CN1448167A - Medicine for treatment of pelvic inflammation, its preparation and preparing method - Google Patents
Medicine for treatment of pelvic inflammation, its preparation and preparing method Download PDFInfo
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Abstract
The present invention is one kind of Chinese medicine preparation for treating pelvic inflammation. The medicine preparation is prepared with peony root bark, sargentgloryvine stem, voila herb and other Chinese medicine materials and through modern technological process. It has determined curative effect, no toxicity, no toxic side effect, high stability and high biological utilization.
Description
Technical field
The present invention relates to a kind of Chinese medicine medicine for the treatment of gynaecopathia, be specifically related to treat Chinese medicine medicine and this pharmaceutical preparation and the preparation method of pelvic inflammatory disease.
Background technology
Chronic pelvic inflammatory disease means the other connective tissue of female sex organs and palace thereof, pelvic inflammatory disease film etc. is located to take place chronic inflammatory disease person and is referred to as, clinically with hypogastralgia, leucorrhoea grow in quantity, menoxenia, infertile, waist low miserable etc. be principal character, it is the commonly encountered diseases of serious harm WomanHealth, frequently-occurring disease and outbreak repeatedly, touching difficulty is more; Because intrauterine surgical increases, and its sickness rate also increases day by day, become one of principal disease that threatens WomanHealth in recent years, consequently brought long-term chronic pelvic pain, infertility or ectopic pregnancy wait a series of families, social problem.
The still to no effect significant at present specific treatment of western medical treatment chronic pelvic inflammatory disease, not only curative effect is bad for long-term antibiotic therapy, easily produces drug resistance and side effect on the contrary, the patient is depressed thus, and resistivity descends, and can not adhere to treatment, symptom repeatedly, thereby be absorbed in the vicious cycle.
Shortcomings such as the decoction therapy is adopted in existing Chinese medicine treatment more, and its course of treatment is long, and the medicine suffering is anti-, and the long-term oral imapirment of the spleen and stomach that has, and bioavailability is low; Shortcomings such as the administration of employing Chinese medicine decoction coloclysis also exists the administration inconvenience, and the availability of effective ingredient is low, as: CN123191 has introduced a kind of compound preparation that is used for the treatment of chronic pelvic inflammatory disease; CN1165668 has introduced a kind of Chinese medicine for the treatment of pelvic inflammatory disease, all is that this Chinese medicine is made decoction, adopts the method for clyster administration.
Summary of the invention
Research worker of the present invention is utilized the characteristic of Chinese herb decoction advantage and the rich experiences of the accumulation that studies for a long period of time, at the defective of above-mentioned Chinese and western medicine in existence aspect the treatment chronic pelvic inflammatory disease, develop a kind of Chinese medicine medicine of new treatment chronic pelvic inflammatory disease, and can be made into the modern Chinese medicine preparation of different dosage form in conjunction with modern preparation process.
Medicine of the present invention contains the following weight proportion raw material: Cortex Moutan 15-17 part, Herba Violae 15-17 part and Caulis Sargentodoxae 15-17 part;
Medicine of the present invention is preferably and contains the following weight proportion raw material: Cortex Moutan 15-17 part, Caulis Sargentodoxae 15-17 part, Herba Violae 15-17 part, Herba Patriniae 15-17 part, Radix Paeoniae Alba 15-17 part, rhizoma sparganic 10-11 part, Rhizoma Curcumae 10-11 part and Rhizoma Chuanxiong 10-11 part;
Medicine of the present invention more preferably contains the following weight proportion raw material: Cortex Moutan 15-17 part, Caulis Sargentodoxae 15-17 part, Herba Violae 15-17 part, Herba Patriniae 15-17 part, Radix Paeoniae Alba 15-17 part, rhizoma sparganic 10-11 part, Rhizoma Curcumae 10-11 part, Rhizoma Chuanxiong 10-11 part, Rhizoma Smilacis Glabrae 15-17 part, Herba Solani Lyrati 15-17 part, Herba Hedyotidis Diffusae 15-17 part, Radix Patriniae heterophyllae 15-17 part, Cortex Ailanthi 15-17 part and Radix Angelicae Sinensis 15-17 part;
Medicine of the present invention is best for containing the following weight proportion raw material: 15.7 parts of 15.7 parts of Cortex Moutans, 15.7 parts of Caulis Sargentodoxae, 15.7 parts of Herba Violaes, 15.7 parts of Herba Patriniae, 15.7 parts of the Radix Paeoniae Albas, 10.5 parts of rhizoma sparganic, 10.5 parts of Rhizoma Curcumae, 10.5 parts of Rhizoma Chuanxiongs, 15.7 parts of Rhizoma Smilacis Glabraes, 15.7 parts of Herba Solani Lyrati, 15.7 parts of Herba Hedyotidis Diffusaes, 15.7 parts of Radix Patriniae heterophyllaes, 15.7 parts of Cortex Ailanthis and Radix Angelicae Sinensis.
Principle according to " curing the disease " than asking it, the stagnant heat stasis of blood stagnates and causes pain, band and the disease of seeing, control when heat clearing and blood stasis dispersing, damp-clearing pain-relieving, the present invention selects medicine with this order, the hot hardship of loosing of Cortex Moutan is fallen refrigerantly in the side, and " specially controlling the blood fire second of the three ten-day periods of the hot season, heat clearing away and restlessness relieving " (Compendium of Material Medica) " accumulation of heat in institute's lead to person blood vessels " " the thin essence of book on Chinese herbal medicine " Caulis Sargentodoxae hardship is fallen and invigorated blood circulation; The Herba Violae bitter cold, clearing away heat-damp and promoting diuresis, removing toxic substances and promoting subsidence of swelling, three medicines share, the heat clearing and blood stasis dispersing damp-clearing pain-relieving.
The rhizoma sparganic lowering the adverse QI with bitter drugs and dispersing the accumulated pathogen with pungent drugs, flat and not strong, except that " old addiction is levied abdominal mass, gathers caking ... the pain relieving circulation of qi promoting.(" Kaibao Bencao "), the non-very speed of making contributions suddenly of property " (" record of medical science inner feelings Chinese and Western "); Join Rhizoma Curcumae circulation of qi promoting removing blood stasis, removing food stagnancy pain relieving, and both all go into liver, spleen channel, the liver stasis of blood that can disappear is long-pending, can manage insufficiency of the spleen stagnating, for old, weak, of a specified duration strongly fragrant person also available it, be " key medicine of blood stasis dispelling " so Zhang Xichun calls this to medicine.The removing blood stasis circulation of qi promoting that the case of a physically strong patient running a high fever is used, the pain relieving that helps digestion, deficiency and excess is used it, the smooth blood of blood stasis removing.And Rhizoma Curcumae " is made all gas, appetite-stimulating indigestion-relieving ", and (" all families of solar corona book on Chinese herbal medicine ") very claims " the present doctor family controls and gathers all gas, is the medicine of wanting most ", (" the modern book on Chinese herbal medicine of figure "); " Herba Patriniae be the cloudy medicine of brothers' yangming syncope also, the dense removing blood stasis of kind row " (Compendium of Material Medica); The hot temperature of Rhizoma Chuanxiong is walked and is not kept activating QI to alleviate the depression, promoting blood circulation and stopping pain, " the up head, the descending sea of blood " (" pearl sac "); Radix Paeoniae Alba picric acid is slightly cold, nourshing blood and promoting blood circulation, and easing the affected liver to relieve pain with blood stasis dispelling medicine mutually 5, has benefit in being intended to rush down, and has fosterly in dredging, so that heresy is gone and just do not hindered, capable the stagnating of this five medicine invigorated blood circulation, blood-activating analgetic, all monarchs drug are washed away the stasis of blood and are stagnated with coronary circulation-promoting pain-relieving.
Rhizoma Smilacis Glabrae is sweet light flat, the power that eliminating damp, detoxifying is arranged, the Compendium of Material Medica meaning: " this medicine is longer than damp eliminating ... and wet exceeding for many so also ", Herba Hedyotidis Diffusae is bitter sweet cold, the merit that heat-clearing and toxic substances removing is arranged, zoopery shows, this product can obviously strengthen skein cell and leukocytic phagocytic activity, show the defensive rising of human body in the immunologic process, thereby raising body immunity, reach anti-inflammation, the disease that the purpose (teaching and research group of Shanghai College of Traditional Chinese Medicine volume " People's Health Publisher, Chinese medicine clinical handbook Shanghai) of analgesia, calmness is suitable for chronic pelvic inflammatory disease simulataneous insufficiency and excessive especially; Herba Solani Lyrati is bitter cool, but heat-clearing and toxic substances removing, dampness removing; The Radix Patriniae heterophyllae bitter in the mouth is cool in nature, the clearing away dryness blood stasis removing that wets; The Cortex Ailanthi bitterness is cold in nature, heat clearing and damp drying, and astringent or styptic treatment for spontaneous sweating leukorrhagia stopping, this five medicines clearing heat and removing internal wetness, consolidating Chong Vessel for stopping leukorrhagia makes the wet heat clearing away of going, and band ends, and dash and appoint logical the accent, the vessels of the uterus smoothness, clear wet the going of heat, soreness of waist stomachache, bitter taste in the mouth and dry throat is from removing.
Radix Angelicae Sinensis flavor dryness hardship, go into to dash and appoint, the regulating menstruation by adjusting the flow of blood pain relieving is used together with Radix Paeoniae, the relieving spasm to stop pain of enriching blood, with the same usefulness of Cortex Moutan, the row dissipating blood stasis and clearing away heat pain relieving that stagnates, " medicine that must use for blood man " " the hundred kinds of records in herbal capital ", " specially go into liver " (" medicine justice ") to wish the sea of blood, and in the cold and cool medicine of group, Radix Angelicae Sinensis temperature and not dry simply, row and not violent, sweet slow-readjustment and, remarkably true to life, can prevent the fraud of blood stasis dispelling heat clearing away impairment of YIN, can draw blood again and go into to dash and appoint and reach disease institute, with for making, as seen our reasonable recipe, medication is precise and appropriate, so be effective in clinical.
With the different auxiliary material of medicine of the present invention as raw material and the frequent use of pharmacy, adopt conventional preparation technology medicine of the present invention can be made different pharmaceutical dosage forms, its dosage form can be any pharmaceutical dosage form pharmaceutically, but be preferably liquid oral medicine and solid orally ingestible, wherein solid preparation is preferably capsule, granule, tablet and their slow releasing preparation; Oral liquid is a syrup, solution, lotion, enema, dosage forms such as oral liquid, the optimal formulation of medicine of the present invention are granule, and its preparation method is: Cortex Moutan, rhizoma sparganic, Rhizoma Curcumae, Herba Patriniae, Rhizoma Chuanxiong, Rhizoma Smilacis Glabrae, Radix Patriniae heterophyllae, mixing such as Radix Angelicae Sinensis add 8-12 times of water gaging and soak 1～2h, extract volatile oil with steam distillation, filter, the aqueous solution after distillation device is in addition collected, merging such as medicinal residues and residue flavour of a drug Caulis Sargentodoxae, decoct with water 1-4 time, add 6-10 times of water gaging at every turn, decocted 1-3 hour, collecting decoction, filter, filtrate and above-mentioned aqueous solution merge, and are evaporated to clear paste, add ethanol, stir evenly, leave standstill, get supernatant, decompression recycling ethanol, be concentrated into thick paste, drying under reduced pressure becomes dried cream, is ground into fine powder, add an amount of dextrin and stevioside, mixing is granulated drying;
Get β-CD, it is an amount of to add water, and heating makes dissolving, is cooled to 50 ℃, and volatile oil dilutes with dehydrated alcohol, injects β-CD solution, constant temperature stirs, and puts coldly, and refrigerator cold-storage 24h takes out, and sucking filtration is collected filtering residue, low-temperature vacuum drying is pulverized, and adds above-mentioned granule, mixing, promptly.
This method is preferably: Cortex Moutan, rhizoma sparganic, Rhizoma Curcumae, Herba Patriniae, Rhizoma Chuanxiong, Rhizoma Smilacis Glabrae, Radix Patriniae heterophyllae, mixing such as Radix Angelicae Sinensis add 10 times of water gagings and soak 1～2h, extract volatile oil 3h with steam distillation, filter, the aqueous solution after distillation device is in addition collected, merging such as medicinal residues and residue flavour of a drug Caulis Sargentodoxae, decoct with water 2 times, add 8 times of water gagings at every turn, decocted 1.5 hours, collecting decoction, filter, filtrate and the merging of above-mentioned aqueous solution are evaporated to relative density and are 1.10～1.12 the cream that confuses, adding ethanol makes and contains alcohol amount and reach 50%, stir evenly, left standstill 24 hours, draw supernatant, decompression recycling ethanol, be concentrated into relative density and be 1.25～1.30 thick paste, drying under reduced pressure becomes dried cream, is ground into fine powder, add an amount of dextrin and stevioside, mixing is granulated drying;
(oil: β-CD is 1ml: 1-8g), it is an amount of to add water, and heating makes dissolving, is cooled to 50 ℃ to get β-CD; Volatile oil is by 1: and 1-5 (oil: dehydrated alcohol) with the dehydrated alcohol dilution, the β of injection-CD solution, constant temperature stirs 2h, cold preservation 24h, sucking filtration is collected filtering residue, and drying and crushing adds above-mentioned granule, mixing, promptly.
Medicinal granule of the present invention is preferably with respect to adult's dosage: 24 gram/every days, being equivalent to take every day the crude drug amount is 97.5 grams.
The present inventor is by consulting lot of documents, effective ingredient to each medicine in the present invention's prescription carries out detailed analysis and study, different physicochemical properties according to effective ingredient in every kind of medicine, take different extractions, preparation technology respectively, obtain and protected effective ingredient to greatest extent, as: medicines such as Radix Patriniae heterophyllae, Caulis Sargentodoxae, Herba Solani Lyrati, Herba Hedyotidis Diffusae, Cortex Ailanthi play the water soluble ingredient that is mainly of drug effect in the present invention, have therefore taked the extraction process of direct water extraction; And medicines such as Cortex Moutan, rhizoma sparganic, Rhizoma Curcumae, Rhizoma Chuanxiong, Herba Patriniae play the existing volatile oil of drug effect in the present invention water soluble ingredient is arranged, thereby adopted first extraction volatile oil to extract the two-step method extraction process of water soluble ingredient again; In addition, in the process of preparation pharmaceutical preparation of the present invention; because it is bigger that the volatile oil effective ingredient of collecting is influenced by temperature factor; therefore the present inventor is by experiment repeatedly; finishing screen is selected with the full legal granulation of β-CD water; thereby the effective ingredient of yet having protected the present invention to obtain is not destroyed; and according to the pharmacological action, recipe quantity, production of the contained effective ingredient of each flavour of a drug in the prescription and many-sided factor such as clinical; through experimentation repeatedly, relatively obtain above-mentioned ideal extraction, preparation technology thereby analyze.
Therefore medicine of the present invention have determined curative effect, nontoxic, have no side effect, can reach both frauds of anti-activating blood and eliminatng dampness impairment of YIN at chronic pelvic inflammatory disease, the gentleness merit of pain relieving of enriching blood is arranged again, and can draw all medicines and go into to dash to appoint regulating menstruation blood, full side's heat clearing and blood stasis dispersing, damp-clearing pain-relieving; And this pharmaceutical preparation good stability, taking convenience, bioavailability height.
Pharmacological action characteristics at Drug therapy chronic pelvic inflammatory disease of the present invention, research worker of the present invention has been carried out systematic observation to its drug action by experiment, found that: medicine of the present invention significantly suppresses aerobic bacterium and anaerobe growth, oral administration has certain protective role to infecting mouse in staphylococcus aureus and the Klebsiella pneumonia body; Rat paw edema and mice granuloma induced by implantation of cotton pellets all have the inhibitory action of significance due to the Mice Auricle inflammatory swelling that xylol brings out, the carrageenin; Rabbit all there is obvious facilitation at shrinkage amplitude, contraction frequency, tension force and the isolated rat uterine smooth muscle shrinkage amplitude of body uterine smooth muscle; The chronic endometritis model there is good therapeutical effect, can significantly improve the inaccessible adhesion of uterine cavity, chamber wall construction disorder, epithelial cell degeneration, necrosis, come off, endo cell soaks into and fibroblast proliferation, increases chronic endometritis rat model immunoglobulin and T lymhocyte transformation rate.
Below by the invention will be further elaborated about concrete experiment and embodiment, but be not limited to this.
Pharmacodynamic experiment
1 material
1.1 animal
Kunming mouse, the animal quality certification number: real moving accurate No. 01 of Anhui; The Wistar rat, the animal quality certification number: real moving accurate No. 03 of Anhui; Livid purple blue rabbit, hybrid is provided by Anhui Prov. Medical Science Inst. Animal Experimental Study chamber.
1.2 medicine and reagent
Be subjected to reagent: pelvic inflammatory disease granule (obtaining), lot number: 20000512 by the embodiment of the invention 3 preparation methoies.Every gram granule is equivalent to the 4.1g crude drug.Clinical people's consumption per day (pressing the crude drug amount) is 97.5g, and be two months the course of treatment.Positive control drug is selected the preparation formulation Ainsliaea fragrans Champ. granule identical with the clinical treatment indication for use, Jiangxi Jing Tong pharmaceutical Co. Ltd product, lot number: 991120.Injection liquid of gentamicin, Wuhu pharmaceutical factory product, lot number 991208,4 ten thousand u/ml/ prop up.Adenosine diphosphate (ADP) disodium (ADP), Shanghai uncle bio tech ltd product difficult to understand, lot number: 000411.Diethylstilbestrol injection, Shanghai the 9th pharmaceutical factory's product, lot number: 980605.All the other reagent are commercially available product, analytical pure.
1.3 instrument
724 microcomputer type visible spectrophotometers, optical instrument factory, Shanghai product.LIANG100 blood specific viscosity meter, Instrument Factory, Shanghai Medical Science Univ.'s product.MPG-3E blood is assembled instrument, the electric equipment company limited product of this grand doctor of Shanghai.Desk-top self-balancing recorder, the big magnificent instrument product in Shanghai.The isolated organ thermostatic bath, Zhenghai, Zhejiang telecommunication factory product.T-F photo-thermal dolorimeter, the institute of Materia Medica,Chinese Academy of Medical Sciences product.
2 methods and result
2.1 the outer antibacterial experiment of pelvic inflammatory disease granule
It is 2g crude drug/ml that pelvic inflammatory disease granule, distilled water are mixed with concentration, boils the 30min sterilization, and 4 ℃ of refrigerators are preserved stand-by.It is 1g crude drug/ml that Ainsliaea fragrans Champ. granule, distilled water are mixed with concentration, boils 30min and eliminates bacterium, and 4 ℃ of refrigerators are preserved stand-by.Select strain for use: escherichia coli 8099, give by Anhui Province health and epidemic prevention station, staphylococcus aureus, klebsiella pneumoniae, streptococcus, bacillus pyocyaneus, Candida albicans, yeast provides (wherein staphylococcus aureus is a type strain 25923, and all the other are hospital's separated strain) by Affiliated Hospital of Medical University Of Anhui.Culture fluid: dextrose bouillon buffering culture fluid.The reference literature method adopts the micromethod primary dcreening operation, and the plate method is determined minimum inhibitory concentration.With pelvic inflammatory disease granule and Ainsliaea fragrans Champ. granule from 1g/ml, press 6 concentration of coubling dilution dilution, gentamycin is pressed coubling dilution from the 100u/ml beginning and is diluted 12 concentration, adds in 96 well culture plates, the 100ul/ hole, after each bacterium being diluted by 1: 5000, equivalent adds culture plate, puts 37 ℃ and cultivates 24h again, observe the culture fluid turbidity, getting does not have obviously muddy culture fluid and carries out antibacterial culturing with Plating, bacterium colony＜5 be judged to feminine gender, be minimum inhibitory concentration than drug level.Each drug level is established 3 multiple holes during experiment, establishes the medicine blank simultaneously, antibacterial contrast and cultivation contrast.More than experiment all repeats twice.The results are shown in Table 1.
Table 1 pelvic inflammatory disease granule in-vitro antibacterial minimum inhibitory concentration
Strain pelvic inflammatory disease granule Ainsliaea fragrans Champ. granule gentamycin (u/ml)
(mg/ml)???????(mg/ml)
Gold Portugal bacterium 250 500 0.196 klebsiella pneumoniaes 250 500 0.196
Escherichia coli 125 125 0.196
Streptococcus 125 125 0.196 Candida albicans 250 500-
Bacillus pyocyaneus 125 250-
Yeast 250 500-
Annotate: the no bacteriostasis of "-" expression
2.2 antibacterial experiment in the pelvic inflammatory disease granule
2.2.1 protective effect to the infection of staphylococcus aureus mice
2.2.1.1 staphylococcus aureus dosage is selected
Get 50 of the Kunming mouses of body weight 18～22g, male and female half and half are divided into 5 groups at random, are 10 * 10 with concentration
8The staphylococcus aureus liquid of CFU/ml is made doubling dilution with 5% yeast soln, only presses 0.5ml/, from 9 * 10
8CFU/ml concentration rises, and to the staphylococcus aureus liquid of each group mice difference abdominal vein injection variable concentrations, observes in 7 days and respectively organizes mortality of mice.Found that: lumbar injection 0.5ml, the minimum bacterial concentration that causes mice 90% death is 6 * 10
8CFU/ml.
2.2.1.2 medicament protection experiment
Get 50 of the Kunming mouses of body weight 20～22g, male and female half and half are divided into the blank group at random, little, middle and high dosage group of pelvic inflammatory disease granule and Ainsliaea fragrans Champ. groups of grains, every group of 10 mices.(bacterial concentration is 6 * 10 to give every Mus lumbar injection 0.5ml staphylococcus aureus liquid respectively
8CFU/ml).Behind infecting mouse, irritate the medicinal liquid that stomach gives variable concentrations respectively by dosage shown in the table immediately.Each is organized mice and normally raises, and observes 7d continuously, calculates death toll and the survival time of animals of mice.The results are shown in Table 2, table 3.
Table 2 pelvic inflammatory disease granule is to the protective effect of infection of staphylococcus aureus mice; (the group dosage of x ± S); (g/kg) animal; (N) survival rate; (%) mean survival time; (d) blank group 10 0 0.6 ± 0.52 pelvic inflammatory disease granule 14.6 10 0 1.2 ± 0.92 pelvic inflammatory disease granules 29.3 10 20 2.8 ± 2.49
*Pelvic inflammatory disease granule 58.5 10 20 3.3 ± 2.36
*Ainsliaea fragrans Champ. granule 21.0 10 10 1.9 ± 1.97
Compare P＜0.05 with the blank group,
*P＜0.01
Table 3 pelvic inflammatory disease granule influences death toll behind the group dosed administration to what the infection of staphylococcus aureus dead mouse distributed
(g/kg) 1d 2d 3d 4d 5d 6d 7d blank group 4600000 pelvic infecton particles 14.6 2521000 pelvic infecton particles 29.3 1321100 pelvic infecton particles 58.5 0321110 Ainsliaea particles 21.0 1521000
The result shows: the administration of pelvic inflammatory disease granule therapy is remarkable to the protective effect of infecting mouse in the staphylococcus aureus body, compares with the blank group, and the survival rate and the mean survival time of administration treated animal all are significantly improved.
2.2.2 protective effect to the Klebsiella pneumonia infecting mouse
2.2.2.1 Klebsiella pneumonia dosage is selected
Get 50 of the Kunming mouses of body weight 18～22g, male and female half and half are divided into 5 groups at random, and reference literature is 6 * 10 with concentration
6The Klebsiella pneumonia liquid of CFU/ml is made doubling dilution with 5% yeast soln, only presses 0.5ml/, from 6 * 10
6CFU/ml concentration rises, and to the Klebsiella pneumonia liquid of mouse peritoneal injection variable concentrations, observes in 7 days and respectively organizes mortality of mice.Found that: lumbar injection 0.5ml causes that the minimum bacterial concentration of mice 90% death is about 3 * 10
6CFU/ml.
2.2.2.2 medicament protection experiment
Get 50 of the Kunming mouses of body weight 18～22g, male and female half and half are divided into the blank group at random, little, middle and high dosage group of pelvic inflammatory disease granule and Ainsliaea fragrans Champ. groups of grains, every group of 10 mices.Give every Mus lumbar injection 0.5ml respectively, concentration is 3 * 10
6The Klebsiella pneumonia liquid of CFU/ml.Behind infecting mouse, irritate the medicinal liquid that stomach gives variable concentrations respectively by dosage shown in the table immediately.Each is organized mice and normally raises, and observes 7d continuously, calculates death toll and the survival time of animals of mice.The results are shown in Table 4, table 5.
Table 4 pelvic inflammatory disease granule is to the protective effect of Klebsiella pneumonia infecting mouse (x ± S)
| Group | Dosage (g/kg) | Animal (N) | Survival rate (%) | Mean survival time (d) |
| The blank group | ????10 | ????10 | ????1.6±1.90 | |
| The pelvic inflammatory disease granule | ????14.6 | ????10 | ????10 | ????2.0±1.89 |
| The pelvic inflammatory disease granule | ????29.3 | ????10 | ????30 | ????3.2±2.70 |
| The pelvic inflammatory disease granule | ????58.5 | ????10 | ????20 | ????2.6±2.41 |
| The Ainsliaea fragrans Champ. granule | ????21.0 | ????10 | ????10 | ????2.0±1.89 |
Table 5 pelvic inflammatory disease granule to the Klebsiella pneumonia infecting mouse dead distribute influence death toll behind the group dosed administration
(g/kg) 1d 2d 3d 4d 5d 6d 7d blank group 0900000 pelvic infecton particles 14.6 0621000 pelvic infecton particles 29.3 0421000 pelvic infecton particles 58.5 0521000 Ainsliaea particles 21.0 0621000
The result shows: to infecting mouse in the Klebsiella pneumonia body, the administration of pelvic inflammatory disease granule therapy is compared with the blank group, and the survival rate of each treated animal has raising, and also there is raising the mean survival time.
2.3 the influence of pelvic inflammatory disease granule xylol induced mice auricle edema
Get 60 of Kunming mouses, 18～22g, male.At random animal is divided into blank group, pelvic inflammatory disease granule little, in, heavy dose of (14.6g/kg, 29.3g/kg and 58.5g/kg) group and Ainsliaea fragrans Champ. granule (21.0g/kg) organize.Press the 0.5ml/20g body weight, give the medicinal liquid of each administration group filling stomach variable concentrations respectively, successive administration 7d, the blank group gives the equivalent distilled water.1h after the last administration smears dimethylbenzene 0.05ml for respectively every mouse right ear and causes inflammation, and left ear compares.Cause scorching back 1h, disconnected neck is put to death mice, take off auricle with card punch and weigh, with about the difference of two ear auricle weight be the swelling degree, and calculate and suppress percentage rate, the results are shown in Table 6.
The result shows: the pelvic inflammatory disease granule of various dose and Ainsliaea fragrans Champ. granule all can significantly suppress the mice auricle swelling that auricle partial smearing dimethylbenzene causes, unknown significance difference is compared in effect between various dose.But compare with the blank group, remarkable statistical significance is arranged.
Table 6 pelvic inflammatory disease granule xylol causes influence (group dosage (g/kg) number of animals (N) auricle swelling degree (mg) suppression ratio (%) blank group 12 17.13 ± 4.10 pelvic inflammatory disease granules 14.6 12 9.42 ± 4.06 of x ± S) of mice ear
*45 pelvic inflammatory disease granules 29.3 12 9.63 ± 3.54
*43.8 pelvic inflammatory disease granule 58.5 12 8.61 ± 3.47
*49.7 Ainsliaea fragrans Champ. granule 21.0 12 9.15 ± 3.07
*46.6
Compare with the blank group:
*P＜0.01
2.4 pelvic inflammatory disease granule Dichlorodiphenyl Acetate causes the influence that the mouse peritoneal capillary permeability increases
Get 60 of Kunming mouses, body weight 18～22g, male and female half and half are divided into the blank group at random by sex, the pelvic inflammatory disease granule is little, in, heavy dose of (14.6g/kg, 29.3g/kg and 58.5g/kg) group and Ainsliaea fragrans Champ. granule (21.0g/kg) organize.Each organizes the continuous 7d of gastric infusion, capacity 0.5ml/20g body weight, and the blank group waits the capacity distilled water.With each treated animal fasting 12h, drinking-water is not limit before the last administration.1h after the last administration, press the 0.1ml/10g body weight, give mice from tail vein injection 0.5% AZO-blue normal saline solution respectively, lumbar injection 1.2% spirit of vinegar (Hac) solution 0.2ml/20g body weight behind the 20min, is put to death the disconnected neck of mice immediately, cut off skin of abdomen and muscle, divide several to wash the abdominal cavity with the 6ml normal saline, the sucking-off cleaning mixture adds normal saline to 10ml.Cleaning mixture is got supernatant and is measured optical density (A) value down in the 590nm wavelength with the centrifugal 15min of 3000rpm, the results are shown in Table 7.
The influence that the mouse peritoneal capillary permeability that causes table 7 pelvic cavity granule Dichlorodiphenyl Acetate increases (x ± S)
Group dosage (g/kg) number of animals (N) A value blank group 12 0.34 ± 0.16 pelvic inflammatory disease granule 14.6 12 0.24 ± 0.11 pelvic inflammatory disease granules 29.3 12 0.20 ± 0.09
*Pelvic inflammatory disease granule 58.5 12 0.17 ± 0.07
*Ainsliaea fragrans Champ. granule 21.0 12 0.25 ± 0.12
Compare with the blank group:
*P＜0.05,
*P＜0.01
The result shows: compare with the blank group, the big or middle dosage Dichlorodiphenyl Acetate of pelvic inflammatory disease granule induced mice abdominal cavity capillary permeability increases obvious inhibitory action.Ainsliaea fragrans Champ. granule Dichlorodiphenyl Acetate induced mice abdominal cavity capillary permeability increases reduction trend, but not statistically significant.
2.5 the pelvic inflammatory disease granule is to the influence of mice granuloma induced by implantation of cotton pellets
Get 75 of Kunming mouses, male, body weight 42 ± 5g.Under the sterile working, every mouse web portion otch will be implanted mice hypogastric region groin place, myometrial suture with the two anti-10mg sterilization cotton balls of handling of mycillin in advance.Behind the 24h, with the mice of implanting cotton balls be divided at random blank group, pelvic inflammatory disease granule little, in, heavy dose of (14.6g/kg, 29.3g/kg and 58.5g/kg) group and Ainsliaea fragrans Champ. granule (21.0g/kg) organize.Press the 0.5ml/20g body weight, to the medicinal liquid of each group mouse stomach variable concentrations, successive administration 10d cut off hypogastric region with the disconnected neck execution of mice, and peeled off granuloma induced by implantation of cotton pellets gently on the 11 day respectively.The granuloma induced by implantation of cotton pellets of peeling off is placed in the baking oven, 80 ℃ of dry 4h, taking-up is weighed.With granuloma induced by implantation of cotton pellets weight (mg)/10g body weight representation unit body weight granulation weight, and calculate the granuloma induced by implantation of cotton pellets suppression ratio, the results are shown in Table 8.
Table 8 pelvic inflammatory disease granule is to the influence of mice granuloma induced by implantation of cotton pellets (x ± S)
The heavy suppression ratio group of dosage number of animals granuloma (g/kg) is (mg/10g body weight) (%) blank group 15 5.19 ± 0.61 pelvic inflammatory disease granule 14.6 15 3.14 ± 0.69 (N)
*39 pelvic inflammatory disease granules 29.3 15 2.81 ± 0.54
*45.9 pelvic inflammatory disease granule 58.5 15 2.07 ± 0.40
*60 Ainsliaea fragrans Champ. granules 21.0 15 3.45 ± 0.49
*33.5
Compare with the blank group:
*P＜0.01
The result shows: compare with the blank group, the pelvic inflammatory disease granule of various dose concentration and Ainsliaea fragrans Champ. granule all can obviously suppress the increase of mice granuloma induced by implantation of cotton pellets weight.Pelvic inflammatory disease granule 29.3g/kg and 58.5g/kg effect obviously are better than the Ainsliaea fragrans Champ. granule.
2, toxicity test
Experiment material
1, animal: healthy kunming mice, body weight 18-22 gram, male and female half and half are provided by the Academy of Medical Sciences, Anhui Province institute laboratory animal laboratory.The quality certification: No. 01, the moving accurate word of Anhui hospital.
2, the scorching granule in chamber (obtaining) by the embodiment of the invention 3 preparation methoies, lot number: 20000430.Every gram pelvic inflammatory disease granule contains crude drug 4 grams.
Experimental technique:
1, experiment: get 10 of white mice, with the 1.0g/20g body weight, irritate stomach pelvic inflammatory disease granule to animal, every gram is equivalent to contain crude drug 4 grams.Observe in the week, mice poisons or death condition.Found that the position has animal to poison and the phenomena of mortality.Observe its maximum dosage-feeding experimental technique so adopt.
2, dosage experiment
(1) removes 20 male and female half and half of mice, body weight 18-22g.Gave each Mus gastric infusion three times respectively in 24 hours, irritate stomach at every turn and give pelvic inflammatory disease granule 0.8g/20g, accumulative total gavages 2.4g, and the Real Time Observation mice poisons and death condition, observes continuously 7 days.
Experimental result: in the week, mice does not all have death behind the above animals administer, and the activity of each treated animal, the mental status, diet, defecation etc. there is no unusually, mice body weight change table 1 before and after the administration
Body weight (g) after one week of body weight administration before the sex administration
Male 19.65 ± 1.0 24.1 ± 0.97
The every gram extractum of female 20.25 ± 1.27 25.2 ± 1.03 pelvic inflammatory disease granules contains crude drug 4 grams, and the mice average weight is 20g, adds up to irritate stomach pelvic inflammatory disease granule 2.4g.
Pelvic inflammatory disease granule maximum dosage-feeding=576g (crude drug)/kg (body weight); 60kg is a standard with adult's average weight, and the particulate crude drug consumption per day of pelvic inflammatory disease is 97.5 grams.The average weight of Kunming mouse is 20g, and actual crude drug amount is 11.52g, calculates the margin of safety of pelvic inflammatory disease granule.
Margin of safety=11.52g/20g ÷ 97.5g/60000g=354.5 (doubly)
Conclusion: under the condition of the acute administration of above-mentioned experimental result explanation pelvic inflammatory disease granule, orally do not see toxic reaction, the activity of animal, the mental status, diet, defecation etc. be sees unusual.
The specific embodiment
Embodiment 1,
Prescription (calculating): Cortex Moutan 3, Caulis Sargentodoxae 3, Herba Violae 3 with kilogram;
Cortex Moutan is added 10 times of water gagings soak 1～2h, extract volatile oil 3h, filter with steam distillation, aqueous solution after distillation device is in addition collected, and merging such as medicinal residues and residue flavour of a drug Caulis Sargentodoxae decoct with water 2 times, 8 times of water gagings of each adding, decocted 1.5 hours, collecting decoction filters, filtrate and above-mentioned aqueous solution merge, be evaporated to clear paste, add ethanol, stir evenly, leave standstill, draw supernatant, reclaim ethanol, be concentrated into thick paste, be dried and crushed into fine powder, add an amount of dextrin and stevioside, mixing is granulated drying; (oil: β-CD: be 1ml: 2g), it is an amount of to add water to get β-CD; The volatile oil of collecting was by 1: 2 (oil: dehydrated alcohol) with the dehydrated alcohol dilution, inject β-CD solution, constant temperature stirring 2h, refrigerator cold-storage 24h, take out, sucking filtration is collected filtering residue, cold drying, pulverize, add above-mentioned granule, mixing is distributed into the granule that specification is the 8g/ bag.
Embodiment 2
Prescription (calculating): Cortex Moutan 15, Caulis Sargentodoxae 15, Herba Violae 15, Herba Patriniae 15, the Radix Paeoniae Alba 15, rhizoma sparganic 10, Rhizoma Curcumae 10 and Rhizoma Chuanxiong 11 with kilogram;
Cortex Moutan, rhizoma sparganic, Rhizoma Curcumae, Rhizoma Chuanxiong, Herba Patriniae mixing are added 10 times of water gagings soak 1～2h, extract volatile oil 3h, filter with steam distillation, aqueous solution after distillation device is in addition collected, and merging such as medicinal residues and residue flavour of a drug Caulis Sargentodoxae decoct with water 2 times, 8 times of water gagings of each adding decocted collecting decoction 1.5 hours, filter, filtrate and above-mentioned aqueous solution merge, and are evaporated to clear paste, add ethanol, stir evenly, leave standstill, draw supernatant, reclaim ethanol, be concentrated into thick paste, be dried and crushed into fine powder; (oil: β-CD is 1ml: 2g), it is an amount of to add water to get β-CD; (oil: dehydrated alcohol) with the dehydrated alcohol dilution, inject β-CD solution, constant temperature stirred 2h, and refrigerator cold-storage 24h takes out, and sucking filtration is collected filtering residue, and cold drying is pulverized, and adds above-mentioned granule, and mixing divides the capsule of packing into, promptly by 1: 2 with the volatile oil collected.
Embodiment 3,
Prescription (calculating): Cortex Moutan 1.57, Caulis Sargentodoxae 1.57, Herba Violae 1.57, Herba Patriniae 1.57, the Radix Paeoniae Alba 1.57, rhizoma sparganic 1.05, Rhizoma Curcumae 1.05, Rhizoma Chuanxiong 1.05, Rhizoma Smilacis Glabrae 1.57, Herba Solani Lyrati 1.57, Herba Hedyotidis Diffusae 1.57, Radix Patriniae heterophyllae 1.57, Cortex Ailanthi 1.57, Radix Angelicae Sinensis 1.57 with kilogram;
With Cortex Moutan, rhizoma sparganic, Rhizoma Curcumae, Herba Patriniae, Rhizoma Chuanxiong, mixing such as Radix Patriniae heterophyllae add 10 times of water gagings and soak 1～2h, extract volatile oil 3h with steam distillation, filter, the aqueous solution after distillation device is in addition collected, merging such as medicinal residues and residue flavour of a drug Caulis Sargentodoxae, decoct with water 2 times, add 8 times of water gagings at every turn, decocted 1.5 hours, collecting decoction, filter, filtrate and the merging of above-mentioned aqueous solution are evaporated to relative density and are 1.10～1.12 clear paste, adding ethanol makes and contains alcohol amount and reach 50%, stir evenly, left standstill 24 hours, draw supernatant, decompression recycling ethanol, be concentrated into relative density and be 1.25～1.30 thick paste, drying under reduced pressure becomes dried cream, is ground into fine powder, add an amount of dextrin and stevioside, mixing is granulated drying.
Get β-CD (oil: β-CD: be 1ml: 5g), add water and dissolve in right amount; The volatile oil of collecting was by 1: 3 (oil: dehydrated alcohol) with the dehydrated alcohol dilution, inject β-CD solution, constant temperature stirring 2h, put coldly, put refrigerator (below 10 ℃) cold preservation 24h, take out, sucking filtration, collect filtering residue, low temperature (below 40 ℃) vacuum drying is pulverized, add above-mentioned granule, mixing is made 5Kg, and packing promptly.
Claims (9)
1, a kind of medicine for the treatment of pelvic inflammatory disease is characterized in that this medicine contains the following weight proportion raw material: Cortex Moutan 15-17 part, Herba Violae 15-17 part and Caulis Sargentodoxae 15-17 part.
2, according to the medicine of claim 1, it is characterized in that this medicine contains the following weight proportion raw material: Cortex Moutan 15-17 part, Caulis Sargentodoxae 15-17 part, Herba Violae 15-17 part, Herba Patriniae 15-17 part, Radix Paeoniae Alba 15-17 part, rhizoma sparganic 10-11 part, Rhizoma Curcumae 10-11 part and Rhizoma Chuanxiong 10-11 part.
3, according to the medicine of claim 2, it is characterized in that this medicine also contains the following weight proportion raw material: Cortex Moutan 15-17 part, Caulis Sargentodoxae 15-17 part, Herba Violae 15-17 part, Herba Patriniae 15-17 part, Radix Paeoniae Alba 15-17 part, rhizoma sparganic 10-11 part, Rhizoma Curcumae 10-11 part, Rhizoma Chuanxiong 10-11 part, Rhizoma Smilacis Glabrae 15-17 part, Herba Solani Lyrati 15-17 part, Herba Hedyotidis Diffusae 15-17 part, Radix Patriniae heterophyllae 15-17 part, Cortex Ailanthi 15-17 part and Radix Angelicae Sinensis 15-17 part.
4, according to the medicine of claim 3, it is characterized in that this medicine also contains the following weight proportion raw material: 15.7 parts of 15.7 parts of Cortex Moutans, 15.7 parts of Caulis Sargentodoxae, 15.7 parts of Herba Violaes, 15.7 parts of Herba Patriniae, 15.7 parts of the Radix Paeoniae Albas, 10.5 parts of rhizoma sparganic, 10.5 parts of Rhizoma Curcumae, 10.5 parts of Rhizoma Chuanxiongs, 15.7 parts of Rhizoma Smilacis Glabraes, 15.7 parts of Herba Solani Lyrati, 15.7 parts of Herba Hedyotidis Diffusaes, 15.7 parts of Radix Patriniae heterophyllaes, 15.7 parts of Cortex Ailanthis and Radix Angelicae Sinensis.
5, according to the described medicine of above-mentioned arbitrary claim, the dosage form that it is characterized in that this medicine is oral liquid and oral solid formulation, and wherein oral liquid is an oral liquid; Oral solid formulation is granule, capsule, tablet and slow release formulation thereof.
6, require 5 described medicines according to aforesaid right, the dosage form that it is characterized in that this medicine is a granule.
7, require 6 described medicines according to aforesaid right, it is characterized in that this medicinal granule preparation method is: Cortex Moutan, rhizoma sparganic, Rhizoma Curcumae, Herba Patriniae, Rhizoma Chuanxiong, Rhizoma Smilacis Glabrae, Radix Patriniae heterophyllae, mixing such as Radix Angelicae Sinensis add 8-12 times of water gaging soaked 1～2 hour, extracted volatile oil with steam distillation, filtered, aqueous solution after distillation device is in addition collected, merging such as medicinal residues and residue flavour of a drug Caulis Sargentodoxae decoct with water 1-4 time, add 6-10 times of water gaging at every turn, decocted 1-3 hour, collecting decoction filters, and filtrate and above-mentioned aqueous solution merge, be evaporated to clear paste, add dissolve with ethanol, stir evenly, leave standstill, get supernatant, be concentrated into thick paste, drying under reduced pressure becomes dried cream, is ground into fine powder, add an amount of dextrin and stevioside, mixing is granulated drying;
Get β-CD, it is an amount of to add water, and heating makes dissolving, cooling, and the volatile oil ethanol dilution injects β-CD solution, and constant temperature stirs, and puts coldly, and refrigerator cold-storage 24h takes out, and sucking filtration is collected filtering residue, low-temperature vacuum drying, pulverizing adds above-mentioned granule, mixing, packing, promptly.
8, require 7 described medicines according to aforesaid right, this medicinal granule preparation method is a Cortex Moutan, rhizoma sparganic, Rhizoma Curcumae, Herba Patriniae, Rhizoma Chuanxiong, Radix Patriniae heterophyllae, mixing such as Radix Angelicae Sinensis add 10 times of water gagings and soak 1～2h, extract volatile oil 3h with steam distillation, filter, aqueous solution after distillation device is in addition collected, and merging such as medicinal residues and residue flavour of a drug Caulis Sargentodoxae decoct with water 2 times, 8 times of water gagings of each adding, decocted 1.5 hours, collecting decoction filters, filtrate and above-mentioned aqueous solution merge, be evaporated to relative density and be 1.10～1.12 clear paste, add ethanol and make and contain the alcohol amount and reach 50%, stir evenly, left standstill 24 hours, draw supernatant, decompression recycling ethanol is concentrated into relative density and is 1.25～1.30 thick paste, drying under reduced pressure becomes dried cream, be ground into fine powder, add an amount of dextrin and stevioside, mixing, granulate drying;
(oil: β-CD: be 1ml: 1-8g), it is an amount of to add water, and heating for dissolving is reduced to 50 ℃ to get β-CD; Volatile oil is by 1: and 1-5 (oil: dehydrated alcohol) with the dehydrated alcohol dilution, the β of injection-CD solution, constant temperature stirs 2h, cold preservation 24h, sucking filtration is collected filtering residue, and drying and crushing adds above-mentioned granule, mixing, packing, promptly.
9, medicine according to claim 8, it is characterized by this medicine was 24 gram/every days for the dosage of being grown up, being equivalent to take every day the crude drug amount is 97.5 grams.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB021164312A CN1186052C (en) | 2002-04-04 | 2002-04-04 | Medicine for treatment of pelvic inflammation, its preparation and preparing method |
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| CNB021164312A CN1186052C (en) | 2002-04-04 | 2002-04-04 | Medicine for treatment of pelvic inflammation, its preparation and preparing method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101066410B (en) * | 2007-06-01 | 2011-09-28 | 刘桂兰 | Chinese medicine preparation for treating women's chronic pelvic inflammation and its preparation process |
| CN104474473A (en) * | 2014-12-04 | 2015-04-01 | 吴瑞岚 | Traditional Chinese medicine composition for treating gynecologic inflammation and preparation method thereof |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107050178A (en) * | 2017-02-28 | 2017-08-18 | 河南中医药大学 | A kind of Chinese medicine for treating cervical carcinoma |
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2002
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101066410B (en) * | 2007-06-01 | 2011-09-28 | 刘桂兰 | Chinese medicine preparation for treating women's chronic pelvic inflammation and its preparation process |
| CN104474473A (en) * | 2014-12-04 | 2015-04-01 | 吴瑞岚 | Traditional Chinese medicine composition for treating gynecologic inflammation and preparation method thereof |
| CN104474473B (en) * | 2014-12-04 | 2017-11-10 | 吴瑞岚 | A kind of Chinese medicine composition for treating gynaecological imflammation and preparation method thereof |
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| CN1186052C (en) | 2005-01-26 |
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