CN101744850A - Preparation and application of total flavone extracted from plants, as well as pharmaceutical preparations thereof - Google Patents
Preparation and application of total flavone extracted from plants, as well as pharmaceutical preparations thereof Download PDFInfo
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- CN101744850A CN101744850A CN200810238299A CN200810238299A CN101744850A CN 101744850 A CN101744850 A CN 101744850A CN 200810238299 A CN200810238299 A CN 200810238299A CN 200810238299 A CN200810238299 A CN 200810238299A CN 101744850 A CN101744850 A CN 101744850A
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Abstract
The invention discloses preparation and application of total flavone extracted from plants, as well as pharmaceutical preparations thereof. The invention is characterized in that total flavone extract of which the content is over 50 percent is extracted, separated and prepared from abelmoschus manihot, and then is mixed with pharmaceutical excipients and is prepared into a pharmaceutically acceptable solid preparation, and pharmacological experiment shows that the total flavone pharmaceutical preparations have hypoglycemic effect and can be applied to the treatment of diabetes.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine pharmacy, be specifically related to a kind of preparation and application of from plant, extracting total flavones and pharmaceutical preparation thereof.
Background technology
Flos abelmoschi manihot is the dry corolla (band stamen and style) of Malvaceae plant Abelmoschus manihot Abelmoschus manihot (L.) Medic., records in " Jiangsu Province's Chinese crude drug standard " (version in 1989) enlarged edition, " Shandong Province's Chinese crude drug standard " version in 2002.Have eliminating damp-heat, the effect of eliminating inflammation and expelling toxin is the traditional medicinal plants of China, and the history of being used as medicine can trace back to " Handbook of Prescriptions for Emergencies " that the Jin Chaoge flood is shown before 1500, and " treating stranguria, detumescence is detoxified to put down in writing it.Control gonorrhea, swollen ulcer drug, the burning hot wound of soup." among the people more application arranged, in order to treatment furuncle, parotitis, urinary tract infection, cough due to lung-heat and burn and scald etc.In recent years, along with going deep into gradually that its effective ingredient and pharmacology etc. are studied, the potential exploitation of Flos abelmoschi manihot is worth more and more to be paid attention to by people.Modern chemistry composition Study data shows; the main component of Flos abelmoschi manihot is a flavone compound; aspect pharmacological experiment study, there is the flavones ingredient of bibliographical information Flos abelmoschi manihot to have pharmacological actions such as antiinflammatory is analgesic, anti-herpesvirus, protection myocardial ischemia, heart and brain hypoxic damage, the treatment nephrotic syndrome.Report that in addition Pedicle abelmoschi manihot has the pharmacologically active of treatment diabetic nephropathy.Chinese patent 200610097615.6 discloses a kind of total flavone extract of maniod eibish and has been used for preparation treatment nephritis medicine; Chinese patent 200610097615.6 discloses a kind of total flavone extract of maniod eibish, its preparation and has been used for the purposes of nephritis aspect; We have declared Chinese patent 200410035741.X in early stage, disclose a kind of total flavones preparation technology.But do not see that so far having with the Flos abelmoschi manihot total flavones is the medicine appearance of active component, more do not see the report of the pharmaceutical preparation treatment diabetes made from Flos abelmoschi manihot total flavones.
We find in the pharmacology prerun process in that total flavone extract of maniod eibish is carried out, it is lower than model group blood glucose value that this extractive of general flavone (0.5-1g/kg) causes mice mice fasting blood sugar to the lumbar injection streptozotocin, shows that this product has significantly blood sugar reducing function.Above-mentioned result of the test has pointed out total flavone extract of maniod eibish to can be used as the application of active component at the medicine of preparation blood sugar lowering.Therefore, exploitation is the pharmaceutical preparation of raw material with the Flos abelmoschi manihot total flavones, be used for the treatment of diabetes, especially for type 2 diabetes mellitus,, can not tackle the problem at its root though Western medicine emerges in an endless stream, and western medicine has certain side effect and " treatment was lost efficacy ", the toxic and side effects that makes full use of Chinese medicine is less relatively, and the advantage that patient can take for a long time will have broad application prospects.
Summary of the invention
The object of the present invention is to provide a kind of extractive of general flavone of Flos abelmoschi manihot.
The Flos abelmoschi manihot total flavones effective site of indication of the present invention is refered in particular to Chinese invention patent 200410035741.X and is extracted the total flavone extract of maniod eibish that obtains, the present invention strictly observes the preparation method in the above-mentioned patent, in order to prove conclusively quality, we control main effective ingredient hyperin and general flavone content in the extract with high performance liquid chromatogram and ultraviolet-spectrophotography.
Another object of the present invention is to provide this extractive of general flavone to be prepared into the preparation method of various peroral dosage forms and injection type.Extractive of general flavone can combine with pharmaceutically acceptable carrier or other proper excipient, makes the dosage form of oral administration and drug administration by injection according to conventional method.
The purposes of medicine in the preparation hypoglycemic medicine that a further object of the present invention is to provide this extractive of general flavone to make.
The present invention is achieved through the following technical solutions:
1, the extraction separation purification of extractive of general flavone
Get the Flos abelmoschi manihot medical material, add 50～90% alcohol reflux, extracting solution concentrates, water precipitating 24h, and sucking filtration, filtrate is adopted pure water gradient elution by macroporous adsorptive resins, and eluent is concentrated, dry, obtains Flos abelmoschi manihot effective site---extractive of general flavone.
2, the prescription of preparation
It is the 60-80 weight portion that tablet consists of extractive of general flavone, and pharmaceutic adjuvant is the 20-40 weight portion; It is the 40-60 weight portion that granule consists of extractive of general flavone, and pharmaceutic adjuvant is the 140-160 weight portion; It is the 40-60 weight portion that capsule consists of extractive of general flavone, and pharmaceutic adjuvant is the 40-60 weight portion; It is the 40-60 weight portion that the drop pill agent consists of extractive of general flavone, and pharmaceutic adjuvant is the 340-360 weight portion; It is the 40-60 weight portion that oral liquid consists of extractive of general flavone, and pharmaceutic adjuvant is the 540-560 weight portion; It is the 40-60 weight portion that aqueous injection consists of extractive of general flavone, and pharmaceutic adjuvant is the 540-560 weight portion; It is the 40-60 weight portion that injectable powder consists of extractive of general flavone, and pharmaceutic adjuvant is the 540-560 weight portion.
3, the preparation of preparation
Get extractive of general flavone, add acceptable pharmaceutic adjuvant on the pharmaceutics, be prepared into tablet, granule, capsule, drop pill, oral aqueous injection, injectable powder with conventional pharmaceutical technology.
Essence for a better understanding of the present invention specifies the application of medicine in diabetic therapy that Flos abelmoschi manihot total flavones is made below.
The specific embodiment
The preparation of embodiment 1 total flavone extract of maniod eibish
It is an amount of that Flos abelmoschi manihot is added 80% ethanol, extracts 1 time, extracted 2 hours, merge extractive liquid, filters, and relative density was 1.13～1.16 concentrated solution when filtrate was condensed into 60 ℃, add suitable quantity of water water precipitating 24h, sucking filtration is concentrated into respective volume, passes through macroporous adsorptive resins, adopt pure water gradient elution, 3 column volumes of water elution, 3 column volumes of each eluting of 10% and 30% ethanol, 1 column volume of 70% ethanol elution.Eluent concentrates, dry, obtain total flavone extract of maniod eibish after pulverizing, its total flavones is 65% with content.
The preparation of embodiment 2 total flavone extract of maniod eibish tablets
Get total flavone extract of maniod eibish 150g, starch 50g, microcrystalline Cellulose 45g, mixing, the ethanol wet granulation is crossed 20 mesh sieves.Add magnesium stearate 5g, mixing, compacting heavily is 1000 in the tablet of 0.25g/ sheet in flakes, every contains total flavone extract of maniod eibish 150mg.Usage: each 2, every day three times.
The capsular preparation of embodiment 3 total flavone extract of maniod eibish
Get total flavone extract of maniod eibish 150g, starch 150g, magnesium stearate 50g crosses the abundant mixing of 80 mesh sieves, dry granulation, 1000 of fill capsules, every contains total flavone extract of maniod eibish 150mg.Usage: each 2, every day three times.
The preparation of embodiment 4 total flavone extract of maniod eibish granules
Get total flavone extract of maniod eibish 150g, dextrin 450g crosses the abundant mixing of 80 mesh sieves, and the ethanol wet granulation is packaged into 1000 bags of the granules of every bag of 6g, and every bag contains total flavone extract of maniod eibish 150mg.
Usage: each 1～2 bag, every day three times.
The blood sugar lowering pharmacodynamic experiment of embodiment 5 total flavone extract of maniod eibish
1 material
1.1 laboratory animal: the Male Kunming strain mice of growing up, body weight 20 ± 2g
1.2 medicine and reagent
Total flavone extract of maniod eibish.Medicine preparation: get powder 500mg and be dissolved in the 20ml distilled water.Positive drug: insoral (Phenformin Hydrochloride Tablets), 250mg/ sheet.Get 1 of insoral (250mg) during use, grind, add water to 30ml.Alloxan: HONG KONG FARCO Chemical Supplies batch number 42011-3E; Blood glucose test kit: Zhongsheng Beikong Biological Science ﹠ Technology Co., Ltd.'s product, lot number 24011; The SOD test kit: bio-engineering research institute product, lot number 20030123 are built up in Nanjing; The MDA test kit: bio-engineering research institute product, lot number 20030107 are built up in Nanjing; The anti-mice Insulin of rabbit immunohistochemical staining test kit: Tianjin Hao ocean biological product science and technology limited Company product.
1.3 key instrument
Finland MK-3 type microplate reader; Germany ZK15 type ultralow temperature centrifuge; Japan Olympus VANOX type all purpose microscope; The world, Beijing very color pathological cells microscopic analysis of century-old science and technology limited Company TD-2000 type system.
2 methods
2.1 the preparation of alloxan diabetes mouse model:
(after body weight 20 ± 2g) first adaptabilities fed for 1 week, fasting 24h freely drank water with the bull Kunming mouse in experiment.Alloxan is made into 0.7% injection with normal saline, and every mice is pressed the disposable injection of 70mg/kg tail vein.Fasting glucose was surveyed on the 5th day in the injection back, and fasting blood sugar is included diabetes model in greater than 10.00mmol/L person.
2.2 animal grouping and processing
10 of normal mouses are the normal control group, and 40 of diabetic mices are divided into 4 groups at random by the blood glucose height, are respectively model control group, medicine matched group, experimental group (large and small dosage group).Experimental session is respectively organized mice and is all given the piece material and feed, and experimental group gavages total flavone extract of maniod eibish solution 0.5ml/kg (heavy dose of group), 0.2ml/kg (small dose group) every day respectively; The medicine matched group gavages insoral 0.2g/kg every day; Model control group and normal control group gavage the distilled water of respective volume every day.Be 3 weeks experimental period.
2.3 detect
Before the experiment and after the experiment, get eye socket venous sinus blood behind the laboratory animal fasting 12h respectively, separation of serum is measured the mice fasting glucose with full automatic biochemical apparatus.Testing result shows, compares with the normal control group, and model group mouse blood sugar level obviously increases (P＜0.001), and mice diabetes model modeling success is described.Two dosage groups of blood sugar lowering sample blood glucose value is compared with the model group blood glucose value, and significantly blood sugar reducing function is all arranged.The result sees table 1 for details.
Table 1 blood sugar lowering sample causes the influence (X ± SD) of mice diabetes blood sugar level to streptozotocin
Annotate: the P value is that each test group and model group compare
In sum, the Flos abelmoschi manihot total flavones sample has hypoglycemic activity preferably.
The blood sugar reducing function clinical observation of embodiment 6 total flavone extract of maniod eibish sheets
In order to verify total flavone extract of maniod eibish sheet blood sugar lowering and symptomatolytic curative effect and safety, we have investigated the situation of 159 routine diabetics clinical practices, now the result are summarized as follows.
1 object and method
1.2 tcm diagnosis and differentiation of symptoms and signs for classification of syndrome:
Allly have that thirsty polydipsia, rapid digestion of food are easily hungry, frequent micturition and sweet, body see that gradually three-many-one-little symptom such as become thin can make a definite diagnosis.Primary symptom is with thirst and liking drink, easy hungry polyphagia, or frequent micturition yellow skin; Inferior disease is with fatigue and weakness, spontaneous sweating, the lazy speech of breathing hard, dysphoria with feverish sensation in the chest palms and soles, palpitation and insomnia, constipation, red tongue, do, few tongue, the thready and rapid pulse without strength person.
1.2 Western medicine diagnose standard: with reference to Ministry of Public Health " Western medicine Clinical Researches of New Drugs guideline ".
1.3 case is selected:
Select the maturity-onset diabetes patient of fasting glucose 〉=7.84mmolL-1, do not have serious complication.Two groups age, 2h blood glucose and 24h glucose in urine there are no significant difference on an empty stomach and after the meal, routine urinalysis, serum paddy ammonia-acetone acid transaminase are through check there are no significant difference, and data has comparability.
1.4 case exclusion standard:
(1) anemia of pregnant woman, teenager and insulin-dependent patient.(2) noncooperationist refers to cooperate diet control or the medication person of affecting the treatment in accordance with regulations not.(3) though before patient's medication blood glucose be higher than normal value, and since after the diet control fasting glucose drop to＜7.28mmolL-1 or 2h blood glucose decline＜10.08mmolL-1 person after the meal.
1.5 experimental technique
Adopt the method for random packet, case is divided into Flos abelmoschi manihot total flavones sheet group and glyburide group.Flos abelmoschi manihot total flavones sheet group 102 examples, oral Flos abelmoschi manihot total flavones sheet, every day 3 times, when curative effect occurring, is reduced to 2 times maintenance dose every day gradually by each 2; Glyburide group 57 examples, oral glyburide (lot number 9405007), every day 3 times, each 1.25～2.50mg, be 1 month the course of treatment.Check fasting glucose, 2h blood glucose, 24h glucose in urine after the meal after the medication weekly, in order to adjust dosage and to observe the variation of the state of an illness.Medication before and after look blood, routine urinalysis and mensuration liver, renal function and serum cholesterol content have no side effect to observe medicine.
1.6 criterion of therapeutical effect: " the new Chinese medicine clinical research guideline " issued with reference to Ministry of Public Health.
1.7 statistics and analysis: use SPSS and SAS statistical software and carry out the variance analysis of randomized block design data, relatively adopt the Studen_Newman_Keuls method between mean, the partial data data adopts completely random design data variance analysis and RiditAnalysis.
2 results
2.1 total effects contrast
Flos abelmoschi manihot total flavones sheet treatment group obvious effective rate is 38.24%, and total effective rate is 89.21%; Glyburide group obvious effective rate is 26.32%, and total effective rate is 85.96%, two group of relatively there was no significant difference (P＞0.05).
2.2 the influence to blood glucose, glucose in urine the results are shown in Table 2.
Table 2 test group and glyburide to the influence of diabetics blood glucose, glucose in urine (± s, mmolL-1)
Annotate: with comparison before the medicine,
*P＜0.05,
*P＜0.01; Compare △ P＜0.05 with the 1st week of administration; Compare #P＜0.05 with the glyburide group.
By table 2 as seen: two groups of patients compare before each all fasting glucose, 2h blood glucose and 24h glucose in urine and the treatment after the meal after treatment, and decline (P＜0.05, P＜0.01) is all arranged.Flos abelmoschi manihot total flavones sheet group is 2h blood glucose and the in addition lasting downward trend of 24h glucose in urine after the meal, and the 2nd, 3,4 all averages have been compared significant difference (P＜0.05) with the 1st week; Wherein the reduction rate of 24h glucose in urine is lower than glyburide group (P＜0.05), and when finishing to observation, Flos abelmoschi manihot total flavones sheet group descends 76.76%, and the glyburide group descends 68.07%.
2.3 the symptom Comparison of therapeutic sees Table 3.
The comparison of table 3 liang group symptom curative effect
Annotate: compare with the glyburide group,
*P＜0.05,
*P＜0.01,
* *P＜0.001.
Annotate: with comparison before the medication,
*P＜0.05,
*P＜0.01.
Table 3 is the result show, to diabetes cardinal symptom such as thirst and liking drink, easy hungry polyphagia, frequent micturition yellow skin etc., two groups total effective rate are 83.33%～88.88%, there was no significant difference; Flos abelmoschi manihot total flavones sheet group is better than the glyburide group to fatigue and weakness, spontaneous perspiration, night sweat, the improvement of breathing hard primary and secondary diseases such as deficiency of both QI and YIN such as lazy speech, dysphoria with feverish sensation in the chest palms and soles, cardiopalmus, insomnia, and difference has highly significant meaning (P＜0.001 or P＜0.05).
2.4 the influence to liver, renal function and hemogram: two groups of patients are after treatment, and its liver, renal function and hemogram be the preceding no significant change of treatment.
Claims (6)
1. preparation method of extracting the medicine of total flavones from plant is characterized by:
(1) the extraction separation purification of extractive of general flavone
Get the Flos abelmoschi manihot medical material, add 50～90% alcohol reflux, extracting solution concentrates, water precipitating 24h, and sucking filtration, filtrate is adopted pure water gradient elution by macroporous adsorptive resins, and eluent is concentrated, dry, obtains Flos abelmoschi manihot effective site---extractive of general flavone;
(2) preparation of preparation
Get extractive of general flavone, add acceptable pharmaceutic adjuvant on the pharmaceutics, be prepared into various oral solid formulations, oral liquid, the ejection preparation that allows on the pharmaceutics with conventional pharmaceutical technology.
2. a kind of preparation method of extracting the medicine of total flavones from plant as claimed in claim 1, wherein the described oral solid formulation of step (2) is tablet, granule, drop pill and capsule.
3. a kind of preparation method of extracting the medicine of total flavones from plant as claimed in claim 1, wherein the described oral liquid of step (2) is an oral liquid.
4. a kind of preparation method of extracting the medicine of total flavones from plant as claimed in claim 1, wherein the described ejection preparation of step (2) is aqueous injection and injectable powder.
5. a kind of preparation method of from plant, extracting the medicine of total flavones as claimed in claim 1, wherein the preparation prescription of the described preparation of step (2) is: it is the 60-80 weight portion that tablet consists of extractive of general flavone, pharmaceutic adjuvant is the 20-40 weight portion; It is the 40-60 weight portion that granule consists of extractive of general flavone, and pharmaceutic adjuvant is the 140-160 weight portion; It is the 40-60 weight portion that capsule consists of extractive of general flavone, and pharmaceutic adjuvant is the 40-60 weight portion; It is the 40-60 weight portion that the drop pill agent consists of extractive of general flavone, and pharmaceutic adjuvant is the 340-360 weight portion; It is the 40-60 weight portion that oral liquid consists of extractive of general flavone, and pharmaceutic adjuvant is the 540-560 weight portion; It is the 40-60 weight portion that aqueous injection consists of extractive of general flavone, and pharmaceutic adjuvant is the 540-560 weight portion; It is the 40-60 weight portion that injectable powder consists of extractive of general flavone, and pharmaceutic adjuvant is the 540-560 weight portion.
6. the medicine of a kind of extractive of general flavone that from plant, extracts according to claim 1, the application of the medicine aspect preparation treatment diabetics.
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| CN102008081A (en) * | 2010-11-11 | 2011-04-13 | 浙江农林大学 | Abelmoschus manihot leaf extract and production method of health-care instant tea thereof |
| CN102579644A (en) * | 2012-03-13 | 2012-07-18 | 河南中医学院 | Compound Chinese hawthorn leaf total flavone dripping pill and preparation method thereof |
| CN105125598A (en) * | 2015-07-29 | 2015-12-09 | 江南大学 | Traditional Chinese medicine composition for treatment of nephritic syndromes and chronic renal failure and preparation method of traditional Chinese medicine composition |
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| CN109432148A (en) * | 2018-12-25 | 2019-03-08 | 江苏农牧科技职业学院 | A method of extracting sunset abelmoschus flower extract |
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| CN102008081A (en) * | 2010-11-11 | 2011-04-13 | 浙江农林大学 | Abelmoschus manihot leaf extract and production method of health-care instant tea thereof |
| CN102008081B (en) * | 2010-11-11 | 2012-09-26 | 浙江农林大学 | Abelmoschus manihot leaf extract and production method of health-care instant tea thereof |
| CN102579644A (en) * | 2012-03-13 | 2012-07-18 | 河南中医学院 | Compound Chinese hawthorn leaf total flavone dripping pill and preparation method thereof |
| CN102579644B (en) * | 2012-03-13 | 2013-09-18 | 河南中医学院 | Compound Chinese hawthorn leaf total flavone dripping pill and preparation method thereof |
| CN105125598A (en) * | 2015-07-29 | 2015-12-09 | 江南大学 | Traditional Chinese medicine composition for treatment of nephritic syndromes and chronic renal failure and preparation method of traditional Chinese medicine composition |
| CN106820111A (en) * | 2016-12-22 | 2017-06-13 | 四川天源油橄榄有限公司 | A kind of health product of Sunset Abelmoschus Root olive and preparation method thereof |
| CN106963807A (en) * | 2017-04-21 | 2017-07-21 | 皖南医学院 | A kind of hypoglycemic oral liquid and preparation method thereof |
| CN106963807B (en) * | 2017-04-21 | 2018-01-30 | 皖南医学院 | A kind of hypoglycemic oral liquid and preparation method thereof |
| CN109432148A (en) * | 2018-12-25 | 2019-03-08 | 江苏农牧科技职业学院 | A method of extracting sunset abelmoschus flower extract |
| CN109432148B (en) * | 2018-12-25 | 2021-07-30 | 江苏农牧科技职业学院 | Method for extracting abelmoschus manihot extract |
| WO2020248776A1 (en) * | 2019-06-13 | 2020-12-17 | 江苏苏中药业集团股份有限公司 | Use of abelmoschi corolla extract in preparation of drug for treating fibrosis |
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Open date: 20100623 |