WO2018040008A1 - 一种用于治疗糖尿病的生物中药内服药及其制备方法 - Google Patents

一种用于治疗糖尿病的生物中药内服药及其制备方法 Download PDF

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WO2018040008A1
WO2018040008A1 PCT/CN2016/097644 CN2016097644W WO2018040008A1 WO 2018040008 A1 WO2018040008 A1 WO 2018040008A1 CN 2016097644 W CN2016097644 W CN 2016097644W WO 2018040008 A1 WO2018040008 A1 WO 2018040008A1
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chinese medicine
traditional chinese
parts
million
enzyme
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PCT/CN2016/097644
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English (en)
French (fr)
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区士衡
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广州市利士诺丹生物科技有限公司
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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)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9062—Alpinia, e.g. red ginger or galangal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Definitions

  • the invention relates to a medicine for treating diabetes and a preparation method thereof, in particular to a biological Chinese medicine internal medicine for treating diabetes and a preparation method thereof.
  • Diabetes mellitus is a group of metabolic disorders such as protein, fat and electrolytes caused by insufficient absolute or relative secretion of insulin and decreased sensitivity of insulin to target tissues.
  • Hyperglycemia is the main marker.
  • the main clinical manifestations of diabetes are polydipsia, polyuria, polyphagia, and weight loss ("three more than one less"), as well as high blood sugar and glucose in the urine (normal urine should not contain glucose). If effective treatment is not available, it can cause multiple systemic damage; leading to chronic damage and dysfunction of various tissues, especially eyes, kidneys, heart, blood vessels and nerves. Some patients require lifelong insulin therapy.
  • the number of people with diabetes in China ranks first in the world; according to incomplete statistics in 2015, the number of people with diabetes in China is about 100 million, which is still increasing and anxious. Among them, type I diabetes accounted for 5%, type II diabetes accounted for 90%, pregnancy diabetes accounted for 4%, and other diabetes accounted for 1%.
  • the biomedical internal medicine is composed of a Chinese medicine partial prescription and an internal enzyme preparation
  • the Chinese medicine part prescription comprises the following preparation materials: Bidens, Minguecao, and whitening Grass, Agrimony, American ginseng, spatholobus, yam meat, medlar, native land, Uncaria and Yizhiren
  • the prescription of the traditional Chinese medicine is prepared by a combination of conventional decoction extraction method and biotechnological enzymatic method
  • the enzyme used in the biotechnological enzymatic hydrolysis method is an external enzyme, which is a pectinase, a lipase, an amylase, a soybean protease, and a cellulase
  • the internal enzyme is a compound islet repairing enzyme
  • the compound islet repair enzyme comprises pancreatic kininogenase, trypsin, DNA polymerase, dismutase, beer enzyme and papain.
  • the partial prescription of the traditional Chinese medicine of the invention has good curative effect on the diseases of the heart, the cerebrovascular, the kidney, the fundus and the nervous system of the diabetes.
  • the partial prescription of the traditional Chinese medicine is as follows:
  • Bidens, Minguecao, turfgrass, Agrimony, and native habitat all stimulate the proliferation of islet cells, pancreatic ⁇ -cell proliferation, inhibition of ⁇ -cell sensitivity, promote insulin function in pancreatic organs, and reduce diabetes Dependence on insulin; promote blood sugar metabolism, reduce blood viscosity; spatholobus, yam meat, yoghurt, yin essence, regulate and promote brain health. Uncaria helps to form blood vessels to prevent thrombosis, especially It has a significant effect on the brain. The above drugs have a good effect on diabetes, heart, cerebrovascular, kidney, fundus and nervous system.
  • the traditional Chinese medicine liquid extracted by the medicine decoction method contains a large amount of pectin, fat, starch, sugar classification and the like, which affects the release of the active ingredient, so it is reused in the Chinese medicine liquid and the medicine residue extracted by the Chinese medicine decoction method.
  • Biological enzyme extraction can maximize the release of active ingredients of traditional Chinese medicine.
  • the combination of the two methods is higher and more pure than the effective ingredients of traditional Chinese medicine obtained by any single method.
  • the internal enzyme preparation that is, the compound islet repair enzyme has two major effects: 1.
  • a traditional Chinese medicine extract obtained by concentration and drying, a certain combination is added, and a certain amount of biological enzymes constitute an internal dosage form. Let the therapeutic effect of traditional Chinese medicine be greatly improved;
  • the islet repairing enzyme "stimulates, activates, promotes the function of insulin reconstitution in the pancreas, reduces the dependence of diabetic patients on insulin treatment, promotes blood sugar metabolism, and promotes blood viscosity at the bottom.
  • the traditional Chinese medicine part prescription comprises the following raw materials of the traditional Chinese medicine: 1 to 10 parts of Bidens pilosa, 1 to 10 parts of Minguecao, and whitish 1 to 10 parts of grass, 1 to 10 parts of Agrimony, 1 to 10 parts of American ginseng, 1 to 10 parts of spatholobus, 1 to 10 parts of hawthorn meat, 1 to 10 parts of alfalfa, 1 to 10 parts of native land, and uncaria 1 to 10 parts, 1 to 10 parts of Yizhiren.
  • the internal enzyme preparation comprises the following enzymes: trypsin 0.1 million-100 ⁇ g, pancreatic kininogen 0.1 million-100 ⁇ ⁇ g, DNA polymerase 0.1 million-100 ⁇ g, dismutase 0.1 million-100 ⁇ g, beer enzyme 0.1 million-100 ⁇ g, papain 0.1 million-100 ⁇ g.
  • the present invention also provides a preparation method of the biomedical internal medicine for treating diabetes, comprising the following steps:
  • Extracting the active ingredients of some prescriptions of traditional Chinese medicine mixing the traditional Chinese medicines required for partial prescription of traditional Chinese medicines, mixing the mixture of traditional Chinese medicines with water at 1:20, and extracting at low temperature of 50-60 °C for 2-3 hours to obtain the filtrate of traditional Chinese medicine.
  • the water and the traditional Chinese medicine filtrate were mixed at 1:10, and extracted at a low temperature of 50-60 ° C for 1-2 h.
  • Bio-enzymatic enzymatic hydrolysis method further extracts the active ingredients of the prescription of the traditional Chinese medicine: the Chinese medicine filtrate obtained in the step (1) is mixed with the traditional Chinese medicine dregs, cooled to 30-50 ° C, and the enzyme required for the preparation of the external enzyme is dissolved in parts. To the traditional Chinese medicine filtrate and Chinese medicine dregs In the mixture, at a pH of 4-6, a temperature of 30-50 ° C, the enzymatic hydrolysate 2-20h, filtered, to obtain a traditional Chinese medicine serum, dried to Chinese medicine powder;
  • the preparation procedure of the preparation method of the biological Chinese medicine internal medicine for treating diabetes is as follows: screening clean Chinese herbal medicine ⁇ crushing ⁇ component mixing ⁇ conventional boiling extraction twice ⁇ cooling ⁇ adding enzyme enzymatic extraction ⁇ filtration ⁇ Concentration ⁇ Drying ⁇ Inspection ⁇ The biological enzyme is mixed with the traditional Chinese medicine extract obtained by concentration and drying to form an internal dosage form ⁇ test ⁇ package ⁇ into the warehouse.
  • the active ingredient of the partial prescription of the traditional Chinese medicine is prepared by the following preparation method:
  • Extracting the active ingredients of some prescriptions of traditional Chinese medicine mixing the traditional Chinese medicines required for partial prescription of traditional Chinese medicines, mixing the mixture of traditional Chinese medicines with water at 1:20, and extracting at low temperature of 50-60 °C for 2-3 hours to obtain the filtrate of traditional Chinese medicine. Mixing the water with the traditional Chinese medicine filtrate at 1:10, and extracting at a low temperature of 50-60 ° C for 1-2 h;
  • Bio-enzymatic enzymatic hydrolysis method further extracts the active ingredients of the prescription of the traditional Chinese medicine: the Chinese medicine filtrate obtained in the step (1) is mixed with the traditional Chinese medicine dregs, cooled to 30-50 ° C, and the enzyme required for the preparation of the external enzyme is dissolved in parts. To the mixture of the traditional Chinese medicine filtrate and the traditional Chinese medicine dregs, the enzyme is digested for 2-20 h at a pH of 4-6 and a temperature of 30-50 ° C, and filtered to obtain a traditional Chinese medicine clear solution, which is dried to a traditional Chinese medicine powder.
  • a preferred embodiment of the preparation method of the biomedical internal medicine for treating diabetes according to the present invention wherein the prescription of the traditional Chinese medicine in the step (1) comprises the following raw materials of the traditional Chinese medicine: 1 to 10 parts of the genus Bidens, and the moon 1 to 10 parts of grass, 1 to 10 parts of turfgrass, 1 to 10 parts of Agrimony, 1 to 10 parts of American ginseng, 1 to 10 parts of spatholobus, 1 to 10 parts of hawthorn meat, 1 to 10 parts of alfalfa, soil 1 to 10 parts of raw land, 1 to 10 parts of Uncaria, and 1 to 10 parts of Yizhi.
  • the prescription of the traditional Chinese medicine in the step (1) comprises the following raw materials of the traditional Chinese medicine: 1 to 10 parts of the genus Bidens, and the moon 1 to 10 parts of grass, 1 to 10 parts of turfgrass, 1 to 10 parts of Agrimony, 1 to 10 parts of American ginseng, 1 to 10 parts of spatholobus, 1 to 10 parts of hawthorn meat,
  • the external enzyme preparation in the step (2) is pectinase, lipase, amylase, soybean protease, cellulase.
  • the external enzyme preparation can effectively digest the pectin, fat, starch, sugar classification and the like, so that the active ingredients of the traditional Chinese medicine are released and obtained to the maximum extent.
  • the internal enzyme preparation in the step (3) comprises the following enzyme: trypsin 0.1 million-100 ⁇ g , pancreatic kininogenase 0.1 million-100 ⁇ g, DNA polymerase 0.1 million-100 ⁇ g, dismutase 0.1 million-100 ⁇ g, beer enzyme 0.1 million-100 ⁇ g, papain 0.1 million-100 ⁇ g.
  • a preferred embodiment of the preparation method of the biomedical internal medicine for treating diabetes according to the present invention the outer The enzyme unit and the amount of the enzyme used in the enzyme preparation are: pectinase 0.1 million-100 ⁇ g, 1-10 parts; lipase 0.11 million-100 million ⁇ g, 1-10 parts, amylase 0.1 million-100 10,000 ⁇ g, 1-10 parts, soy proteinase 0.1 million to 1 million ⁇ g, 1-10 parts, cellulase 0.1 million to 1 million ⁇ g, 1-10 parts.
  • the step (1) further comprises the step (1a): pulverizing the traditional Chinese medicine raw material of each Chinese medicine partial prescription.
  • the raw material is pulverized, which is advantageous for extracting the effective substance in the raw material.
  • the traditional Chinese medicine clear liquid is dried to a powder and pulverized to 60-120 mesh.
  • the internal enzyme preparation and the Chinese medicine powder may be mixed in proportion to prepare various internal dosage preparations. .
  • the present invention discloses a pharmaceutical composition
  • a pharmaceutical composition comprising the biomedical internal medicine and the pharmaceutically acceptable excipient or carrier for treating diabetes according to any one of claims 1 to 4.
  • the pharmaceutically acceptable excipient or carrier is water, starch, wine, capsule shell or the like.
  • the pharmaceutical composition is in the form of a capsule, a tablet, a powder, a pill or an oral solution or the like.
  • the biomedical internal medicine of the present invention combines biotechnology with traditional Chinese medicine, and adds an internal enzyme prescription to the traditional Chinese medicine ingredient, and proposes a research and creation.
  • the invention relates to a medicine for treating diabetes and a new idea and a new method.
  • the traditional Chinese medicine component of the invention can treat diabetes, and has the following characteristics: 1. stimulates and promotes insulin function of the pancreas organ, and reduces the insulin resistance of the diabetic patient. Dependence; 2, promote blood sugar metabolism, reduce blood viscosity; promote kidney and brain health ⁇ kidney lean marrow ⁇ : adjust brain nerves, balance pituitary hormone secretion, diastolic cerebrovascular.
  • the traditional Chinese medicine extract of the present invention and the pharmaceutical composition containing the traditional Chinese medicine extract have an effective rate of treating 100% of diabetes and a long-term cure effect of type II diabetes of more than 90%.
  • the preparation method of the biological Chinese medicine internal medicine for treating diabetes is combined with the conventional decoction method and the biotechnology enzymatic method to extract the effective substance in the Chinese medicinal material, thereby improving the release of the active ingredient of the traditional Chinese medicine and obtaining of The effective ingredients of traditional Chinese medicine are higher and purer.
  • the preparation method of the traditional Chinese medicine extract of the invention has the active ingredient of the bottom medicine extracted by the biological enzyme and the enzymatic hydrolysis is four or five times higher than the conventional extraction, and provides the possibility that the medicine can be absorbed by the human body to the maximum extent, and the pharmaceutical composition is possible.
  • the enzyme converts, dissolves, and transforms the active ingredients of various traditional Chinese medicines into the multi-column (multi-molecular, multi-substance) plant "glutamin-like acid" in the gastrointestinal tract, and completes the change from substance to mass.
  • the effective ingredients of traditional Chinese medicine for treating diabetes, and the effective substances that have been converted into "nano-scale" by enzymatic hydrolysis provide the possibility that the medicine can be absorbed by the human body to the utmost extent.
  • the biomedical internal medicine for treating diabetes can be made into various therapeutic forms for treating diabetes organisms, and the "general case comprehensive description" in the following examples adopts the prescription and preparation of the internal medicine of the biological Chinese medicine according to the present invention.
  • the method of treating diabetes is "bio-Chinese medicine capsule".
  • the preparation raw material of the biological Chinese medicine internal medicine is: partial disposition of the traditional Chinese medicine: 1 part of Bidens, 10 parts of Mingueca, and whitish 10 parts of grass, 10 parts of Agrimony, 1 part of American ginseng, 10 parts of Spatholobus suberectus, 1 part of Hawthorn meat, 1 part of medlar, 1 part of native land, 10 parts of Uncaria, 10 parts of Yizhiren; Pectinase 0.1 million-100 ⁇ g, 1 part, lipase 0.11 million-100 million ⁇ g, 10 parts, amylase 0.1 million-100 million ⁇ g, 10 parts, soy protein 0.1 million-100 million ⁇ g, 10 parts, cellulase 0.1 million to 1 million ⁇ g, 1 part; internal enzyme preparation: trypsin 0.1 million-100 ⁇ g, pancreatic kininogenase 0.1 million-100 ⁇ g
  • Bio-enzymatic enzymatic hydrolysis method further extracts the active ingredients of the prescription of the traditional Chinese medicine: the Chinese medicine filtrate obtained in the step (1) is mixed with the traditional Chinese medicine dregs, cooled to 30-50 ° C, and the enzyme required for the preparation of the external enzyme is dissolved in parts. To the mixture of the traditional Chinese medicine filtrate and the traditional Chinese medicine dregs, under the conditions of pH 4-6, temperature 30-50 ° C, the hydrolysate is 2-20h, filtered, and the traditional Chinese medicine clear liquid is obtained, and dried to the traditional Chinese medicine powder;
  • the internal enzyme preparation is added to the traditional Chinese medicine powder obtained in the step (2) according to the required ratio, and various internal dosage forms are conventionally composed, inspected and packaged, and the biological Chinese medicine for treating diabetes according to the present invention is obtained.
  • the preparation raw material of the biological Chinese medicine internal medicine is: partial disposition of the traditional Chinese medicine: 10 parts of Bidens, 1 part of Mingueca, and whitish 1 part of grass, 1 part of Agrimony, 10 parts of American ginseng, 1 part of spatholobus, 10 parts of hawthorn meat, 10 parts of medlar, 10 parts of native land, 1 part of Uncaria, 1 part of Yizhiren; Pectinase 0.1 million-100 ⁇ g, 10 parts, lipase 0.11 million-100 million ⁇ g, 1 part, amylase 0.1 million-100 million ⁇ g, 1 part, soy protein protease 0.1 million-100 million ⁇ g, 1 part, cellulase 0.1 million to 1 million ⁇ g, 10 parts; internal enzyme preparation: trypsin 0.1 million-100 ⁇ g, pancreatic kininogenase 0.1 million-100 ⁇ g
  • the preparation method of the biological Chinese medicine internal medicine for treating diabetes in the present embodiment is the same as that in the first embodiment.
  • the preparation raw material of the biological Chinese medicine internal medicine is: partial dissection of the traditional Chinese medicine: 5 parts of Bidens, 8 parts of Mingueca, and whitening 9 parts of grass, 6 parts of Agrimony, 5 parts of American ginseng, 7 parts of spatholobus, 9 parts of hawthorn meat, 8 parts of alfalfa, 8 parts of native land, 9 parts of Uncaria, 8 parts of E.
  • the preparation method of the biological Chinese medicine internal medicine for treating diabetes in the present embodiment is the same as that in the first embodiment.
  • the pharmaceutical composition of the present embodiment comprises the biomedical internal medicine and the pharmaceutically acceptable excipient or carrier for treating diabetes.
  • the preparation materials for the internal medicine of the biological Chinese medicine are: partial dispensing of traditional Chinese medicine: 7 parts of Bidens pilosa, 9 parts of Minguecao, 8 parts of turfgrass, 9 parts of Agrimony, 8 parts of American ginseng, 6 parts of spatholobus, 6 parts of yam meat 7 parts, 6 parts, 6 parts of native land, 7 parts of Uncaria, 8 parts of Yizhiren; external enzyme preparation: pectinase 0.1 million-100 ⁇ g, 4 parts, lipase 0.11 million-100 million ⁇ g, 5 parts, amylase 0.1 million-100 million ⁇ g, 6 parts, soy proteinase 0.1 million-100 million ⁇ g, 5 parts, cellulase 0.1 million-100 million ⁇ g, 9 parts; Enzyme prescription: trypsin 0.1 million-100 ⁇
  • the preparation method of the biological Chinese medicine internal medicine for treating diabetes in the present embodiment is the same as that in the first embodiment.
  • the pharmaceutical composition of the present invention is then prepared into a biologic Chinese medicine capsule dosage form using a conventional production process.
  • the shortest course of the disease is 9 months;
  • the longest course of the disease is 36 years;
  • treatment medication internal treatment of diabetes "biological Chinese medicine capsules";
  • treatment time 60 days [a course of treatment]
  • the pulse string is thin, the tongue is reddish, the tongue is slightly yellow, and the complexion is stagnant.
  • the diagnosis is yin deficiency and internal heat, liver qi stagnation, kidney essence loss, and long-term accumulation of diabetes.
  • the oral hypoglycemic drugs were stopped. After 30 days, after testing, urine protein, blood sugar, returned to normal. Continue to maintain the regular dose, after a course of treatment, stop the drug. After two years of return visits, the test indicators are normal.
  • the patient was seen in August 2009. Has a history of diabetes for 13 years, the main oral hypoglycemic agents.
  • ECG shows coronary artery insufficiency, diagnosed as coronary heart disease, hypertension (stage II). Adding drugs such as cardiovascular and cerebrovascular diseases has not been effective so far.
  • ECG ST-T changes.
  • Fundus examination of the ENT retinopathy stage II, with a little old bleeding, vein dilatation. Diagnosed as diabetic recurrent retinopathy, diabetic heart disease, diabetic nephropathy, diabetic peripheral neuropathy.
  • the effective ingredient of the traditional Chinese medicine for treating diabetes can be "maximally absorbed by the human body”.
  • the complication of diabetes is rooted in diabetes, "the skin does not exist, the hair is attached.” As long as the diabetes is treated clinically, it will create good physiological conditions for other complications to be alleviated or healed. Moreover, the efficacy of prescription drugs for such complications is also significant.

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Abstract

一种治疗糖尿病的生物中药内服药，所述内服药由中药组合物和内种酶组成，中药原料包含：鬼针草、明月草、委陵菜、仙鹤草、西洋参、鸡血藤、山茱萸、茯苓、白背三七、钩藤、益智仁，所述中药采用煎煮法与酶解法制得，酶解法所用的酶为果胶酶、脂肪酶、淀粉酶、大豆蛋白酶和纤维素酶；内种酶包含胰激肽原酶、胰蛋白酶、DNA聚合酶、歧化酶、啤酒酶和木瓜酶。

Description

一种用于治疗糖尿病的生物中药内服药及其制备方法 技术领域
本发明涉及一种用于治疗糖尿病的药物及其制备方法，具体涉及一种用于治疗糖尿病的生物中药内服药及其制备方法。
背景技术
糖尿病(diabetes mellitus)是一组因胰岛素绝对或相对分泌不足、以及靶组织细胞对胰岛素敏感性降低引起蛋白质、脂肪和电解质等一系列代谢紊乱综合征，其中高血糖为主要标志。糖尿病的主要临床表现为多饮、多尿、多食和体重下降(“三多一少”)，以及血糖高、尿液中含有葡萄糖(正常的尿液中不应含有葡萄糖)等。若得不到有效的治疗，可引起身体多系统的损害；导致各种组织，特别是眼、肾、心脏、血管、神经的慢性损害、功能障碍。部分患者需要终身胰岛素治疗。
中国糖尿病患者人数居全球之首；据2015年不完全统计，中国糖尿病患者人数约1亿多人，还在不断增加，令人焦急。其中I型糖尿病占比5％，II型糖尿病占比90％，娠糖尿病占比4％，其他糖尿病占比1％。
发明内容
本发明的目的在于克服现有技术的不足之处而提供一种用于治疗糖尿病的生物中药内服药。
为实现上述目的，本发明采取的技术方案为：所述生物中药内服药由中药部分处方和内种酶处方组成，所述中药部分处方包含下述制备原料：鬼针草、明月草、翻白草、仙鹤草、西洋参、鸡血藤、山萸肉、茯苓、土生地、钩藤和益智仁；所述中药部分处方采用常规煎煮提取法与生物技术酶解法相结合的方法制得；其中，生物技术酶解法中所用的酶为外种酶，所述外种酶为果胶酶、脂肪酶、淀粉酶、大豆蛋白酶和纤维素酶；所述内种酶处方为复方胰岛修复酶，所述复方胰岛修复酶包含胰激肽原酶、胰蛋白酶、DNA聚合酶、歧化酶、啤酒酶和木瓜酶。
本发明所述中药部分处方对糖尿病并发心、脑血管、肾脏、眼底及神经系统等病变均有很好疗效，具体而言，中药部分处方方解如下：
鬼针草、明月草、翻白草、仙鹤草、土生地、均有剌激胰岛细胞增殖、胰β-细胞增生、抑制α-细胞的敏感度，促进胰脏器官再造胰岛素功能，减少糖尿病患者对胰岛素的依赖；促进血糖代谢、降底血液粘稠度；鸡血藤、山萸肉、益智仁，益精生髓，调节、促进大脑健康.钩藤对舒缓血管防止血栓的形成，特别在大脑部位有明显效果。以上诸药对糖尿病并发心、脑血管、肾脏、眼底及神经系统等病变均有很好疗效。
药煎煮法提取的中药液内包含了大量的果胶、脂肪、淀粉、糖分类等物质，影响了有效成分的释放，故在中药煎煮法提取的中药液及药渣中再运用生物酶提取，能最大程度提高中药有效成分的释放。两法合用，比单纯任何一法获取的中药有效成份要高、要纯。
所述内种酶处方，即复方胰岛修复酶有两大功效：1、即在经已浓缩干燥获得的中药提取物中、加入一定组合，一定数量的生物酶，组成内服剂型。让中药治疗功效大幅提升；2、
Figure PCTCN2016097644-appb-000001
方胰岛修复酶”对剌激、激活，促进胰脏器官再造胰岛素功能，减少糖尿病患者对治疗胰岛素的的依赖，促进血糖代谢、降底血液粘稠度起促进作用。
作为本发明所述用于治疗糖尿病的生物中药内服药的优选实施方式，所述中药部分处方包含下述重量份的中药原料：鬼针草1～10份、明月草1～10份、翻白草1～10份、仙鹤草1～10份、西洋参1～10份、鸡血藤1～10份、山萸肉1～10份、茯苓1～10份、土生地1～10份、钩藤1～10份、益智仁1～10份。
作为本发明所述用于治疗糖尿病的生物中药内服药的优选实施方式，所述内种酶处方包含下述含量的酶：胰蛋白酶0.1万-100ц\g、胰激肽原酶0.1万-100ц\g、DNA聚合酶0.1万-100ц\g、歧化酶0.1万-100ц\g、啤酒酶0.1万-100ц\g、木瓜酶0.1万-100ц\g。
另外，本发明还提供了一种所述用于治疗糖尿病的生物中药内服药的制备方法，包括以下步骤：
(1)、提取中药部分处方的有效成分：将中药部分处方所需中药原料按比例混合，将中药混合物与水按1∶20混合，50-60℃低温提取2-3h，得中药滤液，再将水与中药滤液按1∶10混合，50-60℃低温提取1-2h。
(2)、生物酶酶解法进一步提取中药部分处方的有效成分：将步骤(1)所得中药滤液与中药药渣混合，冷却至30-50℃，将外种酶处方所需酶按分量溶解加至中药滤液与中药药渣的 混合物中，在PH为4-6、温度为30-50℃的条件下，酶解物2-20h，过滤，得中药清液，干燥至中药粉；
(3)按所需比例将内种酶处方加入步骤(2)所得的中药粉中，按常规组成各种内服剂型，检验，包装，得本发明所述用于治疗糖尿病的生物中药内服药。
本发明所述用于治疗糖尿病的生物中药内服药的制备方法的工艺程序为：筛选清洁中药材→粉碎→按分量调配→常规煎煮提取两次→冷却→加生物酶酶解提取→过滤→浓缩→干燥→检验→生物酶与浓缩干燥获得的中药提取物混合组成内服剂型→检验→包装→入库。其中本发明所述用于治疗糖尿病的生物中药内服药的制备方法中，中药部分处方的有效成分采用以下制备方法制得：
(1)、提取中药部分处方的有效成分：将中药部分处方所需中药原料按比例混合，将中药混合物与水按1∶20混合，50-60℃低温提取2-3h，得中药滤液，再将水与中药滤液按1∶10混合，50-60℃低温提取1-2h；
(2)、生物酶酶解法进一步提取中药部分处方的有效成分：将步骤(1)所得中药滤液与中药药渣混合，冷却至30-50℃，将外种酶处方所需酶按分量溶解加至中药滤液与中药药渣的混合物中，在PH为4-6、温度为30-50℃的条件下，酶解物2-20h，过滤，得中药清液，干燥至中药粉。
作为本发明所述用于治疗糖尿病的生物中药内服药的制备方法的优选实施方式，所述步骤(1)中中药部分处方包含下述重量份的中药原料：鬼针草1～10份、明月草1～10份、翻白草1～10份、仙鹤草1～10份、西洋参1～10份、鸡血藤1～10份、山萸肉1～10份、茯苓1～10份、土生地1～10份、钩藤1～10份、益智仁1～10份。作为本发明所述用于治疗糖尿病的生物中药内服药的制备方法的优选实施方式，所述步骤(2)中外种酶处方为果胶酶、脂肪酶、淀粉酶、大豆蛋白酶、纤维素酶。所述外种酶处方，能有效酶解果胶、脂肪、淀粉、糖分类等物质，使得中药有效成分最大程度释放并获得。
作为本发明所述用于治疗糖尿病的生物中药内服药的制备方法的优选实施方式，所述步骤(3)中所述内种酶处方包含下述含量的酶：胰蛋白酶0.1万-100ц\g、胰激肽原酶0.1万-100ц\g、DNA聚合酶0.1万-100ц\g、歧化酶0.1万-100ц\g、啤酒酶0.1万-100ц\g、木瓜酶0.1万-100ц\g。
作为本发明所述用于治疗糖尿病的生物中药内服药的制备方法的优选实施方式，所述外 种酶处方中所用酶的酶单位及份量为：果胶酶0.1万-100ц\g、1-10份；脂肪酶0.11万-100万ц\g、1-10份，淀粉酶0.1万-100万ц\g、1-10份，大豆蛋白酶0.1万-100万ц\g、1-10份、纤维素酶0.1万-100万ц\g、1-10份。
作为本发明所述用于治疗糖尿病的生物中药内服药的制备方法的优选实施方式，所述步骤(1)之前还包括步骤(1a)：将各中药部分处方的中药原料粉碎。将原料粉碎，有利于提取原料中的有效物质。
作为本发明所述用于治疗糖尿病的生物中药内服药的制备方法的优选实施方式，所述步骤(2)中将中药清液干燥成粉后粉碎至60-120目。
作为本发明所述用于治疗糖尿病的生物中药内服药的制备方法的优选实施方式，所述步骤(3)中可以将内种酶处方与中药粉按比例混匀后制备成各种内服剂型制剂。
另外，本发明公开一种药物组合物，所述药物组合物包含权利要求1～4任一项所述用于治疗糖尿病的生物中药内服药和药物学上接受的赋形剂或载体。
作为本发明所述药物组合物的优选实施方式，所述药物学上接受的赋形剂或载体为水、淀粉、酒、胶囊壳等。
作为本发明所述药物组合物的优选实施方式，所述药物组合物的剂型为胶囊、片剂、粉剂、丸剂或口服液等。
与现有技术相比，本发明的有益效果为：首先，本发明所述生物中药内服药运用生物技术与中医药相结合，在传统中药成分中添加内种酶处方，提出了一个研究、创造医治糖尿病有效的药物以及新思路、新方法；其次，本发明所述中药成分可治疗糖尿病，且其具有以下特点：1、剌激、促进胰脏器官再造胰岛素功能，减少糖尿病患者对医药胰岛素的的依赖；2、促进血糖代谢、降底血液粘稠度；促进肾、脑健康{肾生精益髓}：调整大脑神经、平衡脑垂体激素分泌、舒张脑血管。通过调节大脑功能，对促进胰岛素再生能力非常有效。经临床验证，本发明的中药提取物及含有该中药提取物的药物组合物治疗糖尿病的有效率达100％，对II型糖尿病远期治愈效果达90％以上。
另外，本发明所述用于治疗糖尿病的生物中药内服药的制备方法，其综合使用常规煎煮法与生物技术酶解法来提取中药材中的有效物质，这样能提高中药有效成分的释放，获取的 中药有效成份更高、更纯。
本发明中药提取物的制备方法通过生物酶、酶解所提取的底物中药的有效成分比常规提取高出四、五倍含量，为药物能最大限度被人体吸收提供可能，而药物组合物中的酶把多种中药的有效成分在胃肠道内酶解、溶合、转变成多分多合(多分子，多物质结合)植物“类谷维酸”，完成了物质从量到质的变化，这时候治疗糖尿病的中药有效成分、已经被酶解转变成“纳米级”的有效物质，为药物能最大限度被人体吸收提供可能。
具体实施方式
为更好地说明本发明的目的、技术方案和优点，下面将结合具体实施例对本发明作进一步说明。
本发明所述用于治疗糖尿病的生物中药内服药可制成各种治疗糖尿病生物中药剂型，以下实施例中的“临床病例综合简述”采用的是本发明所述生物中药内服药处方、制备方法制作成的治糖尿病“生物中药胶囊”。
实施例1
本发明所述用于治疗糖尿病的生物中药内服药的一种实施例，本实施例所述生物中药内服药的制备原料为：中药部分处分：鬼针草1份、明月草10份、翻白草10份、仙鹤草10份、西洋参1份、鸡血藤10份、山萸肉1份、茯苓1份、土生地1份、钩藤10份、益智仁10份；外种酶处方：果胶酶0.1万-100ц\g、1份，脂肪酶0.11万-100万ц\g、10份，淀粉酶0.1万-100万ц\g、10份，大豆蛋白0.1万-100万ц\g、10份，纤维素酶0.1万-100万ц\g、1份；内种酶处方：胰蛋白酶0.1万-100ц\g，胰激肽原酶0.1万-100ц\g，DNA聚合酶0.1万-100ц\g，歧化酶0.1万-100ц\g，啤酒酶0.1万-100ц\g，木瓜酶0.1万-100ц\g。其中，所述份均为重量份。
本实施例所述用于治疗糖尿病的生物中药内服药的制备方法为：
(1)筛选清洁中药制备原料，并将制备原料均粉碎至20
Figure PCTCN2016097644-appb-000002
(2)、低温提取中药部分处方的有效成分：将中药部分处方所需中药原料按比例混合，将中药混合物与水按1∶20混合，50-60℃低温提取2h，得中药滤液，再将水与中药滤液按1∶10混合，50-60℃低温提取1h。
(3)、生物酶酶解法进一步提取中药部分处方的有效成分：将步骤(1)所得中药滤液与中药药渣混合，冷却至30-50℃，将外种酶处方所需酶按分量溶解加至中药滤液与中药药渣的混合物中，在PH为4-6、温度为30-50℃的条件下，酶解物2-20h，过滤，得中药清液，干燥至中药粉；
(4)按所需比例将内种酶处方加入步骤(2)所得的中药粉中，按常规组成各种内服剂型，检验，包装，得本发明所述用于治疗糖尿病的生物中药内服药。
实施例2
本发明所述用于治疗糖尿病的生物中药内服药的一种实施例，本实施例所述生物中药内服药的制备原料为：中药部分处分：鬼针草10份、明月草1份、翻白草1份、仙鹤草1份、西洋参10份、鸡血藤1份、山萸肉10份、茯苓10份、土生地10份、钩藤1份、益智仁1份；外种酶处方：果胶酶0.1万-100ц\g、10份，脂肪酶0.11万-100万ц\g、1份，淀粉酶0.1万-100万ц\g、1份，大豆蛋白酶0.1万-100万ц\g、1份，纤维素酶0.1万-100万ц\g、10份；内种酶处方：胰蛋白酶0.1万-100ц\g，胰激肽原酶0.1万-100ц\g，DNA聚合酶0.1万-100ц\g，歧化酶0.1万-100ц\g，啤酒酶0.1万-100ц\g，木瓜酶0.1万-100ц\g。其中，所述份均为重量份。
本实施例所述用于治疗糖尿病的生物中药内服药的制备方法同实施例1。
实施例3
本发明所述用于治疗糖尿病的生物中药内服药的一种实施例，本实施例所述生物中药内服药的制备原料为：中药部分处分：鬼针草5份、明月草8份、翻白草9份、仙鹤草6份、西洋参5份、鸡血藤7份、山萸肉9份、茯苓8份、土生地8份、钩藤9份、益智仁8份；外种酶处方：果胶酶0.1万-100ц\g、4份，脂肪酶0.11万-100万ц\g、5份，淀粉酶0.1万-100万ц\g、6份，大豆蛋白酶0.1万-100万ц\g、4份，纤维素酶0.1万-100万ц\g、8份；内种酶处方：胰蛋白酶0.1万-100ц\g，胰激肽原酶0.1万-100ц\g，DNA聚合酶0.1万-100ц\g，歧化酶0.1万-100ц\g，啤酒酶0.1万-100ц\g，木瓜酶0.1万-100ц\g。其中，所述份均为重量份。
本实施例所述用于治疗糖尿病的生物中药内服药的制备方法同实施例1。
实施例4
本发明所述药物组合物的一种实施例，本实施例所述药物组合物包含所述用于治疗糖尿病的生物中药内服药和药物学上接受的赋形剂或载体。所述生物中药内服药的制备原料为：中药部分处分：鬼针草7份、明月草9份、翻白草8份、仙鹤草9份、西洋参8份、鸡血藤6份、山萸肉7份、茯苓6份、土生地8份、钩藤7份、益智仁8份；外种酶处方：果胶酶0.1万-100ц\g、4份，脂肪酶0.11万-100万ц\g、5份，淀粉酶0.1万-100万ц\g、6份，大豆蛋白酶0.1万-100万ц\g、5份，纤维素酶0.1万-100万ц\g、9份；内种酶处方：胰蛋白酶0.1万-100ц\g，胰激肽原酶0.1万-100ц\g，DNA聚合酶0.1万-100ц\g，歧化酶0.1万-100ц\g，啤酒酶0.1万-100ц\g，木瓜酶0.1万-100ц\g。其中，所述份均为重量份。所述药物学上接受的载体为胶囊壳。
本实施例所述用于治疗糖尿病的生物中药内服药的制备方法同实施例1。然后采用常规生产工艺，将本发明所述药物组合物制备成生物中药胶囊剂型。
实施例5
我们将本发明的用于治疗糖尿病的生物中药内服药用于临床中，考察了其效果。具体考察方式以及考察结果如下：
根据糖尿病新诊断标准1999WHO，以及2002年《中医新药临床研究指导原则》中所列症状的疾病及主要检测指标、疗效判定标准，以及糖尿病症状分级量表中所列症状，并经临床资料判定符合I、II型糖尿病诊断，归纳简述如下：
1.1、临床时间：2009-2014；
1.2、糖尿病临床病例资料150例，有家族糖尿病史者15例；
1.3、按糖尿病性质排：
1型糖尿病患者15例，占10％；
2型糖尿病患者135例，占90％；
有糖尿病并发症者例，占60％；在合并症中，有的患者几个合并症同时兼有；
1.4、按糖尿病患病时间排：
病程最短者9个月；
病程最长者36年；
1.5、按糖尿病患者年龄排：
16-68岁其中：
16——25岁5例；占3％；
26——40岁38例；占25％；
41——55岁63例；占42％；
56岁——60岁以上45例占30％；
1.6、治疗用药：内服治疗糖尿病“生物中药胶囊”；
1.7、用量与用法：每天4\6粒，早、午、晚饭后服用，内服2\3粒；
1.8、治疗时间：60天[一个疗程]；
1.9、用药治疗原则：
对使用医药胰岛素或其它降糖药的糖尿病患者，在服用治疗糖尿病“生物中药胶囊”同时，不能马上停止医药胰岛素或其它降糖药物的服用，原因是身体及病程对新的药物有一个缓冲接受过程，必须根据病情循序替代，至治疗糖尿病“生物中药胶囊”起效，控制其病程，方可停止服用其它的药物。对于刚发现有II糖尿病症状，血糖偏高类糖尿病患者，直接服用治疗糖尿病“生物中药胶囊”即可。该药也可用于保健预防糖尿病的发生；
1.10、治疗效果：
现抽取五个典型病例介绍：
【临床案例1】
【姓名】陈生【性别】男【年龄】50岁
【病史】5年
【症状】糖尿病患者
【治疗用药】内服”《专治糖尿病生物中药胶囊》，2粒/次，2次/日
【症状】
糖尿病患者陈生于5年前患糖尿病，曾在广东省医院多处求医，医疗效果反反复复，血糖时高时底，初诊于2009年6月19日，经检测：空腹血糖16.45mmol/L，尿蛋白+++，糖化血糖12.30mmol/L。临床症状：常头晕，健忘，心烦易怒，情志抑郁。口苦，咽干，小便偏黄，大便经常秘结，三多症状不明显，体质虚胖，常感乏力。脉弦细，舌质偏红，舌心略黄，面色晦滞。诊为阴虚内热，肝气郁结，肾精亏损，天长日久积屈而成糖尿病。
服用“《专治糖尿病生物中药胶囊》”10天后，停用口服降糖药物。30天后，经检测，尿蛋白，血糖、恢复正常。继续保持常规药量，一疗程后，停药。两年后回访，各化验指标正常。
【临床案例2】
【姓名】李女士【性别】女【年龄】55岁
【病史】24年
【症状】糖尿病兼肾功能障碍【肾病】
【治疗用药】内服《专治糖尿病生物中药胶囊》3粒/次，2次/日
【症状】
2010年3月5日就诊：面部浮肿，双下肢轻压下指印明显，口干渴，饮不多，夜间尿频，面晦、头晕，耳鸣，眼晴干涩，乏力，腰膝酸软，便溏量少，舌质黯淡，舌下静脉有青紫斑点，苔白腻，脉沉弱细涩。空腹血糖12.83mmol/L，尿蛋白+++，血尿素氮24mg％，
Figure PCTCN2016097644-appb-000003
1mg％，血压165/90mmHg，辩证为脾肾阳虚，水湿内停，瘀血阻滞属糖尿病肾功能减退而至水肿。
服用《专治糖尿病生物中药胶囊》10天后，血糖基本稳定，各症状减轻。减少前药、直至停用其它降糖药物。内服《专治糖尿病生物中药胶囊》60天后，浮肿，其它症状消失，肾功能得到明显改善，病情稳定。经检测，尿蛋白，血糖、恢复正常。继续保持常规药量一疗程。2011年6月回访，病情没有出现反复，化验指标正常，自我感觉良好。
【临床案例3】
【姓名】黄生【性别】男【年龄】61岁
【病史】13年
【症状】糖尿病并发冠心病、高血压病
【治疗药物】内服《专治糖尿病生物中药胶囊》2粒/次，3次/日
【症状】
患者2009年8月就诊。有糖尿病史13年，日常口服降糖药为主。查病历综述：半年前消瘦乏力加重，伴心悸、头晕、神疲、胸闷不适，针刺样胸痛阵作，口干欲饮，大便干结，舌暗红有瘀点，苔薄少津，舌体胖，边有齿印，舌下静脉青紫，脉沉细涩无力。心电图示冠状动脉供血不足，诊断为冠心病，高血压病(II期)。加服心脑血管等药物至今，效果并不显著。化验：空腹血13.8mmol/L，
Figure PCTCN2016097644-appb-000004
(+++)，
Figure PCTCN2016097644-appb-000005
体(++)三酰苷油2.5mmol/L，胆固醇6.9mmol/L，脂蛋白(a)480mg/L，血浆粘度2.18mpas。血压24/13.5KPa。
内服《专治糖尿病生物中药胶囊》，10天后，各症状减轻，减少前药、直至停用其它降糖药物。60天后，复查：心电图心肌缺血症状明显消失，空腹血糖6.8mmol/L，血脂、血浆黏度指数正常，并发症已不明显，血糖得到控制。加一疗程巩固治疗。一年后回访，未见上述诸症出现。
【临床案例4】
【姓名】邓生【性别】男【年龄】58岁
【病史】8年
【症状】糖尿病合并心脑血管硬化、视网膜炎、
【治疗用药】内服《专治糖尿病生物中药胶囊》2粒/次，3次/日
【症状】
2012年3月15号患者就诊，自述：2011年8月自觉头昏目眩、视力莫糊，心悸气喘、日暂加重。广州某三甲医院诊断为糖尿病并发心脑血管硬化、视网膜炎、曾住院，舒缓后出院，反反复复，终日不得安宁，Bp8.5/4KPa，ECG示心供血不足，空腹血糖14.5mmol/L，尿蛋白(++++)，
内服《专治糖尿病生物中药胶囊》10天后，减少前药、直至只服用《专治糖尿病生物中药胶囊》一疗程，头晕目眩等症状消失，双脉细缓有力，视力明显改善。查空腹血糖、尿蛋白均降至正常。加一疗程巩固治疗。2013年8月回访，未见上述诸症出现。
【临床案例5】
【姓名】曾女士
【性别】女
【年龄】52岁
【病史】10年
【就诊时间】2012年4月5号
【症状】糖尿病并发视网膜病变，心脏病，肾脏病，周围性神经病变
【治疗用药】内服《专治糖尿病生物中药胶囊》2粒/次，3次/日
【症状】
一、2012年4月5号患者就诊，诊见：面浮、四肢肿、面色萎黄憔悴，语声低微、心烦心悸、短气似喘，胸前剧痛，少寝多梦，盗汗，五心烦热，渴饮无度，小便频数急胀，浑浊秽臭，有泡沫浮油样物，口腔溃烂，口泛涎痰，口秽喷人，齿衄鼻衄，手指关节及膝踝关节疼痛麻木，胃痛厌食，眼睛干涩不适，视物模糊，视力显著减退，舌干无苔，脉细数而涩。查：空腹血糖20.5mmol/l，尿糖++++，尿蛋白+++，尿酮体-，血沉23mm/h。心电图：ST-T改变。五官科眼底检查：视网膜病变II期，伴有少许陈旧性出血，静脉扩张。诊为糖尿病并发性视网膜病变，糖尿病性心脏病，糖尿病性肾脏病，糖尿病性周围神经病变。
【治疗用药】患者就诊所前所用药物不变，加内服《专治糖尿病生物中药胶囊》，15天后，减 少前药、直至只服用《专治糖尿病生物中药胶囊》一疗程，上述症状好转明显，加一疗程巩固治疗。2013年8月回访，未见上述诸症出现。查空腹血糖、尿蛋白均降至正常。
从以上结果可以看出，本发明所述用于治疗糖尿病的生物中药内服药具有良好治疗效果，对其进行药物疗效拆分，其最大的特点是：1、剌激、促进胰脏器官再造胰岛素功能，减少糖尿病患者对医药胰岛素的的依赖；2、促进血糖代谢、降底血液粘稠度；3、促进肾、脑健康{肾生精益髓}：调整大脑神经、平衡脑垂体激素分泌、舒张脑血管.通过调节大脑功能，对促进胰岛素再生能力非常有效。
任何药物，不管多么对症、功效多么神奇，要产生良好医疗效果必须具备两个条件；1、足够的药量；2、最大限度被人体吸收。生物技术通过外种生物酶、酶解提取底物中药的有效成分比常规提取高出四、五倍含量，这相对地满足了第一个条件，并为药物最大限度被人体吸收创造了可能。而内种生物酶把多种中药的有效成分在胃肠道内酶解、溶合、转变成多分多合(多分子，多物质结合)植物“类谷维酸”，就象大米变成酒，完成了物质从量到质的变化，这时候治疗糖尿病“生物中药胶囊”的中药有效成分、已经被酶解转变成“纳米级”的有效物质，能够“最大限度被人体吸收”。而糖尿病所带来的并发症，其根在糖尿病，“皮之不存，毛之焉附”。在临床上只要医治了糖尿病，就为其它的并发症缓解或全愈，创造了很好的生理条件。更何况处方的药物对这类并发症的疗效也十分显著。
最后所应当说明的是，以上实施例仅用以说明本发明的技术方案而非对本发明保护范围的限制，尽管参照较佳实施例对本发明作了详细说明，本领域的普通技术人员应当理解，可以对本发明的技术方案进行修改或者等同替换，而不脱离本发明技术方案的实质和范围。

Claims (10)

  1. 一种用于治疗糖尿病的生物中药内服药，其特征在于，所述生物中药内服药由中药部分处方和内种酶处方组成，所述中药部分处方包含下述制备原料：鬼针草、明月草、翻白草、仙鹤草、西洋参、鸡血藤、山萸肉、茯苓、土生地、钩藤和益智仁；
    所述中药部分处方采用常规煎煮提取法与生物技术酶解法相结合的方法制得；其中，生物技术酶解法中所用的酶为外种酶，所述外种酶为果胶酶、脂肪酶、淀粉酶、大豆蛋白酶和纤维素酶；
    所述内种酶处方为复方胰岛修复酶，所述复方胰岛修复酶包含胰激肽原酶、胰蛋白酶、DNA聚合酶、歧化酶、啤酒酶和木瓜酶。
  2. 如权利要求1所述用于治疗糖尿病的生物中药内服药，其特征在于，所述中药部分处方包含下述重量份的中药原料：鬼针草1～10份、明月草1～10份、翻白草1～10份、仙鹤草1～10份、西洋参1～10份、鸡血藤1～10份、山萸肉1～10份、茯苓1～10份、土生地1～10份、钩藤1～10份、益智仁1～10份。
  3. 如权利要求1所述用于治疗糖尿病的生物中药内服药，其特征在于，所述内种酶处方包含下述含量的酶：胰蛋白酶0.1万-100ц\g、胰激肽原酶0.1万-100ц\g、DNA聚合酶0.1万-100ц\g、歧化酶0.1万-100ц\g、啤酒酶0.1万-100ц\g、木瓜酶0.1万-100ц\g。
  4. 如权利要求1所述用于治疗糖尿病的生物中药内服药，其特征在于，所述外种酶处方中所用酶的酶单位及份量为：果胶酶0.1万-100ц\g、1-10份；脂肪酶0.11万-100万ц\g、1-10份，淀粉酶0.1万-100万ц\g、1-10份，大豆蛋白酶0.1万-100万ц\g、1-10份、纤维素酶0.1万-100万ц\g、1-10份。
  5. 一种如权利要求1～4任一项所述用于治疗糖尿病的生物中药内服药的制备方法，其特征在于，包括以下步骤：
    (1)、提取中药部分处方的有效成分：将中药部分处方所需中药原料按比例混合，将中药混合物与水按1∶20混合，50-60℃提取2-3h，得中药滤液，再将水与中药滤液按1∶10混合，50-60℃低温提取1-2h；
    (2)、生物酶酶解法进一步提取中药部分处方的有效成分：将步骤(1)所得中药滤液与 中药药渣混合，冷却至30-50℃，将外种酶处方所需酶按分量溶解加至中药滤液与中药药渣的混合物中，在PH为4-6、温度为30-50℃的条件下，酶解物2-20h，过滤，得中药清液，干燥至中药粉；
    (3)按所需比例将内种酶处方加入步骤(2)所得的中药粉中，按常规组成各种内服剂型，检验，包装，得本发明所述用于治疗糖尿病的生物中药内服药。
  6. 如权利要求5所述用于治疗糖尿病的生物中药内服药的制备方法，其特征在于，所述步骤(1)之前还包括步骤(1a)：将各中药部分处方的中药原料粉碎。
  7. 如权利要求5所述用于治疗糖尿病的生物中药内服药的制备方法，其特征在于，所述步骤(2)中将中药清液干燥成粉后粉碎至60-120目。
  8. 一种药物组合物，包含权利要求1～4任一项所述用于治疗糖尿病的生物中药内服药和药物学上接受的赋形剂或载体。
  9. 如权利要求8所述的药物组合物，其特征在于，所述药物学上接受的赋形剂或载体为水、淀粉、酒、胶囊壳。
  10. 如权利要求8或9所述的药物组合物，其特征在于，所述药物组合物的剂型为胶囊、片剂、粉剂、丸剂、酒剂、口服液等制剂型。
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