CN100361693C - Health restoring agastache dripping pill preparation and its preparing method - Google Patents
Health restoring agastache dripping pill preparation and its preparing method Download PDFInfo
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- CN100361693C CN100361693C CNB2005102006709A CN200510200670A CN100361693C CN 100361693 C CN100361693 C CN 100361693C CN B2005102006709 A CNB2005102006709 A CN B2005102006709A CN 200510200670 A CN200510200670 A CN 200510200670A CN 100361693 C CN100361693 C CN 100361693C
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Abstract
The present invention relates to a drop pill preparation of healthy energy of wrinkled gianthyssop and a preparation method thereof. The drop pill preparation is prepared from traditional Chinese medicinal materials such as patchouli, perilla leaf, dahurian angelica, stir-fired largehead atractylodes rhizome, dried tangerine peel, prepared pinellia tuber, processed officinal magnolia bark with ginger, tuckahoe, etc. Compared with the prior art, medicines and base materials are well mixed in the present invention, the mixture of the medicines and the base materials is dropped in condensate liquid to contract and condense into drop pills, and the mixture can not dissolve in the condensate liquid, so the present invention has high biological availability and favorable stability. The present invention enhances biological availability, simultaneously reduces technological process and production cost, improves spherical degree and enhances the qualified rate of the pills. The preparation process, particularly the dropping process has good operability, and the convenience for carrying and oral taking is greatly enhanced.
Description
Technical field: the present invention relates to a kind of Add Flavor Healthy Tendency Drop Pill of Wrinkled Giant Hyssop Preparation and Preparation Method, belong to the field of drug technique
Technical background: huoxiang zhengqi powder is Song dynasty " formulary of peaceful benevolent dispensary " contained preparation, tool induce sweat dampness dissipating, QI regulating and in merit, be mainly used to the card of affection of exogenous wind-cold, internal injury humidity hysteresis, go through the clinical practice of nearly one thousand years, determined curative effect.Can also be used for treatment of diseases such as asthma of cold-type, drowsiness, insomnia, diabetes, hepatitis B.Medicamental pulverata residued between slot, tongue when but powder was taken, and was difficult to swallow, and felt more uncomfortable, and can't use immediately, must get and take after the Rhizoma Zingiberis Recens Fructus Jujubae is fried in shallow oil soup, very inconvenience.So in succession it has been carried out a large amount of research from many so far pharmacy workers of 1950's end.As application number is " 03135284.7 ", name is called the patent application of " a kind of new method of HUOXIANG ZHENGQI JIAONANG preparation ", and application number is " 200310122427.0 ", name is called the patent application of " a kind of preparation method of 'Jia Wei Huo Xiang ' soft capsule and method of quality control ", though the product that obtains has certain curative effect, but still have a lot of problems: the content of capsule bonding easily is rotten, and medicine stability is not good; And can soft capsule produce bioavailability preferably, depend on oral after disintegrate in time, its cyst membrane is with compositions such as a certain proportion of gelatin, G ﹠ Ws, domestic expert generally believes that the character of its main component gelatin all seems very important to formability, the dissolubility of softgel shell, but with the gelatin is the soft capsule of glue shell Main Ingredients and Appearance, cause that owing to gelatin is with the passing of time aging disintegration, disqualification rate was high in storage period; Soft capsule causes capsule deformation and seepage because of the moisture that absorbs in the medicinal liquid; These problems have influenced the curative effect of our product to a great extent.So seek a kind ofly have excellent curative, mouthfeel is good, technology rationally feasible formulation products satisfies the demand in market.
Summary of the invention: the object of the invention is to provide a kind of Add Flavor Healthy Tendency Drop Pill of Wrinkled Giant Hyssop Preparation and Preparation Method, and product stability is good, and long term store also can keep curative effect, enlarges the application of classics side, satisfies market demand.
The present invention constitutes like this: the extract that calculates by Herba Pogostemonis 653.6g, Folium Perillae 217.8g, Radix Angelicae Dahuricae 217.8g, Rhizoma Atractylodis Macrocephalae (parched) 435.8g, Pericarpium Citri Reticulatae 435.8g, Rhizoma Pinelliae Preparata 435.8g, Sichuan Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 435.8g, Poria 217.8g, Radix Platycodonis 435.8g, Radix Glycyrrhizae 435.8g, Pericarpium Arecae 217.8g, Rhizoma Zingiberis Recens 65.4g and Fructus Jujubae 109g or corresponding weight according to weight proportion is prepared from.
The preparation method of described health restoring agastache dripping pill preparation: Cortex Magnoliae Officinalis is with 60% ethanol extraction three times, and each 1 hour, the ethanol consumption was 8,6,6 times, filtered, and merging filtrate reclaims ethanol, is 1.15 clear paste I when being concentrated into 80 ℃ of relative densities; Herba Pogostemonis, Folium Perillae, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Dahuricae vapor distillation extract volatile oil, add 10 times of water distillations 6 hours, and the aqueous solution after the distillation filters, and device is collected in addition; The medicinal residues and the Rhizoma Pinelliae, Poria, Radix Platycodonis, Radix Glycyrrhizae, Pericarpium Arecae, Rhizoma Zingiberis Recens 65.4g and Fructus Jujubae 109g decoct with water secondary, for the first time adding 6 times of decoctings boiled 2 hours, for the second time adding 6 times of decoctings boiled 1 hour, collecting decoction, merge with above-mentioned aqueous solution, filter, filtrate is concentrated into the clear paste that relative density is 1.12 (80 ℃), supernatant concentration is 1.15 clear paste II during to 80 ℃ of relative densities, merge clear paste I and II, high speed centrifugation is 1.30～1.35 thick paste when being concentrated into 80 ℃ of relative densities, drying under reduced pressure, be ground into fine powder, sieve, spray into volatile oil, get drug extract, the refabrication drop pill.
The preparation method of described health restoring agastache dripping pill preparation: the thing extract of getting it filled, join in the molten matrix, reuse dropping preparation method pill is condensed in the coolant and removes coolant behind the ball, dry and drop pill.Substrate is Macrogol 4000, calculates medicine: substrate=1: 1.2-1.3 by weight proportion.Coolant is selected liquid Paraffin, and temperature is 10 ℃.Dripping the system temperature is that 85 ℃, droplets speed is 15d/min, drips apart from being 15cm.
Among the present invention: Herba Pogostemonis can hot dispersing wind and cold, evacuates the pathogenic factor in the exterior heat-damp in summer, again can removing dampness by means of aromatics, and the spleen and stomach regulating is monarch drug in the side; The hot warm pulvis aromaticus wind of compatibility, external-open fur are let out the logical space between skin and muscles of lung, in open septum pectorale Folium Perillae and the hot dispersing wind and cold that the stomach removing dampness stagnates of being amusing and reach skin outward, descending the intestines and stomach is dispeled the Radix Angelicae Dahuricae of turbid damp and is evacuated pathogenic factor in the exterior; Cortex Magnoliae Officinalis that compatibility the spleen strengthening and damp drying, alleviating distention in middle-JIAOization stagnate and circulation of qi promoting intestinal stasis relieving, alleviating distention in middle-JIAO remove the turbid Pericarpium Arecae of damp eliminating that expands, and the two removes distension and fullness of the chest and abdomen altogether; The Radix Platycodonis lung qi dispersing removes expectorant; The Rhizoma Pinelliae, Pericarpium Citri Reticulatae regulating the stomach and sending down the abnormal ascending QI remove nausea and vomiting; Rhizoma Atractylodis, Poria invigorating the spleen and regulating the stomach, dispelling dampness and promoting diuresis are to help the fortune function of taste; Radix Glycyrrhizae, Fructus Jujubae, Rhizoma Zingiberis Recens harmonizing yingfen and weifen.
Compared with prior art, product tool provided by the invention induce sweat dampness dissipating, QI regulating and in merit, be used for the treatment of the card of affection of exogenous wind-cold, internal injury humidity hysteresis, determined curative effect; Can also be used for treatment of diseases such as asthma of cold-type, drowsiness, insomnia, diabetes, hepatitis B.Among the present invention the applicant with medicine and substrate mixing after, splash in the not miscible condensed fluid, shrink and to be condensed into drop pill, bioavailability height, good stability.The applicant finds that in development the Herba Pogostemonis among the we, Folium Perillae, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, the Radix Angelicae Dahuricae contain a large amount of volatile oil, if the too high then effective ingredient of melt temperature is easy to scatter and disappear when dripping system, if it is low excessively to drip the system temperature, molding is difficulty relatively again; And the roundness of this product is very poor, finds to drip apart from being the main cause that causes the roundness difference by a large amount of experiments, drips apart from too small, and dropping liquid has little time to shrink, and the ball type is rounding not; Drip apart from excessive, drop becomes flat or is fallen to loose because of action of gravity to produce piller easily; And roundness is to weigh the important indicator of drop pill quality, so by after having carried out a large amount of research work, established the optimum condition that comprises the preparation preparation drop pill of the present invention that drips distance; Substrate is Macrogol 4000, calculates medicine: substrate=1: 1.2 by weight proportion.Coolant is selected liquid Paraffin, and temperature is 10 ℃.Dripping the system temperature is that 85 ℃, droplets speed is 15d/min, drips apart from being 15cm.The present invention has reduced technological process when having improved bioavailability, reduced production cost, has improved roundness, has improved the heavy qualification rate of ball, and it is good that preparation process is particularly dripped the system process operation, and the convenience of carrying and taking also strengthens greatly.
The applicant carries out a series of experiments, and is effectively controlled to confirm method provided by the invention, the preparation good effect.
Experimental example 1 pharmacodynamic study
1.1 therapeutical effect to energy-stagnation stomachache.
1.1.1 analgesic activity: hot plate temperature is (55 ± 0.5) ℃.Selecting the threshold of pain (occurring licking the metapedes response time) is 50 of the female mices of 10～30s, body weight (18～22) g is divided into 5 groups at random: be respectively model group, positive controls, JIAWEI HUOXIANG ZHENGQI WAN group, JIAWEI HUOXIANG ZHENGQI RUANJIAONANG group and drop pill group of the present invention.The threshold of pain of its average before as administration got in the administration before measurement threshold of pain 2 times.JIAWEI HUOXIANG ZHENGQI WAN group, JIAWEI HUOXIANG ZHENGQI RUANJIAONANG group and drop pill group mice of the present invention then, gastric infusion JIAWEI HUOXIANG ZHENGQI WAN, JIAWEI HUOXIANG ZHENGQI RUANJIAONANG group and drop pill of the present invention are measured mice administration 60,80 with hot plate method respectively, threshold of pain during 100min, the result is as follows:
Hot plate method is caused pain mice analgesic test result
| Group | The threshold of pain | |||
| 0min | 60min | 80min | 100min | |
| Model group positive controls JIAWEI HUOXIANG ZHENGQI WAN group JIAWEI HUOXIANG ZHENGQI RUANJIAONANG group drop pill group of the present invention | 12.5±3.5 14.1±5.6 13.8±4.1 14.0±7.6 14.9±3.0 | 13.6±6.7 37.8±16.4 31.8±14.2 33.4±10.7 44.7±13.5 | 15.5±8.4 42.7±11.55 45.3±14.5 45.2±6.1 50.9±17.2 | 13.3±9.2 50.6±22.1 49.8±15.6 51.3±20.7 52.5±18.2 |
The result shows that drop pill of the present invention has certain analgesic activity, and rapid-action, and effect is better than JIAWEI HUOXIANG ZHENGQI WAN and JIAWEI HUOXIANG ZHENGQI RUANJIAONANG.
1.1.2 influence to gastric emptying
Get 50 of body weight 18～22g mices, be divided into 5 groups at random: normal control group, positive controls, JIAWEI HUOXIANG ZHENGQI WAN group, JIAWEI HUOXIANG ZHENGQI RUANJIAONANG group and drop pill group of the present invention.Difference gastric infusion JIAWEI HUOXIANG ZHENGQI WAN, JIAWEI HUOXIANG ZHENGQI RUANJIAONANG group and drop pill of the present invention, every day 1 time, continuous 5 days, fasting 12h before the experiment can't help water.Behind last administration 45min, irritate the phenol red reagent of stomach (gelatin 3g, water 50ml, 0.05% phenol red 20ml) 0.6ml for every.Get stomach behind the 15min and shred, place the NaOH solution of 20ml 0.1mol/L, leave standstill 60min after, get its supernatant 5ml, add 20% trichloroacetic acid 0.5ml, it is centrifugal to shake up the back, gets supernatant 2ml, the NaOH solution that adds 3ml0.5mol/L, the 560nm colorimetric is measured absorbance.
Influence to gastric emptying
The group absorbance
Normal control group 0.0901 ± 0.0357
Positive controls 0.1064 ± 0.0692
JIAWEI HUOXIANG ZHENGQI WAN group 0.1142 ± 0.0314
JIAWEI HUOXIANG ZHENGQI RUANJIAONANG group 0.1201 ± 0.0415
Drop pill group 0.1103 ± 0.0241 of the present invention
The result shows that drop pill of the present invention can obviously suppress the mice gastric emptying.In conjunction with above research, show drop pill of the present invention its function of scalable when gastrointestinal function is hyperfunction, reach the effect of spasmolysis and analgesia, can be in order to the treatment energy-stagnation stomachache.
1.2 therapeutical effect to hepatitis B
Liver Fibrosis Model is duplicated: select 30 of SD rat for use, male and female half and half, every about 130～160g of body weight.Modeling is respectively organized in the 1st day peeling of experiment and is injected 40%CCl down
40.5ml/100g body weight, later per 4 days subcutaneous injection 40%CCl
4, olive oil 0.3ml/100g body weight, continuous 8 weeks.Each group is all fed with normal diet, freely drinks water.
The experiment grouping: 50 rats are divided into 5 groups at random: model group, positive controls, JIAWEI HUOXIANG ZHENGQI WAN group, JIAWEI HUOXIANG ZHENGQI RUANJIAONANG group and drop pill group of the present invention, 10 every group.Difference gastric infusion JIAWEI HUOXIANG ZHENGQI WAN, JIAWEI HUOXIANG ZHENGQI RUANJIAONANG group and drop pill of the present invention, dosage is 7g/kg, and every day 1 time, each organizes rat from modeling beginning in the 2nd day administration, finishes up to experiment.The 8th week was put to death rat, got blood, detected hyaluronic acid (HA), laminin (LN) and PC-III.
Each organizes rat blood serum HA, LN, PC-III content relatively
| Group | The Mus number | HA | LN | PC-III |
| Model group positive controls JIAWEI HUOXIANG ZHENGQI WAN group JIAWEI HUOXIANG ZHENGQI RUANJIAONANG group drop pill group of the present invention | 10 10 10 10 10 | 336.72±25.36 144.08±17.04 147.54±56.12 143.43±53.38 145.38+60.58 | 257.01±42.32 97.25±12.56 105.74±50.48 108.93±47.41 102.67+45.45 | 248.12±12.31 98.14±10.45 98.57±34.72 102.27±30.57 96.49±29.50 |
The detection index of hepatic fibrosis is more, and joint-detection HA, LN, PC-III can reflect the dynamic change of hepatic fibrosis, and hepatic fibrosis is the pathological common grounds of various chronic hepatopathys.The result shows that drop pill of the present invention can improve chronic viral hepatitis B patient symptom, and effect and JIAWEI HUOXIANG ZHENGQI WAN and JIAWEI HUOXIANG ZHENGQI RUANJIAONANG do not have significant difference.
The screening of experimental example 2 moulding processs
2.1 the initial option of substrate
Drop pill requires preparation to bring into play curative effect rapidly, and medicine contains volatile ingredient in addition, so select fusing point low, the PEG4000 with fine dispersion power and big cohesiveness satisfies the requirement of clinical treatment and active ingredient character as substrate.Preliminary study shows that when making substrate with PEG4000, the hardness of drop pill, flowability are all good, the results are shown in following table.
Substrate screening experiment result
| Matrix species | Hardness | Roundness | Hangover |
| PEG4000 | +++ | +++ | Do not hold in the palm tail |
| PEG6000 | +++ | + | A little holds in the palm tail |
Annotate: +++show fine; ++ show better; + show general
2.2 medicine and substrate composition
Mix the back situation with substrate and drip the system complexity with medicine, establish the proportioning of medicine and substrate.See the following form.The result shows that the ratio of medicine and Macrogol 4000 is at 1: 1.2～1.3 o'clock, and medicine and substrate amalgamation are better, and hardness, roundness are suitable, and be easy to the system of dripping, drug loading is big.
The proportioning test result of medicine and substrate
| The proportioning of medicine and substrate | Hardness | Roundness | Hangover |
| 1∶1 | + | - | Obviously |
| 1∶1.1 | ++ | - | Obviously |
| 1∶1.2 | +++ | +++ | Do not trail |
| 1∶1.3 | +++ | +++ | Do not trail |
| 1∶1.5 | +++ | ++ | Do not trail |
Annotate: +++show fine; ++ show better; + show general;-differential
2.3 coolant is selected
Earlier with medicine: the ratio of Macrogol 4000=1: 1.2, from methyl-silicone oil (viscosity 1000,200,100), liquid Paraffin, soybean oil, Oleum Arachidis hypogaeae semen, rapeseed oil, select suitable condensing agent.Decrease speed, molding situation with drop pill are index, with the investigation result of each index by good to poorly using " +++" successively, " ++ ", "+", "-" expression the results are shown in following table.
The selection experimental result of coolant
| Condensing agent | Decrease speed | The molding situation |
| Methyl-silicone oil 1000 | - | - |
| Methyl-silicone oil 200 | + | + |
| Methyl-silicone oil 100 | ++ | + |
| Liquid Paraffin | +++ | +++ |
| Soybean oil | +++ | - |
| Rapeseed oil | +++ | + |
Annotate: +++show fine; ++ show better; + show general
As seen from the above table, coolant selection liquid Paraffin is good.
2.4 dripping the system temperature selects
The too high meeting of polyethylene glycols heating temperature color and luster occurs and deepens to be difficult for solidifying.Drip the system temperature as can be known when 80 ℃ of left and right sides by prerun test, it is very slow to drip speed, and molding is bad.Select to drip the system temperature about 85 ℃, a speed is moderate, and molding is good.By preferred medicine and substrate composition, extractum and substrate to be put in the water-bath heat, fusion adds in the drop pill machine, and the different temperatures insulation is spent so that pill shaped circle is whole, and the state of oozing is an index, the results are shown in following table.
Drip the selection experimental result of system temperature
| Drip the system temperature (℃) | Roundness | Ooze state |
| 70 | - | Can not drip |
| 80 | + | Slower |
| 85 | +++ | Easily ooze |
| 90 | + | Too fast |
Annotate; +++show is fine; ++ show better; + show general;-differential
2.5. coolant temperature is investigated
By preferred medicine and substrate composition, extractum and substrate put in the water-bath heat, fusion, in the adding drop pill machine, 85 ℃ of insulations splash in the coolant of different temperatures.Chilling temperature is respectively 1～5 ℃, and 10 ℃, 1～5 ℃ of rounding not as a result; 10 ℃ of roundings, smooth are so select 10 ℃ of chilling temperatures.
2.6 resitting an exam, ball examines
By above optimum condition, select the dropper of different bores, drip and make ball, with the whole degree of pill shaped circle, hardness, hangover the results are shown in following table for index.
Ball is resit an exam and is examined experimental result
| Bore (inside/outside mm/mm) | Ball is (mg) more | Rounding is sent out | Hardness | Hangover |
| 4.0/5.0 | 30 | +++ | + | Do not hold in the palm tail |
| 4.5/5.5 | 40 | +++ | +++ | Do not hold in the palm tail |
| 5.0/6.0 | 60 | - | + | The holder tail |
Annotate; +++show is fine; ++ show better; + show general;-differential
So can determine that by last table ball heavily is 40mg.
Investigate by above optimum condition 2.7 drip speed, select the different speed of dripping, drip and make ball, with the whole degree of pill shaped circle, hardness, trailing is index, the results are shown in following table.
Drip speed and investigate experimental result
| Drip speed (d/min) | Roundness | Hardness | Hangover |
| 10 | +++ | + | Do not trail |
| 15 | +++ | +++ | Do not trail |
| 20 | - | +++ | Hangover |
Annotate: +++show fine; ++ show better; + show general;-differential
So can determine that by last table dripping speed is 15d/min.
2.8 drip apart from investigating
By above optimum condition, select the different distances of dripping, drip and make ball, with the whole degree of pill shaped circle, hardness, hangover the results are shown in Table for index.
Drip apart from investigating experimental result
| Drip apart from (cm) | Roundness | Hardness | Hangover |
| 5 | - | ++ | Hangover |
| 10 | - | ++ | Hangover |
| 15 | +++ | +++ | Do not trail |
| 20 | + | +++ | Do not trail |
Annotate: +++show fine; ++ show better; + show general;-differential
So can determine that by last table dripping distance is 15cm.
The specific embodiment:
Embodiments of the invention 1: take by weighing Herba Pogostemonis 653.6g, Folium Perillae 217.8g, Radix Angelicae Dahuricae 217.8g, Rhizoma Atractylodis Macrocephalae (parched) 435.8g, Pericarpium Citri Reticulatae 435.8g, Rhizoma Pinelliae Preparata 435.8 g, Sichuan Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 435.8g, Poria 217.8g, Radix Platycodonis 435.8g, Radix Glycyrrhizae 435.8g, Pericarpium Arecae 217.8g, Rhizoma Zingiberis Recens 65.4g, Fructus Jujubae 109g
Cortex Magnoliae Officinalis is with 60% ethanol extraction three times, and each 1 hour, the ethanol consumption was 8,6,6 times, filtered, and merging filtrate reclaims ethanol, is 1.15 clear paste I when being concentrated into 80 ℃ of relative densities; Herba Pogostemonis, Folium Perillae, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Dahuricae vapor distillation extract volatile oil, add 10 times of water distillations 6 hours, and the aqueous solution after the distillation filters, and device is collected in addition; The medicinal residues and the Rhizoma Pinelliae, Poria, Radix Platycodonis, Radix Glycyrrhizae, Pericarpium Arecae, Rhizoma Zingiberis Recens 65.4g and Fructus Jujubae 109g decoct with water secondary, for the first time adding 6 times of decoctings boiled 2 hours, for the second time adding 6 times of decoctings boiled 1 hour, collecting decoction merges with above-mentioned aqueous solution, filters, filtrate is concentrated into the clear paste that relative density is 1.12 (80 ℃), supernatant concentration is 1.15 clear paste II during to 80 ℃ of relative densities, merges clear paste I and II, high speed centrifugation, it when being concentrated into 80 ℃ of relative densities 1.30～1.35 thick paste, drying under reduced pressure is ground into fine powder, sieves, spray into volatile oil, get drug extract, join in the fused Macrogol 4000, calculate by weight proportion, medicine: substrate=1: 1.2-1.3, (drip the system temperature is 85 ℃ to reuse dropping preparation method pill, dripping speed is 15d/min, dripping distance is 15cm), be condensed into ball (coolant is selected liquid Paraffin, and temperature is 10 ℃) back in the coolant and remove coolant, dry and drop pill, oral, a 1.5g, 2 times on the one.
Embodiments of the invention 2: take by weighing Herba Pogostemonis 653.6g, Folium Perillae 217.8g, Radix Angelicae Dahuricae 217.8g, Rhizoma Atractylodis Macrocephalae (parched) 435.8g, Pericarpium Citri Reticulatae 435.8g, Rhizoma Pinelliae Preparata 435.8g, Sichuan Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 435.8g, Poria 217.8g, Radix Platycodonis 435.8g, Radix Glycyrrhizae 435.8g, Pericarpium Arecae 217.8g, Rhizoma Zingiberis Recens 65.4g, Fructus Jujubae 109g
Cortex Magnoliae Officinalis is with 60% ethanol extraction three times, and each 1 hour, the ethanol consumption was 8,6,6 times, filtered, and merging filtrate reclaims ethanol, is 1.15 clear paste I when being concentrated into 80 ℃ of relative densities; Herba Pogostemonis, Folium Perillae, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Dahuricae vapor distillation extract volatile oil, add 10 times of water distillations 6 hours, and the aqueous solution after the distillation filters, and device is collected in addition; The medicinal residues and the Rhizoma Pinelliae, Poria, Radix Platycodonis, Radix Glycyrrhizae, Pericarpium Arecae, Rhizoma Zingiberis Recens 65.4g and Fructus Jujubae 109g decoct with water secondary, for the first time adding 6 times of decoctings boiled 2 hours, for the second time adding 6 times of decoctings boiled 1 hour, collecting decoction, merge with above-mentioned aqueous solution, filter, filtrate is concentrated into the clear paste that relative density is 1.12 (80 ℃), supernatant concentration is 1.15 clear paste II during to 80 ℃ of relative densities, merge clear paste I and II, high speed centrifugation, it when being concentrated into 80 ℃ of relative densities 1.30～1.35 thick paste, drying under reduced pressure, be ground into fine powder, sieve, spray into volatile oil, drug extract, be substrate with the Macrogol 4000, according to medicine: Macrogol 4000: the part by weight of polyoxyethylene monostearate=1: 1.5: 0.5 adds, mixing, the employing internal diameter is 4.0mm, external diameter is the dropper of 6.0mm, drips 80 ℃ of system temperature, dripping speed is 20～30d/min, drip apart from being 6cm, splash in the long cooling column of 140cm, be liquid coolant again with the methyl-silicone oil, the cooling of employing gradient: the Temperature Distribution of gradient liquid coolant is 40 ℃～50 ℃, 10 ℃～30 ℃, 0 ℃～4 ℃, pill promptly gets drop pill.
Embodiments of the invention 3: take by weighing Herba Pogostemonis 653.6g, Folium Perillae 217.8g, Radix Angelicae Dahuricae 217.8g, Rhizoma Atractylodis Macrocephalae (parched) 435.8g, Pericarpium Citri Reticulatae 435.8g, Rhizoma Pinelliae Preparata 435.8g, Sichuan Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 435.8g, Poria 217.8g, Radix Platycodonis 435.8g, Radix Glycyrrhizae 435.8g, Pericarpium Arecae 217.8g, Rhizoma Zingiberis Recens 65.4g, Fructus Jujubae 109g.
Cortex Magnoliae Officinalis is with 60% ethanol extraction three times, and each 1 hour, the ethanol consumption was 8,6,6 times, filtered, and merging filtrate reclaims ethanol, is 1.15 clear paste I when being concentrated into 80 ℃ of relative densities; Herba Pogostemonis, Folium Perillae, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Dahuricae vapor distillation extract volatile oil, add 10 times of water distillations 6 hours, and the aqueous solution after the distillation filters, and device is collected in addition; The medicinal residues and the Rhizoma Pinelliae, Poria, Radix Platycodonis, Radix Glycyrrhizae, Pericarpium Arecae, Rhizoma Zingiberis Recens 65.4g and Fructus Jujubae 109g decoct with water secondary, for the first time adding 6 times of decoctings boiled 2 hours, for the second time adding 6 times of decoctings boiled 1 hour, collecting decoction, merge with above-mentioned aqueous solution, filter, filtrate is concentrated into the clear paste that relative density is 1.12 (80 ℃), supernatant concentration is 1.15 clear paste II during to 80 ℃ of relative densities, merge clear paste I and II, high speed centrifugation, it when being concentrated into 80 ℃ of relative densities 1.30～1.35 thick paste, drying under reduced pressure, be ground into fine powder, sieve, spray into volatile oil, drug extract, with Macrogol 4000: polyethylene glycol 6000=1: 1 mixture is a substrate, according to medicine: the part by weight of substrate=1: 4 adds Macrogol 4000 and polyethylene glycol 6000, mixing, the employing internal diameter is 3.5mm, external diameter is the dropper of 4.5mm, drips 90 ℃ of system temperature, dripping speed is 20～30d/min, drip apart from being 7cm, splash in the long cooling column of 100cm, be liquid coolant again with the methyl-silicone oil, the cooling of employing gradient: the Temperature Distribution of gradient liquid coolant is 10 ℃～20 ℃, 0 ℃～5 ℃, pill promptly gets drop pill.
Embodiments of the invention 4: take by weighing Herba Pogostemonis 653.6g, Folium Perillae 217.8g, Radix Angelicae Dahuricae 217.8g, Rhizoma Atractylodis Macrocephalae (parched) 435.8g, Pericarpium Citri Reticulatae 435.8g, Rhizoma Pinelliae Preparata 435.8g, Sichuan Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 435.8g, Poria 217.8g, Radix Platycodonis 435.8g, Radix Glycyrrhizae 435.8g, Pericarpium Arecae 217.8g, Rhizoma Zingiberis Recens 65.4g, Fructus Jujubae 109g
Cortex Magnoliae Officinalis is with 60% ethanol extraction three times, and each 1 hour, the ethanol consumption was 8,6,6 times, filtered, and merging filtrate reclaims ethanol, is 1.15 clear paste I when being concentrated into 80 ℃ of relative densities; Herba Pogostemonis, Folium Perillae, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Dahuricae vapor distillation extract volatile oil, add 10 times of water distillations 6 hours, and the aqueous solution after the distillation filters, and device is collected in addition; The medicinal residues and the Rhizoma Pinelliae, Poria, Radix Platycodonis, Radix Glycyrrhizae, Pericarpium Arecae, Rhizoma Zingiberis Recens 65.4g and Fructus Jujubae 109g decoct with water secondary, for the first time adding 6 times of decoctings boiled 2 hours, for the second time adding 6 times of decoctings boiled 1 hour, collecting decoction, merge with above-mentioned aqueous solution, filter, filtrate is concentrated into the clear paste that relative density is 1.12 (80 ℃), supernatant concentration is 1.15 clear paste II during to 80 ℃ of relative densities, merge clear paste I and II, high speed centrifugation, it when being concentrated into 80 ℃ of relative densities 1.30～1.35 thick paste, drying under reduced pressure, be ground into fine powder, sieve, spray into volatile oil, drug extract, be substrate with the Macrogol 4000, according to medicine: the part by weight of substrate=1: 5 adds Macrogol 4000, mixing, the employing internal diameter is 3.0mm, external diameter is the dropper of 5.0mm, drips 85 ℃ of system temperature, dripping speed is 25～35d/min, drip apart from being 5cm, splash in the long cooling column of 120cm, be liquid coolant again with the methyl-silicone oil, the cooling of employing gradient: the Temperature Distribution of gradient liquid coolant is 10 ℃～30 ℃, 0 ℃～10 ℃, pill promptly gets drop pill.
Claims (5)
1. health restoring agastache dripping pill preparation calculates extract by Herba Pogostemonis 653.6g, Folium Perillae 217.8g, Radix Angelicae Dahuricae 217.8g, Rhizoma Atractylodis Macrocephalae (parched) 435.8g, Pericarpium Citri Reticulatae 435.8g, Rhizoma Pinelliae Preparata 435.8g, Sichuan Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 435.8g, Poria 217.8g, Radix Platycodonis 435.8g, Radix Glycyrrhizae 435.8g and Pericarpium Arecae 217.8g or corresponding weight according to weight proportion and adds suitable adjuvant and be prepared from; It is characterized in that: Cortex Magnoliae Officinalis is with 60% ethanol extraction three times, and each 1 hour, the ethanol consumption was respectively 8,6,6 times, filtered, and merging filtrate reclaims ethanol, is 1.15 clear paste I when being concentrated into 80 ℃ of relative densities; Herba Pogostemonis, Folium Perillae, Pericarpium Citri Reticulatae, the Rhizoma Atractylodis Macrocephalae, the Radix Angelicae Dahuricae add 10 times of water, and vapor distillation extracts volatile oil,, the aqueous solution after the distillation filters, and device is collected in addition; The medicinal residues and the Rhizoma Pinelliae, Poria, Radix Platycodonis, Radix Glycyrrhizae, Pericarpium Arecae, Rhizoma Zingiberis Recens 65.4g and Fructus Jujubae 109g decoct with water secondary, for the first time adding 6 times of decoctings boiled 2 hours, for the second time adding 6 times of decoctings boiled 1 hour, collecting decoction, merge with above-mentioned aqueous solution, filter, the survey relative density was 1.12 clear paste when filtrate was concentrated into 80 ℃, supernatant concentration is 1.15 clear paste II during to 80 ℃ of relative densities, merge clear paste I and II, high speed centrifugation is 1.30～1.35 thick paste when being concentrated into 80 ℃ of relative densities, drying under reduced pressure, be ground into fine powder, sieve, spray into volatile oil, get drug extract, add suitable substrate: Macrogol 4000 prepares drop pill.
2. according to the described health restoring agastache dripping pill preparation of claim 1, it is characterized in that: the thing extract of getting it filled, join in the molten matrix, reuse dropping preparation method pill is condensed in the coolant and removes coolant behind the ball, dry and drop pill.
3. according to the described health restoring agastache dripping pill preparation of claim 1, it is characterized in that: calculate medicine: substrate=1: 1.2-1.3 by weight proportion.
4. according to the described health restoring agastache dripping pill preparation of claim 2, it is characterized in that: coolant is selected liquid Paraffin, and temperature is 10 ℃.
5. according to the described health restoring agastache dripping pill preparation of claim 2, it is characterized in that: dripping the system temperature is that 85 ℃, droplets speed is 15d/min, drips apart from being 15cm.
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| CN103239586A (en) * | 2013-05-17 | 2013-08-14 | 海南德泽药物研究有限公司 | Flavored agastache turbidity-dispelling external preparation as well as preparation method and application thereof |
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| 中华人民共和国卫生部《药品标准》（中药成方制剂）. 中华人民共和国卫生部药典委员会，第36页. 1997 * |
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