MXPA00006377A - Pharmaceutical composition having antitumor activity and process for the preparation thereof - Google Patents

Abstract

The present invention relates to a pharmaceutical composition having antitumor activity and comprising Pulsatillae Radix and/or Ulmaceae cortex, and more particularly the composition may be prepared by extracting powdered Pulsatilla Radix and/or powdered Ulmaceae cortex, and optionally one or more ingredients selected from powdered Ginseng Radix and Glycyrrhizae Radix in a solvent at the temperature of below 60°C, filtering and lyophilizing the extract, or admixing the above extracted solution with conventional auxiliaries, then filtering and lyophilizing the resulting mixture, and then formulating the lyophilized powder thus obtained to a pharmaceutical preparation by a conventional method used in the pharmaceutics. The present antitumor composition is stable and maintains efficacy even if it is preserved for several years.

Description

PHARMACEUTICAL COMPOSITION THAT HAS ANTITUMORAL ACTIVITY AND PROCESS FOR THE PREPARATION OF THE SAME DESCRIPTION OF THE INVENTION The present invention relates to a pharmaceutical composition having antitumor activity that contains herbal medicines as the main ingredient, and a process for the preparation of the same. The inventor has invented a pharmaceutical composition of medicines from herbs having antitumor activity and a process for the preparation thereof, and the invention was granted with Korean patent No. 72982. The aforementioned patent discloses a pharmaceutical composition containing Pulsatillae Radix (Korean Pulsatilla Nakai, P. cernua, P. danurica, P. ratensis, 'China Pulsatillae, Mongola Pulsatillae) and / or Clematis Chinensis Osbecio (so-called, Chinese clematis) as main ingredients, and optionally Ulmacecae Cortex, Armeniacae Semen, Ginseng Radix and Glycyrrhizae Radix and a process for the preparation of it. Pulsatillae species grow wild all over the world, and Pulsatillae Radix has been used as an antiphlogistic agent, astringent agent and hemostatic agent and thus for the treatment of dysentery in Korea. It is known that Pulsatillae Radix contains anemonin, protoanemonin and saponin. Protoanemonin is the precursor of anemonin, and both can dissolve water, alcohol, chloroform, methylene chloride and the like. Clematis Radix contains anemonin, anemonol and saponin. It has been used as an agent for gout, diuretic agents and agents for difficult menstruation. Ulmaceae cortex contains mucin and tannin, and has been used as a palliative and adhesive. Ginseng Radix has been known since ancient times as a wonderful medicine in the Far East. It has been used as a tonic, agent for acute gastritis and agent for various bleeding diseases. Recently, it has been reported that Ginseng Radix has anti-tumor activity and contains Ginseng alkaloids, Ginseng saponins, oil essence, etc. • Glycyrrhizae Radix contains glycyrrhizin, liquiritin, licoricidin and liquiritocide and has been used as a remedy for cough, expectorant, diaphoretic and agent for gastritis. The present invention relates to a pharmaceutical composition having excellent antitumor activity and containing extract or powder of Pulsatillae Radix and / or Clematis Radix as main ingredients, and optionally powder extracts of Ulmaceae cortex, Armeniacae Semen, Ginseng Radix and Glycyrrhizae Radix.

By the method of the present invention, the composition can be prepared by drying and finely converting each herb ingredient to powder; extracting the ingredients of the herbs in a solvent selected from water, lower alcohol, chloroform, methylene chloride and others that can dissolve the effective ingredients of the herbs at a temperature of 0 ° C - boiling point of the solvent used for 30 minutes at 24 hours and then vaporizing the solvent used to provide the extract; or by dissolving the extract in water, alcohol or the mixed solvent thereof. When the effective ingredients are extracted, each boil can be extracted independently or two or more herbs can be extracted together. Then, the extract is turned into powder and formulated in a pharmaceutical preparation using vehicles such as lactose, different starches, sucrose, mannitol, sorvitol and inorganic salts such as calcium phosphate, calcium sulfate, aluminum silicate and calcium carbonate; binders such as sucrose, glucose, starch, gelatin, carboxymethyl cellulose, methyl cellulose, gum arabic, tragacanth gum, ethyl cellulose, sodium alginate, hydroxypropyl methyl cellulose, polyvinyl pyrrolidone and soluble cellulose; disintegrators such as starch, carboxymethylcellulose, methylcellulose and crystalline cellulose; lubricants such as magnesium stearate and calcium stearate; humidifying agents such as glycerin, glycolpropylenic and sorbitol; preservatives such as sodium benzoate, methyl p-hydroxylbenzoate, propyl p-hydroxybenzoate, benzalkonium chloride, chlorobutanol and sodium hydroacetate; solvent agents such as soluble alcohols and derivatives thereof, and various surfactants; antioxidants such as sodium sulfite, sodium pyrosulfate, sodium metasulfate, sodium bisulfite, rongalite and ascorbic acids; isotonic agents such as sodium chloride and dextrose; indolent agents such as benzylalcohol and chlorobutanol; and ointment bases, petrolatum, liquid paraffin, different vegetable oils, waxes and lanolin; and other conventional auxiliary vehicles or carriers. The invention has continued with intensive study to improve the antitumor composition and it has been found that the composition of the present invention is very unstable for preservation whereby it can easily lose its pharmaceutical effects from 3 to 6 months. Accordingly, an object of the present invention is to provide an improved pharmaceutical composition which is stable and maintains its pharmaceutical efficacy even if it is conserved for several years, comprising freeze-dried Pulsatillae powder, Ulmaceae cortex or mixtures thereof as main herbal ingredients. and optionally one or more auxiliary herb ingredients selected from Ginseng Radix and Glycyrrhizae Radix, and conventional auxiliaries such as those used in the previous invention (Korean Patent No. 72982). Particularly, the inventor has completed the present invention by discovering that the herbal ingredients should be extracted in a solvent at a temperature below 60 ° C and quickly lyophilized to maintain the effectiveness of the composition and preserve it for a long period of time. DETAILED DESCRIPTION OF THE INVENTION The pharmaceutical composition of the present invention comprises as main active herb ingredient 0-100% by weight of Pulsatillae Radix and 0-100% by weight of Ulmaceae cortex, and optionally, as auxiliary herb ingredient 0-70 % by weight of Radix Ginseng from 0-70% of Glycyrrhizae Radix, where the • content is in terms of drying herbal ingredients. Preferably, the content of Pulsatillae Radix and / or Ulmaceae Cortex is above 30% by weight. The pharmaceutical composition having antitumor activity according to the present invention can be prepared by: Pulsatillae Radix powder extraction and / or Ulmaceae cortex powder, and optionally one or more herbal ingredients selected from powdered Ginseng Radix and Glycyrrhizae Radix in powder in a solvent at a temperature below 60 ° C, filtering and lyophilizing the extract, and mixing the lyophilized powder with conventional auxiliaries, alternately mixing the previous extracted solution with auxiliaries, then filtering and lyophilizing the mixture, and then formulating the lyophilized powder in a pharmaceutical preparation by a conventional method used in the pharmaceutical. In cases where the composition is used by injection, before lyophilization, it is advised that the extracted solution be premixed with conventional auxiliaries including a preservative such as methylparaben, ethylparaben and propylparaben, an isotonic agent such as sodium chloride and an indolent agent such as benzylalcohol . In case the composition is used in the form of capsule, ointment tablet and the like, except injection, the solution extracted from the herbal ingredients is lyophilized and then the lyophilized powder is mixed with conventional auxiliaries as used in the invention of the patent Korean No. 72982 by a conventional method in the pharmaceutical to provide a pharmaceutical preparation. The solvent for the extraction of the herbal ingredients may include water, lower alcohol, acetone, ethyl acetate, hexane and mixtures thereof.

The herbal ingredients are extracted in a solvent at a temperature below 60 ° C, and immediately lyophilized. The lyophilized powder of the aforementioned herbal ingredients can be filled into a container and can be applied by adding distilled water for injection, or the lyophilized powder can be formulated in the form of a capsule, tablet or ointment by a conventional method in the pharmaceutical. Approximately 100 mg to 5g of the present composition based on the lyophilized powder can be administered in one day, once a week in 1-3 times per day. The dose of the composition may vary according to gender, age, disease condition, etc. from the patients. The present invention will be explained in detail together with the following examples and experiments. Comparative Example 1 6.26 g of Pulsatillae Radix were added in 90 ml of purified water and the mixture was heated to 60 ° C and stirred for 60 minutes, then centrifuged at 3,500 rpm for 30 minutes. 50 ml of the centrifuged solution were filtered in a sterilized room below 60 ° C. The resulting solution was converted into isotonic solution by adding NaCl under an aseptic condition, then it was filtered once again in sterile medium and divided into 2.5 ml of the solution in a 3 ml ampule under aseptic condition, and sealed to obtain ampoules of injection. Comparative Example 2 4 g of Pulsatillae powder, 2 g of powdered Ulmaceae cortex, 2 g of powdered Ginseng Radix and 1 g of powdered Glycyrrhizae Radix were added to 90 ml of purified water and the mixture was stirred for 60 minutes at approximately 80 ° adding purified water corresponding to the distilled water. The resulting solution was cooled to room temperature, centrifuged at 3,500 rpm for 30 minutes to obtain 46 ml of the extracted solution. NaCl was added to the extract to obtain an isotonic solution. The isotonic solution was filtered by a conventional method in a sterilized room, filtered in sterile medium and divided in 2 ml of the solution in a 3 ml ampule, sealed and stored in a refrigerator. Comparative Example 3 62.6 g of powdered Pulsatillae Radix, 31.3 g of powdered Ginseng Radix and 10 g of Glycyrrhizae powder were added to 900 ml of purified water and were extracted for 60 minutes at about 60 ° C by adding purified water corresponding to water distilled The resulting 40 ml solution was filtered and concentrated to provide 26.4 g of concentrated extract. Example 1 6 g of powdered Pulsatillae Radix were added to 100 ml of distilled water and extracted for 60 minutes below 60 ° C with stirring. After the extract was centrifuged at 5000 rpm, 9000 mg of NaCl as an isotonic agent and 160 mg of methyl paraoxybenzoate were added thereto, and it was filtered in sterile medium in a sterilized room, divided into 20 5 ml containers , it was quickly lyophilized below -40 ° C and sealed to obtain an injectable powder. Example 2 6 g of powdered Pulsatillae Radix, 4 g of Ulmaceae cortex and 0.9 g of powdered Glycyrrhizae Radix were added to 100 ml of distilled water and extracted for 60 minutes at a temperature of minus 60 ° C with stirring. After the extracted solution was centrifuged at 5000 rpm, 900 mg of NaCl as an isotonic agent and 160 mg of methyl paraoxybenzoate were added as a preservative thereto. The resulting mixture was filtered in sterile medium in a sterilized room, divided into 20 5 ml containers, quickly lyophilized below -40 ° C, and sealed to obtain injectable powder. Example 3 6 g of powdered Pulsatillae Radix, 3 g of powdered Ginseng Radix and 0.9 g of powdered Glycyrrhizae were added to 100 ml of distilled water and were extracted for 60 minutes at a temperature of below 60 ° C with stirring and adding distilled water corresponding to the distilled water. After centrifuging the extracted solution at 5000 rpm, 900 mg of NaCl as an isotonic agent and 160 mg of propyl paraoxybenzoate were added as a preservative thereto. The resulting mixture was filtered in sterile medium in a sterilized room, divided into 20 5 ml containers, and quickly lyophilized below -40 ° C, sealed to obtain injectable powder. Example 4 60 g of Pulsatillae Radix powder, 40 g of Ulmaceae cortex powder and 9 g of Glycyrrhizae Radix were added to 1000 ml of distilled water and were extracted with stirring for 60 minutes at a temperature of below 60 ° C adding distilled water corresponding to distilled water. The extracted solution was centrifuged at 5000 rpm and quickly lyophilized to below -40 ° C to provide 38,150 mg of the lyophilized powder. Example 5 60 g of Pulsatillae Radix powder were added, 60 g of Ulmaceae cortex powder and 9 g of Glycyrrhizae Radix powder to 1000 ml of 5% (v / v) of ethane and were extracted during 60 minutes at the temperature of 50-60 ° C adding the alcohol corresponding to that distillate . The extracted solution was centrifuged at 5000 rpm and quickly lyophilized under steam at -40 ° C to provide 45,150 mg of the lyophilized powder. EXAMPLE 6 60 g of Pulsatillae Radix powder, 30 g of powdered Ginseng Radix and 9 g of powdered Glycyrrhizae Radix were added to 100 ml of 50% (v / v) of acetone aqueous solution and were extracted for 60 minutes at room temperature. temperature of 50-60 ° C adding the solvent corresponding to that distillate. The extracted solution was centrifuged at 5000 rpm and quickly lyophilized below -40 ° C to obtain 34650 mg of the lyophilized powder. Example 7 6 g of Pulsatillae Radix powder, 4 g of Ulmaceae cortex powder and 0.9 g of Glycyrrhizae Radix at 100 m of 70% (v / v) ethanol were added and were extracted for 60 minutes at the temperature below of 60 ° C by stirring and adding the solvent corresponding to that distilled solvent. After the extracted solution was centrifuged at 5000 rpm, 900 mg of NaCl as an isotonic agent and 160 mg of benzyl paraoxybenzoate were added as a preservative thereto. The resulting mixture was filtered in sterile medium in a sterilized room, divided into 5 ml containers, rapidly lyophilized below -40 ° C and sealed to obtain injectable powder. Example 8 10 g of Ulmaceae cuts were added to 100 ml of 50% (v / v) ethanol and were extracted for 60 minutes at a temperature of below 60 ° C with stirring. The extracted solution was centrifuged at 5000 rpm, and 900 mg of NaCl as isotonic agent was added thereto and 160 mg of methyl paraoxybenzoate as preservative. The resulting mixture was filtered in sterile medium in a sterilized room, divided into 20 5 ml containers, quickly lyophilized below -40 ° C, sealed to obtain injectable powder. Example 9 60 g of powdered Pulsatillae Radix, 60 g of Ulmaceae cortex powder and 9 g of Glycyrrhizae Radix were added to 1000 ml of hexane and extracted for 90 minutes at the temperature of below 60 ° C with stirring and adding the corresponding hexane that distilled amount. The extracted selection was centrifuged at 5000 rpm and the resulting solution was rapidly lyophilized to below 40 ° C to obtain the lyophilized powder. Example 10 Lyophilized extract obtained in Example 4 150 mg Crystalline cellulose 50 mg Lactose 50 mg Magnesium Stearate 3 mg The above ingredients were cast into tablets by a conventional method and sealed with aluminum foil. EXAMPLE 11 Lyophilized extract obtained in Example 6 150 mg Lactose 30 mg Corn starch 30 mg Talc 5 mg Magnesium stearate 3 mg The above ingredients were filled into a hard gelatin capsule by a conventional method and sealed with aluminum foil. Example 12 Lyophilized extract obtained in Example 5 1000 mg Conventional ointment base q.s. The above ingredients were formulated in a 10 gram ointment and filled and sealed in an aluminum tube. Experiment 1: Acute Toxicity The lyophilized powder obtained by Example 1 was administered to 8 rats of 234-276 g wherein the LD 50 was 800 mg / kg. Experiment 2: Anti-tumor effect 0.1 ml of Sarcoma suspension 180 cells (lxlO6 cells) was injected (s.c.) in 30 rats at approximately 25 g to develop tumors. After 6 days, a 0.15 ml injection is prepared by dissolving the injectable powder of Example 1 in 5 ml of distilled water to deliver the injection (sc) to 10 rats once a day and 0.15 ml of the injection of Comparative Example 1 were injected (sc) to another 10 rats once a day. While 0.15 ml of physiological saline were injected to 10 other rats for 10 days as a control group. Each 9 rats of the groups were treated with the injection of Example 1 and Comparative Example 1 and were cured by injection for 15 days, every 1 rats of the groups died on day 16, while 10 rats of the control group died at the beginning of the 10th day until the 15th day Experiment 3: Antitumor effect 0.1 ml of Sarcoma suspension was injected (sc) 180 cells (lxlO6 cells) in 30 rats of approximately 25 g to develop tumors After 6 days, the injection of 0.15 ml prepared by dissolving the injectable powder of Example 1 in 5 ml of distilled water for injection was injected (sc) at 10 ° C. rats (group 1) once a day, and 0.15 ml of the injection were injected (sc) from comparative example 1 preserved for 6 months in a refrigerator to another 10 rats (group 2) once a day, and were injected 0.15 ml from the physiological saline solution to the other 10 rats for 10 days as a control group (group 3), 9 rats from group 1 were cured with the injection for 15 days, and 1 rats from group 1 died on day 17. 3 rats from the group 2 were cured by l to injection for 15 days, 1 rat died on day 12, 3 rats died on day 15 and 3 rats died on day 17. 10 rats of group 3 all died at the beginning of the 10th day until the 15th day. Experiment 4: Anti-tumor effect 0.1 ml of Sarcoma suspension 180 cells (lxlO6 cells) was injected (s.c.) in 48 rats of approximately 25 g to develop tumors. Beginning on the 9th day (terminal stage of cancer), an injection sample of 0.15 ml was prepared by dissolving the injectable powder of example 3 in 5 ml of distilled water for injection injected (sc) to 7 rats (group 1) once at day, each 0.15 ml of the injection sample of example 3 were injected (sc) in another 7 rats twice a day (group 2), 0.15 ml of the injection sample of comparative example 1 were injected (sc) into another 7. rats once a day (group 3), each 0.15 ml of injection sample of comparative example 1 were injected (sc) in another 7 rats twice (group 4), 0.15 ml of the injection sample of comparative example 1 which was preserved for 3 months in a refrigerator were injected (sc) into 7 other rats once a day. (group 5), each 0.15 ml of the injection sample of comparative example 1 were kept in a refrigerator for 6 months were injected (sc) in another 7 rats twice a day (group 6), and the other 6 rats were used as a control group. In group 1 and group 3, each 1 rat died in the 15th day of carcinogenesis, every 1 rat died on the 17th day, every 1 rat died on the 18th day and every 1 rat died on the 20th day, while every 3 rats were cured by injection for 20 days (at 29th or day of carcinogenesis). In group 2 and group 4 each 1 rat died on the 16th day of carcinogenesis, each 1 rat died on the 18th day, each rat died on the i9th day, and every 1 rat died on the 21st day, while every 3 rats were cured by injection for 19 days on 28th day of carcinogenesis). In group 5, 1 rat died on the 15th day of carcinogenesis, 1 rat died on the 17th day, 1 rat died on the 18th day, 1 rat died on the 19th day, and 1 rat died on the 21st day, while that 2 rats were cured by injection for 21 days.

In group 6, 1 rat died on the 15th day of carcinogenesis, 1 rat died on the 16th day, 1 rat died on the 18th day, 1 rat died on the i86th day and 2 rats died on the 20th day, while 1 rat was cured by injection for 20 days. In group 7, all rats died on the 15th day of calcinogenesis. Example 5: Clinical test on a volunteer by administering the injection prepared by dissolving the injectable powder of example 1 in distilled water for injection. Subject: Name: KIM, Myung-on (36 years of age to treatment, male) Address: # 6-501, Moran 2cha Apt, Shingi-dong, Dong-gu, Taegu, Korea Type of disease: progressive thyroid cancer Diagnosis: General Hospital affiliated with Youngnam University in Taegu on May 7, 1992. Period of medication: from May 16, 1992 to October 20, 1992. Medication: 12 milliliters of the injection were injected (iv) once a day for 4 days, while each milliliters of the injection were injected into the bulging tumor twice a day for 8 days (15 times in total), and then no injection treatment was performed for 25 days. After that, the medication was repeated by injection (i.v.) and direct injection into the protruding tumor as in the previous method whereby the tumor disappeared completely. After 5 years, the general hospital affiliated with Youngnam University and the general hospital affiliated with Chungnam University decided that the patient was completely cured. Experiment 6 Clinical test on a volunteer administering the injection prepared by dissolving the injectable powder of Example 2 in distilled water for injection Suj eto: Name: KIM, Chul-Ki (50 years of age to treatment, male) -Address: # 1223-404 , Mokdong Apt., Shinj ung-dong, Yangchon-gu, Seoul Korea Type of illness: Progressive lung cancer. Weight loss, cough, bloody phlegm, dyspepsia due to residual cancer after the operation. Diagnosis: Onju Christian Hospital affiliated to Yonsei University on May 18, 1989. Period of medication: From September 3, 1989 to March 5, 1990.

Medication: 10 ml of the injection was injected (i.v.) once a day for 4 days and then no treatment was performed for 3 weeks. The same medication was repeated during 7 months of the previous period, with which the tumor and the related symptoms disappeared completely. After 6 years, the general hospital affiliated with Yonsei University and the General Hospital affiliated with Chungnam University decided that the patient was completely cured. Experiment 7:: Clinical Trial on a volunteer administering the injection prepared by dissolving the injectable powder of Example 2 in distilled water for injection Subject: Name: HUS, Sang-Bong (35 years of age to treatment, male). Address: 756, Shibang-ri, Jang ok-myeon, Geohje-gun, Kyungsangnam-do, Korea Disease type: Progressive rectal cancer. Weight loss and severe pain due to residual cancer after partial removal of the tumor by operation. Diagnosis: Goshin Medical Center in Pusan on July 19, 1991. Period of medication: From November 19, 1991 to May 12, 1992.

Medication: 12 ml of injection were injected (i.v.) once a day for 4 days, after which no treatment was performed for 3 weeks. The same medication was repeated for 7 months of the previous period, where the residual tumor disappeared completely. After 6 years of medication, the Goshin Medical Center in Pusam and the General Hospital affiliated with Chungnam University decided that the patient is completely cured. Experiment 8: Clinical Trial on a volunteer by administering the injection prepared by dissolving the powder of Example 3 in distilled water for injection. Subject: Name: PARK, Ju-Sang (45 years of age, male) Address: 15/2, 387-3, Bugok 1-dong, Kumjeong-gu, Pusan, Korea Disease type: Progressive stomach cancer. Feeling of heaviness in the stomach, dyspepsia and weight loss. Diagnosis: Goshin Medical Center in Pusan on December 29, 1989 Period of medication: from March 1, 1990 to September 29, 1990.

Medication: 12 ml of injection were injected (i.v.) once a day for 4 days, and simultaneously every 173 mg of the sample was taken internally 4 times a day. The injection i.v. It was performed in such a way that the injection was injected i.v. for 4 days and after that no injection was made for 4 weeks, while continuous internal administration. As a result, the symptoms disappeared completely and he was diagnosed as normal by means of the biopsy. After 6 years, the Goshin Medical Center decided that the patient was completely cured. Experiment 9: Clinical Trial on a volunteer administering the injection prepared by dissolving the powder of Example 5 in distilled water for injection. Subject: Name: LEE, Bok-Do (65 years of age to treatment, male) Address: 322-81, Chosan-ri, Hwagok-myeon, Yangsan-gun, Kyungsangbuk-do, Korea Disease type: Progressive liver cancer .

Abdominal bloating, dyspepsia and weight loss due to residual cancer after partial removal of the tumor by operation. Diagnosis: Goshin Medical Center in Pusan on April 8, 199.

Period of medication: from May 31, 1994 to December 30, 1994. Medication: Injected (iv) 9 ml of the injection once a day for 4 days, and simultaneously 4 ml of the mixture were injected directly into the tumor residual in the liver once a day for 3 days and then for 3 weeks no treatment was performed. The same medication was performed 3 times, and after the fourth cycle of medication, only one injection was performed (i.v.), with which the residual tumor disappeared completely. After 3 years, the Goshin Medical Center and the Chungnam University-affiliated Hospital decided that the patient was completely cured. Stability Test 1 Samples of the lyophilized powder for injection prepared by the examples according to the present invention were stored for 2 years and then dissolved in distilled water for injection. The resulting solution was slightly transparent coffee and no precipitation was established. Stability test 2 Injection samples prepared by comparative example 2 were stored for 1 month, 2 months and 3 months respectively. In the resulting solutions, a precipitate was established every month and after three months the solutions were cloudy, so it could not be used for injection. EFFECTS OF THE INVENTION As can be seen from the above experiments, the antitumor compositions by the present invention are sensitive to moisture, and even if stored in a refrigerator, they can be easily deteriorated and the efficiency of them decreases severely, with which can not be kept for a long period of time and can not be used as medicine. However, the present compositions which are prepared by extracting the herbal ingredients from the temperature below 60 ° C and after the extraction immediately lyophilizing the extract did not have in quality and efficacy after a long preservation, with which They can be used safely.

Claims (8)

1. CLAIMS 1. A pharmaceutical composition characterized in that it has antitumor activity prepared by extracting 0-100% by weight of powdered Pulsatillae Radix and 0-100% by weight of Ulmaceae cortex powder in a solvent at a temperature of below 60 ° C, filtering and lyophilizing the extract, and then mixing the lyophilized powder with conventional auxiliaries, or mixing the previously extracted solution with auxiliaries, then filtering and lyophilizing the mixture, and then formulating the lyophilized powder in a pharmaceutical preparation by a conventional method used in the pharmaceutical .
2. 2. A pharmaceutical composition characterized in that it has antitumor activity prepared by extracting 0-100% by weight of powdered Pulsatillae Radix and 0-100% by weight of Ulmaceae cortex powder, with the proviso that the content of Pulsatillae Radix and Ulmaceae Cortex is above 30% by weight, and one or more ingredients selected from 0-70% Ginseng Radix powder and 0-70% by weight Glycyrrhizae Radix in a solvent at a temperature below 60 ° C, filtering and lyophilizing the extract, and mixing the lyophilized powder with auxiliary conventions, or mixing the extracted solution with auxiliaries, filtering and lyophilizing the mixture, and then formulating the lyophilized powder in a pharmaceutical preparation by a conventional method used in the pharmaceutical.
3. 3. The pharmaceutical composition according to claim 1 or 2, characterized in that the solvent is selected from water, alcohol, ketone, ethyl acetate and mixtures thereof and the composition is formulated in a selected form of powder, granules, tablets. , capsules, injectable powder and ointment.
4. 4. The pharmaceutical composition according to claim 1 or 2, characterized in that the auxiliaries are 1 or more selected from diluent, binder, disintegrants, preservatives, indolents, isotonic agents and lubricant.
5. A process for the preparation of a pharmaceutical composition characterized in that it has antitumor activity which comprises extracting 0-100% by weight of Pulsatillae Radix powder and 0-100% Ulmaceae cortex powder in a solvent at a temperature below 60 ° C. filtering and lyophilizing the extract, and mixing the lyophilized powder with conventional auxiliaries, then filtering and lyophilizing the mixture, and then formulating the lyophilized powder in a pharmaceutical preparation by a conventional method used in the pharmaceutical.
6. 6. A process for preparing a pharmaceutical composition having antitumor activity which comprises extracting 0-100% by weight of powdered Pulsatillae Radix and 0-100% by weight of Ulmaceae powder cuts, with the proviso that the content of Pulsatillae Radix and Ulmaceae cortex is above 30% by weight and one or more ingredients selected from 0-70% by weight of Ginseng Radix powder and 0-70% by weight of Glycyrrhizae Radix powder in a solvent at the temperature below 60 ° C, filtering and lyophilizing the extract, and mixing the lyophilized powder with conventional auxiliaries, or mixing the above extracted solution with auxiliaries, then filtering and lyophilizing the mixture, and then formulating the lyophilized powder in a pharmaceutical preparation by a conventional method used in the pharmaceutical. The process according to claim 5 or 6, characterized in that the solvent is selected from water, alcohol, acetone, ethyl acetate and mixtures thereof and the composition is formulated in a selected form of powder, granules, tablets, capsules, injectable powder and ointment. The process according to claim 5 or 6, characterized in that the auxiliaries are one or more selected from diluent, binder, disintegrators, preservatives, indolents, isotonic agent and lubricant.