Summary of the invention
The object of the invention is to provide a kind of pharmaceutical composition for the treatment of diabetes.
The object of the invention is also to provide a kind of preparation method for the treatment of the pharmaceutical composition of diabetes.
The present invention is achieved through the following technical solutions:
The crude drug of pharmaceutical composition of the present invention consists of:
Ramulus Mori 20-60 weight portion Ootheca Mantidis 40-120 weight portion
Fructus Corni 20-60 weight portion Herba Dendrobii 10-30 weight portion.
The crude drug composition of pharmaceutical composition of the present invention is preferably:
Ramulus Mori 40 weight portion Ootheca Mantidis 80 weight portions
Fructus Corni 40 weight portion Herba Dendrobii 20 weight portions.
The crude drug composition of pharmaceutical composition of the present invention is preferably:
Ramulus Mori 25 weight portion Ootheca Mantidis 115 weight portions
Fructus Corni 25 weight portion Herba Dendrobii 28 weight portions.
The crude drug composition of pharmaceutical composition of the present invention is preferably:
Ramulus Mori 55 weight portion Ootheca Mantidis 45 weight portions
Fructus Corni 55 weight portion Herba Dendrobii 12 weight portions.
Pharmaceutical composition of the present invention adds conventional adjuvant to make the tablet of clinical acceptance, capsule, granule, pill or oral liquid according to common process.
The preparation method of pharmaceutical composition of the present invention is: Ramulus Mori, Fructus Corni and Herba Dendrobii are added to water 10-20 and doubly measure, soak 24-48 hour; With slow fire boiling 1-3 time, decoct 1-3 hour at every turn, medicinal liquid is leached, collect standby; Filtrate is concentrated into the thick paste that relative density is 1:1.25-1.35, standby; Ootheca Mantidis is cleaned, with slow fire, fried 5-10 minute, wear into fine powder and above-mentioned thick paste mixes, low-temperature bake 5-15 hour, the powder that gets dry extract, adds conventional adjuvant pharmaceutically to make tablet, capsule, granule, oral liquid, injection or pill dried cream powder.
The preferred preparation method of pharmaceutical composition of the present invention is: Ramulus Mori, Fructus Corni and Herba Dendrobii are added to 15 times of amounts of water, soak 36 hours; With slow fire boiling 2 times, decoct for the first time 2 hours, medicinal liquid is leached stand-by, add for the second time 10 times of water gagings, with slow fire boiling 1 hour, medicinal liquid is leached stand-by; Merge secondary medical filtration, collect filtrate; Filtrate is concentrated into the thick paste that relative density is 1:1.25-1.35, standby; Ootheca Mantidis is cleaned, with slow fire, fried 8 minutes, wear into fine powder and above-mentioned thick paste mixes, low-temperature bake 10 hours, the powder that gets dry extract, adds dried cream powder 75% ethanol of 2 times of amounts again, be evaporated to thick paste shape, add 5 times amount Icing Sugar, add 70% ethanol a little, make soft material, crossing 14 mesh sieves granulates, wet granular is dry at 50 ℃, and dry grain is after 14 mesh sieve granulate, granulation agent.
Pharmaceutical composition of the present invention has the effects such as blood sugar lowering, blood fat reducing, the change of change blood flow and antioxidation, and treatment diabetes are had to good therapeutical effect, and effect is remarkable, has no side effect.
Experimental example is used for further illustrating the present invention below, but is not limited to the present invention.
One, experimental example
1, clinical observation
Treatment group 1 anthology invention Granules in Treating diabetics 50 examples, male's 20 examples wherein, women's 30 examples.
Treatment group 2 anthology invention tablet in treatment diabetics 50 examples, male's 20 examples wherein, women's 30 examples.
Treatment group 3 anthology invention capsules treatments diabetics 50 examples, male's 20 examples wherein, women's 30 examples.
Matched group is selected Ramulus Mori granule, is produced treatment diabetics 50 examples, male's 20 examples wherein, women's 30 examples by Qingdao Haier Pharmaceutical Co., Ltd.
Above patient all meets ADA diabetes diagnosis standard in 2010.
2, medicament selection
Treatment group 1: granule of the present invention (according to embodiment 1 method preparation), treat three courses for the treatment of (10 days courses for the treatment of), 3g/ bag, one day 3 times, one time 1 bag.
Treatment group 2: tablet of the present invention (according to embodiment 2 methods preparations), treat three courses for the treatment of (10 days courses for the treatment of), 0.3g/ sheet, one day 3 times, one time 1.
Treatment group 3: capsule of the present invention (according to embodiment 3 methods preparations), treat three courses for the treatment of (10 days courses for the treatment of), 0.3g/ grain, one day 3 times, one time 1.
Matched group: Ramulus Mori granule, by Qingdao Haier Pharmaceutical Co., Ltd, produced, treat three courses for the treatment of (10 days courses for the treatment of), 3g/ bag, 3 times on the one, one time 1 bag.
3, diagnostic criteria
ADA diabetes diagnosis standard in 2010:
1, glycosated Hb A 1c >=6.5%.
2, fasting glucose FPG >=7.0mmol/l.Being defined as on an empty stomach at least interior empty calory of 8h takes in.
3,2h blood glucose >=11.1mmol/l during oral glucose tolerance test.
4, at the patient with typical hyperglycemia or hyperglycemia crisis symptom, random blood sugar >=11.1mmol/l.
5,, when without clear and definite hyperglycemia, should carry out confirmation standard 1~3 by duplicate detection.
4, criterion of therapeutical effect
Effective: after treatment, symptom disappears substantially, fasting glucose < 7.2mmol/L, (130mg/dl), 2 hours blood glucose < 8.3mmol/L(150mg/dl after the meal), twenty-four-hour urine sugar total amount < 10.0g, or blood glucose, twenty-four-hour urine sugar total amount are treated front decline more than 30%.
Effective: after treatment, symptom is obviously improved, fasting glucose < 8.3mmol/L(150mg/dl), 2 hours blood glucose < 10.0mmol/L(180mg/dl after the meal), twenty-four-hour urine sugar total amount < 25.0g, or blood glucose, twenty-four-hour urine sugar total amount are treated front decline more than 10%.
Invalid: after treatment, symptom is not improved, blood glucose, glucose in urine decline and do not reach above-mentioned standard.
Table 1 treatment group 1 Clinical Laboratory efficacy evaluation (n=50)
Table 2 treatment group 2 Clinical Laboratory efficacy evaluations (n=50)
Table 3 treatment group 3 Clinical Laboratory efficacy evaluations (n=50)
Table 4 matched group Clinical Laboratory efficacy evaluation (n=50)
6, conclusion
Treatment group 1, treatment group 2, treatment group 3 are treated respectively three courses for the treatment of (10 days each courses for the treatment of) with matched group, treatment group 1 fasting glucose and after the meal 2 hours blood glucose total effective rates are 98%, treatment group 2 fasting glucose and after the meal 2 hours blood glucose total effective rates are 94%, treatment group 3 fasting glucose and after the meal 2 hours blood glucose total effective rates are 92%, matched group fasting glucose and after the meal 2 hours blood glucose total effective rates 84%.Treatment group 1 therapeutic effect of the present invention is best, and treatment group 1 of the present invention, treatment group 2 and treatment 3 are obviously better than matched group.
7, discuss
In pharmaceutical composition of the present invention, Ramulus Mori is the twig of moraceae plants Mulberry, has wind-damp dispelling, and the effect of profit joint row aqueous vapor, cures mainly anemofrigid-damp arthralgia, spasm of the limbs, beriberi edema, human body pruritus due to wind pathogen.Ootheca Mantidis is the dry ootheca of Mantidae insecticide Chinese mantid, maculated mantis or huge axe dung beetle, and Ootheca Mantidis has controlling nocturnal emission with astringent drugs reducing urination, the effect of reinforcing the kidney and supporting YANG, and for emission due to deficiency of the kidney, premature ejaculation, sexual impotence, nebulousurine, leukorrhagia.Fructus Corni is machaka or dungarunga, has liver and kidney tonifying, restrains astringent or styptic treatment for spontaneous sweatingly, and controlling nocturnal emission with astringent drugs reducing urination, leukorrhagia stopping only collapse, hidroschesis, also have promoting the production of body fluid to quench thirst effect; Be used for the treatment of soreness of waist and knee joint dizziness and tinnitus, forgetful emission and spermatorrhea, enuresis frequent micturition, bleeding not during menses menoxenia, profuse sweating collapse, interior-heat is quenched one's thirst.Herba Dendrobii is the stem of orchid Dendrobium nobile or its multiple congener, has nourishing YIN and clearing away heat, lung moistening nourishing the stomach, strengthening the tendons and bones.Cure mainly the diseases such as consumption of body fluid caused by febrile disease, xerostomia excessive thirst, stomachache retch, the few expectorant of cough.The all medicine merging of crude drug of the present invention have the effects such as blood sugar lowering, blood fat reducing, the change of change blood flow and antioxidation, and treatment diabetes are had to good therapeutical effect, and effect is remarkable, has no side effect.
Embodiment 1 granule
Ramulus Mori 40kg Ootheca Mantidis 80kg
Fructus Corni 40kg Herba Dendrobii 20kg.
Ramulus Mori, Fructus Corni and Herba Dendrobii are added to 15 times of amounts of water, soak 36 hours; With slow fire boiling 2 times, decoct for the first time 2 hours, medicinal liquid is leached stand-by, add for the second time 10 times of water gagings, with slow fire boiling 1 hour, medicinal liquid is leached stand-by; Merge secondary medical filtration, collect filtrate; Filtrate is concentrated into the thick paste that relative density is 1:1.25-1.35, standby; Ootheca Mantidis is cleaned, with slow fire, fried 8 minutes, wear into fine powder and above-mentioned thick paste mixes, low-temperature bake 10 hours, the powder that gets dry extract, adds dried cream powder 75% ethanol of 2 times of amounts again, be evaporated to thick paste shape, add 5 times amount Icing Sugar, add 70% ethanol a little, make soft material, crossing 14 mesh sieves granulates, wet granular is dry at 50 ℃, and dry grain, after 14 mesh sieve granulate, is packed and be get final product.Granule specification: 3g/ bag, one day 3 times, one time 1 bag.
Embodiment 2 tablets
Ramulus Mori 25kg Ootheca Mantidis 115kg
Fructus Corni 25kg Herba Dendrobii 28kg.
Ramulus Mori, Fructus Corni and Herba Dendrobii are added to 15 times of amounts of water, soak 36 hours; With slow fire boiling 2 times, decoct for the first time 2 hours, medicinal liquid is leached stand-by, add for the second time 10 times of water gagings, with slow fire boiling 1 hour, medicinal liquid is leached stand-by; Merge secondary medical filtration, collect filtrate; Filtrate is concentrated into the thick paste that relative density is 1:1.25-1.35, standby; Ootheca Mantidis is cleaned, with slow fire, fried 8 minutes, wear into fine powder and above-mentioned thick paste mixes, low-temperature bake 10 hours, the powder that gets dry extract, crosses 80 mesh sieves by dried cream powder, adds starch to mix, then adds 10% starch slurry to make soft material, the granulation of sieving, adds magnesium stearate to mix rear tabletting, obtains.Wherein the ratio of mixture A and starch, 10% starch slurry, magnesium stearate is 10:1:0.5:0.05.Tablet specification is: 0.3g/ sheet, every day three times, each 1.
Embodiment 3 capsules
Ramulus Mori 55kg Ootheca Mantidis 45kg
Fructus Corni 55kg Herba Dendrobii 12kg.
Ramulus Mori, Fructus Corni and Herba Dendrobii are added to 12 times of amounts of water, soak 38 hours; With slow fire boiling 2 times, decoct for the first time 2 hours, medicinal liquid is leached stand-by, add for the second time 10 times of water gagings, with slow fire boiling 1 hour, medicinal liquid is leached stand-by; Merge secondary medical filtration, collect filtrate; Filtrate is concentrated into the thick paste that relative density is 1:1.25-1.35, standby; Ootheca Mantidis is cleaned, with slow fire, fried 8 minutes, wear into fine powder with above-mentioned thick paste mixes, low-temperature bake 10 hours, the powder that gets dry extract, the weight ratio that is 1:0.5 by dried cream powder and starch adds adjuvant, granulation, 50 ℃ are dried, after granulate, are sub-packed in capsule.Capsule specification: 0.2g/ grain, one day 3 times, one time 1.