TWI419698B - Pharmaceutical composition for treating diabetes and its preparation method - Google Patents

Description

Medicine composition for treating diabetes and preparation method thereof

The present invention relates to a process for the preparation of a pharmaceutical composition for treating diabetes, and a pharmaceutical composition prepared by the method.

Diabetes is a chronic progressive life-threatening disorder caused by disorders of sugar, protein and fat metabolism in the body, characterized by hyperglycemia and diabetes. This disease can lead to heart and kidney complications, blindness and amputation. In recent years, clinical observation shows that the incidence of diabetes is increasing year by year. At present, there are about 150 million diabetic patients in the world, and the number of diabetes in China is over 40 million. Among the cases of diabetes, a small number are insulin-dependent diabetes mellitus (type I), and most are non-insulin-dependent diabetes mellitus (type II). Most people with diabetes need to take medication for life.

At present, the treatment of diabetes is still based on chemical synthetic drugs, such as sulfonamides, biguanides, glucosidase inhibitors, glinides and insulin sensitizers. However, the long-term side effects of these drugs are relatively large.

Traditional Chinese medicine has a long history of preventing and treating diabetes. After thousands of years of practice, it has accumulated a lot of valuable experience and formed a unique academic system. Chinese medicine classics record many traditional Chinese medicines with hypoglycemic effects, such as Alisma, Anemarrhena, American ginseng, Pueraria, Rehmannia, and pollen. Traditional Chinese medicine treatment of diabetes is based on clinical symptoms. However, there is no good treatment in the period of impaired glucose tolerance and early onset of diabetes.

Diabetes is the first place to be responsible for the liver and stomach. The stagnation of heat is the pathological basis of diabetes, "Mu Yu Da Zhi", "Tu Yu Yu Zhi", so it is mainly based on dredging, that is, "it must be the owner of the disease, and First, the cause." Sugar-sensitive spirit opens the stomach and clears the stomach, nourishing yin and reducing fire, all night It is diarrhea, both the symptoms and the cure, and the stagnation of the stagnation is clear. "Criteria for the rule of law. Dispelling the cloud: "Let the roads to be scattered, the liquid is not dry, the blood is not dry, and the disease is self-defeating." Therefore, the treatment of diabetes is to clear the stomach, nourish the yin and reduce the fire. It is turbid.

According to the traditional Chinese medicine theory, the gastrointestinal stagnation caused by overeating and less movement makes the middle coke atmospheric transport blocked, the atmosphere does not turn, the hepatobiliary leakage is also closed, the stagnation and heat, the hepatobiliary gastrointestinal lung and other three coke fever. Therefore, the use of berberine, rhubarb for the king, huanglianqing stomach heat, rhubarb diarrhea intestinal heat, this is to cure sweet. White peony, scutellaria, and Bupleurum are the ministers. The white sputum is soft and the liver is convulsive. The sage is not to hurt the yin by the heat of the three cokes. The Bupleurum enters the Shaoyang biliary tract and the sputum yin and liver, clears the heat of the liver and gallbladder, and relieves the spleen and stomach. Hepatic and pulmonary heat.枳 、 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生 生Umeic acid is used to succumb to yin and spleen. This is the acid to make sweet, and the combination of Tianhua powder to save the lungs and the yin, so it should be called the yin.

The inventor based on the theory of traditional Chinese medicine "sweet fever", the research found that the composition consisting of medicinal materials such as trichosanthin, Bupleurum, medlar, rhubarb, pinellia, astragalus, berberine, white peony, and ebony has good effect on diabetes. Therapeutic effect. The drug is disclosed in the applicant's early mainland patent application 200410020220.7, however, the patent application uses a conventional alcohol extraction method, and the extract obtained by the method loses a large amount of water-soluble active ingredient; The rate is low, and the content of the active ingredient is small, so the dose is large, and the corresponding side effects are also increased.

SUMMARY OF THE INVENTION An object of the present invention is to provide a pharmaceutical composition for treating diabetes which has the following composition, which is produced by the following method of the present invention, thereby solving the above problems in the prior art.

A further object of the present invention is to provide a process for the preparation of a pharmaceutical composition of the present invention, which comprises the following extracts prepared from raw materials: 5-40 parts of trichosanthin, 10-30 parts of Bupleurum, and medlar 3-15 parts, 1-6 parts of rhubarb, 1-12 parts of Pinellia, 3-15 parts of astragalus, 1-12 parts of berberine, 3-15 parts of white peony and 5-20 parts of ebony, and optionally containing pharmacy An acceptable excipient; the composition is prepared by one of the following methods: Method 1, comprising the steps of: (1) taking the desired medicinal material according to the parts by weight; (2) adding the medicinal material to reflux extraction , extracting the extract, and concentrating under reduced pressure; (3) adding ethanol to the concentrate to an alcohol content of 65-75%, filtering; (4) concentrating the filtrate under reduced pressure into an extract; (5) optionally in the above The excipient is added to the extract to form a pharmaceutically acceptable dosage form; the second method comprises the following steps: (1) taking the desired medicine according to the weight ratio; (2) adding the water to the reflux extraction, The extract is allowed to cool, filtered, and combined to obtain a filtrate; (3) the filtrate is passed through a macroporous adsorption resin, eluted with water, discarded, and continued to be used at a certain concentration. Ethanol elution, combining the eluate, recovering the ethanol to obtain an extract under reduced pressure; (4) optionally adding an auxiliary material to the above-mentioned extract to prepare a pharmaceutically acceptable dosage form; and the third method comprises the following steps: (1) Taking the desired medicinal material according to the weight ratio; (2) The medicinal materials Bupleurum, Radix Paeoniae Alba, Radix Paeoniae Alba, Rhubarb, Radix Astragali, Rhizoma Coptidis are refluxed with a certain concentration of ethanol, and the extracts are allowed to cool, filter and combine; (3) obtained in the previous step Adding other herbs to the dregs, adding water to reflux extraction, extracting the extract under reduced pressure, adding concentrated ethanol to the alcohol content of 65-75%, filtering; (4) combining the filtrates obtained by (2) and (3), concentrating a immersion cream; (5) optionally adding an auxiliary material to the above-mentioned extract to prepare a pharmaceutically acceptable dosage form; and the method 4 includes the following steps: (1) taking the desired medicinal material according to the weight ratio; (2) refluxing the extract of Astragalus membranaceus with water, combining the extracts, adjusting the pH to 1.5-2.0; keeping warm, standing, filtering, precipitating the pH to 5-6 with water, drying to obtain dried powder of Astragalus membranaceus extract; (3) Coptis chinensis is added with ethanol reflux extraction, the extract is combined, filtered, and the ethanol is recovered to a non-alcoholic taste, and the pH is adjusted to 1-2; refrigerated overnight, filtered, and the precipitate is washed with water to a pH of 5-6, and dried to obtain a dry powder of Coptis chinensis extract; (4) Add other herbs to the water for reflux extraction, combine the extracts, concentrate, let cool, add 95% ethanol, make The alcohol content of the liquid is up to 70%; it is allowed to stand, filtered, and the ethanol is recovered to obtain an extract; dried to obtain an extract dry powder; and (5) the dry powder obtained by the above three steps is uniformly mixed; and optionally added The excipients are formulated in a pharmaceutically acceptable dosage form.

In the pharmaceutical composition prepared by the method of the present invention, the preferred weight ratios of various raw materials are: 9 parts of trichosanthin, 12 parts of Bupleurum, 9 parts of medlar, 3 parts of rhubarb, 6 parts of Pinellia, 9 parts of astragalus, and berberine 6 Parts, 9 times of white peony and ebony 9 copies.

Further, on the basis of the above-mentioned pharmaceutical formula, the pharmaceutical composition of the present invention can also be added to the hawthorn in the formula, because the behenic acid is sallow and yin, which can prevent the sputum from being too suffocating and the bitter acid. sweet. It has a good effect in combination with Kaiyuqing. Therefore, a preferred technical solution is that the ratio of parts by weight of various raw materials is: 5-40 parts of trichosanthin, 10-30 parts of Bupleurum, 3-15 parts of medlar, l-6 parts of rhubarb, 1-12 parts of Pinellia ternata. 3-15 parts of astragalus, l-12 parts of berberine, 3-15 parts of white peony, 5-20 parts of ebony and 3-15 parts of hawthorn.

Therefore, it is more preferred that the weight ratio of various raw materials in the pharmaceutical composition of the present invention is: 10-30 parts of trichosanthin, 10-30 parts of Bupleurum, 3-15 parts of medlar, 1-6 parts of rhubarb, and Pinellia 1 -12 parts, 3-15 parts of astragalus, 1-12 parts of berberine, 3-15 parts of white peony, 5-20 parts of ebony and 3-15 parts of hawthorn.

Most preferably, the weight ratio of various raw materials in the pharmaceutical composition of the present invention is: 30 parts of trichosanthin, 12 parts of Bupleurum, 9 parts of medlar, 3 parts of rhubarb, 6 parts of Pinellia, 9 parts of astragalus, and berberine 6 9 parts, 9 times of white peony, 15 parts of ebony and 9 parts of hawthorn; or 15 parts of trichosanthin, 12 parts of Bupleurum, 9 parts of medlar, 3 parts of rhubarb, 6 parts of Pinellia, 9 parts of Astragalus, 6 parts of berberine, 6 parts of white 9 parts, 15 pieces of ebony and 9 parts of hawthorn.

Specifically, in the first method of the present invention, the following operating conditions are preferably employed: 1. In the step (2), preferably, the extract is refluxed twice, each time using 10 times the weight of the medicinal material, each time 1.5. hour. Preferably, the extract is concentrated to a ratio of the original medicinal weight (kg) to the volume (L) of the concentrate of 1:1.

2. In step (3), the concentration of ethanol added is preferably from 90 to 100%, preferably 95%. After adding ethanol, the alcohol content of the obtained concentrate is preferably It is 70%.

Due to the above extraction method of the water extraction and alcohol precipitation of the present invention, the content of the active ingredient in the traditional Chinese medicine composition prepared by the method is remarkably improved, and the content of the impurities is remarkably reduced, thereby reducing the dose to be administered.

In the above method 2 of the present invention, the following operating conditions are preferably employed: 1. In the step (2), it is preferred to add water twice to reflux and extract twice, each time using 10 times the weight of the medicinal material, one hour for each extraction. .

2. In the step (3), the macroporous resin is preferably of the AB-8 type. The weight ratio of the resin to the medicinal material is preferably from 1:1.6 to 1:3, and more preferably 1:2. The loading speed of the extract is preferably 4-6 column volumes/hour. The amount of water washing is preferably 4-6 column volumes. The concentration of ethanol used for elution is preferably from 80% to 95%, further preferably 90%. The amount of ethanol used is preferably from 2 to 5 column volumes. The temperature at which the ethanol is recovered under reduced pressure is preferably 60-80 ° C, and ethanol is recovered under reduced pressure to obtain an extract having a relative density of from 1.25 to 1.35, preferably a relative density of 1.30.

The above preparation method of the invention adopts a water extraction process to ensure that the water-soluble active ingredients, such as saikosaponin, berberine (berberine hydrochloride), baicalin, chrysophanol, paeoniflorin, synephrine, etc., are maximized. The extraction step of using the macroporous resin adsorption, water washing to remove impurities, and the aqueous solution of ethanol to elute the active ingredient, while retaining the active ingredient, removes most of the impurities.

By adopting the above preparation method, the content of the active ingredient in the traditional Chinese medicine composition of the invention is obviously increased, the content of impurities is greatly reduced, thereby reducing the dosage of administration, and also ensuring the stability between product batches.

In the above method 3 of the present invention, the following operating conditions are preferably employed: 1. In the step (2), the concentration of the ethanol used is 75-90%, preferably It is 80%; preferably, it is extracted twice under reflux, each time using 10 times the weight of the medicinal material of step (2), and each extraction is 1.5 hours.

2. In the step (3), it is preferred to add the other medicinal materials to the dregs obtained in the previous step, and extract twice with water, each time the amount of water is the other medicinal materials added in the step (3) and the step (2). The sum of the weights of the dregs is 10 times, each time for 1.5 hours. Preferably, the extract is concentrated to a ratio of the original medicinal weight (kg) to the volume (L) of the concentrate of 1:1. The concentration of ethanol added is preferably from 90 to 100%, further preferably 95%, so that the alcohol content of the concentrate reaches 65 to 75%, preferably 70%.

In the above preparation method of the present invention, the raw materials such as Bupleurum, Radix Paeoniae Alba, Radix Paeoniae Alba, Rhubarb, Radix Astragali, Rhizoma Coptidis, etc. are firstly extracted, and the residue is combined with other herbs to extract water, thereby ensuring that the active ingredients of the six herbs are fully extracted. Other medicinal materials extract only the active ingredients therein by water because the active ingredients are water-soluble. By the above method of the present invention, the content of the active ingredient in the traditional Chinese medicine composition of the present invention is remarkably improved, and the content of impurities is greatly reduced, so that the dose to be administered can be reduced.

In the above method 4 of the present invention, the following operating conditions are preferably employed: 1. In the step (2), it is preferably extracted twice with water under reflux, each time using 10 times the weight of the xanthine, one hour each time. The holding temperature is preferably 75 to 85 ° C, and more preferably 80 ° C.

2. In step (3), it is preferably extracted twice with ethanol under reflux, each time using 10 times the weight of berberine in ethanol for 2 hours each time. The concentration of ethanol used is preferably from 70 to 85%, further preferably 75%.

In the step (2) and the step (3), the pH adjuster is preferably concentrated hydrochloric acid.

3. In step (4), it is preferred to extract the remaining medicinal materials twice with water, Add 10 times more water to the weight of the medicinal material in step (4) for 1 hour each time. The combined extracts are concentrated to a relative density of 1.03-1.07, preferably a relative density of 1.05. After recovering the ethanol, the ethanol extract is concentrated to an extract having a relative density of 1.25 to 1.35, preferably having a relative density of 1.30.

In the above method of the present invention, the astragalus, berberine and other medicinal materials are separately extracted, and respectively subjected to water extraction or alcohol extraction under a certain pH condition according to their own properties, so as to make the active ingredient in the traditional Chinese medicine composition of the present invention. The content is significantly increased, and the amount of impurities is greatly reduced, thereby reducing the dose administered.

A pharmaceutical composition for treating diabetes having the above composition can be prepared by the above method of the present invention, and the pharmaceutical composition of the present invention can be prepared into any conventional preparation by a conventional method of a traditional Chinese medicine preparation using conventional excipients in the art. . For example, the above-mentioned raw material medicine is ground into a powder, or the prepared extract is dried, pulverized, sieved, ground into a powder, or it is made into a tablet or a capsule orally, or it is made into an injection or the like. However, these cannot be used to limit the scope of protection of the present invention.

The pharmaceutical composition prepared by the method of the present invention has a blood sugar lowering effect and has a good therapeutic effect on diabetes.

Herein, when the ethanol concentration or the alcohol content (that is, the amount of ethanol contained in the system) is described by a percentage, it means a volume percentage concentration or a volume percentage unless otherwise specified.

The drug of the present invention and its beneficial effects are further illustrated by the following examples and test examples, but are not intended to limit the scope of the present invention in any way.

Example 1

Drug formula: 750g of trichosanthin, 1500g of Bupleurum chinense, 450g of medlar, 150g of rhubarb, 150g of Pinellia, 450g of Radix Astragali, 150g of Rhizoma Coptidis, 450g of Radix Paeoniae and 750g of ebony.

The pharmaceutical composition of the present invention was prepared according to the following method: 9-flavored medicinal material was extracted twice with water 10 times its weight under reflux for 1.5 hours, and the extract was filtered, and the extract was concentrated under reduced pressure to the original medicinal weight ( The ratio of the volume (L) of the kg) to the concentrate is 1:1, 90% ethanol is added to the alcohol content of 65%, filtered, and concentrated under reduced pressure to form a thick paste.

Example 2

Using the same formulation as in Example 1, the pharmaceutical composition of the present invention was prepared by the following method: Bupleurum, Angelica, Rhizoma, Rhubarb, Astragalus, and Coptidis Rhizome were refluxed twice with 10 times the weight of 75% ethanol, 1.5 hours each time, the extract was filtered and set aside; the powder obtained in the previous step was added with trichosanthin, ebony and pinellia, and extracted twice with water of 10 times the sum of the weights of the herbs and the dregs, each time. 1.5 hours, the extract was concentrated under reduced pressure to a ratio of the original medicinal material weight (kg) to the volume (L) of the concentrate was 1:1, 90% ethanol was added to the alcohol content of 65%, filtered, and used; The liquid was mixed and concentrated under reduced pressure into a thick paste.

Example 3

Using the same formulation as in Example 1, the pharmaceutical composition of the present invention was prepared by the following method: The above 9 herbs were extracted twice with water and refluxed, and 48.5 kg of water was added each time for 1 hour. The extract was allowed to cool, filtered and combined. Over the AB-8 type The pore adsorption resin, the macroporous adsorption resin was used in an amount of 3.2 kg, and the loading speed was 4 column volumes/hour. First elute with 4 column volumes of water, discard the water eluate, then elute with 2 column volumes of 80% ethanol, combine the alcohol eluates, and recover the ethanol to a relative density of 1.25 at 80 ° C under reduced pressure. It was dried under vacuum at 70 ° C, and the dry paste was pulverized through an 80 mesh sieve. The dried powder after sieving is added with lactose to form a capsule.

Example 4

Using the same formulation as in Example 1, the pharmaceutical composition of the present invention was prepared by the following method: adding 10 times its weight of water to the xanthine, and extracting it twice under reflux for 1 hour each time; combining the extracts, adding concentrated hydrochloric acid to adjust the pH value The mixture was kept at 1.5-2.0, 75 ° C for 1 hour, allowed to stand, filtered; the precipitate was washed with water to a pH of 5-6, dried, and the dried paste was pulverized through an 80 mesh sieve to obtain an extract of Astragalus membranaceus.

Add 10 times of its weight to 70% ethanol and reflux it twice for 2 hours each time; combine the extracts, filter, recover the ethanol to a non-alcoholic taste, add concentrated hydrochloric acid to adjust the pH to 1-2, refrigerate overnight, filter; The precipitate was washed with water to a pH of 5-6, dried, and the dried paste was pulverized through an 80 mesh sieve to obtain a Coptidis extract.

The remaining 7 herbs were added with 10 times their weight of water and refluxed for 2 times each time for 1 hour; the extract was concentrated under reduced pressure to a relative density of 1.03, allowed to cool, and 95% ethanol was added to make the alcohol content 70%; After standing, filtering, ethanol was recovered to a relative density of 1.25, dried, and the dry paste was pulverized through an 80 mesh sieve.

Take three kinds of extract dry powder, mix well, add lactose to it to make capsules.

Example 5

Drug formula: 1200g of trichosanthin, 900g of Bupleurum, 450g of medlar, 180g of rhubarb, 360g of Pinellia, 450g of Radix Astragali, 360g of berberine, 450g of Radix And ebony 600g.

The pharmaceutical composition of the present invention was prepared according to the following method: 9-flavored medicinal material was extracted twice with 10 times its weight of water, 1.5 hours each time, the extract was filtered, and the extract was concentrated under reduced pressure to the original medicinal material weight (kg). The ratio of the volume (L) of the concentrate was 1:1, anhydrous ethanol was added to the alcohol content of 75%, filtered, and concentrated under reduced pressure to a thick paste.

Example 6

Using the same formulation as in Example 5, the pharmaceutical composition of the present invention was prepared by the following method: Bupleurum, Angelica, Poria, Rhubarb, Astragalus, and Coptidis Rhizome were extracted twice with 10 times their weight by 90% ethanol, each time. 1.5 hours, the extract was filtered and set aside; the powder obtained in the previous step was added with trichosanthin, ebony and pinellia, and extracted twice with water of 10 times the sum of the weight of the medicinal material and the dregs, 1.5 hours each time. The extract is concentrated under reduced pressure until the ratio of the original medicinal material weight (kg) to the volume (L) of the concentrated solution is 1:1, anhydrous ethanol is added to the alcohol content of 75%, filtered, and used; the two extracts are mixed. Concentrate under reduced pressure into a thick paste.

Example 7

Using the same formulation as in Example 5, the pharmaceutical composition of the present invention was prepared by the following method: The above 9 herbs were extracted twice with water and refluxed, and 49.5 kg of water was added each time for 1 hour. The extract was allowed to cool, filtered and combined. The AB-8 type macroporous adsorption resin has a macroporous adsorption resin dosage of 1.7 kg and a loading speed of 6 column volumes per hour. First elute with 6 column volumes of water, discard water to elute liquid. Then, the mixture was eluted with 5 column volumes of 95% ethanol, and the alcohol eluate was combined. The ethanol was recovered under reduced pressure at 70 ° C to a relative density of 1.35, vacuum dried at 90 ° C, and the dry paste was pulverized through an 80 mesh sieve.

Starch is compressed into tablets in the obtained dry paste.

Example 8

Using the same formulation as in Example 5, the pharmaceutical composition of the present invention was prepared by the following method: xanthine was added with 10 times its weight of water, and refluxed twice for 1 hour each time; the extract was combined, and concentrated hydrochloric acid was added to adjust the pH to 1.5-2.0, incubated at 85 ° C for 1 hour, allowed to stand, filtered; the precipitate was washed with water to a pH of 5-6, dried, and the dry paste was pulverized through an 80 mesh sieve to obtain an extract of Astragalus membranaceus.

Coptis added 10 times its weight of 85% ethanol reflux extraction twice, each time 2 hours; combined extract, filtered, recovered ethanol to no alcohol flavor, added concentrated hydrochloric acid to adjust the pH to 1-2, refrigerated overnight, filtered; The pH was washed with water to 5-6, dried, and the dry paste was pulverized through an 80 mesh sieve to obtain a Coptidis extract.

The remaining 7 herbs were added with 10 times their weight of water for 2 times, one hour each time; the extract was concentrated under reduced pressure to a relative density of 1.07, allowed to cool, and 95% ethanol was added to make the alcohol content 70%; After filtration, the ethanol was recovered to a relative density of 1.35, dried, and the dry paste was pulverized through an 80 mesh sieve.

Three kinds of extract dry powder were taken, mixed evenly, and starch was added thereto to compress into tablets.

Example 9

Drug formula: 630g of trichosanthin, 840g of Bupleurum, 630g of medlar, 210g of rhubarb, 420g of Pinellia, 630g of astragalus, 420g of Rhizoma coptiflora, 630g of Radix Paeoniae Alba and 630g of ebony.

The pharmaceutical composition of the present invention was prepared according to the following method: 9-flavored medicinal materials were extracted twice with 10 times the weight of water and refluxed for 1.5 hours each time, the extract was filtered, and the extract was concentrated under reduced pressure to the original medicinal material weight (kg) and The volume ratio (L) of the concentrate was 1:1, 95% ethanol was added to the alcohol content of 70%, filtered, and concentrated under reduced pressure to a thick paste.

Example 10

Using the same formulation as in Example 9, the pharmaceutical composition of the present invention was prepared by the following method: Bupleurum, Angelica, Poria, Rhubarb, Astragalus, and Coptidis Rhizome were refluxed twice with 10 times the weight of 80% ethanol, each time. 1.5 hours after the extraction, the extract was filtered and set aside; the powder obtained in the previous step was added with trichosanthin, ebony and pinellia, and extracted with water 10 times the sum of the weight of the medicinal material and the dregs twice, 1.5 times each time. In an hour, the extract is concentrated under reduced pressure until the ratio of the original medicinal material weight (kg) to the volume (L) of the concentrate is 1:1, 95% ethanol is added to the alcohol content 70%, filtered, and used; Mix and concentrate under reduced pressure into a thick paste.

Example 11

Using the same formulation as in Example 9, the pharmaceutical composition of the present invention was prepared by the following method: the above 9 herbs were refluxed twice with water, and 50.4 kg of water was added each time for 1 hour. The extract was allowed to cool, filtered and combined. The AB-8 type macroporous adsorption resin has a macroporous adsorption resin dosage of 2.52 kg and a loading speed of 5 column volumes per hour. First elute with 5 column volumes of water. The water eluate was discarded. The alcohol eluate was then combined by eluting with 3 column volumes of 90% ethanol. The ethanol was recovered under reduced pressure at 70 ° C to a relative density of 1.30, vacuum dried at 80 ° C, and the dry paste was pulverized through an 80 mesh sieve.

A concentrated pellet was prepared by adding microcrystalline cellulose to the obtained dry paste.

Example 12

Using the same formulation as in Example 9, the pharmaceutical composition of the present invention was prepared by the following method: xanthine was added with 10 times its weight of water, and refluxed twice for 1 hour each time; the extract was combined, and concentrated hydrochloric acid was added to adjust the pH to 1.5-2.0, incubate at 80 ° C for 1 hour, let stand, filter; the precipitate is washed with water to a pH of 5-6, dried, and the dry paste is crushed through a 80 mesh sieve to obtain an extract of Astragalus membranaceus.

Coptis added 10 times its weight of 75% ethanol reflux extraction twice, each time 2 hours; combined extract, filtered, recovered ethanol to no alcohol flavor, added concentrated hydrochloric acid to adjust the pH to 1-2, refrigerated overnight, filtered; Wash with water to a pH of 5-6, dry, and dry the paste through a 80 mesh sieve to obtain the extract of Coptidis Rhizoma.

The remaining 7 herbs were added with 10 times their weight of water for 2 times, one hour each time; the extract was concentrated under reduced pressure to a relative density of 1.05, allowed to cool, and 95% ethanol was added to make the alcohol content 70%; The solution was filtered, and the ethanol was recovered to a relative density of 1.30, dried, and the dry paste was pulverized through an 80 mesh sieve.

Take three kinds of extract dry powder, mix well, add microcrystalline cellulose to make concentrated pellets.

Example 13

Drug formula: 750g of trichosanthin, 1500g of Bupleurum chinense, 450g of medlar, 150g of rhubarb, 150g of Pinellia, 450g of astragalus, 150g of berberine, 450g of white peony, 750g of ebony and 450g of hawthorn.

The pharmaceutical composition of the present invention is prepared as follows: The 10 herbs were extracted twice with 10 times the weight of water and refluxed for 1.5 hours each time. The extract was filtered, and the extract was concentrated under reduced pressure until the ratio of the original drug weight (kg) to the volume (L) of the concentrate was 1: 1. Add 90% ethanol to 65% alcohol content, filter, and concentrate to a thick paste under reduced pressure.

Example 14

Using the same formulation as in Example 13, the pharmaceutical composition of the present invention was prepared by the following method: Bupleurum, Angelica, Poria, Rhubarb, Astragalus, and Coptis were refluxed twice with 10 times the weight of 75% ethanol, each time. 1.5 hours after the extraction, the extract was filtered and set aside; the powder obtained in the previous step was added with trichosanthin, ebony, pinellia and hawthorn, and extracted twice with water 10 times the sum of the weight of the medicinal material and the dregs. 1.5 hours after the extraction, the extract was concentrated under reduced pressure to a ratio of the original medicinal material weight (kg) to the volume (L) of the concentrate was 1:1, 90% ethanol was added to the alcohol content of 65%, filtered, and set aside; The extract was mixed and concentrated under reduced pressure into a thick paste.

Example 15

Using the same formulation as in Example 13, the pharmaceutical composition of the present invention was prepared by the following method: The above 10 herbs were refluxed twice with water, and 52.5 kg of water was added each time for 1 hour. The extract will be allowed to cool, filtered and combined. The AB-8 type macroporous adsorption resin has a macroporous adsorption resin dosage of 3.5 kg and a loading speed of 4 column volumes per hour. First elute with 4 column volumes of water. The water eluate was discarded. Then, the mixture was eluted with 2 column volumes of 80% ethanol, and the alcohol eluate was combined. The ethanol was recovered under reduced pressure at 80 ° C to a relative density of 1.35, and vacuum dried at 70 ° C. The dry paste is pulverized through an 80 mesh sieve.

Lactose was added to the obtained dry paste to prepare a capsule.

Example 16

Using the same formulation as in Example 13, the pharmaceutical composition of the present invention was prepared by the following method: xanthine was added with 10 times its weight of water, and refluxed twice for 1 hour each time; the extract was combined, and concentrated hydrochloric acid was added to adjust the pH to 1.5-2.0, 75 ° C for 1 hour, standing, filtered; the precipitate was washed with water to a pH of 5-6, dried, and the dry paste was crushed through a 80 mesh sieve to obtain the Astragalus membranaceus extract.

Coptis plus 10 times its weight of 70% ethanol reflux extraction twice, each time 2 hours; combined extract, filtered, recovered ethanol to a non-alcoholic flavor, added concentrated hydrochloric acid to adjust the pH to 1-2, refrigerated overnight, filtered; Wash with water to a pH of 5-6, dry, and dry the paste through a 80 mesh sieve to obtain the extract of Coptidis Rhizoma. The remaining 8 herbs were added with 10 times their weight of water for 2 times, one hour each time; the extract was concentrated under reduced pressure to a relative density of 1.07, allowed to cool, and 95% ethanol was added to make the alcohol content 70%; The solution was filtered, and ethanol was recovered to a relative density of 1.25, dried, and the dry paste was pulverized through an 80 mesh sieve. Take three kinds of extract dry powder, mix well, add lactose to make capsules.

Example 17

Drug formula: 1200g of trichosanthin, 900g of Bupleurum, 450g of medlar, 180g of rhubarb, 360g of Pinellia, 450g of Radix, 360g of berberine, 450g of white peony, 600g of ebony and 450g of hawthorn.

The pharmaceutical composition of the present invention was prepared according to the following method: 10 kinds of medicinal materials were extracted twice with 10 times the weight of water and refluxed for 1.5 hours each time, the extract was filtered, and the extract was concentrated under reduced pressure to the original medicinal weight. The ratio of (kg) to the volume (L) of the concentrate was 1:1, anhydrous ethanol was added to an alcohol content of 75%, filtered, and concentrated under reduced pressure to a thick paste.

Example 18

Using the same formulation as in Example 17, the pharmaceutical composition of the present invention was prepared by the following method: Bupleurum, Angelica, Poria, Rhubarb, Astragalus, and Coptis were refluxed twice with 10 times the weight of 90% ethanol, each time. After 1.5 hours, the extract was filtered and set aside; the powder obtained in the previous step was added with trichosanthin, ebony, pinellia and hawthorn, and extracted twice with water of 10 times the sum of the weights of the herbs and the dregs. 1.5 hours, the extract was concentrated under reduced pressure to a ratio of the original medicinal weight (kg) to the volume (L) of the concentrate was 1:1, anhydrous ethanol was added to the alcohol content of 75%, filtered, and used; Mix and concentrate under reduced pressure into a thick paste.

Example 19

Using the same formulation as in Example 17, the pharmaceutical composition of the present invention was prepared by the following method: The above 10 herbs were refluxed twice with water, and 54 kg of water was added each time for 1 hour. The extract was allowed to cool, filtered and combined. The AB-8 type macroporous adsorption resin has a macroporous adsorption resin dosage of 1.8 kg and a loading speed of 6 column volumes per hour. First elute with 6 column volumes of water. The water eluate was discarded. Then, it was eluted with 5 column volumes of 95% ethanol, the alcohol eluates were combined, and ethanol was recovered under reduced pressure at 70 ° C to a relative density of 1.25, dried at 90 ° C under vacuum, and the dry paste was pulverized through an 80 mesh sieve.

Lactose was added to the obtained dry paste to prepare a capsule.

Example 20

Using the same formulation as in Example 17, the pharmaceutical composition of the present invention was prepared by the following method: xanthine was added with 10 times its weight of water, and refluxed twice for 1 hour each time; the extract was combined, and concentrated hydrochloric acid was added to adjust the pH to 1.5-2.0, incubate at 80 ° C for 1 hour, let stand, filter; the precipitate is washed with water to a pH of 5-6, dried, and the dry paste is crushed through a 80 mesh sieve to obtain an extract of Astragalus membranaceus.

Coptis plus 10 times its weight of 70% ethanol reflux extraction twice, each time 2 hours; combined extract, filtered, recovered ethanol to a non-alcoholic flavor, added concentrated hydrochloric acid to adjust the pH to 1-2, refrigerated overnight, filtered; Wash with water to a pH of 5-6, dry, and dry the paste through a 80 mesh sieve to obtain the extract of Coptidis Rhizoma.

The remaining 8 herbs were added with 10 times their weight of water for 2 times, one hour each time; the extract was concentrated under reduced pressure to a relative density of 1.03, allowed to cool, and 95% ethanol was added to make the alcohol content 70%; After filtration, the ethanol was recovered to a relative density of 1.35, dried, and the dry paste was pulverized through an 80 mesh sieve.

Take three kinds of extract dry powder, mix well, add lactose to make capsules.

Example 21

Drug formula: 833g of trichosanthin, 667g of Bupleurum chinense, 500g of medlar, 167g of rhubarb, 333g of Pinellia ternata, 500g of Radix Astragali, 333g of Rhizoma Coptidis, 500g of Radix Paeoniae, 833g of ebony and 500g of Hawthorn.

The pharmaceutical composition of the present invention was prepared according to the following method: 10 kinds of medicinal materials were extracted twice with 10 times the weight of water and refluxed for 1.5 hours each time, the extract was filtered, and the extract was concentrated under reduced pressure to the original medicinal material weight (kg) and The volume ratio (L) of the concentrate was 1:1, 95% ethanol was added to the alcohol content of 70%, filtered, and concentrated under reduced pressure to a thick paste.

Example 22

Using the same formulation as in Example 21, the pharmaceutical composition of the present invention was prepared by the following method: Bupleurum, Angelica, Poria, Rhubarb, Astragalus, and Coptis were refluxed twice with 10 times the weight of 80% ethanol, each time. 1.5 hours after the extraction, the extract was filtered and set aside; the powder obtained in the previous step was added with trichosanthin, ebony, pinellia and hawthorn, and extracted twice with water 10 times the sum of the weight of the medicinal material and the dregs. 1.5 hours after the hour, the extract was concentrated under reduced pressure to a ratio of the original medicinal material weight (kg) to the volume (L) of the concentrate was 1:1, 95% ethanol was added to the alcohol content 70%, filtered, and used; The extract was mixed and concentrated under reduced pressure into a thick paste.

Example 23

Using the same formulation as in Example 21, the pharmaceutical composition of the present invention was prepared by the following method: The above 10 herbs were refluxed twice with water, and 51.7 kg of water was added each time for 1 hour. The extract was allowed to cool, filtered and combined. The AB-8 type macroporous adsorption resin has a macroporous adsorption resin dosage of 2.6 kg and a loading speed of 5 column volumes per hour. First elute with 5 column volumes of water. The water eluate was discarded. Then, the mixture was eluted with 3 column volumes of 90% ethanol, and the alcohol eluate was combined. The ethanol was recovered under reduced pressure at 70 ° C to a relative density of 1.30, vacuum dried at 80 ° C, and the dry paste was pulverized through an 80 mesh sieve.

A concentrated pellet was prepared by adding microcrystalline cellulose to the obtained dry paste.

Example 24

Using the same formulation as in Example 21, the present invention was prepared by the following method. Pharmaceutical composition: Astragalus plus 10 times its weight of water, reflux extraction twice, each time 1 hour; combined extract, concentrated hydrochloric acid to adjust the pH to 1.5-2.0, 80 ° C for 1 hour, let stand, filtered; precipitation Wash with water to a pH of 5-6, dry, and pulverize the dry paste through an 80 mesh sieve to obtain an Astragalus membranaceus extract.

Coptis added 10 times its weight of 75% ethanol reflux extraction twice, each time 2 hours; combined extract, filtered, recovered ethanol to no alcohol flavor, added concentrated hydrochloric acid to adjust the pH to 1-2, refrigerated overnight, filtered; Wash with water to a pH of 5-6, dry, and dry the paste through a 80 mesh sieve to obtain the extract of Coptidis Rhizoma.

The remaining 8 herbs were added with 10 times their weight of water for 2 times, one hour each time; the extract was concentrated under reduced pressure to a relative density of 1.05, let cool, and 95% ethanol was added to make the alcohol content 70%; The solution was filtered, and the ethanol was recovered to a relative density of 1.30, dried, and the dry paste was pulverized through an 80 mesh sieve.

Take three kinds of extract dry powder, mix well, add microcrystalline cellulose to make concentrated pellets.

Example 25

Drug formula: 500g of trichosanthin, 750g of Bupleurum chinense, 500g of medlar, 250g of rhubarb, 500g of Pinellia, 500g of Radix Scutellariae, 500g of Rhizoma Coptidis, 500g of Radix Paeoniae Alba, 500g of ebony, 500g of Hawthorn and 500g of Hawthorn.

The pharmaceutical composition of the present invention was prepared according to the following method: 10 kinds of medicinal materials were extracted twice with 10 times the weight of water and refluxed for 1.5 hours each time, the extract was filtered, and the extract was concentrated under reduced pressure to the original medicinal material weight (kg) and The volume ratio (L) of the concentrate was 1:1, 95% ethanol was added to the alcohol content of 70%, filtered, and concentrated under reduced pressure to a thick paste.

Example 26

Using the same formulation as in Example 25, the pharmaceutical composition of the present invention was prepared by the following method: Bupleurum, Angelica, Poria, Rhubarb, Astragalus, and Coptis were refluxed twice with 10 times the weight of 80% ethanol, and each was extracted twice. 1.5 hours after the extraction, the extract was filtered and set aside; the powder obtained in the previous step was added with trichosanthin, ebony, pinellia and hawthorn, and extracted twice with water 10 times the sum of the weight of the medicinal material and the dregs. 1.5 hours after the hour, the extract was concentrated under reduced pressure to a ratio of the original medicinal material weight (kg) to the volume (L) of the concentrate was 1:1, 95% ethanol was added to the alcohol content 70%, filtered, and used; The extract was mixed and concentrated under reduced pressure into a thick paste.

Example 27

Using the same formulation as in Example 25, the pharmaceutical composition of the present invention was prepared by the following method: The above 10 flavored herbs were refluxed twice with water, and 50 kg of water was added each time for 1 hour. The extract was allowed to cool, filtered and combined. The AB-8 type macroporous adsorption resin has a macroporous adsorption resin dosage of 2.5 kg and a loading speed of 4 column volumes per hour. First elute with 5 column volumes of water. The water eluate was discarded. Then, the alcohol eluate was eluted with 4 column volumes of 92% ethanol, and the ethanol was recovered under reduced pressure at 75 ° C to a relative density of 1.25, vacuum dried at 85 ° C, and the dry paste was pulverized through an 80 mesh sieve.

A dextrin was added to the obtained dry paste to prepare a tablet.

Example 28

Using the same formulation as in Example 25, the pharmaceutical composition of the present invention was prepared by the following method: Add 10 times its weight of water to the scutellariae and extract twice by reflux for 1 hour. Combine the extract, add concentrated hydrochloric acid to adjust the pH to 1.5-2.0, incubate at 85 ° C for 1 hour, let stand, filter; wash the precipitate with water to pH The value is 5-6, dried, and the dry paste is pulverized through an 80 mesh sieve to obtain an extract of Astragalus membranaceus.

Coptis added 10 times its weight of 85% ethanol reflux extraction twice, each time 2 hours; combined extract, filtered, recovered ethanol to no alcohol flavor, added concentrated hydrochloric acid to adjust the pH to 1-2, refrigerated overnight, filtered; Wash with water to a pH of 5-6, dry, and dry the paste through a 80 mesh sieve to obtain the extract of Coptidis Rhizoma.

The remaining 8 herbs were added with 10 times their weight of water for 2 times, one hour each time; the extract was concentrated under reduced pressure to a relative density of 1.05, let cool, and 95% ethanol was added to make the alcohol content 70%; The solution was filtered, and ethanol was recovered to a relative density of 1.25, dried, and the dry paste was pulverized through an 80 mesh sieve.

Take three kinds of extract dry powder, mix well, add dextrin to make tablets.

Example 29

Drug formula: 1200g of trichosanthin, 800g of Bupleurum chinense, 600g of medlar, 200g of rhubarb, 400g of Pinellia ternata, 400g of Radix Scutellariae, 200g of Rhizoma Coptidis, 400g of Radix Paeoniae Alba, 400g of ebony, 400g of Hawthorn and 400g of Hawthorn.

The pharmaceutical composition of the present invention was prepared according to the following method: 10 kinds of medicinal materials were extracted twice with 10 times the weight of water and refluxed for 1.5 hours each time, the extract was filtered, and the extract was concentrated under reduced pressure to the original medicinal material weight (kg) and The volume ratio (L) of the concentrate was 1:1, 90% ethanol was added to the alcohol content of 68%, filtered, and concentrated under reduced pressure to a thick paste.

Example 30

Using the same formulation as in Example 29, the pharmaceutical composition of the present invention was prepared by the following method: Bupleurum, Radix Paeoniae Alba, Radix Paeoniae Alba, Rhubarb, Radix Astragali, Rhizoma Coptidis, and 10% by weight of 85% ethanol were refluxed twice for 1.5 hours each time. The extract was filtered and used; added to the dregs obtained in the previous step. Trichosanthin, ebony, pinellia and hawthorn, extracted twice with water 10 times the sum of the weight of the medicinal material and the dregs, 1.5 hours each time, the extract was concentrated under reduced pressure to the original medicinal material weight (kg) and concentrated. The volume (L) ratio of the liquid was 1:1, 90% ethanol was added to the alcohol content of 68%, filtered, and set aside; the two extracts were mixed and concentrated under reduced pressure to form a thick paste.

Example 31

Using the same formulation as in Example 29, the pharmaceutical composition of the present invention was prepared by the following method: The above 10 medicinal materials were refluxed twice with water, and 50 kg of water was added each time for 1 hour. The extract was allowed to cool, filtered and combined. The AB-8 type macroporous adsorption resin has a macroporous adsorption resin dosage of 2.0 kg and a loading speed of 6 column volumes per hour. First elute with 4 column volumes of water. The water eluate was discarded. Then, it was eluted with 3 column volumes of 92% ethanol, and the alcohol eluates were combined. The ethanol was recovered under reduced pressure at 65 ° C to a relative density of 1.30, vacuum dried at 75 ° C, and the dry paste was pulverized through an 80 mesh sieve.

A lactose is added to the obtained dry paste to prepare a capsule.

Example 32

Using the same formulation as in Example 29, the pharmaceutical composition of the present invention was prepared by the following method: xanthine was added with 10 times its weight of water, and refluxed twice for 1 hour each time; the extract was combined, and concentrated hydrochloric acid was added to adjust the pH to 1.5-2.0, 75 ° C insulation 1 small At the same time, it was allowed to stand and filtered; the precipitate was washed with water to a pH of 5-6, dried, and the dried paste was pulverized through an 80 mesh sieve to obtain an extract of Astragalus membranaceus.

Coptis added 10 times its weight of 75% ethanol reflux extraction twice, each time 2 hours; combined extract, filtered, recovered ethanol to no alcohol flavor, added concentrated hydrochloric acid to adjust the pH to 1-2, refrigerated overnight, filtered; Wash with water to a pH of 5-6, dry, and dry the paste through a 80 mesh sieve to obtain the extract of Coptidis Rhizoma.

The remaining 8 herbs were added with 10 times their weight of water for 2 times, one hour each time; the extract was concentrated under reduced pressure to a relative density of 1.05, let cool, and 95% ethanol was added to make the alcohol content 70%; After filtration, the ethanol was recovered to a relative density of 1.35, dried, and the dry paste was pulverized through an 80 mesh sieve.

Take three kinds of extract dry powder, mix well, add lactose to make capsules.

Example 33

Drug formula: 1000g of trichosanthin, 600g of Bupleurum chinense, 600g of medlar, 250g of rhubarb, 300g of Pinellia, 500g of Radix Scutellariae, 300g of Rhizoma Coptidis, 500g of Radix Paeoniae Alba, 500g of ebony, and 300g of Hawthorn.

The pharmaceutical composition of the present invention was prepared according to the following method: 10 kinds of medicinal materials were extracted twice with 10 times the weight of water and refluxed for 1.5 hours each time, the extract was filtered, and the extract was concentrated under reduced pressure to the original medicinal material weight (kg) and The volume (L) ratio of the concentrate was 1:1, 99% ethanol was added to an alcohol content of 74%, filtered, and concentrated under reduced pressure to a thick paste.

Example 34

Using the same formulation as in Example 33, the pharmaceutical composition of the present invention was prepared by the following method: Bupleurum, Angelica, Poria, Rhubarb, Astragalus, and Coptidis Rhizome were refluxed twice with 10 times the weight of 90% ethanol, each time 1.5 hours later, the extract was filtered, In the dregs obtained in the previous step, adding the pollen, ebony, pinellia and hawthorn, and extracting twice with water of 10 times the sum of the weights of the herbs and the dregs, 1.5 times each time, the extract is reduced. The pressure is concentrated to a ratio of the original drug weight (kg) to the volume (L) of the concentrate is 1:1, 99% ethanol is added to the alcohol content 74%, filtered, and used; the two extracts are mixed and concentrated under reduced pressure. Thick cream.

Example 35

Using the same formulation as in Example 33, the pharmaceutical composition of the present invention was prepared by the following method: The above 10 herbs were refluxed twice with water, and 48.5 kg of water was added each time for 1 hour. The extract was allowed to cool, filtered and combined. The AB-8 type macroporous adsorption resin has a macroporous adsorption resin dosage of 1.7 kg and a loading speed of 5 column volumes per hour. First elute with 4 column volumes of water. The water eluate was discarded. Then, the mixture was eluted with 5 column volumes of 85% ethanol, and the alcohol eluate was combined. The ethanol was recovered under reduced pressure at 70 ° C to a relative density of 1.35, dried at 90 ° C under vacuum, and the dry paste was pulverized through an 80 mesh sieve.

A lactose is added to the obtained dry paste to prepare a capsule.

Example 36

Using the same formulation as in Example 33, the pharmaceutical composition of the present invention was prepared by the following method: xanthine was added with 10 times its weight of water, and refluxed twice for 1 hour each time; the extract was combined, and concentrated hydrochloric acid was added to adjust the pH to 1.5-2.0, incubate at 80 ° C for 1 hour, let stand, filter; the precipitate is washed with water to a pH of 5-6, dried, and the dry paste is crushed through a 80 mesh sieve to obtain an extract of Astragalus membranaceus.

Coptis plus 10 times its weight of 80% ethanol reflux extraction twice, each time 2 hours; combined extract, filtered, recovered ethanol to no alcohol flavor, added concentrated hydrochloric acid to adjust the pH to 1-2, refrigerated overnight, filtered; Wash with water to a pH of 5-6, dry, and dry the paste through a 80 mesh sieve to obtain the extract of Coptidis Rhizoma.

The remaining 8 herbs were added with 10 times their weight of water for 2 times, one hour each time; the extract was concentrated under reduced pressure to a relative density of 1.05, let cool, and 95% ethanol was added to make the alcohol content 70%; The solution was filtered, and the ethanol was recovered to a relative density of 1.30, dried, and the dry paste was pulverized through an 80 mesh sieve.

Take three kinds of extract dry powder, mix well, add lactose to make capsules.

Test Example 1 Pharmacodynamic test

1) Experimental animals: SPF male SD rats, 60, weighing 200-220 g.

2) Main reagents, drugs and instruments: Streptozotocin (STZ): American sigma company, batch number 024K1211; anhydrous citric acid (C ₆ H ₈ O ₇ · H ₂ O): Tianjin Chemical Reagent No. 1 Plant, batch number 011121; sodium citrate (Na ₃ C ₆ H ₅ 0 ₇ .2H ₂ O): Tianjin Chemical Reagent No. 1 Plant, batch No. 011219; metformin: 250mg/tablet, produced by Tianjin Pacific Pharmaceutical Co., Ltd., batch number 040121; different test cases The prescription group drugs were the extract powders prepared according to Example 3, Example 8 and Example 9, respectively, and were numbered TL-1, TL-2 and TL-3, respectively.

One-Touch Ultra: Lifescan, USA Book number 20032400735.

3) Model preparation: SD rats were conditioned for 1 week and fasted overnight. After intraperitoneal injection of STZ 65 mg/kg (0.1 mmol/l, pH 4.4 citrate buffer to make 2% (W/V) solution), 3 Taking blood from the tail vein to measure blood sugar 16.7mmol/L was successful in modeling.

4) Administration method and observation index: The modeled diabetic rats were randomly divided into a model group, metformin 125 mg/kg group and different prescription groups (the dosage was equivalent to 15.5 g/kg of crude drug). After one week of treatment, the blood glucose was administered by intragastric administration once a day, and the drugs were administered with physiological saline to prepare a suspension. During the experiment, the drinking water was freely taken for 15 days. On the 7th and 14th day after the administration, the rats were fasted for 2 hours after the administration, and blood glucose was measured by a one-touch ultra blood glucose meter in the tail vein, and the body weight of the rats was simultaneously measured.

5) Statistical processing: experimental data with mean ± standard deviation ( ± SD ) indicates that the significance of the difference between the two groups was measured by t test.

6) The results are shown in Table 1. When the dosage of the different prescription groups was equivalent to the dose of 15.5 g/kg of the crude drug, the blood glucose of the STZ hyperglycemic rats was significantly decreased after 7 and 14 days of administration (P<0.01).

Table 1. Changes and comparisons of blood glucose in each group ( ± SD n=10)

Claims (24)

A method for preparing a pharmaceutical composition for treating diabetes, wherein the pharmaceutical composition comprises the following extracts prepared from raw materials: 5-40 parts of trichosanthin, 10-30 parts of Bupleurum, 3-15 parts of medlar, and large 1-6 parts of yellow, 1-12 parts of Pinellia, 3-15 parts of astragalus, 1-12 parts of berberine, 3-15 parts of white peony and 5-20 parts of ebony, and optionally containing pharmaceutically acceptable excipients; The composition is prepared by one of the following methods: Method 1, comprising the steps of: (1) taking the desired medicinal material according to the weight fraction; (2) adding the medicinal material to water for reflux extraction, extracting the solution, and decompressing the extract. Concentration; (3) adding ethanol to the concentrated liquid to an alcohol content of 65-75%, filtering; (4) concentrating the filtrate under reduced pressure into an extract; (5) optionally, adding an auxiliary material to the extract a pharmaceutically acceptable dosage form; wherein, in step (2), the extract is refluxed twice, and the extract is concentrated to the original weight of the medicinal material by using water 10 times the weight of the medicinal material for 1.5 hours each time. And the ratio of the volume (L) of the concentrate is 1:1; and in step (3), the concentration of ethanol added is 90-100%; the second method comprises the following steps: (1) according to (2) The medicinal material is refluxed with water, the extract is cooled, filtered, and combined to obtain a filtrate; (3) the filtrate is passed through a macroporous adsorption resin, eluted with water, discarded and washed. Deliquoring, continue to elute with a certain concentration of ethanol, combine ethanol eluent, and recover under reduced pressure Ethanol is obtained as an extract; (4) optionally, adding an excipient to the extract to form a pharmaceutically acceptable dosage form; wherein, in step (2), adding water and refluxing twice, each time 10 times said The weight of the medicinal material is 1 hour each time; in the step (3), the macroporous resin is AB-8 type; the weight ratio of the resin to the medicinal material is 1:1.5-1:3; the loading speed of the extract is 4-6 times column volume / hour; water washing amount is 4-6 times column volume; elution ethanol amount is 2-5 times column volume; vacuum recovery ethanol temperature is 60-80 ° C, and ethanol is reduced to dip under reduced pressure The relative density of the paste is 1.25-1.35; the third method comprises the following steps: (1) taking the required medicinal materials according to the weight ratio; (2) placing the medicinal materials Bupleurum, Radix Paeoniae Alba, Radix Paeoniae Alba, Rhubarb , Astragalus membranaceus and Rhizoma Coptidis are refluxed with a certain concentration of ethanol, and the extract is allowed to cool, filtered and combined; (3) other medicinal materials are added to the dregs obtained in the previous step, refluxed with water, and the extract is concentrated under reduced pressure and concentrated. Adding ethanol to the alcohol content of 65-75%, filtering; (4) combining the filtrates obtained by (2) and (3), and concentrating into an extract; (5) optionally, adding in the extract The auxiliary material is made into a pharmaceutically acceptable dosage form; the method 4 includes the following steps: (1) taking the desired medicine according to the weight ratio; (2) refluxing the astragalus with water, combining the extract, adjusting the pH value To 1.5-2.0; keep warm, let stand, filter, wash with water to pH 5-6, dry Dry, get the dried extract of Astragalus membranaceus; (3) reflux the extract of Rhizoma Coptidis with ethanol, combine the extract, filter, recover the ethanol to a non-alcoholic taste, adjust the pH to 1-2; refrigerate overnight, filter, wash the precipitate with water to pH 5-6, dry, get dried extract of Rhizoma Coptidis extract; (4) Add other herbs to reflux, extract, extract, concentrate, let cool, add 95% ethanol, make the alcohol content of the extract 70%; Filtration, recovery of ethanol to obtain an extract; drying to obtain an extract dry powder; and (5) mixing the dry powder of the extract obtained in the above three steps uniformly; and optionally adding an auxiliary material to prepare a pharmaceutically acceptable dosage form. The method for preparing a pharmaceutical composition according to claim 1, wherein the weight of each medicinal material is: 9 parts of trichosanthin, 12 parts of Bupleurum, 9 parts of medlar, 3 parts of rhubarb, 6 parts of Pinellia ternata, 9 parts of astragalus, 6 parts of berberine, 9 parts of white peony and 9 parts of ebony. The method for preparing a pharmaceutical composition according to claim 1, wherein the medicinal material for preparing the pharmaceutical composition further comprises hawthorn, and the parts by weight of each medicinal material are: 5-40 parts of trichosanthin, Bupleurum 10-30 parts, 3-15 parts of medlar, 1-6 parts of rhubarb, 1-12 parts of Pinellia, 3-15 parts of astragalus, 1-12 parts of berberine, 3-15 parts of white peony, 5-20 parts of ebony And 3-15 copies of Hawthorn. The method for preparing a pharmaceutical composition according to claim 3, wherein the weight of each medicinal material is: 10-30 parts of trichosanthin, 10-30 parts of Bupleurum, 3-15 parts of medlar, and rhubarb 1-6. 1 part, 1-12 parts of Pinellia, 3-15 parts of Astragalus, 1-12 parts of Coptis, 3-15 parts of white peony, 5-20 parts of ebony and 3-15 parts of hawthorn. Preparation of a pharmaceutical composition as described in claim 4 of the patent application Method, wherein the weight of each medicinal material is: 30 parts of trichosanthin, 12 parts of Bupleurum, 9 parts of medlar, 3 parts of rhubarb, 6 parts of Pinellia, 9 parts of Astragalus, 6 parts of berberine, 9 parts of white peony, 15 parts of ebony And 9 parts of Hawthorn, or the weight of each medicinal material: 15 parts of trichosanthin, 12 parts of Bupleurum, 9 parts of medlar, 3 parts of rhubarb, 6 parts of Pinellia, 9 parts of Astragalus, 6 parts of Rhizoma, 9 parts of white peony, 15 parts of ebony and 9 parts of hawthorn. The method for preparing a pharmaceutical composition according to claim 1, wherein in the first method, in the step (3), the concentration of the added ethanol is 95%; and after the addition of the ethanol, the alcohol content in the concentrated solution is 70%. The method for preparing a pharmaceutical composition according to any one of claims 1 to 5, wherein in the second method, in step (3), the concentration of the ethanol used for elution is from 80% to 95%. The method for producing a pharmaceutical composition according to claim 7, wherein the ethanol concentration is 90%. The method for producing a pharmaceutical composition according to claim 1, wherein the obtained extract has a relative density of 1.30. The method for preparing a pharmaceutical composition according to any one of claims 1 to 5, wherein in the third step, the step (2) is carried out by refluxing with ethanol twice, each time using 10 times the step (2) The ethanol of the medicinal material is extracted for 1.5 hours each time; the concentration of ethanol used is 75-90%. The method for producing a pharmaceutical composition according to claim 10, wherein the ethanol concentration is 80%. The method for preparing a pharmaceutical composition according to any one of claims 1 to 5, wherein in the third step (3), the other medicine is added to the medicine residue obtained in the previous step, and is refluxed with water. Extract two The amount of water used is 10 times the sum of the weights of the other medicinal materials added in the step (3) and the slag obtained in the step (2), and the extraction is performed for 1.5 hours each time; the extract is concentrated to the original medicinal material weight (kg). The ratio of the volume (L) to the concentrate is 1:1. The method for preparing a pharmaceutical composition according to any one of claims 1 to 5, wherein in the third method, in the step (3), the concentration of the added ethanol is 90-100%; The alcohol content is 70%. The method for producing a pharmaceutical composition according to claim 13, wherein the ethanol concentration is 95%. The method for preparing a pharmaceutical composition according to any one of claims 1 to 5, wherein in the method (4), the step (2) is carried out by refluxing twice with water, and the water of the weight of the astragalus is added 10 times each time. , 1 hour each time; the incubation temperature of the extract is 75-85 ° C. The method for producing a pharmaceutical composition according to claim 15, wherein the heat retention temperature is 80 °C. The method for preparing a pharmaceutical composition according to any one of claims 1 to 5, wherein in the method 4 and the step (3), the extract is extracted twice with ethanol, and the weight of the coptis is added 10 times each time. Ethanol, 2 hours each time; the concentration of ethanol is 70-85%. The method for producing a pharmaceutical composition according to claim 17, wherein the ethanol concentration is 75%. The method for producing a pharmaceutical composition according to any one of the items 1 to 5, wherein in the method 4, the steps (2) and (3), the pH adjusting agent is concentrated hydrochloric acid. The method for preparing a pharmaceutical composition according to any one of claims 1 to 5, wherein in the fourth step, in the step (4), the remaining medicinal materials are extracted twice with water, each time being added 10 times in steps. (4) The weight of the medicinal material is 1 hour each time; the combined extract is concentrated to a relative density of 1.03-1.07; after adding ethanol, the ethanol is recovered to obtain an extract having a relative density of 1.25 to 1.35. The method for producing a pharmaceutical composition according to claim 20, wherein the combined extract is concentrated to a relative density of 1.05. The method for producing a pharmaceutical composition according to claim 20, wherein the ethanol is recovered to obtain an extract having a relative density of 1.30. A pharmaceutical composition prepared by the production method according to any one of claims 1 to 22. The pharmaceutical composition of claim 23, wherein the composition is formulated into any pharmaceutically acceptable dosage form.