CN102335249B - Oral capsule for treating II-type diabetes - Google Patents

Oral capsule for treating II-type diabetes Download PDF

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CN102335249B
CN102335249B CN2011103009875A CN201110300987A CN102335249B CN 102335249 B CN102335249 B CN 102335249B CN 2011103009875 A CN2011103009875 A CN 2011103009875A CN 201110300987 A CN201110300987 A CN 201110300987A CN 102335249 B CN102335249 B CN 102335249B
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parts
capsule
diabetes
extractum
capsules
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CN102335249A (en
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王萍
王丽
吴子豪
夏勇
马韫韬
吴燕
王健
夏冰
杨绍静
张永达
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Qilu Hospital of Shandong University
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Qilu Hospital of Shandong University
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Abstract

The invention discloses an oral capsule for treating II-type diabetes. The oral capsule is prepared by the method comprising the following steps: (1) respectively weighing the following components in parts by weight: 30+/-3 parts of raw astragalus mongholicus, 30+/-3 parts of glossy privet fruit, 30+/-3 parts of poria, 9+/-1 parts of American ginseng, 15+/-2 parts of medical dogwood, 15+/-2 parts of kudzuvine root, 15+/-2 parts of chicken's gizzard-membrane, 30+/-2 parts of red-rooted salvia root, 15+/-2 parts of snakegourd fruit, and 9+/-1 parts of golden thread, mixing and sufficiently infiltrating with an infiltration amount of ethanol; (2) heating, refluxing and extracting to obtain an extract; (3) mixing with starch or dextrin by using the prepared extract as an adhesive to prepare a soft material, and screening the soft material through a 20-mesh screen to prepare capsule medicinal filling particles; and (4) selecting 00# capsules, and filling the capsules with the capsule medicinal filling particles to obtain the oral capsules for treating the II-type diabetes. Pharmacological tests prove that the effect of the capsules for treating the II-type diabetes is better than that of a positive control group, and the capsules have important clinical application value.

Description

A kind of oral capsule for the treatment of type ii diabetes
Technical field
The present invention relates to a kind of capsule for the treatment of diabetes, relate in particular to a kind of oral capsule for the treatment of type ii diabetes.
Background technology
Along with living standards of the people improve, the factor affecting such as the change of dietary structure, life style conversion and gene, the sickness rate of diabetes increases day by day.China has about more than 4,000 ten thousand people of diabetics now according to incompletely statistics, and also increase progressively with more than 100 ten thousand people's onset speed every year, wherein suffer from non-insulin-depending type and be that the type ii diabetes patient accounts for the diabetes total number of persons about 90%, human existence and health in serious threat.Lasting hyperglycemia can cause the complication of cardiac muscle, blood vessel, nervous system, kidney etc.Therefore, the control blood sugar increasing becomes the primary and foremost purpose for the treatment of diabetes.At present, the therapeutic scheme of type ii diabetes mainly is oral hypoglycemic (oral hypoglycemic drugs and prolonged application insulin (insulin), but there is side reaction in various degree, and easily lost efficacy or took inconvenience, became study hotspot so seek blood sugar reducing function Chinese Traditional Medicines lasting and that toxicity is little.
Summary of the invention
For clinical demand, the purpose of this invention is to provide the oral capsule of the treatment type ii diabetes that a kind of blood sugar reducing function is lasting and toxicity is little.
The oral capsule for the treatment of type ii diabetes of the present invention makes by the following method:
(1) in weight portion, take by weighing respectively 30 ± 3 parts of Radix Astragali, 30 ± 3 parts of Fructus Ligustri Lucidi, 30 ± 3 parts in Poria, 9 ± 1 parts of Radix Panacis Quinquefoliis, 15 ± 2 parts of Fructus Corni, 15 ± 2 parts of Radix Puerariaes, 15 ± 2 parts of Endothelium Corneum Gigeriae Galli, 30 ± 2 parts of Radix Salviae Miltiorrhizaes, 15 ± 2 parts of Fructus Trichosanthis, 9 ± 1 parts of Rhizoma Coptidis, then mix and be that 70%~80% ethanol fully infiltrates 24-36 hour with the volume ratio of submergence amount;
(2) under 60~70 ℃ of temperature, the heating and refluxing extraction extractum repeats twice, and each 1~4 hour, merge extracted twice liquid, filter, it is 1.2~1.3 (70 ℃) that decompression recycling ethanol, extractum are concentrated into relative density; Then add the water of its 3~4 times of volumes, stir, left standstill 20-40 hour at 0~4 ℃, getting supernatant, to be evaporated to relative density be 1.30 ± 0.1 (70 ℃), obtains extract extractum;
(3) extractum that makes is mixed soft material processed as binding agent with starch or dextrin, then soft material is crossed 20 mesh sieves and made wet granular, wet granular is put 60~70 ℃ of lower oven dry, dried granule namely gets the pharmaceutical capsules filler particles with 20 mesh sieve granulate;
(4) choose capsule No. 00, first capsule medicated cap, capsule status are opened, the capsule body inserts in the capsule board hole, regulate the levels distance, make the capsule mouth equal with the plate face, then the capsule-filling granule is laid on the plate face, vibration capsule plate gently, make particles filled evenly, fill up each capsule after, with the unnecessary pharmaceutical capsules filler particles cleaning of plate face, jack-up capsule body, fit capsule medicated cap takes out capsule, namely gets the oral capsule for the treatment of type ii diabetes.
The oral capsule of above-mentioned treatment type ii diabetes preferably makes by the following method:
(1) in weight portion, take by weighing respectively 30 parts of Radix Astragali, 30 parts of Fructus Ligustri Lucidi, 30 parts in Poria, 9 parts of Radix Panacis Quinquefoliis, 15 parts of Fructus Corni, 15 parts of Radix Puerariaes, 15 parts of Endothelium Corneum Gigeriae Galli, 30 parts of Radix Salviae Miltiorrhizaes, 15 parts of Fructus Trichosanthis, 9 parts of Rhizoma Coptidis, then mix and be that 75% ethanol fully infiltrates 30 hours with the volume ratio of submergence amount;
(2) under 60 ℃ of temperature, the heating and refluxing extraction extractum repeats twice, and each 2 hours, merge extracted twice liquid, filter, it is 1.2~1.3 (70 ℃) that decompression recycling ethanol, extractum are concentrated into relative density; Then add the water of its 3 times of volumes, stir, left standstill 24 hours at 1~4 ℃, getting supernatant, to be evaporated to relative density be 1.30 ± 0.1 (70 ℃), obtains extract extractum;
(3) extractum that makes is mixed soft material processed as binding agent with starch or dextrin, then soft material is crossed 20 mesh sieves and made wet granular, wet granular is put 65 ℃ of lower oven dry, dried granule namely gets the pharmaceutical capsules filler particles with 20 mesh sieve granulate;
(4) choose capsule No. 00, first capsule medicated cap, capsule status are opened, the capsule body inserts in the capsule board hole, regulate the levels distance, make the capsule mouth equal with the plate face, then the pharmaceutical capsules filler particles is laid on the plate face, vibration capsule plate gently, make particles filled evenly, fill up each capsule after, with the unnecessary pharmaceutical capsules filler particles cleaning of plate face, jack-up capsule body, fit capsule medicated cap takes out capsule, namely gets the oral capsule for the treatment of type ii diabetes.
The type ii diabetes traditional Chinese medical science belongs to the diabetes category, and diabetes is many because of intense heat of YANG MING, the bright body fluid that disappears, and damage lung stomach then consumes impairment of QI Tianjin for a long time, more disappears more thirsty.There is now viewpoint to think deficiency of spleen and stomach, deficiency of QI in middle-JIAO, it is to cause this sick main cause that gas Tianjin consumption is hindered, therefore most of diabetics has weakness of the spleen and stomach to show, such as card shapes such as weak, hyperhidrosis, loose stools except the resembling of deficiency of the kidney yin arranged more.What the oral capsule prescription for the treatment of type ii diabetes of the present invention was controlled quenches one's thirst, and belongs to not cloth Tianjin of gas, deficiency of spleen and stomach, stomach Tianjin deficiency person.Reuse Radix Astragali among the we, sweet in the mouth, slightly warm in nature is returned the taste warp, is the key medicine of invigorating the spleen and replenishing QI, and Shennong's Herbal is called its main " tonify deficiency ", and " book on Chinese herbal medicine converges and says " says that more it is " medicine of tonifying the lung spleen invigorating ".For insufficiency of the spleen can not cloth Tianjin quench one's thirst, Radix Astragali can tonifying QI to produce body fluid, promotes the generation of body fluid and defeated cloth and the effect of quenching the thirst is arranged; Fructus Ligustri Lucidi, sweet-bitter flavor is cool in nature, returns the Liver and kidney warp, and the merit of nourishing the liver and kidney is arranged, and essentials of Matea Medica carries it can " liver and kidney tonifying, settling five organs, strong waist knee joint ".Two medicine compatibilities, enriching spleen-QI, nourishing kidney-yin, invigorating both QI and YIN is monarch drug altogether.Poria, sweet in the mouth is and light, and Gan Zeneng mends, lightly then can ooze, but the power of Radix Astragali tonify deficiency is strengthened in both spleen invigorating invigorating middle warmer, but promoting diuresis to eliminate damp pathogen again, make wet without gather the expectorant life of having no way of, eliminating evil and do not hinder healthy energy, the Shennong's Herbal cloud its can " the contrary gas of the main breast side of body ... cold and heat; stuffy sensation with restlessness; cough with dyspnea, mouthful burnt dry tongue, diuresis "; Radix Panacis Quinquefolii, sweet little bitter cool, kind boosting qi and nourishing yin, clearing away heat and promoting production of body fluid, " Bencao Congxin " are called its " relieving restlessness is tired for tonifying the lung pathogenic fire reducing, born fluid, empty and have the fiery person suitable ", with the Radix Astragali, Poria compatibility, can assist strengthening the spleen gas; With the same usefulness of Fructus Ligustri Lucidi, can strengthen again the effect of YIN nourishing and the production of body fluid promoting; Fructus Corni, sour and astringent tepor can liver and kidney tonifying, again can the controlling nocturnal emission with astringent drugs reducing urination, the merit of tool envelope Tibetans again among tonification, say as " property of medicine opinion ": Fructus Corni can " the kidney invigorating gas, emerging vagina add marrow, treat tinnitus ... only the old man urinates and does not save." Materia Medica of Decoction also calls: " and sliding then QI prostration, so astringent is received it, Fructus Corni ends normal urination, secret vital essence is got its sour-puckery flavor to receive cunning." upper three medicine compatibilities, both can assist the monarch drug supplementing QI and nourishing YIN, but clearing heat and expelling damp again hold concurrently astringent or styptic treatment for spontaneous sweating to restrain, invigorating middle warmer has rushes down, and receipts are arranged in the profit, oppose each other and yet also complement each other, be ministerial drug altogether.Radix Puerariae, the sweet in the mouth suffering is cool in nature, return the taste warp, among heat clearing away, can inspire again the gas of the clear sun of taste to rise, and the merit of promoting the production of body fluid to quench thirst is arranged, carry its " main quenching one's thirst " as Shennong's Herbal, " property of medicine opinion " also calls it can " end excessive thirst ", with compatibilities such as the Radix Astragali, Radix Panacis Quinquefoliis, supplementing QI and nourishing YIN, clearing away heat and promoting production of body fluid; Endothelium Corneum Gigeriae Galli, sweet flat, merit is arrogated to oneself invigorating the spleen and stomach, promoting digestion and removing stagnation, the controlling nocturnal emission with astringent drugs reducing urination for preventing enuresis, " Japan hanako materia medica " Yan Qike " stopping leak essence ", the merit that " the southern regions of the Yunnan Province book on Chinese herbal medicine " calls it to be had " alleviating distention in middle-JIAO spleen invigorating, the mill stomach helps digestion ", with the Radix Astragali, Poria mutually 5, stomach invigorating and in; With the Fructus Corni compatibility, add the astringent or styptic treatment for spontaneous sweating power of strong convergence; Radix Salviae Miltiorrhizae, hardship is slightly cold, and has the effect that nourishes blood among invigorating blood circulation concurrently, " Japan hanako materia medica " Yan Qizhu " broken stagnated blood, mend new hemopoietic ", " book on Chinese herbal medicine is just read " more call its " merit is with four things, can blood stasis dispelling with tissue regeneration promoting ... property is gentle and walk blood "; Fructus Trichosanthis, sweet cold and moisten, kind removing heat-phlegm, the promoting the circulation of QI dissipating depression of QI, the Compendium of Material Medica cloud its can " lung moistening be dry, pathogenic fire reducing, the clearing away phlegm knot, throat is only quenched one's thirst ", share with Poria, strengthen the effect that eliminating dampness by diuresis is eliminated the phlegm; With Radix Salviae Miltiorrhizae phase 5, blood circulation promoting and blood stasis dispelling, expectorant powder junction, the product of tonification in the compatibility side, tonify without causing stagnation, eliminating evil just the wound; Rhizoma Coptidis, bitter cold, heat clearing and damp drying, eliminating fire and detoxication, with YIN nourishing and the production of body fluid promoting medicine compatibility, nourishing yin and purging fire, heresy is just taken into account, treating both the principal and the secondary aspects of a disease at the same time.The upper five tastes are adjuvant drug altogether.Full side's compatibility is played supplementing QI and nourishing YIN altogether, the effect that promoting the production of body fluid to quench thirst, heat clearing and blood circulation promoting reduce phlegm.
In order to understand better essence of the present invention, the below illustrates that with pharmacological evaluation and the result of the oral capsule for the treatment of type ii diabetes of the present invention it is at the remarkable result aspect the blood sugar lowering.
Diabetes model preparation: alloxan has the effect of selective destruction β cell, and behind the intravenous injection alloxan, rat is damaged because of beta Cell of islet, the ability of the synthetic and excreting insulin of forfeiture and induced Diabetic.
Use the oral capsule high and low dose group for the treatment of type ii diabetes of the present invention and compare with the normal saline group, capsule of the present invention can significantly reduce the blood glucose of the diabetes rat of model induced by alloxan, C peptide and insulin level in the elevating blood.
The discovery of islet tissue pathological section microscopy, capsule high and low dose group of the present invention is compared with the normal saline group, and the pancreatic tissue pathological lesion is light, and islets of langerhans inner cell check figure order is significantly more than the normal saline group.
Also find in addition, capsule of the present invention can significantly reduce the blood glucose of the hyperglycemia rabbit that epinephrine brings out.
Press WHO diabetes diagnosis Standard Selection type ii diabetes patient 464 examples, be divided at random treatment group and matched group.Treatment group 364 examples, male 197 examples wherein, women 167 examples, 40~65 years old age, the course of disease 1~13 year; Severity extent: slight 58 examples, moderate 172 examples, severe 134 examples.Matched group 100 examples, male 59 examples wherein, women 41 examples, 40~65 years old age, the course of disease 1~12 year; Severity extent: slight 10 examples, moderate 58 examples, severe 32 examples.All keep on a diet on request for two groups.The oral embodiment 1 described capsule for the treatment of group, every 3.5g, each 6, every day 3 times, early, middle and late before the meal 30min is oral.The oral SHENQI JIANGTANG sheet of matched group, every 3.5g, each 5, every day 3 times, early, middle and late before the meal 30min is oral.Two groups of drug treatments are 60 days.According to curative effect determinate standard in " guideline of clinical investigations of new Chinese medicine treatment diabetes (diabetes) " of Ministry of Public Health formulation, the embodiment of the invention 1 described capsule group 364 examples, produce effects 196 examples, effective 114 examples, invalid 54 examples, total effective rate 85.16%.Matched group 100 examples, produce effects 20 examples, effective 48 examples, invalid 32 examples, total effective rate 68%.Produce effects and total effective rate more all have significant difference (P<0.01) between two groups.Prompting to improve thirsty polydipsia, rapid digestion of food and polyorexia, polyuria, the clinical total effective rate such as vexed, body is tired, weak, sweating, capsule treatment group of the present invention is better than matched group, disclosing capsule of the present invention has important clinical value.
The specific embodiment
Embodiment 1:
(1) in weight portion (unit: gram), take by weighing respectively 30 parts of Radix Astragali, 30 parts of Fructus Ligustri Lucidi, 30 parts in Poria, 9 parts of Radix Panacis Quinquefoliis, 15 parts of Fructus Corni, 15 parts of Radix Puerariaes, 15 parts of Endothelium Corneum Gigeriae Galli, 30 parts of Radix Salviae Miltiorrhizaes, 15 parts of Fructus Trichosanthis, 9 parts of Rhizoma Coptidis, then mix and be that 75% ethanol fully infiltrates 30 hours with the volume ratio of submergence amount;
(2) under 60 ℃ of temperature, the heating and refluxing extraction extractum repeats twice, and each 2 hours, merge extracted twice liquid, filter, it is 1.2~1.3 (70 ℃) that decompression recycling ethanol, extractum are concentrated into relative density; Then add the water of its 3 times of volumes, stir, left standstill 24 hours at 1~4 ℃, getting supernatant, to be evaporated to relative density be 1.30 ± 0.1 (70 ℃), obtains extract extractum;
(3) extractum that makes is mixed soft material processed as binding agent with starch or dextrin, then soft material is crossed 20 mesh sieves and made wet granular, wet granular is put 65 ℃ of lower oven dry, dried granule namely gets the pharmaceutical capsules filler particles with 20 mesh sieve granulate;
(4) choose capsule No. 00, first capsule medicated cap, capsule status are opened, the capsule body inserts in the capsule board hole, regulate the levels distance, make the capsule mouth equal with the plate face, then the pharmaceutical capsules filler particles is laid on the plate face, vibration capsule plate gently, make particles filled evenly, fill up each capsule after, with the unnecessary pharmaceutical capsules filler particles cleaning of plate face, jack-up capsule body, fit capsule medicated cap takes out capsule, namely get the oral capsule for the treatment of type ii diabetes, wherein contain 3.5g medicine filler particles/capsules.
Embodiment 2:
The experimentation of embodiment 1 described capsule hypoglycemic activity
1 experiment material
1.1 animal: the Wistar rat, male, body weight 200~300g; Purebred new zealand rabbit, male, body weight 2~3kg, Shandong University new drug evaluation center provides.
1.2 reagent: alloxan, epinephrine, glyburide, insoral, diabetes pill is available from medication purchasing supply station, Shandong; C peptide and insulh RIA medicine box are available from Beijing Chinese Research Institute of Atomic Energy Sciences.
1.3 instrument: blood-sugar detecting instrument and blood glucose strip (Luo Shi diagnostic companies); The automatic Y calculating instrument of four probes (Beijing permanent Order instrument and meter company limited).
2 methods and result
2.1 embodiment 1 described capsule is on the impact of blood glucose, C peptide, insulin and the pancreatic tissue of the diabetes rat of model induced by alloxan.
Get 70 of healthy male Wistar rats, body weight 200~300g.(10 of 3.3~5mmol/L) rats are as Normal group, and all the other survey blood glucose with blood-sugar detecting instrument and blood glucose strip all through tail vein injection alloxan 40mg/kg respectively behind the injection 48h to select blood glucose normal range.Get 40 of the rats of range of blood sugar 7~27mmol/L, be divided at random 4 groups by the blood glucose height.Medication group gastric infusion every day 1 time, matched group and Normal group wait respectively the normal saline of capacity, give 1mL by every 100g body weight, continuous use 70d.Respectively at behind the medicine the 20th, 40,70 day, fasting 12h surveyed blood glucose 1 time, the results are shown in Table 1.
Table 1 embodiment 1 described capsule on the impact of a large amount of blood glucose of hyperglycemia of model induced by alloxan (
Figure BDA0000097073230000041
N=10)
Annotate: with normal saline group ratio, *P<0.05, *P<0.01.
Last is surveyed behind the blood glucose respectively from heart extracting blood 4mL, centrifugally goes out serum, puts with C peptide and insulin and exempts from medicine box and survey respectively C peptide and insulin concentration, the results are shown in Table 2.
Table 2 embodiment 1 described capsule on the impact of model induced by alloxan hyperglycemic rat plasma C peptide and insulin level (
Figure BDA0000097073230000043
N=10)
Annotate: with normal saline group ratio, *P<0.05, *P<0.01.
Last sacrificed by decapitation rat, the taking-up pancreatic tissue of cutting open the belly is fixed with 10% formalin, paraffin embedding, section is with H.E and Gomori aldehyde-fuchsin (G.A) dyeing, microscopy.
Acetonideexample 1 described capsule high and low dose group is compared with the normal saline group, and the pancreatic tissue infringement is light, and the pancreatic islet endocrine form is normal, structural integrity.Embodiment 1 described capsule high and low dose group navy blue cell check figure is (individual/μ m 2) be respectively 7.92 ± 0.35 and 7.75 ± 0.95, compare P<0.01 and P<0.05 with normal saline group 5.02 ± 1.11.
2.2 the impact of the hyperglycemia Rabbits ' Blood Sugar that embodiment 1 described capsule brings out epinephrine.
Get 36 of purebred new zealand rabbits, measure respectively and record the front blood glucose value of each rabbit medicine.Get 30 of blood glucose normal rabbits, be divided at random 5 groups.Medication group gastric infusion every day 1 time, matched group wait the normal saline (4ml/kg) of capacity, continuous use 14d.1h measures respectively the record blood glucose value behind the last medicine.Then each rabbit is distinguished subcutaneous injection epinephrine 0.08mg/kg, and each rabbit 1h, 2h and 4h blood glucose value behind the mensuration Injection of Adrenaline the results are shown in Table 3.
Table 3 embodiment 1 described capsule on epinephrine bring out the hyperglycemia Rabbits ' Blood Sugar impact (
Figure BDA0000097073230000051
N=6)
Figure BDA0000097073230000052
Annotate: with normal saline group ratio, *P<0.05, *P<0.01.
3 discuss
Experimental result shows, capsule high and low dose group of the present invention is compared with the normal saline group, can significantly reduce the blood glucose of the diabetes rat of model induced by alloxan, C peptide and insulin level in the elevating blood.
The discovery of islet tissue pathological section microscopy, capsule high and low dose group of the present invention is compared with the normal saline group, and the pancreatic tissue pathological lesion is light, and islets of langerhans inner cell check figure order is significantly more than the normal saline group.
Also find in addition, capsule of the present invention can significantly reduce the blood glucose of the hyperglycemia rabbit that epinephrine brings out.
Embodiment 3:
The report of embodiment 1 described capsule clinical treatment type ii diabetes
3.1 case is selected:
Case is pressed WHO diabetes diagnosis Standard Selection, is the II diabetics, and meets the dialectical standard of deficiency of both QI and YIN disease in " guideline of clinical investigations of new Chinese medicine treatment diabetes (diabetes) ".Accept altogether patient's 464 examples for medical treatment, be divided at random treatment group and matched group.Treatment group 364 examples, male 197 examples wherein, women 167 examples, 40~65 years old age, the course of disease 1~13 year; Severity extent: slight 58 examples, moderate 172 examples, severe 134 examples.Matched group 100 examples, male 59 examples wherein, women 41 examples, 40~65 years old age, the course of disease 1~12 year; Severity extent: slight 10 examples, moderate 58 examples, severe 32 examples.
3.2 Therapeutic Method:
All keep on a diet on request for two groups.The oral embodiment 1 described capsule for the treatment of group, every 3.5g, each 6, every day 3 times, early, middle and late before the meal 30min is oral.The oral SHENQI JIANGTANG sheet of matched group, every 3.5g, each 5, every day 3 times, early, middle and late before the meal 30min is oral.Two groups of drug treatments are 60 days.
3.3 observation index
Fasting glucose and 2 hours blood glucoses after the meal.
3.4 clinical development standard
With reference to curative effect determinate standard in " guideline of clinical investigations of new Chinese medicine treatment diabetes (diabetes) " of Ministry of Public Health formulation.
3.5 therapeutic outcome:
Embodiment 1 described capsule group 364 examples, produce effects 196 examples, effective 114 examples, invalid 54 examples, total effective rate 85.16%.Matched group 100 examples, produce effects 20 examples, effective 48 examples, invalid 32 examples, total effective rate 68%.Produce effects and total effective rate more all have significant difference (P<0.01) between two groups.Prompting to improve thirsty polydipsia, rapid digestion of food and polyorexia, polyuria, the clinical total effective rate such as vexed, body is tired, weak, sweating, treatment group (capsule of the present invention) is better than matched group, disclosing capsule of the present invention has important clinical value.
Fasting glucose and the after the meal relatively demonstration of 2 hours blood glucoses before and after two groups of patient treatments, two groups to fasting glucose with the curative effect of 2 hours blood glucoses is all relatively good after the meal, with before the treatment significant difference (P<0.01) is arranged more all, there was no significant difference relatively between group sees Table 4.
Before and after the treatment of table 4 liang group on an empty stomach and the after the meal comparison of 2 hours blood glucoses (
Figure BDA0000097073230000061
MmolL -1)
Figure BDA0000097073230000062
Annotate: with group ratio before and after the treatment, *P<0.01.

Claims (2)

1. oral capsule for the treatment of type ii diabetes makes by the following method:
(1) in weight portion, take by weighing respectively 30 ± 3 parts of Radix Astragali, 30 ± 3 parts of Fructus Ligustri Lucidi, 30 ± 3 parts in Poria, 9 ± 1 parts of Radix Panacis Quinquefoliis, 15 ± 2 parts of Fructus Corni, 15 ± 2 parts of Radix Puerariaes, 15 ± 2 parts of Endothelium Corneum Gigeriae Galli, 30 ± 2 parts of Radix Salviae Miltiorrhizaes, 15 ± 2 parts of Fructus Trichosanthis, 9 ± 1 parts of Rhizoma Coptidis, then mix and be that 70%~80% ethanol fully infiltrates 24-36 hour with the volume ratio of submergence amount;
(2) under 60~70 ℃ of temperature, the heating and refluxing extraction extractum repeats twice, and each 1~4 hour, merge extracted twice liquid, filter, it is 1.2~1.3 under 70 ℃ that decompression recycling ethanol, extractum are concentrated into relative density; Then add the water of its 3~4 times of volumes, stir, left standstill 20-40 hour at 0~4 ℃, getting supernatant, to be evaporated to relative density be 1.30 ± 0.1 under 70 ℃, obtains extract extractum;
(3) extractum that makes is mixed soft material processed as binding agent with starch or dextrin, then soft material is crossed 20 mesh sieves and made wet granular, wet granular is put 60~70 ℃ of lower oven dry, dried granule namely gets the pharmaceutical capsules filler particles with 20 mesh sieve granulate;
(4) choose capsule No. 00, first capsule medicated cap, capsule status are opened, the capsule body inserts in the capsule board hole, regulate the levels distance, make the capsule mouth equal with the plate face, then the pharmaceutical capsules filler particles is laid on the plate face, vibration capsule plate gently, make particles filled evenly, fill up each capsule after, with the unnecessary pharmaceutical capsules filler particles cleaning of plate face, jack-up capsule body, fit capsule medicated cap takes out capsule, namely gets the oral capsule for the treatment of type ii diabetes.
2. the oral capsule for the treatment of type ii diabetes as claimed in claim 1 is characterized in that, makes by the following method:
(1) in weight portion, take by weighing respectively 30 parts of Radix Astragali, 30 parts of Fructus Ligustri Lucidi, 30 parts in Poria, 9 parts of Radix Panacis Quinquefoliis, 15 parts of Fructus Corni, 15 parts of Radix Puerariaes, 15 parts of Endothelium Corneum Gigeriae Galli, 30 parts of Radix Salviae Miltiorrhizaes, 15 parts of Fructus Trichosanthis, 9 parts of Rhizoma Coptidis, then mix and be that 75% ethanol fully infiltrates 30 hours with the volume ratio of submergence amount;
(2) under 60 ℃ of temperature, the heating and refluxing extraction extractum repeats twice, and each 2 hours, merge extracted twice liquid, filter, it is 1.2~1.3 under 70 ℃ that decompression recycling ethanol, extractum are concentrated into relative density; Then add the water of its 3 times of volumes, stir, left standstill 24 hours at 1~4 ℃, getting supernatant, to be evaporated to relative density be 1.30 ± 0.1 under 70 ℃, obtains extract extractum;
(3) extractum that makes is mixed soft material processed as binding agent with starch or dextrin, then soft material is crossed 20 mesh sieves and made wet granular, wet granular is put 65 ℃ of lower oven dry, dried granule namely gets the pharmaceutical capsules filler particles with 20 mesh sieve granulate;
(4) choose capsule No. 00, first capsule medicated cap, capsule status are opened, the capsule body inserts in the capsule board hole, regulate the levels distance, make the capsule mouth equal with the plate face, then the pharmaceutical capsules filler particles is laid on the plate face, vibration capsule plate gently, make particles filled evenly, fill up each capsule after, with the unnecessary pharmaceutical capsules filler particles cleaning of plate face, jack-up capsule body, fit capsule medicated cap takes out capsule, namely gets the oral capsule for the treatment of type ii diabetes.
CN2011103009875A 2011-10-09 2011-10-09 Oral capsule for treating II-type diabetes Expired - Fee Related CN102335249B (en)

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CN103202423A (en) * 2013-04-17 2013-07-17 合肥工业大学 Fructus trichosanthis polysaccharide composite capsule and preparation method thereof
CN104474193A (en) * 2014-11-17 2015-04-01 孙静 Coordinated application of traditional Chinese medicines in diabetes prevention acupuncture therapy
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