Summary of the invention: the object of the invention is to provide Chinese medicine preparation of a kind of evident in efficacy and treatment prostatic hyperplasia of having no side effect and preparation method thereof, solves the problem that prior art exists.
The present invention is achieved in that according to components by weight percent and calculates: it is with 83~248 parts of Cortex Phellodendris, 83~248 parts of Radix Paeoniae Rubra, 83~248 parts of Radix Angelicae Sinensis, 83~248 parts of Rhizoma Chuanxiongs, 83~248 parts of Rhizoma Smilacis Glabraes, 50~150 parts of rhizoma sparganic, 66~198 parts of Rhizoma Alismatis, 66~198 parts of Herba Portulacaes, 66~198 parts of Herba Verbenae, 66~198 parts of Herba Saxifragaes, 50~150 parts of Radix Bupleuri, 50~150 parts of Radix Cyathulaes, Radix Glycyrrhizae is prepared into tablet for 17~50 parts, granule, soft capsule, oral liquid, drop pill, pill, medicated wine, tincture, extractum, ejection preparation, comprise: common injection, injectable powder, lyophilized injectable powder, infusion solution, other special preparations; Comprise sustained-release preparation, membranous patch, gel etc.Its dosage form is reasonable to be tablet, granule, soft capsule, oral liquid or pill.The preparation method of the Chinese medicine preparation of this treatment prostatic hyperplasia: get Cortex Phellodendri, Rhizoma Alismatis, Radix Angelicae Sinensis, Rhizoma Chuanxiong, add 4~8 times of amounts 40~80% alcohol refluxs or heating extraction 2~3 times, each 1~3 hour, filter, decompression filtrate recycling ethanol, it is standby to be condensed into clear paste; Other gets Radix Paeoniae Rubra, Rhizoma Smilacis Glabrae, rhizoma sparganic, Herba Portulacae, Herba Verbenae, Herba Saxifragae, Radix Bupleuri, Radix Cyathulae, Radix Glycyrrhizae, decoct with water 2~3 times, the each decoction 1~3 hour, filter, the merging filtrate concentrating under reduced pressure, gained clear paste and above-mentioned clear paste merge, continue to be condensed into thick paste, drying under reduced pressure, dried cream powder is broken, and the reuse diverse ways is made different preparations.Method for preparing tablet thereof is: gets Cortex Phellodendri, Rhizoma Alismatis, Radix Angelicae Sinensis, Rhizoma Chuanxiong, adds 4~6 times of amounts 40~60% alcohol refluxs or heating extraction 2~3 times, and each 1~2 hour, filter, decompression filtrate recycling ethanol, it is standby to be condensed into clear paste; Other gets Radix Paeoniae Rubra, Rhizoma Smilacis Glabrae, rhizoma sparganic, Herba Portulacae, Herba Verbenae, Herba Saxifragae, Radix Bupleuri, Radix Cyathulae, Radix Glycyrrhizae, decoct with water 2~3 times, decocted 1~2 hour at every turn, filter, the merging filtrate concentrating under reduced pressure, gained clear paste and above-mentioned clear paste merge, and continue to be condensed into thick paste, drying under reduced pressure, dried cream powder is broken, with concentration is 70% alcohol granulation, tabletting, promptly.The preparation method of granule is: gets Cortex Phellodendri, Rhizoma Alismatis, Radix Angelicae Sinensis, Rhizoma Chuanxiong, adds 6~8 times of amounts 40~80% alcohol refluxs or heating extraction 2~3 times, and each 2~3 hours, filter, decompression filtrate recycling ethanol, it is standby to be condensed into clear paste; Other gets Radix Paeoniae Rubra, Rhizoma Smilacis Glabrae, rhizoma sparganic, Herba Portulacae, Herba Verbenae, Herba Saxifragae, Radix Bupleuri, Radix Cyathulae, Radix Glycyrrhizae, decocts with water 2~3 times, decocts 2~3 hours at every turn, filter, the merging filtrate concentrating under reduced pressure, gained clear paste and above-mentioned clear paste merge, continue to be condensed into thick paste, drying under reduced pressure, dried cream powder is broken, concentration is to make soft material behind 8% the starch slurry mix homogeneously, sieve system granule, drying, granulate promptly gets granule.The preparation method of pill is: gets Cortex Phellodendri, Rhizoma Alismatis, Radix Angelicae Sinensis, Rhizoma Chuanxiong, adds 4~8 times of amounts 40~80% alcohol refluxs or heating extraction 2~3 times, and each 1~3 hour, filter, decompression filtrate recycling ethanol, it is standby to be condensed into clear paste; Other gets Radix Paeoniae Rubra, Rhizoma Smilacis Glabrae, rhizoma sparganic, Herba Portulacae, Herba Verbenae, Herba Saxifragae, Radix Bupleuri, Radix Cyathulae, Radix Glycyrrhizae, decoct with water 2~3 times, decocted 1~3 hour at every turn, filter, the merging filtrate concentrating under reduced pressure, gained clear paste and above-mentioned clear paste merge, and continue to be condensed into thick paste, drying under reduced pressure, dried cream powder is broken, add refined honey (relative density 1.35) and boiled water, pill, promptly.
According to the theory of motherland's medical science, be detained the pathogenic characteristic of obstruction of collaterals by blood stasis at primary disease is damp and hot, according to " element ask the most pure virginity will discuss greatly " " treating heat syndrome with cold-natured drugs ", " diseases with invaded pathogens should be treated by expelling ", " disease caused by accumulations of pathogen should be treated with therapy of dispersion ", " promoting circulation of QI-blood make it reach, and it is flat to make peace ", and " medicine to " " ecphractic therapy relieving stagnation " (drawing) thirty years of age eliminating damp-heat from Compendium of Material Medica, blood circulation promoting and blood stasis dispelling, turbid treating stranguria method disappears, make wet reducing phlegm and internal heat clearly, the stasis of blood ruton that looses, glandular tube is unobstructed, and then all cards can be healed.Cortex Phellodendri in the side, bitter in the mouth is cold in nature, goes into kidney, urinary bladder channel, but both heat-clearing and toxic substances removing is again can dampness removing treating stranguria, can make damp and hot heresy from letting out down; Damp and hot for a long time strongly fragrantly do not change goes into network and do not loose, and obstructed with the hyperamization network, blood stasis is not all right, the glandular tube drainage difficulty, stagnation of QI and blood may bring about pain, and the turbid knot of the damp and hot stasis of blood is stagnant, thus touching difficulty is more, so let out the Radix Paeoniae Rubra that is slightly cold with hardship, the main Liver Channel of returning, the heat clearing away that is slightly cold, hardship is let out blood stasis dispelling, promoting blood circulation and stopping pain again can tonneau urine, with Cortex Phellodendri be monarch drug altogether.Rhizoma sparganic is arduous, flat, and promoting blood circulation is good in the removing blood stasis circulation of qi promoting, is the key medicine of blood circulation promoting and blood stasis dispelling, with monarch drug mutually 5, receives eliminating damp-heat altogether, promoting blood circulation to remove blood stasis, the effect of dredging obstruction.Sweeter, light, flat with Rhizoma Smilacis Glabrae, return liver, stomach warp, removing dampness and detoxicating; Liver, spleen channel are returned in Herba Verbenae hardship, cold, and promoting blood circulation to remove blood stasis, inducing diuresis to remove edema, three medicines are ministerial drug altogether.The monarch and his subjects' compatibility, eliminating damp-heat are with Qing Qiyuan, and promoting blood circulation to remove obstruction in the collateral is with its stasis of blood of loosing, and diuresis is let out turbid with logical its key.Again with the hot cold Herba Saxifragae of bitter in the mouth, the Herba Portulacae that acid is cold, heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, row is turbid for dampness removing; Rhizoma Alismatis diuresis, clearing away damp-heat, three medicines are to help the Cortex Phellodendri heat-clearing and toxic substances removing, and dampness removing is let out turbid.The Rhizoma Chuanxiong promoting flow of QI and blood; The Radix Cyathulae eliminating blood stasis and inducing menstruation, inducing diuresis for treating stranguria syndrome has eliminating stasis and resolving masses and does not hinder just characteristics.Radix Bupleuri is returned the liver and gall warp, hernia and colic under the meridian of Foot-JUE YIN, and the Radix Glycyrrhizae sweet in the mouth is flat, and heat-clearing and toxic substances removing in the sweet mitigation, both can have been strengthened the power of Cortex Phellodendri heat-clearing and toxic substances removing, can prevent the fraud of cold and cool product damaging the spleen and stomach again; With " tip " person, be the merit of getting its treating stranguria pain relieving, Gu has " going directly " stem to end to drench saying of pain.More than seven medicines all be adjuvant drug.The Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, holding concurrently is messenger drug.The all medicines in full side share, and the removing dampness detoxifcation is to radically reform, and promoting blood circulation to remove blood stasis is with promoting flow of QI and blood, and diuresis is let out turbid evil descending to draw, and becomes eliminating damp-heat altogether, blood circulation promoting and blood stasis dispelling, and turbid treating stranguria merit disappears.Reduce phlegm and internal heat clearly in order to do wet, blood works freely, and turbidization key is logical, and all cards can remove.Tablet dose provided by the invention is accurate, and the content content difference is little, steady quality, and some easy oxidation deterioration and deliquescent medicine can be protected by coating, and light, air, moisture etc. are less to its influence; Granule provided by the invention, GI irritation is little; Drug loading is big, and mouthfeel is good, is beneficial to acceptance; Oral liquid provided by the invention absorbs fast, the bioavailability height, and the use crowd is wide; Injection bioavailability height provided by the invention, onset speed is fast, no first pass effect, be applicable to can not be oral the patient; Sustained-release preparation provided by the invention is easy to use, provides balance persistent effective blood drug concentration, needing to be particularly useful for the patient of long-term prescription.The present invention is directed to prior art simultaneously, the volatile oil that Rhizoma Atractylodis, Rhizoma Cyperi, Radix Angelicae Sinensis, Rhizoma Chuanxiong distillation extraction are gone out carries out enclose with cyclodextrin, can prevent the volatilization of volatile oil; Improve stability of drug; Also can cover the bad smell of volatile oil simultaneously.The present invention is used for treatment of diseases such as chronic prostatitis and prostate hyperplasia, and special obvious effects is arranged; Solved the problem that prior art exists.
The applicant carries out a series of experiments, and can confirm that method provided by the invention is effectively controlled, the preparation good effect.
Experimental example 1: xylol causes the influence of mice ear
Get body weight 18-22g mice, irritate stomach and give pharmaceutical composition of the present invention, every day 1 time, continuous 7 days, be coated with dimethylbenzene 0.1ml in the Mus auris dextra back of the body in 30 minutes after the last administration, mice is put to death in the cervical vertebra dislocation after 2 hours, lays round auricle with card punch in left and right sides ear same area, weighs, ratio with interaural difference and left ear is the swelling degree, compare each group difference, the result shows: it is similar to the capsule preparations group that preparation of the present invention all can suppress dimethylbenzene induced mice ear swelling, sees the following form.
Group |
Number of animals |
Contrast |
Cause scorching ear weight (%) |
Capsule matched group tablet experimental group granule experimental group pill agent experimental group oral liquid experimental group |
10 10 10 10 10 |
100.0 100.0 100.0 100.0 100.0 |
119.6±39.2 113.9±27.2 111.3±31.4 115.1±25.6 115.7±16.1 |
Experimental example 2: adjuvant screening
In preparation process, whether the adjuvant of adding proper direct quality and the clinical application effect that influences preparation, and the applicant attempted many different adjuvants, therefrom selects best for using; For this reason, the applicant has also carried out a series of experiments to obtain best technology.
Measure to adopt the dump box method angle of repose: fill fine powder in rectangular box, its Strobilus Pini degree is suitable, till box is progressively tilted to micropowder and begins to flow out.The angle that box tilts is angle of repose.If the result is mobile poor, easily loose greater than 45%.
The hygroscopicity experiment: get test sample, about 2g puts in the weighing botle, and accurate the title decides, the weighing bottle cap is opened, put into relative humidity respectively and be 92% environment, in 25 ℃ of constant incubators, placed 84 hours, take out weighing botle, add a cover the accurate title in back and decide, calculate the moisture absorption percentage rate.The low more explanation of result value is difficult for moisture absorption.
Check disintegration: adopting changes the basket method, and lift disintegration tester, tablet are got 6, and granule is got 6, observes in 30 minutes the situation by screen cloth.Pill is got 6 balls, observes in 60 minutes the situation by screen cloth.Percent of pass height then disintegrative is good, more pleasant bulk absorption.
Tablet |
Wetting agent |
Ethanol |
Syrup |
Gelatine size |
Concentration (%) angle of repose (°) hygroscopicity experiment (%) disintegration |
20 54 20 2 |
70 40 19 0 |
80 42 25 0 |
20 41 25 3 |
50 45 22 2 |
70 51 21 4 |
10 46 26 2 |
20 45 25 3 |
30 42 23 1 |
(not by the screen cloth number)
Granule |
Wetting agent |
Ethanol |
Syrup |
Starch slurry |
Concentration (%) angle of repose (°) hygroscopicity experiment (%) disintegration |
20 52 25 2 |
50 45 24 1 |
80 43 28 1 |
30 45 24 3 |
50 43 22 1 |
70 50 23 3 |
5 41 20 3 |
8 42 20 0 |
10 44 24 3 |
(not by the screen cloth number)
Pill |
Refined honey |
The relative density hygroscopicity is tested (%) disintegration |
1.35 40 0 |
1.37 43 1 |
1.40 50 3 |
(not by the screen cloth number)
The specific embodiment:
Embodiments of the invention 1:
Cortex Phellodendri 83g Radix Paeoniae Rubra 83g Radix Angelicae Sinensis 83g Rhizoma Chuanxiong 83g
Rhizoma Smilacis Glabrae 83g rhizoma sparganic 50g Rhizoma Alismatis 66g Herba Portulacae 66g
Herba Verbenae 66g Herba Saxifragae 66g Radix Bupleuri 50g Radix Cyathulae 40g
Radix Glycyrrhizae 17g
Get Cortex Phellodendri, Rhizoma Alismatis, Radix Angelicae Sinensis, Rhizoma Chuanxiong, add 4 times of amount 40% alcohol reflux 2 times, each 1 hour, filter, decompression filtrate recycling ethanol, it is standby to be condensed into clear paste; Other gets Radix Paeoniae Rubra, Rhizoma Smilacis Glabrae, rhizoma sparganic, Herba Portulacae, Herba Verbenae, Herba Saxifragae, Radix Bupleuri, Radix Cyathulae, Radix Glycyrrhizae, decocts with water 2 times, decocts 1 hour at every turn, filter, the merging filtrate concentrating under reduced pressure, gained clear paste and above-mentioned clear paste merge, continue to be condensed into thick paste, drying under reduced pressure, dried cream powder is broken, is 70% alcohol granulation with concentration, tabletting, promptly get tablet, oral, every day 3 times, each 3.
Embodiments of the invention 2:
Cortex Phellodendri 248g Radix Paeoniae Rubra 248g Radix Angelicae Sinensis 248g Rhizoma Chuanxiong 248g
Rhizoma Smilacis Glabrae 248g rhizoma sparganic 150g Rhizoma Alismatis 198g Herba Portulacae 198g
Herba Verbenae 198g Herba Saxifragae 198g Radix Bupleuri 150g Radix Cyathulae 150g
Radix Glycyrrhizae 50g
Get Cortex Phellodendri, Rhizoma Alismatis, Radix Angelicae Sinensis, Rhizoma Chuanxiong, add 8 times of amount 80% alcohol reflux 3 times, each 3 hours, filter, decompression filtrate recycling ethanol, it is standby to be condensed into clear paste; Other gets Radix Paeoniae Rubra, Rhizoma Smilacis Glabrae, rhizoma sparganic, Herba Portulacae, Herba Verbenae, Herba Saxifragae, Radix Bupleuri, Radix Cyathulae, Radix Glycyrrhizae, decocts with water 3 times, decocts 3 hours at every turn, filter, the merging filtrate concentrating under reduced pressure, gained clear paste and above-mentioned clear paste merge, continue to be condensed into thick paste, drying under reduced pressure, dried cream powder is broken, concentration is to make soft material behind 8% the starch slurry mix homogeneously, sieve system granule, drying, granulate promptly gets granule.
Embodiments of the invention 3:
165 parts of 165 parts of Radix Angelicae Sinensis of 165 parts of Radix Paeoniae Rubra of Cortex Phellodendri
99 parts of 165 parts of rhizoma sparganic of 165 parts of Rhizoma Smilacis Glabraes of Rhizoma Chuanxiong
132 parts of 132 portions of Herba Verbenae of 132 portions of Herba Portulacaes of Rhizoma Alismatis
99 parts of 99 portions of Radix Cyathulaes of 132 parts of Radix Bupleuri of Herba Saxifragae
33 parts in Radix Glycyrrhizae
Get Cortex Phellodendri, Rhizoma Alismatis, Radix Angelicae Sinensis, Rhizoma Chuanxiong, add 4 times of amount 40% ethanol heating extraction 2 times, each 1 hour, filter, decompression filtrate recycling ethanol, it is standby to be condensed into clear paste; Other gets Radix Paeoniae Rubra, Rhizoma Smilacis Glabrae, rhizoma sparganic, Herba Portulacae, Herba Verbenae, Herba Saxifragae, Radix Bupleuri, Radix Cyathulae, Radix Glycyrrhizae, decoct with water 2 times, decocted 1 hour at every turn, filter, the merging filtrate concentrating under reduced pressure, gained clear paste and above-mentioned clear paste merge, and continue to be condensed into thick paste, drying under reduced pressure, dried cream powder is broken, add refined honey (relative density 1.35) and boiled water, pill, promptly.
Embodiments of the invention 4:
165 parts of 165 parts of Radix Angelicae Sinensis of 165 parts of Radix Paeoniae Rubra of Cortex Phellodendri
99 parts of 165 parts of rhizoma sparganic of 165 parts of Rhizoma Smilacis Glabraes of Rhizoma Chuanxiong
132 parts of 132 portions of Herba Verbenae of 132 portions of Herba Portulacaes of Rhizoma Alismatis
99 parts of 99 portions of Radix Cyathulaes of 132 parts of Radix Bupleuri of Herba Saxifragae
33 parts in Radix Glycyrrhizae
Get Cortex Phellodendri, Rhizoma Alismatis, Radix Angelicae Sinensis, Rhizoma Chuanxiong, add 8 times of amounts 80% alcohol refluxs or heating extraction 3 times, each 3 hours, filter, decompression filtrate recycling ethanol, it is standby to be condensed into clear paste; Other gets Radix Paeoniae Rubra, Rhizoma Smilacis Glabrae, rhizoma sparganic, Herba Portulacae, Herba Verbenae, Herba Saxifragae, Radix Bupleuri, Radix Cyathulae, Radix Glycyrrhizae, decoct with water 3 times, the each decoction 3 hours, filter, the merging filtrate concentrating under reduced pressure, gained clear paste and above-mentioned clear paste merge, continue to be condensed into thick paste, drying under reduced pressure adds syrup and distilled water, promptly gets oral liquid.