preparation process and new indications - Google Patents
Novel drug administration route of semen armeniacae amarum injection, its preparation process and new indications Download PDFInfo
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- CN1730014A CN1730014A CN 200510089072 CN200510089072A CN1730014A CN 1730014 A CN1730014 A CN 1730014A CN 200510089072 CN200510089072 CN 200510089072 CN 200510089072 A CN200510089072 A CN 200510089072A CN 1730014 A CN1730014 A CN 1730014A
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Abstract
The invention relates to a traditional Chinese medicinal injection for treating common cold, upper respiratory tract infection, acute tonsillitis, pneumonia, acute bronchitis and trauma infection, its preparing process, new route of administration and new indications. The injection is prepared from Kumu as raw material, and can be made into the forms of concentrated solution, freeze-dried powder injection, germ-free powdery 5% glucose injection, and 0.9% sodium chloride injection.
Description
Technical field:
The present invention relates to new route of administration of Chinese medicine preparation Ramulus Et Folium Picrasmae injection and preparation technology thereof, new indication.
Technical background:
KUMU ZHUSHEYE is to extract to make with extra care through scientific method and form according to dry root, the stem of folk remedy by the quassia Ramulus Et Folium Picrasmae, contain active ingredients such as multiple guassin and Ramulus Et Folium Picrasmae lactone, it has broad-spectrum anti-inflammation and good antiinflammatory, analgesic activity bibliographical information, and the clinical illness such as treatment flu, upper respiratory tract infection, acute tonsillitis, enteritis, bacillary dysentery that are widely used in all have effect preferably.In development in 1971, approval was gone into operation, and is used for the treatment of the infective fever illness through how tame hospital clinical, total effective rate 91%.Since this product good effect, steady quality, side effect is little, and therefore volume of production and marketing rises year by year over more than 20 year, and the market demand is very big.
In our preclinical research of change route of administration, this medicine can also be used for the treatment of diseases such as pneumonia, acute/chronic bronchitis, infantile diarrhea, trauma infection contamination, skin infection, acute keratitis, acute iritis, acute cystitis, pyelonephritis, urinary tract infection.
But KUMU ZHUSHEYE adopts the intramuscular injection method aspect practical clinical, 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 a kind of about the new route of administration of KUMU ZHUSHEYE, and new indication.
Ramulus Et Folium Picrasmae injection 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 diseases such as pneumonia, acute/chronic bronchitis, infantile diarrhea, trauma infection contamination, skin infection, acute keratitis, acute iritis, acute cystitis, pyelonephritis, urinary tract infection.
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 Ramulus Et Folium Picrasmae, be ground into coarse powder, divide the post bake reflux, extract, with 8 times of amount 80%～85% ethanol, merge extractive liquid, reclaims ethanol, is condensed into thick paste, gradation adds 13 times of amount ethanol makes dissolving, filters merging filtrate, with about sodium hydroxide solution adjust pH to 9, leave standstill, filter, filtrate recycling ethanol, be condensed into thick paste, be extracted into extracting solution inanimate object alkali reaction with 2% hydrochloric acid solution gradation till, merge extractive liquid,, with sodium hydroxide solution adjust pH to 5～6, leave standstill, filter, filtrate is condensed into thick paste, gradation does not have till the obvious alkaloid with ethanol extraction to extracting solution, merge extractive liquid, is condensed into thick paste, checks loss on drying.(when preparation injection and bulk capacity injection, recipe quantity is pressed dry product and is calculated, and makes the 1ml injected dose with every 5mg extract and feeds intake; When preparing the injection of other types, make the 1ml injected dose with every 25mg extract and feed intake).An amount of water for injection being added in the thick paste several times, stir and to make dissolving, filter, get filtrate, is 1～2 with 10% hydrochloric acid solution adjust pH, and heated and boiled is put coldly, filters, and filtrate is 6.5～7.0 with 20% sodium hydroxide solution adjust pH, and filtration gets filtrate, and is standby.
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: said extracted liquid is filtered, add pluronic F-68 in the filtrate and (add 3～4g) and sodium chloride solution (every 1000ml finished product sodium chloride-containing 4g) in every 1000ml finished product, adjust pH to 7～7.5, add to the full amount of water for injection, after assay meets the requirements, filter just, fine straining is qualified to clarity test, embedding, sterilization, promptly.
(2) preparation process of sterilized powder is as follows: said extracted liquid is filtered, (add 10～15g) and sodium chloride solution (every 1000ml finished product sodium chloride-containing 4g) in every 1000ml finished product, adjust pH to 7～7.5 add to the full amount of water for injection to add pluronic F-68 in the filtrate, after assay meets the requirements, filter just, fine straining is qualified to clarity test, and filtrate is sprayed with the spray drying tower under the aseptic condition, make sterilized powder, packing, labeling, promptly.
(3) preparation process of dry powder injection is as follows: said extracted liquid is filtered, add pluronic F-68 in the filtrate and (add 10～15g) and sodium chloride solution (every 1000ml finished product sodium chloride-containing 4g) in every 1000ml finished product, adjust pH to 7～7.5, add to the full amount of water for injection, after assay meets the requirements, filter just, fine straining is qualified to clarity test, filtrate adds injection water nearly full dose, 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
(4) preparation process of concentrated solution for injection is as follows: said extracted liquid is filtered, add pluronic F-68 in the filtrate and (add 10～15g) and sodium chloride solution (every 1000ml finished product sodium chloride-containing 4g) in every 1000ml finished product, adjust pH to 7～7.5 add to the full amount of water for injection, after assay meets the requirements, filter just, fine straining is qualified to clarity test, and filtrate is evaporated under aseptic condition in right amount, embedding, sterilization, promptly.
The preparation process of (5) 5% glucose injections is as follows: said extracted liquid is filtered, add glucose 50g, pluronic F-68 in the filtrate and (add 3～4g) and sodium chloride solution (every 1000ml finished product sodium chloride-containing 4g) in every 1000ml finished product, adjust pH to 7～7.5 add to the full amount of water for injection, after assay meets the requirements, filter just, fine straining is qualified to clarity test, filters embedding, sterilization, promptly.
The preparation process of (6) 0.9% glucose injections is as follows: said extracted liquid is filtered, add pluronic F-68 in the filtrate and (add 3～4g) and sodium chloride solution (every 1000ml finished product sodium chloride-containing 9g) in every 1000ml finished product, adjust pH to 7～7.5 add to the full amount of water for injection, after assay meets the requirements, filter just, fine straining is qualified to clarity test, filters 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.
Extract drugs composition in the Ramulus Et Folium Picrasmae 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.Ramulus Et Folium Picrasmae injection of the present invention exists with unit dosage form, as every of injection, every bottle of the powder pin etc.
Ramulus Et Folium Picrasmae 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.
Ramulus Et Folium Picrasmae 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:
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:
We change KUMU ZHUSHEYE, and route of administration has been carried out antiinflammatory, cough-relieving, has been reduced phlegm, antibacterial, antipyretic pharmacodynamic study, and compares with original this medicine approach.
1, the antiinflammatory action of KUMU ZHUSHEYE is got 30 of body weight 27.0 ± 1.5g male mices, is divided into three groups at random, intravenously administrable group 40g/kg, same dose intramuscular administration group and blank group.Every group 10, once a day, behind the administration 1.5h, every Mus left side ear is coated with the caused by dimethylbenzene xylene inflammation, and auris dextra in contrast.After causing scorching 30min mice is put to death, lay auricle at same position respectively, weigh with diameter 9mm card punch.Heavily subtracting the auris dextra recast with left ear is the swelling degree, and administration group and matched group compare, and calculate its suppression ratio.The result shows that intravenously administrable group xylol induced mice auricle edema has obvious inhibitory action, and its curative effect and intramuscular administration group are relatively.
See Table 1.
Table 1 xylol causes the influence of mice auricle swelling
| Dosage | n | Swelling degree (mg) | Suppression ratio | The P value |
| (g/kg) | (x±s) | (％) | |||
| Intravenously administrable group intramuscular administration group matched group | 40 40 40 | 10 10 10 | 6.80±3.25 7.82±3.14 10.24±2.65 | 57.6 35.7 - | ＜0.01 ＜0.05 ＜0.05 |
2, the cough-suppressing phlegm-dispelling functions of KUMU ZHUSHEYE
(1) mice ammonia is drawn the antitussive action of coughing and get 30 of body weight 20.0 ± 1.5g Kunming mouses, male and female half and half are divided into three groups at random, and 10 every group, group and administering mode are the same.Behind the administration 1.5h, place the special glass cover, stimulate mice 1min, take out mice, observe cough number of times in the 3min immediately with ammonia.The number of times of intramuscular administration group and intravenously administrable group cough as a result obviously is less than matched group, illustrates that these two kinds of route of administration all have tangible antitussive action, wherein with intravenously administrable group most pronounced effects.See Table 2.
Table 2 KUMU ZHUSHEYE is drawn the antitussive action of coughing to mice ammonia
| Dosage (g/kg) | Cough number of times in the 3min | The P value | |
| Intramuscular administration group intravenously administrable group blank group | - 40 40 | 12.50±4.36 8.42±3.61 18.63±5.26 | ＜0.05 ＜0.05 ＜0.01 |
(2) phlegm-dispelling functions of mice is got 40 of body weight 20.0 ± 1.2g Kunming mouses, male and female half and half, grouping and administering mode are the same.Inject 0.25% phenol red solution 0.5ml to mouse peritoneal respectively behind the administration 1h, mice is put to death in the 30min cervical vertebra dislocation of injection back, secretions with 5%NaHCO3 solution lavation mice trachea and bronchus, each with NaHCO3 solution 0.5ml, lavation is 4 times continuously, collect irrigating solution 1.5ml, with 722 type spectrophotometers in wavelength 520nm place colorimetric.Relatively, the result shows that KUMU ZHUSHEYE vein group can make the mouse breathing road phenol red amount of secretions greater than intramuscular administration group, matched group between organizing.Illustrate that this medicine has good phlegm-dispelling functions, and the intravenously administrable curative effect is better than the intramuscular administration group.See Table 3.
Table 3 KUMU ZHUSHEYE is to the mice phlegm-dispelling functions
| Dosage (g/kg) | Phenol red solution (μ g/ml) | The P value | |
| Intravenously administrable group intramuscular administration group saline control group | 40 40 40 | 0.42±0.13 0.32±0.17 0.25±0.15 | ＜0.05 ＜0.05 ＜0.01 |
3,40 of rabbits are got in the influence of pyrogenicity rabbit body temperature, divide equally 4 groups (10 every group, male and female half and half), be blank group (normal saline 2ml/kg), intravenously administrable group, intramuscular administration group (40g/kg) and positive drug group (erythromycin ethylsuccinate), every day 2 times.More than each group press shown in the continuous gastric infusion of dosage 3 days, after the last administration, use triple vaccine pyrogenicity, the variation of observed and recorded rabbit body temperature behind 1h.The result shows that KUMU ZHUSHEYE intravenously administrable group and intramuscular administration group, normal saline group, positive controls compare, and the cooling effect difference that triple vaccine is caused the rabbit fervescence has significance.
4, toxicologic study:
Acute toxicity test is tested and is shown, mouse tail vein injection Baphicacanthus cusia detoxifcation injection fails to measure 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, KUMU ZHUSHEYE is a kind of anti-inflammation preferably, eliminating phlegm and stopping cough, falls the heat effect medicine, except that being used for the treatment of illness such as flu, upper respiratory tract infection, acute tonsillitis, enteritis, bacillary dysentery, we find to treat diseases such as pneumonia, acute/chronic bronchitis, infantile diarrhea, trauma infection contamination, skin infection, acute keratitis, acute iritis, acute cystitis, pyelonephritis, urinary tract infection.And changing original intramuscular administration is intravenously administrable, can increase obviously that it is antibiotic, antiinflammatory, clinical efficacy such as analgesic, does not have tangible toxicity in addition, and therefore prolonged application safety, be worth clinical and further apply.
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 is as follows:
Prescription:
Ramulus Et Folium Picrasmae 500g
F-68 3～4g
Sodium chloride 4g
Make 1000ml
Preparation method:
Get Ramulus Et Folium Picrasmae, be ground into coarse powder, divide the post bake reflux, extract, with 8 times of amount 80%～85% ethanol, merge extractive liquid, reclaims ethanol, is condensed into thick paste, gradation adds 13 times of amount ethanol makes dissolving, filters merging filtrate, with about sodium hydroxide solution adjust pH to 9, leave standstill, filter, filtrate recycling ethanol, be condensed into thick paste, be extracted into extracting solution inanimate object alkali reaction with 2% hydrochloric acid solution gradation till, merge extractive liquid,, with sodium hydroxide solution adjust pH to 5～6, leave standstill, filter, filtrate is condensed into thick paste, gradation does not have till the obvious alkaloid with ethanol extraction to extracting solution, merge extractive liquid, is condensed into thick paste, checks loss on drying.During the preparation injection, recipe quantity is pressed dry product and is calculated, and makes the 1ml injected dose with every 5mg extract and feeds intake.Add an amount of water for injection in the thick paste several times, stirring makes dissolving, filters, and gets filtrate, with 10% hydrochloric acid solution adjust pH is 1～2, heated and boiled is put coldly, filters, filtrate is 6.5～7.0 with 20% sodium hydroxide solution adjust pH, filter, filtrate, middle adding pluronic F-68 (adds 3～4g) and sodium chloride solution (every 1000ml finished product sodium chloride-containing 4g) in every 1000ml finished product, adjust pH to 7～7.5, add to the full amount of water for injection, after assay meets the requirements, filter just, fine straining is qualified to clarity test, embedding, sterilization, promptly.
Embodiment 2:
The preparation method of sterilized powder of the present invention is as follows:
Prescription:
Ramulus Et Folium Picrasmae 2500g
F-68 15～20g
Sodium chloride 4g
Make 1000
Preparation method:
Get Ramulus Et Folium Picrasmae, be ground into coarse powder, divide the post bake reflux, extract, with 8 times of amount 80%～85% ethanol, merge extractive liquid, reclaims ethanol, is condensed into thick paste, gradation adds 13 times of amount ethanol makes dissolving, filters merging filtrate, with about sodium hydroxide solution adjust pH to 9, leave standstill, filter, filtrate recycling ethanol, be condensed into thick paste, be extracted into extracting solution inanimate object alkali reaction with 2% hydrochloric acid solution gradation till, merge extractive liquid,, with sodium hydroxide solution adjust pH to 5～6, leave standstill, filter, filtrate is condensed into thick paste, gradation does not have till the obvious alkaloid with ethanol extraction to extracting solution, merge extractive liquid, is condensed into thick paste, checks loss on drying.During the preparation sterilized powder, make the 1ml injected dose with every 25mg extract and feed intake.An amount of water for injection is added in the thick paste several times, stir and make dissolving, filter, getting filtrate, is 1～2 with 10% hydrochloric acid solution adjust pH, heated and boiled, put cold, filter, filtrate is 6.5～7.0 with 20% sodium hydroxide solution adjust pH, filters, get filtrate, (add 10～15g) and sodium chloride solution (every 1000ml finished product sodium chloride-containing 4g) in every 1000ml finished product, adjust pH to 7～7.5 add to the full amount of water for injection to add pluronic F-68, after assay meets the requirements, filter just, fine straining is qualified to clarity test, and filtrate is sprayed with the spray drying tower under the aseptic condition, make sterilized powder, packing, labeling, promptly.
Embodiment 3:
The preparation method of lyophilized powder of the present invention is as follows:
Prescription:
Ramulus Et Folium Picrasmae 2500g
F-68 15～20g
Sodium chloride 4g
Make 1000 bottles
Preparation method:
Get Ramulus Et Folium Picrasmae, be ground into coarse powder, divide the post bake reflux, extract, with 8 times of amount 80%～85% ethanol, merge extractive liquid, reclaims ethanol, is condensed into thick paste, gradation adds 13 times of amount ethanol makes dissolving, filters merging filtrate, with about sodium hydroxide solution adjust pH to 9, leave standstill, filter, filtrate recycling ethanol, be condensed into thick paste, be extracted into extracting solution inanimate object alkali reaction with 2% hydrochloric acid solution gradation till, merge extractive liquid,, with sodium hydroxide solution adjust pH to 5～6, leave standstill, filter, filtrate is condensed into thick paste, gradation does not have till the obvious alkaloid with ethanol extraction to extracting solution, merge extractive liquid, is condensed into thick paste, checks loss on drying.During the preparation lyophilized powder, make the 1ml injected dose with every 25mg extract and feed intake.Add an amount of water for injection in the thick paste several times, stirring makes dissolving, filters, and gets filtrate, with 10% hydrochloric acid solution adjust pH is 1～2, heated and boiled is put coldly, filters, filtrate is 6.5～7.0 with 20% sodium hydroxide solution adjust pH, filter, filtrate, add pluronic F-68 and (add 10～15g) and sodium chloride solution (every 1000ml finished product sodium chloride-containing 4g) in every 1000ml finished product, adjust pH to 7～7.5, add to the full amount of water for injection, after assay meets the requirements, filter just, fine straining is qualified to clarity test, filtrate adds injection water nearly full dose, 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 4:
The preparation method of concentrated solution for injection of the present invention is as follows:
Prescription:
Ramulus Et Folium Picrasmae 2500g
F-68 15～20g
Sodium chloride 4g
Make 1000ml
Preparation method:
Get Ramulus Et Folium Picrasmae, be ground into coarse powder, divide the post bake reflux, extract, with 8 times of amount 80%～85% ethanol, merge extractive liquid, reclaims ethanol, is condensed into thick paste, gradation adds 13 times of amount ethanol makes dissolving, filters merging filtrate, with about sodium hydroxide solution adjust pH to 9, leave standstill, filter, filtrate recycling ethanol, be condensed into thick paste, be extracted into extracting solution inanimate object alkali reaction with 2% hydrochloric acid solution gradation till, merge extractive liquid,, with sodium hydroxide solution adjust pH to 5～6, leave standstill, filter, filtrate is condensed into thick paste, gradation does not have till the obvious alkaloid with ethanol extraction to extracting solution, merge extractive liquid, is condensed into thick paste, checks loss on drying.During the preparation concentrated solution for injection, make the 1ml injected dose with every 25mg extract and feed intake.An amount of water for injection is added in the thick paste several times, stir and make dissolving, filter, get filtrate, with 10% hydrochloric acid solution adjust pH is 1～2, and heated and boiled is put cold, filter, filtrate is 6.5～7.0 with 20% sodium hydroxide solution adjust pH, filters, and gets filtrate, add pluronic F-68 and (add 10～15g) and sodium chloride solution (every 1000ml finished product sodium chloride-containing 4g) in every 1000ml finished product, adjust pH to 7～7.5 add to the full amount of water for injection, after assay meets the requirements, filter just, fine straining is qualified to clarity test, and 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 is as follows:
Prescription:
Ramulus Et Folium Picrasmae 500g F-68 3～4g
Sodium chloride 4g glucose 50g
Make 1000ml
Preparation method:
Get Ramulus Et Folium Picrasmae, be ground into coarse powder, divide the post bake reflux, extract, with 8 times of amount 80%～85% ethanol, merge extractive liquid, reclaims ethanol, is condensed into thick paste, gradation adds 13 times of amount ethanol makes dissolving, filters merging filtrate, with about sodium hydroxide solution adjust pH to 9, leave standstill, filter, filtrate recycling ethanol, be condensed into thick paste, be extracted into extracting solution inanimate object alkali reaction with 2% hydrochloric acid solution gradation till, merge extractive liquid,, with sodium hydroxide solution adjust pH to 5～6, leave standstill, filter, filtrate is condensed into thick paste, gradation does not have till the obvious alkaloid with ethanol extraction to extracting solution, merge extractive liquid, is condensed into thick paste, checks loss on drying.During the preparation concentrated solution for injection, make the 1ml injected dose with every 5mg extract and feed intake.An amount of water for injection is added in the thick paste several times, stir and make dissolving, filter, get filtrate, with 10% hydrochloric acid solution adjust pH is 1～2, and heated and boiled is put cold, filter, filtrate is 6.5～7.0 with 20% sodium hydroxide solution adjust pH, filters, and gets filtrate, add glucose 50g, pluronic F-68 and (add 3～4g) and sodium chloride solution (every 1000ml finished product sodium chloride-containing 4g) in every 1000ml finished product, adjust pH to 7～7.5 add to the full amount of water for injection, after assay meets the requirements, filter just, fine straining is qualified to clarity test, filters embedding, sterilization, promptly.
Embodiment 6:
The preparation method of the present invention's 0.9% sodium chloride injection is as follows:
Prescription:
Ramulus Et Folium Picrasmae 500g
F-68 3～4g
Sodium chloride 4g
Make 1000ml
Preparation method:
Get Ramulus Et Folium Picrasmae, be ground into coarse powder, divide the post bake reflux, extract, with 8 times of amount 80%～85% ethanol, merge extractive liquid, reclaims ethanol, is condensed into thick paste, gradation adds 13 times of amount ethanol makes dissolving, filters merging filtrate, with about sodium hydroxide solution adjust pH to 9, leave standstill, filter, filtrate recycling ethanol, be condensed into thick paste, be extracted into extracting solution inanimate object alkali reaction with 2% hydrochloric acid solution gradation till, merge extractive liquid,, with sodium hydroxide solution adjust pH to 5～6, leave standstill, filter, filtrate is condensed into thick paste, gradation does not have till the obvious alkaloid with ethanol extraction to extracting solution, merge extractive liquid, is condensed into thick paste, checks loss on drying.During the preparation concentrated solution for injection, make the 1ml injected dose with every 5mg extract and feed intake.An amount of water for injection is added in the thick paste several times, stir and make dissolving, filter, get filtrate, with 10% hydrochloric acid solution adjust pH is 1～2, and heated and boiled is put cold, filter, filtrate is 6.5～7.0 with 20% sodium hydroxide solution adjust pH, filters, and gets filtrate, add pluronic F-68 and (add 3～4g) and sodium chloride solution (every 1000ml finished product sodium chloride-containing 9g) in every 1000ml finished product, adjust pH to 7～7.5 add to the full amount of water for injection, after assay meets the requirements, filter just, fine straining is qualified to clarity test, filters embedding, sterilization, promptly.
Claims (6)
1 one kinds of new Ramulus Et Folium Picrasmae injections is characterized in that being formed for the raw material processing and preparing by Ramulus et Folium Picrasmae.
The new route of administration of 2 claim 1 refers to that the Ramulus Et Folium Picrasmae injection is used for multiple intravenously administrables such as intravenous drip, intravenous injection.
The new indication of 3 claim 1 refers to diseases such as pneumonia, acute/chronic bronchitis, trauma infection contamination, skin infection, acute keratitis, acute iritis, acute cystitis, pyelonephritis, urinary tract infection.
The preparation type of 4 claim 2 comprises the injection dosage forms such as (lyophilized powder, sterilized powders) of small-volume injection (injection, concentrated solution for injection), bulk capacity injection (5% glucose injection, 0.9% sodium chloride injection) and specific type.
The preparation method of 5 any one injection of claim 1-4 is characterized in that, the process following steps:
A: the preparation of extract:
Get Ramulus Et Folium Picrasmae, be ground into coarse powder, divide the post bake reflux, extract, with 8 times of amount 80%～85% ethanol, merge extractive liquid, reclaims ethanol, is condensed into thick paste, gradation adds 13 times of amount ethanol makes dissolving, filters merging filtrate, with about sodium hydroxide solution adjust pH to 9, leave standstill, filter, filtrate recycling ethanol, be condensed into thick paste, be extracted into extracting solution inanimate object alkali reaction with 2% hydrochloric acid solution gradation till, merge extractive liquid,, with sodium hydroxide solution adjust pH to 5～6, leave standstill, filter, filtrate is condensed into thick paste, gradation does not have till the obvious alkaloid with ethanol extraction to extracting solution, merge extractive liquid, is condensed into thick paste, checks loss on drying.(when preparation injection and bulk capacity injection, recipe quantity is pressed dry product and is calculated, and makes the 1ml injected dose with every 5mg extract and feeds intake; When preparing the injection of other types, make the 1ml injected dose with every 25mg extract and feed intake).An amount of water for injection being added in the thick paste several times, stir and to make dissolving, filter, get filtrate, is 1～2 with 10% hydrochloric acid solution adjust pH, and heated and boiled is put coldly, filters, and filtrate is 6.5～7.0 with 20% sodium hydroxide solution adjust pH, and filtration gets filtrate, and is standby.
B: the activated feedstock that the extract that obtains with above step is used as injection makes injection through the galenic pharmacy routine techniques;
The preparation method of 6 claim 5 is characterized in that,
Wherein:
(1) preparation process of injection is as follows: said extracted liquid is filtered, add pluronic F-68 in the filtrate and (add 3～4g) and sodium chloride solution (every 1000ml finished product sodium chloride-containing 4g) in every 1000ml finished product, adjust pH to 7～7.5, add to the full amount of water for injection, after assay meets the requirements, filter just, fine straining is qualified to clarity test, embedding, sterilization, promptly.
(2) preparation process of sterilized powder is as follows: said extracted liquid is filtered, (add 10～15g) and sodium chloride solution (every 1000ml finished product sodium chloride-containing 4g) in every 1000ml finished product, adjust pH to 7～7.5 add to the full amount of water for injection to add pluronic F-68 in the filtrate, after assay meets the requirements, filter just, fine straining is qualified to clarity test, and filtrate is sprayed with the spray drying tower under the aseptic condition, make sterilized powder, packing, labeling, promptly.
(3) preparation process of lyophilized injectable powder is as follows: said extracted liquid is filtered, add pluronic F-68 in the filtrate and (add 10～15g) and sodium chloride solution (every 1000ml finished product sodium chloride-containing 4g) in every 1000ml finished product, adjust pH to 7～7.5, add to the full amount of water for injection, after assay meets the requirements, filter just, fine straining is qualified to clarity test, filtrate adds injection water nearly full dose, 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
(4) preparation process of concentrated solution for injection is as follows: said extracted liquid is filtered, add pluronic F-68 in the filtrate and (add 10～15g) and sodium chloride solution (every 1000ml finished product sodium chloride-containing 4g) in every 1000ml finished product, adjust pH to 7～7.5 add to the full amount of water for injection, after assay meets the requirements, filter just, fine straining is qualified to clarity test, and filtrate is evaporated under aseptic condition in right amount, embedding, sterilization, promptly.
The preparation process of (5) 5% glucose injections is as follows: said extracted liquid is filtered, add glucose 50g, pluronic F-68 in the filtrate and (add 3～4g) and sodium chloride solution (every 1000ml finished product sodium chloride-containing 4g) in every 1000ml finished product, adjust pH to 7～7.5 add to the full amount of water for injection, after assay meets the requirements, filter just, fine straining is qualified to clarity test, filters embedding, sterilization, promptly.
The preparation process of (6) 0.9% glucose injections is as follows: said extracted liquid is filtered, add pluronic F-68 in the filtrate and (add 3～4g) and sodium chloride solution (every 1000ml finished product sodium chloride-containing 9g) in every 1000ml finished product, adjust pH to 7～7.5 add to the full amount of water for injection, after assay meets the requirements, filter just, fine straining is qualified to clarity test, filters embedding, sterilization, promptly.
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|---|---|---|---|
| CN 200510089072 CN1730014A (en) | 2005-08-05 | 2005-08-05 | Novel drug administration route of semen armeniacae amarum injection, its preparation process and new indications |
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|---|---|---|---|
| CN 200510089072 CN1730014A (en) | 2005-08-05 | 2005-08-05 | Novel drug administration route of semen armeniacae amarum injection, its preparation process and new indications |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111675722A (en) * | 2018-02-13 | 2020-09-18 | 陕西含光生物科技有限公司 | Ailanthus altissima kusnezoff derivative, preparation thereof and application of ailanthus altissima kusnezoff derivative as antiviral drug |
| CN114931565A (en) * | 2022-04-01 | 2022-08-23 | 广东万年青制药股份有限公司 | Preparation method of quassia atomization inhalation solution |
| CN115317420A (en) * | 2022-09-02 | 2022-11-11 | 水羊化妆品制造有限公司 | Quassine extract, preparation method, detection method, composition and application |
-
2005
- 2005-08-05 CN CN 200510089072 patent/CN1730014A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111675722A (en) * | 2018-02-13 | 2020-09-18 | 陕西含光生物科技有限公司 | Ailanthus altissima kusnezoff derivative, preparation thereof and application of ailanthus altissima kusnezoff derivative as antiviral drug |
| CN111675722B (en) * | 2018-02-13 | 2022-06-24 | 陕西含光生物科技有限公司 | Ailanthus altissima kusnezoff derivative, preparation thereof and application of ailanthus altissima kusnezoff derivative as antiviral drug |
| CN114931565A (en) * | 2022-04-01 | 2022-08-23 | 广东万年青制药股份有限公司 | Preparation method of quassia atomization inhalation solution |
| CN115317420A (en) * | 2022-09-02 | 2022-11-11 | 水羊化妆品制造有限公司 | Quassine extract, preparation method, detection method, composition and application |
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