CN1657055A - Traditional Chinese oral preparation of ophiopogon and coptisine and its preparation method - Google Patents
Traditional Chinese oral preparation of ophiopogon and coptisine and its preparation method Download PDFInfo
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Abstract
An orally applied Chinese medicing 'Donglian' for treating diabetes and its complications is prepared fro, ophiopogon root and coptis root, and contains ophiopogon polyose and coptis alkaloid. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to the winter connects oral preparation of Chinese traditional medicinal and preparation method thereof, belongs to medical technology.
Background technology
China has more than diabetics 4,000 ten thousand people at present, and this numeral has increased by 5 times in nearest 10 years.This disease death that causes because of blood sugar disorders has become one of Chinese's main causes of death, is only second to cardiovascular and cerebrovascular disease and cancer.The traditional Chinese medical science thinks that the cause of disease of diabetes mainly is: eating and drinking without temperance; Disorder of emotion; Deficiency of kidney-YIN.Diabetes are a kind of metabolism disturbance syndromes due to the multiple reason, causing blood glucose, glucose in urine to raise with the relative or absolute deficiency of insulin is characteristics, the diabete of traditional Chinese medical science meaning, the clinical symptoms such as polydipsia, polyphagia, polyuria, the fatigue of becoming thin that occur, especially middle age is with fatigue and weakness, nocturia is a main symptom, if long-term Western medicine control, just antibody can appear, often can cause the heart, cerebrovascular, kidney, optical fundus, retina and nervous system lesion, complication such as ketoacidosis hyperosmolar coma can take place when serious.The traditional Chinese medical science thinks that the cause of disease of diabetes mainly is: eating and drinking without temperance; Disorder of emotion; Deficiency of kidney-YIN.
Purpose of the present invention is according to motherland's Chinese medicine theory, provides a kind of blood sugar lowering oral preparation of Chinese traditional medicinal and preparation method thereof that is used in conjunction with the pharmacology of diabetes.This oral preparation of Chinese traditional medicinal is that pharmaceutically active ingredient share in two kinds, and the type of YIN-deficiency and interior-heat diabetes are had the effect of clearing away heat and nourishing YIN, can obviously alleviate polydipsia polyphagia polyuria symptom, makes the patient recover ideal body weight; This medicine also has the QI invigorating effect, can effectively improve weak symptom, the while activating blood circulation to dissipate blood stasis and dredge the collateral, and diabetic nephropathy, diabetic renal papillary necrosis, diabetic peripheral neuropathy that diabetic microvascular complication is caused all have good efficacy; We can also increase Abwehrkraft des Koepers in addition, improve immunity, have the merit of strengthening vital QI to eliminate pathogenic factors.Thereby diabetes complicated various infection all there is good effect.
Summary of the invention
1, the invention provides the oral preparation of Chinese traditional medicinal that the winter falls blood glucose, it is characterized in that containing two kinds of Chinese crude drugs: Chinese medicine A and Chinese medicine B.Chinese medicine A is the Radix Ophiopogonis polysaccharide, and content is 50%～90%, and Chinese medicine B is a Rhizoma Coptidis alkaloid, and content is 50%～90%.Its set of dispense than (weight portion) in crude drug: A: B=10: 90～90: 10.
2, the present invention also provides the winter to fall the preparation method of the oral preparation of Chinese traditional medicinal of blood glucose, it is characterized in that: the preparation method of Chinese crude drug A active component and Chinese crude drug B active component is as follows:
Chinese crude drug A active component preparation method: get the A medical material, dry stem piece chopping, decoct twice with little boiling water, with the liquid concentration after decocting, with 5 times 80% alcohol reflux 3 times, reclaim ethanol, residue is with the distilled water heating extraction of 5 times of amounts, and filtrate stirs evenly with 0.1% active carbon, leave standstill filtration, filtrate is 30000 ultrafilter membrane by molecular weight, is evaporated to the 1KG/ liter, adds 4 times of amount dehydrated alcohol, leave standstill filtration, get supernatant, use dehydrated alcohol, washing with acetone 4 times, 60 degrees centigrade of vacuum dryings.
Chinese crude drug B active component preparation method: get the B medical material, add acid alcohol solution, backflow 1 ~ 2h filters, and filtering residue repeats to extract 2 times, filtrate be concentrated into original volume 1/2 back constantly stir add down the solid industrial table salt (for cumulative volume 10%), with calculogenesis tone ph9 ~ 10, to filter, filtrate is transferred ph1 ~ 2 with HCl, stir, leave standstill; Filtration drying gets crude product, through the water recrystallization, and obtains elaboration.
3, the winter of the present invention falls the blood glucose oral preparation of Chinese traditional medicinal, confirm through clinical trial, this oral preparation of Chinese traditional medicinal can not only effectively improve subjective symptomss such as patient's polydipsia, polyphagia, polyuria, the soreness of waist, five hearts are scorching, limb cold, can also effectively control on an empty stomach and post-prandial glycemia, improves every biochemical indicator.
4, oral preparation of Chinese traditional medicinal of the present invention is that pharmaceutically active ingredient share in two kinds, and the type of YIN-deficiency and interior-heat diabetes are had the effect of clearing away heat and nourishing YIN, can obviously alleviate polydipsia polyphagia polyuria symptom, makes the patient recover ideal body weight; This medicine also has the QI invigorating effect, can effectively improve weak symptom, the while activating blood circulation to dissipate blood stasis and dredge the collateral, and diabetic nephropathy, diabetic renal papillary necrosis, diabetic peripheral neuropathy that diabetic microvascular complication is caused all have good efficacy; We can also increase Abwehrkraft des Koepers in addition, improve immunity, have the merit of strengthening vital QI to eliminate pathogenic factors; Thereby diabetes complicated various infection all there is good effect.
Drug mechanism
Oral preparation of Chinese traditional medicinal of the present invention can reduce blood glucose in diabetic rats level due to the intraperitoneal injection streptozotocin, improves its carbohydrate tolerance, reduces albumen saccharifying value and improve the diabetes rat insulin content, and these effects obviously are better than glyburide; Have the LPO content, the SOD activity improving that reduce experimental diabetic rats, improve the activity of GSH-Px in the pancreas simultaneously, thereby suppress the intravital oxygen free radical reaction of diabetes rat; Effect with disturbance state of the gonad function that improves male and female diabetes rat.
Oral preparation of Chinese traditional medicinal of the present invention has the effect of clearing away heat and nourishing YIN to the type of YIN-deficiency and interior-heat diabetes, can obviously alleviate polydipsia polyphagia polyuria symptom, makes the patient recover ideal body weight.Also have the QI invigorating effect, can effectively improve weak symptom, the while activating blood circulation to dissipate blood stasis and dredge the collateral, diabetic nephropathy, diabetic renal papillary necrosis, diabetic peripheral neuropathy that diabetic microvascular complication is caused all have good efficacy.Can increase Abwehrkraft des Koepers, improve immunity, have the merit of strengthening vital QI to eliminate pathogenic factors.Thereby diabetes complicated various infection all there is good effect.
The pharmacological research data
1. pharmacodynamics data:
Treat the effectiveness of diabetes and inquire into its mechanism of action for confirmation oral preparation of Chinese traditional medicinal of the present invention, we use the streptozotocin intraperitoneal injection and duplicate the rat diabetes model, and blood and some tissue of rat carried out a series of experiments.These experiments include: the saccharifying value of carbohydrate tolerance, serum insulin content, blood plasma fructosamine content, hemoglobin and histone, lipid peroxide (LPO) content, superoxide dismutase (SOD) activity, glutathion oxide enzyme (GSH-PX) activity, plasma testosterone and estradiol content.The result shows that oral preparation of Chinese traditional medicinal of the present invention can reduce blood glucose in diabetic rats level due to the intraperitoneal injection streptozotocin, improve its carbohydrate tolerance, reduces albumen saccharifying value and improve the diabetes rat insulin content, and these effects obviously are better than glyburide; Have the LPO content, the SOD activity improving that reduce experimental diabetic rats, improve the activity of GSH-Px in the pancreas simultaneously, thereby suppress the intravital oxygen free radical reaction of diabetes rat; Effect with disturbance state of the gonad function that improves male and female diabetes rat.
Table 1. streptozotocin lumbar injection respectively organize after 3 days rat blood sugar content and carbohydrate tolerance (X ± SD, n=10)
| Grouping | Blood sugar content (mmol/L) | ||
| 0 hour | 1 hour | 2 hours | |
| Dosage group treatment low dose group glyburide group model matched group normal control group in the treatment of treatment high dose group | ??16.29±3.41 a??14.90±2.53 a??14.36±3.11 a??15.24±4.75 a??16.41±3.14 a??3.75±0.56 | ??18.80±2.63 a??16.61±2.72 a??16.27±2.43 a??16.13±4.16 a??17.65±2.81 a??7.18±0.92 | ??17.85±2.46 a??14.96±2.55 a??14.64±2.62 a??15.63±4.24 a??17.29±2.71 a??3.97±0.41 |
Annotate:
aCompare P＜0.0001 with the normal control group
Table 2. respectively organize rat plasma insulin content, blood plasma fructosamine and Hb saccharifying value and pancreas and kidney protein saccharifying value testing result (X ± SD, n=10)
| Grouping | Insulin content | Fructosamine (DMF) content | Hb saccharifying value | Pancreas albumen saccharifying value | Kidney protein saccharifying value |
| (IU/L) | (mmol/L) | (OD/gHb) | (OD/g albumen) | (OD/g albumen) | |
| Dosage group treatment low dose group glibenclamide group model control group Normal group in the treatment for the treatment of high dose group | 17.66±4.41 ? 17.49±2.55 ? 17.20±3.70 ? 14.86±3.39 ? 14.29± 3.39 c21.17±5.38 | 2.00±0.16 acd? 2.20±0.09 acd? 2.18±0.22 acd? 2.79±0.17 ac? 3.25±0.25 b? 1.65±0.17 | 27.24±3.65 acd? 29.07±3.48 acd? 27.83±2.09 acd? 37.69±6.07 ab? 41.61±3.33 b? 23.05±2.45 | ??238±23 acd? ??267±19 acd? ??261±15 acd? ??313±14 b? ??337±17 b? ??201±17 | ??219±15 acd? ??240±20 acd? ??255±20 acd? ??318±32 b? ??321±53 b? ??195±7 |
Annotate:
aCompare P＜0.0001 with model control group; Compare with the normal control group,
bP＜0.0001,
cP＜0.01; Compare with the glyburide group,
dP＜0.01
Each organizes rat plasma LPO content, SOD and the active measurement result of GSH-Px
Table 3 respectively organize rat plasma LPO content, SOD and the active measurement result of GSH-Px (X ± SD, n=10)
| Grouping | Blood plasma LPO content | The GSH-Px activity | The SOD activity |
| ??(μmol/L) | ??(u/gHb) | ????(u/gHb×10 3) | |
| Dosage group treatment low dose group glyburide group model matched group normal control group in the treatment of treatment high dose group | ??4.71±0.63 acd??5.12±0.50 acd??5.17±0.51 acd??7.10±0.78 b??7.68±0.76 b??3.67±0.25 | ??227±31 acd??238±32 acd??261±43 acd??268±62 b??295±44 b??216±36 | ????3.49±0.90 acd????2.94±0.73 acd????2.61±0.74 acd????1.80±0.53 b????1.60±0.68 b????4.18±1.09 |
Annotate:
aCompare P＜0.0001 with model control group; Compare with the normal control group,
bP＜0.0001,
cP＜0.01; Compare with the glyburide group,
dP＜0.01
2. safety testing data
Emergency toxicology research
Body weight 18-22g Kunming kind white mice each 20, male and female half and half, give maximum volume and the Cmax capsule is irritated the harmonization of the stomach intraperitoneal injection, observed continuously 7 days.Capsule filling stomach of the present invention (total dosage is 66.66g/Kg) mice any unusual performance do not occur and there is no an example death.So capsule gastric infusion LD50＞66.66g/Kg of the present invention.Intraperitoneal injection drug (total dosage is 12.5g/Kg) was observed 7 days continuously, and writhing response appears in mice 5-10min after administration, and none example is dead.
Long-term toxicologic study
In order to study the long term toxicity effect of oral preparation of Chinese traditional medicinal of the present invention to animal, we use the capsule of the present invention of three kinds of various dose, and (dosage is respectively: 20.0/kg, 10.0g/kg, 5.0g/kg) give Wistar rat oral gavage 3 months continuously, 6 times weekly, the normal control group gives the normal saline of same volume and irritates stomach, and the experimental session rat does not have death.Experimental result confirms, the general state of each dosage group rat and rats in normal control group, all Non Apparent Abnormality performances such as outward appearance sign, behavioral activity, feces character etc.An index such as each dosage group rat serum routine urinalysis, blood biochemical and meeting renal function is no abnormal, and compares statistics with rats in normal control group and do not have significant difference.The main organs of heavy dose of group (20.0g/kg) rat after one's own heart, internal organs such as liver, spleen, lung, adrenal gland, testis, uterus observe Non Apparent Abnormality and each organ index of each dosage group rat and normal control group no difference of science of statistics down through naked eyes and light microscopic.The dosage (this dosage is 100 times of clinical equivalent dosage) that experiment discloses 20.0g/kg.d is the safe dose scope.
3. clinical research data
The tcm syndrome integration relatively before two groups of treatments
| The cold of group limb | n | The polydipsia total mark | Polyphagia | Polyuria | The soreness of waist | Dysphoria with feverish sensation in the chest palms and soles |
| I group II group | 59 15 | 1.01±1.08 1.13±1.07 | 0.69±0.83 0.98±0.92 | 1.64±1.08 1.86±0.99 | ?1.32±1.09 ?1.13±0.87 | 0.96±0.86 1.03±0.99 |
| 0.73±0.89 | 12.20±3.43 | |||||
Check through t: each organizes tcm symptom integrated value P＞0.05, and comparability is arranged.
Two groups of clinical symptom treatment backs relatively
| Group | Produce effects n%) | Effective n (%) | Invalid n (%) | Total effective rate n (%) |
| I group (59 example) II group (15 example) | ??25??(42.3) ???5??(33.3) | ??29??(49.2) ???5??(33.3) | ??5??(8.5) ??5??(33.3) | ??54????(90.5) ??10????(66.6) |
Result: X
2 I-III=7.65 P＜0.01 X
2 II-III=4.33 P＜0.05
From table as can be known: the tcm clinical practice symptom of Chinese medicine I group through treatment after, treatment I group total effective rate reaches 90.5%, with Western medicine II group relatively, significance P＜0.01～0.05 is arranged.
Two groups of laboratory indexes change
| Group | Blood glucose | 2h blood glucose after the meal | |
| Treatment I group (59) contrast II group (15) | Behind the medicine prodrug behind the medicine prodrug | ????14.77±9.11 ????8.69±2.66 *Δ????????17.84±8.22 ????6.92±4.13 ** | ????18.69±4.72 ????11.72±6.33 *Δ ????????19.83±7.11 ????8.19±6.28 * |
Annotate: compare between * P＜0.05 * * P＜0.01 * * * P＜0.001 Δ group: P＜0.05, down together
Above index shows, two groups of medicines self relatively, to blood glucose, 2h blood glucose all makes its decline effect (P＜0.05～0.01) after the meal.
Relatively, I group, II organize relatively between group, are reducing fasting glucose and on the 2h blood glucose significant difference are being arranged after the meal
Two groups of blood biochemistry index change
| Project | The I group | The II group |
| Glycolated hemoglobin (SOD/gHb) plasma insulin (mIu/L) fructosamine content (mmol/L) | Preceding 44.27 ± 4.63 backs 32.26 ± 1.60 **Preceding 10.87 ± 5.73 backs 13.46 ± 6.94 ***Preceding 2.50 ± 0.55 backs 1.88 ± 0.33 *** | 44.7±3.1 ? 39.4±3.2 *12.09±4.28 8.89±3.52 ***3.14±0.54 2.70±0.39 *** |
From table as can be known, after taking capsule of the present invention, the patient increases on blood insulin content, and relatively there were significant differences for self, decreases on the contrary before treating and take the insulin level of glyburide group.Each content of organizing patient's fructosamine and glycolated hemoglobin all has decline after experiment, there were significant differences, and the content of the glycolated hemoglobin of capsule group wherein of the present invention approaches normally.
Each organize the Aeg treat before and after plasma estradiol and testosterone concentration change (X ± S)
| Group | Estradiol (ng/dl) | Testosterone (ng/dl) | ????E 2/T×10 -3 | |||
| Before | After | Before | After | Before | After | |
| I group (13 example) II group (7 example) | ??8.7±3.9 ??11.2±1.9 | ??5.7±2.4 *??10.7± ?????1.7 | ?470±128 ?480±108 | 506±158 *492±101 | ?20.5± ???5.8 ??23.6± ????2.2 | ??11.2± ????2.8 *??22.2± ????3.7 |
| Normal group | ???????????5.8±2.5 | ????609±167 | ????9.5±3.6 | |||
Annotate: self relatively
*P＜0.05,
*P＜0.01
Each organize the aeg treat before and after plasma estradiol and testosterone concentration change (X ± S)
| Group | Estradiol (ng/dl) | Testosterone (ng/dl) | ??????????E 2/T×10 -3 | |||
| Before | After | Before | After | Before | After | |
| I group (5 example) II group (8 example) | 7.3±2.2 7.6±2.5 | ?7.4±1.7 ?7.7±2.0 | ??148± ????11.0 ??126± ????21.0 | ??107± ????40.0 *??127± ????22.0 | ?50.0±17.0 ?61.0±19.0 | ????75.0± ????????24.0 *????61.0±16.0 |
| Normal group | ??????14.7±6.0 | ????609±167 | ??????165.0±41.0 | |||
Respectively organize patient's male estradiol before experiment as seen from table and all be higher than normal group, testosterone all is lower than normal group, simultaneously ratio (the E of estradiol and testosterone
2/ T) also be higher than normal group; Estradiol content obviously reduces after taking capsule of the present invention, and testosterone concentration obviously raises, thereby E
2/ T also significantly reduces; Yet the patient of glyburide group, these three indexs have no significant change before and after experiment.
Four, clinical research summary
Confirm that through clinical trial oral preparation of Chinese traditional medicinal of the present invention can not only effectively improve subjective symptomss such as patient's polydipsia, polyphagia, polyuria, Yao Acid, dysphoria with feverish sensation in the chest palms and soles, limb cold, can also effectively control on an empty stomach and post-prandial glycemia, improve every biochemical indicator.
Capsule traditional Chinese medical science disease total effective rate of the present invention is 90.5%, and wherein obvious effective rate is 42.3%.The matched group obvious effective rate is that 33.3% total effective rate is 66.6%.Treatment I group compares with matched group, significant difference is arranged and single from the disease angle analysis, and the treatment group is to syndrome of deficiency of both qi and yin such as weak, dysphoria with feverish sensation in the chest palms and soles better effects if.
Treatment diabetes and chronic complicating diseases clinical efficacy are reliable.The plasma insulin content of taking capsule patient of the present invention (I group) has remarkable rising.Patient's saccharification hemoglobin content approaches normal level.Take to compare on the contrary obviously before patient's insulin level and the experiment of glyburide (II group) and reduce, patient's saccharification hemoglobin content is higher than normal level.
Male blood plasma estradiol (E2) and testosterone (T) Determination on content result show, take capsule of the present invention after estradiol content obviously reduce, testosterone concentration obviously raises; Yet this index of the patient of glyburide group has no significant change before and after experiment.Each is organized women's plasma estradiol (E2) and testosterone (T) Determination on content result and shows, testosterone content obviously reduced after each was organized female patients and takes capsule of the present invention, and the estradiol amount obviously raises; Yet this index of the patient of glyburide group has no significant change before and after experiment.
Through the years of researches evidences, no matter still be clinical efficacy from zoopery on, its effect is all good, has no side effect.Medicine is fewer but better, and market prospect is wide, and medicament sources is convenient.
A kind of hypoglycemic oral preparation of Chinese traditional medicinal of the present invention can be a solution, suspensoid, tablet, capsule, granule, pill, powder, drop pill; Preferred capsule, tablet, granule; More preferably capsule.Composition A and B can be mixed in suitable carriers, in diluent or the excipient.Specific embodiment is as follows, includes but not limited to the following example.
Embodiment 1
Winter falls the agent of blood glucose Chinese medicinal capsule, it is characterized in that containing two kinds of Chinese crude drug A and B, its set of dispense than (weight portion) in crude drug: A: B=60: 40
Winter of the present invention falls the preparation method of the Chinese medicinal capsule agent of blood glucose, it is characterized in that: the preparation method of the active component of Chinese crude drug A and Chinese crude drug B active component is as follows:
The active component preparation method of Chinese crude drug A: get the A medical material, dry stem piece chopping, decoct twice with little boiling water, with the liquid concentration after decocting, with 5 times 80% alcohol reflux 3 times, reclaim ethanol, residue is with the distilled water heating extraction of 5 times of amounts, and filtrate stirs evenly with 0.1% active carbon, leave standstill filtration, filtrate is 30000 ultrafilter membrane by molecular weight, is evaporated to the 1KG/ liter, adds 4 times of amount dehydrated alcohol, leave standstill filtration, get supernatant, use dehydrated alcohol, washing with acetone 4 times, 60 degrees centigrade of vacuum dryings.
The preparation method of Chinese crude drug B active component: get the B medical material, add acid alcohol solution, backflow 1 ~ 2h filters, and filtering residue repeats to extract 2 times, filtrate be concentrated into original volume 1/2 back constantly stir add down the solid industrial table salt (for cumulative volume 10%), with calculogenesis tone ph9 ~ 10, to filter, filtrate is transferred ph1 ~ 2 with HCl, stir, leave standstill; Filtration drying gets crude product, through the water recrystallization, and obtains elaboration.
Incapsulate by the formula proportion mix homogeneously, reinstall in the bottle and seal.
Embodiment 2
Winter falls the blood glucose Chinese medicine granules, it is characterized in that containing two kinds of Chinese crude drug A and B, its set of dispense than (weight portion) in crude drug: A: B=60: 40
Winter of the present invention falls the preparation method of the Chinese medicinal capsule agent of blood glucose, it is characterized in that: the preparation method of the active component of Chinese crude drug A and Chinese crude drug B active component is as follows:
The active component preparation method of Chinese crude drug A: get the A medical material, dry stem piece chopping, decoct twice with little boiling water, with the liquid concentration after decocting, with 5 times 80% alcohol reflux 3 times, reclaim ethanol, residue is with the distilled water heating extraction of 5 times of amounts, and filtrate stirs evenly with 0.1% active carbon, leave standstill filtration, filtrate is 30000 ultrafilter membrane by molecular weight, is evaporated to the 1KG/ liter, adds 4 times of amount dehydrated alcohol, leave standstill filtration, get supernatant, use dehydrated alcohol, washing with acetone 4 times, 60 degrees centigrade of vacuum dryings.
The preparation method of Chinese crude drug B active component: get the B medical material, add acid alcohol solution, backflow 1 ~ 2h filters, and filtering residue repeats to extract 2 times, filtrate be concentrated into original volume 1/2 back constantly stir add down the solid industrial table salt (for cumulative volume 10%), with calculogenesis tone ph9 ~ 10, to filter, filtrate is transferred ph1 ~ 2 with HCl, stir, leave standstill; Filtration drying gets crude product, through the water recrystallization, and obtains elaboration.
Press the formula proportion mix homogeneously, add adjuvant, make soft material in right amount with ethanol, the system granule, cold drying behind the granulate, is distributed into bag.
Embodiment 3
Winter falls the blood glucose Chinese medicinal tablet, it is characterized in that containing two kinds of Chinese crude drug A and B, its set of dispense than (weight portion) in crude drug: A: B=60: 40
Winter of the present invention falls the preparation method of the Chinese medicinal capsule agent of blood glucose, it is characterized in that: the preparation method of the active component of Chinese crude drug A and Chinese crude drug B active component is as follows:
The active component preparation method of Chinese crude drug A: get the A medical material, dry stem piece chopping, decoct twice with little boiling water, with the liquid concentration after decocting, with 5 times 80% alcohol reflux 3 times, reclaim ethanol, residue is with the distilled water heating extraction of 5 times of amounts, and filtrate stirs evenly with 0.1% active carbon, leave standstill filtration, filtrate is 30000 ultrafilter membrane by molecular weight, is evaporated to the 1KG/ liter, adds 4 times of amount dehydrated alcohol, leave standstill filtration, get supernatant, use dehydrated alcohol, washing with acetone 4 times, 60 degrees centigrade of vacuum dryings.
The preparation method of Chinese crude drug B active component: get the B medical material, add acid alcohol solution, backflow 1 ~ 2h filters, and filtering residue repeats to extract 2 times, filtrate be concentrated into original volume 1/2 back constantly stir add down the solid industrial table salt (for cumulative volume 10%), with calculogenesis tone ph9 ~ 10, to filter, filtrate is transferred ph1 ~ 2 with HCl, stir, leave standstill; Filtration drying gets crude product, through the water recrystallization, and obtains elaboration.
Press the formula proportion mix homogeneously, add a small amount of magnesium stearate and other adjuvants, compacting is distributed into bag in flakes.
Embodiment 4
Winter falls the agent of blood glucose Chinese medicinal soft capsule, it is characterized in that containing two kinds of Chinese crude drug A and B, its set of dispense than (weight portion) in crude drug: A: B=60: 40
Winter of the present invention falls the preparation method of the Chinese medicinal capsule agent of blood glucose, it is characterized in that: the preparation method of the active component of Chinese crude drug A and Chinese crude drug B active component is as follows:
The active component preparation method of Chinese crude drug A: get the A medical material, dry stem piece chopping, decoct twice with little boiling water, with the liquid concentration after decocting, with 5 times 80% alcohol reflux 3 times, reclaim ethanol, residue is with the distilled water heating extraction of 5 times of amounts, and filtrate stirs evenly with 0.1% active carbon, leave standstill filtration, filtrate is 30000 ultrafilter membrane by molecular weight, is evaporated to the 1KG/ liter, adds 4 times of amount dehydrated alcohol, leave standstill filtration, get supernatant, use dehydrated alcohol, washing with acetone 4 times, 60 degrees centigrade of vacuum dryings.
The preparation method of Chinese crude drug B active component: get the B medical material, add acid alcohol solution, backflow 1 ~ 2h filters, and filtering residue repeats to extract 2 times, filtrate be concentrated into original volume 1/2 back constantly stir add down the solid industrial table salt (for cumulative volume 10%), with calculogenesis tone ph9 ~ 10, to filter, filtrate is transferred ph1 ~ 2 with HCl, stir, leave standstill; Filtration drying gets crude product, through the water recrystallization, and obtains elaboration.
Press the formula proportion mix homogeneously, add adjuvant, make soft capsule, packing.
Embodiment 5
Winter falls the blood glucose Traditional Chinese Medicine Dropping Pill, it is characterized in that containing two kinds of Chinese crude drug A and B, its set of dispense than (weight portion) in crude drug: A: B=60: 40
Winter of the present invention falls the preparation method of the Chinese medicinal capsule agent of blood glucose, it is characterized in that: the preparation method of the active component of Chinese crude drug A and Chinese crude drug B active component is as follows:
The active component preparation method of Chinese crude drug A: get the A medical material, dry stem piece chopping, decoct twice with little boiling water, with the liquid concentration after decocting, with 5 times 80% alcohol reflux 3 times, reclaim ethanol, residue is with the distilled water heating extraction of 5 times of amounts, and filtrate stirs evenly with 0.1% active carbon, leave standstill filtration, filtrate is 30000 ultrafilter membrane by molecular weight, is evaporated to the 1KG/ liter, adds 4 times of amount dehydrated alcohol, leave standstill filtration, get supernatant, use dehydrated alcohol, washing with acetone 4 times, 60 degrees centigrade of vacuum dryings.
The preparation method of Chinese crude drug B active component: get the B medical material, add acid alcohol solution, backflow 1 ~ 2h filters, and filtering residue repeats to extract 2 times, filtrate be concentrated into original volume 1/2 back constantly stir add down the solid industrial table salt (for cumulative volume 10%), with calculogenesis tone ph9 ~ 10, to filter, filtrate is transferred ph1 ~ 2 with HCl, stir, leave standstill; Filtration drying gets crude product, through the water recrystallization, and obtains elaboration.
Press the formula proportion mix homogeneously, add adjuvant, make drop pill, packing.
Claims (7)
1. the winter connects oral preparation of Chinese traditional medicinal and preparation method thereof, it is characterized in that containing two kinds of Chinese crude drugs: Chinese medicine A and Chinese medicine B.Chinese medicine A is the Radix Ophiopogonis polysaccharide, and content is 50%～90%, and Chinese medicine B is a Rhizoma Coptidis alkaloid, and content is 50%～90%.Its set of dispense than (weight portion) in crude drug: A: B=10: 90～90: 10.
2, the Chinese medicine A of claim 1 and Chinese medicine B, its set of dispense in crude drug, also is A: B=20: 80～80: 20 than (weight portion).
3, the Chinese medicine A of claim 1 and Chinese medicine B, its set of dispense in crude drug, also is A: B=30: 70～70: 30 than (weight portion).
4, the Chinese medicine A of claim 1 and Chinese medicine B, its set of dispense in crude drug, also is A: B=40: 60～60: 40 than (weight portion).
5, the Chinese medicine A of claim 1 and Chinese medicine B, its set of dispense in crude drug, also is A: B=50: 50～50: 50 than (weight portion).
6. the preparation method of a kind of hypoglycemic oral preparation of Chinese traditional medicinal of claim 1, it is characterized in that: the preparation method of Chinese crude drug A active component and Chinese crude drug B active component is as follows:
Chinese crude drug A active component preparation method: get the A medical material, dry stem piece chopping, decoct twice with little boiling water, with the liquid concentration after decocting, with 5 times 80% alcohol reflux 3 times, reclaim ethanol, residue is with the distilled water heating extraction of 5 times of amounts, and filtrate stirs evenly with 0.1% active carbon, leave standstill filtration, filtrate is 30000 ultrafilter membrane by molecular weight, is evaporated to the 1KG/ liter, adds 4 times of amount dehydrated alcohol, leave standstill filtration, get supernatant, use dehydrated alcohol, washing with acetone 4 times, 60 degrees centigrade of vacuum dryings.
Chinese crude drug B active component preparation method: get the B medical material, add acid alcohol solution, backflow 1 ~ 2h filters, and filtering residue repeats to extract 2 times, filtrate be concentrated into original volume 1/2 back constantly stir add down the solid industrial table salt (for cumulative volume 10%), with calculogenesis tone ph9 ~ 10, to filter, filtrate is transferred ph1 ~ 2 with HCl, stir, leave standstill; Filtration drying gets crude product, through the water recrystallization, and obtains elaboration.
7. the winter of claims 1 falls the oral preparation of Chinese traditional medicinal of blood glucose, is solution, suspensoid, tablet, capsule, granule, pill, powder, drop pill; Preferred capsule, tablet, granule; More preferably capsule.
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| CN105326929A (en) * | 2014-06-24 | 2016-02-17 | 毕京 | Rhizoma coptidis and panax notoginseng traditional Chinese medicinal oral preparation and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105326929A (en) * | 2014-06-24 | 2016-02-17 | 毕京 | Rhizoma coptidis and panax notoginseng traditional Chinese medicinal oral preparation and preparation method thereof |
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Effective date of registration: 20070105 Address after: Xiyuan Haidian District Chinese Medicine Research Institute, 1 Xiyuan grassland street, Beijing, China Applicant after: Gao Pu Co-applicant after: Beijing Puhui Tianyue Biotechnology Co. Ltd. Address before: Xiyuan Haidian District Chinese Medicine Research Institute, 1 Xiyuan grassland street, Beijing, China Applicant before: Gao Pu |
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