CN101028325B - Medicinal composition containing sailonggu, and its preparation and quality detection method - Google Patents
Medicinal composition containing sailonggu, and its preparation and quality detection method Download PDFInfo
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- CN101028325B CN101028325B CN2007100983864A CN200710098386A CN101028325B CN 101028325 B CN101028325 B CN 101028325B CN 2007100983864 A CN2007100983864 A CN 2007100983864A CN 200710098386 A CN200710098386 A CN 200710098386A CN 101028325 B CN101028325 B CN 101028325B
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Abstract
A composite medicine for treating rheumatic and rheumatoid diseases and cancer pain is prepared from Sailonggu, snow lotus flower and safflower. Its preparing process and its quality control method are also disclosed.
Description
[technical field]
The invention belongs to technical field of Chinese medicines, be specifically related to a kind of pharmaceutical composition that contains Bailey Myospalax Born and preparation method thereof and method of quality control.
[background technology]
Sialon is the Tibetan language name of Cricetidae animal Myospalax baileyi, is commonly called as " blind mouse ".Medicinal its dry skeleton is so claim Bailey Myospalax Born.Be distributed in the vast farming in Qinghai, grassland, pastoral area, farmland.Have about 200,000,000, to the steppe vegetation hazard area above 1,660,000 hectares.Bailey Myospalax Born belongs to the new medical material of a national class animal, identifies by the national Chinese Academy of Sciences November nineteen ninety; Obtain Chinese Academy of Sciences's scientific and technological progress first prize in 1991, obtained national science and technology progress third prize in 1999, obtain national new product certificate the same year; Obtaining Qinghai Province in 1993 gives ample rewards to.The Bailey Myospalax Born slightly warm in nature, saltyly enters Liver Channel at acrid in the mouth, has dispersing cold for relieving pain, relaxing muscles and tendons and activating QI and blood in the collateral, and strengthening the tendons and bones strengthens the effect of human body resistance.The various syndromes that the treatment rheumatism and arthritis causes, such as rheumatic arthritis, rheumatoid arthritis, the diseases such as joint rheumatism, osteoarthritis are a kind of new drugs that replaces Os Tigris.
Herba Saussureae Involueratae also has distribution in Xinjiang, Qinghai, Sichuan, the Yunnan of China except producing Tibet.Various places are among the people with the Herba Saussureae Involueratae all herbal medicine, cure mainly snow the region between the heart and the diaphragm, toothache, rheumatic arthritis, sexual impotence, menoxenia, redly collapse, the disease such as leucorrhea.India's Herba Saussureae Involueratae of going back among the people is treated many chronics.Such as diseases such as gastric ulcer, hemorrhoid, bronchitis, heart disease, epistaxis and venom.Herba Saussureae Involueratae is as the existing long history of medicine on Tibetan medicine.All on the books on Tibetanmedicine document " month king's medicine is precious " and the Four-Volume Medical Code.
Herba Saussureae Involueratae has the physiologically active effective ingredient.Wherein umbelliferone have significantly antibiotic, blood pressure lowering is calm, spasmolysis; Scopoletin has and dispels the wind, antiinflammatory, pain relieving, eliminates the phlegm and antitumor action, and treating clinically dyspnea with rapid respiration chronic bronchitis effective percentage is that 96.6% apigenin has smooth muscle spasmolysis and anti-ulcer effect; Antelope base benzophenone there is obvious choleretic effect.Full of interest especially is colchicine contained in the Herba Saussureae Involueratae, this composition is a Typical Representative of cell mitogen, and the growth of energy anticancer is clinical in to treat cancer, with breast carcinoma certain curative effect is arranged especially, skin carcinoma, leukemia and what king's evil etc. are also had certain effect.To the special effect of gout acute attack, reduce inflammation in 12-24 hour and rapidly pain relieving, life-time service can reduce attack times.Have in addition the estrogen-like effects activity, energy prolong rats rutting period and metoestrus, and shorten dioestrus and proestrus.But the toxicity of colchicine is larger, can cause nausea, loss of appetite, abdominal distention, and enteroparalysis and the side effect such as constipation, extremities aching pain can appear in severe patient.Owing to contain good effect and the larger colchicine of toxicity in the Herba Saussureae Involueratae, so among the peoplely can't take when curing mainly rheumatic arthritis and gynaecopathia steeping in wine with Herba Saussureae Involueratae more.
Flos Carthami is feverfew.Annual or biennial herb.Leaf egg shape lanceolar, edge have the thorn-like sharp mouth.Inflorescence is tubular flower all, and yellow when just opening fades to salmon pink.Achene white.The florescence 6-7 month, the fruit phase 8-9 month.Like warm dry climate, certain cold-resistant, drought-enduring, salt resistance ability are arranged, intolerant to waterlogging.Originate in Egyptianly, there is cultivation in Europe, America, Australia and many places such as Chinese now.
Flos Carthami is to develop in the world in recent years very fast oil crop, before this always as medical material and dye yielding herb cultivation.Seed oil-containing 35-47%, fatty acid is rich in linoleic acid, oleic acid and myristic acid, Palmic acid etc. in forming, also at abundant vitamin E.Wherein linoleic acid content occupies the hat of edible oil up to 84%, and blood fat reducing and serum cholesterol are arranged, the effect of atherosclerosis.Pharmaceutically safflower oil is widely used as the stabilizing agent of antioxidant and vitamin A, D.Flos Carthami contains carthamin, Flos Carthami quinone glycoside and neocarthamin, and the effect of promoting blood circulation to restore menstrual flow, stasis-dispelling and pain-killing is arranged, and cures mainly dysmenorrhea amenorrhea, traumatic injury, joint aches, coronary heart disease.Fruit medicine, effect with spend identical.
Patent documentation CN1350852A has carried out certain open to the prescription that is used for rheumatism and rheumatoid disease treatment of Bailey Myospalax Born, mentioned in this patent and adopted the compatible combination of Bailey Myospalax Born, Herba Saussureae Involueratae Flos Carthami, but do not provided concrete dosage and implementation method.The present invention is based on this prompting optimization and obtained dosage and the implementation method of three kinds of drug regimens, realized the present invention.
[summary of the invention]
The object of the present invention is to provide a kind of pharmaceutical composition that contains Bailey Myospalax Born.
Another object of the present invention is to provide the preparation method of the pharmaceutical composition that contains Bailey Myospalax Born.
Another object of the present invention is to provide the method for quality control of the pharmaceutical composition that contains Bailey Myospalax Born.
Specifically, the pharmaceutical composition that contains Bailey Myospalax Born of the present invention is by following ingredients: Bailey Myospalax Born 300-1000 weight portion, Herba Saussureae Involueratae 100-600 weight portion, Flos Carthami 50-200 weight portion; Preferred Bailey Myospalax Born 300-600 weight portion, Herba Saussureae Involueratae 100-500 weight portion, Flos Carthami 50-150 weight portion; More preferably Bailey Myospalax Born 500 weight portions, Herba Saussureae Involueratae 400 weight portions, Flos Carthami 100 weight portions; All right preferred Bailey Myospalax Born 400 weight portions, Herba Saussureae Involueratae 300 weight portions, Flos Carthami 100 weight portions.
The above-mentioned pharmaceutical composition that contains Bailey Myospalax Born can make oral formulations or external preparation, wherein oral formulations comprises medicated wine, powder, pill, unguentum, Tablet and Capsula.
The above-mentioned preparation method that contains the pharmaceutical composition of Bailey Myospalax Born is: above-mentioned Bailey Myospalax Born and Herba Saussureae Involueratae are pulverized, and mixing with Flos Carthami afterwards with concentration is that the soak with ethanol of 5-100% is made.
The preparation method of the above-mentioned pharmaceutical composition that contains Bailey Myospalax Born also can for: Bailey Myospalax Born is ground into coarse powder, decocts with water 2-4 time, add water 6-10 and doubly measure, decocted 6-10 hour at every turn, collecting decoction filters, and gets filtrate A; Herba Saussureae Involueratae is pulverized rear and Flos Carthami mixing, decocts with water 2-4 time, adds water 8-12 and doubly measures, and decocts 1-4 hour at every turn, and collecting decoction filters, and gets liquor B; Filtrate A and concentrated rear merging of liquor B are made oral formulations or external preparation.
The preparation method of aforementioned pharmaceutical compositions is preferably: Bailey Myospalax Born is ground into coarse powder, decocts with water 2 times, adds water 6-10 the 1st time doubly to measure, and decocts 8-10 hour, adds water 6-10 the 2nd time doubly to measure, and decocts 3-4 hour, and collecting decoction filters, and gets filtrate A; With the Flos Carthami mixing, decoct with water 2 times after Herba Saussureae Involueratae is pulverized, add water 10-12 the 1st time doubly to measure, decocted 2 hours, add water 8-10 the 2nd time doubly to measure, decocted 1 hour, filtration gets liquor B; Filtrate A and concentrated rear merging of liquor B are made oral formulations or external preparation.
The preparation method of aforementioned pharmaceutical compositions is more preferably: Bailey Myospalax Born is ground into coarse powder, decocts with water 2 times, add 10 times of amounts of water the 1st time, decocted 8 hours, add 8 times of amounts of water the 2nd time, decocted 4 hours, collecting decoction filters, and gets filtrate A; Herba Saussureae Involueratae is pulverized rear and Flos Carthami mixing, decocts with water 2 times, adds 10 times of amounts of water for the first time, decocts 2 hours, adds 8 times of amounts of water for the second time, decocts 1 hour, filters, and gets liquor B; Filtrate A and concentrated rear merging of liquor B are made oral formulations or external preparation.
The above-mentioned method of quality control that contains the pharmaceutical composition of Bailey Myospalax Born is: get Bailey Myospalax Born control medicinal material 1 gram, add 5 milliliters of 60% ethanol, reflux 30 minutes lets cool, and filters, and filtrate is medical material solution in contrast.Other gets isoleucine, lysine and valine reference substance, adds 60% ethanol and makes respectively per 1 milliliter of mixed solution that contains 0.5 milligram, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw need testing solution and above-mentioned control medicinal material solution each 3 μ l, reference substance solution 2 μ l under [assay] item, put respectively on same silica gel g thin-layer plate, take n-butyl alcohol-glacial acetic acid-water (3: 1: 1) as developing solvent, launch, take out, dry, spray is with 1% ethanol solution of ninhydrin, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, the speckle of aobvious same color.
The above-mentioned method of quality control that contains the pharmaceutical composition of Bailey Myospalax Born is: get solid dosage forms of the present invention, add 15 milliliters of 80% acetone solns, jolting was extracted 1 hour, left standstill, and got supernatant, as need testing solution.Other gets Flos Carthami control medicinal material 0.5 gram, gets control medicinal material solution with legal system.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw respectively each 6 μ l of above-mentioned two kinds of solution, point is on same silica gel g thin-layer plate, take ethyl acetate-formic acid-water-methanol (4: 1: 1: 1) as developing solvent, spray is with 1% vanillin sulfuric acid solution, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, respectively with the corresponding position of control medicinal material chromatograph on, the speckle of aobvious same color.
The above-mentioned method of quality control that contains the pharmaceutical composition of Bailey Myospalax Born is: get solid preparation of the present invention, porphyrize, mixing, get 2 grams, accurately weighed, put in the tool plug conical flask, accurate 25 milliliters of 60% ethanol, close plug, the weighed weight of adding, reflux 30 minutes lets cool, more weighed weight, supply the weight that subtracts mistake with 60% ethanol, shake up, filter, get subsequent filtrate as need testing solution.Precision takes by weighing the isoleucine reference substance, adds 60% ethanol and makes per 1 milliliter of solution that contains 0.5 milligram, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw need testing solution 4 μ l, reference substance solution 1 μ l and 2 μ l, the cross point is on same silica gel g thin-layer plate respectively, take n-butyl alcohol-glacial acetic acid-water (3: 1: 1) as developing solvent, launch, take out, dry, spray is with 1% ethanol solution of ninhydrin, it is clear to be heated to the speckle colour developing at 105 ℃, takes out, and covers onesize glass plate at lamellae, use immobilization with adhesive tape on every side, according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), wavelength: λ s=500nm, measure test sample trap integrated value and reference substance trap integrated value, calculate, and get final product.This product unit's solid preparation containg sialon bone is with isoleucine (C
6H
13NO
2) meter, must not be less than 0.20 milligram.
Contain in the pharmaceutical composition of Bailey Myospalax Born and contain Bailey Myospalax Born, three kinds of medicines that have traditionally function of promoting blood circulation to disperse blood clots of Herba Saussureae Involueratae Flos Carthami, among the present invention by optimization and technique and prescription, make three kinds of medicine combinations among the strong ones in the prescription, rheumatism and rheumatoid disease are had good therapeutic effect, and what get concern is that this prescription also has significant therapeutic effect for the treatment cancerous pain.
[specific embodiment]
Embodiment 1
Prescription: Bailey Myospalax Born 300 gram Herba Saussureae Involuerataes 100 gram Flos Carthamis 50 grams
Method for making: Bailey Myospalax Born and Herba Saussureae Involueratae are ground into coarse powder, and add 1500 milliliters of immersions of 20% ethanol that content is behind the Flos Carthami mixing and get final product.Medicated wine of the present invention can be used for external and for oral administration.
Embodiment 2
Prescription: Bailey Myospalax Born 1000 grams, Herba Saussureae Involueratae 600 grams, Flos Carthami 200 grams.
Method for making: Bailey Myospalax Born and Herba Saussureae Involueratae are ground into coarse powder, and add 1500 milliliters of immersions of 40% ethanol that content is behind the Flos Carthami mixing and get final product.Medicated wine of the present invention can be used for external and for oral administration.
Embodiment 3
Prescription: Bailey Myospalax Born 300 gram Herba Saussureae Involuerataes 600 gram Flos Carthamis 50 grams
Method for making: Bailey Myospalax Born and Herba Saussureae Involueratae are ground into coarse powder, and add 1500 milliliters of immersions of 60% ethanol that content is behind the Flos Carthami mixing and get final product.Medicated wine of the present invention can be used for external and for oral administration.
Embodiment 4
Prescription: Bailey Myospalax Born 300 gram Herba Saussureae Involuerataes 600 gram Flos Carthamis 200 grams
Method for making: Bailey Myospalax Born and Herba Saussureae Involueratae are ground into coarse powder, and add 1500 milliliters of immersions of 70% ethanol that content is behind the Flos Carthami mixing and get final product.Medicated wine of the present invention can be used for external and for oral administration.
Embodiment 5
Prescription: Bailey Myospalax Born 1000 gram Herba Saussureae Involuerataes 300 gram Flos Carthamis 50 grams
Method for making: Bailey Myospalax Born and Herba Saussureae Involueratae are ground into coarse powder, and add 3000 milliliters of immersions of 90% ethanol that content is behind the Flos Carthami mixing and get final product.Medicated wine of the present invention can be used for external and for oral administration.
Embodiment 6
Prescription: Bailey Myospalax Born 1000 gram Herba Saussureae Involuerataes 600 gram Flos Carthamis 50 grams
Method for making: Bailey Myospalax Born and Herba Saussureae Involueratae are ground into coarse powder, and add 3000 milliliters of immersions of 95% ethanol that content is behind the Flos Carthami mixing and get final product.Medicated wine of the present invention can be used for external and for oral administration.
Embodiment 7
Prescription: Bailey Myospalax Born 500 gram Herba Saussureae Involuerataes 400 gram Flos Carthamis 100 grams
Method for making: Bailey Myospalax Born and Herba Saussureae Involueratae are ground into coarse powder, and add 1500 milliliters of immersions of 5% ethanol that content is behind the Flos Carthami mixing and get final product.Medicated wine of the present invention can be used for external and for oral administration.
Embodiment 8
Prescription: Bailey Myospalax Born 400 gram Herba Saussureae Involuerataes 300 gram Flos Carthamis 100 grams
Method for making: Bailey Myospalax Born and Herba Saussureae Involueratae are ground into coarse powder, and add 1500 milliliters of immersions of 50% ethanol that content is behind the Flos Carthami mixing and get final product.Medicated wine of the present invention can be used for external and for oral administration
Embodiment 9
Prescription: Bailey Myospalax Born 300 gram Herba Saussureae Involuerataes 100 gram Flos Carthamis 50 grams
Method for making: Bailey Myospalax Born and Herba Saussureae Involueratae are ground into coarse powder, and add 1500 milliliters of percolation of 70% ethanol that content is behind the Flos Carthami mixing and get final product.Medicated wine of the present invention can be used for external and for oral administration.
Embodiment 10
Prescription: Bailey Myospalax Born 1000 grams, Herba Saussureae Involueratae 600 grams, Flos Carthami 200 grams.
Method for making: Bailey Myospalax Born and Herba Saussureae Involueratae are ground into coarse powder, and add 1500 milliliters of percolation of 80% ethanol that content is behind the Flos Carthami mixing and get final product.Medicated wine of the present invention can be used for external and for oral administration.
Embodiment 11
Prescription: Bailey Myospalax Born 300 gram Herba Saussureae Involuerataes 600 gram Flos Carthamis 50 grams
Method for making: Bailey Myospalax Born and Herba Saussureae Involueratae are ground into coarse powder, and add 1500 milliliters of percolation of 60% ethanol that content is behind the Flos Carthami mixing and get final product.Medicated wine of the present invention can be used for external and for oral administration.
Embodiment 12
Prescription: Bailey Myospalax Born 300 gram Herba Saussureae Involuerataes 600 gram Flos Carthamis 200 grams
Method for making: Bailey Myospalax Born and Herba Saussureae Involueratae are ground into coarse powder, and add 1500 milliliters of percolation of 70% ethanol that content is behind the Flos Carthami mixing and get final product.Medicated wine of the present invention can be used for external and for oral administration.
Embodiment 13
Prescription: Bailey Myospalax Born 1000 gram Herba Saussureae Involuerataes 300 gram Flos Carthamis 50 grams
Method for making: Bailey Myospalax Born and Herba Saussureae Involueratae are ground into coarse powder, and add 3000 milliliters of percolation of 90% ethanol that content is behind the Flos Carthami mixing and get final product.Medicated wine of the present invention can be used for external and for oral administration.
Embodiment 14
Prescription: Bailey Myospalax Born 1000 gram Herba Saussureae Involuerataes 600 gram Flos Carthamis 50 grams
Method for making: Bailey Myospalax Born and Herba Saussureae Involueratae are ground into coarse powder, and add 3000 milliliters of percolation of 90% ethanol that content is behind the Flos Carthami mixing and get final product.Medicated wine of the present invention can be used for external and for oral administration.
Embodiment 15
Prescription: Bailey Myospalax Born 500 gram Herba Saussureae Involuerataes 400 gram Flos Carthamis 100 grams
Method for making: Bailey Myospalax Born and Herba Saussureae Involueratae are ground into coarse powder, and add 1500 milliliters of immersions of 70% ethanol that content is behind the Flos Carthami mixing and get final product.Medicated wine of the present invention can be used for external and for oral administration.
Embodiment 16
Prescription: Bailey Myospalax Born 400 gram Herba Saussureae Involuerataes 300 gram Flos Carthamis 100 grams
Method for making: Bailey Myospalax Born and Herba Saussureae Involueratae are ground into coarse powder, and add 1500 milliliters of percolation of 70% ethanol that content is behind the Flos Carthami mixing and get final product.Medicated wine of the present invention can be used for external and for oral administration
Embodiment 17
Prescription: Bailey Myospalax Born 300 gram Herba Saussureae Involuerataes 100 gram Flos Carthamis 50 grams
Method for making: Bailey Myospalax Born is ground into coarse powder, decocts with water 2 times, adds 10 times of amounts of water for the first time, decocts 8 hours, adds 8 times of amounts of water for the second time, decocts 4 hours, and collecting decoction filters, and filtrate concentrates and be spray dried to extract powder; Herba Saussureae Involueratae is cataclasm and the Flos Carthami mixing, decocts with water 2 times, adds 10 times of amounts of water for the first time, decocted 2 hours, and added 8 times of amounts of water for the second time, decocted 1 hour, filter, filtrate is concentrated and be spray dried to extract powder, merges above-mentioned extract powder, it is an amount of to add starch, lactose, carboxymethyl starch sodium, and mixing is granulated, drying adds magnesium stearate, tabletting, make 1000, and get final product.
Embodiment 18
Prescription: Bailey Myospalax Born 1000 grams, Herba Saussureae Involueratae 600 grams, Flos Carthami 200 grams.
Method for making: Bailey Myospalax Born is ground into coarse powder, decocts with water 2 times, adds 10 times of amounts of water for the first time, decocts 8 hours, adds 8 times of amounts of water for the second time, decocts 4 hours, and collecting decoction filters, and filtrate concentrates and be spray dried to extract powder; Herba Saussureae Involueratae is cataclasm and the Flos Carthami mixing, decocts with water 2 times, adds 10 times of amounts of water for the first time, decocted 2 hours, and added 8 times of amounts of water for the second time, decocted 1 hour, filter, filtrate is concentrated and be spray dried to extract powder, merges above-mentioned extract powder, it is an amount of to add starch, lactose, carboxymethyl starch sodium, and mixing is granulated, drying adds magnesium stearate, tabletting, make 1000, and get final product.
Embodiment 19
Prescription: Bailey Myospalax Born 300 gram Herba Saussureae Involuerataes 600 gram Flos Carthamis 50 grams
Method for making: Bailey Myospalax Born is ground into coarse powder, decocts with water 2 times, adds 10 times of amounts of water for the first time, decocts 8 hours, adds 8 times of amounts of water for the second time, decocts 3 hours, and collecting decoction filters, and filtrate concentrates and be spray dried to extract powder; Herba Saussureae Involueratae is cataclasm and the Flos Carthami mixing, decocts with water 2 times, adds 8 times of amounts of water for the first time, decocted 2 hours, and added 8 times of amounts of water for the second time, decocted 1 hour, filter, filtrate is concentrated and be spray dried to extract powder, merges above-mentioned extract powder, it is an amount of to add starch, lactose, carboxymethyl starch sodium, and mixing is granulated, drying adds magnesium stearate, tabletting, make 1000, and get final product.
Embodiment 20
Prescription: Bailey Myospalax Born 500 gram Herba Saussureae Involuerataes 400 gram Flos Carthamis 100 grams
Method for making: Bailey Myospalax Born is ground into coarse powder, decocts with water 2 times, adds 10 times of amounts of water for the first time, decocts 8 hours, adds 8 times of amounts of water for the second time, decocts 4 hours, and collecting decoction filters, and filtrate concentrates and be spray dried to extract powder; Herba Saussureae Involueratae is cataclasm and the Flos Carthami mixing, decocts with water 2 times, adds 10 times of amounts of water for the first time, decocted 2 hours, and added 8 times of amounts of water for the second time, decocted 1 hour, filter, filtrate is concentrated and be spray dried to extract powder, merges above-mentioned extract powder, it is an amount of to add starch, lactose, carboxymethyl starch sodium, and mixing is granulated, drying adds magnesium stearate, tabletting, make 1000, and get final product.
Embodiment 21
Prescription: Bailey Myospalax Born 300 gram Herba Saussureae Involuerataes 600 gram Flos Carthamis 200 grams
Method for making: Bailey Myospalax Born is ground into coarse powder, decocts with water 2 times, adds 10 times of amounts of water for the first time, decocts 8 hours, adds 8 times of amounts of water for the second time, decocts 4 hours, and collecting decoction filters, and filtrate concentrates and be spray dried to extract powder; Herba Saussureae Involueratae is cataclasm and the Flos Carthami mixing, decocts with water 2 times, adds 10 times of amounts of water for the first time, decocted 2 hours, and added 8 times of amounts of water for the second time, decocted 1 hour, filter, filtrate is concentrated and be spray dried to extract powder, merges above-mentioned extract powder, it is an amount of to add starch, lactose, carboxymethyl starch sodium, and mixing is granulated, drying adds magnesium stearate, tabletting, make 1000, and get final product.
Embodiment 22
Prescription: Bailey Myospalax Born 1000 gram Herba Saussureae Involuerataes 600 gram Flos Carthamis 50 grams
Method for making: Bailey Myospalax Born is ground into coarse powder, decocts with water 2 times, adds 6 times of amounts of water for the first time, decocts 8 hours, adds 6 times of amounts of water for the second time, decocts 4 hours, and collecting decoction filters, and filtrate concentrates and be spray dried to extract powder; Herba Saussureae Involueratae is cataclasm and the Flos Carthami mixing, decocts with water 2 times, adds 10 times of amounts of water for the first time, decocted 2 hours, and added 8 times of amounts of water for the second time, decocted 1 hour, filter, filtrate is concentrated and be spray dried to extract powder, merges above-mentioned extract powder, it is an amount of to add starch, lactose, carboxymethyl starch sodium, and mixing is granulated, dry, the fill capsule is made 2000, and be get final product.
Embodiment 23
Prescription: Bailey Myospalax Born 1000 gram Herba Saussureae Involuerataes 300 gram Flos Carthamis 50 grams
Bailey Myospalax Born is ground into coarse powder, decocts with water 2 times, adds 10 times of amounts of water for the first time, decocts 10 hours, adds 10 times of amounts of water for the second time, decocts 4 hours, and collecting decoction filters, and filtrate concentrates and be spray dried to extract powder; Herba Saussureae Involueratae is cataclasm and the Flos Carthami mixing, decocts with water 2 times, adds 12 times of amounts of water for the first time, decocted 2 hours, and added 10 times of amounts of water for the second time, decocted 1 hour, filter, filtrate is concentrated and be spray dried to extract powder, merges above-mentioned extract powder, it is an amount of to add starch, lactose, carboxymethyl starch sodium, and mixing is granulated, dry, the fill capsule is made 2000, and be get final product.
Embodiment 24
Prescription: Bailey Myospalax Born 400 gram Herba Saussureae Involuerataes 300 gram Flos Carthamis 100 grams
Method for making: Bailey Myospalax Born is ground into coarse powder, decocts with water 2 times, adds 10 times of amounts of water for the first time, decocts 8 hours, adds 8 times of amounts of water for the second time, decocts 4 hours, and collecting decoction filters, and filtrate concentrates and be spray dried to extract powder; Herba Saussureae Involueratae is cataclasm and the Flos Carthami mixing, decocts with water 2 times, adds 10 times of amounts of water for the first time, decocted 2 hours, and added 8 times of amounts of water for the second time, decocted 1 hour, filter, filtrate is concentrated and be spray dried to extract powder, merges above-mentioned extract powder, it is an amount of to add starch, lactose, carboxymethyl starch sodium, and mixing is granulated, drying adds magnesium stearate, tabletting, make 1000, and get final product.
Embodiment 25
Prescription: Bailey Myospalax Born 1000 gram Herba Saussureae Involuerataes 300 gram Flos Carthamis 50 grams
Method for making: Bailey Myospalax Born, Herba Saussureae Involueratae Flos Carthami mixing are ground into 400-500 purpose fine powder, add lubricant and divide and install in 1000 parts of powders for oral.
Embodiment 26
Prescription: Bailey Myospalax Born 1000 gram Herba Saussureae Involuerataes 300 gram Flos Carthamis 50 grams
Method for making: Bailey Myospalax Born, Herba Saussureae Involueratae Flos Carthami mixing are ground into 400-500 purpose fine powder, add refined honey and starch, make in 1000 pills for oral.
The optimization of water addition ratio example when Bailey Myospalax Born extracts among experimental example 1-the present invention
The conventional amount of water of this research production on probation compares test, investigates amount of water to the impact of the key cream yield of Sialon and isoleucine content.
Test method: get each 6 parts of Bailey Myospalax Born 250 grams, the according to the form below amount of water is tested respectively, investigates dried cream yield and measures isoleucine content, the results are shown in Table 1:
Table 1 amount of water is investigated the result
Result of the test shows, test dried cream yield No. 1 and No. 2 and isoleucine content all higher, in conjunction with the practical situation of producing, save corresponding energy consumption, reduce production costs, determining to extract Bailey Myospalax Born, to extract amount of water be 10 times of amounts for the first time, the second time, 8 times of amounts were more excellent.
Test according to the extraction process of determining, take by weighing Bailey Myospalax Born medical material 500 grams by recipe quantity, 6 parts of operation repetitives calculate dried cream yield and measure the content of isoleucine in the dried cream.The results are shown in Table 2
Table 2 Bailey Myospalax Born amount of water process certification result of the test
Demonstration test result shows that this process stabilizing is feasible.So determine the extraction process of Bailey Myospalax Born medical material be: decoct with water 2 times, add 10 times of water gagings for the first time, decocted 8 hours, add 8 times of water gagings for the second time, decocted 4 hours.
The research of experimental example 2-Flos Carthami of the present invention, Herba Saussureae Involueratae extraction process
The conventional amount of water of this research production on probation compares test, investigates amount of water to the impact of the dried cream yield of Herba Saussureae Involueratae Flos Carthami.Test method: get each 3 parts of Herba Saussureae Involueratae 200 grams, Flos Carthami 50 grams, the according to the form below amount of water is tested respectively, investigates dried cream yield, the results are shown in Table 3:
Table 3 Herba Saussureae Involueratae, Flos Carthami amount of water are investigated the result
Herba Saussureae Involueratae, the test of extraction process of Carthamus tinctorius L time verifying: test according to the extraction process of determining, take by weighing Herba Saussureae Involueratae 400 grams, flos carthami 100 grams by recipe quantity, 3 parts of operation repetitives calculate dried cream yield.The results are shown in Table 4.
Table 4 Herba Saussureae Involueratae, Flos Carthami amount of water process certification result of the test
Result of the test shows, it is higher to test dried cream yield No. 1 and No. 2, in conjunction with the practical situation of producing, saves corresponding energy consumption, reduces production costs, and determines that amount of water that snow connects flower, extraction process of Carthamus tinctorius L be 10 times of amounts for the first time, the second time 8 times of amounts.Demonstration test result shows, determines that the extraction process of Herba Saussureae Involueratae, flos carthami is: decoct with water 2 times, add 10 times of water gagings for the first time, decocted 2 hours, add 8 times of water gagings for the second time, decocted 1 hour; Process stabilizing is feasible.
Experimental example 3-method of quality control of the present invention
Get Bailey Myospalax Born control medicinal material 1 gram, add 5 milliliters of 60% ethanol, reflux 30 minutes lets cool, and filters, and filtrate is medical material solution in contrast.Other gets isoleucine, lysine and valine reference substance, adds 60% ethanol and makes respectively per 1 milliliter of mixed solution that contains 0.5 milligram, in contrast product solution.Test according to thin layer chromatography (an appendix VI of 20 05 years versions of Chinese Pharmacopoeia B), draw need testing solution and above-mentioned control medicinal material solution each 3 μ l, reference substance solution 2 μ l, put respectively on same silica gel g thin-layer plate, take n-butyl alcohol-glacial acetic acid-water (3: 1: 1) as developing solvent, launch, take out, dry, spray is with 1% ethanol solution of ninhydrin, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, the speckle of aobvious same color.
Experimental example 4-method of quality control of the present invention
Get solid dosage forms of the present invention, add 15 milliliters of 80% acetone solns, jolting was extracted 1 hour, left standstill, and got supernatant, as need testing solution.Other gets Flos Carthami control medicinal material 0.5 gram, gets control medicinal material solution with legal system.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw respectively each 6 μ l of above-mentioned two kinds of solution, point is on same silica gel g thin-layer plate, take ethyl acetate-formic acid-water-methanol (4: 1: 1: 1) as developing solvent, spray is with 1% vanillin sulfuric acid solution, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, respectively with the corresponding position of control medicinal material chromatograph on, the speckle of aobvious same color.
Experimental example 5-method of quality control of the present invention
Get solid preparation of the present invention, porphyrize, mixing, get 2 grams, accurately weighed, put in the tool plug conical flask, accurate 25 milliliters of 60% ethanol, close plug, the weighed weight of adding, reflux 30 minutes lets cool, more weighed weight, supply the weight that subtracts mistake with 60% ethanol, shake up, filter, get subsequent filtrate as need testing solution.Precision takes by weighing the isoleucine reference substance, adds 60% ethanol and makes per 1 milliliter of solution that contains 0.5 milligram, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw need testing solution 4 μ l, reference substance solution 1 μ l and 2 μ l, the cross point is on same silica gel g thin-layer plate respectively, take n-butyl alcohol-glacial acetic acid-water (3: 1: 1) as developing solvent, launch, take out, dry, spray is with 1% ethanol solution of ninhydrin, it is clear to be heated to the speckle colour developing at 105 ℃, takes out, and covers onesize glass plate at lamellae, use immobilization with adhesive tape on every side, according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), wavelength: λ s=500nm, measure test sample trap integrated value and reference substance trap integrated value, calculate, and get final product.This product unit solid preparation containg sialon bone is with isoleucine (C
6H
13NO
2) meter, must not be less than 0.20 milligram.
The rheumatoid clinical observation of experimental example 6-tablet in treatment of the present invention
Rheumatoid arthritis is that a kind of joint on every side involved is the main struvite autoimmune disease of multisystem, and the purpose of this experiment is to verify that the present invention is for the clinical efficacy of rheumatoid disease.
1 clinical data
1.1 diagnostic criteria: adopt American Rheumatism Association (ARA) revised standard in 1987: 1. morning deadlock at least 1 hour, 〉=6 weeks; 2. 3 or 3 above arthroncuss, 〉=6 weeks; 3. wrist, the palm refer to, proximal interphalangeal joint is swollen, 〉=6 weeks; 4. symmetry swollen joint, 〉=6 weeks; 5. subcutaneous nodule; 6. the hands x-ray resembles change; 7. rheumatoid factor 〉=1: 32.Meet these 7 persons and can be diagnosed as rheumatoid arthritis.
1.2 exclusion standard: 1. do not use immunosuppressant such as acting on slowly antirheumatic, Cytotoxic drugs, 17-hydroxy-11-dehydrocorticosterone (CS), Radix Tripterygii Wilfordii more than at least 3 months, 2. late deformity, deformity, forfeiture labourer; 3. the age is below 16 years old, or person more than 70 years old; 4. gestation or women breast-feeding their children; 5. merge serious former or the secondary disease person such as cardiovascular, Liver and kidney, hemopoietic system; 8. the full person of medication or data in accordance with regulations not.
1.3 inclusive criteria: allly meet diagnostic criteria, do not belong to exclusion standard, cooperate voluntarily and observe therapist, people's group is included the observation case at random.
1.4 Standards of Chinese Medical Syndrome Differentiation: 1. joint swelling and pain, miserable numbness, tenderness, dysfunction, the Mental fatigue face is grey, and is dizzy; 2. meet cold, the cloudy day, rainy, windy day disorder of QI feelings increase the weight of; 3. light red tongue has ecchymosis, petechia. and tongue is greasy or HUANGBAI(sic) is alternate, soft and rapid pulse or heavy string in vain.All possess above 1-3 item person and can be dialectical be (Liver and kidney QI and blood) exogenous pathogen (the wind and cold wet hot phlegm stasis of blood) rheumatoid disease just.
1.5 physical data: meet above standard person totally 60 examples, be divided at random two groups by the table of random number method.Treatment group 30 examples, male 6 examples, women 24 examples: age 17-62 year, average 39.9 ± 13.3 years old; The course of disease 3 months-5 years, average 20.9 ± 18.4 months; Matched group 30 examples, male 4 examples, women 26 examples; Age 15-58 year, average 38.1 ± 11.9 years old; The course of disease 3 months-5 years, average 19.3 ± 18.4 months.Two groups of patients learn by statistics at aspects such as sex, age, the course of disease, correlative factor (comprising wound, operation, childbirth or artificial abortion, infection, unknown cause), functional classification [grade scale is with reference to American Rheumatism Association (ARA) formulation standard], differentiation of symptoms and signs for classification of syndrome and process without significant difference (P＞0.05), have comparability.
2 Therapeutic Method
2.1 treatment group: each 3 of the present invention (embodiment 20), oral every day 3 times, took continuously for 6 weeks.
2.2 matched group: methotrexate (MTX) 5mg, 1 time/week, oral; Sulfasalazine (SSZ) 500mg, 3 times/days, oral, took continuously for 6 weeks.
Two groups of treatments were 1 course for the treatment of in 3 months.
3 observation of curative effect see Table 5
Table 5 the present invention contrasts rheumatoid treatment
1. joint swelling and pain, miserable numbness, tenderness, dysfunction, the Mental fatigue face is grey, and is dizzy; 2. meet cold, the cloudy day, rainy, windy day disorder of QI feelings increase the weight of; 3. light red tongue has ecchymosis, petechia. and tongue is greasy or HUANGBAI(sic) is alternate, soft and rapid pulse or heavy string in vain.All possess above three persons and can be dialectical be rheumatoid disease.The cases of all alleviating in three indexs are decided to be produce effects, and 1-2 item index is alleviated and is decided to be effectively, do not have vicissitudinous be decided to be invalid.Above experimental data explanation the present invention is definite to rheumatoid therapeutic effect.
The clinical observation of experimental example 7-medicated wine treatment of the present invention rheumatism
With orally taken for curing rheumatic arthritis of the present invention, satisfactory effect is reported as follows.
1 clinical data
1.1 physical data is observed case totally 60 examples, is divided into two groups by the random packet method.Treatment group 40 examples, male 13 examples, women 27 examples; 23～65 years old age, average (47.42 ± 13.66) year; The course of disease is the shortest 3 months, and is the longest 12 years, average (23.02 ± 39.98) moon.Matched group 20 examples, male 4 examples, women 16 examples; 25～62 years old age, average (48.25 ± 10.71) year; The course of disease is the shortest 3 months, and is the longest 6 years, average (22.55 ± 20.98) moon.Compare no significant difference (P＞0.05) between group.
1.2 the diagnostic criteria of diagnostic criteria rheumatic arthritis is worked out with reference to " the clinical guidance principle of new Chinese medicine treatment numbness disease ".(1) clinical manifestation: the streptococcal infection history is arranged more; Acute stage, can have multiple and the migration arthralgia; Mostly occur in large joint, can be with redness pain or tuberosity or erythema; Chronic phase, can only be felt arthralgia.(2) laboratory examination: anti-" 0 " is more than 500U, or erythrocyte sedimentation rate speeds, or antistreptokinase surpasses more than the 80U, or antihyaluronidase is more than 128U.(3) x-ray is taken the photograph sheet without bone damage.
The dialectical standard reference of rheumatic arthritis " guideline of clinical investigations of new Chinese medicine treatment numbness disease ", the diagnostic criteria of cold dampness accumulation pattern: the limbs joint cold type of pain is heavy, or swelling, local fear of cold, color of the leather is not red, and that touches is not hot, pain increase in intensity under coldness, enlarged tongue is light dark, and tongue is greasy or whiten in vain, and stringy and tense pulse or string are slow.
2 therapeutic outcomes
Treatment group: take the present invention (embodiment 16), 15 milliliters of every days, 10 days was 1 course for the treatment of, general 5 courses for the treatment of
Matched group: matched group is taken merely placebo, and 15 milliliters of every days, 10 days was 1 course for the treatment of, general 5 courses for the treatment of.
Concrete curative effect is as follows:
Table 6 the present invention contrasts rheumatoid treatment
1. the limbs joint cold type of pain is heavy, or swelling; 2. local fear of cold; 3. color of the leather is not red, and that touches is not hot; 4. pain increase in intensity under coldness; 6. enlarged tongue is light dark, and tongue is greasy or whiten in vain; 7. during stringy and tense pulse or string delay.Improve 5-6 item person in the above symptom and be decided to be produce effects, the 2-4 item is improved as effectively, and 0-1 item improver is invalid.
The clinical observation of experimental example 8-medicated wine external application for curing of the present invention cancerous pain
Pain is the modal symptom of late tumor, although morphine class analgesic drug product analgesic effect certainly, often because of gastrointestinal reaction, respiration inhibition, drug dependence and other side effect, has dwindled subject range to a certain extent.Chinese medicine is of long standing and well established to the diagnosis and treatment of pain, and it is effective that traditional Chinese medical science ancient books is put down in writing many treatment by Chinese herbs pain, and external application Chinese medicine treatment pain also has extraordinary Clinical Basis.
1. object and method
1.1 object of study
This organizes 60 routine patients, local pain is all arranged, localized pain.Male 39 examples wherein, women 21 examples; Minimal ages 29 years old, maximum 75 years old, 59 years old mean age; Hepatocarcinoma pain in the hepatic region 17 examples, pulmonary carcinoma chest pain 22 examples, breast carcinoma local pain 8 examples, bone shifts local pain 13 examples;
1.2 research method
1.2.1 grouping: MethodsThe cases enrolled is divided into treatment group and matched group at random.Treatment group 40 examples wherein, matched group 20 examples.
1.2.2 Therapeutic Method:
1.2.2.1 Primary Care: pain degree is pressed the classification of VAS method, mismatches other analgesic for≤3 grades;＞3 and≤6 grades, then add 25 milligrams of enteric indometacin, 3 times/days;＞6 grades then add 2 of Galakes, 3 times/days.
1.2.2.2 therapeutic intervention: treatment group is given medicated wine of the present invention (embodiment 15) external application sore spot, 3-6 times/day; Matched group gives all identical placebo of profile, color, excipient, 2 times/days.Be 10 days the course for the treatment of.
1.2.3 observation index: pain degree is observed in double blinding and local skin has non-stimulated, anaphylaxis.
2. experimental result
2.1 pain degree
The rear pain curative effect for the treatment of relatively between table 7 group
2.2 local skin stimulates
Table 8 a liang group medicine compares the stimulation of skin
2.3 anaphylaxis
Table 9 liang group drug anaphylaxis relatively
In this group test, in treatment group and the matched group observation of curative effect after treatment, treatment group pain relief or stable 19 examples are arranged, matched group is 9 examples, comparison between group is through X
2Check, P＜0.05, prompting treatment group alleviating pain obviously is better than matched group.
3. discuss
The traditional Chinese medical science thinks that pain is divided into real pain and empty pain, and real person mostly is qi depression to blood stasis, hematogenous blockage, and stagnation of QI and blood may bring about pain, its pain characteristics are localized pain, the sore spot tenderness; Empty pain is then because of insufficiency of vital energy and blood, and the internal organs passages through which vital energy circulates loses supports, Rong Ze pain not, and its pain characteristics are migratory pains, sore spot is liked warm pain relieved by pressing.Medicated wine of the present invention select have blood circulation promoting and blood stasis dispelling, the Chinese medicine of resolving mass and removing the obstruction of the collateral pain relieving is main the composition, the real pain for the treatment of cancer patient cures the disease and asks it, so receive good therapeutic effect.In a word, medicated wine of the present invention has preferably analgesic effect for the cancer patient, for the real pain of cancer certain clinical value is arranged.
Claims (1)
1. quality determining method that contains the pharmaceutical composition of Bailey Myospalax Born, this pharmaceutical composition is made by following medicine:
Bailey Myospalax Born 500 gram Herba Saussureae Involuerataes 400 gram Flos Carthamis 100 grams;
Preparation method is:
Bailey Myospalax Born is ground into coarse powder, decocts with water 2 times, adds 10 times of amounts of water for the first time, decocts 8 hours, adds 8 times of amounts of water for the second time, decocts 4 hours, and collecting decoction filters, and filtrate concentrates and be spray dried to extract powder; Herba Saussureae Involueratae is cataclasm and the Flos Carthami mixing, decocts with water 2 times, adds 10 times of amounts of water for the first time, decocted 2 hours, and added 8 times of amounts of water for the second time, decocted 1 hour, filter, filtrate is concentrated and be spray dried to extract powder, merges above-mentioned extract powder, it is an amount of to add starch, lactose, carboxymethyl starch sodium, and mixing is granulated, drying adds magnesium stearate, tabletting, make 1000, and get final product;
Adopt one of following quality determining method:
(1), get Bailey Myospalax Born control medicinal material 1 gram, add 5 milliliters of 60% ethanol, reflux 30 minutes, let cool, filter, filtrate is medical material solution in contrast, and other gets isoleucine, lysine and valine reference substance, add 60% ethanol and make respectively per 1 milliliter of mixed solution that contains 0.5 milligram, product solution according to the thin layer chromatography test, is drawn each 3 μ l of need testing solution and above-mentioned control medicinal material solution in contrast, reference substance solution 2 μ l, put respectively on same silica gel g thin-layer plate, take n-butyl alcohol-glacial acetic acid-water (3:1:1) as developing solvent, launch, take out, dry, spray is with 1% ethanol solution of ninhydrin, and it is clear to be heated to the speckle colour developing at 105 ℃, in the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, the speckle of aobvious same color;
(2), get solid dosage forms, add 15 milliliters of 80% acetone solns, jolting was extracted 1 hour, leave standstill, get supernatant, as need testing solution, other gets Flos Carthami control medicinal material 0.5 gram, get control medicinal material solution with legal system, according to the thin layer chromatography test, draw respectively each 6 μ l of above-mentioned two kinds of solution, put on same silica gel g thin-layer plate, take ethyl acetate-formic acid-water-methanol (4:1:1:1) as developing solvent, spray is with 1% vanillin sulfuric acid solution, and it is clear to be heated to the speckle colour developing at 105 ℃, in the test sample chromatograph, respectively with the corresponding position of control medicinal material chromatograph on, the speckle of aobvious same color;
(3), get solid preparation, porphyrize, mixing, get 2 grams, accurately weighed, put in the tool plug conical flask, accurate 25 milliliters of 60% ethanol that add, close plug, weighed weight, reflux 30 minutes, let cool, weighed weight is supplied the weight that subtracts mistake with 60% ethanol again, shakes up, filter, get subsequent filtrate as need testing solution, precision takes by weighing the isoleucine reference substance, adds 60% ethanol and makes per 1 milliliter of solution that contains 0.5 milligram, product solution in contrast, according to the thin layer chromatography test, draw need testing solution 4 μ l, reference substance solution 1 μ l and 2 μ l, the cross point is on same silica gel g thin-layer plate respectively, take n-butyl alcohol-glacial acetic acid-water (3:1:1) as developing solvent, launch, take out, dry, spray is with 1% ethanol solution of ninhydrin, it is clear to be heated to the speckle colour developing at 105 ℃, takes out, and covers onesize glass plate at lamellae, use immobilization with adhesive tape on every side, according to thin layer chromatography, wavelength: λ s=500nm, measure test sample trap integrated value and reference substance trap integrated value, calculate, and get final product, this product unit's solid preparation containg sialon bone must not be less than 0.20 milligram in isoleucine.
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| CN104483440B (en) * | 2014-12-26 | 2016-03-02 | 成都乾坤动物药业有限公司 | A kind of quality determining method of three horse particles |
| CN105055449B (en) * | 2015-07-27 | 2019-08-09 | 中国科学院西北高原生物研究所 | A kind of Sailongbone extracts with anti-inflammatory and antalgic activity, preparation method and Chinese materia medica preparation |
| CN115300539B (en) * | 2022-08-16 | 2023-05-26 | 西安今正制药有限公司 | Compound sialon capsule, preparation method and application thereof in aspect of rheumatism bone diseases |
| CN116251133B (en) * | 2023-01-14 | 2024-02-02 | 西安今正制药有限公司 | Pharmaceutical composition and traditional Chinese medicine preparation for treating rheumatism and rheumatoid diseases by using sialon bone |
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| CN1301544A (en) * | 1999-12-30 | 2001-07-04 | 中国科学院西北高原生物研究所 | Medicinal composition for curing arthritis and osteoarthropathy and its preparing method |
| CN101032540A (en) * | 2005-12-29 | 2007-09-12 | 青海唐古拉药业有限公司 | Medicine composition for curing arthritis and the preparing method and purpose thereof |
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