A kind of pharmaceutical composition for the treatment of the hyperhidrosis of children's's pure
Technical field
The present invention relates to field of medicaments, relate in particular to the pharmaceutical composition of a kind of children's's for the treatment of pure hyperhidrosis.
Background technology
Hyperhidrosis is the common symptom of children's, and it can be a symptom of some disease, can also be a simple symptom and without Other diseases.Children's's internal organs are tender and lovely, deficiency of primordial QI, and interspaces of skin and muscles being loose, sweating is more, easily has a cold and catches a cold.Night, sweating was more, caused agitation, sleep disorder, affected life, the study on daytime.
Children's due to body constitution a little less than, use Western medicine to treat often side effect larger.And Chinese Traditional Medicine often adopts modes such as decocting decoction, oral tablet, capsule to produce, but may greatly reduce at its effective ingredient after human gastrointestinal tract.Therefore, for the exploitation of new dosage form also in continuous research.
Umbilicus, cave name Shenque, for the important acupuncture point of conception vessel, Gu has saying of " Shenque, curing mainly all kinds of diseases and ailments, and old man, empty people have loose bowels as god ", position, umbilicus place is again that chong channel is through row part, Conception Vessel and Governor Vessel is the exterior and the interior each other, and commander's human body is all through hundred arteries and veins, therefore umbilical part is by above meridians and all internal organs organ close ties of whole body.Human body stomach wall is thin, and local application is easy to absorb, and no pain, is the agents area that makes further investigation.
Summary of the invention
The object of this invention is to provide the pharmaceutical composition of a kind of children's's for the treatment of pure hyperhidrosis.
In order to realize object of the present invention, the invention provides the pharmaceutical composition of a kind of children's's for the treatment of pure hyperhidrosis, it is to be made up by weight of following bulk drugs: Herba Moslae Soochowensis 20-50 part, Rhizoma begoniae pedatifidae 25-40 part, Herba Silenes conoideae 20-40 part, cypress vine pine 20-30 part, Cortex Ampelopsis Aconitifoliae Radicis 10-20 part, Rhizoma Atractylodis 10-30 part, Radix Oenotherae erythrosepalae 10-30 part, Flos Caryophylli 10-20 part, Herb Pararuelliae delavayanae 10-20 part, Herba Elsholtziae Ciliatae 10-30 part, Fructus Leonuri 10-20 part, Folium Symplocoris Caudatae 10-20 part, Rhizoma Alismatis 10-20 part, Radix Puerariae 1-10 part, Radix Salviae Miltiorrhizae 5-15 part, the peppery 5-15 part of wild tea, Fructus Lycii 1-5 part, Fructus Corni 1-5 part, Fructus Arctii 1-5 part, Herba Pogostemonis 1-5 part and Radix Angelicae Dahuricae 1-5 part.
Preferably, the pharmaceutical composition for the treatment of of the present invention children's pure hyperhidrosis is to be made up by weight of following bulk drugs: 1 part of 32 parts of Herba Moslae Soochowensiss, 28 parts of Rhizoma begoniae pedatifidaes, 30 parts of Herba Silenes conoideaes, 25 parts of cypress vine pines, 15 parts of Cortex Ampelopsis Aconitifoliae Radiciss, 20 parts of Rhizoma Atractylodis, 18 parts of Radix Oenotherae erythrosepalaes, 18 parts of Flos Caryophyllis, 16 parts of Herb Pararuelliae delavayanaes, 12 parts of Herba Elsholtziae Ciliataes, 10 parts of Fructus Leonuris, 10 parts of Folium Symplocoris Caudataes, 13 parts of Rhizoma Alismatis, 8 parts of Radix Puerariaes, 6 parts of Radix Salviae Miltiorrhizaes, peppery 6 parts of wild tea, 3 parts of Fructus Lycii, 2 parts of Fructus Corni, 1 part of Fructus Arctii, 2 parts of Herba Pogostemoniss and the Radix Angelicae Dahuricae.
More preferably, described medicine can be tablet, dispersible tablet, disintegrating tablet, instant, enteric coatel tablets, umbilicus patch or decoction.
More preferably, described pharmaceutical composition is prepared by following method: get that Herba Moslae Soochowensis, Rhizoma begoniae pedatifidae, Herba Silenes conoideae, cypress vine pine, Cortex Ampelopsis Aconitifoliae Radicis, Rhizoma Atractylodis, Radix Oenotherae erythrosepalae, Flos Caryophylli, Herb Pararuelliae delavayanae, Herba Elsholtziae Ciliatae, Fructus Leonuri, Folium Symplocoris Caudatae, Rhizoma Alismatis, Radix Puerariae, Radix Salviae Miltiorrhizae, wild tea are peppery, Fructus Lycii, Fructus Corni, Fructus Arctii, Herba Pogostemonis and the Radix Angelicae Dahuricae, add 5 liters, water, under the condition refluxing, heat 5 hours, filter, obtain filtering residue and filtrate 1; In filtering residue, add 3 liters, water, under the condition refluxing, heat 3 hours, filter, obtain filtering residue and filtrate 2; Merging filtrate 1 and filtrate 2, be concentrated into relative density 1.20 at 50 ℃, inlet temperature be under 120 ℃, the infusion pump rotating speed condition that is 20r/min, spray dry, thereby obtain dried powder, in above-mentioned powder, add 400 grams of lanolines, be stirred into paste, be coated on breathability sticker, evenly cut into 300 umbilicus patches.
Generally acknowledged that at present " organic conception ", " determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs ", " compound recipe use ", " compound compatibility medication is as used military forces " are the most scientific the most several large advantages of the traditional Chinese medical science, wherein " compound compatibility medication is as used military forces " is the original theory of Chinese medicine of very science.Each medicine tight compatibility all linked with one another as arrayed troops for battle in traditional Chinese medical science prescription is its effective means that is better than Western medicine formula.Tcm prescription theory is thought, each prescription, not only need to select the appropriate compatibility of suitable medicine according to etiology and pathogenesis, also should meet the basic structure of prescription simultaneously, the i.e. prescription compatibility theory of " monarch, minister, help, make ", the prescription compatibility of so-called " monarch, minister, help, make " is exactly that it is based upon the scientific matching on the comprehensive judgement basis of disease pathogenesis.In medical square tube cross too many levels, many target spots and integrate the biological mechanism regulating, can obtain than Western medicine more lastingly, therapeutic effect that more green natural has no side effect, and this curative effect is to be based upon on the accurate instruction of the original theory of above-mentioned traditional Chinese medical science tradition, the present invention is just following this principle.
In compositions of the present invention:
Herba Moslae Soochowensis (Latin formal name used at school Mosla soochowensis Matsuda[Or-thodon soochowensis (Matsuda) C.Y.Wu]) warm in nature, micro-pungent.Return lung meridian; Stomach warp.Have induce sweat, drive away summer heat, the effect such as regulating QI to relieve pain.Rhizoma begoniae pedatifidae ([base is former] is the rhizome of Begoniaceae Begonia plant Pharmacognostical Study, [former plant] Pharmacognostical Study Begonia pedatifida l é vl.) property is flat, and sour in the mouth, has expelling wind and activating blood circulation, diuretic, the effects such as removing toxic substances.(Latin formal name used at school Silene conoidea L.) is sweet for Herba Silenes conoideae, and micro-hardship is cool, returns lung, Liver Channel, has the effect such as yin nourishing, heat clearing away.(Latin formal name used at school Quamoclit pennata (Lam.) Bojer) is sweet for cypress vine pine, cold, has the effects such as removing toxic substances, removing heat from blood.(Latin formal name used at school Vernonia cumingiana Benth.) is pungent for Cortex Ampelopsis Aconitifoliae Radicis, and heat, has the effect such as promoting blood circulation to remove blood stasis, eliminating inflammation and expelling toxin.Rhizoma Atractylodis: meridian distribution of property and flavor: pungent, bitter, temperature.Return spleen, stomach, Liver Channel.Cure mainly transporting imbalance, inappetence, vomiting is unhappy, and abdominal distention is had loose bowels, arthralgia.Radix Oenotherae erythrosepalae (Latin formal name used at school Oenothera biennis L.) sweet in the mouth; Bitter; Warm in nature, there is wind-damp dispelling; The effects such as bone and muscle strengthening.Flos Caryophylli: acrid in the mouth is warm in nature, warming middle-JIAO warming the kidney, stopping nausea and vomiting by lowering the adverse flow of QI, mainly contain eugenol etc., its alabastrum distills the Flos Caryophylli volatile oil of producing, and has special strong fragrance, energy antifungal activity pathogenic bacterium, and various pathogens is had to inhibitory action, can treat for stomachache, warm up public region, antihalitosis, toothache.(Latin formal name used at school Pararuellia delauayana (Baill.) E.Hossain) is sweet light for Herb Pararuelliae delavayanae, flat, has heat-clearing and toxic substances removing, the effects such as dissipating blood stasis for subsidence of swelling.Herba Elsholtziae Ciliatae (Latin formal name used at school Herba Elsholtziae Ciliatae) acrid in the mouth; Micro-hardship; Warm in nature, having dispels the wind delivers; Blood-arresting catamenia-regulating; The effects such as subduing swelling and detoxicating.Fructus Leonuri is pungent, bitter, is slightly cold.GUIXIN, Liver Channel.There is promoting blood flow to regulate menstruation, the effects such as liver heat removing and eyesight improving.Folium Symplocoris Caudatae (Latin formal name used at school Symplocos sumuntia Buch.-Hamex DDon S.Caudata Wall.], be the leaf of Symplocaceae plant mountain vitriol) acid, puckery, micro-sweet, property is flat, attaches to the lung and stomach meridians, and has the effect such as heat-clearing and toxic substances removing, astringing to arrest bleeding.Rhizoma Alismatis: sweet in the mouth is light, cold in nature.Return kidney; Urinary bladder channel.There is effect for reducing blood fat.Radix Puerariae: property feeble QI, taste is micro-bitter.Deliver and bring down a fever, promoting the production of body fluid to quench thirst.Cure mainly: table disease fever without perspiration, rigidity pain on the head and nape, calentura is thirsty, quenches one's thirst, and macule is not saturating, diarrhea due to hypofunction of the spleen.Better to improving the symptom effects such as headache, dizziness, stiffness of the nape, tinnitus, numb limbs and tense tendons.Radix Salviae Miltiorrhizae: return through the popular feeling, Liver Channel.Function: promoting blood circulation to remove obstruction in the collateral, removing heat from blood detumescence, relieving restlessness clears away heart-fire.Wild tea peppery (Latin formal name used at school Cipedessa cinerascens(Pell.) Hand.Mazz.[C.fruticosa Bl.var.cinerascens Pell.; C.baccifera(Roth) Miq.var.sinenisWils.]) pungent; Bitter; Tepor, cures mainly dispel the wind removing dampness, promoting the circulation of QI to relieve pain etc.Fructus Lycii: nature and flavor: cool in nature, sweet in the mouth.Function: relieve inflammation or internal heat, bring down a fever.Fructus Corni: liver and kidney tonifying, essence astringing and desertion stemming.Quench one's thirst for vertigo and tinnitus, soreness of waist and knee joint, impotence and seminal emission, enuresis frequent micturition, bleeding not during menses, profuse sweating collapse, interior-heat.Fructus Arctii: pungent, bitter, cold.Enter lung, stomach warp.There is the effects such as dispelling wind and heat pathogens, sore-throat relieving eliminating stagnation, removing toxic substances rash.Herba Pogostemonis: acrid in the mouth; Slightly warm in nature.Fruit can make spice, and leaf and stem are all rich in volatile aromatic oil, have strong fragrance, are aromatic oil raw material.The Radix Angelicae Dahuricae: acrid in the mouth is warm in nature, has antibacterial, detumescence, pain relieving effect, can treat have a toothache, rhinitis, dermatosis, and the skin of moistening, fragrance pain nine orifices, flat enter blood, on passing through inside, reach, fragrance is pleasant.
For compositions of the present invention, according to the prescription compatibility theory of " monarch, minister, help, make ", Herba Moslae Soochowensis, Rhizoma begoniae pedatifidae, Herba Silenes conoideae, cypress vine pine are monarch drug; Cortex Ampelopsis Aconitifoliae Radicis, Rhizoma Atractylodis, Radix Oenotherae erythrosepalae, Flos Caryophylli, Herb Pararuelliae delavayanae are ministerial drug; Herba Elsholtziae Ciliatae, Fructus Leonuri, Folium Symplocoris Caudatae, Rhizoma Alismatis, Radix Puerariae are adjuvant drug; Radix Salviae Miltiorrhizae, wild tea are peppery, Fructus Lycii, Fructus Corni, Fructus Arctii, Herba Pogostemonis and the Radix Angelicae Dahuricae be for making medicine.All medicines are harmonious in the present invention, and reasonable recipe has determined curative effect, safe ready, has no side effect, cheap feature.
The specific embodiment
Further illustrate the present invention below by embodiment.It should be understood that embodiments of the invention are for the present invention rather than limitation of the present invention are described.The simple modifications that essence according to the present invention is carried out the present invention all belongs to the scope of protection of present invention.Except as otherwise noted, the percent otherwise in the present invention is percetage by weight.
Embodiment patch of the present invention
Get 10 grams of 320 grams of Herba Moslae Soochowensiss, 280 grams of Rhizoma begoniae pedatifidaes, 300 grams of Herba Silenes conoideaes, 250 grams of cypress vine pines, 150 grams of Cortex Ampelopsis Aconitifoliae Radiciss, 200 grams of Rhizoma Atractylodis, 180 grams of Radix Oenotherae erythrosepalaes, 180 grams of Flos Caryophyllis, 160 grams of Herb Pararuelliae delavayanaes, 120 grams of Herba Elsholtziae Ciliataes, 100 grams of Fructus Leonuris, 100 grams of Folium Symplocoris Caudataes, 130 grams of Rhizoma Alismatis, 80 grams of Radix Puerariaes, 60 grams of Radix Salviae Miltiorrhizaes, peppery 60 grams of wild tea, 30 grams of Fructus Lycii, 20 grams of Fructus Corni, 10 grams of Fructus Arctiis, 20 grams of Herba Pogostemoniss and the Radixs Angelicae Dahuricae, add 5 liters, water, under the condition refluxing, heat 5 hours, filter, obtain filtering residue and filtrate 1; In filtering residue, add 3 liters, water, under the condition refluxing, heat 3 hours, filter, obtain filtering residue and filtrate 2; Merging filtrate 1 and filtrate 2, be concentrated into relative density 1.20 at 50 ℃, using ZLPG6-10 spray dryer (Jiangsu Fan Qun drying equipment factory) is spray and be dried under 120 ℃, the infusion pump rotating speed condition that is 20r/min in inlet temperature, thereby obtain dried powder, in above-mentioned powder, add 400 grams of lanolines, be stirred into paste, be coated on breathability sticker, evenly cut into 300 umbilicus patches.
Pharmacology pharmacodynamic report
Acute toxicity test report
Laboratory animal: Kunming mouse, female 12, male 12, body weight 18~22g, purchased from Shanghai Slac Experimental Animal Co., Ltd..
Trial drug: get 10 grams of 320 grams of Herba Moslae Soochowensiss, 280 grams of Rhizoma begoniae pedatifidaes, 300 grams of Herba Silenes conoideaes, 250 grams of cypress vine pines, 150 grams of Cortex Ampelopsis Aconitifoliae Radiciss, 200 grams of Rhizoma Atractylodis, 180 grams of Radix Oenotherae erythrosepalaes, 180 grams of Flos Caryophyllis, 160 grams of Herb Pararuelliae delavayanaes, 120 grams of Herba Elsholtziae Ciliataes, 100 grams of Fructus Leonuris, 100 grams of Folium Symplocoris Caudataes, 130 grams of Rhizoma Alismatis, 80 grams of Radix Puerariaes, 60 grams of Radix Salviae Miltiorrhizaes, peppery 60 grams of wild tea, 30 grams of Fructus Lycii, 20 grams of Fructus Corni, 10 grams of Fructus Arctiis, 20 grams of Herba Pogostemoniss and the Radixs Angelicae Dahuricae, add 5 liters, water, under the condition refluxing, heat 5 hours, filter, obtain filtering residue and filtrate 1; In filtering residue, add 3 liters, water, under the condition refluxing, heat 3 hours, filter, obtain filtering residue and filtrate 2; Merging filtrate 1 and filtrate 2, regulate concentration to being equivalent to 1.5g crude drug/ml.
Experimental procedure:
1. mice adaptability is fed 3~4 days, and body weight control is in 22g
2. before mice administration, water 12h is can't help in fasting;
3. grouping, with table of random number method by mice be assigned to blank organize and administration group in, 12 every group, male and female half and half.
4. administration, blank group gives normal saline, medicinal liquid prepared by administration group, gavage amount 0.25ml/10g.One day twice.
Experimental result: after gavage, mice is movable to be reduced, and loss of appetite, after 24 hours, is recovered gradually.After 48 hours, completely normal.Feed 1 week continuously, not abnormal appearance.There is not the phenomenon of dead mouse, general mortality rate 0.According to the experience of Chinese medicine studies on acute toxicity, can think that medicament of the present invention is safe.
Long term toxicity test report
Laboratory animal: SD rat, body weight is at 120-130g, and male and female half and half, purchased from Shanghai Slac Experimental Animal Co., Ltd..
Trial drug: the medicinal liquid that adopts preparation in anxious poison test.
Experimental procedure: get 20 of rat, be divided into 2 groups, every group 10, wherein the 1st group as administration group, feed by filling with for 2 times every every day, each 6ml, the 2nd group of normal feeding (do not give any Drug therapy as a control group, only normally raise), once a day, continuous irrigation is fed 90 days, survey body weight, 24 hours sacrificed by decapitation after last administration, survey blood, routine urinalysis, liver function, renal function, core, the internal organs such as kidney, the variation of tissues observed form, observe the effect of dosage, observe diet, movable variation, experimental results show that administration group and matched group are relatively without significant change, show that medicament of the present invention is safe.
Clinical trial
100 examples are out-patient, are divided into two groups, wherein treatment group 50 examples, male 25 examples, female's 25 examples; 1~3 year old 18 example, 3~7 years old 15 example, 7~14 years old 17 example; Only movable rear hyperhidrosis 12 examples, hyperhidrosis 6 examples when quiet, hyperhidrosis at night 50 examples.Matched group 50 examples, male 25 examples, female's 25 examples; 1~3 year old 16 example, 3~7 years old 20 example, 7~14 years old 14 example; Only movable rear hyperhidrosis 14 examples, hyperhidrosis 6 examples when quiet, hyperhidrosis at night 49 examples.Between two groups, case load, age, sex, the state of an illness are all without significant difference (P>0.05).All cases is all got rid of the diseases such as other febrile diseases, rickets, tuberculosis, and except hyperhidrosis, ordinary circumstance is good, and blood, routine urinalysis are normal, and blood calcium, phosphorus, magnesium are normal.
Matched group oral placebo Themgran Junior drop (production of Shanghai Shi Guibao pharmaceutical Co. Ltd of Sino-U.S.), once-a-day, each 1 milliliter, treats 3 days.
Treatment group is used the patch of preparing in embodiment, once a day, a slice patch is attached on patient's umbilicus at every turn, treats 3 days.
Curative effect determinate standard
Cure: after 1 course for the treatment of, symptom disappears completely, follow up a case by regular visits to 1 month without recurrence.Effective: after 2 courses for the treatment of, hyperhidrosis obviously improves, nothing is frightened, muscular soreness easily.Invalid: symptom is without improvement.
Result
Through treatment, the therapeutic outcome of two groups sees the following form:
Group |
Number of cases |
Cure |
Effectively |
Invalid |
Total effective rate (%) |
Treatment group |
50 |
46 |
4 |
0 |
100 |
Matched group |
50 |
1 |
7 |
42 |
16 |
Model case
Zhang, man, 5 years old, dripping sweat when activity at ordinary times, antiperspirant, as under bean, is perspired compared with other children many, to our hospital on March 3rd, 2013, uses the patch of preparing in embodiment, once a day, a slice patch is attached on patient's umbilicus at every turn, treats 3 days.In the time playing with playfellow, dripping sweat, antiperspirant are as the transference cure under bean.Follow up a case by regular visits to 1 month without recurrence.
King so-and-so, female, 5 years old, perspired serious night, vest and bedding are drenched, the head of a family gets rid of the factors such as the quilt of excess Temperature in room temperature, sleep lid is too much.To our hospital on May 15th, 2013, use the patch of preparing in embodiment, once a day, a slice patch is attached on patient's umbilicus at every turn, treat 3 days.The sleep serious phenomenon of not perspiring under normal condition.Follow up a case by regular visits to 1 month without recurrence.
Close so-and-so, female, 6 years old, the continuous perspiration while being seated of attending class at ordinary times, drenched clothes.To our hospital on June 21st, 2013, use the patch of preparing in embodiment, once a day, a slice patch is attached on patient's umbilicus at every turn, treat 3 days.The serious phenomenon of not perspiring under the condition of normally sitting quietly.Follow up a case by regular visits to 1 month without recurrence.