CN104784235A - Method for preparing fresh ginsengfreeze-dried oral instant preparation - Google Patents
Method for preparing fresh ginsengfreeze-dried oral instant preparation Download PDFInfo
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Abstract
The invention discloses a method for preparing a fresh ginsengfreeze-dried oral instant preparation, and belongs to the technical field of medicinalhealthcare products. The method for preparing the fresh ginsengfreeze-dried oral instant preparation comprises the following steps: adding pure water into fresh ginseng, grinding by using a grinding machine, filtering, squeezing the residues, combining the filtrate, feeding the filtrate into a high-pressure equipment kettle, boosting the pressure to be 500-600MPa, keeping the pressure for 10-15 minutes so as to obtain a ginseng extract, filling the ginseng extract into a freeze-drying bottle, putting into a freeze-drying machine for rapid freezing, vacuuming, and heating a plate layer until analysis drying is completed, thereby preparing the fresh ginsengfreeze-dried oral instant preparation. The fresh ginsengfreeze-dried oral instant preparation prepared by using the method has the characteristics of being highin disintegration speed, high in bioavailability, high in dissolution rate, small in nutrient component consumption, easy to absorb by human bodies, high in absorption speed and relatively small in volatile oil component loss.
Description
Technical field
The present invention relates to the preparation method of fresh ginseng freeze-dry orally dissolution formulation, belong to drugs and health care products technical field.
Background technology
Radix Ginseng is a kind of important traditional medicine, and (Latin is called to generally comprise Radix Ginseng
panax ginsengc. A. Mey.) and Radix Panacis Quinquefolii (
panax quinquefoliuml.) and Radix Notoginseng (
panax notoginseng(Burk.) F.H.Chen), ginseng medicine material contains multiple physiologically active ingredient, containing tens kinds of ginsenosides, polysaccharide, polypeptide and volatile ingredients, current research shows, Radix Ginseng has strongly invigorating primordial QI, and multiple arteries and veins takes off admittedly, invigorating the spleen to benefit the lung, effect of promoting the production of body fluid and inducing sedation of the mind.
Ginseng medicine material solid dosage forms known at present mainly contains conventional tablet and capsule, pellet form, general is all adopt Radix Ginseng or Radix Ginseng Rubra decoction pieces to be directly used as medicine or to extract to be used as medicine, these Radix Ginseng decoction pieces are all adopt to dry drying or steaming and decocting medical material preparation, these gen-sengs normally gastrointestinal disintegrate absorb, generally in dozens of minutes not etc., bioavailability is lower in medicine disintegration stripping.The said goods Chinese medicine composition generally all adopts the organic solvent of long-time at elevated temperature to extract, and ginseng effective component such as ginsenoside, polypeptide, polysaccharide and volatile ingredient have comparatively lossy, and Radix Ginseng physiologically active decreases.There are some researches prove, fresh ginseng has more active component than Radix Ginseng and Radix Ginseng Rubra, as bibliographical information, Japanese plum halls etc. are " active ginseng and fresh ginseng, Radix Ginseng and Radix Ginseng Rubra comparison of ingredients research (I) ", " active ginseng and fresh ginseng, Radix Ginseng and Radix Ginseng Rubra comparison of ingredients research (II) " and " active ginseng and fresh ginseng, Radix Ginseng, Radix Ginseng Rubra volatile oil component comparative study (III) " in respectively to fresh ginseng, active ginseng, Radix Ginseng, the ginsenoside contained in Radix Ginseng Rubra, aminoacid and inorganic elements, volatilization wet goods composition compares, research shows no matter the effective ingredient contained by fresh ginseng is that kind and total amount substantially exceed drying Radix Ginseng.But in fact because fresh ginseng is difficult to preserve, often directly dry and make decoction pieces or be used as medicine through extracting, conventional extracting method mainly adopts solvothermal reflux, extract, and organic solvent soak extraction, also have and adopt supercritical process to extract, document and patent report more, solvent heating or soak extraction, owing to having introduced organic solvent and heating, will destroy Radix Ginseng natural component or bring unsafe factor, supercritical extraction extracts not exclusively for some water soluble ingredients and cost is higher.Dry drying decoction pieces itself also partial destruction medical material some physiologically actives of preparation.Existing market also has a kind of Radix Ginseng decoction pieces freeze-drying prods, mainly adopt the direct lyophilizing of fresh ginseng medical material to make, its physiologically active is better than the Radix Ginseng decoction pieces of drying preparation, but still is medical material raw product, effective ingredient is still housed in plant cell, absorbs not bery desirable.
In Radix Ginseng, effective ingredient is present in plant cell usually, rely on the method such as solvent heating extraction or supercritical, although composition wherein can be extracted, but the native state of Radix Ginseng all the components may be destroyed, therefore obtained extract is a certain fractions composition, can not embody the whole composition of ginseng-cell.
Freeze drying technology about natural component has been reported a lot, but find no and close the report that ginseng juice extracts lyophilizing, at present report is had no to some parameters of freeze-drying process of Radix Ginseng natural component group, and under normal circumstances, the lyophilizing parameter understood the object that will carry out lyophilizing is very important.
Have about Radix Ginseng Preparation process and extraction process and gen-seng or pertinent literature at present, China Patent Publication No. CN1586597 discloses ginseng oral disintegration tablet and preparation technology thereof, raw material adopts Radix Ginseng, and content does not relate to fresh ginseng and extracts and lyophilized formulations method.China Patent Publication No. CN1718191 discloses total secondary ginseng glucoside oral disintegration tablets and its preparation method and application, raw material adopts Radix Ginseng extract, this invention does not relate to fresh ginseng and extracts and lyophilizing Chinese patent CN CN200710071981.9 ginseng freeze-dried slice processing technique, is to adopt the direct lyophilizing of ginseng crude drug to form.Chinese patent CN200710071982.3 method for processing American ginseng freeze-dried slice adopts the direct lyophilizing of American ginseng medicine to form.Do not find lyophilized formulations and the bibliographical information of fresh ginseng extracting solution at present.
Summary of the invention
The present invention is in order to solve the problems of the technologies described above, provide the preparation method of fresh ginseng freeze-dry orally dissolution formulation, the ginseng freeze-dried oral instant preparation adopting the method to prepare has obvious skeletal structure shape, and disintegration rate is fast, bioavailability is high, dissolution is high, nutritional labeling loss is little, be easily absorbed by the body, absorb soon, volatile oil component runs off less feature.
For solving the problem, the present invention is achieved through the following technical solutions:
The preparation method of fresh ginseng freeze-dry orally instant powder, comprise the steps: to get the pure water that fresh ginseng adds 1-5 times of fresh ginseng weight, use grinder at 20-25 DEG C of grinding 5-20 minute, be warming up to 65-70 DEG C of grinding 4-6 minute, filter, press residue, merging filtrate, load in extra-high tension unit still, boost to 500-600Mpa, maintain 10-15 minute, obtain Radix Ginseng extractive solution, by Radix Ginseng extractive solution's fill in lyophilizing bottle, put into freezer dryer, quick-freezing is to-50 DEG C--55 DEG C, keep 2 hours, be evacuated to 1-5Pa, then by flaggy temperature extremely-40 DEG C, maintain 3-5 hour, be warming up to-30 DEG C, maintain 3-5 hour, complete to sublimation drying, and then flaggy temperature is risen to 30 DEG C, until parsing-desiccation completes, make fresh ginseng freeze-dry orally instant powder.
The preparation method of above-mentioned ginseng freeze-dried oral instant powder, can also add fresh ginseng weight 0.005-0.05 skeletal substance doubly while adding pure water, and skeletal substance adds in grinder and grinds together with fresh ginseng and pure water.
Above-mentioned skeletal substance can be the one in Radix Ginseng starch, ripening Radix Ginseng, mannitol, xanthan gum, fresh Herba Dendrobii.
Above-mentioned grinder is colloid mill grinder.
Above-mentioned Radix Ginseng is Radix Ginseng, Radix Panacis Quinquefolii or Radix Notoginseng.
The preparation method of fresh ginseng freeze-dry orally rapidly dissolving tablet, comprise the steps: to get the pure water that fresh ginseng adds 1-5 times of fresh ginseng weight, use grinder at 20-25 DEG C of grinding 5-20 minute, be warming up to 65-70 DEG C of grinding 4-6 minute, filter, press residue, merging filtrate, load in extra-high tension unit still, boost to 500-600Mpa, maintain 10-15 minute, obtain Radix Ginseng DEG C DEG C DEG C extracting solution, by Radix Ginseng extractive solution's fill in plastic-aluminum vesicle, spray into liquid nitrogen flash freezer, put into freezer dryer, quick-freezing is to-50 DEG C--55 DEG C, keep 2 hours, be evacuated to 1-5Pa, then by flaggy temperature extremely-40 DEG C, maintain 3-5 hour, be warming up to-30 DEG C, maintain 3-5 hour, until sublimation drying completes, and then flaggy temperature is risen to 30 DEG C, until parsing-desiccation completes, overlay film is packed, and makes fresh ginseng freeze-dry orally rapidly dissolving tablet.
The preparation method of above-mentioned ginseng freeze-dried oral instant-dissolving tablet, can also add fresh ginseng weight 0.005-0.05 skeletal substance doubly while adding pure water, and skeletal substance adds in grinder and grinds together with fresh ginseng and pure water.
Above-mentioned skeletal substance can be the one in Radix Ginseng starch, ripening Radix Ginseng, mannitol, xanthan gum, fresh Herba Dendrobii.
Above-mentioned grinder is colloid mill grinder.
Above-mentioned Radix Ginseng is Radix Ginseng, Radix Panacis Quinquefolii or Radix Notoginseng.
Owing to adopting technique scheme, tool of the present invention is had the following advantages and effect:
Radix Ginseng freeze-dry orally dissolution formulation preparation method of the present invention, compared with conventional method, Conventional solvents is not had to extract the step of the destruction ginseng nutrient compositions such as high-temperature heating, there is no phase inversion process, can more reservation constituent of ginseng, the loss of effective components of Radix Ginseng is few, and especially volatile ingredient retains more, and Radix Ginseng flavour is more dense.Oral cavity of the present invention lyophilized formulations has obvious skeletal structure shape, and porosity is high, in the oral cavity can disintegrate and dissolving rapidly, is absorbed and enters blood, effectively can avoid liver first-pass effect by oral mucosa, pharynx and esophagus biomembrane.Gen-seng prepared by the inventive method is taking Shi Buxu water, can dissolve rapidly in the oral cavity, there is good mouthfeel, taking convenience, absorb fast, bioavailability high, for old man, child and function of deglutition are bad and the patient of water intaking inconvenience provides conveniently.
Fresh ginseng freeze-dry orally dissolution formulation of the present invention improves a lot than the disintegration rate of commercial preparation as capsule and ordinary tablet, and the disintegrate of ginseng freeze-dried oral instant preparation prepared by the present invention is generally within 2 seconds.
Accompanying drawing explanation
Fig. 1 is the In Vitro Dissolution curve chart of Radix Ginseng total saponins in the fresh ginseng freeze-dry orally dissolution formulation prepared of embodiment 1 and other several gen-seng.
Fig. 2 is the In Vitro Dissolution curve chart of Radix Ginseng total saponins in the fresh ginseng freeze-dry orally dissolution formulation of embodiment 4 preparation.
Fig. 3 is the In Vitro Dissolution curve chart of Radix Ginseng total saponins in the fresh ginseng freeze-dry orally dissolution formulation of embodiment 6 preparation.
Fig. 4 is the In Vitro Dissolution curve chart of Radix Ginseng total saponins in the fresh ginseng freeze-dry orally dissolution formulation of embodiment 7 preparation.
Detailed description of the invention
In order to the preparation method of fresh ginseng extracting method of the present invention and its oral cavity lyophilized formulations is better described, embodiment is as follows:
Embodiment 1:
Getting 10kg fresh ginseng and 25kg pure water after cleaning uses colloid mill grinder to grind 10 minutes at 20 DEG C, be incubated 67 DEG C of grindings 5 minutes, filter, press residue, merging filtrate, load in extra-high tension unit still, boost to 550Mpa, maintain 10 minutes, obtain Radix Ginseng extractive solution, by Radix Ginseng extractive solution's fill in plastic-aluminum vesicle, spray into liquid nitrogen flash freezer, put into freezer dryer, quick-freezing is to-52 DEG C, keep 2 hours, be evacuated to 1.5Pa, then by flaggy temperature extremely-40 DEG C, maintain 3 hours, be warming up to-30 DEG C, maintain 3 hours, until sublimation drying completes, and then flaggy temperature is risen to 30 DEG C, until parsing-desiccation completes, overlay film is packed, and is prepared into fresh ginseng freeze-dry orally rapidly dissolving tablet.
Measuring total Ginsenosides Content is 3.6%, 0.4 second disintegration.
Embodiment 2:
Getting the fresh Radix Panacis Quinquefolii of 10kg and 10kg pure water after cleaning uses colloid mill grinder to grind 20 minutes at 25 DEG C, be incubated 70 DEG C of grinding 4 clocks, filter, press residue, merging filtrate, load in extra-high tension unit still, boost to 500Mpa, maintain 15 minutes, obtain Radix Panacis Quinquefolii extracting solution, by Radix Panacis Quinquefolii extracting solution fill in lyophilizing bottle, put into freezer dryer, quick-freezing, to-55 DEG C, keeps 2 hours, be evacuated to 2Pa, then by flaggy temperature extremely-40 DEG C, maintain 3 hours, be warming up to-30 DEG C, maintain 4 hours, until sublimation drying completes; And then flaggy temperature is risen to 30 DEG C, until parsing-desiccation completes, be prepared into fresh ginseng freeze-dry orally instant powder.
Measuring total Ginsenosides Content is 6.8%, 0.6 second disintegration.
Embodiment 3:
Get after cleaning and be cut into the fresh Radix Panacis Quinquefolii of granular 10kg, 30kg pure water, 500g cuts shape fresh Herba Dendrobii into pieces, colloid mill grinder is used to grind 12 minutes at 20 DEG C, be incubated 65 DEG C of grindings 6 minutes, filter, press residue, merging filtrate, load in extra-high tension unit still, boost to 600Mpa, maintain 12 minutes, obtain Radix Panacis Quinquefolii extracting solution, by Radix Panacis Quinquefolii extracting solution fill in lyophilizing bottle, put into freezer dryer, quick-freezing is to-50 DEG C, keep 2 hours, be evacuated to 1Pa, then by flaggy temperature extremely-40 DEG C, maintain 4 hours, be warming up to-30 DEG C, maintain 3 hours, until sublimation drying completes, and then flaggy temperature is risen to 30 DEG C, until parsing-desiccation completes, be prepared into American ginseng dendrobium freeze-dry orally instant powder.
Measuring total Ginsenosides Content is 6.3%, and disintegration is 0.5 second.
Embodiment 4:
Get clean 10kg fresh ginseng, cut into granular, add 30kg pure water, add 200g mannitol, use colloid mill grinds, 22 DEG C of grindings 10 minutes, be incubated 68 DEG C of grindings 4 minutes, filter, press residue, merging filtrate, load in extra-high tension unit still, boost to 600Mpa, maintain 15 minutes, obtain Radix Ginseng and extract solution, quantitative filling is in lyophilizing bottle, put into freezer dryer, quick-freezing is to-53 DEG C, keep 2 hours, be evacuated to 1.5Pa, then by flaggy temperature extremely-40 DEG C, maintain 4 hours, be warming up to-30 DEG C, maintain 4 hours, until sublimation drying completes, and then flaggy temperature is risen to 30 DEG C, until parsing-desiccation completes, be prepared into fresh ginseng freeze-dry orally instant powder.
Measuring total Ginsenosides Content is 3.35%, and disintegration is 0.3 second.
Embodiment 5:
Get fresh Radix Panacis Quinquefolii 10kg after cleaning, cut into granular, add 15kg pure water, add 50g xanthan gum, fine grinding machine such as colloid mill is used to grind, 20 DEG C are ground 20 minutes, be incubated 70 DEG C of grindings 5 minutes, filter, press residue, merging filtrate, load in extra-high tension unit still, boost to 600Mpa, maintain 7 minutes, obtain Radix Ginseng and extract solution, fill is in plastic-aluminum vesicle, spray into liquid nitrogen flash freezer, put into freezer dryer, , quick-freezing is to-50 DEG C, keep 2 hours, be evacuated to 2Pa, then by flaggy temperature extremely-40 DEG C, maintain 3 hours, be warming up to-30 DEG C, maintain 3 hours, until sublimation drying completes, and then flaggy temperature is risen to 30 DEG C, until parsing-desiccation completes, overlay film is packed, and is prepared into fresh American ginseng freeze-dried oral instant tablet.
Measuring total Ginsenosides Content is 6.7%, and disintegration is 0.3 second.
Embodiment 6:
Get 10kg fresh ginseng clean after, add 50kg pure water, add 500g Radix Ginseng starch, use colloid mill grinds, and 25 DEG C are ground 7 minutes, is incubated 70 DEG C of grindings 6 minutes, filter, press residue, merging filtrate, load in extra-high tension unit still, boost to 500Mpa, maintain 14 minutes, obtain Radix Ginseng and extract solution, quantitative filling is in lyophilizing bottle, put into freezer dryer, quick-freezing, to-51 DEG C, keeps 2 hours, be evacuated to 1.3Pa, then by flaggy temperature extremely-40 DEG C, maintain 3 hours, be warming up to-30 DEG C, maintain 4 hours, until sublimation drying completes; And then flaggy temperature is risen to 30 DEG C, until parsing-desiccation completes, be prepared into fresh ginseng freeze-dry orally instant powder.
Measuring total Ginsenosides Content is 3.2%, and disintegration is 1.2 seconds.
Embodiment 7:
Get 10kg fresh ginseng clean after, cut into granular, add 50kg pure water, add 300g ripening Radix Ginseng, use grinder grinds, 25 DEG C are ground 5 minutes, be incubated 65 DEG C of grindings 5 minutes, filter, press residue, merging filtrate, load in extra-high tension unit still, boost to 500Mpa, maintain 15 minutes, obtain Radix Ginseng extractive solution, by Radix Ginseng extractive solution's fill in plastic-aluminum vesicle, spray into liquid nitrogen flash freezer, put into freezer dryer, quick-freezing is to-55 DEG C, keep 2 hours, be evacuated to 1Pa, then by flaggy temperature extremely-40 DEG C, maintain 4 hours, be warming up to-30 DEG C, maintain 4 hours, until sublimation drying completes, and then flaggy temperature is risen to 30 DEG C, until parsing-desiccation completes, overlay film is packed, and is prepared into fresh ginseng freeze-dry orally dissolving tablet.
Measuring total Ginsenosides Content is 3.9%, and disintegration is 1.8 seconds.
Embodiment 8:
Get the fresh Radix Notoginseng Radix Ginseng of 10kg clean after, cut into granular, add 40kg pure water, use colloid mill grinds, grind 20 minutes under 22 DEG C of conditions, be incubated 66 DEG C of grindings 5 minutes, filter, press residue, merging filtrate, load in extra-high tension unit still, boost to 580Mpa, maintain 10 minutes, obtain Radix Ginseng and extract solution, quantitative filling is in customization plastic-aluminum vesicle, spray into liquid nitrogen flash freezer, put into freezer dryer, quick-freezing is to-53 DEG C, keep 2 hours, be evacuated to 1.7Pa, then by flaggy temperature extremely-40 DEG C, maintain 3 hours, be warming up to-30 DEG C, maintain 3 hours, until sublimation drying completes, and then flaggy temperature is risen to 30 DEG C, until parsing-desiccation completes, overlay film is packed, and is prepared into the ginseng freeze-dried oral instant-dissolving tablet of fresh Radix Notoginseng.
Measuring total saponin content is 9.6%, and disintegration is 0.3 second.
Embodiment 9:
Get the fresh Radix Notoginseng Radix Ginseng of clean 10kg, add 30kg pure water, add 200g mannitol, use colloid mill grinds, 24 DEG C of grindings 6 minutes, be incubated 69 DEG C of grindings 6 minutes, filter, press residue, merging filtrate, load in extra-high tension unit still, boost to 530Mpa, maintain 13 minutes, obtain Radix Ginseng and extract solution, quantitative filling is in lyophilizing bottle, put into freezer dryer, quick-freezing is to-51 DEG C, keep 2 hours, be evacuated to 1.5Pa, then flaggy temperature is slowly warming up to-40 DEG C, maintain 4 hours, be warming up to-30 DEG C, maintain 3 hours, until sublimation drying completes, and then gradually flaggy temperature is risen to 30 DEG C, until parsing-desiccation completes, be prepared into fresh ginseng freeze-dry orally instant powder.
Measuring total saponin content is 9.4%, and disintegration is 0.4 second.
Below in order to verify that the effect of fresh ginseng freeze-dry orally dissolution formulation prepared by the inventive method is tested as follows further.
One, the effect of fresh ginseng freeze-dry orally dissolution formulation prepared of above-described embodiment 1-9 method is determined mainly through the active component total amount contained in comparison and detection Radix Ginseng formulation ingredients of the present invention and the gen-seng conventionally prepared, and the effect of lyophilized formulations prepared by extract embodiment 1-9 method of the present invention is determined by contrast and commercial preparation disintegration and animal pharmacokinetics result.Active component detects as ginsenoside measures, and method is as follows: the detection method of content of each Radix Ginseng saponin constituent, and adopt high-efficient liquid phase technique, its system flow is acetonitrile mutually: water, by gradient elution program, and determined wavelength 203nm, flow velocity 1mL/min.After testing, in the ginseng freeze-dried oral instant preparation that the inventive method is obtained, ginsenoside's composition is close with content with fresh ginseng medical material kind, illustrates and adopts Freeze Drying Technique can retain effective ingredient in fresh ginseng, lose less.
Two, the volatile oil detection method of fresh ginseng freeze-dry orally dissolution formulation of the present invention, fresh ginseng freeze-dry orally dissolution formulation ether merceration prepared by embodiment of the present invention 1-9 method extracts twice, merges ether solution, volatilizes ether, sample introduction gas chromatographic detection.Condition determination is: chromatographic column: PEG-20M/0.25mm; Pressure 1.6kg/cm before post
2; Column temperature: 100-190 DEG C, according to 40 DEG C/min temperature programming; Vaporizer: 280 DEG C; Fractional distillation is compared: 3 week Ban; Flow velocity: 1mL/min; Carrier gas: He; Detector: FID; Detector temperature: 280 DEG C.After testing, in fresh ginseng, volatile oil content is that in the obtained fresh ginseng freeze-dry orally dissolution formulation of 0.154%, embodiment 1-9 method, volatile oil content is 0.134-0.141%, and in the two, volatile oil component is close, illustrate and adopt freeze-drying method processing, volatile oil component runs off less.
Three, get the fresh ginseng freeze-dry orally dissolution formulation prepared according to embodiment 1-9 preparation method, get commercially available Radix Ginseng tablet, measure according to pharmacopeia annex disintegration time mensuration method, result is, lyophilizing sheet of the present invention disintegration is 0.3-1.8 second, and commercially available is 48 minutes.
Four, get the fresh ginseng freeze-dry orally dissolution formulation prepared by embodiment 1-9 and carry out bioavailability experiment, specific as follows: to get SD rat 300, male, body weight 200g.Rat is divided into ten groups, often organize 30,1-9 group is respectively the ginseng freeze-dried preparation gavage group that embodiment of the present invention 1-9 method is made, and the 10th group is commercially available Radix Ginseng slice's gavage group, equal fasting 12h before often organizing Mus experiment.Upon administration 0.25,0.5,0.75,1,2,3,4,6,9,12h, each time point often group gets 3 animals, gets blood be about 1mL and put in centrifuge tube respectively at orbital venous plexus.In serum, ginsenoside Rb1's assay method adopts high-efficient liquid phase technique, and its system flow is acetonitrile mutually: water, by gradient elution program, and determined wavelength 203nm, flow velocity 1mL/min.Sample treatment, gets rat blood serum appropriate, adds 5 times amount methanol, and after concussion mixing, centrifuging and taking supernatant, nitrogen dries up, and methanol constant volume, to 1mL, through 0.45 μ L membrane filtration, obtains test solution.
Ten groups of rats gavage ginseng freeze-dried of the present invention and commercially available Radix Ginseng slice respectively, try to achieve by pharmacokinetic parameters the 287-305% that ginseng freeze-dried relative bioavailability is commercially available conventional tablet.
Five, the lyophilizing tablet preparation that 200g fresh ginseng obtains according to embodiment 1-9 method is got respectively; Get same amount fresh ginseng and adopt soak by water technique, add 5 times of soak by water 2 hours, totally twice, merge concentrated, dry to obtain extract, pulverizing compressed tablets, obtain Radix Ginseng powder's preparation; Get same amount fresh ginseng and prepare Radix Ginseng according to processing procedure, direct pulverizing, pulverizing compressed tablets; Get same amount fresh ginseng and prepare Radix Ginseng Rubra according to generally known processing procedure, then add 5 times of soak by water 2 hours, totally twice, merge extractive liquid, concentrates, and dries extract, pulverizing compressed tablets, measures ginsenoside and volatile oil and disintegration according to assay method.Experimental result is, embodiment 1-9 lyophilized formulations, total saponins 3.0-3.8%, and volatile oil is 0.134-0.141%, ginseng polypeptide 0.79-0.87%, 0.3-0.6 second disintegration; Fresh ginseng soak by water technique extract powder preparation total saponins is 2.2%, and volatile oil is 0.026%, ginseng polypeptide 0.5%, 50 minutes disintegrations; Radix Ginseng pulverizing preparation total saponins is 2.1%, and volatile oil is 0.018%, ginseng polypeptide 0.6%, 58 minutes disintegrations; Radix Ginseng Rubra extract powder preparation total saponins is 2.5%, and volatile oil is 0.013%, ginseng polypeptide 0.2%, 48 minutes disintegrations.
Six, get the various fresh ginseng freeze-dry orally dissolution formulation dissolution in vitro tests prepared by embodiment 1,4,6,7, method is as follows:
Dissolution determination presses Chinese Pharmacopoeia version two dissolution methods the 3rd method in 2010, with distilled water 300mL for dissolution medium, bath temperature (37 ± 0.5) DEG C, slurry rotating speed 100 turns/min, respectively at the microporous filter membrane filtration sampling of setting-up time through 0.8 μm, sampling amount is 2.0mL, adds 2.0mL equality of temperature medium simultaneously.Sample solution (2.0mL) 10mL chloroform divides 3 extractions, discards chloroform solution, is added by aqueous solution in peroxidating aluminum D101 type macroporous adsorptive resins, 70% ethanol elution is used again after rinsing with water, collect eluent, evaporate to dryness, residue measures according to the method under ginsenoside's item.With actual content in sample for 100%, calculate the cumulative defaultlogic of Radix Ginseng total saponins.Obtain following ginsenoside's In Vitro Dissolution curve (Fig. 1, Fig. 2, Fig. 3, Fig. 4), calculate embodiment 1, embodiment 4, embodiment 6, embodiment 7 tablet t
50value is 0.1-0.2min, fresh ginseng sheet (water extraction) t
50for 10.0min, Radix Ginseng sheet t
50for 17.8min, Radix Ginseng Rubra sheet (water extraction) t
50for 10.4min.
Seven, get the fresh ginseng freeze-dry orally dissolution formulation prepared according to embodiment 1-9 preparation method, observe outward appearance, the fresh ginseng freeze-dry orally dissolution formulation of preparation, comprises instant powder and tablet, has obvious skeletal structure shape, and duct is obvious, sucks and namely changes.
Claims (10)
1. the preparation method of fresh ginseng freeze-dry orally instant powder, it is characterized in that the pure water that it comprises the steps: to get fresh ginseng and adds 1-5 times of fresh ginseng weight, use grinder at 20-25 DEG C of grinding 5-20 minute, be warming up to 65-70 DEG C of grinding 4-6 minute, filter, press residue, merging filtrate, load in extra-high tension unit still, boost to 500-600Mpa, maintain 10-15 minute, obtain Radix Ginseng extractive solution, by Radix Ginseng extractive solution's fill in lyophilizing bottle, put into freezer dryer, quick-freezing is to-50 DEG C--55 DEG C, keep 2 hours, be evacuated to 1-5Pa, then by flaggy temperature extremely-40 DEG C, maintain 3-5 hour, be warming up to-30 DEG C, maintain 3-5 hour, complete to sublimation drying, and then flaggy temperature is risen to 30 DEG C, until parsing-desiccation completes, make fresh ginseng freeze-dry orally instant powder.
2. the preparation method of fresh ginseng freeze-dry orally instant powder according to claim 1, it is characterized in that described add pure water while can also add fresh ginseng weight 0.005-0.05 skeletal substance doubly, skeletal substance adds in grinder and grinds together with fresh ginseng and pure water.
3. the preparation method of fresh ginseng freeze-dry orally instant powder according to claim 2, is characterized in that described skeletal substance can be the one in Radix Ginseng starch, ripening Radix Ginseng, mannitol, trehalose, cyclodextrin, xanthan gum, fresh Herba Dendrobii.
4. the preparation method of fresh ginseng freeze-dry orally instant powder according to claim 1 and 2, is characterized in that described grinder is colloid mill grinder.
5. the preparation method of fresh ginseng freeze-dry orally instant powder according to claim 1 and 2, is characterized in that described Radix Ginseng is Radix Ginseng, Radix Panacis Quinquefolii or Radix Notoginseng.
6. the preparation method of fresh ginseng freeze-dry orally rapidly dissolving tablet, it is characterized in that the pure water that it comprises the steps: to get fresh ginseng and adds 1-5 times of fresh ginseng weight, use grinder at 20-25 DEG C of grinding 5-20 minute, be warming up to 65-70 DEG C of grinding 4-6 minute, filter, press residue, merging filtrate, load in extra-high tension unit still, boost to 500-600Mpa, maintain 10-15 minute, obtain Radix Ginseng extractive solution, by Radix Ginseng extractive solution's fill in plastic-aluminum vesicle, spray into liquid nitrogen flash freezer, put into freezer dryer, quick-freezing is to-50 DEG C--55 DEG C, keep 2 hours, be evacuated to 1-5Pa, then flaggy temperature is slowly warming up to-40 DEG C, maintain 3-5 hour, be warming up to-30 DEG C, maintain 3-5 hour, until sublimation drying completes, and then flaggy temperature is risen to 30 DEG C, until parsing-desiccation completes, overlay film is packed, and makes fresh ginseng freeze-dry orally rapidly dissolving tablet.
7. the preparation method of fresh ginseng freeze-dry orally rapidly dissolving tablet according to claim 6, it is characterized in that described add pure water while can also add fresh ginseng weight 0.005-0.05 skeletal substance doubly, skeletal substance adds in grinder and grinds together with fresh ginseng and pure water.
8. the preparation method of fresh ginseng freeze-dry orally rapidly dissolving tablet according to claim 7, is characterized in that described skeletal substance can be the one in Radix Ginseng starch, ripening Radix Ginseng, mannitol, xanthan gum, fresh Herba Dendrobii.
9. the preparation method of the fresh ginseng freeze-dry orally rapidly dissolving tablet according to claim 6 or 7, is characterized in that described grinder is colloid mill grinder.
10. the preparation method of the fresh ginseng freeze-dry orally rapidly dissolving tablet according to claim 6 or 7, is characterized in that described Radix Ginseng is Radix Ginseng, Radix Panacis Quinquefolii or Radix Notoginseng.
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| CN106942743A (en) * | 2017-03-31 | 2017-07-14 | 泸州德高生物科技有限公司 | The preparation method of the ecological oral freeze-dried powder of ginseng |
| CN106983779A (en) * | 2017-03-31 | 2017-07-28 | 泸州德高生物科技有限公司 | The ecological oral freeze-dried powder, preparation method thereof of American Ginseng |
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