CN102100857B - Medicament composition used for treating chronic pelvic inflammatory disease and preparation method thereof - Google Patents

Medicament composition used for treating chronic pelvic inflammatory disease and preparation method thereof Download PDF

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CN102100857B
CN102100857B CN 201010608891 CN201010608891A CN102100857B CN 102100857 B CN102100857 B CN 102100857B CN 201010608891 CN201010608891 CN 201010608891 CN 201010608891 A CN201010608891 A CN 201010608891A CN 102100857 B CN102100857 B CN 102100857B
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inflammatory disease
radix
parts
pelvic inflammatory
rhizoma
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CN102100857A (en
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张丽
马宝璋
曲文华
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SUNFLOWER PHARMACEUTICAL GROUP (YICHUN) CO Ltd
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Abstract

The invention relates to a granule used for treating chronic pelvic inflammatory disease. The granular formulation is characterized by being prepared from the following components in parts by weight: 1-75 parts of honeysuckle, 5-65 parts of red peony root, 3-50 parts of scutellaria baicalensis or golden cypress, 8-30 parts of sanguisorba or cacumen biotae, 5-20 parts of radix bupleuri, 1-40 partsof corydalis tuber or the rhizome of szechuan lovage rhizome, 2-40 parts of rhizoma cyperi or Chinese angelica and the root of three-nerved spicebush, 2-25 parts of semen coicis and 1-20 parts of rhizoma dioscoreae nipponicae. On the basis of 'dampness, heat, stagnation and obstruction', the granule is applied according to indications and has obvious treatment effect on pelvic inflammatory disease; and Chinese herbal medicines in the formula are available, the cost is relatively low, and the medicine is convenient to prepare by mass production.

Description

A kind of pharmaceutical composition that is used for the treatment of chronic pelvic inflammatory disease and preparation method thereof
Technical field
The present invention relates to medicine medicine, specifically, relate to a kind of pharmaceutical composition and preparation method thereof.
Background technology
Chronic pelvic inflammatory disease (Chronic pelvic inflammatory disease, CPID) refers to that reproductive tract infection causes the general name of chronic inflammation disease, and it comprises chronic metritis, chronic salpingo-ocphoritis, chronic pelvic paramitritis; Be commonly encountered diseases, the difficult disease of harm WomanHealth, outbreak, touching difficulty more are difficult problems in the gynecological clinic repeatedly; Its main clinical manifestation is menoxenia, leucorrhoea grow in quantity, waist abdomen pain and infertile etc., as forming chronic adnexitis, then can touch lump;
The Etiological that causes pelvic inflammatory disease has: 1, infect puerperal or post-abortion: a minute puerperium puerpera has a delicate constitution, the cervix uteri mouth is because there being the turbid liquid stream of residual blood to go out, in time do not close, placental release surface in the uterine cavity, or childbirth causes injury of birth canal, or has Placenta Hominis, fetal membrane residual etc., or sexual life is arranged puerperal too early, pathogen is invaded in the uterine cavity in an opponent's defence, easily causes infection; Spontaneous abortion, drug induced abortion process medial vagina bleeding time are long, or thing residues in the uterine cavity in a organized way, or the artificial abortion operation sterile working does not strictly wait and all can occur to infect post-abortion;
2, operation technique postoperative infection in the uterine cavity: as placing or take out intrauterine contraceptive device in utero, the dilatation and curettage, hydrotubation, hysterosalpingography, hysteroscopy, mucosa hysteromyoma enucleation etc., sexual life or operation sterilizing are strict or the selection of art prospective adaptation disease is improper owing to having before the art, the original chronic inflammatory disease of reproductive tract, underwent operative are disturbed and are caused acute attack and diffusion; Do not note Personal hygiene behind the corrective surgery that also has, or postoperative is against medical advice, can makes equally the up infection of antibacterial, cause pelvic inflammatory disease;
3, menstrual hygiene is bad: if do not note menstrual hygiene, use unclean sanitary towel and protective pad, bath in a tub in menstrual period, sexual intercourse in menstrual period etc. all can make the pathogen intrusion and cause inflammation; 4, the inflammation direct extension of adjacent organs: modal when being appendicitis, peritonitis, because they and internal genital organs of female adjoin, inflammation can be passed through direct extension, causes pelvic inflammation; When suffering from chronic cervicitis, inflammation also can be passed through lymph circulation, causes inflammation of pelvic connective tissue;
5, acute attack of chronic pelvic inflammatory disease etc.;
Namely in sum, chronic pelvic inflammatory disease is a kind of inflammation, and the harm of waiting a moment property pelvic inflammatory disease is as follows:
1, the harm of infertility pelvic inflammatory disease maximum is to cause infertility.Uterus, fallopian tube and ovary or the tissue around it comprise peritoneum in the pelvic cavity in women's pelvic cavity, when any one is inflamed, can cause woman infertility.Fail to be transformed into when thoroughly treating chronic when acute inflammation, perhaps pelvic inflammatory disease treatment is untimely, delays into when chronic, usually causes woman infertility.
2, nephropathy
Because the pelvic cavity connective tissue links to each other with connective tissue behind the peritoneum, upwards can reach around the kidney, if so acute pelvic inflammatory disease's untreated, inflammation not only can diffuse to the histoorgans such as fallopian tube, pelvic peritoneum, cause pelvic abscess, can also to vertical spread, cause perinephric abscess.
3, spiritual psychological impact
Chronic inflammatory disease is because obstinate, outbreak can impact normal operation and life and physically and mentally healthy repeatedly.
Sickness rate: all lack the large sample statistical data at home and abroad, it is reported that the U.S. has more than 100 ten thousand women to receive treatment because of acute pelvic inflammatory disease every year, year is costed 4,000,000,000 dollars of (Washington AE, katz P.Gost of and pavment Source for pelvir inflammatorv disease trends and Proiections.1983 through 2000.JAMA 1991; 266:2565-2569), US Experts Kate is grown professor and is added: " also having countless trouble ' concealment ' pelvic inflammatory disease women to face chronic pelvic pain, ectopic pregnancy and infertile larger danger with these Symptomatic women " (PcterA Rice.MD Julius Schachter.PhD.[J] JAMA Chinese edition in August, 1992 (11) 4:195-202).Although China should the disease sickness rate statistics, but we are according to the caused married woman's stomachache of CPID, lumbago, distending pain of the breast, preceeded menorrhea, menostaxis, intermenstrual bleeding, metrorrhagia, leukorrheal diseases, tubo-ovarian cyst, hydrops, infertility etc., think that CPID accounts for about Out-patient Clinic of Department of Gynecology amount half, visible primary disease sickness rate is very high; Therefore, the therapeutic purposes of chronic pelvic inflammatory disease are exactly to prevent and recover the dysfunction that reproductive tract infection causes fallopian tube, ovary and pelvic cavity that chronic inflammatory disease causes.
Use clinically at present western medicine therapy, such as treatment CPID such as antibiotic, glucocorticoid and physiotherapys that some are complementary, but the antibiotic not antiinflammatory of antibiotic, the acute attack that can only control inflammation becomes without obviously improvement effect infertile, ectopic pregnancy, chronic pelvic pain chronic diseases; And the not antibiotic and obvious side effect of glucocorticoid antiinflammatory, so seldom be used for the treatment of clinically primary disease.
In recent years, the research of employing traditional Chinese medical herbal treatment chronic pelvic inflammatory disease makes great progress and obtains the attention of gynecological's academia, this has reflected that on the one hand Chinese medicine is more comprehensive and deep to the understanding of chronic pelvic inflammatory disease, and the validity and reliability of TCM therapy for Chronic Pelvic Inflammation also is described on the other hand.
Up to the present the report of TCM therapy for Chronic Pelvic Inflammation nearly ten years is more than 3000 pieces, and majority is limited to clinical observation on the therapeutic effect and general pharmacodynamic study.How further deeply, systematic research Traditional Chinese Medicine Function mechanism, summarized improves, seeking best therapeutic scheme and square medicine is the matter of utmost importance that needs to be resolved hurrily at present.
Present common Chinese patent medicine:
FULE CHONGJI (is comprised of Caulis Sargentodoxae, Caulis Lonicerae, Folium Isatidis, Herba Taraxaci, Radix Paeoniae Rubra, Cortex Moutan, Fructus Toosendan, Rhizoma Corydalis, Radix Et Rhizoma Rhei, Radix Glycyrrhizae etc., 6g * 20 bag/boxes, the precious light Pharmaceutical in Sichuan is produced): the merit with heat-clearing and toxic substances removing, soothing the liver circulation of qi promoting, cooling blood and relieving pain.Usage: every day 2 times, each 1 bag, 1 month was 1 course for the treatment of.
Rhizoma Smilacis Bockii syrup (capsule, tablet): main component is Rhizoma Smilacis Bockii, has another name called Rhizoma Smilacis Chinensis, Rhizoma Smilacis Scobinicaulis, Jia Rhizoma Dioscoreae Septemlobae, belongs to liliaceous plant, and property is sweet, and temperature is nontoxic, energy wind-damp dispelling, diuresis, detumescence pain.Furen Pharmaceutical Co., Ltd., Hubei produces.Usual amounts is each 15-20ml, every day 3 times; Or each 4,3 times on the one.
FUKE QIANJIN JIAONANG: mainly being comprised of multi-medicaments such as Radix Flemingiae Philippinensis, Radix Rosae Laevigatae, Radix Angelicae Sinensis, Radix Codonopsis, Herba Andrographis, Caulis Spatholobis has benefiting qi and nourishing blood, the merit that detoxifcation is invigorated blood circulation.Produced by Zhuzhou Qianjin Pharmacy Co., Ltd.Every fill 0.4 the gram usual amounts be one time 2,3 times on the one, 14 days is a course for the treatment of.
KANGGONGYAN PIAN: by Folium Callicarpae Formosanae, the Radix Linderae, the compositions such as Herba Leonuri, Huaihua Zhenghao Pharmaceutical Co., Ltd. produces, the 0.25g/ sheet.Promoting flow of QI and blood.Usage: every day 3 times, each 5,10 days was 1 course for the treatment of, continuous 3 courses for the treatment of.
SANJIN PIAN: Radix Rosae Laevigatae, Rhizoma Smilacis Chinensis, YANGKAIKOU, Herba lygodii etc. form to be produced by Sanjin Pharmaceutical Co., Ltd., Guilin.Heat-clearing and toxic substances removing, dampness removing is treating stranguria.Method: take every day 3 times, each 5,10 days was 1 course for the treatment of.
JINJI PIAN: be comprised of Caulis Spatholobi, Herba Andrographis, Radix Flemingiae Philippinensis, Radix Zanthoxyli etc., Hengsheng Pharmaceutical Co., Ltd., Zhongshan City produces.Heat-clearing and toxic substances removing, the spleen invigorating dehumidifying, collateral dredging is invigorated blood circulation.Every 0.53 the gram, one time 6,3 times on the one.
GONGYANPING PIAN (Herba Melastomatis dodecandri, Radix Zanthoxyli, Radix Cudraniae, Herba Fici Simplicissimae, Radix Angelicae Sinensis etc.) Mt.Luofushan traditional Chinese medicines limited company produces, blood circulation promoting and blood stasis dispelling.Every 0.26 gram usage: every day 3 times, each 4.
Yuqin's KANGGONGYAN PIAN: select the recurrence due to taking drug sides such as Callicarpa kwangtungensis Chun, the Radix Linderae, Herba Leonuri formulated, Huaihua Zhenghao Pharmaceutical Co., Ltd. produces, promoting flow of QI and blood, and every contains dry extract 0.375 gram, and usual amounts is each 4,3 times on the one.
FUYANKANGFU sheet (be comprised of Herba Patriniae, Radix Bupleuri, Pericarpium Citri Reticulatae etc., Chongqing East field Pharma Inc. produces), clearing away heat-damp and promoting diuresis, blood-activating analgetic.Every 0.35 gram, usage: every day 3 times, each 2.
Fuyanshu capsule (composition: the compositions such as Caulis Lonicerae, Caulis Sargentodoxae, Radix Paeoniae Rubra, Herba Taraxaci, Radix Salviae Miltiorrhizae, Rhizoma Polygoni Cuspidati, Yangling Dongke Maidisen Pharmaceutical Co., Ltd produces) and clearing away heat and cooling blood, promoting blood circulation and stopping pain; Every dress 0.4g usage: oral, one time 5,3 times on the one.
The patent medicine of above-mentioned treatment pelvic inflammatory disease of selling in market, after the patient used, its effect majority existed healing time longer, cures not obvious, have even and patient's health produce repulsion and cause that side effect is more obvious.
Application number: 03108148.7, denomination of invention " is applicable to treat Chinese medicine composition, preparation of male and female pelvic inflammation and preparation method thereof ", this patent application patent disclose " Flos Lonicerae 15%, Radix Paeoniae Rubra 9.0%, Radix Scutellariae 7.5%, Fructus Forsythiae 7.5%, Cortex Moutan 6.0%, Semen Persicae 3.5%, Rhizoma Curcumae 7.5%, Rhizoma Cyperi 6.0%, Rhizoma Corydalis (vinegar system) 6.0%, Sargassum 7.5%, Concha Ostreae (calcined) 5.0%, Semen Coicis 7.5%, Spina Gleditsiae 6.0%, Radix Bupleuri 6.0%; Wherein, each composition components all can fluctuate 5% in the proportioning.", the disclosed technical scheme of this patent application patent, but " its deficiency is that administration fills into suppository, and granule is convenient ... dosage is less than enema, and the course for the treatment of is slightly longer than enema; The course for the treatment of of granule, also outline was long than suppository ", there is restriction in the dosage form of this technical scheme, and the healing cycle do not specify, and whether to the pelvic inflammatory disease of which kind of degree all effectively also without any the explanation of character property.
Summary of the invention
The object of the invention is to, for prior art exist and defects provides a kind of granule machine preparation method that is used for the treatment of chronic pelvic inflammatory disease.
A kind of granule that is used for the treatment of chronic pelvic inflammatory disease provided by the invention, its improvements are to comprise that the following component with by weight is prepared from:
Flos Lonicerae 1-75, Radix Paeoniae Rubra 5-65, Radix Scutellariae or Cortex Phellodendri 3-50, Radix Sanguisorbae or Cacumen Platycladi 8-30, Radix Bupleuri 5-20, Rhizoma Corydalis or Rhizoma Chuanxiong 1-40, Rhizoma Cyperi or Radix Angelicae Sinensis, Radix Linderae 2-40, Semen Coicis 2-25, Rhizoma Dioscoreae Nipponicae 1-20.
Provided by the invention first preferably is used for the treatment of the granule of chronic pelvic inflammatory disease, comprises by weight following component is prepared from:
Flos Lonicerae 10-55, Radix Paeoniae Rubra 15-50, Radix Scutellariae or Cortex Phellodendri 10-40, Radix Sanguisorbae or Cacumen Platycladi 10-25, Radix Bupleuri 8-16, Rhizoma Corydalis or Rhizoma Chuanxiong 10-35, Rhizoma Cyperi or Radix Angelicae Sinensis, Radix Linderae 10-30, Semen Coicis 5-20, Rhizoma Dioscoreae Nipponicae 5-15.
Provided by the invention second preferably is used for the treatment of the granule of chronic pelvic inflammatory disease, comprises by weight following component is prepared from:
Flos Lonicerae 20-40, Radix Paeoniae Rubra 20-30, Radix Scutellariae 20-35, Radix Sanguisorbae 15-20, Radix Bupleuri 10-13, Rhizoma Corydalis 15-30, Rhizoma Cyperi 15-20, Semen Coicis 10-15, Rhizoma Dioscoreae Nipponicae 8-12.
The preparation method that is used for the treatment of the granule of chronic pelvic inflammatory disease provided by the invention may further comprise the steps:
1) above-mentioned Flos Lonicerae, Radix Paeoniae Rubra, Rhizoma Cyperi by weight cleaned, screening, pulverize the 10-300 order after, add water reflux, extract, 1-5 time, reflux, each 1-3.0 hour, amount of water is Flos Lonicerae, Radix Paeoniae Rubra or Radix Angelicae Sinensis, the Radix Linderae or Cacumen Platycladi, Radix Sanguisorbae or Cacumen Platycladi weight portion 7-12 times, extracting solution is filtered, merge, being concentrated into relative density is 1.20-1.25 (60 ℃), add 75-98% ethanol and make and contain alcohol amount and reach 75-85%, left standstill under the room temperature 6-10 hour, filter, the supernatant Recycled ethanol also is concentrated into extractum, and is for subsequent use;
2) above-mentioned Radix Bupleuri by weight cleaned, screening, pulverized the 50-300 order, adding the concentration that 5-10 doubly measures pH value 8-9 is 65-80% ethanol, 50-60 ℃ of reflux, extract, 1-5 time, 1-2 hour at every turn; Extracting solution leaves standstill after 10-15 hour Recycled ethanol to without the alcohol flavor, and cold preservation 20-25 hour, centrifugal, get precipitation, for subsequent use;
3) above-mentioned Rhizoma Dioscoreae Nipponicae by weight cleaned, screening, pulverized the 50-200 order, add 6-10 and doubly measure the 80-95% soak with ethanol and spend the night, extracts 1-5 time, each 1-2 hour, the extracting solution filtration, merging is concentrated into extractum, and is for subsequent use;
4) above-mentioned Rhizoma Corydalis or Rhizoma Chuanxiong by weight cleaned, screens, pulverized the 10-200 order, adding concentration is 70-80% ethanol extraction 1-5 time, and the amount that at every turn adds ethanol is 3-8 times of Rhizoma Corydalis weight portion, and extracting solution is evaporated to extractum; It is the 3-5 beta-schardinger dextrin-doubly that adds the weight portion of Rhizoma Corydalis behind the 30-50% dissolve with ethanol that Rhizoma Corydalis extractum adds concentration, grind, and drying and crushing, for subsequent use;
5) above-mentioned Semen Coicis is by weight cleaned, screens, is pulverized the 10-200 order, grinding particle size 150-300 order, for subsequent use;
6) above-mentioned Radix Scutellariae or Cortex Phellodendri by weight cleaned, screens, pulverizes the 10-200 order, decoct with water each 1-2h 1-5 time, amount of water is 8-12 times, extracting solution is concentrated into extractum 1.05-1.25 (60 ℃), 50-70 ℃ of insulation, the mineral acid adjust pH 1.0-2.0 of adding 1-2.5mol/L, 50-65 ℃ is incubated 0.5-1.5 hour, leave standstill 10-20 hour, centrifugal, precipitation, it is that 50% ethanol is washed 1-4 time that 3-7 doubly measures concentration, precipitates for subsequent use;
7) above extraction extractum is mixed, adding weight portion is 2-5 sweeting agent, organic acid, (minor subject) granulation doubly of above-mentioned total extractum, drying, and packing gets final product.
Provided by the invention first preferably is used for the treatment of the preparation method of the granule of chronic pelvic inflammatory disease, and described mineral acid is one or more the mixture that is selected from hydrochloric acid, sulphuric acid, glacial acetic acid or the nitric acid.
Provided by the invention second preferably is used for the treatment of the preparation method of the granule of chronic pelvic inflammatory disease, and described sweeting agent is one or more the mixture that is selected from stevioside, acesulfame potassium and the Aspartame.
The provided by the invention the 3rd preferably is used for the treatment of the preparation method of the granule of chronic pelvic inflammatory disease, and described organic acid is citric acid or malic acid.
The provided by the invention the 4th preferably is used for the treatment of the preparation method of the granule of chronic pelvic inflammatory disease, and described adjuvant is one or more mixture in dextrin, microcrystalline Cellulose, the carboxymethyl starch sodium.
Description of the process: during the effective ingredient of the medical materials such as Flos Lonicerae, Radix Paeoniae Rubra, Rhizoma Cyperi, Radix Sanguisorbae is water-soluble and pure, therefore adopt the method for water extract-alcohol precipitation refining to its extract.The effective ingredient water solublity of Radix Bupleuri, Rhizoma Dioscoreae Nipponicae, Rhizoma Corydalis is bad, is dissolved in the ethanol, therefore adopt the ethanol of variable concentrations that it is extracted.The effective ingredient baicalin of Radix Scutellariae is insoluble to acid, therefore adopt the heavy method of acid refining to it.Semen Coicis is starch because of its most of composition, is used as medicine therefore directly pulverize, and the double effect of doing adjuvant can reduce supplementary product consumption.Technological parameter all gets by craft screening.
Function: eliminating toxic substances to remove stasis, removing damp and stopping pain
Cure mainly: be used for married woman's lower abdomen, few abdomen pain due to chronic pelvic inflammatory disease, the adnexitis, lumbosacral aching pain; Through fore udder distending pain, susceptible to lose temper due to restlessness; Advanced menstruation, menostaxis, intermenstrual bleeding, even metrorrhagia; Profuse leukorrhea has blood such as pus such as water or in being with at ordinary times; Inflammatory masses of pelvic cavity etc.
Usage and dosage: be grown up each 1 bag, measure 10-20mg in 1 bag, every day 3 times, boiled water is taken after mixing it with water; Weight portion is gram, kilogram, ton etc.
Flos Lonicerae heat-clearing and toxic substances removing in the side, the Radix Paeoniae Rubra clearing away heat and cooling blood, stasis-dispelling and pain-killing, the two is monarch; The pain relieving of Radix Scutellariae heat clearing and damp drying, Rhizoma Cyperi, the pain relieving of Rhizoma Corydalis promoting flow of QI and blood, the three is minister; Semen Coicis clearing away heat and discharging pus dampness removing, Radix Sanguisorbae detoxifcation cooling blood for hemostasis, the pain relieving of Rhizoma Dioscoreae Nipponicae eliminating dampness and dredging channels, the three is assistant; The Radix Bupleuri reducing fever by reconciliation enters the liver resolving depression, draws that all medicines reach the sea of blood and for making, and full side gathers the effect of eliminating toxic substances to remove stasis, removing damp and stopping pain altogether.
The chronic pelvic inflammatory disease sickness rate is very high, repeatedly outbreak, and touching difficulty more causes huge injury for numerous women's physical and mental health.The modal symptom of chronic pelvic inflammatory disease is:
1. lower abdomen or lower abdomen both sides are bitterly.Generally be the pain of the swollen sense of pendant, and connect and waist and sacrum pain, also the somebody when closing the room or after tired pain increase the weight of.The reason that causes pain is exactly that chronic basin the disease scar tissue adherent and the pelvic congestion that form cause.
2. menoxenia.During inflammation infringement ovarian function, can make change in menstrual cycle, modal is that menstruation shifts to an earlier date; Inflammation involves can make menstrual blood volume multiplication (showed increased) when endometrium causes the inner membrance inflammation, and the phase significant prolongation (menostaxis) of bleeding.
3. water sample or sanguinous leukorrhea.Chronic salpingo-ocphoritis and endometritis all can make leucorrhoea grow in quantity, are yellow thin water sample; Also sanguinous leukorrhea can be arranged during chronic intimitis.
4. infertile.Aforementioned menoxenia and leukorrhagia just can cause infertile, are the infertile of the obstruction of fallopian tube that causes such as the fallopian tube adhesion obstruction that causes of adnexitis (adnexitis), hydrosalpinx, tubo-ovarian cyst but chronic pelvic inflammatory disease causes infertile main aspect.
5. low grade fever.Chronic pelvic paramitritis, the pathogen surviving is among focus sometimes; The also sometimes acute attack of chronic pelvic inflammatory disease can cause patient that low grade fever is often arranged.
6. other symptom.Because the primary disease course of disease is long, obstinate, repeatedly outbreak causes than major injury to patient's spirit, shows as that lassitude, susceptible are tired, insomnia etc.; Gastrointestinal dysfunction is such as lack of appetite, abdominal distention etc.; Can see the front irritated irritability of menstruation, distending pain of the breast etc. when affecting endocrine.
Can find common rear position, uterus during inspection, limitation of activity or adhesion are fixed; As when being salpingitis, can touching the rope galley proof and increase tenderness is slightly arranged; As when being inflammation of pelvic connective tissue, can touching fan-shaped lamellar and thicken tenderness; Uterosacral ligament increases thick hardening tenderness (+); When hydrosalpinx or tubo-ovarian cyst, can contact the swollen thing of capsule, limitation of activity.
Above-mentioned all diseases are pressed theory of Chinese medical science: its lower abdomen pain is the performance of blood stasis; Its leukorrhagia such as the water yield are many, are the performances of wetting; Its low grade fever, susceptible to lose temper due to restlessness are the performances of heat; The oviducal hydrops of the inflammatory mass of its adnexa, tubo-ovarian cyst are the performances that stasis becomes Disorder, the pathological changes essence of chronic pelvic inflammatory disease be wet, heat, the stasis of blood, knot, for these pathological changes eliminating toxic substances to remove stasis removing damp and stopping pain principle for the treatment of has been proposed.
Compared with prior art, a kind of pharmaceutical composition that is used for the treatment of chronic pelvic inflammatory disease provided by the invention and preparation method thereof has the following advantages:
1, the Flos Lonicerae heat-clearing and toxic substances removing in the component of the present invention, the Radix Paeoniae Rubra clearing away heat and cooling blood, stasis-dispelling and pain-killing, the two is monarch, " heat " card can be effectively treated in the combination of this two flavors medicine, in addition to " 50-60 year female patient 200 examples, symptom concentrates on low grade fever ... " the situation of patient treatment finds out, low thermal phenomenon disappears very soon;
2, Radix Scutellariae heat clearing and damp drying pain relieving, Rhizoma Cyperi, the pain relieving of Rhizoma Corydalis promoting flow of QI and blood, the three is minister; The Radix Bupleuri reducing fever by reconciliation enters the liver resolving depression, draws that all medicines reach the sea of blood and for making, and full side gathers the effect of eliminating toxic substances to remove stasis, removing damp and stopping pain altogether; And " 20-30 year female patient 300 examples, the pain of patient's lower abdomen and lower abdomen both sides pain, the swollen sense of pendant disappears, waist and sacrum pain, the phenomenon of pain and water sample or sanguinous leukorrhea does not all exist when closing the room or after tired.”;
3, Semen Coicis clearing away heat and discharging pus dampness removing, Radix Sanguisorbae detoxifcation cooling blood for hemostasis, the pain relieving of Rhizoma Dioscoreae Nipponicae eliminating dampness and dredging channels, the three,, be imitated obviously so that the Patients with Pelvic Inflammatory Disease symptom disappears very soon with the synergism of monarch drug for assistant;
4, can effectively alleviate because the symptoms such as anomaly ratio such as lassitude, susceptible are tired, insomnia appear in spiritual nerve;
5, gastrointestinal dysfunction is such as lack of appetite, abdominal distention etc.; Can see the front irritated irritability of menstruation, distending pain of the breast etc. when affecting endocrine;
6, from " wet, heat, the stasis of blood, knot " point, suit the remedy to the case, give prominence to remarkable to the therapeutic effect of pelvic inflammatory disease;
7, the Chinese herbal medicine that adopts in the component is bought easily, and cost is relatively low, makes things convenient for large-scale production, and can effectively treat the pelvic inflammatory disease symptom of female patient, promotes that family is firm, social stability.
The specific embodiment
Correlation test
Below by specific embodiment a kind of pharmaceutical composition that is used for the treatment of chronic pelvic inflammatory disease provided by the invention and preparation method thereof is done further more detailed description.
Test 1
Choose immediately 1000 cases, take medicine of the present invention every day to suffering from the Patients with Pelvic Inflammatory Disease that reaches in various degree different symptoms, observe patient's Cure in the different time periods:
Symptom before A, the patient treatment:
20-30 year female patient 300 examples, symptom concentrates on lower abdomen or lower abdomen both sides pain, the pain of the swollen sense of pendant, and connecting and waist and sacrum pain, pain increases the weight of when closing the room or after tired; Water sample or sanguinous leukorrhea.
31-45 year female patient 200 examples, Symptoms is menoxenia in the sympotomatic set, and hysteresis menstruation appears in advance or in some patients were; There is by chance inflammation to involve endometrium and causes the inner membrance inflammation to cause occurring menstrual blood volume multiplication (showed increased), and the phase significant prolongation (menostaxis) of bleeding.
25-30 year female patient 300 examples, it is infertile that symptom concentrates on, and is the infertile of the obstruction of fallopian tube that causes such as the fallopian tube adhesion obstruction that causes of adnexitis (adnexitis), hydrosalpinx, tubo-ovarian cyst because chronic pelvic inflammatory disease causes infertile main aspect.
50-60 year female patient 200 examples, symptom concentrates on low grade fever because chronic pelvic paramitritis, some patients were is because the acute attack of chronic pelvic inflammatory disease produces low grade fever.
Choose immediately in addition 100 cases, lassitude, susceptible are tired, insomnia etc.; Gastrointestinal dysfunction is such as lack of appetite, abdominal distention etc.; Can see the front irritated irritability of menstruation, distending pain of the breast etc. when affecting endocrine.
Symptom behind B, the patient treatment:
20-30 year female patient 300 examples, the pain of patient's lower abdomen and lower abdomen both sides pain, the swollen sense of pendant disappears, waist and sacrum pain, the phenomenon of pain and water sample or sanguinous leukorrhea does not all exist when closing the room or after tired.
31-45 year female patient 200 examples, there is not patient's menstruation in the menstruation rule in advance or hysteresis; Because inflammation involves normal that endometrium causes that the inner membrance inflammation causes menstrual blood volume occurring, the phase of bleeding also shows.
25-30 year female patient 300 examples, adnexitis (adnexitis) is cured, tubal patency, the patient not only successfully becomes pregnant.
50-60 year female patient 200 examples, chronic pelvic paramitritis's transference cure, some patients were is because the acute attack of chronic pelvic inflammatory disease produces low thermal phenomenon disappears.
Choose immediately in addition 100 cases, lassitude, susceptible are tired, insomnia etc.; Gastrointestinal dysfunction is such as lack of appetite, abdominal distention etc.; Can see irritated irritability before the menstruation, distending pain of the breast etc. when affecting endocrine, behind patient's drug administration, sleep, health energy is clearly better, and appetite is improved greatly, and appetite is good, and endocrine is normal, and the healing result of above-mentioned case is added up such as following table 1:
Table 1 adopts the above-mentioned patient's of Drug therapy of the present invention healing result
Figure BSA00000400572100081
Embodiment 1
The granule that is used for the treatment of chronic pelvic inflammatory disease of the present embodiment comprises by weight following component is prepared from:
Flos Lonicerae 1 gram, Radix Paeoniae Rubra 5 grams, Radix Scutellariae 3 grams, Radix Sanguisorbae 8 grams, Radix Bupleuri 5 grams, Rhizoma Corydalis 1 gram, Rhizoma Cyperi 2 grams, Semen Coicis 2 grams, Rhizoma Dioscoreae Nipponicae 1 gram.
The preparation method of the granule of the Chinese medicine composition that is used for the treatment of chronic pelvic inflammatory disease of the present embodiment may further comprise the steps:
1) above-mentioned Flos Lonicerae, Radix Paeoniae Rubra by weight cleaned, screening, pulverize 10 orders after, add the water reflux, extract, 1 time, 70 ℃ of reflux temperatures, each 1 hour, amount of water is Flos Lonicerae and Radix Paeoniae Rubra weight portion 7 times, and extracting solution is filtered, and merges, being concentrated into relative density is 1.20, add 75% ethanol and make and contain alcohol amount and reach 75%, left standstill under the room temperature 6 hours, filter, the supernatant Recycled ethanol also is concentrated into extractum, and is for subsequent use;
2) above-mentioned Radix Bupleuri by weight cleaned, screening, pulverized 50 orders, the concentration that add 5 times of amount pH value 8 are 65% ethanol, 50 ℃ of reflux, extract, 1 time, each 1 hour; Extracting solution leaves standstill after 10 hours Recycled ethanol to without the alcohol flavor, and cold preservation 20 hours is centrifugal, gets precipitation, and is for subsequent use;
3) above-mentioned Rhizoma Dioscoreae Nipponicae by weight cleaned, screen, pulverized 50 orders, add 6 times of amount 80% soak with ethanol and spend the night, extract 1 time, each 1 hour, extracting solution filtered, and merged, and was concentrated into extractum 1.05 (60 ℃), and drying is ground into fine powder;
4) above-mentioned Rhizoma Corydalis by weight cleaned, screen, pulverized 10 orders, adding concentration is 70% ethanol extraction 1 time, and the amount that at every turn adds ethanol is 3 times of Rhizoma Corydalis weight portion, and extracting solution is evaporated to extractum; It is 3 times the beta-schardinger dextrin-that adds the weight portion of Rhizoma Corydalis behind 30% dissolve with ethanol that Rhizoma Corydalis extractum adds concentration, grind, and drying and crushing, for subsequent use;
5) above-mentioned Semen Coicis is by weight cleaned, screens, is pulverized 10 orders, grinding particle size 150 orders, for subsequent use;
6) above-mentioned Radix Scutellariae by weight cleaned, screen, pulverized 10 orders, decoct with water 1 time, each 1h, amount of water is 8 times, extracting solution is concentrated into extractum, 50 ℃ of insulations, the hydrochloric acid adjust pH 1.0 of adding 1mol/L, 50 ℃ are incubated 0.5 hour, leave standstill 10 hours, centrifugal, precipitation, 3 times of amount concentration are that 50% ethanol is washed 1 time, precipitate for subsequent use;
7) above extraction extractum is mixed, adding weight portion is 2-5 stevioside, citric acid, the microcrystalline Cellulose granulation doubly of above-mentioned total extractum, drying, and packing gets final product.
Embodiment 2
The granule that is used for the treatment of chronic pelvic inflammatory disease of the present embodiment comprises by weight following component is prepared from:
Flos Lonicerae 75 grams, Radix Paeoniae Rubra 65 grams, Cortex Phellodendri 50 grams, Cacumen Platycladi 30 grams, Radix Bupleuri 20 grams, Rhizoma Corydalis 40 grams, Radix Angelicae Sinensis 40 grams, Semen Coicis 25 grams, Rhizoma Dioscoreae Nipponicae 20 grams.
The preparation method of the granule of the Chinese medicine composition that is used for the treatment of chronic pelvic inflammatory disease of the present embodiment may further comprise the steps:
1) above-mentioned Flos Lonicerae, Radix Paeoniae Rubra by weight cleaned, screening, pulverize 300 orders after, add the water reflux, extract, 5 times, 80 ℃ of reflux temperatures, each 3.0 hours, amount of water is Flos Lonicerae and Radix Paeoniae Rubra weight portion 12 times, and extracting solution is filtered, and merges, being concentrated into relative density is 1.25, add 98% ethanol and make and contain alcohol amount and reach 85%, left standstill under the room temperature 10 hours, filter, upper table liquid Recycled ethanol also is concentrated into extractum, and is for subsequent use;
2) above-mentioned Radix Bupleuri by weight cleaned, screening, pulverized 300 orders, the concentration that add 10 times of amount pH value 9 are 80% ethanol, 60 ℃ of reflux, extract, 5 times, each 2 hours; Extracting solution leaves standstill after 15 hours Recycled ethanol to without the alcohol flavor, and cold preservation 25 hours is centrifugal, gets precipitation, and is for subsequent use;
3) above-mentioned Rhizoma Dioscoreae Nipponicae by weight cleaned, screen, pulverized 200 orders, add 10 times of amount 95% soak with ethanol and spend the night, extract 5 times, each 2 hours, extracting solution filtered, and merged, and was concentrated into extractum, and drying is ground into fine powder;
4) above-mentioned Rhizoma Corydalis by weight cleaned, screen, pulverized 200 orders, adding concentration is 80% ethanol extraction 5 times, and the amount that at every turn adds ethanol is 8 times of Rhizoma Corydalis weight portion, and extracting solution is evaporated to extractum; It is 5 times the beta-schardinger dextrin-that adds the weight portion of Rhizoma Corydalis behind 50% dissolve with ethanol that Rhizoma Corydalis extractum adds concentration, grind, and drying and crushing, for subsequent use;
5) above-mentioned Semen Coicis is by weight cleaned, screens, is pulverized 200 orders, grinding particle size 300 orders, for subsequent use;
6) above-mentioned Radix Scutellariae by weight cleaned, screen, pulverized 200 orders, decoct with water 5 times, each 2h, amount of water is 12 times, extracting solution is concentrated into extractum 1.25 (60 ℃), 70 ℃ of insulations, the mineral acid adjust pH 2.0 of adding 2.5mol/L, 65 ℃ are incubated 1.5 hours, leave standstill 20 hours, centrifugal, precipitation, 7 times of amount concentration are that 50% ethanol is washed 4 times, precipitate for subsequent use;
7) above extraction extractum is mixed, adding weight portion is 2-5 stevioside, citric acid, the microcrystalline Cellulose granulation doubly of above-mentioned total extractum, drying, and packing gets final product.
5, the preparation method that is used for the treatment of the granule of chronic pelvic inflammatory disease according to claim 4 is characterized in that described mineral acid is one or more the mixture that is selected from hydrochloric acid, sulphuric acid, glacial acetic acid or the nitric acid.
Embodiment 3
The granule that is used for the treatment of chronic pelvic inflammatory disease of the present embodiment comprises by weight following component is prepared from:
Flos Lonicerae 10 grams, Radix Paeoniae Rubra 15 grams, Radix Scutellariae 10 grams, Radix Sanguisorbae 10 grams, Radix Bupleuri 8 grams, Rhizoma Corydalis 10 grams, Radix Angelicae Sinensis 10 grams, Semen Coicis 5 grams, Rhizoma Dioscoreae Nipponicae 5 grams.
Be used for the treatment of the granule of the Chinese medicine composition of chronic pelvic inflammatory disease, may further comprise the steps:
1) above-mentioned Flos Lonicerae, Radix Paeoniae Rubra by weight cleaned, screening, pulverize 200 orders after, add the water reflux, extract, 3 times, 75 ℃ of reflux temperatures, each 3.0 hours, amount of water is Flos Lonicerae and Radix Paeoniae Rubra weight portion 10 times, and extracting solution is filtered, and merges, being concentrated into relative density is 1.20, add 90% ethanol and make and contain alcohol amount and reach 80%, left standstill under the room temperature 8 hours, filter, the supernatant Recycled ethanol also is concentrated into extractum, and is for subsequent use;
2) above-mentioned Radix Bupleuri by weight cleaned, screening, pulverized 100 orders, the concentration that add 8 times of amount pH value 8 are 70% ethanol, 55 ℃ of reflux, extract, 4 times, each 1 hour; Extracting solution leaves standstill after 12 hours Recycled ethanol to without the alcohol flavor, and cold preservation 22 hours is centrifugal, gets precipitation, and is for subsequent use;
3) above-mentioned Rhizoma Dioscoreae Nipponicae by weight cleaned, screen, pulverized 100 orders, add 9 times of amount 90% soak with ethanol and spend the night, extract 4 times, each 1 hour, extracting solution filtered, and merged, and was concentrated into extractum, and drying is ground into fine powder;
4) above-mentioned Rhizoma Corydalis by weight cleaned, screen, pulverized 150 orders, adding concentration is 75% ethanol extraction 3 times, and the amount that at every turn adds ethanol is 3-8 times of Rhizoma Corydalis weight portion, and extracting solution is evaporated to extractum; It is 4 times the beta-schardinger dextrin-that adds the weight portion of Rhizoma Corydalis behind 40% dissolve with ethanol that Rhizoma Corydalis extractum adds concentration, grind, and drying and crushing, for subsequent use;
5) above-mentioned Semen Coicis is by weight cleaned, screens, is pulverized 100 orders, grinding particle size 180 orders, for subsequent use;
6) above-mentioned Radix Scutellariae by weight cleaned, screen, pulverized 80 orders, decoct with water 3 times, each 1h, amount of water is 8-12 times, extracting solution is concentrated into extractum 1.25 (60 ℃), 60 ℃ of insulations, the sulphuric acid adjust pH 1.0 of adding 1.5mol/L, 60 ℃ are incubated 1.5 hours, leave standstill 15 hours, centrifugal, precipitation, 5 times of amount concentration are that 50% ethanol is washed 3 times, precipitate for subsequent use;
7) above extraction extractum is mixed, adding weight portion is 2-5 stevioside, citric acid, the microcrystalline Cellulose granulation doubly of above-mentioned total extractum, drying, and packing gets final product.
Embodiment 4
The granule that is used for the treatment of chronic pelvic inflammatory disease of the present embodiment comprises by weight following component is prepared from:
Flos Lonicerae 55 grams, Radix Paeoniae Rubra 50 grams, Radix Scutellariae 40 grams, Cacumen Platycladi 25 grams, Radix Bupleuri 16 grams, Rhizoma Corydalis 35 grams, Rhizoma Cyperi 30 grams, Semen Coicis 20 grams, Rhizoma Dioscoreae Nipponicae 15 grams; Wherein preparation method is with embodiment 1.
Embodiment 5
The granule that is used for the treatment of chronic pelvic inflammatory disease of the present embodiment comprises by weight following component is prepared from:
Flos Lonicerae 20 grams, Radix Paeoniae Rubra 20 grams, Radix Scutellariae 20 grams, Radix Sanguisorbae 15 grams, Radix Bupleuri 10 grams, Rhizoma Corydalis 15 grams, Rhizoma Cyperi 15 grams, Semen Coicis 10 grams, Rhizoma Dioscoreae Nipponicae 8 grams, preparation method is with embodiment 2.
Embodiment 6
The granule that is used for the treatment of chronic pelvic inflammatory disease of the present embodiment comprises by weight following component is prepared from:
Flos Lonicerae 40 grams, Radix Paeoniae Rubra 30 grams, Radix Scutellariae 35 grams, Cacumen Platycladi 20 grams, Radix Bupleuri 13 grams, Rhizoma Corydalis 30 grams, Rhizoma Cyperi 20 grams, Semen Coicis 15 grams, Rhizoma Dioscoreae Nipponicae 12 grams, wherein preparation method is with embodiment 1.
Should be noted that at last: above embodiment is only in order to illustrate that technical scheme of the present invention is not intended to limit; although with reference to above-described embodiment the present invention is had been described in detail; those of ordinary skill in the field are to be understood that: the technical staff reads after the present specification still and can make amendment or be equal to replacement the specific embodiment of the present invention, does not await the reply within the claim protection domain but these modifications or change all break away from the present patent application.

Claims (3)

1. granule that is used for the treatment of chronic pelvic inflammatory disease is characterized in that being prepared from by by weight following component:
Flos Lonicerae 1-75, Radix Paeoniae Rubra 5-65, Radix Scutellariae 3-50, Radix Sanguisorbae 8-30, Radix Bupleuri 5-20, Rhizoma Corydalis 1-40, Rhizoma Cyperi 2-40, Semen Coicis 2-25, Rhizoma Dioscoreae Nipponicae 1-20.
2. the granule that is used for the treatment of chronic pelvic inflammatory disease according to claim 1 is characterized in that being prepared from by by weight following component:
Flos Lonicerae 10-55, Radix Paeoniae Rubra 15-50, Radix Scutellariae 10-40, Radix Sanguisorbae 10-25, Radix Bupleuri 8-16, Rhizoma Corydalis 10-35, Rhizoma Cyperi 10-30, Semen Coicis 5-20, Rhizoma Dioscoreae Nipponicae 5-15.
3. the granule that is used for the treatment of chronic pelvic inflammatory disease according to claim 1 and 2 is characterized in that being prepared from by by weight following component:
Flos Lonicerae 20-40, Radix Paeoniae Rubra 20-30, Radix Scutellariae 20-35, Radix Sanguisorbae 1520, Radix Bupleuri 10-13, Rhizoma Corydalis 15-30, Rhizoma Cyperi 15-20, Semen Coicis 10-15, Rhizoma Dioscoreae Nipponicae 8-12.
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CN102688410B (en) * 2012-05-28 2013-10-02 代恩艳 Chinese medicinal composition for treating chronic pelvic inflammation
CN103656084B (en) * 2013-11-14 2017-07-21 江苏康缘药业股份有限公司 It is a kind of to treat pharmaceutical composition of chronic pelvic inflammatory disease and preparation method thereof
CN104225358A (en) * 2014-07-24 2014-12-24 烟台瑞智生物医药科技有限公司 Traditional Chinese medicine for treating chronic pelvic inflammation due to damp-heat and blood-stasis syndromes
CN104547964A (en) * 2015-02-13 2015-04-29 范江诺 Traditional Chinese medicine composition and preparation for treating chronic pelvic inflammatory disease
CN104784578A (en) * 2015-05-11 2015-07-22 李汶峰 Traditional Chinese medicine for treating pelvic inflammation
CN105055765A (en) * 2015-08-20 2015-11-18 王滋东 Medicine for treating gynaecological metrorrhagia and metrostaxis
CN107041932A (en) * 2017-03-24 2017-08-15 柳州市妇幼保健院 It is a kind of to be used to treat Chinese medicine preparation of pelvic infecton and preparation method thereof

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