CN1726963A - Oral taking preparation of mulberry leaves possessing function for lowering blood sugar, and detection method - Google Patents

Oral taking preparation of mulberry leaves possessing function for lowering blood sugar, and detection method Download PDF

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Publication number
CN1726963A
CN1726963A CN 200510014597 CN200510014597A CN1726963A CN 1726963 A CN1726963 A CN 1726963A CN 200510014597 CN200510014597 CN 200510014597 CN 200510014597 A CN200510014597 A CN 200510014597A CN 1726963 A CN1726963 A CN 1726963A
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China
Prior art keywords
folium mori
oral formulations
fine
water
blood sugar
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CN 200510014597
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Chinese (zh)
Inventor
苏彤
王颖
宋旭波
张健美
王红星
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Zheng'an Research And Development Of Medicine And Drudgery Co Ltd Tianjin
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Zheng'an Research And Development Of Medicine And Drudgery Co Ltd Tianjin
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Priority to CN 200510014597 priority Critical patent/CN1726963A/en
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  • Medicines Containing Plant Substances (AREA)

Abstract

A Chinese medicine in the form of chewing tablet for decreasing blood sugar is prepared from mulberry leaves through extracting the superfine mulberropolyose powder, proportionally mixing it with medicinal auxiliary and superfine powder of dried mulberry leaf, and tabletting. Its varifying method is also disclosed.

Description

A kind of oral taking preparation of mulberry leaves and detection method thereof with blood sugar reducing function
Technical field
The present invention relates to field of traditional Chinese, in particular, is a kind of oral taking preparation of mulberry leaves with hypoglycemic activity and preparation method thereof, also relates to the quality determining method of said preparation simultaneously.
Background technology
Folium Mori belong to the shrub class, the book on Chinese herbal medicine record, and Folium Mori bitter in the mouth, sweet, sharp the five internal organs are got round by bribery, and the therapeutic method to keep the adverse QI flowing downwards has function of detoxification; Radix Mori, sweet in the mouth, tonify deficiency QI invigorating, preventing phlegm from forming and stopping coughing, whetting the appetite.Folium Mori all over are precious, have liver heat removing and eyesight improving, and the blood ester falls in sharp the five internal organs, blood pressure lowering, and blood sugar lowering suppresses effects such as cancer.China's Folium Mori are abundant, and the source is cheap, therefore, deeply develops Morus alba Resource Development and has vast market prospect.Currently reported content about the Folium Mori aspect, be to share the health mulberry leaf product of making mostly with other Chinese crude drug, health-care tea made of mulberry leaves for example, health mulberry leaf beverage or the like, few about the preparation made from the Folium Mori single component, particularly the chewing tablets made of folium mori made from the Folium Mori single component is not seen bibliographical information as yet.
Summary of the invention
The technical problem to be solved in the present invention is:
(1) a kind of oral taking preparation of mulberry leaves of development with hypoglycemic activity.It is to be main active with the polysaccharide that extracts in the Folium Mori, is equipped with suitable adjuvant, granulate, and Folium Mori superfine powder tabletting and getting.
(2) the present invention discloses the detection method of oral taking preparation of mulberry leaves.Provide the polysaccharide of easy operating, mild condition to detect water bath condition, and proposed new method for said preparation pre-treatment and mensuration when the quality testing.
(3) other the present invention has further studied the preparation method of chewing tablets made of folium mori.
For solving the problems of the technologies described above, the invention provides following technical proposals.
A kind of oral taking preparation of mulberry leaves with blood sugar reducing function is characterized in that it is made up of following materials based on weight:
Fine-powdered extract 1-100
Pharmaceutic adjuvant 0.1-80
Dried Folium Mori superfine powder 0.1-30.
Wherein, exsiccant clean Folium Mori are boiled through decocting, concentrate, high speed centrifugation, centrifugal liquid is by macroporous resin, with the ethanol elution of 35-80%, precipitate with ethanol, precipitation dehydration final vacuum drying, crushing screening or water-soluble spray drying obtain general flavone content and are no less than 18%, and polyoses content is no less than 15% Folium Mori fine-powdered extract.
Specifically prepare according to the following steps:
1. exsiccant clean Folium Mori boil 1-3 time through decocting, and each 2-3 hour, when the water extract is concentrated into proportion 1.2-1.4, high speed centrifugation;
2. centrifugal liquid or concentrate drying get total polysaccharides content and are no less than 15% the yellow or the crude extract of yellowish-brown;
3. macroporous resin through water elution, concentrates after the eluent decolouring, and with 35%-80% ethanol precipitate with ethanol, refrigerator is placed, and filters, and filter cake vacuum drying, crushing screening or spray drying obtain containing polysaccharides of Folium Mori and be not less than 40% white or off-white color fine-powdered extract I; Macroporous resin continues to use the Different concentrations of alcohol eluting, gets the extract II of general flavone content 18%-50%.
4. macroporous resin can be selected the AB-8 and the D101 type of low pole, or selects the highly acidic cation type as 001 * 4 preparation acidic polysaccharose.The Different concentrations of alcohol eluent can be the second alcohol and water (10%-70%) of different proportionings, makes up the extract II that can obtain different general flavone contents by the eluent of different proportionings or different receptions.
5. according to the needs of product, crude extract, extract I, II can be made up respectively, the raw material that makes the different efficacies component content uses for preparation.
Pharmaceutic adjuvant of the present invention is one or more a mixture of diluent, filler, disintegrating agent, lubricant, wetting agent, antioxidant, stabilizing agent, correctives.Conventional diluent, filler (as mannitol, lactose, Polyethylene Glycol) in the preparation for example, binding agent (starch, microcrystalline Cellulose), disintegrating agent (as carboxymethyl cellulose, the low hydroxypropyl cellulose that replaces), lubricant (as Pulvis Talci, magnesium stearate), wetting agent (as propylene glycol, ethanol), antioxidant (as sodium pyrosulfite, sodium thiosulfate), antiseptic (benzyl alcohol); Stabilizing agent (EDTA-2Na, sodium thiosulfate, sodium pyrosulfite, sodium sulfite, ethanolamine, sodium bicarbonate, nicotiamide) or the like.Above-mentioned adjuvant can be a common dose, mix with the fine-powdered extract that with the polysaccharides of Folium Mori is active component with proportioning commonly used, after the fine-powdered extract consumption that with the polysaccharides of Folium Mori is active component was determined, the proportioning between each pharmaceutic adjuvant can suitably be regulated as required.
The present invention has the preparation method of the chewing tablets made of folium mori of blood sugar reducing function, it is characterized in that through following steps:
(1) fine-powdered extract, the pharmaceutic adjuvant that will contain polysaccharides of Folium Mori all pulverized 100 mesh sieves, and mixing makes the Folium Mori granule according to a certain ratio; For example take by weighing and contain 10-70% polysaccharides of Folium Mori fine-powdered extract by the configuration total amount, the filler of adding 30-90%, binding agent, disintegrating agent, lubricant, correctives etc., fully mix and make granule, compacting in 60-70 ℃ of dry 2-4 hour in flakes, make every fine-powdered extract 40-240mg that contains polysaccharides of Folium Mori; Maybe with the wet granular made directly at 60-70 ℃ of dry 2-4 hour.
(2) dried leaves adds outward in the Folium Mori granule after 200 order micronizing, purpose be make press the chewable tablet color and luster pure and fresh, be rich in grass fragrance during chewing; Simultaneously owing to increased fibre composition, make the effect that chewable tablet has had increases gastrointestinal peristalsis, lubricated relieving constipation.
The preferable chewing tablets made of folium mori main components in percentage by weight of the present invention is: fine-powdered extract 1-50 part, dextrin, starch or carboxymethyl starch 2-50 part, mountain plough alcohol or mannitol 1-10 part, citric acid or Palmic acid 0.1-2 part, hydroxypropyl methylcellulose 10-20 part, magnesium stearate 0.1-5 part, dried Folium Mori superfine powder 0.1-20 part.
The measuring method of chewing tablets made of folium mori of the present invention is characterized in that: before (1) carries out determination of polysaccharide, at first will carry out pre-treatment to chewable tablet, extract polysaccharide component in raw material and the superfine powder; When (2) detecting polyoses content, temperature of reaction system is 40 ℃, carries out in the water-bath.The major technique feature is as follows: before the determination of polysaccharide, earlier with qualified chewable tablet porphyrize, 0.5g decided in quantitatively accurate title, add 100ml water backflow 1hr, put coldly, claim to decide weight and water again and supply and subtract weight loss, shake up, filter, precision is measured subsequent filtrate 10.0ml, puts to add water in the 25ml volumetric flask and put scale; When polyoses content detects in addition, quantitatively add medicinal liquid in tool plug test tube, the reaction of phenolsulfuric acid method makes system place 40 ℃ of water-bath half an hour.Take out after 5 minutes, ultraviolet-spectrophotometry polysaccharides of Folium Mori content, every polysaccharides of Folium Mori content is no less than 0.15 gram.
Polysaccharides of Folium Mori the invention has the beneficial effects as follows: owing to can promote the B cell excreting insulin, and the Folium Mori cost is low, the source abundant, therefore, with Folium Mori is that the blood sugar lowering chewable tablet is made in the raw material extraction, avoided diabetic owing to taking the side effect that Western medicine produces for a long time, chewable tablet makes patient's medication convenient simultaneously, has improved patient's compliance, and patient is easy to accept.Going out, more embodying its advantage place under the situation such as tourism especially.Adopt polysaccharides of Folium Mori Determination on content method of the present invention simultaneously, when the polysaccharide of reaction condition and bibliographical information detects 100 ℃ commonly used, 7min compares, and reaction is control, milder easily, makes the collimation of measurement result, repeatability more stable.
The specific embodiment
The present invention is described further below in conjunction with embodiment, and embodiment only means never that for indicative it limits protection scope of the present invention by any way.
Embodiment 1
(1) exsiccant clean Folium Mori 700 grams, water 8000ml (being as the criterion to soak into Folium Mori) decocted 2 hours, and two fry in shallow oil water 5000ml, and 2 hours, three fried in shallow oil water 5000ml, 2 hours, were concentrated into proportion 1.25, high speed centrifugation;
(2) centrifuged supernatant is by macroporous resin such as AB-8 type resin, and water is eluted to no polysaccharide component, and eluent concentrates, and does 65% precipitate with ethanol, and refrigerator is placed 4hrs, filters the filter cake absolute ethanol washing; The fine-powdered extract 110 that vacuum drying, crushing screening or spray drying obtain yellow or yellowish-brown restrains standby.
(3) dry clean Folium Mori 100 grams, after 200 order micronizing, it is standby to get full powder 60 grams of Folium Mori.
Embodiment 2
Fine-powdered Folium Mori extract 110 grams, sorbitol 100 grams, citric acid 40 grams, aspartame 5 grams, starch 350 grams, dextrin 80 grams, Folium Mori superfine powder 60 grams, magnesium stearate 10 grams are made 220.
Embodiment 3
Fine-powdered Folium Mori extract 10 grams, sorbitol 18 grams, citric acid 0.9 gram, aspartame 0.5 gram, starch 57.6 grams, dextrin 14.4 grams, Folium Mori superfine powder 7.2 grams, magnesium stearate 1.5 grams are made 20.
Embodiment 4
Fine-powdered Folium Mori extract 50 grams, sorbitol 120 grams, citric acid 2.5 grams, aspartame 2.5 grams, starch 150 grams, dextrin 58 grams, Folium Mori superfine powder 26 grams, magnesium stearate 20 grams are made 100.
The preparation method of embodiment 2-4:
(1) with the fine-powdered Folium Mori extract, sorbitol, citric acid, aspartame mix homogeneously;
(2) with starch, dextrin, Folium Mori superfine powder mix homogeneously.
(3) (1), (2) are mixed and made into soft material, granulate with 20 mesh sieves, 60 ℃ of dryings, granulate adds the magnesium stearate mixing.
(4) dried Folium Mori are added on outward in the granule, mixing, tabletting.Making sheet heavily is the chewable tablet of 1 gram.
(5) check: check tablet molding and compact structure situation, and do polysaccharides of Folium Mori assay in inspection of microorganism part and the chewable tablet.
(6) packing warehouse-in: the product through being up to the standards can be packed warehouse-in.
The content assaying method of embodiment 5 Folium Mori chewable tablets:
Contain 180 milligrams of polysaccharide in every chewing tablets made of folium mori of ultraviolet-spectrophotometry.
BIO-TEK ultraviolet-visible spectrophotometer (U.S.).
D-anhydrous glucose Nat'l Pharmaceutical ﹠ Biological Products Control Institute lot number: 110833-200302.
The preparation of reference substance solution:
The anhydrous glucose 60mg that precision takes by weighing 105 ℃ of constant weights puts in the measuring bottle of 100ml, is dissolved in water and is diluted to scale, shakes up, promptly.(containing anhydrous glucose 0.6mg among every 1ml).
The preparation of standard curve:
Precision is measured reference substance solution 0.0ml, 1.0ml, 2.0ml, 2.5ml, 3.0ml, 4.0ml and is put respectively in the 50ml measuring bottle, adds water to scale, shakes up.Precision is measured above-mentioned each solution 2.0ml, puts in the tool plug test tube, adds 4% phenol solution 1.0ml respectively, mixing.Add rapidly sulphuric acid 7.0ml and shake up, insulation is 30 minutes in 40 ℃ of water-baths, takes out, and puts in the ice-water bath 5 minutes, take out, with first part be blank, according to spectrophotography (appendix VB), in 490nm wavelength place mensuration trap, with the trap is vertical coordinate, and concentration is abscissa, the drawing standard curve.
Content assaying method:
Get under the tablet weight variation item 10 of this product, porphyrize is got about 0.5g, accurately claims surely, adds water 100ml.Claim decide weight, backflow 1h is put coldly, claims to decide weight again, and water is supplied and subtracted weight loss, shake up, and filtration, precision is measured subsequent filtrate 10.0ml, puts in the 25ml measuring bottle and adds water to scale, shakes up.Precision is measured 2.0ml, puts in the 25ml measuring bottle, adds water to scale and shakes up as sample solution; Other gets the adjuvant that is equivalent to 0.5g sheet powder and handles with method.Precision is measured sample solution and each 2.0ml of adjuvant solution, and the method under the sighting target directrix curve preparation is put in the tool plug test tube, adds 4% phenol solution 1.0ml respectively, mixing.Adding sulphuric acid 7.0ml rapidly shakes up, insulation is 30 minutes in 40 ℃ of water-baths, take out, put in the ice-water bath 5 minutes, taking out, is blank with the adjuvant, measures absorbance according to spectrophotography (appendix VB) at the wavelength place of 490nm, from standard curve, calculate the polysaccharide concentration of sample solution, and calculate the weight (mg) and the percentage composition (%) of polysaccharides of Folium Mori according to extension rate and sample weighting amount.This product is calculated by dry product and is contained polysaccharides of Folium Mori with glucose (C 6H 12O 6) meter, must not be less than 15%.

Claims (9)

1, a kind of oral taking preparation of mulberry leaves with blood sugar reducing function is characterized in that it is made up of following materials based on weight:
Fine-powdered extract 1-100;
Pharmaceutic adjuvant 0.1-80;
Dried Folium Mori superfine powder 0.1-30.
2, oral formulations as claimed in claim 1, wherein the fine-powdered extract is meant: exsiccant clean Folium Mori are boiled through decocting, concentrate, high speed centrifugation, centrifugal liquid is by resin, with the ethanol elution of 35-80%, precipitate with ethanol, precipitation dehydration final vacuum drying, crushing screening or water-soluble spray drying obtain general flavone content and are no less than 18%, and polyoses content is no less than 15% Folium Mori fine-powdered extract.
3, oral formulations as claimed in claim 2, wherein, resin is macroporous resin, gel resin, ion exchange resin.
4, oral formulations as claimed in claim 1, wherein pharmaceutic adjuvant is one or more a mixture of diluent, filler, disintegrating agent, lubricant, wetting agent, antioxidant, stabilizing agent.
5, oral formulations as claimed in claim 1, wherein, oral formulations is tablet, capsule, drop pill, dispersible tablet, buccal tablet, electuary, granule, chewable tablet, pill.
6, oral formulations as claimed in claim 5, wherein, oral formulations is a chewing tablets made of folium mori.
7, oral formulations as claimed in claim 6, wherein, the chewable tablet main components in percentage by weight is: fine-powdered extract 1-50 part, dextrin, starch or carboxymethyl starch 2-50 part, sorbitol or mannitol 1-10 part, citric acid or Palmic acid 0.1-2 part, hydroxypropyl methylcellulose, 10-20 part, aspartame 2-15 part, magnesium stearate 0.1-5 part, dried Folium Mori superfine powder 0.1-20 part.
8, a kind of preparation method with chewing tablets made of folium mori of blood sugar reducing function is characterized in that through following steps:
(1) fine-powdered extract, the pharmaceutic adjuvant that will contain polysaccharides of Folium Mori all pulverized 100 mesh sieves, and mixing makes the Folium Mori granule according to a certain ratio;
(2) dried Folium Mori are sprayed in the Folium Mori granule after 200 order micronizing according to a certain percentage, and tabletting forms.
9, a kind of assay method with chewing tablets made of folium mori of blood sugar reducing function is characterized in that:
(1) earlier with the chewable tablet porphyrize, extract polysaccharide component in raw material and the superfine powder, 0.5g decided in quantitatively accurate title, adds 100ml water, backflow 1hr is put coldly, claims to decide weight and water again and supplies and subtract weight loss, shakes up, filters, precision is measured subsequent filtrate 10.0ml, puts in the 25ml volumetric flask, adds water and puts scale;
(2) in tool plug test tube, quantitatively add the phenolsulfuric acid medicinal liquid, make system place 40 ℃ of water-bath half an hour, take out after 5 minutes, ultraviolet-spectrophotometry calculates by dry product and to contain polysaccharides of Folium Mori with glucose (C 6H 12O 6) meter, must not be less than 15%.
CN 200510014597 2005-07-25 2005-07-25 Oral taking preparation of mulberry leaves possessing function for lowering blood sugar, and detection method Pending CN1726963A (en)

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101002617B (en) * 2006-07-26 2011-04-06 王铁岩 Chewing tablets made of mulberry leaf, and its production process
CN102356836A (en) * 2011-09-14 2012-02-22 上海交通大学 Perilla frutescens nutritional healthcare chewable tablet and preparation method thereof
CN103583951A (en) * 2013-11-15 2014-02-19 郑州轻工业学院 Ramulus mori flavone buccal tablet and preparation method thereof
CN103652089A (en) * 2013-12-10 2014-03-26 华中农业大学 Tea polysaccharide lozenge and preparation method thereof
CN103783507A (en) * 2013-12-12 2014-05-14 西南大学 Preparation method of mulberry leaf health orally-taken lozenges
CN104770637A (en) * 2015-03-18 2015-07-15 四川省农业科学院经济作物育种栽培研究所 Chuanminshen violaceum polysaccharide chewing tablet and preparation method thereof
CN104886317A (en) * 2015-06-17 2015-09-09 山东棉花研究中心 Preparation method of chewable tablets containing mulberry leaf tea
CN112931859A (en) * 2021-03-08 2021-06-11 安庆麦宝瑞生物科技有限公司 Preparation method of mulberry leaf and black tea hypoglycemic tablets

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101002617B (en) * 2006-07-26 2011-04-06 王铁岩 Chewing tablets made of mulberry leaf, and its production process
CN102356836A (en) * 2011-09-14 2012-02-22 上海交通大学 Perilla frutescens nutritional healthcare chewable tablet and preparation method thereof
CN102356836B (en) * 2011-09-14 2013-01-16 上海交通大学 Perilla frutescens nutritional healthcare chewable tablet and preparation method thereof
CN103583951A (en) * 2013-11-15 2014-02-19 郑州轻工业学院 Ramulus mori flavone buccal tablet and preparation method thereof
CN103583951B (en) * 2013-11-15 2015-03-11 郑州轻工业学院 Ramulus mori flavone buccal tablet and preparation method thereof
CN103652089A (en) * 2013-12-10 2014-03-26 华中农业大学 Tea polysaccharide lozenge and preparation method thereof
CN103652089B (en) * 2013-12-10 2015-06-03 华中农业大学 Tea polysaccharide lozenge and preparation method thereof
CN103783507A (en) * 2013-12-12 2014-05-14 西南大学 Preparation method of mulberry leaf health orally-taken lozenges
CN104770637A (en) * 2015-03-18 2015-07-15 四川省农业科学院经济作物育种栽培研究所 Chuanminshen violaceum polysaccharide chewing tablet and preparation method thereof
CN104886317A (en) * 2015-06-17 2015-09-09 山东棉花研究中心 Preparation method of chewable tablets containing mulberry leaf tea
CN112931859A (en) * 2021-03-08 2021-06-11 安庆麦宝瑞生物科技有限公司 Preparation method of mulberry leaf and black tea hypoglycemic tablets

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