CN1544042A - Liuwei Dihuang dripping pills and its preparation - Google Patents
Liuwei Dihuang dripping pills and its preparation Download PDFInfo
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- CN1544042A CN1544042A CNA2003101133479A CN200310113347A CN1544042A CN 1544042 A CN1544042 A CN 1544042A CN A2003101133479 A CNA2003101133479 A CN A2003101133479A CN 200310113347 A CN200310113347 A CN 200310113347A CN 1544042 A CN1544042 A CN 1544042A
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- 229940079593 drug Drugs 0.000 claims abstract description 36
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- 239000000843 powder Substances 0.000 claims abstract description 28
- 238000000034 method Methods 0.000 claims abstract description 16
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 13
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Abstract
The invention relates to Bolus of Six Drugs and the process for preparation, wherein the bolus has the advantages of high biological availability, quick-speed medicine release, fast effective rate, less toxic and side effects, and easiness in use and carrying. The preparation process includes using the Bolus of Six Drugs as the basis, preparing thick grease or dried powder by means of specific extraction technology, charging base material such as polyethylene glycol as surface active agent, mixing evenly heating the mixture to fusion, stirring homogeneously, placing into special-purpose drop pill machine,dropping into condensation agent.
Description
[technical field] the present invention relates to prevent and treat damage of kidney-YIN, dizziness and tinnitus, soreness of the waist and knees, osteopyrexia and fever, night sweat seminal emission, the person of quenching one's thirst, a kind of medicine of diseases such as nephrotic syndrome, diabetes, hypertension, climacteric syndrome, chronic kidney hypofunction and preparation method thereof.
[background technology] LIUWEI DIHUANG WAN is that the shenqi pill of Song Qian Yicong " Medical Treasures of the Golden Chamber " deducts that osmanthus is attached to form.By Radix Rehmanniae Preparata, Fructus Corni, dried Rhizoma Dioscoreae, Rhizoma Alismatis, Cortex Moutan, Poria is formed.In order to control the timid all cards of kidney.We are for the basis side of nourishing YIN now, and from then on the prescription of a lot of nourishing kidney yins all just added and simplified sanction and form later age.Clinical use we have a dizzy spell with waist soreness, feverish sensation in the palms and soles, and the few tongue of red tongue, deep pulse is counted accurately and is its foundation.Reuse the sweet little bitter tepor of Radix Rehmanniae Preparata in the side, the nourishing kidney replenishing essence is a monarch drug; Rhizoma Dioscoreae is sweet flat, spleen reinforcing nourishing the stomach, lung benefiting yin nourishing and controlling nocturnal emission with astringent drugs; The sour and astringent tepor of Fructus Corni, nourishing the liver and kidney and arresting seminal emission, two medicines are minister, play nourishing kidney-yin altogether with monarch drug, nourishing the liver blood, strengthening the spleen the moon and arresting seminal emission.Because deficiency of kidney-YIN often causes hyperactivity of deficient fire, do not fall and kidney is turbid, so it is sweet light cold to be equipped with Rhizoma Alismatis, let out the kidney turbid damp; Poria is sweet light flat, and it is wet to ooze spleen; Cortex Moutan is arduous cool, let out liver-fire clearly, is combined into adjuvant, in case the product of nourishing produce stagnant fraud of being bored with.First three flavor medicine is " benefit ", and three benefits are effected a permanent cure; Back three flavor medicines are " rushing down ", and three rush down and take stopgap measures.The reinforcing and reducing combination is based on benefit.Again from the side " benefit ", " rushing down " with amount of medicament, the consumption of " three mend " is greater than the work amount of " three rush down ", this illustrates that also we are based on nourishing.
We combine with the tonifying liver spleen with tonifying kidney-yin on compatibility of drugs, and based on tonifying kidney-yin.The kidney being the origin of congenital constitution, kidney storing essence, blood stored in the liver, the Liver and kidney part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels of living together, essence and blood sharing the same origin is so there be saying of " The liver and the kidney have a common source ", modern deficiency of kidney yin, should focus on kidney in the treatment, but the Liver and kidney relation is very close, deficiency of kidney-essence, relevant with deficiency of liver-blood, use the Radix Rehmanniae Preparata tonifying kidney-yin in the event side, use Fructus Corni nourishing the liver blood again, hemapodium can be converted into essence.The spleen being the foundation of acquired constitution, the spleen transporting and transforming nutrients from foodstuff is precise and tiny in to support the five internal organs, so use the Rhizoma Dioscoreae tonifying speen and tonifying kidney, makes kidney essense that the source is arranged like this.As seen, deficiency of kidney yin wants on the one hand the moon of the kidney invigorating smart, wants the nourishing the liver strengthening the spleen on the one hand, and make kidney essense have additional and originate, though kidney liver spleen three Yintu(K19)s benefit, both tonifying kidney-yins, tonifying liver spleen again is based on tonifying kidney-yin.So, this tonifying kidney-yin side of LIUWEI DIHUANG WAN, with three flavors " tonic ", three flavors " cathartic ", one mends one rushes down, and dirty at kidney,liver,spleen three respectively, invigorating middle warmer has rushes down, and residence rushes down in benefit, complements each other.Three mend and to effect a permanent cure, and three rush down and take stopgap measures, giving consideration to both the incidental and fundamental, and three mend the moon at kidney liver spleen, tonifying for deficiency syndrome, three rush down at standard card reducing for the excess syndrome, YIN-tonifying drug and eliminating dampness and diuresis medicine compatibility are to stagnate the metabolism of kidney governing water metabolism for wet heap soil or fertilizer over and around the roots of anti-sealing like this, mainly be gasification by kidney, the effect of ascending the clear and descending the turbid, simple nourishing, must not fall by anti-muddy water, if muddy water does not fall, then true water does not rise, the lifting imbalance, then the dysfunction of kidney does not reach the purpose of the kidney invigorating equally.Therefore, in nourishing kidney yin, answer a small amount of eliminating dampness and diuresis medicine of compatibility, use the Rhizoma Alismatis regulating fluid apssage, Poria is light to ooze spleen wet (Rhizoma Dioscoreae also helps spleen fortune), and the result of compatibility makes taste tonify without causing stagnation heresy like this, falls to let out and just do not hinder, to reach the purpose of tonify deficiency.Both considered, started with from pathological change again, kidney-reinforcing drug is played one's part to the full from physiology.
According to considerable bibliographical information in recent years, LIUWEI DIHUANG WAN has been found many new purposes clinically again, makes the application of this Chinese medicine that great expansion leeway arranged.
The new example of listed application in the people's such as Li Rui that " Beijing University of Chinese Medicine's journal " published the research paper just relates to nephritis, nephrotic syndrome, diabetes, infertility, chloasma, hypertension, climacteric syndrome, quenches one's thirst, nearly 16 kinds of commonly encountered diseases, frequently-occurring disease such as albuminuria, infertility, aphtha, chronic kidney hypofunction, lupus erythematosus, dizzy, apoplexy, coronary heart disease.
People's such as Lv Ruixia the article introduction of " packet header medical college journal " publication, LIUWEI DIHUANG WAN be in diseases such as treatment orthopaedics, ophthalmology, pneumosilicosis, and aspects such as anti-curing oncoma, the short stature of treatment have all obtained extensive use, and obtained good effect.
" Shandong journal of Chinese medicine " May calendar year 2001 the 20th, application and the effect of LIUWEI DIHUANG WAN in multiple inside and outside, gynaecopathia such as treatment chronic esophagitis, epilepsy, schizophrenia, advanced lung cancer, hyperosteogeny arthritis, cervical vertebra syndrome, infertility, polycystic ovary syndrome, dermatosis also introduced in people's such as volume the 5th phase Qu Jun research article.
Many articles have also carried out deep analysis and research to its pharmacology and pharmacodynamics, see " China Dispensary " 2003 the 14th the 5th phases of volume for details, people's such as Shen Liehang article " pharmacodynamics of LIUWEI DIHUANG WAN and clinical application research progress " and the 22nd the 8th phase of volume of " medical science Leader " August in 2003, the research article of Wang Gaosheng " the pharmaceutical research progress of LIUWEI DIHUANG WAN (soup) ".
The multiple dosage form of the six drugs containing rehmanniae that utilizes prior art to obtain (as: honeyed pill, the watered pill, concentrated pill, tablet, hard capsule, soft capsule, oral liquid, soft extract, electuary), owing to reasons such as technologies of preparing, exist that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, bioavailability is lower and defective such as liver sausage first pass effect; Though advantages such as soft capsule has efficiently, taking convenience, preserve six months after, its softgel shell is difficult to molten loosing in vivo, with domestic technology status, still a masty difficult problem at present.Owing to above reason, affect the performance of the various dosage form drug effects of existing six drugs containing rehmanniae, also directly affect the effect of treatment, so be necessary to seek a kind of novel form that can better be used for modern clinical treatment and family's control.
[summary of the invention] purpose of the present invention is to remedy the deficiencies in the prior art, provides a kind of bioavailability height to extensive patients and medical personnel, release fast, quick produce effects, toxic and side effects is littler, and uses LIUWEI DIHUANG WAN drop pill easy to carry and preparation method thereof.
Can take following method to obtain LIUWEI DIHUANG WAN drop pill involved in the present invention.
[prescription]
Radix Rehmanniae Preparata 120g Fructus Corni (system) 60g Cortex Moutan 45g
Rhizoma Dioscoreae 60g Poria 45g Rhizoma Alismatis 45g
Substrate (Polyethylene Glycol
1500～10000, in the material such as stearic acid, sodium stearate, glycerin gelatine, glyceryl monostearate, Lac, polyoxyethylene monostearate, polyethers, carboxymethyl starch sodium any one or a few mix mutually).
The raw material powder that extracts and be prepared from and the proportioning of substrate are 1: 1～8;
[preparation method]
The extraction of first step raw material and preparation:
1. the Cortex Moutan steam distillation extracts volatile oil, and the aqueous solution after distillation device is in addition collected, and is standby.
2. Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Rhizoma Alismatis decoct with water more than 1 time, merge decoction liquor, filter.Filtrate and above-mentioned Cortex Moutan aqueous solution merge, and the solution after the merging is put on the supercentrifuge centrifugal more than 10 minutes, get supernatant and carry out ultrafiltration, collect the ultrafiltrate part, and be standby.
3. 3 times of Fructus Corni are more than the amount, and concentration was higher than 50% soak with ethanol after 30 minutes, and reflux, extract, is more than 1 time, and merge extractive liquid, filters.Filtrate decompression is concentrated into does not have the alcohol flavor, standby.
4. after Poria added water boil, warm macerating 1 merged leachate then to for several times in the water-bath more than 50 ℃, filtered filtrate for later use.
5. above gained solution is merged, concentrating under reduced pressure becomes thick paste under 50～100 ℃ temperature conditions, and drying under reduced pressure is ground into fine powder, with above gained paeonol crystallized mixed, obtains making the thick paste or the dry powder of LIUWEIDIHUANG DIWAN.
Annotate: also can be according to the method for making of six drugs containing rehmanniae soft capsule (National Drug Administration-national drug standards WS3-102 (Z-30)-97 (Z)) and six drugs containing rehmanniae oral liquid (National Drug Administration-national drug standards WS3-B-3774-98), thick paste that is prepared into or dry powder.
Thick paste or dry powder that second step made through the first step, the ratio with 1: 1～8 is mixed with matrix phase as adjuvant; Substrate can be Polyethylene Glycol
1500～20000, in the substrate such as stearic acid, sodium stearate, glycerin gelatine, glyceryl monostearate, Lac, polyoxyethylene monostearate, polyethers, carboxymethyl starch sodium any one or a few mix mutually.
The 3rd step was adopted water-bath, oil bath or other mode of heating, and mixed material is heated to fusion, stirred;
The 4th step was inserted special-purpose homemade drop pill machine, and keeping temperature is 70～100 ℃.
The 5th step was selected sizeable drip nozzle, with suitable speed, splashed in 40 →-15 ℃ the condensing agent; Condensing agent can be any one or a few in liquid paraffin, methyl-silicone oil, the vegetable oil.
The 6th step type to be shrunk to takes out, and removes the surface condensation agent, drying, and packing, promptly.
[beneficial effect] LIUWEI DIHUANG WAN (soup) is the name side of enriching yin and nourishing kidney, comes across Song's money second key to Therapeutics of Children's Diseases the earliest, is made up of Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Rhizoma Alismatis, Poria, Fructus Corni, Cortex Moutan Six-element.With controlling the timid all cards of kidney, clinical use we cure mainly the kidney yin deficient syndrome with functions of nourishing yin and invigorating kidney, waist soreness is had a dizzy spell, Hiccough and deaf, night sweat, seminal emission is quenched one's thirst, osteopyrexia and fever, feverish sensation in the palms and soles, dryness of the tongue pharyngalgia, tooth shakes, and talipes calcaneus is had a pain, dribbling urination, and non-closure of fontanels jin infants, the few tongue of red tongue, deep pulse is counted accurately.Reuse Radix Rehmanniae Preparata in the side, enriching yin and nourishing kidney, life essence-filling, marrow-benefitting is monarch drug; Rhizoma Dioscoreae spleen reinforcing nourishing the stomach, lung benefiting yin nourishing and controlling nocturnal emission with astringent drugs; Fructus Corni nourishing the liver and kidney and arresting seminal emission, two medicines are minister, play nourishing kidney-yin altogether with monarch drug, nourishing the liver blood, strengthening the spleen the moon and arresting seminal emission.Because deficiency of kidney-YIN often causes hyperactivity of deficient fire, does not fall and kidney is turbid, so be equipped with Rhizoma Alismatis, lets out the kidney turbid damp; It is wet that Poria oozes spleen; Cortex Moutan is let out liver-fire clearly, is combined into adjuvant, in case the product of nourishing produce the greasy fraud that stagnates.Simultaneously LIUWEI DIHUANG WAN not only the dirty deficiency of the kidney yin of amended copy be main, and with respect to the moon of tonifying liver spleen, also with respect to the fortune function of taste, and nourishing and do not have the fraud of loving heresy.Just, the reason of its tight system side is arranged, so Qian Yiyong controls the disease that children's suffers from a deficiency of the kidney because of LIUWEI DIHUANG WAN.Then physicians from a family for generations family under the inspiration of Qian Shi, has further expanded the clinical application of LIUWEI DIHUANG WAN, and its basis side as tonifying kidney-yin, and derivation goes out the effective famous prescription of many treatment deficiency of the kidney yin.Clinical practice in recent years shows that LIUWEI DIHUANG WAN (soup) serves many purposes, and is used widely at numerous areas.
Utilize the preparation of the six drugs containing rehmanniae that prior art obtains,, be not enough to satisfy fully the needs of clinical treatment because the influence of factors such as the characteristics of dosage form itself and preparation technology also exists some defectives in actual use.Exist after taking as tablet or capsule that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, problem such as liver sausage first pass effect and bioavailability are lower, although soft capsule has high bioavailability and advantage such as easy to use, but less stable, after the Long-term Storage, its softgel shell can not moltenly loose, thereby not only influence the performance of drug effect, also influenced therapeutic effect.
LIUWEIDIHUANG DIWAN involved in the present invention; utilize substrate such as surfactant polyethylene, polyoxyethylene monostearate, polyethers and the six drugs containing rehmanniae crude drug that obtains by specific prepared to make solid dispersion; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases; and substrate is hydrophilic; medicine is had wetting action, can make that medicine is rapidly molten to loose into microgranule or solution, thereby make the dissolving of medicine and absorb and accelerate.Thereby improved bioavailability, brought into play efficient, quick-acting effects etc.
Compare with tablet, capsular administering mode, exist essential distinction.Drop pill with the solid dispersion technology preparation can adopt oral and sublingual administration, and effective ingredient is fully contacted with mucomembranous surface, absorbs by mucomembranous epithelial cell, directly enters blood circulation.Especially sublingual administration administration can directly enter blood circulation without gastrointestinal tract and liver, has avoided first pass effect effectively, thereby it is rapid to have an onset, bioavailability height, characteristics such as side effect is little, and medication is convenient.
1. compare with other oral formulations, this preparation not only can be oral, but sublingual administration still, this just overcome the tablet onset slowly, shortcoming such as low, the gastrointestinal irritation of liver sausage first pass effect, bioavailability.
2. this dropping pill formulation volume is little, in light weight, more is applicable to and carries.After containing entrance cavity, contact promptly with saliva and to dissolve rapidly, and absorb by oral mucosa, not only rapid-action, and the influence of not taken food, promptly all can containing take after meal ante cibum.
3. the contained drug dose of each drop pill of this preparation is accurate, and the patient who is suitable for various disease, the different state of an illness, all ages and classes more flexibly and accurately grasps dosage.
4. the production process equipment for preparing this preparation-drop pill is simple, easy to operate; Operation is few, with short production cycle, automaticity is high, labor intensity is low, production efficiency is high; Workshop does not have dust, helps labor protection and environmental protection; The preparation drop pill need adopt high-tech means and equipment, and principal agent is uniformly dispersed in substrate, and dosage is accurate, and the ball method of double differences is different little than tablet; Production cost is lower than with below 50% of kind tablet.
5. this preparation is by after the heating of solid drugs and substrate, being melt into liquid state, splashes into to make in the not miscible condensed fluid.Therefore, the stability of drug height, not facile hydrolysis, oxidation, and the operation be under liquid state, to carry out, no dust pollution is not subject to the influence of crystal formation, thereby has guaranteed the quality of medicine, has increased stability.
In sum, make this preparation have two advantages of imitating (quick-acting, efficient), three little (taking dose is little, toxicity is little, side effect little), five convenience (convenient for production, store convenience, convenient transportation, easy to carry, easy to use).
The preparation technology of the LIUWEIDIHUANG DIWAN that [specific embodiment] is involved in the present invention, the example of a specific embodiment is as follows:
The extraction of first step raw material and preparation
1. the Cortex Moutan steam distillation extracts volatile oil, and the aqueous solution after distillation device is in addition collected, and is standby.
2. Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Rhizoma Alismatis decoct with water 2 times, merge decoction liquor twice, filter.Filtrate and above-mentioned Cortex Moutan aqueous solution merge, and the solution after the merging was put on the supercentrifuge centrifugal 20 minutes, got supernatant and carried out ultrafiltration, collected the ultrafiltrate part, and is standby.
3. Fructus Evodiae is measured 70% soak with ethanol after 30 minutes for 6 times, reflux, extract, 2 times, and merge extractive liquid, filters.Filtrate decompression is concentrated into does not have the alcohol flavor, standby.
4. after Poria added the decocting in water expense, warm macerating was 2 times in 80 ℃ of water-baths, merges leachate, filters filtrate for later use.
5. above gained solution is merged, be evaporated to thick paste in 80 ℃, drying under reduced pressure is ground into fine powder, with above gained paeonol crystallized mixed, obtains making the dry powder of LIUWEIDIHUANG DIWAN.
Second goes on foot the ratio according to 1: 3, promptly gets 1 part of dry powder, mixes with 3 parts of matrix phases; Substrate is selected Polyethylene Glycol for use
6000
The 3rd step was adopted Electric heating, and mixed material is heated to fusion, stirred.
The 4th step was inserted special-purpose self-control drop pill machine, and keeping temperature is 85 ± 2 ℃.
The 5th step was selected sizeable drip nozzle, with suitable speed, splashed in 20 →-5 ℃ the methyl-silicone oil.
The 6th step type to be shrunk to takes out, and removes the surface condensation agent, drying, and packing, promptly.
[example]
Example one selects different substrates to carry out the experiment of prescription
Experimental design: carry out the influence of prescription in order to observe the raw material and the different substrates that prepare through special process, respectively with Polyethylene Glycol to product involved in the present invention
6000, substrate such as stearic acid, sodium stearate, glycerin gelatine, glyceryl monostearate, Lac, polyoxyethylene monostearate, polyethers mixes mutually with raw material powder, other is all according to the given condition in [specific embodiment], the dry powder that is about to preparation and gets is even with 1: 3 mixed with selected substrate respectively, adopt electrically heated mode that the supplementary material that each assembly makes is heated to molten condition respectively, adopt homemade special drilling pill machine, regulate its water dropper temperature and make and remain on 85 ± 2 ℃; With the methyl-silicone oil is condensing agent, the refrigeration control system of regulating the drop pill machine makes the temperature of condensing agent remain on 20 →-5 ℃, be prepared respectively according to the given technology in front [specific embodiment] again, can obtain the prescription experiment of 8 raw material powders and different substrates, and obtain 8 groups of different experimental results and see attached list one:
The experiment of example two dry powder powder and the different proportionings of substrate
Experimental design: for the different proportionings of observing the raw material for preparing through special process and substrate influence, selection Polyethylene Glycol to product involved in the present invention
6000As substrate, respectively with 1: 1/1: 2/1: 3/1: 4/1: 5/1: 6/1: 7/1: 8 ratio will prepare and dry powder and selected substrate mix homogeneously, other is all according to condition given in [specific embodiment], promptly adopt electrically heated mode that the supplementary material that mixes is heated to molten condition respectively, adopt homemade special drilling pill machine, regulate its water dropper temperature and make and remain on 85 ± 2 ℃; Select methyl-silicone oil as condensing agent, the refrigeration control system of regulating the drop pill machine makes the temperature of condensing agent remain on 20 →-5 ℃, be prepared respectively according to the given technology in front [specific embodiment] again, can obtain the experiment of 8 different proportionings, and obtain 8 groups of different experimental results and see attached list two:
Select the experiment of different water dropper temperature in example three preparation process
Experimental design: in order to observe of the influence of the different water dropper temperature of selection in the preparation process to product involved in the present invention, adopt homemade special drilling pill machine, regulating its water dropper temperature makes and remains on 70 ± 2 ℃ respectively, 80 ± 2 ℃, 90 ± 2 ℃, 100 ± 2 ℃, all according to the given condition in [optimum implementation], substrate is selected Polyethylene Glycol for use for other
6000Mix mutually with 1: 3 ratio with dry powder, adopt electrically heated mode that the supplementary material that mixes is heated to molten condition, under the designed in front respectively temperature conditions, with the methyl-silicone oil is condensing agent, and the refrigeration control system of regulating the drop pill machine makes the temperature of condensing agent remain on 20 →-5 ℃, is prepared respectively according to the given technology in front [specific embodiment] again, can obtain 4 different experiments, and obtain 4 groups of different experimental datas and see attached list three:
Select the experiment of different condensing agents in example four preparation process
Experimental design: select of the influence of different condensing agents in the preparation process to product involved in the present invention in order to observe, respectively with liquid paraffin, methyl-silicone oil, vegetable oil as condensing agent, all according to the given condition in [optimum implementation], substrate is selected Polyethylene Glycol for use for other
6000, mix mutually with 1: 3 ratio with dry powder, adopt electrically heated mode that the supplementary material that mixes is heated to molten condition, adopt homemade special drilling pill machine, regulate its water dropper temperature and make and remain on 85 ± 2 ℃; The refrigeration control system of regulating the drop pill machine makes the temperature of condensing agent remain on 20 →-5 ℃, is prepared respectively according to the given technology in front [specific embodiment] again, can obtain 3 different experiments; And obtain 3 groups of different experimental datas and see attached list four:
Select the experiment of different condensing agent temperature in example five preparation process
Experimental design: select of the influence of different condensing agent temperature in the preparation process to product involved in the present invention in order to observe, regulate the refrigeration control system of drop pill machine, make the temperature of condensing agent remain on 20 →-5 ℃ respectively, 30 →-10 ℃, 40 →-15 ℃ of (20 ℃ of condensation column upper temps, temperature of lower is-5 ℃), all according to the given condition in [optimum implementation], substrate is selected Polyethylene Glycol for use for other
6000, mix mutually with 1: 3 ratio with dry powder, adopt electrically heated mode that the supplementary material that mixes is heated to molten condition, adopt homemade special drilling pill machine, regulate its water dropper temperature and make and remain on 85 ± 2 ℃; With the methyl-silicone oil is condensing agent, is prepared respectively according to the given technology in front [specific embodiment] again, can obtain 3 different experiments; And obtain 3 groups of different experimental datas and see attached list five:
(annotate: the hardness method for expressing in the subordinate list, adopt drop pill is placed on the glass plate, press...with one's finger it, observe its metamorphosis."+" expression flicking promptly is out of shape, " ++ " expression distortion of firmly pressing, and " +++" expression is indeformable by it.)
Table one raw material dry powder and the mutually blended experiment of different substrates
| The substrate title | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Polyethylene Glycol 6000 | ??25.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| Stearic acid | ??25.0 | ??45 | ??＞30 | ??＞10 | ??+ |
| Sodium stearate | ??25.0 | ??57 | ??＜30 | ??＞10 | ??+ |
| Glycerin gelatine | ??25.0 | ??44 | ??＞30 | ??＞10 | ??+ |
| Glyceryl monostearate | ??25.0 | ??66 | ??＜30 | ??＞10 | ??+ |
| Lac | ??25.0 | ??38 | ??＞30 | ??＞10 | ??- |
| The polyoxyethylene monostearate | ??25.0 | ??88 | ??＜30 | ??＜10 | ??++ |
| Polyethers | ??25.0 | ??67 | ??＜30 | ??＜10 | ??++ |
Result by table two can see: in an embodiment, when selecting different substrate, to the rounding rate, the ball method of double differences is different and index influence such as hardness is bigger, do not wait and dissolve scattered time limit institute is influenced.
The experiment of table two raw material dry powder and the different proportionings of substrate
| Dry powder: substrate | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| ??1∶1 | ??50.0 | ??61 | ??＜30 | ??＞10 | ??+ |
| ??1∶2 | ??33.3 | ??73 | ??＜30 | ??＞10 | ??+ |
| ??1∶3 | ??25.0 | ??93 | ??＜30 | ??＜10 | ??+++ |
| ??1∶4 | ??20.0 | ??92 | ??＜30 | ??＜10 | ??+++ |
| ??1∶5 | ??16.7 | ??95 | ??＜30 | ??＜10 | ??+++ |
| ??1∶6 | ??14.3 | ??96 | ??＜30 | ??＜10 | ??+++ |
| ??1∶7 | ??12.5 | ??90 | ??＜30 | ??＜10 | ??+++ |
| ??1∶8 | ??11.1 | ??91 | ??＜30 | ??＜10 | ??+++ |
Result by table one can see: in an embodiment, when the mixed proportion of raw material and substrate is 1: 3, rounding rate index has reached level preferably, and other index institute is influenced less, occurs when the mixed proportion of having only hardness number to work as raw material and substrate is lower than 1: 3 obviously descending.
Table three is selected the experiment of different water dropper temperature
| The water dropper temperature | Effective ingredient (%) | The rounding rate | Dissolve scattered time limit | The ball method of double differences is different | Hardness |
| ??(70±2)℃ | ??25 | ????50 | ????＜30 | ????＜10 | ??++ |
| ??(80±2)℃ | ??25 | ????81 | ????＜30 | ????＜10 | ??++ |
| ??(90±2)℃ | ??25 | ????90 | ????＜30 | ????＜10 | ??+++ |
| ??(100±2)℃ | ??25 | ????86 | ????＜30 | ????＜10 | ??+++ |
Result by table three can see: bigger to rounding rate and hardness number influence when selecting different water dropper temperature in an embodiment, and dissolve scattered time limit is not had obvious influence.
Table four is selected the experiment of different condensing agents
| Condensing agent | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| Liquid paraffin | ??20 | ??91 | ??＜30 | ??＜10 | ??+++ |
| Methyl-silicone oil | ??20 | ??93 | ??＜30 | ??＜10 | ??+++ |
| Vegetable oil | ??20 | ??86 | ??＜30 | ??＜10 | ??+++ |
Result by table four can see: slightly influential to rounding rate index when selecting different condensing agents in an embodiment, and to dissolve scattered time limit, the ball method of double differences is different and index such as hardness does not have obvious influence.
Table five is selected the experiment of different condensing agent temperature
| The condensing agent temperature | Effective ingredient (%) | Rounding rate (%) | Dissolve scattered time limit (minute) | The ball method of double differences different (%) | Hardness |
| 20→-5℃ | ??25 | ??94 | ??＜30 | ??＜10 | ??+++ |
| 30→-10℃ | ??25 | ??90 | ??＜30 | ??＜10 | ??+++ |
| 40→-15℃ | ??25 | ??85 | ??＜30 | ??＜10 | ??+++ |
Result by table five can see: slightly influential to rounding rate index when selecting different condensing agent temperature in an embodiment, and to dissolve scattered time limit, the ball method of double differences is different and index such as hardness does not then have obvious influence.
Part main reference data is as follows:
1. Li Li. LIUWEI DIHUANG WAN side's machine is brief talked. Yunnan Chinese medicine magazine .2001,22 (5): 46
2. Li Rui, Yin Yingjie, Lu Zhaolin. the modern clinical practice of LIUWEI DIHUANG WAN (soup) is commented. the journal .2003 of Beijing University of Chinese Medicine, 26 (3): 5
3. Shen Lie is capable, Xu Ruijun, Yue Fengmei. the pharmacodynamics of LIUWEI DIHUANG WAN and clinical application research progress. and China Dispensary .2003 (14): 5
4. king's promotion. the pharmaceutical research progress of LIUWEI DIHUANG WAN (soup). medical science Leader .2003,22 (8): 561
5. Lu's auspicious pink cloud, Niu Junrui. the clinical new usefulness of LIUWEI DIHUANG WAN (soup). packet header medical college journal.? 17 (?): 368
6. bent army, Wang Fang, Hao Yong, Luo Chaoli. the clinical new overview of using of LIUWEI DIHUANG WAN (soup). Shandong journal of Chinese medicine .2001,20 (5): 381
Claims (7)
- One. a kind of LIUWEIDIHUANG DIWAN, it is characterized in that: this drop pill is based on the LIUWEI DIHUANG WAN prescription, preparation technology one or two makes dry powder or thick paste to specifications, mixes mutually in certain proportion with selected substrate again, forms through specific prepared; Substrate can be used Polyethylene Glycol 1500～20000, in the stearic acid, sodium stearate, glycerin gelatine, glyceryl monostearate, Lac, polyoxyethylene monostearate, polyethers, carboxymethyl starch sodium one or more mix mutually.
- Two. LIUWEIDIHUANG DIWAN according to claim 1 is characterized in that: to specifications the proportioning of the resulting dry powder of preparation technology or thick paste and described substrate with weight portion count 1: 1～8.
- Three. LIUWEIDIHUANG DIWAN according to claim 1 is characterized in that: to specifications the proportioning of the resulting dry powder of preparation technology or thick paste and described substrate more preferred range be 1: 3～6.
- Four. LIUWEIDIHUANG DIWAN according to claim 1 is characterized in that: in the substrate of being addressed, Polyethylene Glycol more preferably 4000～10000
- Five. be used for the preparation method of the described LIUWEIDIHUANG DIWAN of claim 1, it is characterized in that constituting by following step:The extraction of first step raw material and preparation:1. the Cortex Moutan steam distillation extracts volatile oil, and the aqueous solution after distillation device is in addition collected, and is standby.2. Radix Rehmanniae Preparata, Rhizoma Dioscoreae, Rhizoma Alismatis decoct with water more than 1 time, merge decoction liquor, filter.Filtrate and above-mentioned Cortex Moutan aqueous solution merge, and the solution after the merging is put on the supercentrifuge centrifugal more than 10 minutes, get supernatant and carry out ultrafiltration, collect the ultrafiltrate part, and be standby.3. 3 times of Fructus Corni are more than the amount, and concentration was higher than 50% soak with ethanol after 30 minutes, and reflux, extract, is more than 1 time, and merge extractive liquid, filters.Filtrate decompression is concentrated into does not have the alcohol flavor, standby.4. after Poria added water boil, warm macerating 1 merged leachate then to for several times in the water-bath more than 50 ℃, filtered filtrate for later use.5. above gained solution is merged, concentrating under reduced pressure becomes thick paste under 50～100 ℃ temperature conditions, and drying under reduced pressure is ground into fine powder, with above gained paeonol crystallized mixed, obtains making the thick paste or the dry powder of LIUWEIDIHUANG DIWAN.Thick paste that second step will make by the first step or dry powder are (perhaps according to the method for making of six drugs containing rehmanniae soft capsule (National Drug Administration-national drug standards WS3-102 (Z-30)-97 (Z)) and six drugs containing rehmanniae oral liquid (National Drug Administration-national drug standards WS3-B-3774-98), thick paste that is prepared into or dry powder) ratio with 1: 1～8, mix with matrix phase as adjuvant; Substrate can be Polyethylene Glycol 1500～20000, in the substrate such as stearic acid, sodium stearate, glycerin gelatine, glyceryl monostearate, Lac, polyoxyethylene monostearate, polyethers, carboxymethyl starch sodium any one or a few mix mutually.The 3rd step was adopted water-bath, oil bath or other mode of heating, and mixed material is heated to fusion, stirred;The 4th step was inserted special-purpose homemade drop pill machine, and keeping temperature is 70～100 ℃.The 5th step was selected sizeable drip nozzle, with suitable speed, splashed in 40 →-15 ℃ the condensing agent; Condensing agent can be any one or a few in liquid paraffin, methyl-silicone oil, the vegetable oil.The 6th step type to be shrunk to takes out, and removes the surface condensation agent, drying, and packing, promptly.
- Six. the step 4 according to the described preparation method of claim 5 is characterized in that: the preferred scope of temperature of dripping dropping-pill machine head in the system process is 70～90 ℃.
- Seven. the step 5 according to the described preparation method of claim 5 is characterized in that: the optimum temperature range that drips condensed fluid in the system process is 20 →-5 ℃.
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| CN104208427A (en) * | 2014-09-16 | 2014-12-17 | 青岛华仁技术孵化器有限公司 | Pharmaceutical preparation for treating nephritic syndrome and preparation method thereof |
| CN113925950A (en) * | 2021-11-03 | 2022-01-14 | 余焕舟 | Pharmaceutical composition for treating uremia as well as preparation method and application thereof |
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