CN104886579A - Red ginseng pellet and preparation method - Google Patents
Red ginseng pellet and preparation method Download PDFInfo
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- CN104886579A CN104886579A CN201510333551.4A CN201510333551A CN104886579A CN 104886579 A CN104886579 A CN 104886579A CN 201510333551 A CN201510333551 A CN 201510333551A CN 104886579 A CN104886579 A CN 104886579A
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- 235000002789 Panax ginseng Nutrition 0.000 title claims abstract description 75
- 238000002360 preparation method Methods 0.000 title claims abstract description 20
- 239000008188 pellet Substances 0.000 title claims abstract description 16
- 239000000843 powder Substances 0.000 claims abstract description 120
- 239000000284 extract Substances 0.000 claims abstract description 79
- 239000011248 coating agent Substances 0.000 claims abstract description 21
- 238000000576 coating method Methods 0.000 claims abstract description 21
- 239000002775 capsule Substances 0.000 claims abstract description 13
- 239000011122 softwood Substances 0.000 claims description 24
- 241000208340 Araliaceae Species 0.000 claims description 20
- 235000005035 Panax pseudoginseng ssp. pseudoginseng Nutrition 0.000 claims description 20
- 235000003140 Panax quinquefolius Nutrition 0.000 claims description 20
- 235000008434 ginseng Nutrition 0.000 claims description 20
- 239000000463 material Substances 0.000 claims description 19
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 18
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 18
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 18
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 18
- 239000003814 drug Substances 0.000 claims description 17
- 239000000203 mixture Substances 0.000 claims description 17
- 239000006187 pill Substances 0.000 claims description 16
- 229940079593 drug Drugs 0.000 claims description 15
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 14
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 14
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 14
- 239000000741 silica gel Substances 0.000 claims description 14
- 229910002027 silica gel Inorganic materials 0.000 claims description 14
- 239000007921 spray Substances 0.000 claims description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 13
- 239000011812 mixed powder Substances 0.000 claims description 12
- 238000004090 dissolution Methods 0.000 claims description 9
- 210000002784 stomach Anatomy 0.000 claims description 8
- 239000002552 dosage form Substances 0.000 claims description 7
- 238000001035 drying Methods 0.000 claims description 7
- 239000012530 fluid Substances 0.000 claims description 7
- 239000004005 microsphere Substances 0.000 claims description 7
- 238000012545 processing Methods 0.000 claims description 7
- 238000003756 stirring Methods 0.000 claims description 7
- 238000011049 filling Methods 0.000 abstract description 3
- 238000002156 mixing Methods 0.000 abstract description 3
- 239000004615 ingredient Substances 0.000 abstract description 2
- 235000013305 food Nutrition 0.000 abstract 1
- 239000000243 solution Substances 0.000 description 16
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 12
- 235000013312 flour Nutrition 0.000 description 9
- 238000000034 method Methods 0.000 description 9
- 238000002474 experimental method Methods 0.000 description 8
- 238000012360 testing method Methods 0.000 description 7
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 5
- 238000010521 absorption reaction Methods 0.000 description 5
- 238000004458 analytical method Methods 0.000 description 4
- 229930182494 ginsenoside Natural products 0.000 description 4
- 239000002075 main ingredient Substances 0.000 description 4
- 239000001397 quillaja saponaria molina bark Substances 0.000 description 4
- 229930182490 saponin Natural products 0.000 description 4
- 150000007949 saponins Chemical class 0.000 description 4
- 238000007493 shaping process Methods 0.000 description 4
- 239000000853 adhesive Substances 0.000 description 3
- 230000001070 adhesive effect Effects 0.000 description 3
- 239000006286 aqueous extract Substances 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 238000001125 extrusion Methods 0.000 description 3
- 238000009472 formulation Methods 0.000 description 3
- 229940089161 ginsenoside Drugs 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- 239000013558 reference substance Substances 0.000 description 3
- 238000005563 spheronization Methods 0.000 description 3
- 230000004584 weight gain Effects 0.000 description 3
- 235000019786 weight gain Nutrition 0.000 description 3
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 2
- 239000000470 constituent Substances 0.000 description 2
- 238000013270 controlled release Methods 0.000 description 2
- 235000019441 ethanol Nutrition 0.000 description 2
- 238000011156 evaluation Methods 0.000 description 2
- 239000012467 final product Substances 0.000 description 2
- PWAOOJDMFUQOKB-WCZZMFLVSA-N ginsenoside Re Chemical compound O[C@@H]1[C@H](O)[C@@H](O)[C@H](C)O[C@H]1O[C@H]1[C@H](O[C@@H]2[C@H]3C(C)(C)[C@@H](O)CC[C@]3(C)[C@@H]3[C@@]([C@@]4(CC[C@@H]([C@H]4[C@H](O)C3)[C@](C)(CCC=C(C)C)O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O3)O)C)(C)C2)O[C@H](CO)[C@@H](O)[C@@H]1O PWAOOJDMFUQOKB-WCZZMFLVSA-N 0.000 description 2
- AOGZLQUEBLOQCI-UHFFFAOYSA-N ginsenoside-Re Natural products CC1OC(OCC2OC(OC3CC4(C)C(CC(O)C5C(CCC45C)C(C)(CCC=C(C)C)OC6OC(CO)C(O)C(O)C6O)C7(C)CCC(O)C(C)(C)C37)C(O)C(O)C2O)C(O)C(O)C1O AOGZLQUEBLOQCI-UHFFFAOYSA-N 0.000 description 2
- 238000005469 granulation Methods 0.000 description 2
- 230000003179 granulation Effects 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 238000011068 loading method Methods 0.000 description 2
- 239000012085 test solution Substances 0.000 description 2
- 239000000080 wetting agent Substances 0.000 description 2
- 206010004542 Bezoar Diseases 0.000 description 1
- 201000008197 Laryngitis Diseases 0.000 description 1
- LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical class CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 description 1
- 238000000540 analysis of variance Methods 0.000 description 1
- 239000002260 anti-inflammatory agent Substances 0.000 description 1
- 229940124599 anti-inflammatory drug Drugs 0.000 description 1
- 230000001741 anti-phlogistic effect Effects 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 238000011088 calibration curve Methods 0.000 description 1
- 235000013339 cereals Nutrition 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 238000010835 comparative analysis Methods 0.000 description 1
- 230000006837 decompression Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 238000005429 filling process Methods 0.000 description 1
- 230000030136 gastric emptying Effects 0.000 description 1
- 235000013402 health food Nutrition 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000002798 spectrophotometry method Methods 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- MWOOGOJBHIARFG-UHFFFAOYSA-N vanillin Chemical compound COC1=CC(C=O)=CC=C1O MWOOGOJBHIARFG-UHFFFAOYSA-N 0.000 description 1
- 239000003643 water by type Substances 0.000 description 1
- 238000003809 water extraction Methods 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
- 235000020985 whole grains Nutrition 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention relates to a health-care food, in particular to a red ginseng pellet and a preparation method. Medicated effective ingredients of the red ginseng pellet are prepared by mixing red ginseng superfine powder and red ginseng extract powder. The prepared pellet has a high yield, good uniformity, excellent powder flowability and precise capsule filling quantity, a coating has a good moisture-proof effect, reasonable technological parameters are determined, and the pellet yield is guaranteed.
Description
technical field
The present invention relates to a kind of health food, i.e. a kind of red ginseng micropill and preparation method.
Background technology
In the prior art, red ginseng (ginseng) the capsule class goods former powder of many employings crude drug or extract are made, granulating process adopts wet granulation, easily produce powder in rough, size heterogeneity, dry whole grain process, the powder fluidity in filling process be poor, the poor easy moisture and deteriorate of product stability.
Micropill preparation (pellets), also known as pilule, refers to that diameter is about 1 mm, is generally no more than the coccoid peroral dosage form of 2.5 mm.Ancient Times in China just has traditional Chinese medicine pellet preparation; as " Liushen Pills " " laryngitis ball " " antiphlogistic bezoar ball " etc.; but these micropill formulations are limited to more, and prescribed dose is little, the application for the treatment of throat anti-inflammatory drugs, and preparation technology falls behind, and there is the shortcomings such as working strength is large, efficiency is low.Along with the development of pharmacy in modern times, it is found that pellet preparations is compared with other oral formulations, self has many advantages, as a dosage is made up of multiple dispersal unit, after oral can large area, be evenly dispersed in intestines and stomach, improve the bioavilability of medicine; In GI transhipment not by the impact of gastric emptying, absorb favorable reproducibility; The combination of different rate of releasing drug piller, easily realizes the rate of releasing drug of expection, reaches desirable blood concentration; Slow, controlled release micro pill has higher security than slow, the controlled-release administrating system of unit, can avoid the harm that burst drug release brings; There is the flexibility of improvement, can further encapsulated, be pressed into tablet or wrap up specific clothing film etc.
In the market there are no red ginseng (ginseng) micropill class preparation.
Summary of the invention
The object of the invention is to provide for above-mentioned deficiency that a kind of carrying drug ratio is high, the red ginseng micropill of rational technology and preparation method.Specifically solve the problem such as loading amount inaccuracy, the easy moisture absorption of product.
Technical solution of the present invention is: a kind of red ginseng micropill, and its effective medicinal components is mixed by red ginseng Ultramicro-powder and red ginseng extract powder.
Red ginseng micropill, is made up of the bulk drug of following parts by weight: red ginseng Ultramicro-powder: red ginseng extract powder=2:3.
Red ginseng micropill, adds the acceptable auxiliary material of pharmaceutically different dosage form and makes: red ginseng Ultramicro-powder 6-10 part, red ginseng dry extract 12-15 part, microcrystalline cellulose 15-20 part, superfine silica gel powder 0.5-1.0 part, PVPP 0.5-1.0 part.
Preferred: red ginseng micropill, add the acceptable auxiliary material of pharmaceutically different dosage form and make: red ginseng Ultramicro-powder 8 parts, red ginseng dry extract 12 parts, microcrystalline cellulose 16.5 parts, superfine silica gel powder 0.73 part, PVPP 0.73 part.
Red ginseng microsphere and its preparation, is characterized in that step is as follows:
1. Ultramicro-powder: it is for subsequent use that the red ginseng powder that is up to the standards of learning from else's experience is broken into Ultramicro-powder 300 order.
2. extract powder: the red ginseng be up to the standards of learning from else's experience, adds 15 times of water gagings, extracts 3 times, each 60min, merge extract, extract vacuum decompression-0.08MPa is concentrated into relative density 1.25-1.28,70 DEG C, concentrated extract, concentrated extract is spray dried to extract powder and separately purchases use.
3. softwood: get red ginseng Ultramicro-powder, red ginseng extract powder, microcrystalline cellulose, superfine silica gel powder, PVPP join in mixer, mix and pour out for subsequent use in 25 minutes; Get volume fraction be 70% ethanolic solution and mixed powder be placed in flat mixer respectively 9 times in the ratio average mark of 1:1, mix 30 minutes, make softwood.
4. pill: by the softwood made, adds in micropill pellet processing machine, and by extruding rotating speed 80rpm, round as a ball rotating speed 500rpm, round as a ball time 15min makes micropill, crosses 22 mesh sieves, for subsequent use after drying.
5. dressing: get Opadry 200 stomach dissolution type dressing material, be configured to the coating solution of 20%; Stir 45 minutes, cross 80 mesh sieves; Dressing is sprayed, coating solution flow velocity 1.5ml/min, EAT 55-60 DEG C, spray gun atomizing pressure 0.2-0.3bar, blower fan air blast 30 ~ 35Hz, the micropill dry for standby after dressing at the bottom of fluid bed.
6. capsule charge.
Extrusion spheronization method is current widely used one micropill method processed, has the advantages such as granulation efficiency is high, distribution of particles band is narrow, roundness is high, micropill smooth surface.This product adopts extrusion spheronization pill, the technique of fluidized bed coating is made.
Preferred: red ginseng microsphere and its preparation, its step is as follows:
1. Ultramicro-powder: it is for subsequent use that the red ginseng 75kg that is up to the standards of learning from else's experience is ground into Ultramicro-powder 300 order.
2. extract powder: learn from else's experience the red ginseng 270kg be up to the standards, and adds 15 times of water gagings, extracts 3 times, each 60min, merge extract, extract vacuum decompression-0.08MPa is concentrated into relative density 1.25-1.28,70 DEG C, concentrated extract, concentrated extract is spray dried to extract powder and separately purchases use.
3. softwood: get red ginseng Ultramicro-powder 75kg, red ginseng extract powder 112.5kg, microcrystalline cellulose 155kg, superfine silica gel powder 6.8 kg, PVPP 6.8 kg join in mixer, mix and pour out for subsequent use in 25 minutes; Get volume fraction be 70% ethanolic solution and mixed powder be placed in flat mixer respectively 9 times in the ratio average mark of 1:1, mix 30 minutes, make softwood.
4. pill: by the softwood made, adds in micropill pellet processing machine, and by extruding rotating speed 80rpm, round as a ball rotating speed 500rpm, round as a ball time 15min makes micropill, crosses 22 mesh sieves, for subsequent use after drying.
5. dressing: get Opadry 200 stomach dissolution type dressing material 53kg, be configured to the coating solution of 20%; Stir 45 minutes, cross 80 mesh sieves; Dressing is sprayed, coating solution flow velocity 1.5ml/min, EAT 55-60 DEG C, spray gun atomizing pressure 0.2-0.3bar, blower fan air blast 30 ~ 35Hz, the micropill dry for standby after dressing at the bottom of fluid bed.
6. capsule charge.
In above-mentioned each scheme, red ginseng can replace with ginseng.
Advantage of the present invention is: 1, red ginseng (ginseng) micropill adopts Ultramicro-powder to add extract powder mixing granulation, and in Ultramicro-powder, the dissolution rate of general ginsenoside constituents is apparently higher than common flour.The micropill yield made high (yield refer to and sieve after micropill quality account for the percentage of total amount micropill quality), homogeneity is good, powder fluidity is splendid, capsule filling quantitatively accurately, moisture-proof coating is respond well.2, result shows by experiment, and when improving carrying drug ratio, the viscosity increase of micropill forms two ball, dumbbell shaped; Separately with Ultramicro-powder or extract powder pill, carrying drug ratio is all low than mixed powder; Extract powder viscosity is comparatively large, adhere to extrude bar and bucket wall more than other experimental group, therefore yield is low relative to other experimental group; Comprehensive micropill outward appearance, carrying drug ratio, yield three indexs, the mixed powder selecting red ginseng extract powder and red ginseng Ultramicro-powder is major ingredient, improves carrying drug ratio.3, determine reasonable process parameter, ensure that micropill yield.Preferably extrude rotating speed 80rpm, round as a ball rotating speed 500rpm, round as a ball time 15min.
Below in conjunction with accompanying drawing, embodiments of the present invention are described in further detail.
Accompanying drawing explanation
Fig. 1 is coating of pellets moisture absorption weightening finish figure.
Detailed description of the invention
Embodiment 1
Red ginseng Ultramicro-powder 8 parts, red ginseng dry extract 12 parts, microcrystalline cellulose 16.5 parts, superfine silica gel powder 0.73 part, PVPP 0.73 part.
Embodiment 2
Red ginseng microsphere and its preparation (1,000,000 capsules)
1. Ultramicro-powder: it is for subsequent use that the red ginseng 75kg that is up to the standards of learning from else's experience is ground into Ultramicro-powder (300 order).
2. extract powder: learn from else's experience the red ginseng 270kg be up to the standards, add 15 times of water gagings, extract 3 times, each 60min, merge extract, extract vacuum decompression (-0.08MPa) is concentrated into relative density 1.25-1.28(70 DEG C) concentrated extract, concentrated extract is spray dried to extract powder and separately purchases use.
3. softwood: get red ginseng Ultramicro-powder 75kg, red ginseng extract powder 112.5kg, microcrystalline cellulose 155kg, superfine silica gel powder 6.8 kg, PVPP 6.8 kg join in three-dimensional motion mixer, mix and pour out for subsequent use in 25 minutes.Get volume fraction be 70% ethanolic solution and mixed powder be placed in flat mixer respectively 9 times in the ratio average mark of 1:1, mix 30 minutes, make softwood.
4. pill: by the softwood made, adds in micropill pellet processing machine, and by extruding rotating speed 80rpm, round as a ball rotating speed 500rpm, round as a ball time 15min makes micropill, crosses 22 mesh sieves, for subsequent use after drying.
5. dressing: get Opadry 200 stomach dissolution type dressing material 53kg, be configured to the coating solution of 20%.Stir 45 minutes, cross 80 mesh sieves.Dressing is sprayed, coating solution flow velocity 1.5ml/min, EAT 55-60 DEG C, spray gun atomizing pressure 0.2-0.3bar, blower fan air blast 30 ~ 35Hz, the micropill dry for standby after dressing at the bottom of fluid bed.
6. capsule charge: the micropill of dressing is placed in capsule filler, uses 1# Capsules, and loading amount is the filling of 0.48g/ grain.
experimental example
1 red ginseng common flour and red ginseng Ultramicro-powder general ginsenoside stripping comparative analysis
Experimental raw: red ginseng common flour (60 order), red ginseng Ultramicro-powder (300 order)
Total saponin content in 1.1 determined by ultraviolet spectrophotometry red ginsengs
1.1.1 the preparation of reference substance solution
Accurately weighed ginsenoside Re's reference substance 10mg, puts in 10ml measuring bottle, adds methyl alcohol and makes dissolving in right amount and be diluted to scale, shake up, to obtain final product.
1.1.2 the preparation of need testing solution
Take red ginseng Ultramicro-powder and each 1g of common flour respectively, accurately weighed, wrap with neutral filter paper, put in conical flask, add 10 times of water gagings, ultrasonic 250W, extract 3 times, each 20min, merge extract, for subsequent use.Extract adds water to 30-40ml, puts in separatory funnel and extracts with water saturated n-butanol 30ml, totally 4 times.Get upper liquid evaporate to dryness, after adding methyl alcohol dissolving, be transferred in 10ml measuring bottle, with methanol dilution to scale, shake up, to obtain final product.
1.1.3 the making of calibration curve
Accurate absorption ginsenoside Re reference substance 10 μ l, 20 μ l, 30 μ l, 40 μ l, 60 μ l, 80 μ l, 100 μ l put in ground test tube with ground stopper, and water-bath volatilizes methyl alcohol (bath temperature is no more than 90 DEG C).Method of testing: add 8% vanillic aldehyde absolute ethyl alcohol test solution 0.5mL respectively, 72% sulfuric acid test solution 5mL, after shake well mixing, puts in 60 DEG C of waters bath with thermostatic control and heats 10min, cool 10min immediately, shake up with frozen water.Do with reagent blank, measure trap according to AAS respectively in 544nm wavelength place, draw concentration absorption curve, regression equation: Y=0.00542X-0.00903, coefficient R=0.9998.
1.1.4 the assay of total saposins in sample
Get red ginseng medicinal material Ultramicro-powder and each 3 parts of common flour, accurately weighed, by need testing solution, preparation method makes sample respectively, measures in accordance with the law.Result shows, red ginseng Ultramicro-powder is after water extraction is got, and total saponin content comparatively common flour exceeds 10.93%,
Common flour and Ultramicro-powder Aqueous extracts total saponin content measurement result (n=3)
| Test sample | Total saponin content (%) |
| Common flour Aqueous extracts | 3.176 |
| Ultramicro-powder Aqueous extracts | 3.523 |
Conclusion: experimental result shows, in Ultramicro-powder, the dissolution rate of general ginsenoside constituents is apparently higher than common flour.So our selection with red ginseng Ultramicro-powder as the raw material producing micropill.
the technical study of 2 micropill prescriptions and optimization
The research of 2.1 formulation factors
2.1.1 the selection of main ingredient states of matter
The states of matter form of main ingredient is Ultramicro-powder and extract powder, and auxiliary material is microcrystalline cellulose (MCC).In the outward appearance of micropill (roundness), yield, carrying drug ratio (with total Ginsenosides Content) for inspection target.
2.1.1.1 Ultramicro-powder pill
Table 1 Ultramicro-powder experiment exam
2.1.1.2 extract powder pill
Table 2 extract powder experiment exam
2.1.1.3 extract powder adds Ultramicro-powder pill
Table 3 extract powder: Ultramicro-powder (1:1) experiment exam
Table 4 extract powder: Ultramicro-powder (3:2) experiment exam
Table 5 extract powder: Ultramicro-powder (2:3) experiment exam
Conclusion: experimental result shows, when improving carrying drug ratio, the viscosity increase of micropill forms two ball, dumbbell shaped; Separately with Ultramicro-powder or extract powder pill, carrying drug ratio is all low than mixed powder; Extract powder viscosity is comparatively large, adhere to extrude bar and bucket wall more than other experimental group, therefore yield is low relative to other experimental group; Comprehensive micropill outward appearance, carrying drug ratio, yield three indexs, the mixed powder (3:2) selecting extract powder and Ultramicro-powder is main ingredient.
2.1.2 the selection of wet adhesive
The selection of wetting agent kind is relevant with the viscosity of material and drugloading rate according to the literature, extract powder viscosity is relatively large, although material is more dry but mutually bond after adding a small amount of water, namely agglomerating when mediating after the water content that material reaches higher, not faling apart of bullet, therefore should select ethanolic solution as wet adhesive.The ethanolic solution that volume fraction is 70% is have selected through many experiments.
MCC+ medicinal powder 50g feeds intake, select the ethanolic solution 50% of different proportion, 60%, 70%, 80%, 90%(v/v) 50g respectively, obtained softwood, 100rpm speed is extruded, and 500rpm speed is round as a ball, 10min.
| Concentration of alcohol | 50% | 60% | 70% | 80% | 90% |
| Micropill state | Balling-up is larger | Well shaping | Well shaping | Well shaping | Powder is more |
Because the addition of wetting agent is also by the impact of laboratory temperature, humidity, historical facts or anecdotes border addition is just according to the proterties of softwood, the appearance character of extrudate and micro-judgment.Experiment shows that the mixed powder ratio of wet adhesive consumption and main ingredient auxiliary material is when 1:1, and the micropill roundness made is good, and smooth surface is homogeneous.
MCC+ medicinal powder 50g feeds intake, and select 70% ethanol 40g, 50g, 60g to obtain softwood, 100rpm speed is extruded, and 500rpm speed is round as a ball, 10min.
| Binder dosage/g | 40 | 50 | 60 |
| Micropill state | A lot of dumbbell shaped | Well shaping | Balling-up is larger |
2.1.3 the selection of pill making craft
By repeatedly trial test, determine that 3 principal elements affecting extrusion spheronization technique are respectively: extruded velocity (A), round as a ball rotating speed (B) and round as a ball time (C).Select L
9(3
4) orthogonal arrage, with yield, critical angle, angle of repose for evaluation index, the process conditions of micropill are optimized.
orthogonal test factor level table
orthogonal test table
Micropill yield scoring (X)=yield/yield maximum
Plane critical angle scoring (Y)=critical angle minimum of a value/critical angle
Scoring minimum of a value/angle of repose, (Z)=angle of repose, angle of repose
Comprehensive grading (Q)=2X+Y+Z
In evaluation index, the importance at the important ratio critical angle of micropill yield and angle of repose is large, and from actual analysis, micropill yield weight is 2, and critical angle weight is 1, and the weight at angle of repose is 1, calculates comprehensive grading with this.
analysis of variance table
| Soruces of variation | Sum of square of deviations | The free degree | F ratio | Conspicuousness |
| A | 0.085 | 2 | 7.727 | |
| B | 0.279 | 2 | 25.364 | ** |
| C | 0.202 | 2 | 18.364 | * |
| Error | 0.01 | 2 |
F0.01(2，2)=99.00；F0.05(2，2)=19.00；F0.1(2，2)=9.00
In orthogonal table directly perceived, range analysis shows, with the comprehensive grading at micropill yield, plane critical angle, angle of repose for inspection target, affects red ginseng micropill and becomes the factor order of ball technique to be B>C> A.Variance analysis shows that round as a ball rotating speed (B) becomes ball to have the greatest impact to micropill, and significant difference (P<0.05), has statistical significance; The round as a ball time, (C) became ball to have certain influence to micropill, the significance of difference general (0.05<P<0.1); Extruding rotating speed (A) becomes ball impact less, without significant difference on micropill.Show that extraction conditions is: A according to quadrature analysis
1b
2c
2, namely extrude rotating speed 80rpm, round as a ball rotating speed 500rpm, round as a ball time 15min.
3 sucting wet stabilities are investigated
Investigate the coating weight gain of 5%, 10%, 15%, 20% respectively, investigate 75 humidity 10 days, the moisture absorption Gain weight (see figure 1) of different coating weight gain micropill.Conclusion is: when coating weight gain 15% and 20%, sucting wet stability is good, and both othernesses are little, considers production cost, selected 15%.
Claims (10)
1. a red ginseng micropill, is characterized in that its effective medicinal components is mixed by red ginseng Ultramicro-powder and red ginseng extract powder.
2., according to red ginseng micropill according to claim 1, it is characterized in that being made up of the bulk drug of following weight ratio: red ginseng Ultramicro-powder: red ginseng extract powder=2:3.
3. according to the red ginseng micropill described in claim 1 or 2, it is characterized in that the acceptable auxiliary material of pharmaceutically different dosage form adding parts by weight is made: red ginseng Ultramicro-powder 6-10 part, red ginseng dry extract 12-15 part, microcrystalline cellulose 15-20 part, superfine silica gel powder 0.5-1.0 part, PVPP 0.5-1.0 part.
4. according to red ginseng micropill according to claim 3, it is characterized in that the acceptable auxiliary material of pharmaceutically different dosage form adding parts by weight is made: red ginseng Ultramicro-powder 8 parts, red ginseng dry extract 12 parts, microcrystalline cellulose 16.5 parts, superfine silica gel powder 0.73 part, PVPP 0.73 part.
5. a red ginseng microsphere and its preparation as claimed in claim 4, is characterized in that step is as follows:
1. Ultramicro-powder: it is for subsequent use that the red ginseng powder that is up to the standards of learning from else's experience is broken into Ultramicro-powder 300 order;
2. extract powder: the red ginseng be up to the standards of learning from else's experience, adds 15 times of water gagings, extracts 3 times, each 60min, merge extract, extract vacuum decompression-0.08MPa is concentrated into relative density 1.25-1.28,70 DEG C, concentrated extract, concentrated extract is spray dried to extract powder and separately purchases use;
3. softwood: get red ginseng Ultramicro-powder, red ginseng extract powder, microcrystalline cellulose, superfine silica gel powder, PVPP join in mixer, mix and pour out for subsequent use in 25 minutes; Get volume fraction be 70% ethanolic solution and mixed powder be placed in flat mixer respectively 9 times in the ratio average mark of 1:1, mix 30 minutes, make softwood;
4. pill: by the softwood made, adds in micropill pellet processing machine, by extruding rotating speed 80rpm, and round as a ball rotating speed 500rpm, round as a ball time 15min makes micropill, crosses 22 mesh sieves, for subsequent use after drying;
5. dressing: get Opadry 200 stomach dissolution type dressing material, be configured to the coating solution of 20%; Stir 45 minutes, cross 80 mesh sieves; Dressing is sprayed, coating solution flow velocity 1.5ml/min, EAT 55-60 DEG C, spray gun atomizing pressure 0.2-0.3bar, blower fan air blast 30 ~ 35Hz, the micropill dry for standby after dressing at the bottom of fluid bed;
6. capsule charge.
6., according to red ginseng microsphere and its preparation according to claim 5, it is characterized in that step is as follows:
1. Ultramicro-powder: it is for subsequent use that the red ginseng 75kg that is up to the standards of learning from else's experience is ground into Ultramicro-powder 300 order;
2. extract powder: learn from else's experience the red ginseng 270kg be up to the standards, and adds 15 times of water gagings, extracts 3 times, each 60min, merge extract, extract vacuum decompression-0.08MPa is concentrated into relative density 1.25-1.28,70 DEG C, concentrated extract, concentrated extract is spray dried to extract powder and separately purchases use;
3. softwood: get red ginseng Ultramicro-powder 75kg, red ginseng extract powder 112.5kg, microcrystalline cellulose 155kg, superfine silica gel powder 6.8 kg, PVPP 6.8 kg join in mixer, mix and pour out for subsequent use in 25 minutes; Get volume fraction be 70% ethanolic solution and mixed powder be placed in flat mixer respectively 9 times in the ratio average mark of 1:1, mix 30 minutes, make softwood;
4. pill: by the softwood made, adds in micropill pellet processing machine, by extruding rotating speed 80rpm, and round as a ball rotating speed 500rpm, round as a ball time 15min makes micropill, crosses 22 mesh sieves, for subsequent use after drying;
5. dressing: get Opadry 200 stomach dissolution type dressing material 53kg, be configured to the coating solution of 20%; Stir 45 minutes, cross 80 mesh sieves; Dressing is sprayed, coating solution flow velocity 1.5ml/min, EAT 55-60 DEG C, spray gun atomizing pressure 0.2-0.3bar, blower fan air blast 30 ~ 35Hz, the micropill dry for standby after dressing at the bottom of fluid bed;
6. capsule charge.
7. a ginseng micropill, it is characterized in that the acceptable auxiliary material of pharmaceutically different dosage form adding parts by weight is made: ginseng submicron powder 6-10 part, ginseng dry extract 12-15 part, microcrystalline cellulose 15-20 part, superfine silica gel powder 0.5-1.0 part, PVPP 0.5-1.0 part.
8. according to ginseng micropill according to claim 7, it is characterized in that the acceptable auxiliary material of pharmaceutically different dosage form adding parts by weight is made: ginseng submicron powder 8 parts, ginseng dry extract 12 parts, microcrystalline cellulose 16.5 parts, superfine silica gel powder 0.73 part, PVPP 0.73 part.
9. a ginseng microsphere and its preparation as claimed in claim 7 or 8, is characterized in that step is as follows:
1. Ultramicro-powder: it is for subsequent use that the ginseng pulverate that is up to the standards of learning from else's experience is broken into Ultramicro-powder 300 order;
2. extract powder: the ginseng be up to the standards of learning from else's experience, adds 15 times of water gagings, extracts 3 times, each 60min, merge extract, extract vacuum decompression-0.08MPa is concentrated into relative density 1.25-1.28,70 DEG C, concentrated extract, concentrated extract is spray dried to extract powder and separately purchases use;
3. softwood: get ginseng submicron powder, Radix Ginseng extractum's powder, microcrystalline cellulose, superfine silica gel powder, PVPP join in mixer, mix and pour out for subsequent use in 25 minutes; Get volume fraction be 70% ethanolic solution and mixed powder be placed in flat mixer respectively 9 times in the ratio average mark of 1:1, mix 30 minutes, make softwood;
4. pill: by the softwood made, adds in micropill pellet processing machine, by extruding rotating speed 80rpm, and round as a ball rotating speed 500rpm, round as a ball time 15min makes micropill, crosses 22 mesh sieves, for subsequent use after drying;
5. dressing: get Opadry 200 stomach dissolution type dressing material, be configured to the coating solution of 20%; Stir 45 minutes, cross 80 mesh sieves; Dressing is sprayed, coating solution flow velocity 1.5ml/min, EAT 55-60 DEG C, spray gun atomizing pressure 0.2-0.3bar, blower fan air blast 30 ~ 35Hz, the micropill dry for standby after dressing at the bottom of fluid bed;
6. capsule charge.
10., according to ginseng microsphere and its preparation according to claim 9, it is characterized in that step is as follows:
1. Ultramicro-powder: it is for subsequent use that the ginseng 75kg that is up to the standards of learning from else's experience is ground into Ultramicro-powder 300 order;
2. extract powder: learn from else's experience the ginseng 270kg be up to the standards, and adds 15 times of water gagings, extracts 3 times, each 60min, merge extract, extract vacuum decompression-0.08MPa is concentrated into relative density 1.25-1.28,70 DEG C, concentrated extract, concentrated extract is spray dried to extract powder and separately purchases use;
3. softwood: get ginseng submicron powder 75kg, Radix Ginseng extractum's powder 112.5kg, microcrystalline cellulose 155kg, superfine silica gel powder 6.8 kg, PVPP 6.8 kg join in mixer, mix and pour out for subsequent use in 25 minutes; Get volume fraction be 70% ethanolic solution and mixed powder be placed in flat mixer respectively 9 times in the ratio average mark of 1:1, mix 30 minutes, make softwood;
4. pill: by the softwood made, adds in micropill pellet processing machine, by extruding rotating speed 80rpm, and round as a ball rotating speed 500rpm, round as a ball time 15min makes micropill, crosses 22 mesh sieves, for subsequent use after drying;
5. dressing: get Opadry 200 stomach dissolution type dressing material 53kg, be configured to the coating solution of 20%; Stir 45 minutes, cross 80 mesh sieves; Dressing is sprayed, coating solution flow velocity 1.5ml/min, EAT 55-60 DEG C, spray gun atomizing pressure 0.2-0.3bar, blower fan air blast 30 ~ 35Hz, the micropill dry for standby after dressing at the bottom of fluid bed;
6. capsule charge.
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