CN100435814C - Scullcap stem and leaf injection powder and its preparing method - Google Patents
Scullcap stem and leaf injection powder and its preparing method Download PDFInfo
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- CN100435814C CN100435814C CNB2006100654970A CN200610065497A CN100435814C CN 100435814 C CN100435814 C CN 100435814C CN B2006100654970 A CNB2006100654970 A CN B2006100654970A CN 200610065497 A CN200610065497 A CN 200610065497A CN 100435814 C CN100435814 C CN 100435814C
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Abstract
The present invention provides a scutellaria stem and leaf injection powder and a preparation method thereof. The medicine is prepared from scutellaria root stem and leaf extracts and auxiliary materials, wherein the auxiliary materials are hydroxypropyl-beta-cyclodextrin and polyethylene glycol. The preparation method is characterized in that the scutellaria stems and leaves are extracted by water, acidified and refined, and then the extracts are prepared; the extracts are covered by the auxiliary materials, frozen, dried, etc., and then the injection powder is prepared. The injection powder has the same medical care function with homogeneous medicine oral liquids, granules, tablets, capsules, dripping pills, injections, etc. The injection powder can be used for analgesia, inflammation or/and fever relieving and aphrenia resistance, and can also be used for resisting viruses, bacteria, vascular smooth muscle proliferation, oxidation and tumors. The present invention has the advantages of simple manufacturing technology, stable property, little stimulation, convenient transportation and long storage period. Therefore, the injection powder can be used as a novel preparation form of the novel scutellaria stem and leaf medicine to be produced in large scale and popularized and applied in large area.
Description
Technical field:
The invention belongs to technical field of medicine, particularly a kind of Scullcap stem and leaf injection powder and preparation method thereof.
Background technology:
Baikal skullcap root (Scutellaria baicalensis Georgi) tradition is used as medicine with root.Recent years, Chinese patent discloses the new purposes of Caulis et Folium Scutellariae in pharmaceutical field continuously, wherein CN1131066C has announced " Caulis et Folium Scutellariae is preparing analgesia, antiinflammatory or/and the application in the antipyretic analgesics ", and CN1149989C has announced " Caulis et Folium Scutellariae total flavones and scutellarin thereof are as the application of preparation dementia medicine ".Facts have proved outstanding, sure, the safety and low toxicity of clinical efficacy of a kind of really pharmacological action of Caulis et Folium Scutellariae, have analgesia, antiinflammatory or/and source new drugs analgesic and the dementia function.But aforementioned patent then all is being the routine techniquess that adopt aspect the open method for preparing corresponding medicine with Caulis et Folium Scutellariae, promptly adopts routine techniques to make to contain oral liquid, electuary, tablet, capsule, drop pill, injection, spray, liniment, suppository or their dosage forms such as controlled release fertilizer agent of Caulis et Folium Scutellariae or its total flavones or its scutellarin.It is considered herein that traditional dosage form is no doubt available, as medical new product, if can develop good stability, the novel form that zest is low, convenient transportation, storage life are long, appearing on the market and apply beyond doubt a strong support and promotion so for new medicine.Therefore the present invention is to being that the pharmaceutical formulation of raw material has carried out big cholic exploration and research with the Caulis et Folium Scutellariae, and therefrom found practicable production technology.
Summary of the invention:
The object of the present invention is to provide a kind of good stability, Scullcap stem and leaf injection powder that zest is low, convenient transportation, storage life are long and preparation method thereof.Its technical solution is:
A kind of Scullcap stem and leaf injection powder is characterized in that being made up of Caulis et Folium Scutellariae extract and adjuvant.Adjuvant described here is HP-and Polyethylene Glycol.
A kind of preparation method of Scullcap stem and leaf injection powder is characterized in that, is raw material with the Caulis et Folium Scutellariae, is adjuvant with HP-and Polyethylene Glycol, finishes by following step:
(1) Caulis et Folium Scutellariae is placed 10 times of amount boiling water decoction 1 hour, filter, residue adds 8 times of amount boiling water again and decocted 1 hour, and merging filtrate concentrates, and drying gets extractum;
(2) extractum is dissolved in the 50-80 ℃ of hot water, uses 1% sodium hydroxide solution, transfer between the PH9-10, left standstill 30 minutes, filter, filtrate adds 10% hydrochloric acid and reconciles PH8, leaves standstill 30 minutes, filters, filtrate adds 10% hydrochloric acid and reconciles PH1-3, leaves standstill 24 hours, filters, and must precipitate I;
(3) precipitation I washes with water to water lotion and is neutral, and precipitation is dry, gets the Caulis et Folium Scutellariae extract; Precipitate I or use 1% sodium hydroxide solution, transfer between the PH9-10, left standstill 30 minutes, filter, filtrate adds 10% hydrochloric acid and reconciles PH8, leaves standstill 30 minutes, filters, and filtrate adds 10% hydrochloric acid and reconciles PH1-3, left standstill 24 hours, precipitation washes with water to water lotion and is neutral, and precipitation is dry, gets the Caulis et Folium Scutellariae extract; Recording extractive total flavone content by the determination of total flavonoids method is 25-85%;
(4) the Caulis et Folium Scutellariae extract is dissolved in the sodium hydroxide solution of an amount of PH10, add the HP-that 1-5 doubly measures, put on the magnetic stirring apparatus, stirred 2 hours, 70 ℃ of temperature, behind the enclose, reconcile between the PH6.5-7.5, be concentrated into an amount of, add 0.5-2 and doubly measure polyethylene glycol 6000, aseptic filtration behind the mixing, the solution branch installs in the cillin bottle, makes finished product by freeze-drying; Or adopt freeze-drying to make sterilized powder, further packing makes finished product.
Scullcap stem and leaf injection powder provided by the invention, have and the identical medical functions of dosage form such as medicine oral liquid of the same race, electuary, tablet, capsule, drop pill, injection, can be used for analgesia, antiinflammatory or/and analgesic and dementia, also can be used for antiviral, antibiotic, resisting vascular smooth muscle propagation, antioxidation and antineoplaston.Its product is tested through the requirement of 2005 editions relevant injectable powder of Chinese Pharmacopoeia, and every index is all up to specification.
1. antivirus action: this product is to influenza virus, parainfluenza virus, CoxB
3, CoxB
4, CoxB
5, Ard
3, Ard
7, 10 kinds of viral institute cytopathogenic effects such as RSV, HSV-1, HSV-2 have the obvious suppression effect, valid density 0.14-1.07mg/ml, IC
50Value 0.08-0.34mg/ml, therapeutic index is respectively 4 and 8.
2. antibacterial action: this product has showed bacteriostasis in various degree to 13 kind of 38 36 strain in the strain antibacterial of try, to 31 strains expressed bactericidal action in various degree.Wherein, at 0.24-1.88mg/ml, minimal bactericidal concentration (MBC) can reach 0.94mg/ml to the Mlc scope of staphylococcus aureus.The bacteriostasis intensity ordering that with MIC50 is index measuring and calculating is: staphylococcus aureus, block its cloth youth Durham Salmonella, Pseudomonas aeruginosa＞staphylococcus, Jia Xingrongxuexinglianqiujun, beta hemolytic streptococcus, shigella flexneri＞Salmonella paratyphi A＞salmonella typhi, moscow' paratyphi B, Bacillus proteus＞colon bacillus＞streptococcus pneumoniae.
3. antiinflammatory action: 30.1-180.8mgkg
-1This product intraperitoneal injection xylol induced mice auricle acute inflammatory reaction has inhibitory action in various degree, wherein 60.3mgkg
-1Above dosage this product drug administration by injection inflammation suppression ratio reaches 40-71%, waits that action intensity is higher than institute's amount of reagent aspirin under the dosage.
84.4mgkg
-1This product drug administration by injection can significantly suppress the bullate formation of rat granuloma, and action intensity is suitable with aspirin such as dosage such as grade.
4. refrigeration function: 42.2-120.6mgkg
-1This product drug administration by injection can significantly reduce the exothermic reaction of rat due to the yeast, and action intensity is apparently higher than waiting dosage aspirin.
21.5-42.5mgkg
-1This product drug administration by injection can significantly reduce the exothermic reaction of rabbit due to the escherichia coli endotoxin, and action intensity is higher than injection clinical dosage antondin liquid, and effect may persist to behind the medicine 5.5 hours.
The same dosage this product drug administration by injection can significantly reduce the exothermic reaction of rabbit due to the Oleum Terebinthinae, and action intensity is higher than the clinical dosage injection of Radix Bupleuri, and effect may persist to behind the medicine 5.5 hours.
5. analgesic activity: this product 30.1-180.8mg.kg
-14 dosage drug administration by injection all can significantly improve the pain threshold of mice to thermostimulation, wherein 60-90min effect peaking, and performance dose-dependence; Be higher than aspirin Deng analgesic activity intensity under the dosage; Though its analgesic activity intensity is lower than morphine with tiring, effective analgesic activity persistent period is 8 times of morphine.(morphine analgesia effect peak value and effective acting time are at 30-60min).
This product lumbar injection (30.1-180.8mgkg
-1) 4 dosage all can significantly suppress the mouse writhing reaction due to the AA, and be dose-dependence; The subcutaneous injection action intensity is weaker than aspirin slightly, but action intensity and tiring apparently higher than injection of Radix Bupleuri.
42.2mgkg
-1This product drug administration by injection can significantly suppress the reaction of rat to tenderness, and 30-60min effect peaking behind the medicine waits that action intensity is higher than aspirin under the dosage.
The tricorn medicine-feeding test proves that the analgesic mechanism of this product is a central action.
[animal acute toxicity test]:
Maximum dose level 1356.30mgkg
-1, 1:k value 0.75 is divided into 5 dosage groups at random, presses 0.2ml10g
-1The w volume, lumbar injection this product was observed 7 days continuously, and the Bliss method is calculated the median lethal dose(LD 50) LD of mice
50Be 732.11 ± 8.54mgkg
-1, the 95% credible 723.57～740.65mgkg that is limited to
-1
The injectable powder that the present invention adopts freeze drying process to make, dry at low temperatures because of it, so that the effective ingredient of medicine is difficult for is destroyed, good stability, clinical efficacy is good, and adjuvant adopts the cosolvent HP-, the drug powder dissolving is rapid, and quality standard adopts the finger printing control of quality.Compared with prior art, not only technology is simple for it, and is easy to control the quality, and the storage life is long, convenient transportation, therefore, and can large-scale production and large scale application as the novel form of the new medicine of Caulis et Folium Scutellariae.
The specific embodiment:
Below in conjunction with embodiment the present invention is elaborated.
Following embodiment all is raw material with the Caulis et Folium Scutellariae, is adjuvant with HP-and Polyethylene Glycol, prepares Scullcap stem and leaf injection powder by following steps.
Embodiment 1
(1) get Caulis et Folium Scutellariae 1Kg, place 10 times of amount boiling water decoction 1 hour, filter, residue adds 8 times of amount boiling water again and decocted 1 hour, and merging filtrate concentrates, and drying gets extractum.
(2) extractum is dissolved in the 50-80 ℃ of hot water, uses 1% sodium hydroxide solution, transfer between the PH9-10, left standstill 30 minutes, filter, filtrate adds 10% hydrochloric acid and reconciles PH8, leaves standstill 30 minutes, filters, filtrate adds 10% hydrochloric acid and reconciles PH1-3, leaves standstill 24 hours, filters, and must precipitate I.
(3) precipitation I washes with water to water lotion and is neutral, and precipitation is dry, gets the Caulis et Folium Scutellariae extract; Recording extractive total flavone content by the determination of total flavonoids method is 25-85%.
(4) the Caulis et Folium Scutellariae extract is dissolved in the sodium hydroxide solution of an amount of PH10, add the HP-that 1-5 doubly measures, put on the magnetic stirring apparatus, stirred 2 hours, 70 ℃ of temperature, behind the enclose, reconcile between the PH6.5-7.5, be concentrated into an amount of, add 0.5-2 and doubly measure polyethylene glycol 6000, aseptic filtration behind the mixing, the solution branch installs in the cillin bottle, makes finished product by freeze-drying.
Embodiment 2
(1) get Caulis et Folium Scutellariae 1Kg, place 10 times of amount boiling water decoction 1 hour, filter, residue adds 8 times of amount boiling water again and decocted 1 hour, and merging filtrate concentrates, and drying gets extractum;
(2) extractum is dissolved in the 50-80 ℃ of hot water, uses 1% sodium hydroxide solution, transfer between the PH9-10, left standstill 30 minutes, filter, filtrate adds 10% hydrochloric acid and reconciles PH8, leaves standstill 30 minutes, filters, filtrate adds 10% hydrochloric acid and reconciles PH1-3, leaves standstill 24 hours, filters, and must precipitate I;
(3) precipitation I 1% sodium hydroxide solution, transfer between the PH9-10, left standstill 30 minutes, filter, filtrate adds 10% hydrochloric acid and reconciles PH8, left standstill 30 minutes, and filtered, filtrate adds 10% hydrochloric acid and reconciles PH1-3, left standstill 24 hours, precipitation washes with water to water lotion and is neutral, and precipitation is dry, gets the Caulis et Folium Scutellariae extract; Recording extractive total flavone content by the determination of total flavonoids method is 25-85%;
(4) the Caulis et Folium Scutellariae extract is dissolved in the sodium hydroxide solution of an amount of PH10, adds the HP-that 1-5 doubly measures, put on the magnetic stirring apparatus, stirred 2 hours, 70 ℃ of temperature behind the enclose, are reconciled between the PH6.5-7.5, be concentrated into an amount of, add 0.5-2 and doubly measure polyethylene glycol 6000, aseptic filtration behind the mixing, the solution branch installs in the cillin bottle, adopt freeze-drying to make sterilized powder, further packing makes finished product.
Embodiment 3
Step (1), (2), (3) are with embodiment 1, and step (4) is with embodiment 2.
Embodiment 4
Step (1), (2), (3) are with embodiment 2, and step (4) is with embodiment 1.
In addition, in concrete enforcement, adjuvant also can select for use hydroxyethyl-, methyl-beta-schardinger dextrin-, glucose to reach-beta-schardinger dextrin-or its mixture; Adjuvant can also be selected surfactant for use, comprises tween 80, tween 20, Polyethylene Glycol, polyvinylpyrrolidone or its mixture.
Here, 1Kg Caulis et Folium Scutellariae raw material can get 200 of injectable powder, every content 0.6g.Its usage and dosage is, adult every day 1 time, each 1, dissolving back intramuscular injection.Be used for the prevention and the treatment of diseases such as antiviral, antibiotic, antiinflammatory, antipyretic-antalgic, resisting vascular smooth muscle propagation, antioxidation and antitumor.
Claims (1)
1, a kind of preparation method of Scullcap stem and leaf injection powder is characterized in that, is raw material with the Caulis et Folium Scutellariae, is adjuvant with HP-and Polyethylene Glycol, finishes by following step:
(1) Caulis et Folium Scutellariae is placed 10 times of amount boiling water decoction 1 hour, filter, residue adds 8 times of amount boiling water again and decocted 1 hour, and merging filtrate concentrates, and drying gets extractum;
(2) extractum is dissolved in the 50-80 ℃ of hot water, uses 1% sodium hydroxide solution, transfer between the PH9-10, left standstill 30 minutes, filter, filtrate adds 10% hydrochloric acid and reconciles PH8, leaves standstill 30 minutes, filters, filtrate adds 10% hydrochloric acid and reconciles PH1-3, leaves standstill 24 hours, filters, and must precipitate I;
(3) precipitation I washes with water to water lotion and is neutral, and precipitation is dry, gets the Caulis et Folium Scutellariae extract; Or precipitation I 1% sodium hydroxide solution, transfer between the PH9-10, left standstill 30 minutes, filter, filtrate adds 10% hydrochloric acid and reconciles PH8, leaves standstill 30 minutes, filters, and filtrate adds 10% hydrochloric acid and reconciles PH1-3, left standstill 24 hours, precipitation washes with water to water lotion and is neutral, and precipitation is dry, gets the Caulis et Folium Scutellariae extract;
(4) the Caulis et Folium Scutellariae extract is dissolved in the sodium hydroxide solution of an amount of PH10, add the HP-that 1-5 doubly measures, put on the magnetic stirring apparatus, stirred 2 hours, 70 ℃ of temperature, behind the enclose, reconcile between the PH6.5-7.5, be concentrated into an amount of, add 0.5-2 and doubly measure polyethylene glycol 6000, aseptic filtration behind the mixing, the solution branch installs in the cillin bottle, makes finished product by freeze-drying; Or adopt freeze-drying to make sterilized powder, further packing makes finished product.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100654970A CN100435814C (en) | 2006-03-27 | 2006-03-27 | Scullcap stem and leaf injection powder and its preparing method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100654970A CN100435814C (en) | 2006-03-27 | 2006-03-27 | Scullcap stem and leaf injection powder and its preparing method |
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| Publication Number | Publication Date |
|---|---|
| CN1857408A CN1857408A (en) | 2006-11-08 |
| CN100435814C true CN100435814C (en) | 2008-11-26 |
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| CNB2006100654970A Expired - Fee Related CN100435814C (en) | 2006-03-27 | 2006-03-27 | Scullcap stem and leaf injection powder and its preparing method |
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Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104180619A (en) * | 2014-08-25 | 2014-12-03 | 济南康众医药科技开发有限公司 | Scutellaria baicalensis drying method |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1260189A (en) * | 1998-12-31 | 2000-07-19 | 承德医学院中药研究所 | Application of radix scutellariae stem and leaf to pharmaceutical industry |
| CN1383818A (en) * | 2002-01-05 | 2002-12-11 | 承德医学院中药研究所 | Application of skullcap stem and leaf general flavone and wild baicalin in preparing dementia resisting medicine |
-
2006
- 2006-03-27 CN CNB2006100654970A patent/CN100435814C/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1260189A (en) * | 1998-12-31 | 2000-07-19 | 承德医学院中药研究所 | Application of radix scutellariae stem and leaf to pharmaceutical industry |
| CN1383818A (en) * | 2002-01-05 | 2002-12-11 | 承德医学院中药研究所 | Application of skullcap stem and leaf general flavone and wild baicalin in preparing dementia resisting medicine |
Non-Patent Citations (4)
| Title |
|---|
| 中药药剂学. 张兆旺，284-285，中国中医药出版社. 2003 |
| 中药药剂学. 张兆旺，284-285，中国中医药出版社. 2003 * |
| 注射用紫杉醇的制备及过敏试验. 张学农.中国医院药学杂志，第25卷第1期. 2005 |
| 注射用紫杉醇的制备及过敏试验. 张学农.中国医院药学杂志，第25卷第1期. 2005 * |
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