CN1618446A - Medicine for treating diabetes, and its prepn. method - Google Patents
Medicine for treating diabetes, and its prepn. method Download PDFInfo
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- CN1618446A CN1618446A CN 200310115012 CN200310115012A CN1618446A CN 1618446 A CN1618446 A CN 1618446A CN 200310115012 CN200310115012 CN 200310115012 CN 200310115012 A CN200310115012 A CN 200310115012A CN 1618446 A CN1618446 A CN 1618446A
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- panacis quinquefolii
- fructus
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- chinensis
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Abstract
A Chinese medicine in the form of powder for treating type-B diabetes and insulin-resistant syndrome in prepared from 12 Chinese-medicinal materials including American-ginseng, astragalus root root, haw, wolfberry fruit, etc through grinding American ginseng, extracting from others in water, depositing in alcohol, concentrating, drying, pulverizing, and mixing with the powdered American ginseng. Its advantages are high curative effect and no by-effect.
Description
Technical field
The present invention relates to a kind of Chinese patent medicine that is used for the treatment of diabetes and preparation method thereof.
Background technology
Diabetes spp traditional Chinese medical science diabetes category, at present whole world diabetics is about 1.2 hundred million, is the third-largest disease that is only second to tumor and cardiovascular disease, belongs to comparatively thorny " being difficult to cure " the property disease of medical circle, wherein, especially in the majority with II type non-insulin-dependent diabetes mellitus (NIDDM) patient.
Treatment of diabetes is mainly taked orally-taken blood sugar reducing class medicine, as glyburide, diamicron etc., or insulin injection, but the secondary failure of the oral sulfonylureas drugs for diabetes that thereupon produces and injection of insulin opposing syndrome become new treatment difficult point.Thiazolidine diketone derivative class medicine as rosiglitazone, pioglitazone, troglitazone, has blood sugar lowering, antihypertensive effect preferably to II type non-insulin-dependent diabetes mellitus (NIDDM), but its side effect is big, particularly to liver infringement serious, even cause hepatic necrosis, and cost an arm and a leg.And more known Chinese patent medicine curative effects are not good enough.
Therefore, developing a kind of is very important and instant problem to II type non-insulin-dependent diabetes mellitus (NIDDM) good effect, the medicine that has no side effect, is technical problem to be solved by this invention.
Summary of the invention
The purpose of this invention is to provide a kind of pharmaceutical composition that is used for the treatment of diabetes, described pharmaceutical composition comprises following component: Radix Panacis Quinquefolii, the Radix Astragali, Rhizoma Dioscoreae, Radix Rehmanniae, Fructus Corni, Fructus Lycii, Radix Ophiopogonis, the Rhizoma Anemarrhenae, Radix Trichosanthis, Fructus Schisandrae Chinensis, Galla Chinensis, Radix Puerariae.
The preferred technical solution of the present invention is that the component of pharmaceutical composition and parts by weight thereof are: Radix Panacis Quinquefolii 10-25, Radix Astragali 25-40, Rhizoma Dioscoreae 25-40, Radix Rehmanniae 25-40, Fructus Corni 10-25, Fructus Lycii 10-25, Radix Ophiopogonis 6-16, Rhizoma Anemarrhenae 6-16, Radix Trichosanthis 6-16, Fructus Schisandrae Chinensis 6-16, Galla Chinensis 10-25, Radix Puerariae 6-16.
Preferred another technical scheme of the present invention is that the component of pharmaceutical composition and parts by weight thereof are: Radix Panacis Quinquefolii 13-20, Radix Astragali 30-36, Rhizoma Dioscoreae 30-36, Radix Rehmanniae 30-36, Fructus Corni 13-20, Fructus Lycii 13-20, Radix Ophiopogonis 8-14, Rhizoma Anemarrhenae 8-14, Radix Trichosanthis 8-14, Fructus Schisandrae Chinensis 8-14, Galla Chinensis 13-20, Radix Puerariae 8-14.
Most preferred technique scheme of the present invention is that the component of pharmaceutical composition and parts by weight thereof are: Radix Panacis Quinquefolii 16.5, the Radix Astragali 33, Rhizoma Dioscoreae 33, Radix Rehmanniae 33, Fructus Corni 16.5, Fructus Lycii 16.5, Radix Ophiopogonis 11, the Rhizoma Anemarrhenae 11, Radix Trichosanthis 11, Fructus Schisandrae Chinensis 11, Galla Chinensis 16, Radix Puerariae 11.
Aforementioned pharmaceutical compositions also comprises an amount of other pharmaceutically useful adjuvants.
Aforementioned pharmaceutical compositions can be made into several formulations, is preferably capsule, tablet, electuary, oral liquid, is preferably capsule.
The present invention also provides a kind of method for preparing aforementioned pharmaceutical compositions, may further comprise the steps: be ground into fine powder after taking by weighing the Radix Panacis Quinquefolii drying of parts by weight, again with the Radix Astragali, Rhizoma Dioscoreae, Radix Rehmanniae, Fructus Corni, Fructus Lycii, Radix Ophiopogonis, the Rhizoma Anemarrhenae, Radix Trichosanthis, Fructus Schisandrae Chinensis, Galla Chinensis and the Radix Puerariae of required parts by weight after water is carried, with the extracting solution simmer down to extractum of precipitate with ethanol after-filtration gained, be ground into fine powder behind the extract dry again; Again the Radix Panacis Quinquefolii fine powder is mixed with extract powder, promptly get pharmaceutical composition through granulation, dress capsule or tabletting again.
The preferred version of preparation of pharmaceutical compositions method is: the baking temperature of Radix Panacis Quinquefolii is 70 ℃-90 ℃, and the water of the Radix Astragali of required parts by weight, Rhizoma Dioscoreae, Radix Rehmanniae, Fructus Corni, Fructus Lycii, Radix Ophiopogonis, the Rhizoma Anemarrhenae, Radix Trichosanthis, Fructus Schisandrae Chinensis, Galla Chinensis, Radix Puerariae is carried twice.
The most preferably scheme of preparation of pharmaceutical compositions method is: the baking temperature of Radix Panacis Quinquefolii is 80 ℃, and the Radix Panacis Quinquefolii powder of gained is crossed 80 mesh sieves; The Radix Astragali, Rhizoma Dioscoreae, Radix Rehmanniae, Fructus Corni, Fructus Lycii, Radix Ophiopogonis, the Rhizoma Anemarrhenae, Radix Trichosanthis, Fructus Schisandrae Chinensis, Galla Chinensis and Radix Puerariae are carried twice through water, the thickening temperature of extracting solution is 70-90 ℃, be preferably 80 ℃, until obtaining the extractum that relative density is 1.15-1.20; Extractum cooling back adds ethanol, makes it contain the alcohol amount and reaches 50-70v/v%, is preferably 60v/v%, leaves standstill 18-24 hour, and filtrate filtered is preferably in 80 ℃ of ethanol that reclaim in the filtrate, until obtaining the extractum that relative density is 1.15-1.20 at 70 ℃-90 ℃; Extractum is ground into fine powder behind drying under reduced pressure, cross the 60-100 mesh sieve, and the most well 80 mesh sieves are to get extract powder; At last, above-mentioned Radix Panacis Quinquefolii fine powder is mixed with extract powder, promptly get pharmaceutical composition through granulation, dress capsule or tabletting again.
In addition, also can in Radix Panacis Quinquefolii fine powder and extract powder mixed process, add other an amount of pharmaceutically useful adjuvants.
The selected raw material of the present invention reaches Chinese Pharmacopoeia version quality standard in 2000, and its discrimination method is referring under the Chinese Pharmacopoeia version normal term in 2000, and each component has following effect:
Radix Panacis Quinquefolii: be the dry root of Araliaceae Radix Panacis Quinquefolii Panax quingquefoeium L..Radix Panacis Quinquefolii is a monarch drug in this product, chemical constituent is mainly total Saponin, content is more than 5%, mainly contain the ginsenoside Rb1, Re, Rf, Rg1 etc., be triterpenoid saponin, wherein the Dammar methane series Saponin with tetracyclic triterpene is a main active, the acid hydrolysis end product is the panoxadiol, panaxatriol etc., contain low molecular peptide aminoacid in addition, monosaccharide, disaccharidase, three polysaccharide, organic acid, vitamin, trace element etc., have: 1) suppress blood sugar increasing significantly, reduce blood middle reaches ion fatty acid, alleviate " lipid toxicity " detrimental effect, can prevent trunk and microvascular arteriosclerosis islet cells; 2) generation, the development of the gene mutation of II paradiabetes be can suppress, and maintenance and protective effect played; 3) can promote sugared metabolism, especially can promote glycogenolysis or suppress the release that lactic acid synthesizes hepatic glycogen, makes lactic acid minimizing and promotion insulin therefore, have synergism, promptly strengthen the sensitivity of insulin, can reduce or reduce insulin resistant with insulin; 4) traditional medicine is thought, Radix Panacis Quinquefolii has strongly invigorating primordial QI, promote the production of body fluid admittedly take off, and sedative action, it is deficient to cure mainly impairment caused by overstrain, the disease of qi-blood-body fluid deficiency such as quench one's thirst.
The Radix Astragali: be leguminous plant Radix Astagali Astragalus membranaceus (Fisch) bge, the dry root of var mongholicus (Bge) hsiao or film folder Radix Astragali Astragalusmembranaceus (Fisch) Bge., sweet in the mouth, warm in nature.Go into spleen, lung meridian.Energy QI invigorating, consolidating superficial resistance, and effects such as poison holding, diuresis are arranged.Composition contains Sitosterolum, D-β-asparagine, astragalus polysaccharides, daucosterol, γ-Ji butanoic acid and several amino acids in the Radix Astragali.The Radix Astragali root contains 2 ', and 4 ' one, dihydroxy-5,6 dimethoxy isoflavan, gamma aminobutyric acid, the astragaloside that to also have with new triterpene Cycloastragenol be glycoside unit.
Rhizoma Dioscoreae: be the dry rhizome of Dioscoreaceae plant Rhizoma Dioscoreae Dioscorea opposita Thunb., sweet in the mouth, property is flat.Go into spleen, stomach, lung, kidney channel.The energy strengthening spleen, tonifying kidney, the lung moistening and production of body fluid promoting.
Radix Rehmanniae: be the fresh or dry tuber of goatweed Radix Rehmanniae Rehmannia glutinosa libosh, sweet in the mouth, hardship, cold in nature.Go into the heart, liver, kidney channel.Can nourishing YIN to lower pathogenic fire, removing heat from blood, promote the production of body fluid and moisturize.Its water enchroachment (invasion) thing has obvious hypoglycemic activity, is better than Rehmanniae Bolus of Eight Ingredients, also can promote hepatic glycogen synthetic.
Fructus Corni: be the dry mature fruit of Cornaceae plant Fructus Corni Cornus officinalis siebetzucc.Sour in the mouth, puckery, slightly warm in nature is gone into liver, kidney channel.Energy invigorating the liver and kidney, controlling nocturnal emission with astringent drugs gas, and arresting sweating, hemostatic effect are arranged.
Fructus Lycii: be the dry mature fruit of plant of Solanaceae lycium barbarum Lycyumbarbarum L..Sweet in the mouth, property is flat, goes into liver, kidney channel.Fructus Lycii and effective ingredient lycium barbarum polysaccharide thereof have: 1) obviously blood sugar lowering effect, and its blood sugar lowering effective percentage can reach 100%; 2) strengthen immune function of human body, promote and improve peripheral blood T lymphocyte percentage; 3) can promote, improve and recover the beta Cell of islet excreting insulin and increase insulin sensitivity; 4) traditional medicine is thought, Fructus Lycii have nourishing kidney tonifying the lung, tonification disappear in, control asthenia, quench one's thirst and effect such as end.
Radix Ophiopogonis: be the dried root of liliaceous plant Qphiopogon Radix Ophiopogonis japonicus (Thunb) Ker-Gawl.Sweet in the mouth, little hardship, cold in nature.Go into the heart, lung, stomach warp.Energy nourishing YIN and moistening the lung, the stomach reinforcing that promotes the production of body fluid, and the effect that clears away heart-fire is arranged.
The Rhizoma Anemarrhenae: be the dry rhizome of liliaceous plant Rhizoma Anemarrhenae Anemanhena asphooeloies Bge.Bitter in the mouth, cold in nature.Go into spleen, stomach, kidney channel.Can heat clearing away, and nourishing YIN and moistening the lung is arranged, effect such as promote the production of body fluid.Contain multiple steroid saponin in the Rhizoma Anemarrhenae rhizome, separate zhimusaponin A-I, A-II ... Deng, its ruscogenin is a chinaroot greenbrier sapogenin, markogenin and neogitogenin etc.Its water enchroachment (invasion) thing can obviously reduce the blood sugar level of alloxan type diabetic rabbit.
Radix Trichosanthis: have another name called Semen Trichosanthis, be the dry root of cucurbitaceous plant Fructus Trichosanthis Trichosanthes kirilowii Maxim or trichosanthes rosthornii Harms Trichosanthes rosthornii Herms, sweet in the mouth, cold in nature.Go into lung, stomach, large intestine channel.Has the promoting the production of body fluid to quench thirst effect.Can improve the diabetes clinical symptoms, make glucose in urine turn out cloudy or descend.
Fructus Schisandrae Chinensis: be magnoliaceae schisandra Schisandra chinensis (Turcz) Baill or schisandra chinensis Schisandra sphenanthera Rehd, the dry mature fruit of etwls, sour in the mouth, warm in nature, go into lung, kidney channel, have astringe the lung, controlling nocturnal emission with astringent drugs, promote the production of body fluid, the effect of QI invigorating nourishing kidney.Contain schizandrin, to free-radical generating propylhomoserin system and CCl
4The damage of the lipid oxidation of the liver that causes, pancreatic cell film has protective effect. and catabolites such as lipid, steroid entered the exogenous material of human body, plays inducing action, can promote carbohydrate metabolism as the end last conversion process of Insulin receptor INSR.Short hepatic glycogen heteroplasia.
Galla Chinensis: be Anacardiaceae plant Fructus rhois chinensis Rhus chinensis Mill Cathay poplar Rhuspotaninii Maxim or red poplar Rhus punjabensis sfew, the insect gall on varsinica (Diels) the Rehd et Wils leaf.
Radix Puerariae is the dry root of legume pueraria lobata Pnerarialobata (willd) Ohwi or Radix Puerariae puerariathomsoniiBenth, sweet in the mouth, suffering, and property is flat, goes into spleen, flavor warp, and heat radiation is induced sweat, and declares malicious rash, effects such as promoting the production of body fluid to quench thirst and spasmolytic.Secondly contain Flavonoid substances in the Radix Puerariae, total amount can reach 12%, wherein is mainly vicianin, and vicianin unit and puerarin are vicianin unit 4 ', and 6 ' one, the diacetyl puerarin, can reach the effect of steady decrease blood glucose.
The development of medicine of the present invention is based on following traditional Chinese medical science pharmacology: II type non-insulin-dependent diabetes mellitus (NIDDM) belongs to Chinese medical discrimination deficiency of both vital energy and Yin, asthenia of both the spleen and kidney diabetes, can far trace back to " interior warp " in the cause of disease of relevant diabetes, pathogenesis, symptom, treatment scheduling theory basis, the blank of its dialectical system starts from " Medical Treasures of the Golden Chamber ".Be familiar with the control of the complication of diabetes is existing in Tang of Sui " General Treatise on the Cause and Symptoms of Diseases " and " a thousand pieces of gold prescription ", and emphasize " people who quenches one's thirst is healed and do not healed, and often must ponder over has big carbuncle ", it points out " can not often heal ".Modern doctor family think more the not outer natural endowment deficiency of its cause of disease, impairment of the kidney due to indulgence in sexual activities, eating and drinking without temperance, disorder of emotion, factors such as clothes warm-dryness syndrome, always pathogenesis is the deficiency of YIN, scorching.With the understanding of internal organs effect, it is dirty, in recent years, in the majority with kidney spleen theorist always to pay attention to lung, stomach (spleen), kidney three.
Recently relevant diabetes Cheng Fang has manna diabetes capsule, blood sugar lowering first sheet, compound antihypelipidemic sheet etc.During utilization ancient prescription plus-minus prescription, serve as basis side how, on medicine uses, help medicine with air making-up and spleen enlivening, nourishing YIN and supplementing the kidney, clearing away heat and promoting production of body fluid, blood circulation promoting and blood stasis dispelling with Six-element Radix Rehmanniae ball, shenqi pill, Baihu Jia Renshen Tang etc.Yet, go up all medicine compatibilities in the practice, there is antagonism, effect is not satisfactory.
So the inventor is according to supplementing QI and nourishing YIN, the principle of treatment that the spleen kidney is taken into account, ginseng assistant Zhang Xichun " ginseng record in the medical science inner feelings " is grown the main medicine among Magnum drink, good wine soup two sides, and on the basis that a large amount of clinical medicine examples are observed, in conjunction with the side of tearing open " compatibility experiment ", reach tradition and modern Chinese medicine pharmacological research and determine medicine composition of the present invention.
Medicine Radix Panacis Quinquefolii of the present invention is a monarch drug, boosting qi and nourishing yin, and promoting the production of body fluid to quench thirst not only has the effect of ginseng qi-tonifying concurrently, has more the property of nourishing YIN; For increasing the merit of gas air making-up and spleen enlivening, minister is the Radix Astragali, Rhizoma Dioscoreae, matches the gas of tonifying the spleen and stomach then, and replenishing QI and blood the source of vital function with Radix Panacis Quinquefolii.Above-mentioned three medicines phase 5, though temper must be mended, body fluid must be living, takes into account kidney qi, the power of right QI invigorating is had a surplus, and the power deficiency of yin nourishing.Satisfy that more minister is with Radix Rehmanniae, Fructus Corni, the two is associated with, and " closing with the sealing kidney " helps the merit of Radix Panacis Quinquefolii nourishing YIN and supplementing the kidney altogether.Be that the card deficiency of kidney yin is this, right water deficiency, then be difficult to contain wood, and sub-disease also reaches mother Yu, Gu Zuo is with Fructus Lycii, Radix Ophiopogonis, and reach the usefulness of " mutual generation between metal and water ", support the moon of kidney liver lung spleen altogether, right YIN fluid being insufficient, then interior-heat is spontaneous, so the Rhizoma Anemarrhenae, the Radix Trichosanthis of hardship are assistant, the power of help the monarch-minister drug clearind deficient heat altogether, promoting the production of body fluid with sweet trembling with fear.Because of splenic qi tending to ascend, modern its gas is empty, and body fluid is cloth not, satisfies assistant with Radix Puerariae, associates with the Radix Astragali, Rhizoma Dioscoreae, and temper must be mended, lucid YANG getting to ascend, and Central Region fortuneization is had the right.It is solid so to suffer from a deficiency of the kidney, dysfunction of the kidney in storing essence, and then frequent micturition is let out under many, thus be assistant with Fructus Schisandrae Chinensis, Galla Chinensis, the property of Bearberry Extract.
Take a broad view of full side, reinforcing both QI and YIN, spleen kidney are held concurrently and are supported, the clear asthenic fire of residence among nourishing, and sweet cold clear and rich not impairment of YIN, receive astringent or styptic treatment for spontaneous sweating within yin nourishing, consolidating semen Tianjin and solid spleen kidney, sending up the lucid YANG is to help enriching spleen-QI, the liver benefiting lung is with nourishing kidney-yin.Close and play supplementing QI and nourishing YIN, the merit of strengthening spleen, tonifying kidney altogether.
Medicine of the present invention has supplementing QI and nourishing YIN, the effect of strengthening spleen, tonifying kidney.Cure mainly deficiency of both vital energy and Yin, spleen kidney both deficiency type diabetes, i.e. non-insulin-dependent diabetes mellitus (NIDDM).Mostly be primary symptom with shortness of breath and fatigue, soreness of the waist and knees, dry mouth and throat, frequent micturition; Doublely see spontaneous perspiration or night sweat, tinnitus, dizzy, wasting, feverish sensation in the palms and soles, the few tongue of red tongue or light red tongue is fat, thready and rapid pulse or heavy weak or empty big.
The present invention has the following advantages:
1, the hypoglycemic activity of pharmaceutical composition is obvious, and does not have obvious toxic and side effects.In addition, the production technology of preparation is simple and easy to do, and is quality controllable, and stability better is applicable to production in enormous quantities.
2, contain multiple human body essential amino acid in the pharmaceutical composition of the present invention, not only can promote insulin to discharge. but also can strengthen patient's body constitution.
3, pharmaceutical composition of the present invention has tangible blood sugar lowering, effect for reducing fat, and is especially remarkable to II paradiabetes and insuline resistance syndrome effect, can stop and delay the secondary failure of sulfonylurea drugs.
4, the selected medicine of the present invention is natural Chinese medicinal herb, and is with low cost, has no side effect.
5, the present invention can be made into capsule, and is for oral administration easy, is beneficial to absorption, easy to carry.
6, medicine of the present invention is taken for a long time, can play the early prevention effect, can also be as the paramedicines of treatment type ii diabetes.
The specific embodiment
Embodiment 1
Capsule
The prescription of pharmaceutical composition is (unit is gram): Radix Panacis Quinquefolii 165, the Radix Astragali 330, Rhizoma Dioscoreae 330, Radix Rehmanniae 330, Fructus Corni 165, Fructus Lycii 165, Radix Ophiopogonis 110, the Rhizoma Anemarrhenae 110, Radix Trichosanthis 110, Fructus Schisandrae Chinensis 110, Galla Chinensis 165, Radix Puerariae 110.
Preparation method: after the West that takes by weighing required weight participates in 80 ℃ of dryings, be ground into fine powder, Radix Panacis Quinquefolii powder is crossed 80 mesh sieves.Other get above-mentioned weight other ten simply raw material add 15 times of water gagings and soak after 4 hours, decoct secondary, 1.5 hours for the first time, 1 hour for the second time, filter, merge secondary filtrate, 80 ℃ are concentrated into the extractum that relative density is 1.15-1.20, and cooling back adds ethanol, make to contain the alcohol amount and reach 60v/v%, the precipitate with ethanol time of repose is 24 hours, filters filtrate recycling ethanol, 80 ℃ are concentrated into the extractum that relative density is 1.15-1.20, and drying under reduced pressure is ground into fine powder, cross 80 mesh sieves, standby.At last, above-mentioned Radix Panacis Quinquefolii fine powder is mixed with extract powder, encapsulated, promptly getting every heavily is 1000 capsules of 0.4 g.
This product character: capsule, content are brown powder, mildly bitter flavor.
Radix Panacis Quinquefolii is valuable fines medicine among the present invention, should not extract, and adopts full powder to be used as medicine, can play the dispersive effect of dilution to the extract of other flavour of a drug, and mobile better, so in the technology except that Radix Panacis Quinquefolii directly is ground into the fine powder adding, other flavour of a drug all adopt decocting to boil.The inventor adopt orthogonal test preferred the process conditions carried of water, determine that the optimal conditions amount of water is 15 times, secondly be the influence that decocts number of times, the decocting time influence is little, is to fry in shallow oil the time so select 120 minutes for use, two to fry in shallow oil be 90 minutes.It is very high that the astragaloside total amount decocts yield for the second time, and accumulation is received to such an extent that astragaloside content does not have significant difference, is advisable so choosing decocts secondary.
Aqueous extract can be removed part phlegmatic temperament, saccharide through ethanol precipitation, so that pulverize and reduce dose, through inventor's orthogonal test preferred the precipitate with ethanol condition be the 60v/v% ethanol precipitation, overcome that the capsule dose that decoction and water boiling concentration drying make is big, difficult to be pulverized and the shortcoming of sad sieve.
The said preparation moulding process can add or not add other pharmaceutically acceptable auxiliaries, with the Radix Panacis Quinquefolii fine powder with after the extractum fine powder mixes, through granulate, dress capsule or tabletting promptly get pharmaceutical composition of the present invention.
Ministry of Health of China import medical material ministerial standard WS4-16-86 and 2000 editions standards of Chinese Pharmacopoeia are seen in raw materials quality standard of the present invention and discriminating, and this standard can prevent to replace the monarch drug Radix Panacis Quinquefolii to feed intake with Radix Ginseng.
The inventor has prepared three batches of pilot products according to above-mentioned prescription and preparation method, and its lot number is 960505,960508 and 960709, and its result of study is seen Table 1.
The result of study of three batches of pilot products of table 1
| Lot number | 960505 | ?960508 | ?960709 |
| Inventory (kg) | 22 | ?22 | ?22 |
| Paste volume (kg) | 2.79 | ?2.73 | ?2.69 |
| Paste-forming rate (%) | 13.71 | ?13.41 | ?13.21 |
| Powder outlet quantity (kg) | 2.62 | ?2.61 | ?2.59 |
| Flour extraction (%) | 93.90 | ?95.60 | ?96.28 |
| Radix Panacis Quinquefolii powder outlet quantity (kg) | 1.55 | ?1.58 | ?1.55 |
| Radix Panacis Quinquefolii flour extraction (%) | 93.93 | ?95.75 | ?93.93 |
| Output (grain) | 9940 | ?10080 | ?9830 |
| Yield rate (%) | 99.40 | ?100.80 | ?98.30 |
In middle trial production, dosage is bigger, soaks to be degree to medical material is softening in about 4 hours.Because the dispersibility and the flowability of this product are all better, can be directly encapsulated and no longer add adjuvant, also need not granulate, can be used for the mechanization mass production.
After measured, this product stability, precision, repeatability, the response rate all reaches and surpasses ministry standard, and determination of extractives method is routinely measured, and makees solvent with 70% ethanol, and extractum is no less than 36.0%.
Radix Panacis Quinquefolii is the fines medicine in this product, is monarch drug in the side, so by the assay of Ginsenoside Rc in the Radix Panacis Quinquefolii is controlled this product quality.Method is as follows:
Get this product content 4g, the accurate title, decide, and puts in the apparatus,Soxhlet's, it is an amount of to add diethyl ether, and reflux 2 hours discards ether solution, it is an amount of to add methanol, reflux, extract, reclaims methanol to extracting liquid colourless, and residue adds water 20ml makes dissolving, be transferred in the separatory funnel, with water saturated n-butanol extraction 5 times (25,20,20,20,15ml), merge extractive liquid, is washed 2 times with ammonia solution, each 15ml, discard the ammonia layer, reclaim n-butyl alcohol, residue adds methanol makes dissolving, quantitatively be transferred in the 10ml measuring bottle, and add methanol and be diluted to scale, shake up, as need testing solution.Other gets the sweet Re reference substance of Radix Ginseng soap, adds the reference substance solution that the every 1ml of methanol manufactured goods contains 0.5mg.Test according to thin layer chromatography (Chinese Pharmacopoeia version in 2000), draw need testing solution 10 μ l, reference substance solution 6ul and 4 μ l, the cross point is on same glue G lamellae respectively, lower floor's solution of placing 12 hours below 10 ℃ with chloroform-methanol-water (65: 35: 10) is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃, takes out, on lamellae, cover onesize glass plate, use immobilization with adhesive tape on every side, scan wavelength according to thin layer chromatography (2000 editions one appendix VIB thin layer chromatography scanning of Chinese Pharmacopoeia): go into
S=535nm goes into
R=700nm measures test sample trap integrated value and reference substance trap integrated value, calculates, promptly.
The inventor has prepared three batches of pilot products according to above-mentioned prescription and preparation method, its lot number is that 10 batch samples are 011211,011212,011213,020122,020123,020124,021406,020407,020408 and 020409, and the sweet Re Determination on content of its Radix Ginseng soap be the results are shown in Table 2.
The assay data of the sweet Re of table 20 batch sample Radix Ginseng soaps
Lot number sampling sampling amount ginsenoside Re's content mg/ grain average
011211????1??????4.0026?????????????0.17???????????????0.18
2??????4.0153?????????????0.19
011212????1??????4.1051?????????????0.18???????????????0.19
2??????4.0270?????????????0.20
011213????1??????4.0108?????????????0.23???????????????0.21
2??????4.1075?????????????0.19
020122????1??????4.0004?????????????0.13???????????????0.14
2??????4.0844?????????????0.15
020123????1??????4.0273?????????????0.12???????????????0.11
2??????4.0130?????????????0.10
020124????1??????4.0041?????????????0.17???????????????0.16
2??????4.0853?????????????0.15
020406????1??????4.1029?????????????0.12???????????????0.12
2??????4.0852?????????????0.12
020407????1??????4.0184?????????????0.13???????????????0.12
2??????4.0245?????????????0.11
020408????1??????4.0135?????????????0.15???????????????0.14
2??????4.1032?????????????0.13
020409????1??????4.0237?????????????0.16???????????????0.15
2??????4.0349?????????????0.14
Said determination is the result show: every of this product contains Radix Panacis Quinquefolii with ginsenoside Re (C
48H
82O
18) meter, be no less than 0.10mg.
Embodiment 2
Tablet
The prescription of pharmaceutical composition is (gram): Radix Panacis Quinquefolii 10, the Radix Astragali 25, Rhizoma Dioscoreae 25, Radix Rehmanniae 25, Fructus Corni 10, Fructus Lycii 10, Radix Ophiopogonis 6, the Rhizoma Anemarrhenae 6, Radix Trichosanthis 6, Fructus Schisandrae Chinensis 6, Galla Chinensis 10, Radix Puerariae 6 are formed.
Preparation method: with embodiment 1, difference is that the baking temperature of Radix Panacis Quinquefolii is 70 ℃, crosses 60 mesh sieves; The thickening temperature of water extract is 70 ℃; The alcohol amount that contains in the extractum reaches 50v/v%, and precipitate with ethanol left standstill 18 hours, filtered; Ethanol is recovered as 70 ℃, and to be concentrated into relative density be 1.20 extractum; Extractum carries out constant pressure and dry 80 ℃ of dryings, pulverizes the extractum fine powder of gained and crosses 60 mesh sieves, gets extract powder; Get above-mentioned Radix Panacis Quinquefolii fine powder and mix, enter magnesium stearate 10g with extract powder, drying, granulate, tabletting, promptly.
Embodiment 3
Electuary
The prescription of pharmaceutical composition is (gram): Radix Panacis Quinquefolii 25, the Radix Astragali 40, Rhizoma Dioscoreae 40, Radix Rehmanniae 40, Fructus Corni 25, Fructus Lycii 25, Radix Ophiopogonis 16, the Rhizoma Anemarrhenae 16, Radix Trichosanthis 16, Fructus Schisandrae Chinensis 16, Galla Chinensis 25, Radix Puerariae 16.
Preparation method: with embodiment 1, difference is that the baking temperature of Radix Panacis Quinquefolii is 90 ℃; Radix Panacis Quinquefolii powder is crossed 100 mesh sieves; The thickening temperature of water extract is 90 ℃; The alcohol amount that contains in the extractum reaches 70v/v%, and time of repose 32 hours filters; The ethanol recovered temperature is 90 ℃, and to be concentrated into relative density be 1.15 extractum; Extractum is pulverized the back and is crossed 100 mesh sieves at 90 ℃ of drying under reduced pressure; Get above-mentioned Radix Panacis Quinquefolii fine powder and mix with extract powder, drying is granulated, and crosses 100 mesh sieves, pack, promptly.
Embodiment 4
Capsule
Get following raw material (gram): Radix Panacis Quinquefolii 13, the Radix Astragali 30, Rhizoma Dioscoreae 30, Radix Rehmanniae 30, Fructus Corni 13, Fructus Lycii 13, Radix Ophiopogonis 8, the Rhizoma Anemarrhenae 8, Radix Trichosanthis 8, Fructus Schisandrae Chinensis 8, Galla Chinensis 13, Radix Puerariae 8 are formed.
Preparation method: with embodiment 1.
Embodiment 5
Oral liquid
Get following raw material (gram): Radix Panacis Quinquefolii 20, the Radix Astragali 36, Rhizoma Dioscoreae 36, Radix Rehmanniae 36, Fructus Corni 20, Fructus Lycii 20, Radix Ophiopogonis 14, the Rhizoma Anemarrhenae 14, Radix Trichosanthis 14, Fructus Schisandrae Chinensis 14, Galla Chinensis 20, Radix Puerariae 14.
Preparation method: with embodiment 1, difference is to get above-mentioned Radix Panacis Quinquefolii fine powder mixes with extract powder, and distilled water is adjusted to 100ml, filters, and the fill sterilization, promptly.
The drug effect of the embodiment 6 research present compositions
In order to prove that medicine of the present invention is to treatment treatment of diabetes effect, select type ii diabetes outpatient service, inpatient 270 examples, age 18-65 year, adopt the method for grouping, double blind control immediately, it is divided into: the treatment group: 150 routine patients, oral medicine capsule of the present invention; Do not establish the open treatment group of contrast: 30 examples; Matched group: 90 examples, this group patient takes Mudanjiang diabetes capsule that a Pharma Inc. provides that lengthens one's life, and lot number is 20001120, and capsular outward appearance is with the treatment group.Treatment group and matched group sex, age, the state of an illness, every tcm symptom, the traditional Chinese medical science are waited disease integration, fasting glucose, 2 hours after the meal blood glucose, glycolated hemoglobin, blood fat etc. relatively, and learn by statistics and handle, P＞0.05, no significant difference has comparability.
Usage and consumption: oral, capsule, one time 6, every 0.4 gram (every gram medicated powder contains crude drug 5.5g, and encapsulated every 0.4g is about crude drug 2.2g, as follows), 3 times on the one, warm water delivery service.Diagnostic criteria adopts World Health Organization (WHO) in 1999 about diabetes diagnosis classification and standard, adopts the blood glucose value that detects venous plasma without exception.
1, curative effect determinate standard: formulate with reference to " the clinical research guideline of new Chinese medicine treatment diabetes "
Produce effects: fasting glucose FPG＜7.2mmol/L (130mg/dl), 2 hours after the meal blood glucose PPG＜8.3mmol/L (150mg/dl), twenty-four-hour urine sugar quantitatively＜10.0g; Or blood glucose, twenty-four-hour urine sugar quantitatively descends more than 30%, faces the celebrating symptom and disappears substantially;
Effectively: FPG＜8.3mmol/L (150mg/dl), PPG＜10.0mmol/L (180mg/dl), twenty-four-hour urine sugar quantitatively＜25.0g; Or blood glucose, twenty-four-hour urine sugar quantitatively descends more than 10%, faces the celebrating symptom and is clearly better;
Invalid: FPG＞10.0mmol/L, PPG＞11.1mmol/L does not reach above-mentioned standard, faces the celebrating symptom and does not have obvious improvement.
2, the curative effect of above-mentioned 270 examples statistics
| Group | The example number | Produce effects | Effectively | Invalid | ???％ | Total effective rate |
| The treatment group | 150 | ?20 | ?92 | ?38 | ?13.33 | ?74.67 |
| Matched group | 90 | ?15 | ?50 | ?25 | ?16.67 | ?72.22 |
| The open treatment group | 30 | ?5 | ?16 | ?9 | ?16.67 | ?70.00 |
| Add up to | 270 | ?40 | ?158 | ?72 |
Total effective rate=obvious effective rate+effective percentage, and carry out Mann-whitney U check: Z=0.055 P=0.956＞0.05, no significant difference.
In sum, medicine of the present invention has notable therapeutic effect to the type ii diabetes patient.
Claims (9)
1, a kind of pharmaceutical composition that is used to prevent or treat diabetes is characterized in that comprising following component: Radix Panacis Quinquefolii, the Radix Astragali, Rhizoma Dioscoreae, Radix Rehmanniae, Fructus Corni, Fructus Lycii, Radix Ophiopogonis, the Rhizoma Anemarrhenae, Radix Trichosanthis, Fructus Schisandrae Chinensis, Galla Chinensis, Radix Puerariae.
2, pharmaceutical composition according to claim 1, described component and parts by weight thereof are: Radix Panacis Quinquefolii 10-25, Radix Astragali 25-40, Rhizoma Dioscoreae 25-40, Radix Rehmanniae 25-40, Fructus Corni 10-25, Fructus Lycii 10-25, Radix Ophiopogonis 6-16, Rhizoma Anemarrhenae 6-16, Radix Trichosanthis 6-16, Fructus Schisandrae Chinensis 6-16, Galla Chinensis 10-25, Radix Puerariae 6-16.
3, according to the arbitrary described pharmaceutical composition of claim 1-2, described component and parts by weight thereof are: Radix Panacis Quinquefolii 13-20, Radix Astragali 30-36, Rhizoma Dioscoreae 30-36, Radix Rehmanniae 30-36, Fructus Corni 13-20, Fructus Lycii 13-20, Radix Ophiopogonis 8-14, Rhizoma Anemarrhenae 8-14, Radix Trichosanthis 8-14, Fructus Schisandrae Chinensis 8-14, Galla Chinensis 13-20, Radix Puerariae 8-14.
4, according to the arbitrary described pharmaceutical composition of claim 1-3, described component and parts by weight thereof are: Radix Panacis Quinquefolii 16.5, the Radix Astragali 33, Rhizoma Dioscoreae 33, Radix Rehmanniae 33, Fructus Corni 16.5, Fructus Lycii 16.5, Radix Ophiopogonis 11, the Rhizoma Anemarrhenae 11, Radix Trichosanthis 11, Fructus Schisandrae Chinensis 11, Galla Chinensis 16, Radix Puerariae 11.
5, according to the arbitrary described pharmaceutical composition of claim 1-4, also comprise an amount of pharmaceutically acceptable auxiliaries.
6, according to the arbitrary described pharmaceutical composition of claim 1-5, compositions is capsule, tablet, electuary or oral liquid.
7, a kind of method for preparing the arbitrary described pharmaceutical composition of claim 1-6, may further comprise the steps: be ground into fine powder after taking by weighing the Radix Panacis Quinquefolii drying of parts by weight, again with the Radix Astragali, Rhizoma Dioscoreae, Radix Rehmanniae, Fructus Corni, Fructus Lycii, Radix Ophiopogonis, the Rhizoma Anemarrhenae, Radix Trichosanthis, Fructus Schisandrae Chinensis, Galla Chinensis and the Radix Puerariae of required parts by weight after water is carried, with the extracting solution simmer down to extractum of precipitate with ethanol after-filtration gained, be ground into fine powder behind the extract dry again; Again the Radix Panacis Quinquefolii fine powder is mixed with extract powder, promptly get pharmaceutical composition through granulation, dress capsule or tabletting again.
8, method according to claim 7, further comprising the steps of: the baking temperature of Radix Panacis Quinquefolii is 70 ℃-90 ℃ (preferred 80 ℃), pulverizes the Radix Panacis Quinquefolii powder of back gained and crosses 80 mesh sieves; The Radix Astragali, Rhizoma Dioscoreae, Radix Rehmanniae, Fructus Corni, Fructus Lycii, Radix Ophiopogonis, the Rhizoma Anemarrhenae, Radix Trichosanthis, Fructus Schisandrae Chinensis, Galla Chinensis and Radix Puerariae carry twice through water, and extracting solution concentrates down at 70-90 ℃ and obtains extractum; Extractum cooling back adds ethanol to be made it contain the alcohol amount to reach 50-70v/v% (preferred 60v/v%), and precipitate with ethanol time of repose 18-32 hour filters gained filtrate and reclaims ethanol at 70 ℃-90 ℃ (preferred 80 ℃) and obtain extractum; Extractum is pulverized the fine powder of gained and is crossed 60-100 mesh sieve (preferred 80 orders) behind drying under reduced pressure, to get extract powder; At last, above-mentioned Radix Panacis Quinquefolii fine powder is mixed with extract powder, promptly get pharmaceutical composition through granulation, dress capsule or tabletting again.
9, the arbitrary described pharmaceutical composition of claim 1-6 is used for preparing the application of the medicine of the secondary failure of prevention or treatment type ii diabetes, oral sulfonylurea drugs or insuline resistance syndrome.
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