CN1296069C - Preparing technics of composition of Guizhi and Fuling and its use - Google Patents

Preparing technics of composition of Guizhi and Fuling and its use Download PDF

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CN1296069C
CN1296069C CN 200310116836 CN200310116836A CN1296069C CN 1296069 C CN1296069 C CN 1296069C CN 200310116836 CN200310116836 CN 200310116836 CN 200310116836 A CN200310116836 A CN 200310116836A CN 1296069 C CN1296069 C CN 1296069C
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poria
extract
hour
crude drug
group
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CN1546129A (en
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肖伟
戴翔翎
凌娅
王振中
陈艳平
沈静
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Jiangsu Kanion Pharmaceutical Co Ltd
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Jiangsu Kanion Pharmaceutical Co Ltd
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Abstract

The present invention discloses new preparation technology for a cassia twig and tuckahoe composition. Moreover, the present invention provides the application of the cassia twig and tuckahoe composition in medicine for treating the hyperplasia of prostate glands and the hyperplasia of mammary glands. The preparation technology of the present invention comprises two kinds of preparation technology: in one kind of the preparation technology tree peony bark is singly extracted, and a preferable ratio of the extract amount of tuckahoe to the amount of fine powder is 10% to 30%: 70% to 90%; the other kind of preparation technology adopts a method of combining multiple alcohol extraction with water extraction. The preparation technology is stable and feasible. The content of paeonol of a finished product is higher than that of former technology.

Description

Cinnamomi and poria composition and preparation technology thereof
Technical field
The present invention relates to preparation technology of a kind of Chinese medicine composition and uses thereof, particularly relate to preparation technology of a kind of Cinnamomi and poria composition and uses thereof.
Background technology
Ramulus Cinnamomi Poria pill comes from Zhang Zhongjing " Medical Treasures of the Golden Chamber ", it is tcm clinical practice tradition commonly used name side, by Ramulus Cinnamomi, Poria, Cortex Moutan, Semen Persicae, Radix Paeoniae 5 flavor medicines are formed, and are modern commonly used for big honeyed pills, are recorded in " Drug Standard of Ministry of Public Health of the Peoples Republic of China Chinese traditional patent formulation preparation " first, has activating blood circulation to dissipate blood stasis, the function of slow detumescence piece.The improvement dosage form of existing Ramulus Cinnamomi Poria pill, its preparation technology lose more in the concentration process of raw material, and spissated extractum density is unfavorable for mixing, and is difficult for drying, take a lot of work, time-consuming, and the extraction ratio of utilization ratio of raw materials, active ingredient is not high.
Summary of the invention
The preparation technology that provides a kind of Cinnamomi and poria composition new is provided the object of the invention.Another purpose of the present invention is to provide the application of Cinnamomi and poria composition in the medicine of treatment prostatic hyperplasia and cyclomastopathy.
The present invention seeks to be achieved through the following technical solutions:
Concrete processing step is as follows: the extracting method of Cortex Moutan should be medical material and breaks into coarse powder 2mm-1cm and add water, and after moistening 1-2 hour, the circulation vapor distillation extracts, and collects 4-10 and doubly measures distillate, and cold preservation is left standstill; After waiting to separate out crystallization, filter, filtrate is redistillation again, collects the distillate that 2.5-3.5 doubly measures, and cold preservation is left standstill; After waiting to separate out crystallization, filter, filtrate discards, and merges twice paeonol crystallization; Be ground into fine powder after drying in the shade, make fine grained, dry in the shade, the cryogenic seal storage, stand-by; The Poria powder of Ramulus Cinnamomi, the Radix Paeoniae Alba, Semen Persicae and recipe quantity 10%-30% is broken into coarse powder, mixing; Add the Cortex Moutan medicinal residues, add 90% ethanol that medical material 3-5 doubly measures again, soaked 0.5-1 hour, heating and refluxing extraction 1-3 hour, filter; Medicinal residues add 90% ethanol that crude drug 3-5 doubly measures again, reflux, extract, 1-3 hour, filter merging filtrate; Medicinal residues add the water that crude drug 5-7 doubly measures, and reflux, extract, 0.5-1 hour, filter; Medicinal residues add the water that crude drug 3-5 doubly measures again, reflux, extract, 0.5-1 hour, filter; Merging filtrate, medicinal residues are abandoned it; Alcohol extract and water extract be concentrating under reduced pressure respectively, and alcohol extract is recycled to does not have the alcohol flavor; Merge two concentrated solutions, get sepia thickness mastic, relative density is 1.25 at 80 ℃; Other 70%-90% recipe quantity is crossed the Poria fine powder and the above-mentioned extractum mixing of 100 mesh sieves, and drying is pulverized, oven dry; Add the paeonol fine grained, mixing, granulate incapsulates, promptly.
The preparation technology of Cinnamomi and poria composition of the present invention can also be following steps:
The Poria five kinds of Chinese medicine of getting Ramulus Cinnamomi, Semen Persicae, the Radix Paeoniae Alba, Cortex Moutan and 40%-60% recipe quantity is broken into coarse powder, mixing; Add 70%-90% ethanol, soaked 0.5-1 hour, heating and refluxing extraction 1-3 time wherein adds the alcoholic acid amount of 70%-90% at every turn and is 3-5 times of crude drug, and the heating and refluxing extraction time is 1-3 hour; Filter merging filtrate; Medicinal residues add the water that crude drug 5-7 doubly measures, reflux, extract, 1-3 time, wherein each reflux extracting time 0.5-1 hour; Filter, merging filtrate, medicinal residues are abandoned it; Alcohol extract and water extract be concentrating under reduced pressure respectively, and alcohol extract is recycled to does not have the alcohol flavor; Merge two concentrated solutions, get sepia extractum; With the Poria fine powder and the above-mentioned extractum mixing of other 40%-60% recipe quantity, drying is pulverized, and granulates, and granulate incapsulates, promptly.
Two kinds of its process stabilizings of new preparation technology, feasible of Cinnamomi and poria composition of the present invention, the paeonol content of finished product, cinnamic aldehyde content, content of paeoniflorin are all than former technology height, improve the extraction ratio of utilization ratio of raw materials, active ingredient, its Cinnamomi and poria composition can be used for treating prostatic hyperplasia and hyperplasia of mammary glands.
Following experimental example is used to further specify the present invention.
Extract the comparison of paeonol under experimental example 1 different condition
1 experimental technique: paeonol is slightly soluble in water, can separate out in distillate again during cooling with vapor distillation, simultaneously in conjunction with relevant document, has at first investigated the yield of paeonol under following three kinds of conditions, compares.
Method one, Cortex Moutan medical material 120g added water-wet after 1 hour, adopted circulation steam distillation, collected 9 times of amount distillates, and cold preservation is left standstill, after waiting to separate out crystallization, filter, filtrate is redistillation again, collects 3 times of amount distillates, cold preservation is left standstill, and filters after waiting to separate out crystallization, merges twice crystallization, is designated as A.
Method two, Cortex Moutan medical material 120g add water-wet, add 5%NaCL again, after 1 hour, adopt circulation steam distillation, collect 9 times of amount distillates, cold preservation is left standstill, and after waiting to separate out crystallization, filters, the NaCL that filtrate adds above-mentioned amount is redistillation again, collect 3 times of amount distillates, cold preservation is left standstill, and filters after waiting to separate out crystallization, merge twice crystallization, be designated as B.
Method three, Cortex Moutan medical material 120g add water-wet, add 10%NaCL again, after 1 hour, adopt circulation steam distillation, collect 9 times of amount distillates, cold preservation is left standstill, and after waiting to separate out crystallization, filters, the NaCL that filtrate adds above-mentioned amount is redistillation again, collect 3 times of amount distillates, cold preservation is left standstill, and filters after waiting to separate out crystallization, merge twice crystallization, be designated as C.
After A, B, the crystallization of C paeonol are dried in the shade, put in the exsiccator and spend the night, weigh, get in right amount by " one one 137 pages Cortex Moutan assay items of Chinese pharmacopoeia version in 2000 are operation down, result such as table 1.
Table 1 Cortex Moutan medicinal material extract adds and no salt added comparison
Project Paeonol crystallization weight Sampling amount Trap Paeonol content The paeonol total amount The paeonol extraction ratio
Crystalline A B C g 1.4858 1.4207 1.3818 g 0.00670 0.00530 0.00525 A 0.990 0.815 0.839 % 85.7% 89.2% 92.7% g 1.2733 1.2673 1.2809 % 62.1 61.8 62.4
(it is 1.71% that medical material is surveyed paeonol content by the pharmacopeia method)
2 experimental results: above three kinds of extracting method, the paeonol of crystallization C is purer, but three kinds of extracting method are more or less the same for the paeonol extraction ratio, consider the production actual cost, and employing method one is extracted.Be that the Cortex Moutan medical material is directly used the circulation steam extraction, need be with salt.
The influence that experimental example 2 different factors are extracted for paeonol
1 selectes empirical factor and chooses level: for the other factors that influences the Cortex Moutan medicinal material extract, the present invention has selected " medical material particle diameter ", " wetting time " and factors such as " collecting the amount of distillate ", in conjunction with producing, each factor has been chosen 3 levels again, sees Table 2 simultaneously.
Table 2 factor level table
Figure C20031011683600061
2 experimental techniques
By the requirement of experimental design scheme, adopt L 9(3 4) experimentize, be that index is passed judgment on the total amount of paeonol, the results are shown in Table 3.
Table 3: orthogonal experiments table
Annotate: 1. the Cortex Moutan medical material detects, and paeonol content is 1.71%.
2. this experiment is an experimental subject with 1/2 recipe quantity Cortex Moutan medical material.
3. the content detection of paeonol method is by " pertinent regulations operation under one one 137 pages Cortex Moutan assay items of Chinese pharmacopoeia version in 2000.
3 experimental results
Table 4 paeonol extraction and application rate analysis of variance table
Soruces of variation Sum of deviation square Degree of freedom Average variance The F value The P value
SA SB SC SD 0.0137 0.0015 0.0231 0.0002 2 2 2 2 0.0069 0.0008 0.0116 0.0001 69 8 116 1.00 Remarkable significantly especially
F 0.10(2,2)=9 F 0.05(2,2)=19
The A factor has significant difference (P<0.05) as shown in Table 4, and the C factor has special significant difference (P<0.01); As shown in Table 3, A 1<A 2<A 3, B 3<B 1<B 2, C 1<C 2<C 3So, should select A 3B 2C 3, but C 2, C 3Be more or less the same, consider production cost, the present invention selects C for use 2Be that the extraction process of Cortex Moutan should be medical material and breaks into coarse powder and cross 10 mesh sieves, add water-wet after 1.5 hours,, collect 7 times of amount distillates with circulation steam distillation, cold preservation is left standstill, after waiting to separate out crystallization, filter, filtrate is redistillation again, collect 3 times of amount distillates, cold preservation is left standstill, and filters after waiting to separate out crystallization, merges twice crystallization by being proposed the paeonol crystallization.
The research that experimental example 3 distillates are accepted or rejected
Break into coarse powder according to the Cortex Moutan medical material and cross 10 mesh sieves, add 1.5 hours Cortex Moutan extraction processes of water-wet, get 2 parts of the Cortex Moutan medical materials of 1/2 recipe quantity, verify, respectively 1. 2. 1.5309g of 1.5248g of paeonol crystallization; Get for the first time raffinate behind the filtrate redistillation, filtrate is made full wavelength scanner respectively for the second time, the collection of illustrative plates peak shape is consistent with the paeonol reference substance.
Experimental example 4 alcohol extractions and extraction process by water are preferred
Getting Ramulus Cinnamomi 240g, Poria 120g, Semen Persicae 240g, Radix Paeoniae Alba 240g, Cortex Moutan 240g, adopt single factor to investigate method, is index with content of effective in the extract, and the alcohol extraction and the extraction process by water of five tastes medical material carried out preferably.
1 five tastes medical material alcohol extraction process is preferred
Contain in the Ramulus Cinnamomi in cinnamic aldehyde, the Cortex Moutan and contain paeonol, the two is all fat-soluble effective ingredient.According to the physicochemical property of material, we are the investigation factor with concentration of alcohol, extraction time, are performance assessment criteria with the content of cinnamic aldehyde and paeonol in the five tastes medical material ethanol extract, through test, optimize best alcohol extraction process.See Table 5, table 6.
Preferred (the extracting 2 times) of table 5 concentration of alcohol
Sequence number Concentration of alcohol Cinnamic aldehyde content (g) Paeonol content (g)
1 70% 0.24 0.72
2 80% 0.41 1.24
3 90% 0.62 1.80
Preferred (concentration of alcohol is 90%) of table 6 extraction time
Sequence number Extraction time Cinnamic aldehyde content (g) Paeonol content (g)
1 1 time 0.18 0.65
2 2 times 0.67 1.78
3 3 times 0.70 1.81
(annotate: paeonol content is 1.5% in the Cortex Moutan crude drug, and cinnamic aldehyde content is 0.5% in the Ramulus Cinnamomi.)
As shown in Table 5, in the concentration of alcohol factor of choosing, concentration be in " 90% ethanol " its extract cinnamic aldehyde and paeonol for the highest; In the table 6, extraction time is bigger to effective ingredient influence, but for the second time with compare for the third time, it is less that effective ingredient differs, basic zero difference is considered real cost of production, preferred extraction time is " 2 times ".By single factor experiment method, comprehensive content of effective optimizes the alcohol extraction optimised process and is " four Chinese medicine materials such as remaining Poria and Ramulus Cinnamomi are ground into coarse powder, and mixing adds 90% ethanol extraction 2 times ".
2 extraction process by water are preferred
Contain aqueous soluble active constituents such as effective ingredient peoniflorin in the Radix Paeoniae Alba.According to the character of water soluble ingredient, consider the cost of actual production, we extract solvent, are the investigation factor with the extraction time, are performance assessment criteria with paeoniflorin content in the water extract, show that through single factor experiment the extracting in water number of times is " 2 times ".See Table 7.
Table 7 extraction time preferred
Sequence number Extraction time Content of paeoniflorin (g)
1 1 time 0.96
2 2 times 2.56
3 3 times 2.60
(annotate: paeoniflorin content is 2.0% in the Radix Paeoniae Alba crude drug)
As shown in Table 7, content of paeoniflorin increases along with increasing of extraction time in the extract, differs not remarkable but extract 3 times and extract 2 content of paeoniflorin, in order to adapt to the demand of actual production, saves production cost, and the preferred water extraction time is " 2 times ".
The research of experimental example 5 GUIZHI FULING JIAONANG antiinflammatory actions
1 GUIZHI FULING JIAONANG is to the bullate influence of rat granuloma
Be subjected to the reagent thing: title: GUIZHI FULING JIAONANG
The unit of providing: Kangyuan Pharmaceutical Co., Ltd., Jiangsu Prov
Preparation, lot number: the cassia twig tuckahoe extract powder is chocolate brown powder. every gram medicated powder is equivalent to crude drug 3.87g. lot number: 020420.
Compound method: facing the time spent is mixed with the concentration of 5.6% (being equivalent to crude drug 21.6%), 2.8% (being equivalent to crude drug 10.8%) and 1.4% (being equivalent to crude drug 5.4%) with distilled water.Hydrocortisone, Yangzhou pharmaceutical factory produces, specification 5mg/ml, lot number: 010105
Laboratory animal: select adult healthy SD male rat for use, 50, body weight 190 ± 20g is provided by University Of Suzhou's Experimental Animal Center, and laboratory animal is produced occupancy permit number: SCXK (Soviet Union) 2002-0021; Laboratory animal occupancy permit number: SYXK (Soviet Union) 2002-0078.
Experimental technique: get 50 of healthy SD male rats, be divided into 5 groups at random, 10 every group.Be respectively: normal control group, positive controls (with hydrocortisone intramuscular injection 5mg/kg) and the heavy dose of group of GUIZHI FULING JIAONANG (0.56gkg -1, be equivalent to crude drug 2.16gkg -1); Dosage group (0.28gkg in the GUIZHI FULING JIAONANG -1, be equivalent to crude drug 1.08gkg -1); GUIZHI FULING JIAONANG small dose group (0.14gkg -1, be equivalent to crude drug 0.54gkg -1).The test rat is under 4% chloral hydrate light anaesthesia, and the sterile working implants the subcutaneous stitching then of rat both sides axillary fossa with two aseptic rayon balls (weight 10 ± 1mg, diameter 6.5-8.5mm, autoclaving).Postoperative administration on the same day, once a day, hydrocortisone intramuscular injection 0.1ml/100g body weight, GUIZHI FULING JIAONANG group are irritated stomach 1ml/100g body weight, and successive administration is after 7 days, and animal is put to death in dislocation in the 8th day, takes out cotton balls, puts and weighs after 60 ℃ of baking boxs are dried.Deduct the raw cotton ball weight, be granuloma weight.Respectively organize granuloma weight and calculate suppression ratio.The formula that calculates suppression ratio is as follows:
Figure C20031011683600101
Experimental result: the rat administration is after 7 days, and three dosage groups of GUIZHI FULING JIAONANG all have in various degree inhibitory action to connective tissue proliferation.Suppression ratio is respectively 26.48%, 19.47%, 20.25%, especially with the effect of heavy dose group the most obvious (p<0.05).Compare with matched group, the inhibitory action of heavy dose of group is (p<0.05) the most obviously.GUIZHI FULING JIAONANG is implanted the connective tissue proliferation that causes in the rat body to cotton balls certain inhibitory action, illustrates that GUIZHI FULING JIAONANG has the effect of antagonism proliferative inflammation., the results are shown in Table 8.
Table 8 various dose GUIZHI FULING JIAONANG is to the bullate influence of rat granuloma (x ± SD)
Group Dosage Number of animals (only) Granuloma weight (mg) Suppression ratio (%)
Normal control group hydrocortisone GUIZHI FULING JIAONANG GUIZHI FULING JIAONANG GUIZHI FULING JIAONANG 5mg·kg -1 0.54g·kg -1 1.08g·kg -1 2.16g·kg -1 10 10 10 10 10 64.2±21.5 42.3±1.0** 51.2±16.5 51.7±8.4 47.2±9.8* 34.11 20.25 19.47 26.48
Compare * p<0.05 with the normal control group; * p<0.01
2 GUIZHI FULING JIAONANG are to the influence of mice auricle swelling
Be subjected to the reagent thing: title: GUIZHI FULING JIAONANG
The unit of providing: Kangyuan Pharmaceutical Co., Ltd., Jiangsu Prov
Preparation, lot number: the cassia twig tuckahoe extract powder is chocolate brown powder.Every gram medicated powder is equivalent to crude drug 3.87g.Lot number: 020420.
Compound method: facing the time spent is mixed with the concentration of 5.6% (being equivalent to crude drug 21.6%) 2.8% (being equivalent to crude drug 10.8%) and 1.4% (being equivalent to crude drug 5.4%) with distilled water.Hydrocortisone, Yangzhou pharmaceutical factory produces, specification 5mg/ml, lot number: 010105; Dimethylbenzene: Suzhou Jin Cheng chemical reagent work, lot number: 010110;
Laboratory animal: select 50 of adult healthy Kunming mouses for use, male, 23.22 ± 2.31g is provided by University Of Suzhou's Experimental Animal Center, and laboratory animal is produced occupancy permit number: SCXK (Soviet Union) 2002-0021; Laboratory animal occupancy permit number: SYXK (Soviet Union) 2002-0078.
Experimental technique: experiment is divided into 5 groups, 10 every group, is respectively 10 (1.12gkg of the heavy dose of group of normal control group, positive controls (hydrocortisone intramuscular injection 10mg/kg) and GUIZHI FULING JIAONANG -1, be equivalent to crude drug 4.32gkg -1); 10 (0.56gkg of dosage group in the GUIZHI FULING JIAONANG -1, be equivalent to crude drug 2.16gkg -1); 10 (0.28gkg of GUIZHI FULING JIAONANG small dose group -1, be equivalent to crude drug 1.08gkg -1).Mice gavages respectively and is subjected to reagent liquid 0.2ml/10g body weight, hydrocortisone intramuscular injection 0.02ml/10g body weight, normal control group to give isopyknic distilled water filling stomach, and administration was given proinflammatory agent after 30 minutes, and 0.03ml is applied to mouse right ear with dimethylbenzene, and left ear in contrast.2.5 after hour the dislocation of mice cervical vertebra is caused death, cut left and right ear along the auricle baseline, take off same position auricle respectively with diameter 9mm card punch, scales/electronic balance weighing, every Mus auris dextra sheet weight deducts left auricle weight, is the ear swelling degree, carries out statistical disposition.
Experimental result: 1.08,2.16 and 4.32gk G-1The GUIZHI FULING JIAONANG of three dosage has in various degree inhibitory action to the ear swelling of mice.Along with the increase of dosage, inhibitory action progressively strengthens, and the GUIZHI FULING JIAONANG inhibitory action of especially middle heavy dose of group is (p<0.05 the most obviously; P<0.01).The result shows that the swelling that the GUIZHI FULING JIAONANG xylol of three dosage causes has inhibitory action, and certain dose-dependent effect is arranged.See Table 9.
The GUIZHI FULING JIAONANG of table 9 various dose is to the influence of mice ear (x ± SD)
Group Dosage Number of animals (only) Swelling degree (mg)
Normal control group hydrocortisone GUIZHI FULING JIAONANG GUIZHI FULING JIAONANG GUIZHI FULING JIAONANG 10mg·kg -1 1.08g·kg -1 2.16g·kg -1 4.32g·kg -1 10 10 10 10 10 18.6±3.89 11.2±4.47** 15.6±5.27 14.3±3.92* 14.1±2.81**
Compare * p<0.05 with the normal control group; * p<0.01,
Experimental example 6 GUIZHI FULING JIAONANG are to the influence of hemorheology of rat
Be subjected to the reagent thing: title: GUIZHI FULING JIAONANG
The unit of providing: Kangyuan Pharmaceutical Co., Ltd., Jiangsu Prov
Preparation, lot number: the cassia twig tuckahoe extract powder is chocolate brown powder. every gram medicated powder is equivalent to crude drug 3.87g.Lot number: 020420.
Compound method: facing the time spent is mixed with the concentration of 5.6% (being equivalent to crude drug 21.6%), 2.8% (being equivalent to crude drug 10.8%) and 1.4% (being equivalent to crude drug 5.4%) with distilled water.
Positive drug: QIANLIEKANG PIAN, Zhejiang Kang Enbei pharmaceutical Co. Ltd product, lot number: 020115; Facing the time spent is mixed with 17% concentration with distilled water.
Androlin, Shanghai the 9th pharmaceutical factory produces, specification: 25mg/ml. lot number: 020506; Facing the time spent is diluted to 10mg/ml concentration with olive oil.
Laboratory animal and material: male SD rat, 60, body weight 237.9 ± 30.1 gram is provided by University Of Suzhou's Experimental Animal Center, and laboratory animal is produced occupancy permit number: SCXK (Soviet Union) 2002-0021; Laboratory animal occupancy permit number: SYXK (Soviet Union) 2002-0078.
The hemorheology instrument: Beijing Puli gives birth to centre; Model: LBY-N6
Experimental technique: select 60 of healthy male SD rat for use, take out 10 at random as normal group.Use 4% chloral hydrate anesthesia for 50 in addition, under aseptic condition, extract bilateral testes, then skin suture.After one week, castrated rats is divided into 5 groups at random, 10 every group, is respectively model group; The heavy dose of group of GUIZHI FULING JIAONANG (0.56gkg -1, be equivalent to crude drug 2.16gkg -1); Dosage group (0.28gkg in the GUIZHI FULING JIAONANG -1, be equivalent to crude drug 1.08gkg -1); GUIZHI FULING JIAONANG small dose group (0.14gkg -1, be equivalent to crude drug 0.54gkg -1); Positive drug control group (QIANLIEKANG 1.7gkg -1); The laboratory animal sub-cage rearing, except that normal group, all the other rat sc every day androlins (1mg/300g body weight) once, the medication group is gavaged medicinal liquid 1ml/100g body weight simultaneously, normal group gives equal-volume water and irritates stomach.Rat is weighed once weekly, and adjusts dosage.Postoperative played successive administration on the 7th 30.4% chloral hydrate (400mg/kg) anesthesia after the last administration, rat aorta is got blood 4.0ml, injects the anticoagulant tube that heparin is handled, and measures the hemorheology of rat index through the rotary hemorheology instrument of LBY-N6 type.
Experimental result: administration group and model group compare, and whole blood viscosity, whole blood reduced viscosity have than significant difference.The big or middle dosage group of GUIZHI FULING JIAONANG is compared with model group and can significantly be reduced rat blood viscosity (P<0.05; P<0.01).GUIZHI FULING JIAONANG administration group can reduce that the reduction of rat whole blood, whole blood is low cuts, in cut viscosity, compare difference highly significant (P<0.05 with model group; P<0.01).See Table 10.
Table 10 GUIZHI FULING JIAONANG to the influence of prostatic hyperplasia hemorheology of rat (x ± SD, n=10)
Group Dosage (crude drug gkg -1) Whole blood viscosity/mpas Whole blood reduced viscosity/mpas
Low cutting In cut Height is cut Low cutting In cut Height is cut
Normal group model group GUIZHI FULING JIAONANG Ramulus Cinnamomi Indian buead capsule GUIZHI FULING JIAONANG QIANLIEKANG PIAN group 2.16 1.08 0.54 1.7 7.852±0.817 10.972±1.284 9.730±0.989* 9.562±1.341* 11.563±1.894 11.308±1.605 4.682±0.321 5.763±0.343 5.436±0.334* 5.063±0.790* 5.841±0.602 5.895±0.483 4.002±0.267 4.776±0.240 4.559±0.280 4.232±0.764* 4.780±0.519 4.893±0.425 16.094±2.315 20.829±3.059 18.299±2.271 17.229±2.268** 20.954±3.666 20.819±3.048 8.097±1.181 9.33±0.650 8.542±0.978* 7.480±1.397** 8.769±0.976 9.315±0.950 6.355±1.087 7.156±0.433 6.539±0.835 5.656±1.346** 6.511±0.980 7.173±0.844
Compare * P<0.05 with model group; * P<0.01
Experimental example 7 GUIZHI FULING JIAONANG cause the effect of rat mammary gland model of hyperplasia to estrogen
Be subjected to the reagent thing: breast rather increases: get breast and increase 32, be settled to 100ml with water dissolution; GUIZHI FULING JIAONANG heavy dose: get GUIZHI FULING JIAONANG powder 29.7g, be settled to 100ml with water dissolution; Dosage in the GUIZHI FULING JIAONANG: get GUIZHI FULING JIAONANG powder 9.9g, be settled to 100ml with water dissolution; GUIZHI FULING JIAONANG low dose: get GUIZHI FULING JIAONANG powder 3.3g, be settled to 100ml with water dissolution.
Experimental animal: 72 female unpregnancy healthy SD rats, body weight 180 ± 10g is provided by Nanjing University of Traditional Chinese Medicine's Experimental Animal Center.Kinoplaszm: SCXK (Soviet Union) 2002-0012 of Soviet Union.
Experimental technique: Healthy female is 72 of pregnant rats not, be divided into 6 groups at random, normal control group (12), model group (11), breast increases peaceful group of (1.92g/kg, 11), the heavy dose of group of GUIZHI FULING JIAONANG (11.5g crude drug/kg, 11), middle dosage group (3.83g crude drug/kg, 12), small dose group (1.28g crude drug/kg, 11), except that the normal control group, all the other are respectively organized rat and alternately injected estradiol benzoate 0.6mg/kg every 1 day in preceding oxter, inject altogether 10 times, irritate stomach simultaneously respectively and give each relative medicine (normal control group and model group are irritated the isopyknic tap water of stomach), the normal control group is next day injection and the isopyknic physiological saline solution of estradiol benzoate then, and after the last administration 24 hours, the ball posterior vein was got blood, separation of serum is measured E2 in the serum, P, T, PRL level (RIA method); Get the mammary gland of the 3rd pair of breast, carry out embedding, section, HE dyeing, mirror is observed its morphological changes of various tissue components down, and gets uterus and ovary, thymus and spleen, weighs and calculates its organ coefficient, and mirror is observed its morphological changes of various tissue components down.
Experimental result
The pathological grading of 1 pair of mammary gland tissue influence and mirror are observed down
The mammary gland pathological grading: the I level: lobules of mammary gland is obvious, and volume increases, and acinus quantity increases in the lobule, and conduit is extremely expanded, and in the lumen of gland or in the conduit volume secretions is arranged; The II level: lobules of mammary gland is obvious, and volume increases, but it is obvious not have the I level, in tube chamber or the ductal ectasia, lumen of gland or in the conduit secretions is arranged; The III level: the part cyclomastopathy, volume increases, and lumen of gland or conduit are slightly expanded, and in the lumen of gland or in the conduit a small amount of secretions are arranged; IV level (normal galactophore tissue): lobules of mammary gland is hypertrophy not, and the acinus volume is normal, and lumen of gland and conduit are not expanded, and does not see obvious secretions in lumen of gland and the conduit.Om observation the results are shown in Table 11.
Table 11 GUIZHI FULING JIAONANG is to the influence of cyclomastopathy Rats Organs and Tissues coefficient
Group Number of animals n The I level The II level The III level The IV level 95% confidence interval
Normal group model group breast increases dosage group small dose group in peaceful group of heavy dose of group 12 11 11 11 12 11 0 10 8 6 7 8 0 1 3 3 4 2 0 0 0 2 1 1 12 0 0 0 0 0 0.912±0.014 0.322±0.015 ** 0.391±0.015 ## 0.483±0.015 ## 0.456±0.014 ## 0.402±0.015 ##
Annotate: compare #P<0.05 ##P<0.01 with model group
Compare * P<0.05 * * P<0.01 with normal group
By table 1 as seen, relatively there were significant differences for normal group and model group, and each treatment group and model group also have significant difference.
The influence of 2 pairs of cyclomastopathy Rats Organs and Tissues coefficients
Table 12 GUIZHI FULING JIAONANG is to the influence of cyclomastopathy Rats Organs and Tissues coefficient
Group Body weight (g) Thymus coefficient (mg/g) Uterus ovary coefficient (mg/g) Spleen coefficient (mg/g)
Normal group model group breast increases dosage group small dose group in peaceful group of heavy dose of group 238.7±26.0 211.9±20.6 200.8±27.2 237.3±32.4 215.1±16.8 210.4±33.1 2.24±0.47 1.63±0.56 ** 1.33±0.18 1.48±0.48 1.61±0.37 1.55±0.34 2.42±0.78 4.30±1.41 ** 4.12±1.08 3.64±1.12 4.35±1.23 4.31±1.22 5.95±1.61 6.28±1.01 5.84±1.95 5.14±1.57 5.35±1.18 5.20±2.10
Annotate: compare #P<0.05 ##P<0.01 with model group
Compare * P<0.05 * * P<0.01 with normal group
By table 12 as seen, normal group and model group compare the uterus coefficient, there were significant differences for the thymus coefficient, wherein the thymus coefficient of model group obviously reduces, and uterus ovary coefficient and the apparent in view increase of model group, GUIZHI FULING JIAONANG heavy dose, middle dosage and breast increase peaceful group and organ coefficient does not have significant difference.
The influence of 3 pairs of cyclomastopathy rat sex hormone levels
Table 13 GUIZHI FULING JIAONANG is to the influence of gonadal hormone in the cyclomastopathy rat blood serum
Group E 2(pg/ml) T(pg/ml) P(pg/ml) PRL(pg/ml)
Normal group model group breast increases dosage group small dose group in peaceful group of heavy dose of group 97.55±127.37 749.05±100.92 ** 825.30±136.66 844.90±113.24 734.33±109.99 819.08±144.47 17.73±15.93 16.70±15.61 9.50±5.87 12.30±11.39 24.57±20.39 11.90±14.82 11.76±6.95 14.62±11.40 22.09±11.03 27.36±5.12 ## 22.86±12.86 19.83±10.34 0.87±0.38 0.87±0.42 1.27±0.36 ## 1.16±0.66 1.81±1.19 ## 1.96±1.40 ##
Annotate: compare #P<0.05 ##P<0.01 with model group
Compare * P<0.05 * * P<0.01 with normal group
By table 13 as seen, model group serum E 2Level is significantly higher than the normal control group, the cassia twig tuckahoe glue heavy dose P that can raise, and relatively there were significant differences with model group; Breast increases in peaceful group and the cassia twig tuckahoe glue, low dose can raise PRL, and with model group significant difference is arranged relatively.
Experimental example 8 GUIZHI FULING JIAONANG are to the experimentation of treatment rat experiment prostatic hyperplasia pathological model
Be subjected to the reagent thing: title: GUIZHI FULING JIAONANG
The unit of providing: Kangyuan Pharmaceutical Co., Ltd., Jiangsu Prov
Preparation, lot number: the cassia twig tuckahoe extract powder is chocolate brown powder. every gram medicated powder is equivalent to crude drug 3.87g. lot number: 020420.
Compound method: facing the time spent is mixed with the concentration of 5.6% (being equivalent to crude drug 21.6%), 2.8% (being equivalent to crude drug 10.8%) and 1.4% (being equivalent to crude drug 5.4%) with distilled water.
Positive drug: QIANLIEKANG PIAN, Zhejiang Kang Enbei pharmaceutical Co. Ltd product, lot number: 020115; Facing the time spent is mixed with 17% concentration with distilled water.
Androlin: Shanghai the 9th pharmaceutical factory produces, specification: 25mg/ml. lot number: 020506; Facing the time spent is diluted to 10mg/ml concentration with olive oil.
Laboratory animal: the SD rat, male, 60, body weight 237.9 ± 30.1 is provided by University Of Suzhou's Experimental Animal Center.Laboratory animal is produced occupancy permit number: SCXK (Soviet Union) 2002-0021; Laboratory animal occupancy permit number: SYXK (Soviet Union) 2002-0078.
Experimental technique: select 60 of healthy male SD rat for use, take out 10 at random as normal group.Use 4% chloral hydrate anesthesia for 50 in addition, under aseptic condition, extract bilateral testes, then skin suture.After one week, castrated rats is divided into 5 groups at random, 10 every group, is respectively model group; The heavy dose of group of GUIZHI FULING JIAONANG (0.56gkg -1, be equivalent to crude drug 2.16gkg -1); Dosage group (0.28gkg in the GUIZHI FULING JIAONANG -1, be equivalent to crude drug 1.08gkg -1); GUIZHI FULING JIAONANG small dose group (0.14gkg -1, be equivalent to crude drug 0.54gkg -1); Positive drug control group (QIANLIEKANG 1.7gkg -1); The laboratory animal sub-cage rearing, except that normal group, all the other rat sc every day androlins (1mg/300g body weight) once, the medication group is gavaged medicinal liquid 1ml/100g body weight simultaneously, normal group gives equal-volume water and irritates stomach.Rat is weighed once weekly, and adjusts dosage.Postoperative played successive administration on the 7th 30.1h puts to death animal after the last administration, gets each leaf of prostate, and electronic balance claims weight in wet base, and volumetric method is surveyed prostate volume, gets left and right sides head lobe and claims weight in wet base and claim dry weight after 37 ℃ of oven dry, calculated weight coefficient (being the weight of prostate or the volume of every 100g rat body weight).Getting the siphonal lobe prostate is fixed in and does routine paraffin wax section in 10% formalin solution, the HE microscopy.
Experimental result
1, GUIZHI FULING JIAONANG is to rat prostate weight, the influence of volume
Each dosage group of GUIZHI FULING JIAONANG is compared with model group, can obviously alleviate the rat prostate head lobe and do weight in wet base, alleviates the siphonal lobe weight in wet base, reduces prostate volume.Especially the most obvious with the big or middle dosage group of GUIZHI FULING JIAONANG effect, compare difference highly significant (P<0.01) with model group.See Table 14,15.
Table 14 GUIZHI FULING JIAONANG to the outgrowth influence of rat experiment prostate head lobe (x ± SD, n=10)
Group Dosage (g/kg) Head lobe (weight in wet base) left side (mg/100g body weight) right side Head lobe (dry weight) left side (mg/100g body weight) right side
Normal group model group GUIZHI FULING JIAONANG GUIZHI FULING JIAONANG GUIZHI FULING JIAONANG positive drug group 2.16 1.08 0.54 1.7 20.61±5.41 69.34±13.86 47.22±8.76** 51.04±8.13** 49.97±11.46** 45.58±8.10** 24.76±6.43 70.20±11.98 48.77±12.50** 54.15±6.90** 50.59±12.06** 46.96±8.23** 3.92±0.86 13.0±2.60 9.27±2.44** 9.83±1.63** 9.29±1.50** 9.13±2.25** 4.76±1.58 12.58±3.23 9.31±2.01* 9.69±1.55* 9.58±1.74* 9.35±1.96*
Compare * P<0.05 with model group; * P<0.01
Table 15 GUIZHI FULING JIAONANG to the influence of rat prostate siphonal lobe and volume (x ± SD, n=10)
Group Dosage (g/kg) Siphonal lobe (weight in wet base) (mg/100g body weight) Volume (cm 3/ 100g body weight)
Normal group model group GUIZHI FULING JIAONANG GUIZHI FULING JIAONANG GUIZHI FULING JIAONANG 2.16 1.08 0.54 111.18±26.91 270.11±49.03 170.40±42.10** 204.02±34.70** 265.49±84.80 0.132±0.017 0.349±0.058 0.187±0.093** 0.262±0.040** 0.307±0.087
Compare * P<0.05 with model group; * P<0.01
2, pathology microscopy result: normal group prostate body of gland marshalling, lumen of gland does not have expansion, glandular epithelium is the monolayer column, between body of gland visible between matter.Model group shows the body of gland arrangement closely, and the epithelial cell number increases, and is high column more, and the glandular epithelium height increases, and forms mamillary and charges in the lumen of gland, and lumen of gland is obviously expanded, interior visible secretions.GUIZHI FULING JIAONANG small dose group body of gland is arranged slightly tight, visible papillary hyperplasia in the lumen of gland.The heavy dose of group of GUIZHI FULING JIAONANG, middle dosage group pathological examination shows, the lumen of gland expansion is not obvious, hypertrophy glandular epithelium number obviously is less than model group, and low columnar epithelium is seen more, it is normal that part is tending towards recovering, and the lumen of gland diameter is compared with model group with the glandular epithelium height, difference highly significant (P<0.05; P<0.01).See Table 16.
Table 16 GUIZHI FULING JIAONANG is to the influence of rat prostate lumen of gland diameter and glandular epithelium height (x ± SD)
Group Dosage (g/kg) Number of animals (only) Lumen of gland diameter (μ m) Glandular epithelium height (μ m)
Normal group model group GUIZHI FULING JIAONANG GUIZHI FULING JIAONANG GUIZHI FULING JIAONANG positive drug group 2.16 1.08 0.54 1.7 10 10 10 10 10 10 171.0±34.14 287.0±51.43 231.0±41.22* 243.0±34.98* 254.0±39.21 239.0±32.81* 16.9±2.23 27.3±3.65 21.3±3.27** 23.0±4.06* 24.9±4.84 22.5±4.35*
Compare * P<0.05 with model group; * P<0.01
Experimental example 9 GUIZHI FULING JIAONANG are to the influence of the mouse retention gential sinus property implanted prostatic hyperplasia model
Be subjected to the reagent thing: title: GUIZHI FULING JIAONANG
The unit of providing: Kangyuan Pharmaceutical Co., Ltd., Jiangsu Prov
Preparation, lot number: the cassia twig tuckahoe extract powder is chocolate brown powder. every gram medicated powder is equivalent to crude drug 3.87g. lot number: 020420.
Compound method: facing the time spent is mixed with the concentration of 5.6% (being equivalent to crude drug 21.6%), 2.8% (being equivalent to crude drug 10.8%) and 1.4% (being equivalent to crude drug 5.4%) with distilled water.
Positive drug: QIANLIEKANG PIAN, Zhejiang Kang Enbei pharmaceutical Co. Ltd product, lot number: 020115; Facing the time spent is mixed with 17% concentration with distilled water.
Laboratory animal: select 60 of adult healthy Kunming mouses for use, male, 25.41 ± 3.16g is provided by University Of Suzhou's Experimental Animal Center, and laboratory animal is produced occupancy permit number: SCXK (Soviet Union) 2002-0021; Laboratory animal occupancy permit number: SYXK (Soviet Union) 2002-0078.
Experimental technique: select 60 of male mices for use, lumbar injection pentobarbital sodium anesthesia (3%, 60mg/kg), abdomen center, aseptic condition lower edge is cut stomach wall open, separate the prostate siphonal lobe gently with tweezers, the urogenital sinus tissue of implantation tire Mus in 3 16 day ages is sewed up abdominal wall muscle, skin under anatomical lens, mouse cage is put back in sterilization.Divide into groups then, 10 of normal group gavage the equal-volume normal saline, 10 of model group, 10 (1.12gkg of the heavy dose of group of GUIZHI FULING JIAONANG -1, be equivalent to crude drug 4.32gkg -1); 10 (0.56gkg of dosage group in the GUIZHI FULING JIAONANG -1, be equivalent to crude drug 2.16gkg -1); 10 (0.28gkg of GUIZHI FULING JIAONANG small dose group -1, be equivalent to crude drug 1.08gkg -1); 10 (3.4gkg of QIANLIEKANG group -1).The free diet of all mices, in postoperative beginning in the 3rd day gastric infusion, administration volume 0.2ml/10g body weight, once a day, successive administration is after 30 days, and disconnected marrow is put to death mice, gets each leaf of prostate respectively, and testis and seminal vesicle claim weight in wet base with electronic balance.Get a side head lobe and claim weight in wet base and claim dry weight after 37 ℃ of oven dry, calculated weight coefficient (being the body of gland weight of every gram mice body weight) is got prostate siphonal lobe fixation of tissue in addition in 10% formalin solution, send the section microscopy.
Experimental result
1, GUIZHI FULING JIAONANG is to the influence of mice weight of prostate
Each dosage group of GUIZHI FULING JIAONANG is compared with model group, can obviously alleviate mice prostate head lobe and do weight in wet base, alleviate siphonal lobe weight in wet base and weight of seminal vesicle, the most obvious with the big or middle dosage group of GUIZHI FULING JIAONANG effect especially, compare significant difference (P<0.05 with model group; P<0.01).See Table 17.
Table 17 GUIZHI FULING JIAONANG to the influence of mouse experiment prostatic hyperplasia (x ± SD, n=10)
Group Dosage (g/kg) Head lobe Siphonal lobe weight in wet base (mg/g) Seminal vesicle (mg/g) Testis (mg/g)
Weight in wet base (mg/g) Dry weight (mg/g)
Normal group model group GUIZHI FULING JIAONANG GUIZHI FULING JIAONANG GUIZHI FULING JIAONANG positive drug group 4.32 2.16 1.08 3.4 0.780±0.103 1.298±0.377 0.844±0.095 ** 0.935±0.147 * 0.937±0.175 * 0.871±0.136 ** 0.186±0.055 0.304±0.110 0.166±0.027 ** 0.196±0.053 * 0.222±0.074 0.188±0.043 ** 0.395±0.14 0.676±0.162 0.473±0.123 ** 0.478±0.168 * 0.516±0.095 * 0.489±0.157 * 3.737±1.02 5.817±0.726 4.181±0.908 ** 4.416±0.857 ** 4.771±0.811 ** 4.040±0.728 ** 6.203±1.036 4.308±1.217 5.168±1.044 5.383±1.407 5.289±1.062 6.247±0.644 **
Compare * P<0.05 with model group; * P<0.01
2, the pathology microscopy is found
Normal group prostate body of gland marshalling, glandular epithelium is the monolayer column, lumen of gland does not have expansion, between body of gland visible between matter.Model group shows glandular hyperplasia, arranges closely, and companion's stroma hypertrophy, the lumen of gland expansion, the epithelial cell number that is high column increases, and forms mamillary and charges in the lumen of gland.The heavy dose of group of GUIZHI FULING JIAONANG, middle dosage arrangement of mirrors inspection section result shows: the lumen of gland expansion is lighter; Glandular epithelium height, lumen of gland diameter are significantly less than model group, significant difference (P<0.05); Hypertrophy glandular epithelium number obviously is less than model group, and low columnar epithelium is seen more; The small dose group effect is not too obvious, visible more basal cell, and a matter is more.The experimental result prompting: GUIZHI FULING JIAONANG can effectively be treated the mice prostatic hyperplasia.See Table 18
Table 18 GUIZHI FULING JIAONANG is to the influence of mice prostate lumen of gland diameter and glandular epithelium height (x ± SD)
Group Dosage (gkg -1) Number of animals (only) Lumen of gland diameter (μ m) Glandular epithelium height (μ m)
Normal group model group GUIZHI FULING JIAONANG GUIZHI FULING JIAONANG GUIZHI FULING JIAONANG positive drug group 4.32 2.16 1.08 3.4 10 10 10 10 10 10 96.7±33.47 152.0±20.44 127.8±22.10* 131.5±19.44* 139.0±25.14 118.0±30.48* 11.5±2.99 17.1±4.15 13.2±3.16* 13.6±2.80* 15.0±2.87 12.8±3.08*
Compare * P<0.05 with model group
The technology of embodiment 1 preparation Cinnamomi and poria composition
1 raw material is formed: Ramulus Cinnamomi 240g, Poria 240g, Cortex Moutan 240g, Radix Paeoniae Alba 240g, Semen Persicae 240g.Make 1000.
2 preparation technologies: the extraction process of Cortex Moutan should be medical material and breaks into coarse powder and cross 10 mesh sieves, add water-wet after 1.5 hours,, collect 5 times of amount distillates with circulation steam distillation, cold preservation is left standstill, after waiting to separate out crystallization, filter, filtrate is redistillation again, collect 3 times of amount distillates, cold preservation is left standstill, and filters after waiting to separate out crystallization, merges twice crystallization by being proposed the paeonol crystallization.Be ground into fine powder after drying in the shade, make fine grained, dry in the shade, the cryogenic seal storage, stand-by; The Poria powder of Ramulus Cinnamomi, the Radix Paeoniae Alba, Semen Persicae and recipe quantity 20% is broken into coarse powder, mixing; Add the Cortex Moutan medicinal residues, add 90% ethanol of 4 times of amounts of medical material again, soaked 30 minutes, heating and refluxing extraction 2 hours filters, and medicinal residues add 90% ethanol of 3 times of amounts of crude drug again, and reflux, extract, 2 hours filters; Merging filtrate.Medicinal residues add the water of 6 times of amounts of crude drug, and reflux, extract, 1 hour filters; Medicinal residues add the water of 4 times of amounts of crude drug again, and reflux, extract, 1 hour filters, merging filtrate, and medicinal residues are abandoned it; Alcohol extract and water extract be concentrating under reduced pressure respectively, and alcohol extract is recycled to does not have the alcohol flavor.Merge two concentrated solutions, get sepia thickness mastic, relative density is 1.25 (80 ℃); With the Poria fine powder (100 order) and above-mentioned extractum mixing of other 80% recipe quantity, drying is pulverized, and granulates oven dry; Add the paeonol fine grained, mixing is crossed 20 mesh sieves, promptly.
The technology of embodiment 2 preparation GUIZHI FULING JIAONANG
1 raw material is formed: Ramulus Cinnamomi 240g, Poria 240g, Cortex Moutan 240g, Radix Paeoniae Alba 240g, Semen Persicae 240g.Make 1000.
2 preparation technologies: the extraction process of Cortex Moutan should be medical material and breaks into coarse powder and cross 10 mesh sieves, add water-wet after 1.5 hours,, collect 9 times of amount distillates with circulation steam distillation, cold preservation is left standstill, after waiting to separate out crystallization, filter, filtrate is redistillation again, collect 3 times of amount distillates, cold preservation is left standstill, and filters after waiting to separate out crystallization, merges twice crystallization by being proposed the paeonol crystallization.Be ground into fine powder after drying in the shade, make fine grained, dry in the shade, the cryogenic seal storage, stand-by; The Poria powder of Ramulus Cinnamomi, the Radix Paeoniae Alba, Semen Persicae and recipe quantity 20% is broken into coarse powder, mixing; Add the Cortex Moutan medicinal residues, add 90% ethanol of 4 times of amounts of medical material again, soaked 30 minutes, heating and refluxing extraction 2 hours filters, and medicinal residues add 90% ethanol of 3 times of amounts of crude drug again, and reflux, extract, 2 hours filters; Merging filtrate.Medicinal residues add the water of 6 times of amounts of crude drug, and reflux, extract, 1 hour filters; Medicinal residues add the water of 4 times of amounts of crude drug again, and reflux, extract, 1 hour filters, merging filtrate, and medicinal residues are abandoned it; Alcohol extract and water extract be concentrating under reduced pressure respectively, and alcohol extract is recycled to does not have the alcohol flavor.Merge two concentrated solutions, get sepia thickness mastic, relative density is 1.25 (80 ℃); With the Poria fine powder (100 order) and above-mentioned extractum mixing of other 80% recipe quantity, drying is pulverized, and granulates oven dry; Add the paeonol fine grained, mixing is crossed 20 mesh sieves, in incapsulating, makes 1000, promptly.Every heavy 0.31g is equivalent to crude drug 1.20g.
The technology of embodiment 3 preparation GUIZHI FULING JIAONANG
1 raw material is formed: Ramulus Cinnamomi 240g, Poria 240g, Cortex Moutan 240g, Radix Paeoniae Alba 240g, Semen Persicae 240g.Make 1000.
2 preparation technologies: the Poria five kinds of Chinese medicine of getting Ramulus Cinnamomi, Semen Persicae, the Radix Paeoniae Alba, Cortex Moutan and 50% recipe quantity is broken into coarse powder, and mixing adds 90% ethanol of 3 times of amounts of medical material, soaks 0.5 hour, and heating and refluxing extraction 1 hour filters; Medicinal residues add 90% ethanol of 3 times of amounts of crude drug again, and reflux, extract, filters merging filtrate; Medicinal residues add the water of 5 times of amounts of crude drug, and reflux, extract, 0.5 hour filters; Medicinal residues add the water of 5 times of amounts of crude drug, and reflux, extract, 0.5 hour filters; Merging filtrate, medicinal residues are abandoned it; Alcohol extract and water extract be concentrating under reduced pressure respectively, and alcohol extract is recycled to does not have the alcohol flavor; Merge two concentrated solutions, get sepia extractum; With the Poria fine powder and the above-mentioned extractum mixing of other 50% recipe quantity, drying is pulverized, and granulates, and 20 mesh sieves are crossed in oven dry, in incapsulating, make 1000, promptly.Every heavy 0.31g is equivalent to crude drug 1.20g.
The technology of embodiment 4 preparation cassia twig tuckahoe tablets
1 raw material is formed: Ramulus Cinnamomi 240g, Poria 240g, Cortex Moutan 240g, Radix Paeoniae Alba 240g, Semen Persicae 240g.Make 1000.
2 preparation technologies: the Poria five kinds of Chinese medicine of getting Ramulus Cinnamomi, Semen Persicae, the Radix Paeoniae Alba, Cortex Moutan and 50% recipe quantity is broken into coarse powder, and mixing adds 90% ethanol of 3 times of amounts of medical material, soaks 0.5 hour, and heating and refluxing extraction 1 hour filters; Medicinal residues add 90% ethanol of 3 times of amounts of crude drug again, and reflux, extract, filters merging filtrate; Get cinnamic aldehyde content 0.67g, paeonol content 1.78g; Medicinal residues add the water of 5 times of amounts of crude drug, and reflux, extract, 0.5 hour filters; Medicinal residues add the water of 5 times of amounts of crude drug, and reflux, extract, 0.5 hour filters; Content of paeoniflorin 2.56g, merging filtrate, medicinal residues are abandoned it; Alcohol extract and water extract be concentrating under reduced pressure respectively, and alcohol extract is recycled to does not have the alcohol flavor; Merge two concentrated solutions, get sepia extractum; With the Poria fine powder and the above-mentioned extractum mixing of other 50% recipe quantity, drying is pulverized, granulate, and oven dry, through the pelletizing machine granulate, tabletting, every heavy 0.31g is equivalent to crude drug 1.20g.
The application of embodiment 5 Cinnamomi and poria compositions in the medicine of treatment prostatic hyperplasia
Ramulus Cinnamomi 240g, Poria 240g, Cortex Moutan 240g, Radix Paeoniae Alba 240g, Semen Persicae 240g.Make 1000,0.31g/ grain or sheet, the patient of trouble prostatoplasia diseases, oral, each 3, every day 3 times.
The application of embodiment 6 Cinnamomi and poria compositions in the medicine of treatment cyclomastopathy
Ramulus Cinnamomi 240g, Poria 240g, Cortex Moutan 240g, Radix Paeoniae Alba 240g, Semen Persicae 240g.Make 1000,0.31g/ grain or sheet, the patient of trouble hyperplasia of mammary glands, oral, each 3, every day 3 times.

Claims (5)

1, a kind of Cinnamomi and poria composition is characterized in that said composition is prepared by following method:
Get equivalent Ramulus Cinnamomi, Poria, Semen Persicae, the Radix Paeoniae Alba, Cortex Moutan five kinds of Chinese medicine; The Poria five kinds of Chinese medicine of getting Ramulus Cinnamomi, Semen Persicae, the Radix Paeoniae Alba, Cortex Moutan and 40%-60% recipe quantity is broken into coarse powder, mixing; Add 70%-90% ethanol, soaked 0.5-1 hour, heating and refluxing extraction 1-3 time wherein adds the alcoholic acid amount of 70%-90% at every turn and is 3-5 times of crude drug, and the heating and refluxing extraction time is 1-3 hour; Filter merging filtrate; Medicinal residues add the water that crude drug 5-7 doubly measures, reflux, extract, 1-3 time, wherein each reflux extracting time 0.5-1 hour; Filter, merging filtrate, medicinal residues are abandoned it; Alcohol extract and water extract be concentrating under reduced pressure respectively, and alcohol extract is recycled to does not have the alcohol flavor; Merge two concentrated solutions, get sepia extractum; With the Poria fine powder and the above-mentioned extractum mixing of other 40%-60% recipe quantity, drying is pulverized, granulate, and oven dry, granulate, promptly.
2, Cinnamomi and poria composition according to claim 1 is characterized in that said composition is prepared by following method:
Get equivalent Ramulus Cinnamomi, Poria, Semen Persicae, the Radix Paeoniae Alba, Cortex Moutan five kinds of Chinese medicine; The Poria five kinds of Chinese medicine of getting equivalent Ramulus Cinnamomi, Semen Persicae, the Radix Paeoniae Alba, Cortex Moutan and 50% recipe quantity is broken into coarse powder, mixing; Add 90% ethanol, soaked 0.5 hour, heating and refluxing extraction 2 times, the 90% alcoholic acid amount that wherein at every turn adds is 3 times of crude drug, the heating and refluxing extraction time is 1 hour; Filter merging filtrate; Medicinal residues add the water of 5 times of amounts of crude drug, reflux, extract, 2 times, wherein each reflux extracting time 0.5 hour; Filter, merging filtrate, medicinal residues are abandoned it; Alcohol extract and water extract be concentrating under reduced pressure respectively, and alcohol extract is recycled to does not have the alcohol flavor; Merge two concentrated solutions, get sepia extractum; With the Poria fine powder and the above-mentioned extractum mixing of other 50% recipe quantity, drying is pulverized, granulate, and oven dry, granulate, promptly.
3, a kind of preparation method of Cinnamomi and poria composition is characterized in that this method is:
Get equivalent Ramulus Cinnamomi, Poria, Semen Persicae, the Radix Paeoniae Alba, Cortex Moutan five kinds of Chinese medicine; The Poria five kinds of Chinese medicine of getting Ramulus Cinnamomi, Semen Persicae, the Radix Paeoniae Alba, Cortex Moutan and 40%-60% recipe quantity is broken into coarse powder, mixing; Add 70%-90% ethanol, soaked 0.5-1 hour, heating and refluxing extraction 1-3 time wherein adds the alcoholic acid amount of 70%-90% at every turn and is 3-5 times of crude drug, and the heating and refluxing extraction time is 1-3 hour; Filter merging filtrate; Medicinal residues add the water that crude drug 5-7 doubly measures, reflux, extract, 1-3 time, wherein each reflux extracting time 0.5-1 hour; Filter, merging filtrate, medicinal residues are abandoned it; Alcohol extract and water extract be concentrating under reduced pressure respectively, and alcohol extract is recycled to does not have the alcohol flavor; Merge two concentrated solutions, get sepia extractum; With the Poria fine powder and the above-mentioned extractum mixing of other 40%-60% recipe quantity, drying is pulverized, granulate, and oven dry, granulate, promptly.
4, as the preparation method of Cinnamomi and poria composition as described in the claim 3, it is characterized by and be that this method is:
Get equivalent Ramulus Cinnamomi, Poria, Semen Persicae, the Radix Paeoniae Alba, Cortex Moutan five kinds of Chinese medicine; The Poria five kinds of Chinese medicine of getting equivalent Ramulus Cinnamomi, Semen Persicae, the Radix Paeoniae Alba, Cortex Moutan and 50% recipe quantity is broken into coarse powder, mixing; Add 90% ethanol, soaked 0.5 hour, heating and refluxing extraction 2 times, the 90% alcoholic acid amount that wherein at every turn adds is 3 times of crude drug, the heating and refluxing extraction time is 1 hour; Filter merging filtrate; Medicinal residues add the water of 5 times of amounts of crude drug, reflux, extract, 2 times, wherein each reflux extracting time 0.5 hour; Filter, merging filtrate, medicinal residues are abandoned it; Alcohol extract and water extract be concentrating under reduced pressure respectively, and alcohol extract is recycled to does not have the alcohol flavor; Merge two concentrated solutions, get sepia extractum; With the Poria fine powder and the above-mentioned extractum mixing of other 50% recipe quantity, drying is pulverized, granulate, and oven dry, granulate, promptly.
5, as any one Cinnamomi and poria composition as described in the claim 1-2, it is characterized in that this Cinnamomi and poria composition makes oral formulations, its oral formulations is selected from a kind of in the middle of tablet, pill, capsule, granule, suspensoid, drop pill or the oral liquid.
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CN101036709B (en) * 2006-03-15 2011-02-09 北京因科瑞斯生物制品研究所 Chinese medicine preparation for treating gynecopathy and its preparing process
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CN104784286A (en) * 2015-05-11 2015-07-22 李汶峰 Traditional Chinese medicine for treating hyperplasia of mammary glands
CN111122728B (en) * 2019-12-24 2021-03-26 江苏康缘药业股份有限公司 Detection method of cassia twig and poria cocos capsules
CN112545941A (en) * 2020-12-17 2021-03-26 广州环亚化妆品科技有限公司 Traditional Chinese medicine composition with whitening, anti-inflammatory and anti-aging functions and preparation method and application thereof

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