A kind of child's antidiarrheal oral Chinese medicine
One, technical field
The present invention relates to a kind of antidiarrheal pharmaceutical composition, particularly relating to a kind of is the antidiarrheal that raw material is made with the vegetable Chinese herbal medicine.
Two, background technology
Children's diarrhae is meant that defecation frequency increases, and it is thin to defecate, even rushes down as water, or class diseases such as companion stomachache, anorexia even vomiting and nausea.Diarrhoea is Common Pediatric Diseases, frequently-occurring disease, particularly summer and autumn.Child's antidiarrheal is less with oral Chinese medicine at present, and the GEGEN QINLIAN DIWAN curative effect is better.
CN1296835A discloses a kind of child's of can be used for antidiarrheal Traditional Chinese Medicine for external application.
The sick position of children's diarrhae is at taste and large and small intestinal.The traditional Chinese medical science is thought, the young sun of children physique, and taste are tender, easily hindered by diet, raw food, heat-transformation is lit a fire, transporting and transforming function of the spleen and stomach mistake department, retention of water-damp in the body, intestinal conduction is not normal and suffer from diarrhoea, so treat children's diarrhae should be based on heat clearing and damp drying (" element is asked, the big opinion of YIN YANG classification of natural phenomena ").
Compendium of Material Medica record Radix Rubiae rattan bitter in the mouth, cold, nontoxic.But hardship dampness, cold can heat clearing away, be the card of trouble to damp and hot.
" not Lu " meaning Fructus Mume " ends dysentery, good saliva xerostomia ", and Compendium of Material Medica claims Fructus Mume " astringing intestine to stop diarrhea of astringing the lung is only owed the dysentery of coughing ".
The Radix Glycyrrhizae sweet in the mouth is flat, invigorating the spleen and benefiting QI is arranged, relieving spasm to stop pain, multiple function such as coordinating the actions of various ingredients in a prescription.Both can adjust spleen and stomach function, and can close Fructus Mume again and play sour and sweet drugs can transforme into YIN, the effect of the impairment of YIN that prevents to have loose bowels.
The present invention gets this three flavors medicine prescription, and the merit of heat clearing and damp drying, intestine-stabling and anti-diarrheal is arranged, and cures mainly retention of damp-heat in the interior type infantile diarrhea.
Three, summary of the invention
Technical scheme of the present invention is to be raw material with Radix Rubiae rattan, Fructus Mume and Radix Glycyrrhizae, and compatibility is after extract and obtain active ingredient compositions by a certain percentage.
Described certain proportion (percentage by weight, down together) is:
Radix Rubiae rattan 70~80%
Fructus Mume 3~8%
Radix Glycyrrhizae 15~25%.
Preferred ratio is:
Radix Rubiae rattan 72~78%
Fructus Mume 4~7%
Radix Glycyrrhizae 17~23%
Best ratio is:
Radix Rubiae rattan 75%
Fructus Mume 5%
Radix Glycyrrhizae 20%.
Decoct the method that refluxes with solvent behind above-mentioned three kinds of material combinations and extract, obtain extracting solution after cooling, the separation, slough solvent at last and obtain active ingredient compositions.
Described solvent can be water or organic solvent ethanol, acetone etc.Also can water and the mixed solvent of ethanol etc.With water is good.
Said composition can be treated particularly infant retention of damp-heat in the interior type diarrhoea of child below 14 years old, and perhaps Western medicine diagnose is infectivity or noninfectious diarrhea.Symptom is water sample or egg soup sample for stool, or, feels sick vomiting etc. with heating, stomachache.Standard code, oral dose are 1~6 month baby 0.5g/ time (granule, down together), and the child was 1g/ time in 7 months~2 years old, and the child was 2g/ time in three years old, and the child was 3g/ time in four~six years old, and the juvenile was 4g/ time in seven~14 years old.Three times on the one, three days is a course of treatment.
As oral drugs, the aforesaid active principles in combination thing should be processed into certain preparation, be dosage form alleged on the pharmaceutics, concerning the child, be advisable with granule (electuary), in addition, the processing electuary also has convenience when with water extraction, and Here it is concentrates back adding adjuvant dextrin, multitudinous sugar with extracting solution, make granule, be drying to obtain granule (electuary).Can certainly be processed into other dosage forms, as tablet, drop pill, oral liquid etc.
Toxicity test of the present invention and II clinical trial phase result are as follows:
Long-term toxicity test for animals is finished by Shaanxi Normal University, and conclusion is:
The rat long term toxicity shows: young instant granule for curing 2g/Kg, 15g/Kg and 30g/Kg (be equivalent to respectively clinical application amount 7,50 and 100 times), gastric infusion, (drug withdrawal on Sunday) once a day, continuous 2 months of rushing down.3 dosage groups there is no overt toxicity, to the relatively more equal no significant difference of growth, hemogram, hepatic and renal function and main organs etc. and matched group of rat.
The II clinical trial phase is finished by Provincial Hospital's department of pediatrics, Anhui Chinese Medicine College Affiliated Hospital department of pediatrics, Beijing Children's Hospital, Capital Medical University, the attached pediatric hospital of Nanjing University of Traditional Chinese Medicine.Include case in and add up to 422 examples, adopt random packet, the method for single blind contrast, test obtains the conclusion of basically identical, and accumulate type in the treatment children's and have loose bowels, total effective rate 87.7%~90.3%, curative effect and course of disease length and state of an illness weight are irrelevant.Safe and reliable, have no adverse reaction, harmless to the heart, liver, kidney, and also mouthfeel is good.Wherein the result of the test of Provincial Hospital and Nanjing Traditional Chinese Medicine Univ. affiliated hospital also thinks best to the rotaviral enteritis curative effect, and total effective rate is 93.02%~96.15%.
Four, the specific embodiment
Non-limiting examples is described below:
1, get 7 kilograms in Radix Rubiae rattan (calling A in the following text), 0.3 kilogram of Fructus Mume (calling B in the following text), 1.5 kilograms in Radix Glycyrrhizae (calling C in the following text), decoct with water three times, each 1 hour, close And filtrate, obtain Powdered active ingredient compositions 880~900 grams through dehydration, drying, outward appearance is brown.
2, get the A8 kilogram, the B0.8 kilogram, the C2.5 kilogram, reflux is three~four hours in ethanol, and separate the cooling back, and extracting solution is sloughed ethanol and is reclaimed, and obtains Powdered active ingredient compositions 1000~1100g, and outward appearance is brown.
3, get the A7.2 kilogram, the B0.7 kilogram, the C2.3 kilogram is made solvent with acetone, and operation is with embodiment 2.
4, get the A7.8 kilogram, the B0.4 kilogram, the C1.7 kilogram, water and alcohol mixed solvent, operation is with embodiment 2.
5, use water as solvent, the processing granular agent.Get the A7.5 kilogram, the B0.5 kilogram, the C2 kilogram decocts with water three times, and each 1 hour, close And filtrate, vacuum dehydration is concentrated into relative density and is at 1.2~1.3 o'clock and adds 2.8 kilograms in adjuvant dextrin, 1.1 kilograms of sucrose, evenly granulate in the back, and drying obtains 5 kilograms of granules.
6, use water as solvent processing oral liquid.Get 1.5 kilograms of A, 0.1 kilogram of B, 0.4 kilogram of C, decoct with water three times each 1 hour, filter, filtrate is concentrated into about 1200ml, left standstill 24 hours, and filtered, filtrate adds Mel 400g, sucrose 200g and sodium benzoate 5g boil and make dissolving, add water to total amount 2000ml, stir evenly, cold preservation 24~48 hours filters, embedding, sterilization, promptly.