AU2019100737A4 - Anti-Helicobacter Pylori Traditional Chinese Medicine composition and applications - Google Patents

Anti-Helicobacter Pylori Traditional Chinese Medicine composition and applications Download PDF

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AU2019100737A4
AU2019100737A4 AU2019100737A AU2019100737A AU2019100737A4 AU 2019100737 A4 AU2019100737 A4 AU 2019100737A4 AU 2019100737 A AU2019100737 A AU 2019100737A AU 2019100737 A AU2019100737 A AU 2019100737A AU 2019100737 A4 AU2019100737 A4 AU 2019100737A4
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yuhuanglian
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phellodenri
chinesis
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Xiaoli Ye
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Southwest University
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/75—Rutaceae (Rue family)
    • A61K36/756—Phellodendron, e.g. corktree
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/285—Aucklandia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/718—Coptis (goldthread)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

Abstract

The invention belongs to the technical field of the preparation of Traditional Chinese Medicines, and in particular relates to an anti-HP (Helicobacter Pylori) Traditional Chinese Medicine composition and applications. The Traditional Chinese Medicine composition is obtained by an improvement on the basis of the famous classical prescriptions of Zuojin Pills and Xianglian Pills, and comprises Coptidis Rhizoma extract, Yuhuanglian extract and Phellodenri Chinesis Cortex extract, wherein the content of Yuhuanglian is more than 50% to achieve a good Anti-HP effect; meanwhile, the combination with Tetradium ruticarpum and Aucklandiae Radix effectively eliminates the side effects of a product and improves the safety of the medicine; and the combination of the Traditional Chinese Medicine composition and a clinical standard therapy (a triple therapy) for HP can not only further improve a curative effect, but also repair the intestinal flora disorder caused by the triple therapy and eliminate the side effects of the triple therapy.

Description

[0001] 1. Technical Field [0002] The invention belongs to the technical field of the preparation of Traditional Chinese Medicines, and in particular relates to an anti-HP (Helicobacter Pylori) Traditional Chinese Medicine composition and applications.
[0003] 2. Description of Related Art [0004] Coptidis Rhizoma, firstly described in Sheng Nong’s Herbal Classic as a top-grade medicine, is bitter in taste and cold in nature; has functions of purging fire, detoxicating, clearing heat, and drying dampness; and applies to dysphoria and dizziness with smothery sensationvexed heat, insomnia, dampness-heat, distention and fullness, vomiting, abdominal pain, diarrhea, red and swollen eyes, mouth sores, eczema, scald, hematemesis, epistaxis, etc. Numerous research results show that the Coptidis Rhizoma has a strong anti-HP effect (Xu Yi et. al., Study on the Effects of Single and Compound Chinese Herbal Medicines on Suppressing Helicobacter Pylori. Chinese Journal of Integrated Traditional and Western Medicine on Gastro-Spleen, 8 (5): 292. 2000).
[0005] Some studies have reported that berberine is the main anti-HP active ingredient in the Coptidis Rhizoma, and has an excellent anti-HP biological activity (Zhao Xiaoyong. Experimental Study on Treating Helicobacter Pylori Infection with Several Natural Plant Ingredients. Master Thesis of Third Military Medical University, 2006). The dissolution rate of the berberine in a Coptidis Rhizoma extract is obviously better than that in the Coptidis Rhizoma. By utilizing the modern natural pharmaceutical chemistry technology to extract active ingredients such as berberine from the Traditional Chinese Medicines such as the Coptidis Rhizoma, the active ingredients can be significantly
2019100737 05 Jul 2019 improved in concentration and reduced in volume to facilitate the production of capsules for overcoming the disadvantage of poor taste of the Coptidis Rhizomcr, moreover, the dissolution rate of the active ingredients can be increased to improve the anti-HP effect significantly.
[0006] Famous classical prescriptions with the Coptidis Rhizoma as the main raw material involve Zuojin Pills and Xianglian Pills. However, both the Zuojin Pills and the Xianglian Pills are prepared with poor processes and have large volume and poor taste. Researchers have found that both the Zuojin Pills and the Xianglian Pills have the disadvantages of low content of active ingredients, low dissolution rate of the active ingredients, low dosage and weak anti-HP effect, resulting in poor efficacy in eliminating the HP. Although the curative effect can be improved by simply increasing the dosage of the Coptidis Rhizoma or the Zuojin Pills or Xianglian Pills, the side effects are consequently increased with the increase in the dosage due to slightly high content of impurities, which would lead to safety issues.
[0007] Zuojin Capsules are concentrated extracts processed on the basis of the Zuojin pills. However, the content of berberine in the Zuojin Capsules is low, with “40mg berberine hydrochloride per 0.35 g of Zuojin Capsule (about 11%)” (under the item of Zuojin Capsules ffoom Chinese Pharmacopoeia, 2015 edition). Concentrated Xianglian Pills and Xianglian Tablets are concentrated extracts processed on the basis of the Xianglian Pills; the content of berberine in the concentrated Xianglian Pills is also low since “0.17 g of Concentrated Xianglian Pills contains 6.8 mg berberine hydrochloride (about 4%)” (under the item of Concentrated Xianglian Pills from Chinese Pharmacopoeia, 2015 edition); and the content of berberine in the Xianglian Tablets is still low since “O.lg of the Xiangelian Tablet contains 5.6 mg berberine hydrochloride (about 5.6%)” (under the item of Xianglian Tablets from Chinese Pharmacopoeia, 2015 edition). Therefore, their efficacy in eliminating HP is limited, while increasing the dosage of the Coptidis Rhizoma
2019100737 05 Jul 2019 will increase the content of the impurities in the extracts, which is easy to cause safety issues.
BRIEF SUMMARY OF THE INVENTION [0008] To solve the problems above, the invention provides an anti-HP (Helicobacter Pylori') Traditional Chinese Medicine composition, which has an excellent anti-HP effect and high biosecurity.
[0009] An anti-HP Traditional Chinese Medicine composition comprises 60-95 portions of Phellodenri Chinesis Cortex extract, 1-30 portions of Yuhuanglian extract and 0-30 portions of Aucklandiae Radix extract by weight.
[0010] Preferably, the Traditional Chinese Medicine composition comprises 70-90 portions of the Phellodenri Chinesis Cortex extract, 5-20 portions of the Yuhuanglian extract and 5-20 portions of the Aucklandiae Radix extract by weight.
[0011] Preferably, the Traditional Chinese Medicine composition comprises 75-80 portions of the Phellodenri Chinesis Cortex extract, 10-15 portions of the Yuhuanglian extract and 10-15 portions of the Aucklandiae Radix extract by weight.
[0012] Preferably, a method for extracting the Phellodenri Chinesis Cortex extract comprises the steps of: soaking Phellodenri Chinesis Cortex with 0.1-2% (V/V) aqueous sulfuric acid solution for 1-48 hours, and then extracting by percolation; neutralizing a resulting extracted solution with lime to pH=2-5 and filtering, and depressurizing and concentrating a resulting filtrate to 0.1-1 g of raw herb (Phellodenri Chinesis Cortex) per milliliter; filtering a resulting concentrated solution and further adding 0.5-5% (W7V) sodium chloride to the same, standing for 1-24 hours and filtering; and precipitating in distilled water 5 times that of a resulting filtered solution for recrystallization once, thereby obtaining the Phellodenri Chinesis Cortex extract.
[0013] Preferably, a method for extracting the Yuhuanglian extract comprises the
2019100737 05 Jul 2019 steps of: slicing Yuhuanglian; performing extraction on Yuhuanglian slices three times with 40-70% ethanol through heating reflux; combining and filtering resulting extracted solutions; recovering the ethanol and concentrating a resulting solution into thick paste, thereby obtaining the Yuhuanglian extract.
[0014] Preferably, a method for preparing Yuhuanglian comprises the steps of: decocting Tetradium ruticarpum in water, evenly mixing a resulting decoction with pure Coptidis Rhizoma, and frying dry after the decoction is absorbed completely, thereby obtaining the Yuhuanglian.
[0015] Preferably, the Aucklandiae Radix extract is obtained by the steps of: extracting volatile oil from Aucklandiae Radix by steam distillation, and collecting the volatile oil; filtering a water decoction, concentrating the filtered water decoction into thick paste, and drying the thick paste; and combining the volatile oil and extract of the Aucklandiae Radix to obtain the Aucklandiae Radix extract.
[0016] An anti-HP Traditional Chinese Medicine preparation is obtained by preparing the Traditional Chinese Medicine composition above per se, or a mixture of the Traditional Chinese Medicine composition and pharmaceutically acceptable dressings, into pills, capsules, tablets or capsule preparations.
[0017] The invention has the following advantageous effects.
[0018] 1. The Traditional Chinese Medicine composition according to the invention is obtained by an improvement on the basis of the famous classical prescriptions of Zuojin Pills and Xianglian Pills, and comprises Coptidis Rhizoma extract, Yuhuanglian extract and Phellodenri Chinesis Cortex extract, wherein the content of berberine is more than 50% to achieve a good Anti-HP effect; meanwhile, the combination with Tetradium ruticarpum and Aucklandiae Radix effectively eliminates the side effects of a product and improves the safety of the medicine; and the combination of the Traditional Chinese Medicine composition and a clinical standard therapy (a triple therapy) for HP can not
2019100737 05 Jul 2019 only further improve a curative effect, but also repair the intestinal flora disorder caused by the triple therapy and eliminate the side effects of the triple therapy.
[0019] 2. The Traditional Chinese Medicine composition according to the invention has a high berberine content, and thus is small in the volume of a prepared Traditional Chinese Medicine and convenient to be processed into capsules preparations, tablets (coated) and pills (coated) etc., which can efficiently improve the taste of the preparation and significantly enhance the clinical compliance.
[0020] 3. The Traditional Chinese Medicine composition according to the invention not only has the anti-HP effect, but also has the effect of curing gastric and intestinal diseases, and has a good preventive effect on digestive tract tumors (especially the gastric cancer).
[0021] 4. The Traditional Chinese Medicine composition according to the invention has the effect of bi-directional regulation of intestinal microorganisms by inhibiting harmful microorganisms and facilitating beneficial microorganisms in the intestines, and is particularly beneficial for improving the intestinal flora disorder caused by antibiotics and repairing the intestinal function.
DETAILED DESCRIPTION OF THE INVENTION [0022] The technical solution in the embodiments of the invention will be illustrated clearly and completely below. It is obvious that the embodiments described are merely part but not all of the embodiments of the invention. Based on the embodiments of the invention, all other embodiments obtained by those ordinarily skilled in the art without making inventive efforts shall fall within the protection scope of the invention.
[0023] In addition, unless other specified, various raw materials, reagents, instruments and equipment used in the invention are available by market purchasing or can be prepared with methods in the prior art.
2019100737 05 Jul 2019 [0024] Embodiment 1 Preparation of an Anti-HP Medicine Composition [0025] A Phellodenri Chinesis Cortex extract is obtained by the steps of: soaking
100 kg of Phellodenri Chinesis Cortex with 0.1% (V/V) aqueous sulphuric acid solution for 48 hours, and then extracting by percolation; neutralizing a resulting extracted solution with an aqueous lime solution to pH=2 and filtering, and depressurizing and concentrating a resulting filtrate to 0.1 g of raw herb (the Phellodenri Chinesis Cortex) per milliliter; filtering a resulting concentrated solution and further adding 5% (W7V) sodium chloride to the same; standing for 24 hours and filtering; and precipitating in distilled water 5 times that of a resulting filtered solution for recrystallization once, thereby obtaining 3 kg of the Phellodenri Chinesis Cortex extract. The content of the berberine in the Phellodenri Chinesis Cortex extract is 98% based on HPLC analysis.
[0026] A Yuhuanglian extract is obtained by the steps of: performing extraction on 10 kg of the Yuhuanglian three times with 70% ethanol through heating reflux, with 3 hours for the first time, 2 hours for the second time and 1.5 hours for the third time; combining and filtering resulting extracted solutions; recovering the ethanol and concentrating a resulting solution into thick paste, thereby obtaining 2 kg of the Yuhuanglian extract.
[0027] 95 g of the Phellodenri Chinesis Cortex extract (which can also be purchased directly from the market) and 5 g of the Yuhuanglian extract are mixed evenly, granulated and capsuled (0.4g/granule) to obtain the anti-HP medicine composition, where the content of berberine is 93.85% based on the HPLC analysis. A good anti-HP effect can be achieved by taking 2 capsules each time and twice a day, and in particular in combination with the “Triple Therapy” to produce a synergistic anti-HP effect. This composition also has effects of treating diarrhea and improving the intestinal flora.
[0028] Embodiment 2 Preparation of an Anti-HP Medicine Composition [0029] A Phellodenri Chinesis Cortex extract is obtained by the steps of: soaking
2019100737 05 Jul 2019
100 kg of Phellodenri Chinesis Cortex with 2% (V/V) aqueous sulphuric acid solution for hour, and then extracting by percolation; neutralizing a resulting extracted solution with lime to pH=5 and filtering, and depressurizing and concentrating a resulting filtrate to 1 g of raw herb (the Phellodenri Chinesis Cortex) per milliliter; filtering a resulting concentrated solution and further adding 0.1% (W/V) sodium chloride to the same; standing for 24 hours and filtering; and precipitating in distilled water 5 times that of a resulting filtered solution for recrystallization once, thereby obtaining 3.3 kg of the Phellodenri Chinesis Cortex extract. The content of the berberine in the extract is 90% based on the HPLC analysis.
[0030] A Yuhuanglian extract is obtained by the steps of: performing extraction on 10 kg of the Yuhuanglian three times with 40% ethanol through heating reflux, with 3 hours for the first time, 2 hours for the second time and 1.5 hours for the third time; combining and filtering resulting extracted solutions; recovering the ethanol and concentrating a resulting solution into thick paste, thereby obtaining 2.1 kg of the Yuhuanglian extract.
[0031] An Aucklandiae Radix extract is obtained by the steps of: extracting volatile oil from 10 kg of the Aucklandiae Radix by steam distillation, and collecting the volatile oil, which is 0.05 kg; filtering a water decoction, and concentrating the filtered water decoction into thick paste; and mixing the volatile oil and extract to obtain 3 kg of the Aucklandiae Radix extract.
[0032] 60 g of the Phellodenri Chinesis Cortex extract (which can also be purchased directly from the market), 30 g of the Yuhuanglian extract and 10 g of the Aucklandiae Radix extract are mixed evenly, granulated and prepared into tablets (0.2g/tablet) to obtain the anti-HP medicine composition, where the content of berberine is 54.1% based on the HPLC analysis. A good anti-HP effect can be achieved by taking 4 tablets each time and three times a day, and particularly in combination with the “Triple
2019100737 05 Jul 2019
Therapy” to produce a synergistic anti-HP effect. This composition also has effects of treating diarrhea and improving the intestinal flora.
[0033] Embodiment 3 Preparation of an Anti-HP Medicine Composition [0034] A Phellodenri Chinesis Cortex extract is obtained by the steps of: soaking
100 kg of Phellodenri Chinesis Cortex with 0.5% (V/V) aqueous sulphuric acid solution for 12 hours, and then extracting by percolation; neutralizing a resulting extracted solution with lime to pH=4 and filtering, and depressurizing and concentrating a resulting filtrate to 0.4 g of raw herb (the Phellodenri Chinesis Cortex) per milliliter; filtering a resulting concentrated solution and further adding 2% (W7V) sodium chloride to the same; standing for 12 hours and filtering; and precipitating in distilled water 5 times that of a resulting filtered solution for recrystallization once, thereby obtaining 3.1 kg of the Phellodenri Chinesis Cortex extract. The content of the berberine in the extract is 93% based on the HPLC analysis.
[0035] A Yuhuanglian extract is obtained by the steps of: performing extraction on 10 kg of the Yuhuanglian three times with 50% ethanol through heating reflux, with 3 hours for the first time, 2 hours for the second time and 1.5 hours for the third time; combining and filtering resulting extracted solutions; recovering the ethanol and concentrating a resulting solution into thick paste, thereby obtaining 1.9 kg of the Yuhuanglian extract.
[0036] An Aucklandiae Radix extract is obtained by the steps of: extracting volatile oil from 10 kg of the Aucklandiae Radix by steam distillation, and collecting the volatile oil, which is 0.05 kg; filtering a water decoction, and concentrating the filtered water decoction into thick paste; and mixing the volatile oil and extract to obtain 3 kg of the Aucklandiae Radix extract.
[0037] 69 g of the Phellodenri Chinesis Cortex extract (which can also be purchased directly from the market), 1 g of the Yuhuanglian extract and 30 g of the
2019100737 05 Jul 2019
Aucklandiae Radix extract are mixed evenly, granulated and pilled (O.lg/pill) to obtain the anti-HP medicine composition, where the content of berberine is 64.5% based on the HPLC analysis. A good anti-HP effect can be achieved by taking 1 g of pills each time and three times a day, and in particular in combination with the “Triple Therapy” to produce a synergistic anti-HP effect. This composition also has effects of treating diarrhea and improving the intestinal flora.
[0038] Embodiment 4 Preparation of an Anti-HP Medicine Composition [0039] A Phellodenri Chinesis Cortex extract is obtained by the steps of: soaking
100 kg of Phellodenri Chinesis Cortex with 0.6% (V/V) aqueous sulphuric acid solution for 24 hours, and then extracting by percolation; neutralizing a resulting extracted solution with lime to pH=5 and filtering, and depressurizing and concentrating a resulting filtrate to 0.4 g of raw herb (the Phellodenri Chinesis Cortex) per milliliter; filtering a resulting concentrated solution and further adding 3% (W/V) sodium chloride to the same; standing for 24 hours and filtering; and precipitating in distilled water 5 times that of a resulting filtered solution for recrystallization once, thereby obtaining 3.6 kg of the Phellodenri Chinesis Cortex extract. The content of the berberine in the extract is 96% based on the HPLC analysis.
[0040] A Yuhuanglian extract is obtained by the steps of: performing extraction on 10 kg of the Yuhuanglian three times with 60% ethanol through heating reflux, with 3 hours for the first time, 2 hours for the second time and 1.5 hours for the third time; combining and filtering resulting extracted solutions; recovering the ethanol and concentrating a resulting solution into thick paste, thereby obtaining 2.1 kg of the Yuhuanglian extract.
[0041] An Aucklandiae Radix extract is obtained by the steps of: extracting volatile oil from 10 kg of the Aucklandiae Radix by steam distillation, and collecting the volatile oil, which is 0.05 kg; filtering a water decoction, and concentrating the filtered
2019100737 05 Jul 2019 water decoction into thick paste; and mixing the volatile oil and extract to obtain 3 kg of the Aucklandiae Radix extract.
[0042] 90 g of the Phellodenri Chinesis Cortex extract (which can also be purchased directly from the market), 8 g of the Yuhuanglian extract and 2 g of the Aucklandiae Radix extract are mixed evenly, granulated and capsuled (0.4g/capsule) to obtain the anti-HP medicine composition, where the content of berberine is 87.6% based on the HPLC analysis. A good anti-HP effect can be achieved by taking 2 capsules each time and two times a day, and in particular in combination with the “Triple Therapy” to produce a synergistic anti-HP effect. This composition also has effects of treating diarrhea and improving the intestinal flora.
[0043] Embodiment 5 Comparison of Arhi-Helicobacter Pylori (HP) Effect [0044] (1) Test medicine 1: an anti-HP medicine composition prepared according to Embodiment 1, at the dosage of 225mg · kg'1 · d’1.
[0045] (2) Test medicine 2: an anti-HP medicine composition prepared according to Embodiment 2, at the dosage of 225mg · kg'1 · d’1.
[0046] (3) Test medicine 3: an anti-HP medicine composition prepared according to Embodiment 4, at the dosage of 225mg · kg'1 · d’1.
[0047] (4) Control medicine 1: A Phellodenri Chinesis Cortex extract obtained by the steps of: soaking 100 kg of Phellodenri Chinesis Cortex with 0.6% (V/V) aqueous sulphuric acid solution for 24 hours, and then extracting by percolation; neutralizing a resulting extracted solution with lime flour to pH=5 and filtering, and depressurizing and concentrating a resulting filtrate to 0.4 g of raw herb (the Phellodenri Chinesis Cortex) per milliliter; filtering a resulting concentrated solution and further adding 3% (W/V) sodium chloride to the same; standing for 24 hours and filtering; and precipitating in distilled water 5 times that of a resulting filtered solution for recrystallization once, thereby obtaining the Phellodenri Chinesis Cortex extract, which is administrated at the dosage of
2019100737 05 Jul 2019
225mg · kg'1 · d'1.
[0048] (5) Control medicine 2: A Yuhuanglian extract obtained by the steps of:
performing extraction on 100 kg of the Yuhuanglian three times with 60% ethanol through heating reflux, with 3 hours for the first time, 2 hours for the second time and 1.5 hours for the third time; combining and filtering resulting extracted solutions; recovering the ethanol and concentrating a resulting solution into thick paste, thereby obtaining the Yuhuanglian extract, which is administrated at the dosage of 225mg · kg'1 · d’1.
[0049] (6) Control medicine 3: An Aucklandiae Radix extract obtained by the steps of: extracting volatile oil from 100 kg of the Aucklandiae Radix by steam distillation, and collecting the volatile oil, which is 5 kg; filtering a water decoction, and concentrating the filtered water decoction into thick paste to obtain 30 kg of the extract; and mixing the volatile oil and extract to obtain the Aucklandiae Radix extract, which is administrated at the dosage of 225mg · kg'1 · d'1.
[0050] (7) Control medicine 4: A mixture obtained by evenly mixing the
Yuhuanglian extract and Aucklandiae Radix extract, which are prepared from 80 kg of Yuhuanglian and 20kg of Aucklandiae Radix according to the control medicine 2 and the control medicine 3 respectively, which is administrated at the dosage of 225mg · kg'1 · d’1.
[0051] (8) Control medicine 5: A mixture obtained by evenly mixing the
Phellodenri Chinesis Cortex extract and Aucklandiae Radix extract, which are prepared from 80 kg of Phellodenri Chinesis Cortex and 20kg of Aucklandiae Radix according to the control medicine 1 and the control medicine 3 respectively, which is admnistrated at the dosage of 225mg · kg'1 · d'1.
[0052] (9) Control medicine 6: A triple therapy group, which is administrated with mg/kg of Omeprazole, 150 mg/kg of Clarithromycin and 150 mg/kg of Amoxicillin.
[0053] (10) Control medicine 7: A triple therapy group+the test medicine 3, which is administrated with 6 mg/kg of Omeprazole, 150 mg/kg of Clarithromycin and 150
2019100737 05 Jul 2019 mg/kg of Amoxicillin, as well as the test medicine 3 at the dosage of 225mg · kg'1 · d’1.
[0054] Animal Tests (Yang Chen et. al., Experimental Study on Αηύ-Ιlelicobacter Pylori and Anti-Gastric Ulcer Effects of Weiyoukang Gastric-Floating Tablets. China Journal of Hospital Pharmacy, 2018, 38 (5), 482)): (1) Preparation of HP-infected mouse model: Kunming mice were fed adaptively for Id and then fasted for 12h; then each mouse was sterilized with 0.2 mL of ethanol by gavage; and normal diet and water were resumed after 2h. Then the pretreated mice were fasted for 12h and each mouse was given 0.5 mL of HP suspension (with the microbial content of 1 X 109CFU · mL-Ι), which was repeated every 12 hours, 4 times in total. The diet and water was resumed 2h after the last gavage. 5 mice were sacrificed randomly after 5 weeks, and gastric antrum tissues were taken for urease, bacteriological smear examination and histological examination to determine whether HP was successfully infected. (2) Animal grouping and administration: the modeled animals were randomly divided into 11 groups (15 in each group), including: a normal control group, a model control group, test medicine groups 1-3 (225mg · kg'1 · d'1) and control medicine groups 1-5 (225mg · kg'1 · d'1). Each mouse in each administration group was administrated with 0.4-1 mL (of a test medicinal solution prepared from the medicine with purified water), and each mouse in the normal control group and the model group were given physiological saline of the same amount, with 0.4'1 mL each time and once a day for 5 weeks. (3) Test Indicators: After the last administration, the animals were sacrificed after 24-hour fasting, and the gastric antrum tissues were taken for urease, bacteriological smear examination and histological examination to determine the presence of HP. Under an aseptic condition, a mouse stomach was taken out, cut along the greater curvature, and washed with sterile physiological saline to remove residues; the stomach antrum was taken out along an longitudinal axis and cut into three parts, with one part for smear microscopic examination, where the mucosal surface of the mouse stomach antrum was attached to a glass slide for smearing and subjected to the microscopic
2019100737 05 Jul 2019 examination after Gram staining; a second part for histological examination, where stomach tissues were fixed with formaldehyde, and sliced for HE staining and Giemsa staining respectively; and a third part for the urease test. The mouse gastric mucosa was determined to be HP-infected as long as two positive results were obtained from the three tests above. The results are shown in Table 1.
[0055] Table 1 Helicobacter Pylori Clearance Rates of Medicines
Medicine Clearance Rate (%)
Test Medicine 1 67
Test Medicine 2 60
Test Medicine 3 67
Control Medicine 1 67
Control Medicine 2 40
Test Medicine 3 0
Test Medicine 4 20
Test Medicine 5 33
Control Medicine 6 80
Control Medicine 7 93
[0056] As can be seen from Table 1, the test medicine exhibited a desirable clearance rate for HP, the test medicines 1 and 3 are slightly better, and there is no significant difference among the three groups. The test medicine 1 shows a desirable effect on clearing HP, the test medicine 2 shows an effect somewhat decreased, and the test medicine 3 shows no anti-HP effect; the control medicine 4 (the combination of Yuhuanglian and Aucklandiae Radix) shows a certain anti-HP effect, which is very poor; and the control medicine 5 (the combination of the Phellodenri Chinesis Cortex and the Aucklandiae Radix) shows a certain anti-HP effect, which is however undesirable.
[0057] As can also be seen from the table, the anti-HP effect of triple therapy is
2019100737 05 Jul 2019 superior to that of each medicine group, and has a desirable efficacy (the control medicine
6). However, the anti-HP effect of the triple therapy is further improved after its combination with the test medicines, and is very desirable (the control medicine 7), which indicates a good synergistic anti-HP effect thereamong.
[0058] Embodiment 6 Comparison of Effects on Preventing and Resisting Gastric
Cancer [0059] (1) Test medicine according to Embodiment 1.
[0060] (2) Test medicine
1:
2:
An
An anti-HP anti-HP pharmaceutical composition prepared pharmaceutical composition prepared according to Embodiment 2.
[0061] (3) Test medicine
3:
An anti-HP pharmaceutical composition prepared according to Embodiment 3.
[0062] (4) Control medicine 1: A Phellodenri Chinesis Cortex extract obtained by the steps of: soaking 100 kg of Phellodenri Chinesis Cortex with 0.6% (V/V) aqueous sulphuric acid solution for 24 hours, and then extracting by percolation; neutralizing a resulting extracted solution with lime flour to pH=5 and filtering, and depressurizing and concentrating a resulting filtrate to 0.4 g of raw herb (the Phellodenri Chinesis Cortex) per milliliter; filtering a resulting concentrated solution and further adding 3% (W/V) sodium chloride to the same; standing for 24 hours and filtering; and precipitating in distilled water 5 times that of a resulting filtered solution for recrystallization once, thereby obtaining the Phellodenri Chinesis Cortex extract.
[0063] (5) Control medicine 2: A Yuhuanglian extract obtained by the steps of:
performing extraction on 100 kg of the Yuhuanglian three times with 60% ethanol through heating reflux, with 3 hours for the first time, 2 hours for the second time and 1.5 hours for the third time; combining and filtering resulting extracted solutions; recovering the ethanol and concentrating a resulting solution into thick paste, thereby obtaining the Yuhuanglian
2019100737 05 Jul 2019 extract.
[0064] (6) Control medicine 3: An Aucklandiae Radix extract obtained by the steps of: extracting volatile oil from 100 kg of the Aucklandiae Radix by steam distillation, and collecting the volatile oil, which is 5 kg; filtering a water decoction, and concentrating the filtered water decoction into thick paste to obtain 30 kg of the extract; and mixing the volatile oil and extract to obtain the Aucklandiae Radix extract.
[0065] (7) Control medicine 4: A mixture obtained by evenly mixing the
Yuhuanglian extract and Aucklandiae Radix extract, which are prepared from 80 kg of Yuhuanglian and 20kg of Aucklandiae Radix according to the control medicine 2 and the control medicine 3 respectively.
[0066] (8) Control medicine 5: A mixture obtained by evenly mixing the
Phellodenri Chinesis Cortex extract and Aucklandiae Radix extract, which are prepared from 80 kg of Phellodenri Chinesis Cortex and 20kg of Aucklandiae Radix according to the control medicine 1 and the control medicine 3 respectively.
[0067] 100 four-week-old BALB/c-nu nude mice were raised in single cages, with a barrier isolation system for balancing for 3 to 5 days, in the presence of sufficient sterile feed and water. The nude mice were randomly divided into 10 groups, with 10 in each group. Except for the negative control group; the nude mice in each group were inoculated with gastric cancer tumor cells (BGC-823) (0.1 mL/mouse); the mice were raised with the test medicines at a dosage of 225 mg/kg for 30 days, after which the mice were sacrificed; a tumor mass was removed and weighed; and the average weight of the tumor tissues in each group was analyzed. The results are shown in Table 2.
[0068] Table 2 Tests on Anti-tumor Effects
Test Group Average Tumor Weight/g Tumor Incidence Rate/%
Negative Control Group 0.00 ± 0.00 0
2019100737 05 Jul 2019
Positive Control Group 1.51 ±0.54 100
Test Group 1 0.81 ±0.35* 90
Test Group 2 0.71 ±0.26** 80
Test Group 3 0.67 ±0.23** 70
Control Group 1 0.8 ±0.43* 90
Control Group 2 0.80 ±0.30* 80
Control Group 3 1.42 ±0.53 100
Control Group 4 0.89 ±0.32* 90
Control Group 5 0.86 ±0.35* 90
[0069] The results showed that compared with the positive control group (* group), both the medicine groups and the control medicine groups showed the effect on resisting the gastric cancer, and only the control group 3 (with the Aucklandiae Radix extract) showed no anti-gastric-cancer effect. Through the comparison among the medicine groups, it is found that the complex of the Phellodenri Chinesis Cortex extract and the Yuhuanglian extract has an effect against the gastric cancer, and achieves a significant level compared with the model group; the complex of the Phellodenri Chinesis Cortex, the Yuhuanglian and the Aucklandiae Radix has a very noticeable effect against the gastric cancer, which reaches an extremely sinificant level; and compared with the control groups, the complex of the Phellodenri Chinesis Cortex, the Yuhuanglian and the Aucklandiae Radix has the effect against gastric cancer superior to that of the Phellodenri Chinesis Cortex, the Yuhuanglian and the Aucklandiae Radix, and also that of “the combination of Aucklandiae Radix and Yuhuanglian”, “the combination of Phellodenri Chinesis Cortex and Aucklandiae Radix“, and the combination of ’’the Yuhuanglian and the Aucklandiae Radix.
[0070] It can also be seen from the table that the test medicine groups show the effect of preventing the gastric cancer, and in particular, the complex of the Phellodenri
2019100737 05 Jul 2019
Chinesis Cortex, Yuhuanglian and Aucklandiae Radix cork has the best preventive effect.
Embodiment 7 Comparison of Effects on Repairing Intestinal Flora [0071] (1) Test medicine 1: An according to Embodiment 1.
[0072] (2) Test medicine 2: An according to Embodiment 2.
[0073] (3) Test medicine 3: An anti-HP pharmaceutical composition prepared anti-HP pharmaceutical composition prepared anti-HP pharmaceutical composition prepared according to Embodiment 3.
[0074] (4) Control medicine 1: A Phellodenri Chinesis Cortex extract obtained by the steps of: soaking 100 kg of Phellodenri Chinesis Cortex with 0.6% (V/V) aqueous sulphuric acid solution for 24 hours, and then extracting by percolation; neutralizing a resulting extracted solution with lime flour to pH=5 and filtering, and depressurizing and concentrating a resulting filtrate to 0.4 g of raw herb (the Phellodenri Chinesis Cortex) per milliliter; filtering a resulting concentrated solution and further adding 3% (W7V) sodium chloride to the same; standing for 24 hours and filtering; and precipitating in distilled water 5 times that of a resulting filtered solution for recrystallization once, thereby obtaining the Phellodenri Chinesis Cortex extract.
[0075] (5) Control medicine 2: A Yuhuanglian extract obtained by the steps of:
performing extraction on 100 kg of the Yuhuanglian three times with 60% ethanol through heating reflux, with 3 hours for the first time, 2 hours for the second time and 1.5 hours for the third time; combining and filtering resulting extracted solutions; recovering the ethanol and concentrating a resulting solution into thick paste, thereby obtaining the Yuhuanglian extract.
[0076] (6) Control medicine 3: An Aucklandiae Radix extract obtained by the steps of: extracting volatile oil from 100 kg of the Aucklandiae Radix by steam distillation, and collecting the volatile oil, which is 5 kg; filtering a water decoction, and concentrating the
2019100737 05 Jul 2019 filtered water decoction into thick paste to obtain 30 kg of the extract; and mixing the volatile oil and extract to obtain the Aucklandiae Radix extract.
[0077] (7) Control medicine 4: A mixture obtained by evenly mixing the
Yuhuanglian extract and Aucklandiae Radix extract, which are prepared from 80 kg of Yuhuanglian and 20 kg of Aucklandiae Radix according to the control medicine 2 and the control medicine 3 respectively.
[0078] (8) Control medicine 5: A mixture obtained by evenly mixing the
Phellodenri Chinesis Cortex extract and Aucklandiae Radix extract, which are prepared from 80 kg of Phellodenri Chinesis Cortex and 20 kg of Aucklandiae Radix according to the control medicine 1 and the control medicine 3 respectively.
[0079] 100 four-week-old KM mice were balanced with the barrier isolation system for 3 to 5 days in the present of sufficient feed and water. The mice were randomly divided into 10 groups, with 10 mice in each group. For the triple therapy control group (10 mice): the mice were administrated with 20 mg of omeprazole (6mg/kg for the mice), 500 mg of clarithromycin (150 mg/kg for the mice) and 0.5 g of amoxicillin (150 mg/kg for the mice) twice a day. The mice in the test group (80 mice) were divided into 8 groups, with 10 mice in each group. The 8 groups were administrated with 20 mg of omeprazole (6mg/kg for the mice), 500 mg of clarithromycin (150 mg/kg for the mice) and 0.5 g of amoxicillin (150 mg/kg for the mice) twice a day. Then, the mice in each group were administrated with the test medicines or control meicines at the dosage of 225 mg/kg. The administration lasted for 15 days and stopped for 2 days. Then, the feces of the mice were collected, weighed, and analyzed in terms of microbial diversity and abundance therein by using microbiome techniques (Kai He etc., Biochimicaet Biophysica Acta. 1862: 1696-1709, 2016). The results are shown in Table 3.
[0080] Table 3 Results of Repairing Antibiotics-induced Intestinal Flora Disorder with Medicines
2019100737 05 Jul 2019
Test Group Microbial Flora Abundance(Pcs)
Negative Control Group 1200
Control Group of Triple Therapy 511
Test Group 1 765
Test Group 2 921
Test Group 3 1198
Control Group 1 776
Control Group 2 786
Control Group 3 741
Control Group 4 895
Control Group 5 901
[0081] The test results show that after the use of the antibiotics in the triple therapy, the intestinal microbial groups of the mice decrease rapidly, which seriously affects the diversity of the intestinal micro flora, leading to a series of diseases (diarrhea, indigestion, nutrient absorption decrease, etc.); and the diversity of the intestinal microorganisms can be significantly restored with the complex of Phellodenri Chinesis Cortex, Yuhuanglian and Aucklandiae Radix, in particular the test medicine 3 which can substantially restore the diversity of the intestinal microorganisms to a normal level. Although all of the Phellodenri Chinesis Cortex, Yuhuanglian and Aucklandiae Radix have the effect of restoring the diversity of microorganisms, the complex, in particular the complex consisting of the three Chinese herbal medicines, i.e. the Phellodenri Chinesis Cortex, the Yuhuanglian and the Aucklandiae Radix, shows the best effect.
[0082] Embodiment 8 Comparison of Medicinal Safety [0083] (1) Test medicine 1: An anti-HP pharmaceutical composition prepared according to Embodiment 1.
[0084] (2) Test medicine 2: An anti-HP pharmaceutical composition prepared
2019100737 05 Jul 2019 according to Embodiment 2.
[0085] (3) Test medicine 3: An anti-HP pharmaceutical composition prepared according to Embodiment 3.
[0086] (4) Control medicine 1: A Phellodenri Chinesis Cortex extract obtained by the steps of: soaking 100 kg of Phellodenri Chinesis Cortex with 0.6% (V/V) aqueous sulphuric acid solution for 24 hours, and then extracting by percolation; neutralizing a resulting extracted solution with lime flour to pH=5 and filtering, and depressurizing and concentrating a resulting filtrate to 0.4 g of raw herb (the Phellodenri Chinesis Cortex) per milliliter; filtering a resulting concentrated solution and further adding 3% (W/V) sodium chloride to the same; standing for 24 hours and filtering; and precipitating in distilled water 5 times that of a resulting filtered solution for recrystallization once, thereby obtaining the Phellodenri Chinesis Cortex extract.
[0087] (5) Control medicine 2: A Yuhuanglian extract obtained by the steps of:
performing extraction on 100 kg of the Yuhuanglian three times with 60% ethanol through heating reflux, with 3 hours for the first time, 2 hours for the second time and 1.5 hours for the third time; combining and filtering resulting extracted solutions; recovering the ethanol and concentrating a resulting solution into thick paste, thereby obtaining the Yuhuanglian extract.
[0088] (6) Control medicine 3: An Aucklandiae Radix extract obtained by the steps of: extracting volatile oil from 100 kg of the Aucklandiae Radix by steam distillation, and collecting the volatile oil, which is 5 kg; filtering a water decoction, and concentrating the filtered water decoction into thick paste to obtain 30 kg of the extract; and mixing the volatile oil and extract to obtain the Aucklandiae Radix extract.
[0089] (7) Control medicine 4: A mixture obtained by evenly mixing the
Yuhuanglian extract and Aucklandiae Radix extract, which are prepared from 80 kg of Yuhuanglian and 20 kg of Aucklandiae Radix according to the control medicine 2 and the
2019100737 05 Jul 2019 control medicine 3 respectively.
[0090] (8) Control medicine 5: A mixture obtained by evenly mixing the
Phellodenri Chinesis Cortex extract and Aucklandiae Radix extract, which are prepared from 80 kg of Phellodenri Chinesis Cortex and 20 kg of Aucklandiae Radix according to the control medicine 1 and the control medicine 3 respectively.
[0091] (9) Control medicine 6: A triple therapy group, which is administrated with mg/kg of Omeprazole, 150 mg/kg of Clarithromycin and 150 mg/kg of Amoxicillin.
[0092] (10) Control medicine 7: A triple therapy group+the test medicine 3, which is administrated with 6 mg/kg of Omeprazole, 150 mg/kg of Clarithromycin and 150 mg/kg of Amoxicillin, as well as the test medicine 3 at the dosage of 225mg · kg-1 · d-1. (Keep a constant ratio for administration) [0093] 110 four-week-old KM mice were balanced with the barrier isolation system for 3 to 5 days in the presence of sufficient sterile feed and water. The mice were randomly divided into 11 groups, with 10 mice in each group. The test medicines and the control medicines were prepared into a 20% solution, respectively. Except for the negative control group, each medicine test group was intragastrically administered with 0.6 mL three times continuously, once every 8 hours (at a total dosage of 18 mg/kg). Then, the mice were allowed to intake freely and measured in body weight 3 days later. After 15 days, the mortality of each group was counted, with the results shown in Table 4.
[0094] Table 4 Results of safety evaluation tests
Test Group Average Mice Weight After 3 Days (g) Mice Mortality Rate within 15 days (%)
Negative Control Group 28.35±1.21 0
Test Group 1 24.55±3.22 0
Test Group 2 26.3H1.22 0
2019100737 05 Jul 2019
Test Group 3 27.85+1.65 0
Control Group 1 22.31i2.25 10
Control Group 2 25.66il.41 0
Control Group 3 28.llil.23 0
Control Group 4 27.95il.54 0
Control Group 5 27.32il.35 0
Control Group 6 21.56il.65 20
Control Group 7 24.32i2.35 0
[0095] The results show that the Phellodenri Chinesis Cortex extract is poor in safety when used alone, since the body weight of the mice decreases significantly, and even some mice died (in the control group 1); the safety is somewhat increased (in the test group 1) after the Yuhuanglian extract and the Phellodenri Chinesis Cortex extract are compounded; with the addition of the Aucklandiae Radix extract into the Phellodenri Chinesis Cortex extract, an obvious weight gain is shown among the mice, without deaths, which indicates a great increase in the safety (in the control group 5); after the Aucklandiae Radix extract is added in the Yuhuanglian extract (based on the comparison between the control group 2 and the control group 4), the weight gain of the mice is more obvious, and the safety is further improved; and after the extracts of the Phellodenri Chinesis Cortex, Yuhuanglian and Aucklandiae Radix are compounded, the body weight of the mice is close to that in the normal group, indicating extremely high safety.
[0096] The test results also show that the triple therapy is likely to cause weight loss and death of the test animals, with severe side effects (in the control medicine 6); and after the combination with the test medicines, the side effects of the triple therapy may be significantly improved.

Claims (8)

  1. What is claimed is:
    1. An anti-HP (Helicobacter Pylori) Traditional Chinese Medicine composition, comprising 60-95 portions of Phellodenri Chinesis Cortex extract, 1-30 portions of Yuhuanglian extract and 0-30 portions of Aucklandiae Radix extract by weight.
  2. 2. The Traditional Chinese Medicine composition according to Claim 1, comprising 70-90 portions of the Phellodenri Chinesis Cortex extract, 5-20 portions of the Yuhuanglian extract and 5-20 portions of the Aucklandiae Radix extract by weight.
  3. 3. The Traditional Chinese Medicine composition according to Claim 2, comprising 75-80 portions of the Phellodenri Chinesis Cortex extract, 10-15 portions of the Yuhuanglian extract and 10-15 portions of the Aucklandiae Radix extract by weight.
  4. 4. The Traditional Chinese Medicine composition according to Claim 3, wherein a method for extracting the Phellodenri Chinesis Cortex extract comprises the steps of: soaking Phellodenri Chinesis Cortex with 0.1-2% aqueous sulphuric acid solution for 1-48 hours, and then extracting by percolation; neutralizing a resulting extracted solution with lime to pH=2-5 and filtering, and depressurizing and concentrating a resulting filtrate to 0.1-1 g of raw herb (Phellodenri Chinesis Cortex) per milliliter; filtering a resulting concentrated solution and further adding 0.5-5% (W/V) sodium chloride to the same, standing for 1-24 hours and filtering; and precipitating in distilled water 5 times that of a resulting filtered solution for recrystallization once, thereby obtaining the Phellodenri Chinesis Cortex extract.
  5. 5. The Traditional Chinese Medicine composition according to Claim 3, wherein a method for extracting the Yuhuanglian extract comprises the steps of: slicing Yuhuanglian; performing extraction on Yuhuanglian slices three times with 40-70% ethanol through heating reflux; combining and filtering resulting extracted solutions; recovering the ethanol and concentrating a resulting solution into thick paste, thereby obtaining the Yuhuanglian extract.
    2019100737 05 Jul 2019
  6. 6. The Traditional Chinese Medicine composition according to Claim 3, wherein a method for preparing Yuhuanglian comprises the steps of: decocting Tetradium ruticarpum in water, evenly mixing a resulting decoction with pure Coptidis Rhizoma, and frying dry after the decoction is absorbed completely, thereby obtaining the Yuhuanglian.
  7. 7. The Traditional Chinese Medicine composition according to Claim 6, wherein the Aucklandiae Radix extract is obtained by the steps of: extracting volatile oil from Aucklandiae Radix by steam distillation, and collecting the volatile oil; filtering a water decoction, concentrating the filtered water decoction into thick paste, and drying the thick paste; and combining the volatile oil and extract of the Aucklandiae Radix to obtain the Aucklandiae Radix extract.
  8. 8. An anti-HP (Helicobacter Pylori') Traditional Chinese Medicine preparation obtained by preparing the Traditional Chinese Medicine composition per se according to any one of Claims 1-7, or the Traditional Chinese Medicine composition and pharmaceutically acceptable dressings, into pills, capsules, tablets or capsule preparations.
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