CN103055192B - Women inflammation recovery chewable tablet - Google Patents
Women inflammation recovery chewable tablet Download PDFInfo
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- CN103055192B CN103055192B CN201110317384.6A CN201110317384A CN103055192B CN 103055192 B CN103055192 B CN 103055192B CN 201110317384 A CN201110317384 A CN 201110317384A CN 103055192 B CN103055192 B CN 103055192B
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Abstract
The invention belongs to the medicine field, and relates to a medicine-women inflammation recovery chewable tablet for treating chronic pelvic inflammatory disease and leukorrheal diseases, the women inflammation recovery chewable tablet is prepared by herba patriniae, semen coicis, toosendan fruit, radix bupleuri, dried orange peel, Radix Paeoniae Rubra and Scutellaria baicalensis, an volatile oil in an extract is performed with inclusion of cyclodextrin, so that the pharmaceutical effect is obviously enhanced.
Description
Technical field
The present invention relates to a kind of medicine-FUYANKANGFU chewable tablet for the treatment of chronic pelvic inflammatory disease, leukorrheal diseases, is by Herba Patriniae, and the Chinese medicines such as Semen Coicis, Fructus Toosendan, Radix Bupleuri, Pericarpium Citri Reticulatae, Radix Paeoniae Rubra, Radix Scutellariae are made, and belong to field of traditional Chinese.
Background technology
Gynaecopathia belongs to the sick category such as the traditional Chinese medical science " stomachache ", " leukorrheal diseases ", " mass in the abdomen ", " infertile "; how by artificial abortion, wear intrauterine device, puerperal wound etc. and cause Yu Xue Bi Zu Luo road and form; or by menstrual period, the childbirth hematozemia of losing blood; nutrition loss; stagnated heat of liver channel accumulates the deep-sited part of the chong channel and appoints, and stagnation of blood stasis and heat forms; Or by sexual intercourse in menstrual period or operation, exopathogen invasion, fights and forms mutually with QI and blood.Its pathogenesis is deficiency in origin and excess in superficiality.Deficiency in origin person is positive QI-insufficiency, caused by liver and kidney deficiency; Marking real person, is that the stasis of blood, heat, wet three accumulate in born of the same parents, and QI-blood circulation is not smooth, and collaterals of the uterus is obstructed, stagnation of QI and blood may bring about pain.Therefore should take blood circulation promoting and blood stasis dispelling, clearing away heat and eliminating dampness as main in treatment.
Chronic pelvic inflammatory disease be usually due to acute pelvic inflammatory disease treatment not in time, not thoroughly or wrong treatment, or the inflammation delay and coming when poor of patient's body constitution.Main manifestations is lower abdomen lumbosacral region dull pain, when menstrual period, fatigue, sexual intercourse, increases the weight of, and leucorrhea is slightly many or normal, or companion's menoxenia or see disease such as be pregnant.The features such as clinical treatment is mainly with antipyretic and antidotal type Treated with Chinese Decoction, and Chinese medicine is in treatment chronic pelvic inflammatory disease especially determined curative effect, and adverse reaction rate is low.
We derive from the national drug standards new drug WS that becomes a full member
3-139 (X-129)-2002 (Z) Fuyankangfu capsules.Former dosage form name adopts function to add dosage form name.This product before moulding process, is compared with former dosage form in preparation process, does not change, and therefore according to Old Name, adds the name of dosage form name, is FUYANKANGFU chewable tablet.
The raw material of Fuyankangfu capsules is by Herba Patriniae, and the Chinese medicines such as Semen Coicis, Fructus Toosendan, Radix Bupleuri, Pericarpium Citri Reticulatae, Radix Paeoniae Rubra, Radix Scutellariae form, clearing away heat-damp and promoting diuresis, blood-activating analgetic.For women's leukorrhagia due to dampness and heat stasis, yellow skin matter thickness, or as bean dregs shape, gas is smelly, lacks abdomen, lumbus sacrum pain, the diseases such as the dark yellow and greasy fur of tongue, and chronic pelvic inflammatory disease is shown in above-mentioned disease person.
In side, take Herba Patriniae as monarch drug, the effects such as performance heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, detumescence, take Semen Coicis, Radix Scutellariae, Radix Paeoniae Rubra is ministerial drug, be aided with promoting diuresis with drugs of tasteless flavour, heat clearing away, eliminating carbuncle and clearing away heat-damp and promoting diuresis, pathogenic fire purging effect, take Fructus Toosendan, Radix Bupleuri, Pericarpium Citri Reticulatae etc. is adjuvant drug, plays altogether the effect of heat clearing away, dampness removing, blood stasis dispelling, pain relieving.
But, according to traditional extraction technique, produce Fuyankangfu capsules, more lay particular stress on clearing away heat and eliminating dampness, do not lay particular stress on blood circulation promoting and blood stasis dispelling, the present invention is based on this in addition creationary invention.
The present invention be based on motherland's medical science to the understanding of gynaecopathia and Therapeutic Principle, in conjunction with modern pharmacological research achievement and scientific research, clinical practice experience prescription, form.At it, fall ill on clinical syndrome Epidemiological study basis, take ancient literature research as foundation, prompting gynaecopathia deficiency in origin and excess in superficiality.Deficiency in origin person is positive QI-insufficiency, caused by liver and kidney deficiency; Marking real person, is that the stasis of blood, heat, wet three accumulate in born of the same parents, and QI-blood circulation is not smooth, and collaterals of the uterus is obstructed, stagnation of QI and blood may bring about pain.
The present invention, just based on this, starts with from strengthening promoting flow of QI and blood, and specific aim is extracted the volatile oil component of Radix Bupleuri, Pericarpium Citri Reticulatae, Radix Paeoniae Rubra etc., has developed the FUYANKANGFU chewable tablet for the treatment of gynaecopathia, for the treatment of various gynecological diseases.Compare with existing Fuyankangfu capsules, the present invention has strengthened the effect of ministerial drug, adjuvant drug, strengthened invigorate blood circulation, the effect of blood stasis dispelling, pain relieving.
Summary of the invention
The object of the present invention is to provide a kind of FUYANKANGFU chewable tablet, by the raw material of following weight fraction, made:
Medical material part:
Above-mentioned a kind of FUYANKANGFU chewable tablet, preferably the raw material of following weight fraction is made:
Medical material part
Above-mentioned a kind of FUYANKANGFU chewable tablet, preferably the raw material of following weight fraction is made:
Medical material part
Microcrystalline Cellulose described in above-mentioned a kind of FUYANKANGFU chewable tablet can use one or more in methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl emthylcellulose, cross-linking sodium carboxymethyl cellulose, hydroxyethylmethyl-cellulose, hydroxyethyl-cellulose or hydroxypropyl cellulose to substitute.
In above-mentioned a kind of FUYANKANGFU chewable tablet, hydroxypropylβ-cyclodextrin replaces with cyclodextrin or beta-schardinger dextrin-.
Another object of the present invention is to provide the preparation method of above-mentioned FUYANKANGFU chewable tablet, adopt following steps: by above-mentioned seven flavor medicine material, except half amount of Semen Coicis is ground into coarse powder, all the other decoct with water, and filter merging filtrate, be concentrated into thick paste, add Semen Coicis coarse powder and described adjuvant, mix, granulate, dry, granulate, tabletting, obtains.
The preparation method of above-mentioned FUYANKANGFU chewable tablet, adopts following steps:, above-mentioned seven flavor medicine material, except half amount of Semen Coicis is ground into coarse powder, all the other decoct with water three times, and first and second time adds 8 times of amounts of water, decoct 1.0 hours, add for the third time 6 times of amounts of water and decoct 0.5 hour, gradation filters, and merging filtrate, is concentrated into relative density 1.35-1.40,60-80 ℃, thick paste, add Semen Coicis coarse powder and above-mentioned adjuvant, mix, granulate, dry, granulate, tabletting, obtains.
The preparation method of above-mentioned FUYANKANGFU chewable tablet, adopts following steps: above-mentioned seven flavor medicine material, and except half amount of Semen Coicis is ground into coarse powder, all the other decoct with water, and filter, and merging filtrate, is concentrated into thick paste, standby; When decocting with water, collect the volatile oil that steam distillation out obtains, volatile oil is prepared into clathrate with hydroxypropylβ-cyclodextrin or beta-schardinger dextrin-or cyclodextrin, standby; Add Semen Coicis coarse powder, standby thick paste and clathrate, above-mentioned adjuvant, mixes, and usings microcrystalline Cellulose, mannitol and xylitol as adjuvant; Appropriate ethanol is made wetting agent, granulates, dry, granulate, and tabletting, obtains.
The preparation method of above-mentioned FUYANKANGFU chewable tablet, adopt following steps: above-mentioned seven flavor medicine material, except half amount of Semen Coicis is ground into coarse powder, all the other decoct with water three times, first and second time adds 8 times of amounts of water, decoct 1.0 hours, add for the third time 6 times of amounts of water and decoct 0.5 hour, gradation filters, merging filtrate, be concentrated into relative density 1.35-1.40, the thick paste of 60-80 ℃, standby; When decocting with water at every turn, collect the volatile oil that steam distillation out obtains, volatile oil is prepared into clathrate with hydroxypropylβ-cyclodextrin or beta-schardinger dextrin-or cyclodextrin, and the ratio of volatile oil and hydroxypropylβ-cyclodextrin or beta-schardinger dextrin-or cyclodextrin is 1: 5-10ml/g, obtain volatile oil clathrate compound, standby, add Semen Coicis coarse powder, standby thick paste, the volatile oil clathrate compound of hydroxypropylβ-cyclodextrin, above-mentioned adjuvant, mixes, and usings microcrystalline Cellulose, mannitol and xylitol as adjuvant; Appropriate 95% ethanol is made wetting agent, granulates, dry, granulate, and tabletting, obtains.
The preparation method of FUYANKANGFU chewable tablet, adopt following steps: it is 50% alcoholic solution that described volatile oil is made into volume ratio, join in the saturated solution of hydroxypropylβ-cyclodextrin or beta-schardinger dextrin-or cyclodextrin, enclose 2-4 hour under 10-20 ℃ of 120-150 rev/min of condition, collects enclose liquid, puts refrigerator cold-storage 24-36 hour, sucking filtration, the a small amount of water washing of clathrate, 30 ℃ of vacuum drying 10-12 hour, collect clathrate.
Another object of the present invention is to provide the application of above-mentioned FUYANKANGFU chewable tablet in the medicine of preparation treatment chronic pelvic inflammatory disease.
Another object of the present invention is to provide that above-mentioned FUYANKANGFU chewable tablet is antibacterial in preparation, the application of the medicine of antiinflammatory, blood circulation promoting and blood stasis dispelling, analgesia, immunomodulating, treatment leukorrheal diseases.
Pharmacological research proof FUYANKANGFU chewable tablet has mice ear and rat paw edema effect (P < 0.01 in obvious inhibition; There is the effect that obvious inhibition mice produces writhing, in body antibacterial tests confirm its survival rate that can improve coli-infection mice also can reduce rat's blood stasis model whole blood high, in the low viscosity of cutting, plasma viscosity, whole blood reduced viscosity and packed cell volume.Its pharmacological research is laid firm theoretical basis for its treatment in clinical chronic pelvic inflammatory disease.
Range of application of the present invention: leukorrheal diseases.Disease is seen profuse leukorrhea, yellow skin or yellowish green, the sticky or show bubble of matter, has foul smell, the pudendum pain of itching, head dusk pain, irritated irritability, or lower abdomen has a pain, or leukorrhagia color white matter is sticky or bean curd scoriform, pudendal pruritus, yellow urine is few, yellowish fur or thick, soft and rapid pulse.Applicating finger syndrome: the dialectical main points of this product are damp and hot folder poison.Mainly see that disease is indistinctive fever, heaviness sensation over the head and body, xerostomia is wish drink not, and red urine is and unfavorable, and women's leukorrhagia Huang is thick, and foul have taste, greasy fur on tongue, a soft and rapid pulse.It is that its function of certain pharmacological basis cures mainly as clearing away heat-damp and promoting diuresis for the clinical good therapeutic effect of obtaining at present, blood-activating analgetic, volatile oil component more can strengthen promoting flow of QI and blood, for women's leukorrhagia due to dampness and heat stasis, yellow skin matter is sticky or as bean dregs shape, gas is smelly, few abdomen, lumbus sacrum pain, and the diseases such as the dark yellow and greasy fur of tongue and chronic pelvic inflammatory disease are shown in above-mentioned patient.Its clinical manifestation is good, and untoward reaction is less and light, should be in clinical extensive popularization.Content with reference to all standard of new Chinese medicine standard Fuyankangfu capsules is studied the quality of the FUYANKANGFU chewable tablet of our development.Character, FUYANKANGFU chewable tablet is Film coated tablets, removing after coating is brown color; Feeble QI is fragrant, bitter in the mouth.
Discriminating, differentiates except retaining the thin layer chromatography of Fuyankangfu capsules original Semen Coicis microscopical identification item and Pericarpium Citri Reticulatae and baicalin, increased the thin layer chromatography discriminating of Radix Bupleuri, through check, FUYANKANGFU chewable tablet is differentiated up to specification.Check item, content uniformity, limit test of microbe is every through check, all meets 2000 editions pharmacopeia regulations.Assay item, paeoniflorin content measurement result is up to specification.For controlling better the quality of this product, increased the assay of the baicalin in Radix Scutellariae, through sample precision, repeatability, recovery test, proof the method is feasible, can control preferably the quality of this product, through ten batch sample assays, content difference is little, all can meet this standard, every of this product contains Radix Scutellariae in baicalin, must not be less than 3.0mg.
With reference to new Chinese medicine standard Fuyankangfu capsules, the FUYANKANGFU chewable tablet quality that our company is produced is studied, and has carried out methodology checking, and by test, this method can be controlled the quality of this product preferably.Therefore, my company has possessed every testing conditions of development FUYANKANGFU chewable tablet, and its method is science, and quality is controlled, can meet large production testing demand.
Pressing the specification requirement of new Chinese medicine steady quality Journal of Sex Research is simulating three batch samples under commercially available back condition, be positioned over temperature and be under 25 ℃ ± 2 ℃, RH60% ± 5% condition, in sampling in 0,1,2,3,6,12 month, this product has been carried out to the investigation of character, discriminating, disintegration, assay, microbial limit.Result: room temperature test 12 months, indices was compared with 0 month, without significant change.Room temperature test is still underway.
Stability test result shows, FUYANKANGFU chewable tablet of the present invention is through accelerating 6 months and room temperature long term test is investigated for 12 months, and indices all meets the regulation of this drug standard, and this product has certain stability.With reference to the 7th Fuyankangfu capsules of the Sanitation Ministry medicine standard Traditional Chinese medicine historical preparation, the regulation to this product holding conditions, is defined as: sealing.
The production of ten batch samples: carried out amplification sample and produced, produced altogether ten batches, through sampling observation, production sample is all qualified.
The present invention, with reference to new Chinese medicine standard Fuyankangfu capsules standard, is studied FUYANKANGFU chewable tablet quality, and has carried out methodology checking, and by test, this method can be controlled the quality of this product preferably.The long term test of carrying out has been carried out 1 year, and its indices all meets the requirements.FUYANKANGFU chewable tablet steady quality is described, controlled, safety, reliable, can reach production and sales requirement.
The specific embodiment
Embodiment 1
Medical material part
Embodiment 2
A FUYANKANGFU chewable tablet, by the raw material of following weight fraction, made:
Medical material part
Embodiment 3
A FUYANKANGFU chewable tablet, by the raw material of following weight fraction, made:
Medical material part
Embodiment 4
Seven flavor medicine material in above embodiment 1-3, except half amount of Semen Coicis is ground into coarse powder, all the other decoct with water three times, first and second time adds 8 times of amounts of water, decocts 1.0 hours, adds for the third time 6 times of amounts of water and decocts 0.5 hour, gradation filters, and merging filtrate, is concentrated into relative density 1.35-1.40,60-80 ℃, thick paste, add Semen Coicis coarse powder and above-mentioned adjuvant, mix, granulate, dry, granulate, tabletting, obtains.
Embodiment 5
Seven flavor medicine material in above embodiment 1, except half amount of Semen Coicis is ground into coarse powder, all the other decoct with water three times, and first and second time adds 8 times of amounts of water, decoct 1.0 hours, add for the third time 6 times of amounts of water and decoct 0.5 hour, gradation filters, merging filtrate, be concentrated into the thick paste of 1.35,80 ℃ of relative densities, standby
When decocting with water at every turn, collect the volatile oil that steam distillation out obtains, volatile oil is prepared into clathrate with hydroxypropylβ-cyclodextrin, the ratio of volatile oil and hydroxypropylβ-cyclodextrin is 1: 5ml/g, obtain the volatile oil clathrate compound of hydroxypropylβ-cyclodextrin, standby, the preparation method of clathrate is: it is 50% alcoholic solution that described volatile oil is made into volume ratio, join in hydroxypropylβ-cyclodextrin saturated solution, under 15 ℃ of 130 revs/min of conditions, enclose is 3 hours, collect enclose liquid, put refrigerator cold-storage 30 hours, sucking filtration, the a small amount of water washing of clathrate, 30 ℃ of vacuum dryings 11 hours, collect clathrate, add Semen Coicis coarse powder, standby thick paste, the volatile oil clathrate compound of hydroxypropylβ-cyclodextrin, above-mentioned adjuvant, mixes, and usings microcrystalline Cellulose, mannitol, xylitol, magnesium stearate, aspartame as adjuvant, appropriate 95% ethanol is made wetting agent, granulates, dry, granulate, and tabletting, obtains.
Embodiment 6
Seven flavor medicine material in above embodiment 2, except half amount of Semen Coicis is ground into coarse powder, all the other decoct with water three times, and first and second time adds 8 times of amounts of water, decoct 1.0 hours, add for the third time 6 times of amounts of water and decoct 0.5 hour, gradation filters, merging filtrate, be concentrated into the thick paste of 1.40,60 ℃ of relative densities, standby
When decocting with water at every turn, collect the volatile oil that steam distillation out obtains, volatile oil is prepared into clathrate with hydroxypropylβ-cyclodextrin, the ratio of volatile oil and hydroxypropylβ-cyclodextrin is 1: 10ml/g, obtain the volatile oil clathrate compound of hydroxypropylβ-cyclodextrin, standby
The preparation method of clathrate is: it is 50% alcoholic solution that described volatile oil is made into volume ratio, join in beta-schardinger dextrin-saturated solution, under 15 ℃ of 130 revs/min of conditions, enclose is 3 hours, collect enclose liquid, put refrigerator cold-storage 30 hours, sucking filtration, a small amount of water washing of clathrate, 30 ℃ of vacuum dryings 11 hours, collect clathrate;
Add Semen Coicis coarse powder, standby thick paste, the volatile oil clathrate compound of hydroxypropylβ-cyclodextrin, above-mentioned adjuvant, mixes, and usings microcrystalline Cellulose, mannitol, xylitol, magnesium stearate, aspartame as adjuvant; Appropriate 95% ethanol is made wetting agent, granulates, dry, granulate, and tabletting, obtains.
Embodiment 7
Seven flavor medicine material in above embodiment 3, except half amount of Semen Coicis is ground into coarse powder, all the other decoct with water three times, and first and second time adds 8 times of amounts of water, decoct 1.0 hours, add for the third time 6 times of amounts of water and decoct 0.5 hour, gradation filters, merging filtrate, be concentrated into the thick paste of 1.38,70 ℃ of relative densities, standby
When decocting with water at every turn, collect the volatile oil that steam distillation out obtains, volatile oil is prepared into clathrate with hydroxypropylβ-cyclodextrin, the ratio of volatile oil and hydroxypropylβ-cyclodextrin is 1: 8ml/g, obtain the volatile oil clathrate compound of hydroxypropylβ-cyclodextrin, standby, the preparation method of clathrate is: it is 50% alcoholic solution that described volatile oil is made into volume ratio, join in beta-schardinger dextrin-saturated solution, under 15 ℃ of 130 revs/min of conditions, enclose is 3 hours, collect enclose liquid, put refrigerator cold-storage 30 hours, sucking filtration, the a small amount of water washing of clathrate, 30 ℃ of vacuum dryings 11 hours, collect clathrate, add Semen Coicis coarse powder, standby thick paste, the volatile oil clathrate compound of hydroxypropylβ-cyclodextrin, above-mentioned adjuvant, mixes, and usings microcrystalline Cellulose, mannitol, xylitol, magnesium stearate, aspartame as adjuvant, appropriate 95% ethanol is made wetting agent, granulates, dry, granulate, and tabletting, obtains.
Embodiment 8
Seven flavor medicine material in above embodiment 2, except half amount of Semen Coicis is ground into coarse powder, all the other decoct with water three times, and first and second time adds 8 times of amounts of water, decoct 1.0 hours, add for the third time 6 times of amounts of water and decoct 0.5 hour, gradation filters, merging filtrate, be concentrated into the thick paste of 1.35,80 ℃ of relative densities, standby
When decocting with water at every turn, collect the volatile oil that steam distillation out obtains, volatile oil is prepared into clathrate with hydroxypropylβ-cyclodextrin, the ratio of volatile oil and hydroxypropylβ-cyclodextrin is 1: 5ml/g, obtain the volatile oil clathrate compound of hydroxypropylβ-cyclodextrin, standby, the preparation method of clathrate is: it is 50% alcoholic solution that described volatile oil is made into volume ratio, join in hydroxypropylβ-cyclodextrin saturated solution, under 15 ℃ of 130 revs/min of conditions, enclose is 3 hours, collect enclose liquid, put refrigerator cold-storage 30 hours, sucking filtration, the a small amount of water washing of clathrate, 30 ℃ of vacuum dryings 11 hours, collect clathrate, add Semen Coicis coarse powder, standby thick paste, the volatile oil clathrate compound of hydroxypropylβ-cyclodextrin, above-mentioned adjuvant, mixes, and usings microcrystalline Cellulose, mannitol, xylitol, magnesium stearate, aspartame as adjuvant, appropriate 95% ethanol is made wetting agent, granulates, dry, granulate, and tabletting, obtains.
Embodiment 9
Seven flavor medicine material in above embodiment 3, except half amount of Semen Coicis is ground into coarse powder, all the other decoct with water three times, and first and second time adds 8 times of amounts of water, decoct 1.0 hours, add for the third time 6 times of amounts of water and decoct 0.5 hour, gradation filters, merging filtrate, be concentrated into the thick paste of 1.40,60 ℃ of relative densities, standby
When decocting with water at every turn, collect the volatile oil that steam distillation out obtains, volatile oil is prepared into clathrate with hydroxypropylβ-cyclodextrin, the ratio of volatile oil and hydroxypropylβ-cyclodextrin is 1: 10ml/g, obtain the volatile oil clathrate compound of hydroxypropylβ-cyclodextrin, standby, the preparation method of clathrate is: it is 50% alcoholic solution that described volatile oil is made into volume ratio, join in beta-schardinger dextrin-saturated solution, under 15 ℃ of 130 revs/min of conditions, enclose is 3 hours, collect enclose liquid, put refrigerator cold-storage 30 hours, sucking filtration, the a small amount of water washing of clathrate, 30 ℃ of vacuum dryings 11 hours, collect clathrate, add Semen Coicis coarse powder, standby thick paste, the volatile oil clathrate compound of hydroxypropylβ-cyclodextrin, above-mentioned adjuvant, mixes, and usings microcrystalline Cellulose, mannitol, xylitol, magnesium stearate, aspartame as adjuvant, appropriate 95% ethanol is made wetting agent, granulates, dry, granulate, and tabletting, obtains.
Embodiment 10
Seven flavor medicine material in above embodiment 1, except half amount of Semen Coicis is ground into coarse powder, all the other decoct with water three times, and first and second time adds 8 times of amounts of water, decoct 1.0 hours, add for the third time 6 times of amounts of water and decoct 0.5 hour, gradation filters, merging filtrate, be concentrated into the thick paste of 1.38,70 ℃ of relative densities, standby
When decocting with water at every turn, collect the volatile oil that steam distillation out obtains, volatile oil is prepared into clathrate with hydroxypropylβ-cyclodextrin, the ratio of volatile oil and hydroxypropylβ-cyclodextrin is 1: 8ml/g, obtain the volatile oil clathrate compound of hydroxypropylβ-cyclodextrin, standby, the preparation method of clathrate is: it is 50% alcoholic solution that described volatile oil is made into volume ratio, join in beta-schardinger dextrin-saturated solution, under 15 ℃ of 130 revs/min of conditions, enclose is 3 hours, collect enclose liquid, put refrigerator cold-storage 30 hours, sucking filtration, the a small amount of water washing of clathrate, 30 ℃ of vacuum dryings 11 hours, collect clathrate, add Semen Coicis coarse powder, standby thick paste, the volatile oil clathrate compound of hydroxypropylβ-cyclodextrin, above-mentioned adjuvant, mixes, and usings microcrystalline Cellulose, mannitol, xylitol, magnesium stearate, aspartame as adjuvant, appropriate 95% ethanol is made wetting agent, granulates, dry, granulate, and tabletting, obtains.
The extracorporeal bacteria inhibitor test of experimental example 1-FUYANKANGFU chewable tablet of the present invention
The preparation of bacterium liquid: get one of single bacterium colony on the plain agar slant medium of escherichia coli, staphylococcus aureus, Candida albicans and bacillus pyocyaneus test strain, inoculate respectively in 10ml broth bouillon 37 ℃ and cultivate after 16 hours, with physiological saline solution, being diluted to concentration is that 1.0 * 102cfu/ml is standby.
The mensuration of minimal inhibitory concentration (MIC): get some of the small test tubes that 1ml broth bouillon is housed, by double dilution method, drug dilution is become to a series of concentration, then add respectively diluent (being all diluted to 10 times uses afterwards) the 50 μ l of each bacterial strain to mix, cultivate 24 hours for 37 ℃, record the minimum liquor strength of test tube clarification, this concentration is minimal inhibitory concentration embodiment 5 FUYANKANGFU chewable tablet to staphylococcus aureus, Candida albicans, escherichia coli and bacillus pyocyaneus have inhibitory action, minimal inhibitory concentration is respectively 10.11mg crude drug/ml, 20.31mg crude drug/ml, 25.71mg crude drug/ml and 30.27mg crude drug/ml.
The protective effect of experimental example 2-FUYANKANGFU chewable tablet of the present invention to infection of staphylococcus aureus mice
The preparation of bacterium liquid: depletion Staphylococcus aureus is inoculated in broth bouillon, cultivates 16 hours for 37 ℃, with standby after turbidimetry for Determination bacterial concentration.
Prerun test: get standby bacterium liquid and put in sterile test tube, be diluted to the bacteria suspension of variable concentrations with physiological saline solution by 1: 9 multiplying power, be for experiment.With different injection volumes, give respectively body weight 20g left and right female mice lumbar injection, the death toll of observing each treated animal in 24 hours.Through repeatedly many groups prerun, to find out and while treating as formal test, cause that the minimum bacterial concentration of 100% dead mouse is 5 * 102cfu/ml, every Mus lumbar injection amount is 0.5ml.Formal test: get 100 of body weight 20-24g female mices, by body weight, be divided at random 5 groups, every group of 20 animals, be respectively model control group, Fuyankangfu capsules group (20g crude drug/kg), Amoxicillin Capsules group (1.00g/kg), embodiment 6 (10g crude drug/kg, 20g crude drug/kg), embodiment 8 (20g crude drug/kg) gastric infusion every day 1 time, administration is 5 days altogether, and model control group is given and is waited capacity distilled water.30min after last medicine, every Mus lumbar injection concentration is 5 * 102cfu/ml staphylococcus aureus suspension 0.45ml, each treated animal death condition in observed and recorded 24 hours is evaluated the curative effect of medicine with the mortality rate of animal.The results are shown in Table 1.
Table 1
*p < 0.05,
*p < 0.01 (with model control group ratio)
From table, embodiment 6 (10g crude drug/kg) dosage group has the effect trend that reduces infection of staphylococcus aureus mouse death rate, and (20g crude drug/kg group has the effect of obvious reduction infection of staphylococcus aureus mouse death rate to embodiment 8.
Experimental example 3 FUYANKANGFU chewable tablet are on the granulomatous impact of rat due to agar
Get 50 of body weight 200-240g female rats, by body weight, divide 5 groups at random, 10 every group.Be respectively model control group, Fuyankangfu capsules group (20g crude drug/kg), dexamethasone acetate group (1.00mg/kg), embodiment 7 (10g crude drug/kg, 20g crude drug/kg), under pentobarbital sodium 35mg/kg intraperitoneal anesthesia, sterile working, at the agar solution 2ml of Mus dorsal line subcutaneous injection 2%, set up rat agar granuloma model.Modeling starts administration gavage next day, and every day 1 time, model control group gives isometric(al) distilled water.Cause scorching latter the 15th day, the lower execution of pentobarbital sodium anesthesia rat, separates granuloma agar block, takes weight in wet base, the significance of each administration group and model control group difference with electronic balance.The results are shown in Table 2.
Table 2-FUYANKANGFU chewable tablet is on the granulomatous impact of rat (X ± S) due to agar
*p < 0.05,
*p < 0.01 (with model control group ratio)
From table 2, each dosage group of embodiment 7 FUYANKANGFU chewable tablet has the granulomatous effect of rat due to obvious inhibition agar
Experimental example 4-FUYANKANGFU chewable tablet is on. the impact of rat chronic pelvic inflammatory disease model due to Pyrogentisinic Acid's rubber cement
The preparation of phenol rubber cement: liquefied phenol 5ml, tragakanta 1g, glycerol 4ml, adding distil water, to 20ml, is made into 25% phenol rubber cement.
Selecting body weight is 60 of the female rats of 180-220g, by body weight be divided at random blank group, model control group, Fuyankangfu capsules group (20g crude drug/kg),, embodiment 7 (10g crude drug/kg, 20g crude drug/kg), pentobarbital sodium 35mg/kg intraperitoneal anesthesia for all the other animals except blank group, abdominal part routine disinfection, take off the about 2cm of abdominal part median incision, expose uterus, with No. 4 syringe needles at the careful inserting needle in uterus, left side, to ovary direction, slowly inject phenol rubber cement 0.04ml, note is finished, and abdomen is closed in layering, sterilization art district.After modeling, 10d starts gastric infusion, every day 1 time, and continuous 15d, blank group and model control group animal are waited capacity distilled water.After last administration 24 hours, win bilateral uterus, remove after fatty tissue with scales/electronic balance weighing, the weight difference of the left and right sides, uterus is inflammation swelling degree, between organizing relatively.The results are shown in Table 3.
Formalin with 10% after weighing is fixed, paraffin embedding, conventional section.HE dyeing.Light Microscopic observation uterus morphological changes of various tissue components.FUYANKANGFU chewable tablet all has the trend that alleviates rat chronic pelvic inflammatory disease model inflammation of uterus swelling due to phenol rubber cement.
The impact (X ± S) of chronic pelvic inflammatory disease rat model uterus swelling due to table 3-FUYANKANGFU chewable tablet
*p < 0.05,
*p < 0.01 (with model control group ratio)
Obviously, compare with Fuyankangfu capsules, the present invention starts with from strengthening promoting flow of QI and blood, and specific aim is extracted the volatile oil component of Radix Bupleuri, Pericarpium Citri Reticulatae, Radix Paeoniae Rubra etc., and the FUYANKANGFU chewable tablet of development treatment gynaecopathia, for the treatment of various gynecological diseases.Compare with existing Fuyankangfu capsules, the present invention has strengthened the effect of ministerial drug, adjuvant drug, strengthened invigorate blood circulation, the effect of blood stasis dispelling, pain relieving.
Claims (3)
1. a FUYANKANGFU chewable tablet, is characterized in that, by the raw material of following weight, is made:
Medical material part:
Herba Patriniae 200g Semen Coicis 80g Fructus Toosendan 80g Radix Bupleuri 120g
Radix Scutellariae 80g Radix Paeoniae Rubra 120g Pericarpium Citri Reticulatae 80g;
Adjuvant part
β-cyclodextrin 2g aspartame 3g microcrystalline Cellulose 2g xylitol 1.5g
Mannitol 2g magnesium stearate 1.5g;
Preparation method is:
Above seven flavor medicine material, except half amount of Semen Coicis is ground into coarse powder, all the other decoct with water three times, and first and second time adds 8 times of amounts of water, decoct 1.0 hours, add for the third time 6 times of amounts of water and decoct 0.5 hour, gradation filters, merging filtrate, be concentrated into the thick paste of 1.38,70 ℃ of relative densities, standby, when decocting with water at every turn, collect the volatile oil that steam distillation out obtains, volatile oil is prepared into clathrate with beta-schardinger dextrin-, the ratio of volatile oil and beta-schardinger dextrin-is 1: 8ml/g, obtain the volatile oil clathrate compound of beta-schardinger dextrin-, standby, the preparation method of clathrate is: it is 50% alcoholic solution that described volatile oil is made into volume ratio, join in beta-schardinger dextrin-saturated solution, under 15 ℃ of 130 revs/min of conditions, enclose is 3 hours, collect enclose liquid, put refrigerator cold-storage 30 hours, sucking filtration, the a small amount of water washing of clathrate, 30 ℃ of vacuum dryings 11 hours, collect clathrate, add Semen Coicis coarse powder, standby thick paste, the volatile oil clathrate compound of beta-schardinger dextrin-, above-mentioned adjuvant, mixes, and usings microcrystalline Cellulose, mannitol, xylitol, magnesium stearate, aspartame as adjuvant, appropriate 95% ethanol is made wetting agent, granulates, dry, granulate, and tabletting, obtains.
2. the application of a kind of FUYANKANGFU chewable tablet claimed in claim 1 in the medicine of preparation treatment chronic pelvic inflammatory disease.
3. a kind of FUYANKANGFU chewable tablet claimed in claim 1 is in the application of the medicine of antibacterial, the antiinflammatory of preparation, blood circulation promoting and blood stasis dispelling, analgesia, immunomodulating, treatment leukorrheal diseases.
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| CN201110317384.6A CN103055192B (en) | 2011-10-19 | 2011-10-19 | Women inflammation recovery chewable tablet |
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| CN201110317384.6A CN103055192B (en) | 2011-10-19 | 2011-10-19 | Women inflammation recovery chewable tablet |
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| CN103055192B true CN103055192B (en) | 2014-09-10 |
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| CN104800432A (en) * | 2015-04-15 | 2015-07-29 | 刘卓韬 | Application of traditional Chinese medicine composition and acupoint combination acupuncture for treating chronic pelvic inflammation |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1698852A (en) * | 2005-05-23 | 2005-11-23 | 湘潭大学 | Stomach nourishing chewing tablet with aucklandia root and amomum fruit and its preparation process |
| CN101112554A (en) * | 2007-07-30 | 2008-01-30 | 重庆东田药业有限公司 | Film coating tablet for treating gynaecologic disease and method for preparing the same |
| CN101185738A (en) * | 2006-11-15 | 2008-05-28 | 董斌 | Gynaecologic inflammation rehabilitation effervescence granular preparation and confecting method thereof |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1698852A (en) * | 2005-05-23 | 2005-11-23 | 湘潭大学 | Stomach nourishing chewing tablet with aucklandia root and amomum fruit and its preparation process |
| CN101185738A (en) * | 2006-11-15 | 2008-05-28 | 董斌 | Gynaecologic inflammation rehabilitation effervescence granular preparation and confecting method thereof |
| CN101112554A (en) * | 2007-07-30 | 2008-01-30 | 重庆东田药业有限公司 | Film coating tablet for treating gynaecologic disease and method for preparing the same |
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Application publication date: 20130424 Assignee: JIANGXI YAODU RENHE PHARMACEUTICAL CO.,LTD. Assignor: Yang Wenlong Contract record no.: X2023990000192 Denomination of invention: A kind of Fuyan rehabilitation chewable tablet Granted publication date: 20140910 License type: Common License Record date: 20230210 |
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