CN103393937B - A kind of pharmaceutical composition and its production and use - Google Patents

A kind of pharmaceutical composition and its production and use Download PDF

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CN103393937B
CN103393937B CN201310362123.5A CN201310362123A CN103393937B CN 103393937 B CN103393937 B CN 103393937B CN 201310362123 A CN201310362123 A CN 201310362123A CN 103393937 B CN103393937 B CN 103393937B
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extract
parts
pharmaceutical composition
jade
schisandrae chinensis
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CN103393937A (en
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王振鑫
张寒
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SUZHOU YI-KANG HEALTH CARE PRODUCTS Co Ltd
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SUZHOU YI-KANG HEALTH CARE PRODUCTS Co Ltd
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Abstract

The invention discloses a kind of pharmaceutical composition and its production and use; Described pharmaceutical composition is made up of the raw medicinal material of following weight: jade prolong 10 ~ 30 parts, Bombyx Batryticatus 10 ~ 30 parts, Pupa bombycis 3 ~ 15 parts, the Radix Astragali 3 ~ 20 parts, the Rhizoma Anemarrhenae 4 ~ 20 parts, Herba Commelinae 3 ~ 15 parts, the Radix Paeoniae Alba 10 ~ 35 parts, Rhizoma Polygonati Odorati 10 ~ 35 parts, Fructus Schisandrae Chinensis 10 ~ 35 parts.This pharmaceutical composition prevention and therapy diabetes definite effect, to have no side effect, steady quality, taking convenience, and there is no strict consumption restriction, can long-term taking.

Description

A kind of pharmaceutical composition and its production and use
Technical field
The invention belongs to pharmaceutical preparations technology field, particularly a kind of pharmaceutical composition and its production and use.
Background technology
Diabetes are incretion metabolism diseases that in adult, the highest extent of injury of sickness rate is the most serious.Along with the raising of living standards of the people, the change of dietary structure and the minimizing of activity, sickness rate rises year by year, in recent years more in rejuvenation trend.Its clinical manifestation with polydipsia, polyuria, tired, become thin, its Clinical symptoms is that glucose in urine and blood glucose increase, the normal work of light then impact and study, heavy then carbohydrate metabolism disturbance, causes ketosis, acidosis, hydropenia, stupor cause the multiple organ damage complication such as the heart, brain, kidney, eye.Primary disease is apt to occur in the live high off the hog person be engaged in mental work above middle age, and the less mortality rate of age of onset is higher, and male is a little more than women.Motherland's medical science is just on the books in Plain Questions of Huangdi's Internal Classic, claims to say " quenching one's thirst ", and has penetrating discussion.There is no medicine and the method for radical cure diabetes at present, patient must take medicine all the life.
At present, Western medicine is controlling the curative effect having affirmative in blood sugar level, but there is no effective method in control diabetic complication.At improvement and relief of symptoms, improve the quality of life aspect of diabetics or hyperglycemia population, then have effect of its uniqueness with the natural drug of Chinese medicine traditional theory Cheng Fang.Therefore, for current hyperglycemia and onset diabetes rate is high and control particularity, find natural pharmaceutical resources, develop the medicine that control is with better function, act on more fully blood sugar lowering and raising body's immunity, to prevention and therapy diabetes, there is important social meaning.
At present, prove to truly have the natural resources of Chinese medicinal materials of hypoglycemic activity to have through modern medicine: Fructus Hippophae, Radix Ginseng, Radix Codonopsis, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Scrophulariae, Herba Epimedii, Rhizoma Polygonati, Rhizoma Dioscoreae, the Radix Rehmanniae, Radix Rehmanniae Preparata, Radix Ophiopogonis, the Rhizoma Anemarrhenae, pollen, Rhizoma Polygonati Odorati, Radix Polygoni Multiflori, Fructus Schisandrae Chinensis, Cortex Lycii, Herba Dendrobii, Fructus Mume, Radix Salviae Miltiorrhizae, Typhonium flagelliforme (Lodd.) Blume, Rhizoma Coptidis, Stigma Maydis, Rhizoma Alismatis, Rhizoma Atractylodis, Radix Puerariae, Fructus Lycii, Cortex Mori, Fructus Mori, Galla Chinensis, Cortex Phellodendri, Fructus Corni, Pupa bombycis, Bombyx Batryticatus etc.The patent medicine with hypoglycemic activity has YUQUAN WAN, LIUWEI DIHUANG WAN, diabetes pill etc.
The chemicals (Western medicine) of blood sugar lowering class is though there is obvious blood sugar reducing function, and its untoward reaction is comparatively large, is especially on record to the infringement of the hepatic and renal function of human body.Once end-of-dose failure probability is large.And liver function is worsening from the beginning of not having manifest symptom, when symptom is obvious, day after the fair.And the prevention to diabetic complication, there is no effective Western medicine and come out.
At present, prevent and treat diabetes with drug matching, improve symptom though have, the advantage that untoward reaction is few, but it is low to control diabetes effective percentage, patient still needs uninterrupted and or life-time service chemicals.And fixed matured product that is square, quantitative, that determine dosage form is few, existing approved product YUQUAN WAN, LIUWEI DIHUANG WAN etc., general for the clinical effectiveness in diabetes, diabetes pill effect is fair, but based on Western medicine in formula, once drug withdrawal is namely repeatedly.
Summary of the invention
Main purpose of the present invention is under differential diagnosis in tcm discusses the principle controlled, and in conjunction with traditional Chinese medical science tradition typing, screen 6 taste natural Chinese medicines, provide a kind of compositions for prevention and therapy diabetes, said composition curative effect is certain, has no side effect, safe and reliable.
Another object of the present invention is to provide the preparation method of aforementioned pharmaceutical compositions.
Another object of the present invention is to provide the purposes of aforementioned pharmaceutical compositions.
For solving above technical problem, the technical solution used in the present invention is as follows:
First aspect of the present invention, provides a kind of pharmaceutical composition, and it is that the raw medicinal material of following weight is made:
Jade prolong 10 ~ 30 parts, Bombyx Batryticatus (Bombyx Batryticatus or Bombyx Batryticatus) 10 ~ 30 parts, Pupa bombycis 3 ~ 15 parts, the Radix Astragali 3 ~ 20 parts, the Rhizoma Anemarrhenae 4 ~ 20 parts, Herba Commelinae 3 ~ 15 parts, the Radix Paeoniae Alba 10 ~ 35 parts, Rhizoma Polygonati Odorati 10 ~ 35 parts, Fructus Schisandrae Chinensis 10 ~ 35 parts.
As preferred version of the present invention, aforementioned pharmaceutical compositions is made up of the raw medicinal material of following weight: jade prolong 12 ~ 20 parts, Bombyx Batryticatus 12 ~ 20 parts, Pupa bombycis 5 ~ 10 parts, the Radix Astragali 5 ~ 10 parts, the Rhizoma Anemarrhenae 5 ~ 12 parts, Herba Commelinae 4 ~ 10 parts, the Radix Paeoniae Alba 12 ~ 18 parts, Rhizoma Polygonati Odorati 12 ~ 18 parts, Fructus Schisandrae Chinensis 12 ~ 18 parts.
Further preferably, above-mentioned raw materials medical material weight be preferably: jade prolong 13 parts, Bombyx Batryticatus 13 parts, Pupa bombycis 7 parts, the Radix Astragali 7 parts, the Rhizoma Anemarrhenae 8 parts, Herba Commelinae 7 parts, the Radix Paeoniae Alba 15 parts, Rhizoma Polygonati Odorati 15 parts, Fructus Schisandrae Chinensis 15 parts.
When making medicine, according to well known to a person skilled in the art medicament general knowledge, above-mentioned raw materials medical material can be carried out suitable pretreatment, then makes the medicine of the common formulations on various pharmaceutics, such as the medicine of tablet or the dosage form such as capsule or granule.
Second aspect of the present invention, provide the preparation method of aforementioned pharmaceutical compositions, the method comprises the steps:
(1) Bombyx Batryticatus of described proportioning consumption and Pupa bombycis are pulverized (low temperature or conventional pulverizing), sieve (such as 50 ~ 80 mesh sieves), the first fine powder I obtained;
(2) jade of described proportioning consumption prolongs, the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis extract respectively, or extract with various combination in these seven kinds of raw materials, thus obtain one or two or more extract, extract obtainedly optionally carry out concentrating, carry out drying and/or pulverizing (such as spraying dry, or dry and pulverizing) again; With
(3) extract that the first fine powder I step (1) obtained and step (2) obtain mixes, and obtains pharmaceutical composition.
The described method preparing aforementioned pharmaceutical compositions can also be comprise the following steps:
(1) Bombyx Batryticatus of described proportioning consumption and Pupa bombycis are pulverized, the jade of described proportioning consumption is prolonged, the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, in Fructus Schisandrae Chinensis simply or a small amount of by described proportioning consumption of a few taste, such as 5 ~ 20 % by weight pulverize, mix after sieving after mixing again or sieving, or both are pulverized together and are then sieved, thus the first fine powder I obtained;
(2) jade of described proportioning consumption is prolonged, the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, residue in Fructus Schisandrae Chinensis do not pulverize part and extract respectively, or extract with various combination in these seven kinds of raw materials, thus obtaining one or two or more extract, extract obtained optionally carrying out concentrates, carries out drying and/or pulverizing again; With
(3) extract that the first fine powder I step (1) obtained and step (2) obtain mixes, and obtains pharmaceutical composition.
Wherein, the pharmaceutical composition obtained is in interpolation or be conventionally made into various dosage form when not adding adjuvant, the medicine of the forms such as such as granule, powder, tablet, pill, capsule, mixture, drop pill or medicament or preparation.
The present invention also provides a kind of preparation method of aforementioned pharmaceutical compositions, and the method comprises the steps:
(1) Bombyx Batryticatus of formula consumption is added appropriate Drinking Water or other meet pharmaceutical manufacturing require water, extract by vacuum and low temperature mode, temperature≤60 DEG C, obtain extracting solution I;
(2) jade of described proportioning consumption prolongs, the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis extract respectively, or extract with various combination in these seven kinds of raw materials, thus obtain one or two or more extract; With
(3) extract that the extracting solution I step (1) obtained and step (2) obtain mixes, and obtains pharmaceutical composition.
The pharmaceutical composition obtained is when adding or be conventionally made into the medicine of the form such as oral liquid, drop pill or medicament or preparation when not adding adjuvant.
Wherein, the extract obtained in said method step (2) can be extracting solution, can be maybe that extracting solution optionally carries out concentrating, carries out the extract powder that drying and/or pulverizing (such as spraying dry, or dry and pulverizing) obtain again.
Preferably, further for the extracting solution I obtained in step (1) drying (such as lyophilization or spraying dry or alternate manner) is obtained dried powder.Namely the method comprises the following steps:
(1) Bombyx Batryticatus of formula consumption is added appropriate Drinking Water or other meet pharmaceutical manufacturing require water, extract by vacuum and low temperature mode, temperature≤60 DEG C, obtain extracting solution I; Extracting solution I is obtained dried powder through lyophilization or spraying dry further;
(2) jade of described proportioning consumption prolongs, the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis extract respectively, or extract with various combination in these seven kinds of raw materials, thus obtain one or two or more extract; With
(3) extract that dried powder step (1) obtained and step (2) obtain mixes, and obtains pharmaceutical composition.
Wherein, in above pharmaceutical composition preparation method, " extraction " described in step (2) preferably water extraction is extracted or water alcohol method extraction.Preferably, water alcohol method extracts is ethanol extraction decoction liquor; Preferably, water extraction extracts is decoct to extract.
" ethanol " described here refers to the ethanol water of straight alcohol (ethanol of purity >98wt% to 100wt%) or any concentration, the such as ethanol water of 30-98wt% or 30-95wt% concentration or 40-90wt% concentration or 50-85wt% or 60wt% ~ 80wt%.
" extracting with various combination in these seven kinds of raw materials " described in step (2) such as adopts carries out according to following combination the mode extracted: a kind of raw material (such as jade prolongs) wherein carries out extracting (such as extracting, as extracted its decoction liquor with the ethanol water of 50-95wt% concentration with water alcohol method) and other seven kinds of raw materials (such as the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis) and is mixed in and extracts (such as water extraction extraction) (obtaining two kinds of extracts) together; Or two kinds of raw materials (such as jade prolongs and the Radix Astragali) are wherein mixed together and carry out extracting (such as extracting, as extracted its decoction liquor with the ethanol water of 50-95wt% concentration with water alcohol method) and other five kinds of raw materials (such as Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis) and be mixed in and extract (such as water extraction extraction) (obtaining two kinds of extracts) together; Or a kind of raw material (such as jade prolongs) wherein carries out extracting, other two kinds of raw materials (such as Herba Commelinae, the Rhizoma Anemarrhenae) be mixed in carry out together extracting to be mixed in the four kinds of raw materials (Radix Astragali, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis) be left together with carry out extracting (obtaining three kinds of extracts); Or a kind of raw material (such as jade prolongs) wherein carries out separately extracting, another raw material (such as Rhizoma Polygonati Odorati) carry out separately extracting to be mixed in the five kinds of raw materials (Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Fructus Schisandrae Chinensis) be left together with carry out extracting (obtaining three kinds of extracts); Or these seven kinds of raw materials are mixed together and carry out extracting (obtaining a kind of extract), etc.
Such as, aforementioned pharmaceutical compositions can according to method one preparation comprised the steps:
(1) pulverize: the Bombyx Batryticatus of described proportioning consumption and Pupa bombycis are pulverized (low temperature or conventional pulverizing), sieve (such as 50 ~ 80 mesh sieves), the first fine powder I obtained;
(2) water alcohol method extracts: the jade of described proportioning consumption prolongs, the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis add suitable quantity of water and decoct 2 ~ 3 times, each 1 ~ 2 hour, medicinal residues centrifuge dehydration, gained decocting liquid concentrates (become 30 ~ 60% of former filtrate volume, preferably about 50%) obtains concentrated solution; Use ethanol extraction (with 30% ~ 70% of concentrated solution volume) again, reclaim ethanol (can be recycled), the extracting solution spray drying method after recovery obtains dry extract, i.e. extract powder II; With
(3) the extract powder II that the first fine powder I step (1) obtained and step (2) obtain mixes, and obtains pharmaceutical composition.
Or aforementioned pharmaceutical compositions also can be prepared according to the method two comprised the steps:
(1) pulverize: the Bombyx Batryticatus of described proportioning consumption and Pupa bombycis are pulverized (low temperature or conventional pulverizing), sieve (such as 50 ~ 80 mesh sieves), the first fine powder I obtained;
(2) water extraction extracts: the jade of described proportioning consumption prolongs, the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis add suitable quantity of water and decoct 2 ~ 3 times, each 1 ~ 2 hour, medicinal residues centrifuge dehydration, gained decocting liquid concentrates (become 30 ~ 60% of former filtrate volume, preferably about 50%) obtains concentrated solution; Dry extract is obtained again, i.e. extract powder II with spray drying method; With
(3) the extract powder II that the first fine powder I step (1) obtained and step (2) obtain mixes, and obtains pharmaceutical composition.
" optionally " represents " having " or " not having " here or represents " carrying out " or " not carrying out ".
Above-mentioned raw materials medical material is the Chinese crude drug that the national drug standards are recorded respectively, and its source is as follows respectively:
The larva that Bombyx Batryticatus (Bombyx Batryticatus) is Bombycidae insecticide silkworm Bombyx mori Linnaeus4 ~ 5 age infects (or artificial vaccination) muscardine Beauveria bassiana (Bals.) Vuillant and lethal dry body.
Pupa bombycis is the pupa of Bombycidae insecticide bombyx mori.Take out by the Bombyx bombycis after filature, dry or dry.
Jade prolongs (Rhizoma Dioscoreae, the application's jade prolong be used interchangeably with Rhizoma Dioscoreae) is the tuber of Dioscoreaceae plant Rhizoma Dioscoreae.
The Radix Astragali is leguminous plant Radix Astagali Astragalus membranaceus Bge.var.mongholicus(Bge.) root of Hsiao.
The Radix Paeoniae Alba is the root of dicotyledon medicine ranunculaceae plant Radix Paeoniae (cultigen).
Rhizoma Polygonati Odorati is liliaceous plant Rhizoma Polygonati Odorati Polygonatum odoratum(Mill.) dry rhizome of Druce.
Herba Commelinae is the herb of Herba Commelinae kind of plant Herba Commelinae.
The Rhizoma Anemarrhenae (RHIZOMA ANEMARRHENAE with peet) is the dry rhizome of liliaceous plant Rhizoma Anemarrhenae Anemarrhena asphodeloides Bge..
Fructus Schisandrae Chinensis is magnoliaceae schisandra Schisandra chinensis(Turcz.) dry mature fruit of Baill. or schisandra chinensis Schisandrasphenanthera Rehd.et Wils..
In above-mentioned raw materials medicine composition, jade prolongs the function of tool spleen reinforcing nourishing the stomach, the lung benefiting that promotes the production of body fluid, the kidney invigorating arresting seminal emission, cures mainly and quenches one's thirst; Fructus Schisandrae Chinensis Bearberry Extract is astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, the function of kidney calming; Radix Paeoniae Alba tool nourishes blood, the function of astringing YIN to stop sweating, reducing the asthenic fever, and slow all diseases of quenching one's thirst, have share synergism with Fructus Schisandrae Chinensis, to strengthen effect of promoting the production of body fluid; The yin nourishing of Rhizoma Polygonati Odorati tool, moisturizes, relieving restlessness, the function of quenching the thirst, and control calentura the moon wound, cough excessive thirst, deficient fever, rapid digestion of food is easily hungry, frequent micturition.Rhizoma Anemarrhenae tool clearing away heat-fire, the function of moisturizing of promoting the production of body fluid, for the hot excessive thirst of height, interior-heat is quenched one's thirst, dryness of the intestine constipation, and tool reduces blood glucose and reduces the trend of insulin resistance.The capable water of Herba Commelinae tool, heat clearing away, removing heat from blood, the function of removing toxic substances.The Radix Astragali has invigorating QI to consolidate the body surface resistance, expelling pus and toxin by strengthening QI, diuresis, the function of granulation promoting.The present invention gets Rhizoma Polygonati Odorati nourishing YIN and moistening the lung, and promoting the production of body fluid to quench thirst disappears to control; Get jade to prolong spleen invigorating invigorating middle warmer and disappear in controlling; Get the clear part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels deficiency-heat of the Rhizoma Anemarrhenae to disappear to control the inferior, Fructus Schisandrae Chinensis, the Radix Paeoniae Alba promote the production of body fluid convergence, solve the disease of polydipsia polyuria, and Bombyx Batryticatus, Pupa bombycis get the specially good effect of its treatment diabetes.
3rd aspect of the present invention, provides the medicine of aforementioned pharmaceutical compositions for the preparation of prevention and therapy diabetes or the purposes of medicament.
Compared with prior art, the invention has the beneficial effects as follows: our compatibility is proper, all tastes share, steadily effectively can improve the islet function of self, changing patient causes blood glucose to raise due to insulin resistant, hypoinsulinism or relative deficiency, reduce blood sugar for human body level, thus prevent the generation of complication.On the one hand, this medicine effectively can control the state of an illness of pre-diabetes patient; On the other hand, to diabetics, can effective symptom management, be the desirable natural drug goods of diabetics or hyperglycemia population.The capsule using this compositions to make successively is treated more than 200 routine pre-diabetes patients and diabetics, and obvious effective rate reaches more than 80%, and total effective rate reaches 95%
The present invention, according to traditional medical theory, uses Modern preparations technology, and adopt natural Chinese medicine, accurate prescription forms, not containing any chemicals, nontoxic, steady quality, taking convenience.There is no strict consumption restriction, can long-term taking.
Detailed description of the invention
Illustrate the present invention by the following examples, but the present invention is not by any restriction of following examples, any modification in main scope of the present invention all falls within the scope of protection of the present invention.
Embodiment 1
The present embodiment is the capsule of prevention and therapy diabetes medicament, is made up of the raw medicinal material of following weight portion:
Jade prolong 13 parts, Bombyx Batryticatus 13 parts, Pupa bombycis 7 parts, the Radix Astragali 7 parts, the Rhizoma Anemarrhenae 8 parts, Herba Commelinae 7 parts, the Radix Paeoniae Alba 15 parts, Rhizoma Polygonati Odorati 15 parts, Fructus Schisandrae Chinensis 15 parts
The capsule of the present embodiment prevention and therapy diabetes medicament is obtained by the method comprising following key step:
(1), pulverize: by the Bombyx Batryticatus of described proportioning, Pupa bombycis ambient ground, jade is prolonged, the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, every in Fructus Schisandrae Chinensis pulverize by 20 quality % parts in formula ratio simply; Cross 80 mesh sieves, obtain fine powder I for subsequent use;
(2), water alcohol method extracts: prolonged by the jade of surplus, the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis add the soak by water 1.5 hours of appropriate (about 10 times amount of above seven kinds of raw material dry weights), filter, then appropriate soak by water 1 hour is added, filter, merging filtrate, be condensed into about 1 half volumes of former filtrate, obtain concentrated solution; Use the 70% only about half of ethanol extraction of concentrated solution volume again, reclaim ethanol (can be recycled), extracting solution spray drying method obtains dry extract, obtains fine powder II, for subsequent use;
(3), preparation: get above-mentioned steps (1), fine powder I, II mixing that (2) obtain, according to the conventional formulation method of capsule, add appropriate amount of auxiliary materials, make capsule, pack and get final product, every 0.4g.
Embodiment 2
The present embodiment is the tablet of prevention and therapy diabetes medicament, is made up of the raw medicinal material of following weight portion:
Jade prolong 20 parts, Bombyx Batryticatus 15 parts, Pupa bombycis 10 parts, the Radix Astragali 5 parts, the Rhizoma Anemarrhenae 12 parts, Herba Commelinae 4 parts, the Radix Paeoniae Alba 12 parts, Rhizoma Polygonati Odorati 15 parts, Fructus Schisandrae Chinensis 12 parts
The tablet of the present embodiment prevention and therapy diabetes medicament is obtained by the method comprising following key step:
(1), pulverize: the Bombyx Batryticatus of described proportioning, Pupa bombycis are all pulverized through routine, cross 80 mesh sieves, obtain fine powder I for subsequent use;
(2), water extraction extracts: prolonged by the jade of described proportioning, the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis add suitable quantity of water (about 10 times amount of above seven kinds of raw material dry weights) and decoct 2 times, each 1 ~ 2 hour, filter, merging filtrate, is condensed into the half volume of former filtrate; Extracting solution spray drying method obtains dry extract, obtains fine powder II, for subsequent use;
(3), preparation: get above-mentioned steps (1), fine powder I, II mixing that (2) obtain, according to the conventional formulation method of tablet, add appropriate amount of auxiliary materials, make tablet, to obtain final product, every sheet 0.5g.
Embodiment 3
The present embodiment is the oral liquid of prevention and therapy diabetes medicament, is made up of the raw medicinal material of following weight portion:
Jade prolong 15 parts, Bombyx Batryticatus 25 parts, Pupa bombycis 5 parts, the Radix Astragali 10 parts, the Rhizoma Anemarrhenae 18 parts, Herba Commelinae 10 parts, the Radix Paeoniae Alba 12 parts, Rhizoma Polygonati Odorati 18 parts, Fructus Schisandrae Chinensis 10 parts
The oral liquid of the present embodiment prevention and therapy diabetes medicament is obtained by the method comprising following key step:
(1), by the Bombyx Batryticatus of formula ratio and Pupa bombycis add Drinking Water or other meet pharmaceutical manufacturing require water, extract by vacuum and low temperature mode, temperature≤60 DEG C, obtain extracting solution I;
(2), by the jade of described proportioning prolong, the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis add suitable quantity of water and decoct 2 times, each 1 ~ 2 hour, filter, merging filtrate, is condensed into the half of former filtrate volume; Extracting solution spray drying method obtains dry extract, obtains fine powder II, for subsequent use;
(3), preparation: get extracting solution I that above-mentioned steps (1) obtains, fine powder II that step (2) obtains mixes, according to the conventional formulation method of oral liquid, add appropriate amount of auxiliary materials, make mixture (oral liquid), to obtain final product, often to prop up 10mL.
Embodiment 4:
The present embodiment is the tablet of prevention and therapy diabetes medicament, is made up of the raw medicinal material of following weight portion:
Jade prolong 25 parts, Bombyx Batryticatus 15 parts, Pupa bombycis 10 parts, the Radix Astragali 5 parts, the Rhizoma Anemarrhenae 10 parts, Herba Commelinae 8 parts, the Radix Paeoniae Alba 12 parts, Rhizoma Polygonati Odorati 18 parts, Fructus Schisandrae Chinensis 10 parts
The tablet of the present embodiment prevention and therapy diabetes medicament is obtained by the method comprising following key step:
(1), by the Bombyx Batryticatus of formula ratio and Pupa bombycis add Drinking Water or other meet pharmaceutical manufacturing require water, extract by vacuum and low temperature mode, temperature≤60 DEG C, obtain extracting solution; Further for extracting solution lyophilization or spraying dry are obtained dried powder I, for subsequent use;
(2), by the jade of described proportioning prolong, the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis add suitable quantity of water decoct 2 times, each 1 ~ 2 hour, filter, merging filtrate, is condensed into the half of former filtrate volume; Extracting solution spray drying method obtains dry extract, obtains fine powder II, for subsequent use;
(3), preparation: get dried powder I that above-mentioned steps (1) obtains, fine powder II that step (2) obtains mixes, according to the conventional formulation method of tablet, add appropriate amount of auxiliary materials, make tablet, to obtain final product, every sheet 0.5g.
Embodiment 5
The present embodiment is the pill of prevention and therapy diabetes medicament, is made up of the raw medicinal material of following weight portion:
Jade prolong 20 parts, Bombyx Batryticatus 15 parts, Pupa bombycis 8 parts, the Radix Astragali 5 parts, the Rhizoma Anemarrhenae 10 parts, Herba Commelinae 10 parts, the Radix Paeoniae Alba 18 parts, Rhizoma Polygonati Odorati 15 parts, Fructus Schisandrae Chinensis 15 parts
The pill of the present embodiment prevention and therapy diabetes medicament is obtained by the method comprising following key step:
(1), pulverize: the Bombyx Batryticatus of described proportioning and Pupa bombycis are all pulverized through routine, crosses 80 mesh sieves, obtain fine powder I for subsequent use;
(2), extract: prolonged by the jade of described proportioning, Fructus Schisandrae Chinensis adds suitable quantity of water and decoct 2 times, 1.5 hours first times, second time 1 hour, filter, merging filtrate, is condensed into the half volume of former filtrate; Extracting solution spray drying method obtains dry extract, obtains fine powder II, for subsequent use;
The Rhizoma Anemarrhenae of described proportioning, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, Herba Commelinae, the Radix Astragali are added appropriate soak by water 1.5 hours, and decocting liquid filters, and then adds appropriate soak by water 1 hour, and filter, merging filtrate, is condensed into about 1 half volumes of former filtrate, obtains concentrated solution; Use the 70% only about half of ethanol extraction of concentrated solution volume again, reclaim ethanol (can be recycled), extracting solution spray drying method obtains dry extract, obtains fine powder III, for subsequent use;
(3), preparation: get above-mentioned steps (1), fine powder I, II, III mixing that (2) obtain, according to the conventional formulation method of pill, add appropriate amount of auxiliary materials, make pill, to obtain final product, every ball 0.3g.
Clinical trial
Select 205 routine type 2 diabetes mellitus without severe complication person, patient age is 30-71 years old, and great majority are between 41 years old ~ 65 years old.Average 49.75 years old ± 5.35 years old.Wherein male 104 example, women 101 example.
Fasting plasma glucose concentration >=the 7.5mmol/L of patient, average 12.2 ± 3.1mmol/L 2h-plasma glucose 20.1 ± 5.2
Criterion of therapeutical effect, according to the criterion of therapeutical effect that " new Chinese medicine guideline of clinical investigations " is formulated.Effective: after treatment, symptom disappears substantially, fasting glucose < 7.2mmol/L, 2h-plasma glucose < 8.3mmol/L.Effective: after treatment, symptom is obviously improved, fasting glucose < 8.3mmol/L, 2h-plasma glucose < 10.0mmol/L.Invalid: after treatment, symptom is not improved, blood glucose does not decline not and 10%.
Take to experimenter and adopt embodiments of the invention 1 medicine (capsule) treatment, 0.4 gram every, every day 9 ~ 12, points 3 times oral, within 1 month, is a course for the treatment of.To stop using when taking this medicine other Western medicine, take after one month and survey fasting glucose and 2h-plasma glucose routinely
Therapeutic outcome (judging with blood glucose target):
As a result, obvious effective rate reaches more than 80%, and total effective rate reaches 95%.
The comparison of symptom curative effect:
Symptom N/ number of cases Effective/example Effectively/example Invalid/example Effective percentage/%
Thirst and liking drink 128 94 26 8 94.0
Easy hungry polyphagia 92 52 30 10 89.1
Night sweat 50 36 10 4 92.0
Become thin 80 39 35 6 92.5
Frequent micturition yellow skin 119 53 49 17 85.7
Fatigue and weakness 149 91 53 5 96.6
Model case
1, river xx, man, 59 years old, civil servant.
Patient previously feels body and is good for, and appetite is good, and energy is prosperous, the year before self-induction thirst and liking drink companion soreness of waist fatigue and weak.Health check-up find diabetes, once took " diabetes pill blood glucose, still can not well control, chemical examination fasting glucose 11.1mmol/L, post-prandial glycemia 12.8mmol/L.
Now change the capsule taken made by the present invention, every day 12, divide and take for three times.Check after surrounding, chemical examination fasting glucose 5.5mmol/L, after the meal blood 8.4mmol/L.Thirsty, soreness of waist transference cure, the mental status is good, and muscle power is as usual.Follow up a case by regular visits to after 1 year, the state of an illness is still continual and steady, and the chemical examination of fasting glucose, post-prandial glycemia is all in normal range.
2, Liu xx, man, 50 years old, foreign enterprise's white collar.
Weak more than 2 years of self-induction, and increase the weight of gradually, obvious with two lower limb, can not alleviate after rest.Previously body is good for, happiness eating and drinking too much at one meal.Through looking into: chemical examination fasting glucose 8.0mmol/L, post-prandial glycemia 11.9mmol/L.
Through taking the capsule of invention formulation, every day 12, dividing and taking for three times.After one month, weak transference cure, chemical examination fasting glucose 4.8mmol/L, post-prandial glycemia 6.3mmol/L
Patient reduces dose then, every day 6, normal diet.Within in 1 year every two months, look on an empty stomach and post-prandial glycemia all in normal range.Follow up a case by regular visits to and do not recur so far.
3, certain man of gold 60 years old, shipping driver.
Self-induction without obviously thirsty, polydipsia, polyphagia, polyuria, the symptom such as to become thin, does not give attention at ordinary times.
Survey fasting glucose: 16.6mmol/L during health check-up in 2009, and be diagnosed as type 2 diabetes mellitus.
Through taking the capsule of invention formulation, every day 9, dividing and taking for three times.Check after one month, special discomfort is not felt in private prosecution, and aforementioned conditions disappears.Fasting glucose 7.0mmol/L, after the meal 8.0mmol/L.
4, Cui's ××, female, 62 years old, retired employees.
Have diabetic history, self-induction dizziness is weak, and hyperhidrosis xerostomia, takes metformin certainly, and symptom has no and is clearly better, chemical examination fasting glucose 8.4mol/L, post-prandial glycemia 16.3mol/L.
Through taking the capsule of invention formulation, every day 12, dividing and taking for three times.After one month, all diseases of self-induction disappear, chemical examination fasting glucose 7.3mol/L, post-prandial glycemia 7.8mol/L.
5, ×× is opened, female, 47 years old, teacher.
The private prosecution whole body is weak, cloudy urine 1 month.Be diagnosed as diabetes when having a medical check-up before 3 years, nearly January because of the fatigue that works, irregular eating and to cause glycemic control undesirable, occur that the whole body is weak, xerostomia polydipsia, urinary micturition simultaneously, cloudy urine, chemical examination fasting glucose 13.5mmol/L, post-prandial glycemia 18.7mmol/L.
Through taking the capsule of invention formulation, every day 12, dividing and taking for three times.After surrounding, comparatively forward is clear for self-induction urine, and without obvious weak card shape, other all diseases disappear.Chemical examination fasting glucose 5.5mmol/L, after the meal 2 hours blood glucose 7.7mmol/L.

Claims (9)

1. a pharmaceutical composition, is characterized in that: this pharmaceutical composition is made up of the raw medicinal material of following weight: jade prolong 13 parts, Bombyx Batryticatus 13 parts, Pupa bombycis 7 parts, the Radix Astragali 7 parts, the Rhizoma Anemarrhenae 8 parts, Herba Commelinae 7 parts, the Radix Paeoniae Alba 15 parts, Rhizoma Polygonati Odorati 15 parts, Fructus Schisandrae Chinensis 15 parts.
2. pharmaceutical composition according to claim 1, is characterized in that: pharmaceutical composition is the preparation of granule, powder, tablet, pill, capsule, mixture or dripping pill type.
3. prepare the method for pharmaceutical composition according to claim 1, the method comprises the following steps:
(1) Bombyx Batryticatus of described proportioning consumption and Pupa bombycis are pulverized, sieve, the first fine powder I obtained;
(2) jade of described proportioning consumption prolongs, the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis extract respectively, or extract with various combination in these seven kinds of raw materials, thus obtaining one or two or more extract, extract obtained optionally carrying out concentrates, carries out drying and/or pulverizing again; With
(3) extract that the first fine powder I step (1) obtained and step (2) obtain mixes, and obtains pharmaceutical composition.
4. method according to claim 3, is characterized in that: described method comprises following key step:
(1) pulverize: by the Bombyx Batryticatus of described proportioning consumption and Pupa bombycis room temperature or pulverize at low temperature, cross 50 ~ 80 mesh sieves, the first fine powder I obtained;
(2) water alcohol method extracts: the jade of described proportioning consumption prolongs, the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis add suitable quantity of water and decoct 2 ~ 3 times, each 1 ~ 2 hour, medicinal residues centrifuge dehydration, gained decocting liquid is condensed into 30 ~ 60% of former filtrate volume, obtains concentrated solution; Concentrated solution carries out precipitate with ethanol with the ethanol water of 50-95wt% concentration again, and reclaim ethanol, the extracting solution spray drying method after recovery obtains dry extract, i.e. extract powder II; With
(3) the extract powder II that the first fine powder I step (1) obtained and step (2) obtain mixes, and obtains pharmaceutical composition.
5. method according to claim 3, is characterized in that: described method comprises following key step:
(1) pulverize: by the Bombyx Batryticatus of described proportioning consumption and Pupa bombycis room temperature or pulverize at low temperature, cross 50 ~ 80 mesh sieves, the first fine powder I obtained;
(2) water extraction extracts: the jade of described proportioning consumption prolongs, the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis add suitable quantity of water and decoct 2 ~ 3 times, each 1 ~ 2 hour, medicinal residues centrifuge dehydration, gained decocting liquid is condensed into 30 ~ 60% of former filtrate volume, obtains concentrated solution; Dry extract is obtained again, i.e. extract powder II with spray drying method; With
(3) the extract powder II that the first fine powder I step (1) obtained and step (2) obtain mixes, and obtains pharmaceutical composition.
6. prepare the method for pharmaceutical composition according to claim 1, the method comprises the following steps:
(1) Bombyx Batryticatus of described proportioning consumption and Pupa bombycis are pulverized, the jade of described proportioning consumption is prolonged, the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, in Fructus Schisandrae Chinensis simply or a few taste pulverize by 5 ~ 20 % by weight in described proportioning consumption, mix after sieving after mixing again or sieving, or both are pulverized together and are then sieved, thus the first fine powder I obtained;
(2) jade of described proportioning consumption is prolonged, the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, residue in Fructus Schisandrae Chinensis do not pulverize part and extract respectively, or extract with various combination in these seven kinds of raw materials, thus obtaining one or two or more extract, extract obtained optionally carrying out concentrates, carries out drying and/or pulverizing again; With
(3) extract that the first fine powder I step (1) obtained and step (2) obtain mixes, and obtains pharmaceutical composition.
7. prepare the method for pharmaceutical composition according to claim 1, the method comprises the following steps:
(1) Bombyx Batryticatus of formula consumption and Pupa bombycis are added appropriate Drinking Water or other meet pharmaceutical manufacturing require water, extract by vacuum and low temperature mode, temperature≤60 DEG C, obtain extracting solution I;
(2) jade of described proportioning consumption prolongs, the Radix Astragali, Herba Commelinae, the Rhizoma Anemarrhenae, the Radix Paeoniae Alba, Rhizoma Polygonati Odorati, Fructus Schisandrae Chinensis extract respectively, or extract with various combination in these seven kinds of raw materials, thus obtain one or two or more extract; With
(3) extract that the extracting solution I step (1) obtained and step (2) obtain mixes, and obtains pharmaceutical composition.
8. method according to claim 7, is characterized in that: extracting solution I is obtained dried powder through lyophilization or spraying dry in (1) by described method step further; The extract that dried powder step (1) obtained in step (3) and step (2) obtain mixes, and obtains pharmaceutical composition.
9. the pharmaceutical composition of claim 1 is for the preparation of the purposes of the medicine of prevention and therapy diabetes.
CN201310362123.5A 2013-08-19 2013-08-19 A kind of pharmaceutical composition and its production and use Active CN103393937B (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1304751A (en) * 2000-12-01 2001-07-25 张志祥 Scrophularia capsule and its preparing process
CN101637579A (en) * 2009-09-08 2010-02-03 江春德 Traditional Chinese medicine for treating diabetes mellitus and preparation method thereof
CN102698098A (en) * 2012-05-07 2012-10-03 王伟 Traditional Chinese medicine for treating diabetes mellitus

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1304751A (en) * 2000-12-01 2001-07-25 张志祥 Scrophularia capsule and its preparing process
CN101637579A (en) * 2009-09-08 2010-02-03 江春德 Traditional Chinese medicine for treating diabetes mellitus and preparation method thereof
CN102698098A (en) * 2012-05-07 2012-10-03 王伟 Traditional Chinese medicine for treating diabetes mellitus

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