CN107569608B - Pharmaceutical composition for reducing blood sugar - Google Patents
Pharmaceutical composition for reducing blood sugar Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/898—Orchidaceae (Orchid family)
- A61K36/8984—Dendrobium
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/42—Cucurbitaceae (Cucumber family)
- A61K36/424—Gynostemma
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
The application discloses a pharmaceutical composition for reducing blood sugar, which comprises the effective pharmaceutical ingredients of gynostemma total saponin and dendrobium nobile submicron powder. The weight ratio of the gypenosides in the effective medicinal components to the dendrobium nobile submicron powder is 0.5-10, and the gypenoside and the dendrobium nobile submicron powder can form an oral medicinal preparation or a functional health-care product together with acceptable auxiliary components in pharmacy or food. The medicinal composition has simple components and concentrated effective components, and has obvious effects and effects of preventing and treating diabetes and particularly reducing blood sugar through early-stage experimental verification.
Description
Technical Field
The invention relates to the field of medicine preparation, in particular to a medicine composition for reducing blood sugar, and more particularly relates to a gynostemma total saponin and dendrobium stem superfine powder composition.
Background
Diabetes is a frequent and common chronic metabolic disease, is caused by insulin secretion deficiency or damaged biological action, blood sugar is the only standard for diagnosing diabetes, and clinically, the blood sugar value of a fasting blood sugar is greater than or equal to 7.0mmol/L, and the blood sugar value of two hours after a meal is greater than or equal to 11.1 mmol/L, so that the diabetes can be diagnosed. The hyperglycemia existing in the body for a long time in the diabetes can cause chronic damage and dysfunction of various tissues of the human body, particularly eyes, kidneys, hearts, blood vessels and nerves, and seriously endanger the health of human beings. The research and development of hypoglycemic drugs with good drug effect and high safety are always hot spots of clinical research and drug basic research.
Gynostemma pentaphylla (Gynostemma pentaphylum (Thunb.) Makino) also called herba Gynostemmatis, herba Adenophorae, radix Hemsleyae Macrospermae, etc., is a plant of Gynostemma of Cucurbitaceae of dicotyledonous class. Pharmacological experimental research shows that the gynostemma pentaphylla has good effects of reducing blood sugar and blood fat, resisting tumors and aging, improving immunity and the like. The gypenosides are important medicinal active ingredients in Gynostemma pentaphyllum, and more than 80 gypenosides have the same class III, IV, VIII and VII structures as ginsenoside-Rb 1, Rb3, Rd and F2, and have higher content. Compared with the whole plant of gynostemma pentaphylla, the total saponin of gynostemma pentaphylla has more concentrated and obvious effects of resisting hyperlipidemia and hyperglycemia, improving immunity and the like.
Dendrobium nobile (Dendrobium nobile Lindl), also called herba Hedyotidis Diffusae and radix et rhizoma Rhei Lespedezae Bicoloris, is a monocotyledonous plant belonging to the genus Dendrobium of the family Orchidaceae, is a Chinese traditional and precious Chinese medicine, and has effects of enhancing immunity, nourishing yin, replenishing vital essence, promoting fluid production, invigorating stomach, regulating blood lipid, reducing blood sugar, etc. The main medicinal active ingredients of the dendrobium nobile are dendrobine, dendron polysaccharide and the like. The dendrobium nobile lindl superfine powder takes freeze-dried stems as raw materials, and is obtained by crushing and sieving, compared with dried stems such as dendrobium nobile lindl and other products, the dendrobium nobile lindl superfine powder has high efficacy, fast release speed of active ingredients of the medicine and short onset time.
The two components have insignificant curative effect when being used as hypoglycemic drugs independently, and the prior art has no report that the two components are mixed together to be used as hypoglycemic drug combination.
Disclosure of Invention
The invention aims to research a hypoglycemic drug composition, solve the problem that a single medicinal plant has no remarkable curative effect, and provide a simple, safe and effective drug composition which can be prepared into drugs of different formulations or functional health products with corresponding medicinal effects by matching with auxiliary materials which can be used in medicines or foods.
The invention relates to a pharmaceutical composition for reducing blood sugar, which comprises the effective pharmaceutical ingredients of gynostemma total saponin and dendrobium nobile submicron powder.
Further, the weight ratio of the gypenosides in the effective medicinal components to the dendrobium nobile submicron powder is 0.5-10.
Further, the weight ratio of the gypenosides in the effective medicinal components to the dendrobium nobile submicron powder is 0.5-1.
Further, the weight ratio of the gypenosides in the effective medicinal components to the dendrobium nobile ultrafine powder is 1: 0.4.
the invention has the beneficial effects that: the gynostemma pentaphylla and dendrobium nobile have the function of reducing blood sugar, and the total saponin of the gynostemma pentaphylla, which is an effective blood sugar reducing medicinal component in the gynostemma pentaphylla, is extracted, so that the effect is more concentrated, the dosage is less, and the dendrobium nobile is safer. The dendrobium nobile lindl has more remarkable effect of synergistically reducing the blood sugar when being matched with dendrobium nobile lindl with the same blood sugar reducing effect. The dendrobium nobile lindl adopts a superfine powder form, so that the inherent color, smell and nutrient components of the dendrobium nobile lindl are retained, the dendrobium nobile lindl is dehydrated thoroughly, and the product shelf life is longer. The superfine powder has short action time, quick release of effective components and convenient administration. Meanwhile, animal experiments prove that the dendrobium stem superfine powder composition containing the gypenosides can obviously reduce the postprandial blood glucose value and has the characteristics of safety and no toxicity. Therefore, the pharmaceutical composition prepared by the invention can effectively reduce the postprandial blood sugar level.
Furthermore, the gypenosides in the effective medicinal components are whole plant extracts of natural medicinal plants of gynostemma pentaphyllum, wherein the content of the gypenoside is more than 95%. The gypenoside is an important medicinal active ingredient in gynostemma pentaphylla, and the structure of gypenoside in more than 80 gypenoside types is the same as that of ginsenoside-Rb 1, Rb3, Rd and F2, and the content of gypenoside is higher. The Gynostemma pentaphyllum extract can exert ginseng-like effects without ginseng-like side effects, and is superior and inexpensive compared with expensive ginseng. Compared with the whole plant of gynostemma pentaphylla, the total saponins of gynostemma pentaphylla have more obvious effects on treating hyperlipidemia and hyperglycemia, improving immunity and the like. In addition, the gynostemma pentaphylla extract can be replaced by a method reported in documents or patents, such as a method for extracting gypenoside from gynostemma pentaphylla reported in Chinese patent CN105456332A and a method for preparing the gypenoside reported in CN 103923150A.
Furthermore, the dendrobium nobile lindl ultra-fine powder in the effective medicine components is derived from vacuum freeze-dried stems of dendrobium nobile lindl which is a natural medicinal plant, and the dendrobium nobile lindl ultra-fine powder is obtained by sieving the dendrobium nobile lindl ultra-fine powder with a 300-mesh sieve after being crushed by an ultra-fine crusher. Compared with the dendrobium stem strips, the stem strips dried after vacuum freezing have the advantages of small loss of effective components, high efficacy of the ultrafine powder, high release speed of active ingredients of the medicine and short onset time in the drying process.
The application of the pharmaceutical composition for reducing blood sugar comprises that the pharmaceutical composition and auxiliary components acceptable in pharmacy or food form an oral pharmaceutical preparation or a functional health-care product. The pharmaceutical composition comprising the gypenosides and the dendrobium nobile ultrafine powder can be prepared into oral medicines of different dosage forms or oral functional health products with corresponding medicinal effects, such as powder, granules, tablets, capsules, pellets and the like, by being matched with auxiliary materials which can be used in medicines or foods. Wherein, the pharmaceutical or food auxiliary materials acceptable for oral preparations or health care products comprise flavoring agents, disintegrating agents, lubricating agents, binding agents, filling agents and the like.
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FIG. 1 is a comparison graph of the effect of herba Gynostemmatis total saponin Dendrobium nobile Lindl superfine powder pharmaceutical composition on drinking water and food intake of mice caused by alloxan and blank group,* p＜0.05, ** p＜0.01, *** p< 0.001, data results are expressed as mean ± sem.
Detailed Description
The present invention will be described in further detail below by way of specific embodiments:
example 1: a pharmaceutical composition for reducing blood sugar comprises the following steps
Step one, preparing dendrobium nobile submicron powder: cleaning fresh dendrobium nobile stems (three-year-old stems), draining, slicing, pre-freezing for 12h at the thickness of-20 ℃ for about 1mm, then putting the fresh dendrobium nobile stems into a vacuum freeze dryer, vacuumizing to 15-25 kPa, starting refrigeration, reducing the temperature of a cold trap of the vacuum freeze dryer to-40 ℃ to-65 ℃ within 2-4 h, keeping the temperature for 0.5-2 h, heating dendrobium nobile to 0-15 ℃ within 9-30 h, drying the dendrobium nobile, putting the dried dendrobium nobile into a superfine pulverizer, and sieving with a 300-mesh sieve after the pulverization is finished to obtain the dendrobium nobile superfine powder.
Step two, preparation of the pharmaceutical composition: taking 1g of commercially available herba Gynostemmatis total saponin (content is 98%), grinding, sieving with 80 mesh sieve, and mixing with 2g of the above herba Dendrobii micropowder to obtain the pharmaceutical composition.
Example 2 differs from example 1 only in that: mixing herba Gynostemmatis total saponin 1g and herba Dendrobii micropowder 1 g.
Example 3 differs from example 1 only in that: mixing herba Gynostemmatis total saponin 1g and herba Dendrobii micropowder 0.4 g.
Blood sugar lowering function test
Preparation of pharmaceutical composition: sodium carboxymethylcellulose (CMC-Na) (1 g) was dissolved in distilled water to prepare a 0.1% CMC-Na aqueous solution. Preparing 25mg/mL CMC-Na suspension from the gypenosides, and preparing 42mg/mL, 83mg/mL and 250mg/mL CMC-Na suspension from the dendrobium nobile ultrafine powder. And finally, according to the total saponins of the gynostemma pentaphylla: and (3) mixing the suspension according to the volume ratio of the dendrobium nobile submicron powder =9:1 to obtain a Low (LG), Medium (MG) and High (HG) group medicine mixture. Taking rosiglitazone to prepare CMC-Na suspension of 0.12mg/mL to obtain a positive control drug (RL).
Animal experiments: 150 mice 18-20 g C57BL/6J are purchased, and after adaptive feeding for one week, the weight and the fasting blood glucose value of the mice are determined and are randomly divided into 15 groups and 10 mice/group. Group 1 was fed normally as a blank control group (BC); 1 group was sham operated (FP), and was fed normally after intraperitoneal injection of physiological saline (0.01 mL/g); group 1 served as high-dose drug control group (HG), gavage with high-dose drug, gypenosides (25 mg/mL): dendrobium nobile ultrafine powder (250 mg/mL) =9:1, 1 d/time, and common feed is always given. Injecting alloxan into abdominal cavity of other 12 groups of mice at 150mg/kg dose, and determining fasting blood glucose value after 7 days, wherein the mice with blood glucose value greater than 10mmol/L are model animals, and the model animals are always fed with common feed. 70 of the model mice are selected and divided into 7 groups and 10 mice per group according to the blood sugar value, and the average blood sugar value of each group is close to that of the other group. A blank control group (BC), a sham operation group (FP), and a high-dose drug control group (HG) were added to 10 groups. Respectively as follows: blank control group (BC), sham operation group (FP), high dose drug control group (HG), model group (MC): diabetic mice were gavaged daily with 0.1% CMC-Na aqueous solution 0.2mL/d, low dose drug group (MC + LG): daily gavage of diabetic mice with a mixture of drugs, gypenosides (25 mg/mL): dendrobium stem superfine powder (42 MG/mL) =9:1, medium-dose medicine group (MC + MG): daily gavage of diabetic mice with a mixture of drugs, gypenosides (25 mg/mL): dendrobium stem superfine powder (83 mg/mL) =9:1, high-dose medicine group (MC + HG): daily gavage of diabetic mice with a mixture of drugs, gypenosides (25 mg/mL): dendrobium nobile super fine powder (250 mg/mL) =9:1, gypenoside group (Gy): intragastric administration of gypenoside (25 mg/mL) and dendrobium nobile (Den) group (Den) to diabetic mice every day: the diabetic mice are fed with the dendrobium nobile ultrafine powder (250 mg/mL) and the positive drug group (MC + RL) every day: diabetic mice were gavaged daily with 0.12mg/mL rosiglitazone. The administration is performed 1 time per day, the intragastric administration dosage is 0.01mL/g, and the intragastric administration is continuously performed for 30 days. The fasting blood glucose, body weight, drinking water and food consumption of the mice were measured, and the results are shown in the following tables 1 and 2, and fig. 1.
TABLE 1 Effect of herba Dendrobii total saponin micropowder pharmaceutical composition on mouse diabetes model induced by alloxan
In comparison with the blank set, the results,* p＜0.05, ** p＜0.01, *** pless than 0.001, compared to the model group,# p＜0.05, ## p< 0.01, data results are expressed as mean ± sem.
The results in table 1 show that after 7 days of alloxan injection, the blood sugar value of the model group mice is significantly increased compared with that of the blank group, and after 30 days, the blood sugar value is greater than 10mmol/L, which indicates that the diabetes model is successfully established and the model is stable. After the administration by gastric lavage, compared with a model group, the blood sugar values of the gynostemma total saponin group, the dendrobium stem superfine powder group, the pharmaceutical composition group and the positive pharmaceutical group are obviously reduced, wherein the gynostemma total saponin group, the dendrobium stem superfine powder group, the medium and high doses and the positive pharmaceutical group have statistical differences, the effect of the administration for 30 days is better than that of the administration for 15 days, the blood sugar reducing effect of the pharmaceutical composition is better than that of the single gynostemma total saponin group or the dendrobium stem superfine powder group, the blood sugar reducing effect of the single gynostemma total saponin group is equivalent to that of the dendrobium stem superfine powder group, and the blood sugar reducing effect of the medium dose group pharmaceutical composition is better than that of rosiglitazone. The blood glucose value of the high-dose drug control group is reduced, but compared with the blank group, the blood glucose value is not significantly different. The above experimental results demonstrate that: the gynostemma total saponin dendrobium stem superfine powder medicine composition has a remarkable effect of reducing blood sugar value increase of mice caused by alloxan, and has a better effect compared with a single gynostemma total saponin or a single dendrobium stem superfine powder. The medicinal composition has no significant influence on the blood sugar of a normal mouse, and has high safety.
Table 2. influence of herba Gynostemmatis total saponin dendrobium nobile submicron powder pharmaceutical composition on mouse body weight caused by alloxan
In comparison with the blank set, the results,* p＜0.05, ** p＜0.01, *** p< 0.001, data results are expressed as mean ± sem.
The results in table 2 show that after 7 days of alloxan injection, the body weight of the mice in the model group was significantly reduced compared to the blank group, indicating that the body weight results are consistent with the "weight reduction" description of the diabetic model, and that after 30 days, the body weight of the model group was still reduced compared to the blank group, and was statistically different, indicating that the hyperglycemic model was stable. The weight of the administered group is increased, which shows that the rosiglitazone, the pharmaceutical composition, the gypenosides and the dendrobium nobile ultrafine powder can relieve the weight reduction caused by hyperglycemia, and the pharmaceutical composition with the medium dosage has the best effect and has the same effect with the previous blood sugar effect. The weight of the mice in the high-dose drug control group is increased, but compared with the blank group, the high-dose drug control group has no significant difference, which indicates that the drug per se has no significant influence on the weight of the mice and the drug safety is higher.
The results in fig. 1 show that after 7 days of alloxan injection, the drinking amount of the mice in the model group is obviously increased, which indicates that the mice conform to the description of "polydipsia and polyphagia" of the diabetes model, and the diabetic mice are successfully modeled. Compared with the normal group, the high-dose drug group has no significant influence on the water intake and the food intake of the mice, which indicates that the high-dose drug has higher safety and does not stimulate the normal gastrointestinal tract function of the mice.
The foregoing is merely an example of the present invention, and common general knowledge in the field of known specific structures and characteristics is not described herein in any greater extent than that known in the art at the filing date or prior to the priority date of the application, so that those skilled in the art can now appreciate that all of the above-described techniques in this field and have the ability to apply routine experimentation before this date can be combined with one or more of the present teachings to complete and implement the present invention, and that certain typical known structures or known methods do not pose any impediments to the implementation of the present invention by those skilled in the art. It should be noted that, for those skilled in the art, without departing from the structure of the present invention, several changes and modifications can be made, which should also be regarded as the protection scope of the present invention, and these will not affect the effect of the implementation of the present invention and the practicability of the patent. The scope of the claims of the present application shall be determined by the contents of the claims, and the description of the embodiments and the like in the specification shall be used to explain the contents of the claims.
Claims (4)
1. The medicinal composition for reducing blood sugar is characterized in that the effective medicinal components of the medicinal composition are total gypenosides and dendrobium nobile submicron powder, and the weight ratio of the total gypenosides to the dendrobium nobile submicron powder is 1: 0.4, wherein the content of saponin in the gynostemma pentaphylla total saponin is more than 95%.
2. The pharmaceutical composition for lowering blood glucose according to claim 1, wherein: the gypenoside in the effective medicinal components is a whole plant extract of a natural medicinal plant, namely, gynostemma pentaphylla.
3. The pharmaceutical composition for lowering blood glucose according to claim 1, wherein: the dendrobium nobile lindl superfine powder in the effective medicine components is derived from vacuum freeze-dried stems of dendrobium nobile lindl which is a natural medicinal plant, and the dendrobium nobile lindl superfine powder is obtained by sieving the dendrobium nobile lindl superfine powder with a 300-mesh sieve after being crushed by a superfine pulverizer.
4. The pharmaceutical composition for lowering blood sugar according to claim 1, wherein the pharmaceutical composition and pharmaceutically or food acceptable auxiliary components together form an oral pharmaceutical preparation or a functional health product.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1586507A (en) * | 2004-07-12 | 2005-03-02 | 浙江省中药研究所 | Officinal Dendrobium stem capsule and preparing method |
| CN102987022A (en) * | 2012-12-03 | 2013-03-27 | 湖北民族学院 | Method for processing dendrobium candidum gynostemma pentaphyllum zhulan scented tea |
| CN105029408A (en) * | 2015-06-12 | 2015-11-11 | 浙江仙人草保健品有限公司 | Dendrobium officinale and gynostemma pentaphylla capsule and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1586507A (en) * | 2004-07-12 | 2005-03-02 | 浙江省中药研究所 | Officinal Dendrobium stem capsule and preparing method |
| CN102987022A (en) * | 2012-12-03 | 2013-03-27 | 湖北民族学院 | Method for processing dendrobium candidum gynostemma pentaphyllum zhulan scented tea |
| CN105029408A (en) * | 2015-06-12 | 2015-11-11 | 浙江仙人草保健品有限公司 | Dendrobium officinale and gynostemma pentaphylla capsule and preparation method thereof |
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| Title |
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| 绞股蓝皂甙对实验性糖尿病小鼠的降糖作用研究;林臻桢等;《龙岩学院学报》;20110731;第29卷;第51-53页，尤其是第53页左栏第2-3段 * |
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