CN110179893A - Ten tastes ginseng returns enema fluid and its preparation process - Google Patents

Ten tastes ginseng returns enema fluid and its preparation process Download PDF

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CN110179893A
CN110179893A CN201910528050.XA CN201910528050A CN110179893A CN 110179893 A CN110179893 A CN 110179893A CN 201910528050 A CN201910528050 A CN 201910528050A CN 110179893 A CN110179893 A CN 110179893A
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alcohol
tastes
ginseng
enema fluid
extract
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CN110179893B (en
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何艳春
莫秋瑜
黄瑞松
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NANNING HEALTHCARE HOSPITAL FOR WOMEN CHILDREN
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NANNING HEALTHCARE HOSPITAL FOR WOMEN CHILDREN
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Abstract

The invention discloses a kind of herbal mixtures, are mainly made of following medicinal material: Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, rhizoma corydalis, Asiatic plantain, peach kernel, cordate houttuynia, Artemisia anomala, dandelion, radix paeoniae rubra, field pennycress.Accordingly, inventor develop ten tastes ginseng return enema fluid and its preparation process.The product has clearing heat and detoxicating, promoting blood circulation, promoting qi circulation and relieving pain, resolving hard lump effect, is suitable for junction type, damp-heat accumulation type, Accumulation of Dampness Heat and Blood Stasis type, qi stagnation and blood stasis type urgent chronic pelvic inflammatory disease in clinical common ecchymosis.Clinical practice proves that ten tastes ginseng of the invention returns enema fluid prescription effective to the pelvic inflammatory disease disease of each parting, is alleviated obviously using rear patient symptom, patient's tolerance is good, cure rate is high, and recurrence rate is low, adverse reaction seldom occurs, therefore clinical use is safe and reliable, and it is curative for effect, toxic side effect is not found.

Description

Ten tastes ginseng returns enema fluid and its preparation process
Technical field
The invention belongs to technical field of traditional Chinese medicines, more particularly to a kind of ten tastes ginseng to return enema fluid and its preparation process.
Background technique
Pelvic inflammatory disease (PID) refers to one group of infectious diseases of genital tract on Female in child bearing period, mainly includes uterus Intimitis, salpingitis, tubo-ovarian abscess, pelvic peritonitis.Pelvic inflammatory disease does not obtain in time thoroughly treatment such as, It may result in a series of sequelae, i.e. sequelae of pelvic inflammatory disease (SPID), main pathological change is disorganization, extensively General adhesion, hyperplasia and cicatrization；Then lead to a series of corresponding clinical symptoms, such as chronic pelvic pain, infertile.SPID is Common gynecological disease, frequently-occurring disease are that pelvic inflammatory disease continues existing chronic inflammatory state, and feature is that fibrous connective tissue increases Raw, fallopian tubal ovary and surrounding tissue, organ adhesion, cicatricial contracture, blood fortune is unsmooth, or forms mass, ponding, leads to focal zone Carry malabsorption.Because a little, the treatment to pelvic inflammatory disease need to find more effective treatment method.
Doctor trained in Western medicine thinks, chronic pelvic inflammatory disease is the inflammatory persistently generated after Lower Female Genital Tract pathogen retrograde infection to pelvic cavity Reaction can cause pelvic organs and surrounding tissue hyperemia, oedema, exudation and extensive adhesion.Doctor trained in Western medicine is routinely using oral or quiet Arteries and veins instillation antibiotic anti-inflammatory treatment, and the measures such as physical therapy, local application of auxiliary, implement operative treatment when necessary.But due to basin Structure is complicated for anatomical cavity, inflammation can cluster occur, and can lead to various bacteria infection, time-consuming for inflammatory resolution, is used for a long time anti- Raw element easily causes hepatorenal damage, causes flora imbalance, or even cause antibiotics resistance.In addition, after some patientss take antibiotic Sensory symptoms, which are alleviated, to be blindly discontinued, and easily causes Relapse rate, protracted course of disease.
Traditional Chinese medicine thinks, it is contemplated that pelvic inflammatory disease using abdominal pain, lumbosacral pain, intercourse pain and with neoplasm as Major Clinical table Existing, with pelvic inflammation mass when serious, Chinese medicine should belong to scopes such as " abdominal pain " " vaginal discharge diseases " " wei lumps in the abdomen ".Chinese medicine thinks, the interpretation of the cause, onset and process of an illness Mostly improper by taking good care of oneself after menstrual period, sexual strain, postpartum or intrauterine surgery, when vessels of the uterus is hollow, damp and hot, cold-evil or heat toxin are taken advantage of a weak point, and are coagulated Poly- bet, stops up in uterus collaterals of the uterus, makes qi and blood stagnation, and cold-dampness stagnates, and cold-dampness heat toxin is mutually tied with blood, causes operation unsmooth, injures punching and appoints, The stasis of blood and be lump in the abdomen and fall ill.Currently, the more commonly used tcm methods for the treatment of pelvic inflammatory disease have Chinese medicine for oral administration, ironing with Chinese medicine, Chinese medicine with card Acupoint injection therapy, herbal retention enema etc..The enema of the domestic pelvic inflammatory disease for the treatment of at present is of less types, and price is higher, Bu Nengman Sufficient clinical patients demand.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of dosage forms, and ten tastes ginseng novel, easy to use, that stability is high is returned Enema fluid and its preparation process, product treatment pelvic inflammatory disease (acute/chronic) is curative for effect, clinical effectiveness is good, is easy to facing Bed is promoted the use of.
In order to solve the above technical problems, the invention adopts the following technical scheme:
Herbal mixture is mainly made of following medicinal material: Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, rhizoma corydalis, Asiatic plantain, peach kernel, cordate houttuynia, Liu post Slave, dandelion, radix paeoniae rubra, field pennycress.
Application of the above-mentioned herbal mixture in preparation treatment pelvic inflammatory disease drug.
Treatment pelvic inflammatory disease drug is that ten tastes ginseng returns enema fluid.
Ten tastes ginseng returns enema fluid, is mainly made of the medicinal material of following parts by weight: 50 parts of Radix Salviae Miltiorrhizae, 75 parts of Radix Angelicae Sinensis, rhizoma corydalis 50 Part, 75 parts of Asiatic plantain, 75 parts of peach kernel, 75 parts of cordate houttuynia, 50 parts of Artemisia anomala, 75 parts of dandelion, 50 parts of radix paeoniae rubra, 75 parts of field pennycress systems At.
Above-mentioned ten tastes ginseng returns the preparation process of enema fluid, is extracted by Radix Salviae Miltiorrhizae, two taste medicinal material of rhizoma corydalis through ethyl alcohol and obtains alcohol extracting Liquid obtains water extract-alcohol precipitation filtrate through water extract-alcohol precipitation by remaining eight taste medicinal materials, alcohol extract and water extract-alcohol precipitation filtrate be separately recovered ethyl alcohol, Merge after concentration and is made.
Ethyl alcohol extraction operation is carried out as follows: take Radix Salviae Miltiorrhizae 50g, rhizoma corydalis 50g, with 70% alcohol reflux extraction 2 times, every time 1.5 hours, combined extract, filtration, filtrate recycling ethanol was concentrated into the clear cream that relative density is 1.10~1.20 (80 DEG C), standby With.
It is extracted in 2 times with 70% alcohol reflux, 70% amount of alcohol added is for the first time 6 times of medicinal material amount, is for the second time 5 Times.
Operation is carried out as follows in water extract-alcohol precipitation: the 8 total 550g of taste medicinal material under remainder is added water to cook 2 times, and 2 hours for the first time, the Secondary 1.5 hours, collecting decoction, filtration was concentrated into 550ml, and relative density is 1.10~1.20 (80 DEG C), stands, lets cool, add Enter 2 times of amount ethyl alcohol 1100ml, stir evenly, stand 24 hours, filtration, it is 1.10~1.20 that filtrate recycling ethanol, which is concentrated into relative density, The clear cream of (80 DEG C).
It adds water to cook in 2 times, first time amount of water is 13 times of amounts of medicinal material amount, and second of amount of water is 10 times of medicinal material amount Amount.
Operation is carried out as follows in merging: two kinds of clear creams of gained merge after alcohol extract is concentrated respectively with water extract-alcohol precipitation filtrate, Add water to adjust total amount to 1000ml, stir evenly, be packed as every bottle of 100ml, pressure sterilizing to get
Aiming at the problem that gynecology pelvic inflammatory disease lacks economy, active drug, under instruction of Chinese Medicine theory, inventor is according to clinic Couple herbs are summarized, and are had developed a kind of herbal mixture by Long-term clinical verifying optimization, are mainly made of following medicinal material: Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, rhizoma corydalis, Asiatic plantain, peach kernel, cordate houttuynia, Artemisia anomala, dandelion, radix paeoniae rubra, field pennycress.Accordingly, inventor develops ten Taste ginseng returns enema fluid and its preparation process.The product has clearing heat and detoxicating, promoting blood circulation, promoting qi circulation and relieving pain, resolving hard lump effect, is applicable in In junction type, damp-heat accumulation type, Accumulation of Dampness Heat and Blood Stasis type, qi stagnation and blood stasis type urgent chronic pelvic inflammatory disease in clinical common ecchymosis.Clinical practice card Bright, ten tastes ginseng of the invention returns enema fluid prescription effective to the pelvic inflammatory disease disease of each parting, is alleviated obviously using rear patient symptom, Patient's tolerance is good, and cure rate is high, and recurrence rate is low, adverse reaction seldom occurs, therefore clinical use is safe and reliable, curative for effect, Toxic side effect is not found.
Detailed description of the invention
Fig. 1 is the preparation technology figure that ten tastes ginseng of the invention returns enema fluid.
Specific embodiment
Ten tastes join the development for returning enema fluid
One, prescription theoretical foundation
Ten tastes ginseng returns enema fluid to be made of Ten Herbs such as Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, dandelions, and Radix Salviae Miltiorrhizae promoting blood circulation in side is calmed the nerves Calming heart, apocenosis, analgesic；Chinese Angelica blood replonishing activating microcirculation and removing stasis medicinal；Field pennycress, dandelion, cordate houttuynia be clearing heat and detoxicating, cool blood detumescence, softening hard masses dissipate Knot；Asiatic plantain clearing heat and promoting diuresis；Rhizoma corydalis promoting qi circulation and relieving pain；Artemisia anomala temperature, which dissipates, is apt to walk, on the one hand energy activating microcirculation and removing stasis medicinal can help rhizoma corydalis row Gas analgesic, on the other hand can anti-dandelion, field pennycress, cordate houttuynia bitter cold too, play the role of using corrigent.All medicines share, Quan Fang Play clearing heat and detoxicating, activating microcirculation and removing stasis medicinal, promoting qi circulation and relieving pain, resolving hard lump effect altogether, the stagnant interpretation of the cause, onset and process of an illness of the hot, wet of pelvic inflammatory disease of just hitting, the stasis of blood, Therefore preferable curative effect can be obtained.Suitable for junction type, damp-heat accumulation type, Accumulation of Dampness Heat and Blood Stasis type, qi stagnation and blood stasis type in clinical common ecchymosis Urgent chronic pelvic inflammatory disease.
Two, using background
For many years applicant always in the form of for decoction agent our unit use, for treat junction type in common ecchymosis, Damp-heat accumulation type, Accumulation of Dampness Heat and Blood Stasis type, qi stagnation and blood stasis type urgent chronic pelvic inflammatory disease, clinical total treatment number of cases is more than 10000, and curative effect obtains Approve to clinician and patient.Case 100 are observed and recorded in recent years, to knot, damp-heat accumulation, Accumulation of Dampness Heat and Blood Stasis, gas in ecchymosis The effective percentage of stagnant 4 type pelvic inflammatory disease of blood stasis is followed successively by 92.3%, 95.7%, 92.6%, 91.7%.Clinical use is safe and reliable, treats Effect is definite, does not find toxic side effect, the good of patient's tolerance
Three, preparation process
Composition
Radix Salviae Miltiorrhizae 50g, Radix Angelicae Sinensis 75g, rhizoma corydalis 50g, Asiatic plantain 75g, peach kernel 75g, cordate houttuynia 75g, Artemisia anomala 50g, Pu Gong English 75g, radix paeoniae rubra 50g, field pennycress 75g；Enema fluid 1000ml is made altogether
Preparation method
Above ten taste, Radix Salviae Miltiorrhizae, rhizoma corydalis are extracted 2 times with 70% alcohol reflux, and 1.5 hours every time, combined extract was filtered It crosses, filtrate recycling ethanol is concentrated into the clear cream that relative density is 1.10~1.20 (80 DEG C), spare.Remaining 8 taste medicinal materials add decocting It boils 2 times, 2 hours for the first time, second 1.5 hours, collecting decoction, filtration, is concentrated into 550ml, relative density is 1.10~ 1.20 (80 DEG C) stand, let cool, 2 times of amount ethyl alcohol 1100ml are added, stir evenly, and stand 24 hours, filtration, and filtrate recycling ethanol is dense It is reduced to the clear cream that relative density is 1.10~1.20 (80 DEG C).Merge two kinds of clear creams obtained as above, adds water adjustment total amount extremely 1000ml is stirred evenly, and is packed as every bottle of 100ml, pressure sterilizing to get.
Four, rational technology Journal of Sex Research
(1) selection of dosage form
" retention enema " method is the medical fluid that will have decocted appropriate, is filled into rectum by the direct per anum of conduit, therefore not It is influenced by factors such as gastrointestinal enzyme, digestive juice and liver first-pass effects.Patient suitable for inconvenience oral administration.Women Special physiology anatomical features, after rectal mucosa absorbs medical fluid, drug can be quickly in pelvic cavity disperse, it is therefore an objective to blood be promoted to follow Ring improves histotrophic nutrition, reduces capillary permeability, reduces inflammatory seep, is conducive to inhibit connective tissue proliferation, promotes scorching Property mass absorb.And local administration concentration is high, good absorbing, and patient's no pain, expense are low.Its mechanism of action is except reduction is at fiber The content of Smad3 albumen in cell, to control outside the formation of pelvic cavity position fibrosis hyperplasia.Wherein, Radix Angelicae Sinensis, Asiatic plantain, fish The ingredients such as raw meat grass, dandelion can also directly kill the multiple pathogenic microorganisms for causing pelvic inflammatory disease.This method can overcome because of chronic inflammation Fibrous connective tissue hyperplasia, pelvic cavity blood circulation are poor, and the systemic administrations method such as oral, injection is difficult to the shortcomings that reaching lesion.
This product is since prescription medicine amount is big, if the oral preparations such as tablet, capsule are made, manufactured goods quantity can be made big, led Cause dose big, it is bad to take, it can not also overcome oral drugs not high in inflammation local drug concentration, the poor disadvantage of curative effect. In addition, enema can avoid the bad smell and taste of oral drugs, medicament effective component per rectum mucosa absorption is directly made For pelvic cavity, local drug concentration is high, has to states such as hemostasis, inflammation and significantly improves effect, curative effect is good.In can defining Medicine retention enema has a particular advantages for surmounting general oral and intravenously administrable method, and it is cheap, patient compliance is good, nothing Obvious adverse reaction.
(2) technical study
The research of 1 Radix Salviae Miltiorrhizae, rhizoma corydalis extraction process
The main component of the selection Radix Salviae Miltiorrhizae of 1.1 extracting methods contains two big groups, i.e. danshensu, protocatechualdehyde, tanshin polyphenolic acid B The equal liposoluble constituents such as water soluble ingredients and tanshinone IIA, isotanshinone, Cryptotanshinone, rhizoma corydalis mainly contain tetrahydropalmatine, Soluble easily in water or ethyl alcohol.Certain density alcoholic solution can effectively extract water-soluble and liposoluble constituent simultaneously, and penetration is strong, molten Agent facilitates recycling, therefore the extraction of Radix Salviae Miltiorrhizae, rhizoma corydalis is considered as alcohol reflux extracting method.By orthogonal experiment, medicine is investigated The principal elements such as material degree of fragmentation, concentration of alcohol, amount of alcohol, reflow's cycle, return time, and with content of danshinolic acid B, rhizoma corydalis second Cellulose content is performance assessment criteria, and determining influences the optimum process condition that alcohol reflux extracts principal element.
The research of 1.2 alcohol reflux extraction conditions
1.2.1 experimental design
1.2.1.1 the preparation of test solution selects L8(27) orthogonal arrage, investigate medicinal material degree of fragmentation, concentration of alcohol, ethyl alcohol Five amount, reflow's cycle, return time factors, respectively take two levels to be tested, factor level is shown in Table 1.Extracting solution test method Are as follows: take tetrahydropalmatine to be broken into most coarse powder (5 mesh or 10 mesh), Radix Salviae Miltiorrhizae is cut into the thin slice of (2mm or 4mm) thickness, respectively weighs at 3/10 Fang Liang returns the condition of each test arrangement in enema fluid extraction process flow chart and table 1 to carry out refluxing extraction, merges by ten tastes ginseng, Filtration, gained extracting solution add corresponding concentration ethyl alcohol to be settled to 50ml, shake up molten to get alcohol reflux extraction orthogonal test sample Liquid.
The factor level that 1 alcohol reflux of table extracts
Note: the rhizoma corydalis in factor A is coarse powder, and horizontal unit is mesh, and Radix Salviae Miltiorrhizae is slice, horizontal unit mm.
1.2.1.2 the preparation of reference substance solution takes tetrahydropalmatine reference substance appropriate, adds methanol that tetrahydropalmatine is made and contains Amount is the reference substance solution of every 65.8 μ g/ml；It takes tanshin polyphenolic acid B reference substance appropriate, adds 75% methanol that content of danshinolic acid B is made to be The reference substance solution of 0.162mg/ml.
1.2.1.3 the preparation of sample test solution
The preparation of tanshin polyphenolic acid B sample test solution: precision measures sample solution 1.5ml, sets in 10ml measuring bottle, adds corresponding dense The ethyl alcohol of degree shakes up to scale, take subsequent filtrate to get.
The preparation of tetrahydropalmatine sample test solution: take sample molten directly as sample test solution.
1.2.1.4 chromatographic condition
Chromatographic column: Féraud door Gemini C18 (4.6mm × 250mm, 5 μm)；Mobile phase: tanshin polyphenolic acid B is methanol: acetonitrile: Formic acid: water (30:10:1:59)；Tetrahydropalmatine is methanol: 0.1% phosphoric acid solution (60:40)；Flow velocity: 1.0ml/min；Detection Wavelength is respectively as follows: tanshin polyphenolic acid B 286nm；Tetrahydropalmatine 280nm；Column temperature: 30.0 DEG C.
1.2.1.5 measuring method
It takes tanshin polyphenolic acid B reference substance solution and each 10 μ l of tanshin polyphenolic acid B sample test solution to be measured, and calculates orthogonal sample The content of tanshin polyphenolic acid B in product.Tetrahydropalmatine reference substance solution and each 20 μ l of tetrahydropalmatine sample test solution is taken to carry out Measurement, and calculate the content of tetrahydropalmatine in orthogonal sample.The result shows that:
1. tanshin polyphenolic acid B: influence factor primary and secondary: D > E > C > A > B, A, B, C, D, E, without significant between five influence factors Difference, therefore can any combination process conditions.
2. tetrahydropalmatine: influence factor primary and secondary: A > B > C > E > D, other than D factor, other factors are to ethyl alcohol Effect of Alcohol Extracting Procedureto Total has significant difference, optimum combination condition: A2B1C2D1(or D2)E2。
3. alcohol reflux extraction conditions only have an impact (except reflow's cycle to the yield of tetrahydropalmatine through comprehensive analysis Outside), it does not make significant difference to the yield of tanshin polyphenolic acid B.Therefore determine that optimal extract process is A2B1C2D1E2, i.e. rhizoma corydalis is broken Cross 10 meshes, Radix Salviae Miltiorrhizae slice is 2mm；Concentration of alcohol is 70%；6 times that amount of alcohol first time is medicinal material amount are added, second is 5 Times；Refluxing extraction 2 times, every time 1.5 hours.It is shown in Table 2.
2 Radix Salviae Miltiorrhizae of table, yanhusu alcohol reflux extract orthogonal test table and measurement result
F0.05 (1,1)=161.4, F0.01 (1,1)=4052
1.2.1.6 optimization of process conditions
According to the above-mentioned preferred A of analysis result2B1C2D1E2For Radix Salviae Miltiorrhizae, the best ethanol extraction process condition of rhizoma corydalis, i.e. ethyl alcohol Concentration is 70%；Refluxing extraction number is 2 times, is every time 1.5 hours；Amount of alcohol is added: being for the first time 6 times of medicinal material amount, Second is 5 times；Medicinal material is broken to spend broken 10 mesh of mistake of tetrahydropalmatine, Radix Salviae Miltiorrhizae is cut into the thin slice of 2mm.
The technical study of the 8 taste medicinal material water extract-alcohol precipitation part such as 2 Radix Angelicae Sinensis
The selection of 2.1 extracting methods
Radix Angelicae Sinensis mainly contains the compositions such as ferulic acid, volatile oil；Asiatic plantain mainly contains flavones ingredient and benzyl carbinol glycoside: as greatly Plantagin, luteolin etc.；Peach kernel mainly contains amarogentin；Cordate houttuynia mainly contains volatile oil and Flavonoid substances: such as cordate houttuynia Element, Quercetin etc.；Artemisia anomala mainly contains sesquiterpene lactone class, flavonoids and Coumarins composition: as wormwood artemisia flavones, cumarin, Liu post Slave's lactone, arteanomalactone and volatile oil etc.；Dandelion mainly contains taraxasterol alnulin taraxacin, flavonoids, soap The substances such as glycosides, choline, synanthrin, pectin；Radix paeoniae rubra mainly contains Paeoniflorin；Field pennycress mainly contains villoside, morroniside, loganin Etc..It can be seen that the above-mentioned main effective component of each medicine is mostly water-soluble.Make molten coal with water, economical and easily available, safety is big, is suitble to Industrial production, and traditional medication of Chinese medicine can be kept to be accustomed to, therefore water boiling method is used to extract.
2.2 the research of water extract-alcohol precipitation extraction process
2.2.1 experimental design
2.2.1.1 the preparation of test solution
Influence Chinese herbal medicine water boiling and extraction factor may generally have medicinal material degree of fragmentation, boil the number mentioned, boil the time mentioned, Amount of water and alcohol precipitation concentration.Therefore when studying the technique of water extract-alcohol precipitation, this 5 factors is selected to be designed.Select L8(27) orthogonal Table investigates medicinal material degree of fragmentation, boils and mention number, boil and propose five factors such as time, amount of water and alcohol precipitation concentration, respectively takes two horizontal to carry out Test, factor level are shown in Table 3.Extracting solution test method are as follows: take Radix Angelicae Sinensis, Dan peach kernel, Asiatic plantain, cordate houttuynia, Artemisia anomala, Pu Gong The 8 taste medicinal material such as English, radix paeoniae rubra, field pennycress (piece, segment or broken) each 2/5 recipe quantity, returns enema fluid extraction process by ten tastes ginseng The condition of each test arrangement carries out in flow chart and table 3 plus boiling mentions, and constantly addition water is to maintain water, collecting decoction, filter It crosses, is concentrated, lets cool, ethyl alcohol is added, is sufficiently stirred, stand 24 hours, filtration takes filtrate that corresponding concentration ethyl alcohol is added to be dissolved to 100ml shakes up to get aqueous extraction-alcohol precipitation technology orthogonal test sample solution.
The factor level table of 3 water extract-alcohol precipitation of table
2.2.1.2 the preparation of reference substance solution
The preparation of reference substance solution takes ferulic acid reference substance appropriate, adds 70% methanol, and ferulaic acid content is made and is The reference substance solution of 0.010mg/ml；It takes amarogentin reference substance appropriate, adds 70% methanol, amarogentin content, which is made, is 0.1172mg/ml reference substance solution.
2.2.1.3 the preparation of sample test solution
The preparation of ferulic acid sample test solution: sample solution 5ml is taken, is set in 10ml measuring bottle, the ethyl alcohol of respective concentration is added To scale, shake up, take subsequent filtrate to get.
The preparation of amarogentin sample test solution: sample solution 1ml is taken, is set in 5ml measuring bottle, the ethyl alcohol of respective concentration is added To scale, shake up, take subsequent filtrate to get.
2.2.1.4 chromatographic condition
Chromatographic column: Féraud door Gemini C18 (4.6mm × 250mm, 5 μm)；Mobile phase: ferulic acid is acetonitrile: 0.085% Phosphoric acid solution (17:83)；Amarogentin is methanol: water (20:80)；Flow velocity: 1.0ml/min；Detection wavelength is respectively as follows: ferulic acid 316nm；Amarogentin 210nm；Column temperature: 35.0 DEG C of ferulic acid；30 DEG C of amarogentin.
2.2.1.5 measuring method
The measurement of ferulic acid takes each 5ml of orthogonal test test solution respectively, is set in 10ml measuring bottle respectively, adds respective concentration Ethyl alcohol to scale, shake up, measured according to method under 2010 editions Radix Angelicae Sinensis [assay] ferulic acid items of Chinese Pharmacopoeia.Tester Calculation the results are shown in Table 4.
The measurement of amarogentin takes orthogonal test test solution (1~No. 8) 1ml respectively, sets in 5ml measuring bottle, adds corresponding The ethyl alcohol of concentration shakes up, to scale according to method under 2010 pressing product of Chinese Pharmacopoeia, one peach kernel [assay] amarogentin item Measurement.
As a result: 1. ferulic acid: influence factor primary and secondary: A > E > B > C > D, A, B, C, D, E, each factor is to water boiling and extraction There was no significant difference for technique, optimum combination condition: A2B2C1D1E2；
2. amarogentin: influence factor primary and secondary: A > D > E > B > C, other than C factor, other factors decoct water Extraction process has significant difference, therefore can any combination process conditions.
3. through comprehensive analysis, aqueous extraction-alcohol precipitation technology condition only has an impact and (takes outside extraction time) to the yield of amarogentin, In conjunction with industrial actual conditions, water extract-alcohol precipitation optimum extraction process should be A2B1C1D2E1, i.e. medicinal materials such as whole grass Asiatic plantain It is cut into the section of a length of 2cm, root class medicinal material Radix Angelicae Sinensis etc. is cut into the thin slice that thickness is 0.5cm, and peach kernel is not crushed；It adds water to cook 2 times；1st Secondary amount of water is 13 times of medicinal material amount, the 2nd time plus water is 10 times；1st decoction 2h, the 2nd decoction 1.5h；Ethyl alcohol is added when alcohol precipitation Amount is 2 times of amounts of medical fluid.It is shown in Table 4.
The eight taste liquid medicine such as 4 Radix Angelicae Sinensis of table, which boils, extracts orthogonal array and experimental result
F0.05 (1, l)=161.4
2.2.1.6 optimization of process conditions
Therefore, according to the above-mentioned preferred A of analysis result2B1C1D2E1For the optimal extract process of the 8 taste medicine such as Radix Angelicae Sinensis, i.e., entirely Careless dissection (2cm) or rhizome slice (0.50cm), peach kernel whole grain；It adds water to cook 2 times, first time amount of water is 13 times of medicinal material amount Amount decocts 2 hours；Second of amount of water is 10 times of amounts of medicinal material amount, is decocted 1.5 hours；It is medical fluid that amount of alcohol is added when alcohol precipitation 2 times of amounts of concentrate are used as optimum extraction process.
The trial-production of 3 amplification techniques
Preparation process is determined by the studies above, according to above-mentioned test result, with the best alcohol extracting of optimization and extraction process by water item Part has carried out 8 times of continuous 6 batches of amplification technique experimental studies of amount of recipe quantity, and 6 batches of laboratory pilot sample yields are 95.0% ~97.5%, illustrate this stable processing technique, meets production requirement.
It is prepared as described above the ginseng of ten tastes made from technique and returns enema fluid, tested through chemical component, contain saponin, flavonoid The ingredients such as object, alkaloid, organic acid；Thin layer identification can detect the medicinal materials such as Radix Salviae Miltiorrhizae, rhizoma corydalis, radix paeoniae rubra and peach kernel, content of danshinolic acid B It is all larger than 0.20mg/ml.As a result this product meets the regulation of this product quality standard through long-time stability and accelerated stability test With hygienic requirement.Show to join according to ten tastes made from this preparation process return enema fluid substantially and can retain the activity of ingredients at Point and original soup agent quality, and quality stablize, illustrate that the preparation process is reasonable, feasible
4 " ten tastes ginseng returns enema fluid " clinical observation on the therapeutic effect
" ten tastes ginseng returns enema fluid " is as follows using system observation case clinical summary for many years:
4.1 research object
With in May, -2015 in April, 2014, applicant's outpatient service was made a definite diagnosis, urgent chronic pelvic inflammatory disease patient 100 are research pair As.It is age 21~42 years old, 31.25 years old average.All case diagnosis all meet the Western medicine diagnostic criteria of pelvic inflammatory disease.Wherein acute basin Chamber is 68, the course of disease 2~3 weeks, chronic pelvic inflammatory disease 32, the course of disease 4~6 weeks scorching.All cases meet Syndrome Differentiation of Traditional Chinese Medicine standard, point For junction type 26 in ecchymosis, damp-heat accumulation type 23,27, Accumulation of Dampness Heat and Blood Stasis type, qi stagnation and blood stasis type 24.Clinical cardinal symptom table Existing: hypogastralgia 92, lumbus sacrum pain 39, profuse leukorrhea 91, leukorrhagia color is 80 yellow, and smelly 36, leukorrhagia gas, low-heat rises and falls 36, dysmenorrhea aggravates 38.
4.2 prescriptions and usage and dosage
Prescription: Radix Salviae Miltiorrhizae 5g, Radix Angelicae Sinensis 7.5g, rhizoma corydalis 5g, Asiatic plantain 7.5g, peach kernel 7.5g, cordate houttuynia 7.5g, Artemisia anomala 5g, dandelion 7.5g, radix paeoniae rubra 5g, field pennycress 7.5g.
Usage: one dose per day is prepared by technique, and decocting liquid is condensed into 100ml, one dose per day retention enema, retain 0.5~ 1 hour, 7 doses as a treatment course, adds and subtracts 2~3 doses of correspondences depending on prognosis situation and consolidates and strengthen or lighten the burden treatment.Menstrual period deactivate, treatment phase Between avoid love life.It is recommended that acute pelvitis of pelvic cavity medication is no less than 2 courses for the treatment of, chronic pelvic inflammatory disease medication is no less than 4 courses for the treatment of.Treatment knot Curative effect is evaluated after beam.
4.3 efficacy determination
Treat advance promoting circulation of blood routine test, erythrocyte sedimentation rate, adnexa uteria ultrasound diagnosis, vagina, cervical secretions plate coating checking or training It supports and laboratories is waited to check 1 time.Related symptoms, sign and tcm syndrome, before and after treatment each observation 1 time.Each symptom, sign and disease It is scored according to the light and heavy degree (diseased region and range, pressure tenderness degree, mass size etc.) of local patholoic change.Asymptomatic sign and The note 0 of disease is divided, and has symptom, sign and disease, by gently to reset determine weight score value be 2 points, 4 points, 6 points.
(1) acute pelvitis of pelvic cavity
(1) diseases such as hypogastralgia and fever disappear after recovery from illness treatment, and general inspection, gynecologial examination and physico-chemical examination are normal. Syndrome, somatic feature score and reduction >=95%.Drug withdrawal is not recurred in January.
(2) diseases such as hypogastralgia and fever disappear after effective treatment, and general inspection, gynecologial examination and physico-chemical examination obviously change It is kind.Syndrome, somatic feature score and reduction >=70%.
(3) diseases such as hypogastralgia and fever mitigate effectively after treatment, and general inspection, gynecologial examination and physico-chemical examination are changed It is kind.Disease, somatic feature score and reduction >=30%.
(4) after futile treatment the diseases such as hypogastralgia and fever without mitigating or have exacerbation, general inspection, gynecologial examination and physics and chemistry Checking improves or has exacerbation before relatively treating.Syndrome, somatic feature score and reduction < 30%.
(2) chronic pelvic inflammatory disease
(1) diseases such as hypogastralgia and waist sacrum distending pain disappear after recovery from illness treatment, and gynecologial examination and physico-chemical examination are normal.Syndrome, Sign and point and reduce >=95%.It is not recurred in January after drug withdrawal.
(2) diseases such as hypogastralgia and waist sacrum distending pain mitigate after effective treatment, and gynecologial examination and physico-chemical examination make moderate progress.Disease Time, somatic feature score and reduction >=70%.
(3) diseases such as hypogastralgia and waist sacrum distending pain mitigate effectively after treatment, and gynecologial examination and physico-chemical examination make moderate progress.Disease Time, somatic feature score and reduction >=30%.
(4) after futile treatment the diseases such as hypogastralgia and waist sacrum distending pain without mitigating or have exacerbation, gynecologial examination and physico-chemical examination Compared with before treatment without improving or have exacerbation.Syndrome, somatic feature score and reduction < 30%.
(3) main indicator (local sign) efficacy assessment standard
(1) sign disappears after recovery from illness treatment, and integrated value reduces >=95%, or reduces by 2 ranks.
(2) sign is substantially reduced after effective treatment, and integrated value reduces >=70%, or reduces by 1 rank.
(3) sign is mitigated effectively after treatment, and integrated value reduces >=30%, or reduces less than 1 rank.
(4) for sign without improving or having exacerbation, syndrome integral value reduces < 30% after futile treatment
(4) disease efficacy assessment standard
(1) each symptom is substantially reduced after recovery from illness treatment, and syndrome integral reduces >=95%
(2) each symptom is substantially reduced after effective treatment, and syndrome integral value significantly reduces >=70%
(3) each symptom is mitigated effectively after treatment, and syndrome integral value significantly reduces >=30%
(4) for symptom without mitigating or having exacerbation, syndrome integral value reduces < 30% after futile treatment
4.4 result
(1) acute and chronic curative effect distribution situation
Acute pelvitis of pelvic cavity has 68, wherein 35 (51.5%) of recovery from illness, effective 24 (35.3%), effective 7 (10.3%), invalid 3 (4.4%), total effective rate 95.6%；Chronic pelvic inflammatory disease has 32, wherein recovery from illness 13 (40.6%), effective 11 (34.4%), effective 3 (9.4%), invalid 4 (12.5%), total effective rate 87.5%.It is anxious Property and chronic curative effect it is variant, Acute Phase to it is chronic effectively, but difference does not have statistical difference, P > 0.05.100 pelvic inflammatory disease Total effective rate is 93% in patient.It is shown in Table 5.
The distribution of 5 acute and chronic curative effect of table
Note: it is acute compared with chronic without significant difference, P > 0.05.
(2) curative effect distribution situation of the acute and chronic in TCM Syndrome Type
It is acute in 100 Patients with Pelvic Inflammatory Disease to account for 68%, it is chronic to account for 32%.Through dialectical, four card type proportions are as follows: ecchymosis Interior knot acute 24 (92.3%) is chronic 2 (7.7%)；Damp-heat accumulation is acute 21 (91.3%), chronic 2 (8.7%)； Accumulation of Dampness Heat and Blood Stasis is acute 22 (81.5%), chronic 5 (18.8%)；Qi stagnation and blood stasis type is acute 1 (4.2%), and chronic 23 (95.8%).It is shown in Table 6.
Distribution of 6 acute and chronic of table in TCM Syndrome Type
(3) four groups of TCM syndrome curative effects compare
Junction type 26 in ecchymosis, wherein 13 (50.0%) of recovery from illness, effective 9 (34.6%), effective 2 (7.7%), nothing Imitate 2 (7.7%), total effective rate 92.3%；Damp-heat accumulation type 23, wherein 12 (52.2%) of recovery from illness, effective 8 (34.8%), effective 2 (8.7%), invalid 1 (4.3%), total effective rate 95.7%；27, Accumulation of Dampness Heat and Blood Stasis type, wherein fullying recover from an illness More 13 (48.1%), effective 9 (33.3%), effective 3 (11.1%), invalid 2 (7.4%), total effective rate is 92.6%；Qi stagnation and blood stasis type 24, wherein 10 (41.7%) of recovery from illness, effective 9 (37.5%), effective 3 (12.5%), nothing Imitate 2 (8.3%), total effective rate 91.7%；Each TCM syndrome parting total effective rate no difference of science of statistics, P > 0.05.It is shown in Table 7。
7 four groups of TCM syndrome curative effects of table compare
Note: each equal indifference of comparison among groups, P > 0.05.
4.5 discussing
Dandelion, field pennycress, cordate houttuynia all have antipyretic and antidote functions in " ten tastes ginseng returns enema fluid " bowel lavage side；Radix Salviae Miltiorrhizae, Rhizoma corydalis, peach kernel activating microcirculation and removing stasis medicinal, promoting qi circulation and relieving pain；Radix Angelicae Sinensis is tonic, and solid protection healthy tendency enhances human immunity；Radix paeoniae rubra heat-clearing is cool Blood；Asiatic plantain reducing fever and causing diuresis is by wet；Artemisia anomala blood-breaking promoting menstruation, healing up sore and subduing swelling.The herbal enema side of above each taste medicine composition is comprehensive The characteristics of to return liver, spleen, the heart channel of Hang-Shaoyin to be main, globally for the stasis of blood, heat, wet all heresies, to play clearing heat and detoxicating, the Eradicates stasis of blood of invigorating blood circulation, row The effect of gas analgesic, resolving hard lump.
The present invention " ten tastes ginseng returns enema fluid " retention enema, absorbs drug per rectum mucous membrane veniplex, without liver generation It thanks, alleviates burden of liver, also avoid stimulation of the bitter and cold medicines to gastrointestinal tract.In view of this disease harmfulness, this research does not set control Group.Separately because clinical use Western medicine method case is less, control group is not added again.But west is shown according to the clinical research of Huang Liesheng Medicine adds penicillin 6,400,000 U/ days using 5% glucose injection 250ml, and 0.5% Metronidazule injection 200ml/ days, vein dripped Note, 1 times/day；The person that has gastrointestinal reaction, takes orally paspertin metoclopramide 10mg, and 3 times/day；There is mycotic infection person to take orally this benevolence promise 0.1,1 Times/day, it even served 2 weeks；There are mycoplasma and choamydiae infection person to take orally josamycin or roxithromycin.Total effective rate is 65.33%, There are significant differences with Treated in Retention Enema with Chinese Medicine group is used.Song Ling's studies have shown that use conventional anti-infection, fluid infusion etc. pair Disease supportive treatment, total effective rate are only 60.0%.There are significant differences with Treated in Retention Enema with Chinese Medicine group is used.Wang Haina etc. Studies have shown that Western medicine adds Cefotaxime Sodium 2.01g using 5% glucose saline 250ml；And 0.5% Metronidazule injection 100ml intravenous drip, 2 times/d, 7d is 1 course for the treatment of, totally 2 courses for the treatment of.There are fungal infections to increase and takes orally Fluconazole 0.12g, 1 Secondary/d even served 6d, and total effective rate 77.5%, there are significant differences with Treated in Retention Enema with Chinese Medicine group is used.
Statistical data shows in the majority with acute onset in Patients with Pelvic Inflammatory Disease.The acute attack stage course of disease is short, mostly because of hypogastralgia Come to go to a doctor extremely with leukorrhagia.Its clinical primary symptom and chronic difference are there is fever or lasting with aversion to cold, low-heat, and physical examination has Hypogastralgia companion or not companion's rebound tenderness, lifting pain, palace body tenderness, the local sign of attachment area tenderness.When acute pelvitis of pelvic cavity not It can thoroughly treat or patient's constitution is poor, protracted course is not cured, and is finally translated into chronic inflammation, and damp evil blocks mechanism of qi at this time, is led Stagnation of QI-blood is caused, therefore chronic pelvic inflammatory disease category qi stagnation and blood stasis type is in the majority.Symptoms include except hypogastralgia, the leukorrhagia that acute stage also occurs are different Often outer to see also except lumbus sacrum pain, spiritlessness and weakness, dysmenorrhea exacerbation, shape cold limb cold, diarrhea with loose stool etc., physical examination has uterus living Dynamic limited or adhesion is fixed with tenderness；Attachment area tenderness.
According to theory of traditional Chinese medical science, referring to " the Clinical Researches of New Drugs guideline of Chinese medicine treatment pelvic inflammatory disease ", according to clinical characters By the Patients with Pelvic Inflammatory Disease medicine typing of observation, there are knot, damp-heat accumulation, Accumulation of Dampness Heat and Blood Stasis, 4 type of qi depression to blood stasis in ecchymosis.Wherein ecchymosis Interior junction type 26 (accounting for 26%), damp-heat accumulation 23 (accounting for 23%), Accumulation of Dampness Heat and Blood Stasis 27 (accounting for 27%), qi depression to blood stasis example 24 (accounts for 24%).It can be seen that in the pelvic inflammatory disease patient of the studies above, with acute attack with knot in ecchymosis, damp-heat accumulation, damp and hot Stasis type is in the majority.Knot in ecchymosis, damp-heat accumulation, Accumulation of Dampness Heat and Blood Stasis, 4 type of qi depression to blood stasis effective percentage be followed successively by 92.3%, 95.7%, 92.6%, 91.7%, 4 groups of TCM syndrome curative effect no difference of science of statistics.Illustrate that ten tastes ginseng returns enema fluid prescription to the basin of each parting Chamber inflammation is waited effective.
4.6 conclusion
" ten tastes ginseng return enema fluid " prescription is for urgent chronic pelvic inflammatory disease, according to Syndrome Differentiation of Traditional Chinese Medicine, for knot in ecchymosis, wet Heat is pented up, Accumulation of Dampness Heat and Blood Stasis, 4 type opinion of qi depression to blood stasis are controlled and obtain good effect, i.e. remission is obvious, and patient's tolerance is good, Cure rate is high, and recurrence rate is low, and adverse reaction occurs in only a few, therefore clinical use is safe and effective.

Claims (10)

1. a kind of herbal mixture, it is characterised in that be mainly made of following medicinal material: Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, rhizoma corydalis, Asiatic plantain, peach kernel, Cordate houttuynia, Artemisia anomala, dandelion, radix paeoniae rubra, field pennycress.
2. application of the herbal mixture described in claim 1 in preparation treatment pelvic inflammatory disease drug.
3. application according to claim 2, it is characterised in that: the treatment pelvic inflammatory disease drug is that ten tastes ginseng returns enema fluid.
4. ten tastes ginseng as claimed in claim 3 returns enema fluid, it is characterised in that be mainly made of the medicinal material of following parts by weight: Radix Salviae Miltiorrhizae 50 parts, 75 parts of Radix Angelicae Sinensis, 50 parts of rhizoma corydalis, 75 parts of Asiatic plantain, 75 parts of peach kernel, 75 parts of cordate houttuynia, 50 parts of Artemisia anomala, dandelion 75 Part, 50 parts of radix paeoniae rubra, 75 parts of field pennycress be made.
5. ten tastes described in claim 4 join the preparation process for returning enema fluid, it is characterised in that passed through by Radix Salviae Miltiorrhizae, two taste medicinal material of rhizoma corydalis Ethyl alcohol, which extracts, obtains alcohol extract, obtains water extract-alcohol precipitation filtrate, alcohol extract and water extract-alcohol precipitation through water extract-alcohol precipitation by remaining eight taste medicinal materials Filtrate is separately recovered after ethyl alcohol, concentration to merge and be made.
6. the preparation process that ten taste according to claim 5 ginseng returns enema fluid, it is characterised in that the ethyl alcohol extract by with Under operated: take Radix Salviae Miltiorrhizae 50g, rhizoma corydalis 50g, with 70% alcohol reflux extract 2 times, 1.5 hours every time, combined extract, Filtration, filtrate recycling ethanol is concentrated into the clear cream that relative density is 1.10~1.20, spare.
7. the preparation process that ten tastes ginseng according to claim 6 returns enema fluid, it is characterised in that described to be returned with 70% ethyl alcohol Stream extracts in 2 times, and 70% amount of alcohol added is for the first time 6 times of medicinal material amount, is for the second time 5 times.
8. the preparation process that ten taste according to claim 5 ginseng returns enema fluid, it is characterised in that the water extract-alcohol precipitation press with Under operated: the 8 total 550g of taste medicinal material under remainder is added water to cook 2 times, 2 hours for the first time, second 1.5 hours, is merged and is decocted Liquid, filtration are concentrated into 550ml, and relative density is 1.10~1.20, stand, let cool, 2 times of amount ethyl alcohol 1100ml are added, stir evenly, 24 hours are stood, filtration, filtrate recycling ethanol is concentrated into the clear cream that relative density is 1.10~1.20.
9. the preparation process that ten tastes ginseng according to claim 8 returns enema fluid, it is characterised in that described to add water to cook 2 times In, first time amount of water is 13 times of amounts of medicinal material amount, and second of amount of water is 10 times of amounts of medicinal material amount.
10. according to right want 5 described in ten tastes ginseng return the preparation process of enema fluid, it is characterised in that the merging is carried out as follows Operation: two kinds of clear creams of gained merge after alcohol extract is concentrated respectively with water extract-alcohol precipitation filtrate, add water adjustment total amount to 1000ml, stir It is even, be packed as every bottle of 100ml, pressure sterilizing to get.
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