Pharmaceutical composition for treating diabetes and its process for preparation

A method for preparing a pharmaceutical composition for treatment of diabetes mellitus, the pharmaceutical composition comprises extracts of the following crude drugs:

• 5-40 weight parts of Radix Trichosanthis (Tianhuafen), 10-30 weight parts of Radix Bupleuri (Chaihu), 3-15 weight parts of Fructus Aurantii Immaturus (Zhishi), 1-6 weight parts of Radix et Rhizoma Rhei (Dahuang), 1-12 weight parts of Rhizoma Pinelliae (Banxia), 3-15 weight parts of Radix Scutellariae (Huangqin), 1-12 weight parts of Rhizoma Coptidis (Huanglian), 3-15 weight parts of Radix Paeoniae Alba (Baishao) and 5-20 weight parts of Fructus Mume (Wumei), and optionally comprises pharmaceutically acceptable excipient;
• the pharmaceutical composition is prepared by any one of the following methods:
• The first method comprises the following:
• providing the crude drugs in accordance with the weight parts as described above;
• extracting the crude drugs with water by reflux, filtering the extract liquid and concentrating under reduced pressure;
• adding ethanol into the concentrated extract liquid to make the ethanol content to 65-75% and filtering;
• concentrating the filtrate under reduced pressure to produce an extract;
• optionally adding excipient into the extract of the extract derived from concentrating the filtrate to prepare into pharmaceutically acceptable dosage form;
• The second method comprises the following:
• providing the crude drugs in accordance with weight parts as described above;
• extracting the crude drugs with water by reflux, cooling down the extract liquid, filtering and combining to give a filtrate;
• loading the filtrate onto macro-porous adsorption resin, firstly washing with water, discarding the eluate, continuing to wash with ethanol having a certain concentration, combining the ethanol eluate and recovering ethanol under reduced pressure to give an extract;
• optionally adding excipient into the extract from the loading the filtrate to prepare into pharmaceutically acceptable dosage form;
• The third method comprises the following:
• providing the crude drugs in accordance with weight parts as described above;
• extracting the following crude drugs with ethanol having a certain concentration by reflux:
• Radix Bupleuri, Radix Paeoniae Alba, Fructus Aurantii Immaturus, Radix et Rhizoma Rhei, Radix Scutellariae and Rhizoma Coptidis, cooling down the extract liquid, filtering and combining;
• adding the other drugs into the drug residue from the extracting the crude drugs, continuously extracting with water by reflux, concentrating the extract liquid under reduced pressure, followed by adding ethanol into the concentrated extract liquid to make the ethanol content to 65-75% and filtering;
• combining the filtrate of the extracting the crude drugs and the adding the other drugs and concentrating into an extract;
• optionally adding excipient into the extract from the combining the filtrate prepare into pharmaceutically acceptable dosage form;
• The fourth method comprises the following:
• providing the crude drugs in accordance with weight parts as described above;
• extracting the Radix Scutellariae with water by reflux, combining the extract liquid, adjusting pH value to 1.5-2.0, keeping temperature, standing still, filtering, washing the sediments with water until the pH value becomes 5-6, drying to give the dry powder of Radix Scutellariae extract;
• extracting the Rhizoma Coptidis with ethanol by reflux, combining the extract liquid, filtering, recovering ethanol until no flavor of ethanol can be smelled, adjusting the pH value to 1-2, storing under a cold condition overnight, filtering, washing the sediments with water until the pH value becomes 5-6, drying to give the dry powder of Rhizoma Coptidis extract;
• extracting the other drugs with water by reflux, combining the extract liquid, concentrating, cooling down, followed by adding 95% ethanol to make the ethanol content to 70%, standing still, filtering, recovering ethanol to give an extract, drying to give the dry powder of extract, and;
• combining well the dry powder of extracts obtained in the above three steps, into which excipient is added optionally to prepare into pharmaceutically acceptable dosage form.