CN101450137B - Preparation method of anti-virus traditional Chinese medicine - Google Patents
Preparation method of anti-virus traditional Chinese medicine Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition preparation process using forsythia fruit, honegsukle flower, radix isatidis, rheum officinale, pogostemon, male fern rhizome, rhodiola rosea, menthol, ephedra stem, toasted almond, cordate houttuynia, licorice and gypsum as raw material. In the preparation process, vacuum drying process is adopted as the exact drying process, the preferred technological conditions is reasonable, consequently, the effective components can be protected and the process is favorable for continuous mass production.
Description
Technical field
The present invention relates to a kind of anti virus herb preparation of compositions method, particularly, the present invention relates to the improvement about drying process in the preparation process of a kind of anti virus herb compositions.
Background technology
A kind of anti virus herb compositions and method for preparing, as the treatment and the prophylactic of severe acute respiratory syndrome, it is principle that said composition expels the heat-evil with antipyretic and detoxicated, lung qi dispersing; Suitably compatibility repelling foulness with aromatics, QI invigorating are set upright, and focus on the removing summer-heat interior-heat, smooth activating QI machine; Adjustment human body normal function, disease resistance enhancemen.This anti virus herb compositions, process by following crude drug: Fructus Forsythiae, Flos Lonicerae, Radix Isatidis, Radix Et Rhizoma Rhei, Herba Pogostemonis, Rhizoma Dryopteris Crassirhizomatis, Radix Rhodiolae, Mentholum, Herba Ephedrae, stir-baked SEMEN ARMENIACAE AMARUM, Herba Houttuyniae, Radix Glycyrrhizae, Gypsum Fibrosum, its extract drugs technology is:
(1), Fructus Forsythiae, Flos Lonicerae, Radix Isatidis, Radix Et Rhizoma Rhei, Herba Pogostemonis, Rhizoma Dryopteris Crassirhizomatis, Radix Rhodiolae, Mentholum, Herba Ephedrae, stir-baked SEMEN ARMENIACAE AMARUM, Herba Houttuyniae, Radix Glycyrrhizae, Gypsum Fibrosum are taken by weighing Chinese crude drug by weight proportion, clean;
(2), Herba Pogostemonis is cataclasm, add 8-10 times of water gaging and extract volatile oil and clean; Carry the 4 hours time of oil, collect volatile oil, subsequent use behind the extracting liquid filtering, residue discards;
(3), Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei, doubly measure the ethanol extraction 2 times of 50-90% with 6-10,2 hours for the first time, 1.5 hours for the second time, extracting liquid filtering, filtrating merging is reclaimed ethanol, and is subsequent use;
(4), Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae, add 7-11 times of water gaging and decoct to boiling, add Semen Armeniacae Amarum, decoct 2 times, 1.5 hours for the first time; 1 hour for the second time, extracting liquid filtering, filtrating merges, and adds the aqueous solution after Herba Pogostemonis is carried oil simultaneously; Be condensed into relative density 1.10-1.15 clear paste, add 95% ethanol, the limit edged stirs, to determining alcohol 70%; Cold preservation was placed 24 hours, filtered, and filtrate recycling ethanol merges with alcohol extract to there not being the alcohol flavor; Be concentrated into relative density 1.15-1.20 clear paste, 45-80 degree spray drying, powder promptly gets dry extract;
(5), according to dried cream powder: the ratio of adjuvant=1: 0.5-1.0 adds 85% alcohol granulation;
(6), spray in the granulation fine powder after Mentholum, Herba Pogostemonis Volatile oil added dissolve with ethanol, with the granule mixing, be used for preparing clinically the base stock of tablet, capsule, powder, granule, pill, electuary.
The present invention is the improvement invention of on the basis of Chinese patent ZL03143211.5, carrying out, and quotes in full the content of this patent document record at this.According to above-mentioned technology, in the process of preparation medicine, occurred because the clear paste thickness; Be not easy spray drying, can't launch the phenomenon of successive big production, select for use the thermostatic drying chamber drying influential the physical and chemical index of medicine; And drying time is oversize, is not suitable for successive big production, the present invention is directed to this situation; Carry out technological innovation, improved production efficiency, guaranteed the quality of medicine.
Summary of the invention
The present invention relates to a kind of anti virus herb preparation of compositions method; This pharmaceutical composition is that crude drug is formed by Fructus Forsythiae, Flos Lonicerae, Radix Isatidis, Radix Et Rhizoma Rhei, Herba Pogostemonis, Rhizoma Dryopteris Crassirhizomatis, Radix Rhodiolae, Mentholum, Herba Ephedrae, stir-baked SEMEN ARMENIACAE AMARUM, Herba Houttuyniae, Radix Glycyrrhizae, Gypsum Fibrosum, and its preparation technology comprises: (1) cleans medical material; (2) Herba Pogostemonis extracts volatile oil; (3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei, alcohol extraction, extracting liquid filtering merges, and reclaims ethanol, and is subsequent use; (4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae, bitter almond water are carried, and extracting liquid filtering merges with alcohol extract, concentrates and drying, and powder promptly gets dry extract; (5) dried cream powder is granulated; (6), with Mentholum, Herba Pogostemonis Volatile oil sprays in the granulation fine powder after adding dissolve with ethanol, with the granule mixing, becomes the base stock that is used to prepare tablet, capsule, powder, granule, pill, electuary clinically.
The object of the present invention is to provide clear paste drying process improvement in a kind of anti virus herb preparation of compositions technology; Its method is following: water extract and alcohol extract merge back concentrate drying preparation technology and adopt vacuum drying process; Operating condition is: extractum proportion is 1.20, and vacuum drying vacuum is 0.1Mpa, and baking temperature is 70-110 ℃; Charging rate be the 8-12 liter/hour, crawler belt speed is the 10-15 cm per minute.
Preferably, the operating condition of concentrate drying is: baking temperature is 90 ℃, and charging rate is 8 liters/hour, and crawler belt speed is 15 cm per minute.
In this pharmaceutical composition, described raw material medicines in portions by weight is:
Fructus Forsythiae 200-300, Flos Lonicerae 200-300, Radix Isatidis 200-300, Radix Et Rhizoma Rhei 40-60, Herba Pogostemonis 60-1 00; Rhizoma Dryopteris Crassirhizomatis 200-300, Radix Rhodiolae 60-100, Mentholum 5-9, Herba Ephedrae 60-100; Stir-baked SEMEN ARMENIACAE AMARUM 60-100, Herba Houttuyniae 200-300, Radix Glycyrrhizae 60-100, Gypsum Fibrosum 200-300.
Preferably, in this pharmaceutical composition, described raw material medicines in portions by weight is:
Fructus Forsythiae 255, Flos Lonicerae 255, Radix Isatidis 255, Radix Et Rhizoma Rhei 51, Herba Pogostemonis 85, Rhizoma Dryopteris Crassirhizomatis 255, Radix Rhodiolae 85, Mentholum 7.5, Herba Ephedrae 85, stir-baked SEMEN ARMENIACAE AMARUM 85, Herba Houttuyniae 255, Radix Glycyrrhizae 85, Gypsum Fibrosum 255.
For the optimum curative effect that guarantees medicine and enhance productivity, the present invention carries out preferably through the drying process of continuous vacuum drying equipment to clear paste.
1 instrument and reagent
1.1 instrument LC-10ATvp high performance liquid chromatograph (manufacturer: day island proper Tianjin); AG285 electronic balance (manufacturer: Shanghai prunus mume (sieb.) sieb.et zucc. Teller-Tuo benefit Instr Ltd.); BV450 vacuum belt drier group (Wenzhou imperial examinations light industry and machinery company limited); Ultrasonic cleaner (Xiangshan County, Zhejiang Province stone Pu sea day electronics instrument plant); Digital display type Constant Temp. Oven (Shanghai sunlight experimental apparatus company limited).
1.2 reagent Flos Lonicerae control medicinal material, chrysophanic acid, ephedrine hydrochloride, phillyrin reference substance are all available from Nat'l Pharmaceutical & Biological Products Control Institute, (lot number is respectively: 121060-200303; 0757-200206; 171241-200506; 110821-200406); Chemical reagent: acetonitrile is a chromatographically pure, and all the other are analytical pure, and water is double distilled water.
2. experimental technique and result
2.1 Orthogonal Experiment and Design [analytical chemistry handbook [M]. first fascicle. Beijing: Chemical Industry Press, 2001:624.]
According to influencing vacuum drying 3 principal elements: baking temperature (A), charging rate (B), crawler belt speed (C); On the basis of fixedly extractum proportion (1.20) and vacuum drying vacuum (0.1Mpa); Choosing above 3 levels respectively investigates; Moisture, Flos Lonicerae control medicinal material with sample after the drying differentiated, chrysophanic acid is differentiated, ephedrine hydrochloride is differentiated, phillyrin content is aggregative indicator, adopts L
9(3
4) orthogonal test table carries out orthogonal test, factor level is seen table 1.
Table 1: factor level table
| Level | Factor | |||
| The A temperature (℃) | B charging rate (L/h) | C crawler belt speed (cm per minute) | D is blank | |
| 1 | 70 | ?8 | 10 | 1 |
| 23 | 90110 | ?10?12 | 12.515 | 23 |
2.2 assay method
2.2.1 determination of water
Get test sample 2-5g, by " one one of Chinese pharmacopoeia [Chinese Pharmacopoeia Commission. Chinese Pharmacopoeia [S]. one one. Beijing: Chemical Industry Press, 2005: appendix 47.] aquametry first method measures, and the result sees table 2, and table 3 is seen in variance analysis.
2.2.2 the phillyrin assay [State Food and Drug Administration. the national drug standards [S] .YBZ03752004.]
Utilize phillyrin content in the high effective liquid chromatography for measuring test specimen, the result sees table 2, and table 4 is seen in variance analysis.
2.2.3 thin layer is differentiated
With reference to interrelated data [State Food and Drug Administration. the national drug standards [S] .YBZ03752004.], test specimen is carried out Chinese medicine honeysuckle, chrysophanic acid, ephedrine hydrochloride thin layer differentiates that the result sees table 5.
2.3. Orthogonal experiment results
Orthogonal experiment results sees table 2 for details, and table 3, table 4 are seen in variance analysis.
Table 2: orthogonal test moisture, content results
| Test | A | B | C | D | Moisture | Phillyrin (g/mg) |
| Number | (％) | |||||
| 1 2 3 4 5 6 7 8 9 | 1 1 1 2 2 2 3 3 3 | 1 2 3 1 2 3 1 2 3 | 1 2 3 2 3 1 3 1 2 | 1 2 3 3 1 2 2 3 1 | 7.5 8.0 8.5 5.3 5.5 6.0 3.8 4.2 4.5 | 0.83 0.80 0.85 0.71 0.75 0.74 0.60 0.56 0.58 |
| Moisture K i K ii K iiiR content K i K ii K iii R | 8.000 5.600 4.167 3.833 0.827 0.733 0.580 0.247 | 5.533 5.900 6.333 0.800 0.713 0.703 0.723 0.020 | 5.900 5.933 5.933 0.033 0.710 0.697 0.733 0.036 | 5.833 5.933 6.000 0.167 0.720 0.713 0.707 0.013 | ||
Table 3: variance analysis (moisture)
| Soruces of variation | Sum of deviation square | Degree of freedom | Mean square | The F value | The P value |
| ABC | 22.509 0.962 0.002 | 2 2 2 | 11.254 0.481 0.001 | 535.929 22.905 0.048 | P＜0.01** P＜0.05* P＞0.05 |
| Error | 0.042 | 2 | 0.021 |
F checks marginal value: * * F
0.01(2,2)=99.00; * F
0.05(2,2)=19.00
Table 4: variance analysis (content)
| Soruces of variation | Sum of deviation square | Degree of freedom | Mean square | The F value | The P value |
| A B C error | 0.093 0.001 0.001 0.001 | 2 2 2 2 | 0.0465 0.0005 0.0005 0.0005 | 93.000 1.000 1.000 | P＜0.01** P＞0.05 P＞0.05 |
F checks marginal value: * * F
1-0.01(2,2)=99.00; * F
1-0.05(2,2)=19.00
By table 2 intuitive analysis, each factor to the moisture size order be A＞＞B＞＞C; Each factor to the content influence size order be A＞＞C＞B.Can be known by table 3, table 4 variance analysis: factor A, B are remarkable to moisture, and C is to not influence of moisture; With regard to content, factor A is remarkable to its influence, and B, C do not have obvious influence.
Table 5: orthogonal test identification result
| The experiment number | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 |
| Chinese medicine honeysuckle | +++ | +++ | +++ | +++ | +++ | +++ | +++ | +++ | +++ |
| Chrysophanic acid | ++++ | ++++ | ++++ | ++++ | ++++ | ++++ | ++++ | ++++ | ++++ |
| Ephedrine hydrochloride | +++ | +++ | +++ | +++ | ++ | ++ | + | - | + |
Can be found out by table 5: each factor is differentiated not obviously influence to Flos Lonicerae, chrysophanic acid; And temperature has a significant effect to ephedrine hydrochloride, and temperature is high more, and big more to ephedrine hydrochloride destruction, charging rate and crawler belt speed differentiate that to ephedrine hydrochloride certain influence is also arranged.
Comprehensive above-mentioned analysis in conjunction with big practical situation and the quality quality index check situation of producing, confirms that optimum drying technology is: A
2B
1C
3, promptly baking temperature is 90 ℃, 8 liters/hour of charging rates, crawler belt speed 15 cm per minute.
3. result
The optimised process that the present invention optimizes is A
2B
1C
3, promptly baking temperature is 90 ℃, 8 liters/hour of charging rates, crawler belt speed 15 cm per minute.Phillyrin and ephedrine hydrochloride are relatively more responsive to baking temperature, and temperature is high, and it is had destruction, thus should select suitable temperature, to ensure drug quality and curative effect.Along with the requirement to drug quality improves constantly, when selection process, except that molding and moisture were carried out routine examination, also whether considered physical and chemical index and content's index can reach the regulation requirement.Through mensuration, confirmed the storage requirement in the big production, simultaneously also for selecting suitable packaging material that reference frame is provided to critical relative humidity.
The specific embodiment
Embodiment 1:
A) the crude drug prescription is:
Fructus Forsythiae 255g Flos Lonicerae 255g Herba Ephedrae 85g stir-baked SEMEN ARMENIACAE AMARUM 85g
Gypsum Fibrosum 255g Radix Isatidis 255g Rhizoma Dryopteris Crassirhizomatis 255g Herba Houttuyniae 255g
Herba Pogostemonis 85g Radix Et Rhizoma Rhei 51g Radix Rhodiolae 85g Mentholum 7.5g
Radix Glycyrrhizae 85g
B) preparation technology:
(1), Fructus Forsythiae, Flos Lonicerae, Radix Isatidis, Radix Et Rhizoma Rhei, Herba Pogostemonis, Rhizoma Dryopteris Crassirhizomatis, Radix Rhodiolae, Mentholum, Herba Ephedrae, stir-baked SEMEN ARMENIACAE AMARUM, Herba Houttuyniae, Radix Glycyrrhizae, Gypsum Fibrosum are taken by weighing Chinese crude drug by weight proportion, clean;
(2), Herba Pogostemonis is cataclasm, add 8-10 times of water gaging and extract volatile oil and clean; Carry the 4 hours time of oil, collect volatile oil, subsequent use behind the extracting liquid filtering, residue discards;
(3), Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei, doubly measure the ethanol extraction 2 times of 50-90% with 6-10,2 hours for the first time, 1.5 hours for the second time, extracting liquid filtering, filtrating merging is reclaimed ethanol, and is subsequent use;
(4), Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae, add 7-11 times of water gaging and decoct to boiling, add Semen Armeniacae Amarum, decoct 2 times, 1.5 hours for the first time; 1 hour for the second time, extracting liquid filtering, filtrating merges, and adds the aqueous solution after Herba Pogostemonis is carried oil simultaneously; Be condensed into relative density 1.10-1.15 clear paste, add 95% ethanol, the limit edged stirs, to determining alcohol 70%; Cold preservation was placed 24 hours, filtered, and filtrate recycling ethanol merges with step (3) gained alcohol extract to there not being the alcohol flavor; Being concentrated into relative density extractum proportion is 1.20, adopts vacuum drying process, and vacuum drying vacuum is 0.1Mpa, and baking temperature is 90 ℃; Charging rate is 8 liters/hour, and crawler belt speed is 15 cm per minute, and powder promptly gets dry extract.
(5), according to dried cream powder: the ratio of adjuvant=1: 0.5-1.0 adds 85% alcohol granulation;
(6), spray in the granulation fine powder after Mentholum, Herba Pogostemonis Volatile oil added dissolve with ethanol, with the granule mixing, be used for preparing clinically the base stock of tablet, capsule, powder, granule, pill, electuary.
Embodiment 2:
A) the crude drug prescription is:
Fructus Forsythiae 200g Flos Lonicerae 220g Herba Ephedrae 60g Semen Armeniacae Amarum 60g
Gypsum Fibrosum 200g Radix Isatidis 250g Rhizoma Dryopteris Crassirhizomatis 200g Herba Houttuyniae 200g
Herba Pogostemonis 60g Radix Et Rhizoma Rhei 60g Radix Rhodiolae 60g Mentholum 5.0g
Radix Glycyrrhizae 60g
B) preparation technology:
(1), Fructus Forsythiae, Flos Lonicerae, Radix Isatidis, Radix Et Rhizoma Rhei, Herba Pogostemonis, Rhizoma Dryopteris Crassirhizomatis, Radix Rhodiolae, Mentholum, Herba Ephedrae, stir-baked SEMEN ARMENIACAE AMARUM, Herba Houttuyniae, Radix Glycyrrhizae, Gypsum Fibrosum are taken by weighing Chinese crude drug by weight proportion, clean;
(2), Herba Pogostemonis, cataclasm, add 8-10 times of water gaging and extract volatile oil and clean; Carry the 4 hours time of oil, collect volatile oil, subsequent use behind the extracting liquid filtering, residue discards;
(3), Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei, doubly measure the ethanol extraction 2 times of 50-90% with 6-10,2 hours for the first time, 1.5 hours for the second time, extracting liquid filtering, filtrating merging is reclaimed ethanol, and is subsequent use;
(4), Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae, add 7-11 times of water gaging and decoct to boiling, add Semen Armeniacae Amarum, decoct 2 times, 1.5 hours for the first time; 1 hour for the second time, extracting liquid filtering, filtrating merges, and adds the aqueous solution after Herba Pogostemonis is carried oil simultaneously; Be condensed into relative density 1.10-1.15 clear paste, add 95% ethanol, the limit edged stirs, to determining alcohol 70%; Cold preservation was placed 24 hours, filtered, and filtrate recycling ethanol merges with step (3) gained alcohol extract to there not being the alcohol flavor; Being concentrated into relative density extractum proportion is 1.20, adopts vacuum drying process, and vacuum drying vacuum is 0.1Mpa, and baking temperature is 90 ℃; Charging rate is 8 liters/hour, and crawler belt speed is 15 cm per minute, and powder promptly gets dry extract.
(5), according to dried cream powder: the ratio of adjuvant=1: 0.5-1.0 adds 85% alcohol granulation;
(6), with Mentholum, Herba Pogostemonis Volatile oil sprays in the granulation fine powder after adding dissolve with ethanol, with the granule mixing, is used for preparing clinically the base stock of tablet, capsule, powder, granule, pill, electuary.
Claims (2)
1. anti virus herb preparation of compositions method, this anti virus herb compositions is made up of following bulk drugs: Fructus Forsythiae 255, Flos Lonicerae 255, Radix Isatidis 255; Radix Et Rhizoma Rhei 51, Herba Pogostemonis 85, Rhizoma Dryopteris Crassirhizomatis 255, Radix Rhodiolae 85; Mentholum 7.5, Herba Ephedrae 85, stir-baked SEMEN ARMENIACAE AMARUM 85, Herba Houttuyniae 255; Radix Glycyrrhizae 85, Gypsum Fibrosum 255, its preparation technology comprises: (1) cleans medical material; (2) Herba Pogostemonis extracts volatile oil; (3) Fructus Forsythiae, Herba Ephedrae, Herba Houttuyniae, Radix Et Rhizoma Rhei, alcohol extraction, extracting liquid filtering merges, and reclaims ethanol, and is subsequent use; (4) Flos Lonicerae, Gypsum Fibrosum, Radix Isatidis, Rhizoma Dryopteris Crassirhizomatis, Radix Glycyrrhizae, Radix Rhodiolae, bitter almond water are carried, and extracting liquid filtering merges with alcohol extract, concentrates and drying, and powder promptly gets dry extract; (5) dried cream powder is granulated; (6) with Mentholum; Herba Pogostemonis Volatile oil sprays in the granulation fine powder after adding dissolve with ethanol, with the granule mixing, becomes the base stock that is used to prepare tablet, capsule, powder, granule, pill, electuary clinically; It is characterized in that: water extract and alcohol extract merge back concentrate drying preparation technology and adopt vacuum drying process; Operating condition is: extractum proportion is 1.20, and vacuum drying vacuum is 0.1Mpa, and baking temperature is 70-110 ℃; Charging rate be the 8-12 liter/hour, crawler belt speed is the 10-15 cm per minute.
2. method for preparing as claimed in claim 1, it is characterized in that the operating condition of said vacuum drying process is: baking temperature is 90 ℃, and charging rate is 8 liters/hour, and crawler belt speed is 15 cm per minute.
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| CN101991694B (en) * | 2009-08-25 | 2016-05-18 | 北京以岭药业有限公司 | The application of a kind of Chinese medicine composition in the medicine of preparing anti-influenza A H 1 N 1 virus |
| CN102379957A (en) * | 2010-09-03 | 2012-03-21 | 北京以岭药业有限公司 | TCM composition applied to preparation of medication for treating herpes zoster |
| CN104345111B (en) * | 2013-08-08 | 2017-04-05 | 石家庄以岭药业股份有限公司 | The assay method of various active component content in a kind of Chinese medicinal composition preparation |
| WO2020211088A1 (en) * | 2019-04-19 | 2020-10-22 | 石家庄以岭药业股份有限公司 | Traditional chinese medicine composition and use thereof |
| CN115192678A (en) * | 2021-09-16 | 2022-10-18 | 广州智园生物科技有限公司 | Natural antiviral atomization composition and preparation method thereof |
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Effective date of registration: 20201203 Address after: 102600, Beijing Zhongguancun Daxing District science and Technology Park, Daxing pharmaceutical industry base, Tian Fu Street, No. 17 Patentee after: BEIJING YILING PHARMACEUTICAL Co.,Ltd. Address before: 050035 No. 238 Tianshan Avenue, Shijiazhuang hi tech Development Zone, Hebei, China Patentee before: HEBEI YILING MEDICINE RESEARCH INSTITUTE Co.,Ltd. |
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