CN103301378B - Pharmaceutical composition for treating nocturia of children - Google Patents
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Abstract
The invention discloses a pharmaceutical composition for treating nocturia of children, so as to solve the problem of treatment of the nocturia of children. The pharmaceutical composition is characterized by being prepared from the following crude drugs: bark of himalayan coralbean, smallflower bracketplant herb, bobbin, alpinia japonica, jasminum grandiflorum, immature bitter orange, dark malt, burnt medicated leaven, Chinese ephedra root, manis pentadactyla, peach gum, and rhizome anemones altaicae. The clinical test shows that the pharmaceutical composition has the characteristics of good curative effect and high safety on treatment of the nocturia of children, and is worthy of clinical application and popularization.
Description
Technical field
The present invention relates to the field of Chinese medicines, be specifically related to a kind of pharmaceutical composition for the treatment of nocturia of children.
Background technology
Nocturia of children (nocturia), refers to involuntaryly to urinate night.The enuresis before three years old is physiological, and within three years old, the later enuresis is a kind of abnormal phenomenon.Abnormal enuresis is born in night, so be nocturia because of multiple.The common disease childhood period that nocturia of children being, reduces with the increase at age.According to statistics, when 5 years old, sickness rate is 15% ~ 20%, and when 7 years old, sickness rate is 10%, although every year with 15% ratio spontaneous regression, still have the infant Symptoms last of 1% ~ 2% to being grown up, and the order of severity of the enuresis increases the weight of with the increase at age.
Current orientation treatment is mainly started with from improving vassopressin level and utilizing cholinergic receptor-blocking agent to remove smooth muscle of bladder spasm angle, and the former is as synthetic vassopressin, and the latter is as oxibutynin.But above two kinds of therapeutic modalities only take stopgap measures, rapid-action, but easily recur.
Chinese traditional treatment nocturia of children thinks that this disease is deficiency syndrome more, and the setting about for the treatment of is a little to tonify Qi of the kidney, conventional representative prescription as large complement decoct, Gu Yin decocts.But inventor's clinical research finds that blood supply minimizing and cicatrization etc. all can cause mucous membrane of urethra atrophy, and gauffer reduces, thus makes urethra follow the string, suitable closedown swaging can not be provided to become urinary incontinence under sleep state.Also namely this disease also has mucous membrane of urethra solid pathological product to occur on deficiency syndrome basis, so should fully take into account mucous membrane of urethra to lose foster atrophy, these key pathological links of connective tissue arrangement disorder fibrosis.
Summary of the invention
Technical assignment of the present invention is for above the deficiencies in the prior art, provides a kind of curative effect certainly and the pharmaceutical composition of the little treatment nocturia of children of side effect.
The technical scheme that the present invention solves its technical problem is: a kind of pharmaceutical composition for the treatment of nocturia of children, it is characterized in that being prepared from by the crude drug of following weight proportion: Cortex erythrinae 10 ~ 30 parts, Herba Chlorophyti Laxi 6 ~ 12 parts, go back 3 ~ 10 parts, bobbin, Alpinia japonica (Thunb.) Miq. 6 ~ 12 parts, Flos jasmini 3 ~ 10 parts, Fructus Aurantii Immaturus 6 ~ 12 parts, Fructus Hordei Germinatus (parched to brown) 6 ~ 12 parts, Massa Medicata Fermentata (parched to brown) 6 ~ 12 parts, Radix Ephedrae 6 ~ 12 parts, Squama Manis 1 ~ 5 part, gumshiraz 3 ~ 10 parts, Rhizoma Anemones Altaicae 10 ~ 25 parts.
Chinese medicine of the present invention is prepared from by the raw material of following optimum weight part proportioning: Cortex erythrinae 20 parts, Herba Chlorophyti Laxi 10 parts, go back 6 parts, bobbin, Alpinia japonica (Thunb.) Miq. 10 parts, Flos jasmini 6 parts, Fructus Aurantii Immaturus 10 parts, Fructus Hordei Germinatus (parched to brown) 10 parts, Massa Medicata Fermentata (parched to brown) 10 parts, Radix Ephedrae 10 parts, Squama Manis 2 parts, gumshiraz 6 parts, Rhizoma Anemones Altaicae 20 parts.
Wherein said: Cortex erythrinae is bark or the root bark of pulse family Erythrinae Arborescentis Erythrina indica Lam..Nature and flavor are bitter, flat.Return liver, kidney channel.Merit can wind-damp dispelling, channels sootheing and network vessel quickening.Wind-damp dispelling, the meridian dredging, parasite killing.
Herba Chlorophyti Laxi is herb or the root of feverfew Prenanthes henryi Dunn Prenanthes henryi Dunn.Bitter in the mouth; Cold in nature.Merit can heat-clearing and toxic substances removing; Dissipating blood stasis stops blooding.
Also bobbin is the fruit of orchid Rhizoma Gastrodiae Gastrodia elata Bl..Sweet in the mouth; Cold in nature.Merit can tonify deficiency subduing the wind syndrome.Main dizzy; Pupil; Wind syndrome of head is had a headache; Weak breath consumption of essence; Early whitening of beard and hair.
Alpinia japonica (Thunb.) Miq., is Zingiberaceae Alpinia plants Alpinia japonica (Thunb.) Miq. Alpinia japonica Miq., is used as medicine with root stock.Nature and flavor are pungent, warm.Return lung, spleen, Liver Channel.Merit can dispelling wind and removing obstruction in the collateral, regulating QI to relieve pain.
Flos jasmini is Oleaceae plants Flos jasmini Jasminu, the dry flower of grandiflorum L..Property mildly bitter flavor; Property is put down.Return Liver Channel.Merit can soothing liver-QI for relieving depression, promoting the circulation of QI to relieve pain.
Fructus Aurantii Immaturus is the dry young fruit of rutaceae Citrus aurantium Linn. Citrus aurantium L. and variety or Fructus Citri sinensis Citrus sinensis Osbeck.Merit can dispelling the stagnated QI intestinal stasis relieving.Nature and flavor are bitter, pungent, sour, temperature.Return spleen, stomach warp.Merit can dispelling the stagnated QI removing food stagnancy, loose painful abdominal mass of reducing phlegm.
Fructus Hordei Germinatus (parched to brown), for the mature fruit of grass Fructus Hordei Vulgaris Hordeum vulgare L. is through drying of germinateing, fries to burnt brown according to frying method, cooling, sieve dedust bits.Nature and flavor are sweet, flat.Return spleen, stomach warp.Merit can promote qi circulation digestion promoting, and spleen benefiting and stimulating the appetite, moves back newborn relieving distension.
Massa Medicata Fermentata (parched to brown), for the medicines such as Herba polygoni hydropiperis, Herba Artemisiae Annuae, Semen Armeniacae Amarum add flour or wheat bran mixed after, through the herbal leaven of fermentation, fry to burnt brown according to frying method.Nature and flavor sweet, acrid, warm.Enter spleen, stomach warp.Merit can invigorating the spleen and regulating the stomach, helps digestion in adjusting.
Radix Ephedrae is the dry root and rhizome of Ephedraceae plant plait Herba Ephedrae Ephedra sinica Stapf or epheday intermedia Ephedra intermedia Schrenk et C. A. Mey..Nature and flavor are sweet, flat.GUIXIN, lung meridian.Merit can hidroschesis.
Squama Manis is the scute of Manidae animal Squama Manis Manis pentadactyla Linnaeus.Nature and flavor are salty, are slightly cold.Return liver, stomach warp.Merit can be stimulated the menstrual flow stimulating milk secretion, detumescence and apocenosis, expel wind to dredge collateral.
Gumshiraz is rosaceous plant Fructus Persicae Prunus persica (L.) Batsch, the resin that trunk flows out.Nature and flavor are bitter, flat.Merit can be invigorated blood circulation, and QI invigorating is quenched the thirst.
Rhizoma Anemones Altaicae, is Ranunculaceae thimbleweed anemone altaica Anemone altaica Mey., is used as medicine with root stock.Nature and flavor are pungent, temperature.Merit can causing resuscitation with aromatic drugs, reduces phlegm, calms the nerves.
Composition principle: Chinese traditional treatment nocturia of children thinks that this disease is deficiency syndrome more, the setting about for the treatment of is a little to tonify Qi of the kidney, conventional representative prescription as large complement decoct, Gu Yin decocts.But inventor's clinical research finds that blood supply minimizing and cicatrization etc. all can cause mucous membrane of urethra atrophy, and gauffer reduces, thus makes urethra follow the string, suitable closedown swaging can not be provided to become urinary incontinence under sleep state.Also namely this disease also has mucous membrane of urethra solid pathological product to occur on deficiency syndrome basis, so should fully take into account mucous membrane of urethra to lose foster atrophy, these key pathological links of connective tissue arrangement disorder fibrosis.
Compared with prior art, the present invention has following characteristics:
1, prescription is unique, avoids using medicine of tonifying Qi of the kidney in a large number: get Cortex erythrinae in side, go back bobbin for monarch, the Cortex erythrinae dosage recorded in " China is herbal " is: " for oral administration: to decoct soup, 6-12g "; Inventor to test in proof heavy dose of Cortex erythrinae (10 ~ 30g) and can recover by specific promotion urethral wall mucosa, and goes back bobbin and have similar smooth muscle dual regulation, unbalance for sphincter vesicae shrinkage expansion;
2, characteristic of the present invention is also balance and restriction: record Cortex erythrinae in 1. " must joining book on Chinese herbal medicine ": " insufficiency of blood heated person forbid ", but infant resembling often with deficiency of YIN-blood, and now use Cortex erythrinae, then have and fear its hematozemia and cause yin asthenia generating intrinsic heat to occur; Therefore add Herba Chlorophyti Laxi and go back bobbin, also bobbin merit can train base by tonify deficiency, and can prevent Cortex erythrinae from consuming cloudy blood and liver-wind stirring up internally, and Herba Chlorophyti Laxi bitter in the mouth is cold in nature, utilize on the one hand it coldly to prevent heated, its merit can dissipating blood stasis hemostasis on the other hand, has out entire merit in blood system, prevent Cortex erythrinae to wander away dynamic blood, also can not affect Cortex erythrinae works orderly effect simultaneously; 2. in we, the use of Rhizoma Anemones Altaicae is: a causing resuscitation with aromatic drugs and benefaction, two Yin Yang balancings, and to balance the bitter cold of our invasion by pathogenic cold medicine of a cold nature thing, inventor's clinical research finds that Rhizoma Anemones Altaicae is activated yang and do not consume the moon in addition, is suitable for child and uses; In prescription of the present invention, the application characteristic of Rhizoma Anemones Altaicae is: measure larger (consumption in " Chinese Pharmacopoeia " is 1.5-6g), so too disperse for preventing, gets again Radix Ephedrae convergence assistant system;
3, supplementary drug thing is fewer but better: get Alpinia japonica (Thunb.) Miq. assistant in side and help Herba Chlorophyti Laxi, it act as giving treatment in accordance with the tendency of pathological change, regulating air activity; Fructus Aurantii Immaturus and Herba Chlorophyti Laxi are arranged in pairs or groups removing toxic substances, eliminating stagnation effect, for these pathological products of connective tissue arrangement disorder fibrosis; Inventor's clinical research shows: Flos jasmini can alleviate bladder irritation effectively; Gumshiraz is invigorated blood circulation, and contributes to drag residence in local, penetration enhancement;
4, inventor's clinical research finds, Fructus Hordei Germinatus (parched to brown), the external of Massa Medicata Fermentata (parched to brown) decoct can promote local mucous membrane blood circulation;
5, Squama Manis is supplementary drug thing, and the consumption recorded in " China's book on Chinese herbal medicine " is: " for oral administration: to decoct soup, 6 ~ 12g ", and the present inventor's experimental study finds, gets low dose of Squama Manis decocting liquid and can improve in vitro mucous membrane of urethra cytoactive;
6, the homogeneous medicine multiple-effect of institute's thing of getting it filled in side, contributes to reducing medicament categories and consumption, does not increase local excitation;
7, medicine material consumption of the present invention is groped to sum up to draw through inventor in a large number, and each raw material dosage is for all to have good curative effect in following weight parts scope.
Detailed description of the invention
Below in conjunction with practical situation, the specific embodiment of the present invention is elaborated.
Embodiment 1, crude drug weight proportion: Cortex erythrinae 20g, Herba Chlorophyti Laxi 10g, go back bobbin 6g, Alpinia japonica (Thunb.) Miq. 10g, Flos jasmini 6g, Fructus Aurantii Immaturus 10g, Fructus Hordei Germinatus (parched to brown) 10g, Massa Medicata Fermentata (parched to brown) 10g, Radix Ephedrae 10g, Squama Manis 2g, gumshiraz 6g, Rhizoma Anemones Altaicae 20g.
The preparation method of embodiment 1 is: by Cortex erythrinae, Herba Chlorophyti Laxi, go back bobbin, Alpinia japonica (Thunb.) Miq., Flos jasmini, Fructus Aurantii Immaturus, Fructus Hordei Germinatus (parched to brown), Massa Medicata Fermentata (parched to brown), Radix Ephedrae, Squama Manis, gumshiraz, the decoction of Rhizoma Anemones Altaicae mixing and water adding, filtrate is got after 30 minutes, medicinal residues add water continue decoction get filtrate after 20 minutes, twice filtrate merges soak, once a day.
Embodiment 2, crude drug weight proportion: Cortex erythrinae 10 parts, Herba Chlorophyti Laxi 6 parts, go back 3 parts, bobbin, Alpinia japonica (Thunb.) Miq. 6 parts, Flos jasmini 3 parts, Fructus Aurantii Immaturus 6 parts, Fructus Hordei Germinatus (parched to brown) 6 parts, Massa Medicata Fermentata (parched to brown) 6 parts, Radix Ephedrae 6 parts, Squama Manis 1 part, gumshiraz 3 parts, Rhizoma Anemones Altaicae 10 parts.
Embodiment 3, crude drug weight proportion: Cortex erythrinae 20 parts, Herba Chlorophyti Laxi 10 parts, go back 6 parts, bobbin, Alpinia japonica (Thunb.) Miq. 10 parts, Flos jasmini 6 parts, Fructus Aurantii Immaturus 10 parts, Fructus Hordei Germinatus (parched to brown) 10 parts, Massa Medicata Fermentata (parched to brown) 10 parts, Radix Ephedrae 10 parts, Squama Manis 2 parts, gumshiraz 6 parts, Rhizoma Anemones Altaicae 20 parts.
Embodiment 4, crude drug weight proportion: Cortex erythrinae 30 parts, Herba Chlorophyti Laxi 12 parts, go back 10 parts, bobbin, Alpinia japonica (Thunb.) Miq. 12 parts, Flos jasmini 10 parts, Fructus Aurantii Immaturus 12 parts, Fructus Hordei Germinatus (parched to brown) 12 parts, Massa Medicata Fermentata (parched to brown) 12 parts, Radix Ephedrae 12 parts, Squama Manis 5 parts, gumshiraz 10 parts, Rhizoma Anemones Altaicae 25 parts.
The Chinese medicine of embodiment 2 ~ 4 can be prepared from by following method:
(1) by Cortex erythrinae, Fructus Aurantii Immaturus, Radix Ephedrae coarse powder distilling under reduced pressure extraction volatile oil respectively, and mixing for standby use after collecting, medicinal residues mixing for standby use;
(2) will go back bobbin decompression decoction 2 times, each 30min, collecting decoction, filters after leaving standstill, obtains filtrate for subsequent use;
(3) gained medicinal residues in Herba Chlorophyti Laxi, Alpinia japonica (Thunb.) Miq., Flos jasmini, Fructus Hordei Germinatus (parched to brown), Massa Medicata Fermentata (parched to brown), Squama Manis, gumshiraz, Rhizoma Anemones Altaicae and step 1 are added 10 times of water yields, decoct with water 2 times, each 1 hour, collecting decoction, filter after leaving standstill, obtain filtrate for subsequent use;
(4) step 2 gained filtrate and step 3 gained filtrate are merged, concentrating under reduced pressure becomes dry extract, pulverizes to obtain dry extract;
(5) spray in step 4 gained dry extract by gained volatile oil in step 1, mixing, cross 100 mesh sieves, subpackage forms.
The efficient combination of said medicine, coordinates mutually, effectively reach the object for the treatment of nocturia of children, and side effect is less.The above results is clinical data sufficient proof, and interrelated data is as follows.
1 object and method.
1.1 object.
1 data and method.
1.1.1 case selection: in December, 2009 ~ 2013 are diagnosed as nocturia of children patient 73 example year June, and eliminating excreting excrement system infects and kidney disease, previously without operation on pelvis history and neuromuscular pathological changes.
1.1.2 the diagnostic criteria of nocturia of children: the diagnostic criteria of the nocturia of children that international children's's urinary continence association (ICCIS) was announced in 1998: (1) occurs to urinate normally at unaccommodated or social unacceptable when and where, namely urinate in bed during the sleep of enuresis infant, usually can not wake up because urinating wet, having genetic predisposition; (2) age is more than or equal to 5 years old; (3) below 10 years old monthly more than at least 2 times, more than 10 years old monthly at least 1 time; (4) urine volume should drench sheet.
1.1.3 divide into groups: be divided into soak group 37 example and deposited umbilicus group 36 example.Compare in sex, age, the state of an illness, the course of disease before two groups of patient treatments, no significant difference (P>0.05), has comparability.
1.2 method.
1.2.1 Therapeutic Method: soak group with gained decoct umbilical part soak in the embodiment of the present invention 1,3 times/d.Applying umbilicus group adjusts rear umbilical part to dress with gained powder vinegar in the embodiment of the present invention 3,1 time/d.February is a course for the treatment of.
1.2.2 observation index: conventional inquiry medical history before and after medication, and carry out general questionnaire survey scoring, evaluate its situation of urinating.
1.2.3 criterion of therapeutical effect: recovery from illness: nocturia complete incidence graph (or without nocturia or have urine to wake up oneself to go to urinate); Take a turn for the better: nocturia partial rcsponse (the more former obvious minimizing of bed-wetting number of times, or sometimes can wake up oneself go to urinate); Invalid: nocturia is not alleviated completely.
1.2.4 statistical analysis: SPSS 16.0 carries out statistical analysis.ICIQ-SF scoring adopts nonparametric statistics.Measurement data t checks, enumeration data χ
2inspection.
2 results.
2.1 clinical efficacies: medication is after 8 weeks, and the obvious effective rate of soak group, effective percentage, inefficiency are respectively 43.24%, 40.54%, 16.22%, total effective rate is 83.78%.The obvious effective rate of deposited umbilicus group, effective percentage, inefficiency are respectively 33.33%, 47.22%, 19.44%, and total effective rate is 80.56%.
2.2 adverse reaction rates: two groups of patients all do not occur obvious adverse reaction.
Relapse rate in 2.3 drug withdrawal half a year: soak group has 3.23%(4/124) there is recurrence in case, applying umbilicus group has 0.81%(1/124) there is recurrence in case.
3. conclusion.
This result of study shows, and soak group of the present invention and deposited umbilicus group treatment nocturia of children total effective rate are 83.78% and 80.56%, apply the cure rate of umbilicus group higher than soak group.Have the advantage that untoward reaction is comparatively light, safety is higher.
Claims (1)
1. treat a pharmaceutical composition for nocturia of children, it is characterized in that being prepared from by the crude drug of following weight proportion:
Cortex erythrinae 20 parts, Herba Chlorophyti Laxi 10 parts, go back 6 parts, bobbin, Alpinia japonica (Thunb.) Miq. 10 parts, Flos jasmini 6 parts, Fructus Aurantii Immaturus 10 parts, Fructus Hordei Germinatus (parched to brown) 10 parts, Massa Medicata Fermentata (parched to brown) 10 parts, Radix Ephedrae 10 parts, Squama Manis 2 parts, gumshiraz 6 parts, Rhizoma Anemones Altaicae 20 parts; Described pharmaceutical composition is umbilical external application preparation.
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