阅读说明：本技术 香连丸产物的新用途 (New application of xianglian pill product ) 是由 李学刚 叶小利 于 2020-05-28 设计创作，主要内容包括：本发明公开了香连丸产物在预防或治疗幽门螺旋杆菌、消化道肿瘤、萎缩性胃炎、心脑血管疾病等方面的新用途；解决了香连丸治疗作用一直限于“用于大肠湿热所致的痢疾,症见大便脓血、里急后重、发热腹痛,肠炎、细菌性痢疾见上述症候者”,新的治疗作用一直未得到开发的问题；本发明香连丸产物具有抗幽门螺旋杆菌Hp的作用,其安全性比黄连和黄连提取物更高；本发明香连丸产物还可以用于消化道肿瘤的治疗；此外,本发明香连丸产物还具有预防包括动脉粥样硬化在内的心脑血管疾病的作用。(The invention discloses a new application of a xianglian pill product in the aspects of preventing or treating helicobacter pylori, digestive tract tumor, atrophic gastritis, cardiovascular and cerebrovascular diseases and the like; solves the problem that the therapeutic action of the xianglian pill is always limited to 'treating dysentery caused by damp-heat in large intestine with symptoms of purulent blood in stool, tenesmus, fever and abdominal pain, enteritis and bacillary dysentery with the symptoms' and the new therapeutic action is not developed all the time; the product of the xianglian pill has the function of resisting helicobacter pylori Hp, and the safety of the xianglian pill is higher than that of the coptis chinensis and the coptis chinensis extract; the product of the xianglian pill can also be used for treating digestive tract tumors; in addition, the product of the xianglian pill also has the effect of preventing cardiovascular and cerebrovascular diseases including atherosclerosis.)

1. A new use of XIANGLIAN pill in preventing or treating helicobacter pylori is provided; the product of the xianglian pill comprises at least one of a xianglian pill, a concentrated xianglian pill, a xianglian capsule and a new xianglian capsule.

2. The new use as claimed in claim 1, wherein said xinxianglian capsule is prepared according to the following method: weighing 4 parts of golden thread and 1 part of costus root, and mixing; crushing a sample; reflux-extracting with 5 times of 30-80% ethanol for 1-3 times; mixing extractive solutions, recovering solvent to obtain extract, drying, pulverizing, and making into capsule.

3. A new use of XIANGLIAN pill in preventing or treating digestive tract tumor is provided; the product of the xianglian pill comprises at least one of a xianglian pill, a concentrated xianglian pill, a xianglian capsule and a new xianglian capsule.

4. The new use as claimed in claim 3, wherein said Xinxianglian capsule is prepared according to the following method: weighing 4 parts of golden thread and 1 part of costus root, and mixing; crushing a sample; reflux-extracting with 5 times of 30-80% ethanol for 1-3 times; mixing extractive solutions, recovering solvent to obtain extract, drying, pulverizing, and making into capsule.

5. The novel use according to claim 3, wherein the tumor of the digestive tract comprises gastric or colon cancer.

6. A new use of XIANGLIAN pill in preventing or treating atrophic gastritis; the product of the xianglian pill comprises at least one of a xianglian pill, a concentrated xianglian pill, a xianglian capsule and a new xianglian capsule.

7. The new use as claimed in claim 7, wherein said Xinxianglian capsule is prepared according to the following method: weighing 4 parts of golden thread and 1 part of costus root, and mixing; crushing a sample; reflux-extracting with 5 times of 30-80% ethanol for 1-3 times; mixing extractive solutions, recovering solvent to obtain extract, drying, pulverizing, and making into capsule.

8. A new use of XIANGLIAN pill in preventing or treating cardiovascular and cerebrovascular diseases is provided; the product of the xianglian pill comprises at least one of a xianglian pill, a concentrated xianglian pill, a xianglian capsule and a new xianglian capsule.

9. The new use as claimed in claim 8, wherein said Xinxianglian capsule is prepared according to the following method: weighing 4 parts of golden thread and 1 part of costus root, and mixing; crushing a sample; reflux-extracting with 5 times of 30-80% ethanol for 1-3 times; mixing extractive solutions, recovering solvent to obtain extract, drying, pulverizing, and making into capsule.

10. The new use according to claim 8, wherein the cardiovascular and cerebrovascular disease comprises atherosclerosis.

Technical Field

The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a new application of a xianglian pill product.

Background

Xianglian Wan is from Li Jiang Bing Yan Ji Fang (hand-collected prescription for Lijian Bing) from Juan Qi of political and materia Medica, and is composed of Coptidis rhizoma and radix aucklandiae. Through evolution, the xianglian pill collected and carried by the current Chinese pharmacopoeia consists of 4 parts of golden thread and 1 part of costus root. Has effects in clearing away heat, eliminating dampness, promoting qi circulation, and relieving pain, and can be used for treating dysentery due to damp-heat in large intestine, with symptoms of purulent blood in stool, tenesmus, fever, abdominal pain, enteritis, and bacillary dysentery.

The xianglian pill contains a large amount of coptis root, so that the xianglian pill has poor (bitter) taste and large volume and is not beneficial to oral administration. Therefore, enterprises develop the concentrated xianglian pills as the concentrated xianglian pills, and the main processes comprise: pulverizing radix aucklandiae into fine powder; pulverizing Coptidis rhizoma into coarse powder or coarse powder, soaking in 45% ethanol solvent for 24 hr, percolating until percolate is colorless, collecting percolate, recovering ethanol, concentrating to appropriate amount, mixing with above fine powder, adding appropriate amount of starch or microcrystalline cellulose, making into 1000 pills, drying, and polishing to obtain the final product (2015 edition of Chinese pharmacopoeia). The volume of the concentrated xianglian pill is reduced by 60 percent compared with that of the xianglian pill. The process directly crushes the costustoot into the medicine, so that the volume of the concentrated xianglian pill is still larger, and the taste of the pill is still poorer.

Later, based on the concentrated xianglian pill, the enterprises developed the xianglian capsule, and the main processes include: extracting volatile oil from radix aucklandiae by steam distillation, and collecting volatile oil; filtering the water solution after extracting volatile oil, concentrating the filtrate to appropriate amount, drying, and pulverizing into fine powder; reflux-extracting Coptidis rhizoma with 70% ethanol at 75-80 deg.C for three times, the first time for 2 hr, and the second and third times for 1 hr, mixing extractive solutions, filtering, recovering ethanol from filtrate, concentrating to appropriate amount, drying, pulverizing into fine powder, adding above fine powder and appropriate amount of adjuvants, mixing, granulating, drying, spraying radix aucklandiae volatile oil, mixing, and making into capsule of 1000 granules. The volume of the xianglian capsule is 25 percent of that of the xianglian pill. The xianglian capsule has obviously reduced volume, improved taste and other advantages. However, the xianglian capsule has complex process, and volatile oil is firstly extracted and then water-soluble extract is extracted; the extract is viscous, and starch is forced to be added in the process of encapsulating; the addition of starch also affects the volume of the capsules.

The xianglian pill is a classic and famous prescription, and the treatment effect of the xianglian pill is always limited to 'treating dysentery caused by damp-heat in large intestine with symptoms of purulent blood in stool, tenesmus, fever and abdominal pain, enteritis and bacillary dysentery with the symptoms', and a new treatment effect is not developed.

Disclosure of Invention

Aiming at the problem that the existing xianglian pill has a treatment effect which is always limited to be used for treating dysentery caused by large intestine damp-heat, with symptoms of stool purulent blood, tenesmus, fever and abdominal pain, enteritis and bacillary dysentery with the symptoms, a new treatment effect is not developed, and the invention discloses a new application of a xianglian pill product in the aspects of preventing or treating helicobacter pylori, digestive tract tumor, atrophic gastritis, cardiovascular and cerebrovascular diseases and the like.

The invention provides a new application of a xianglian pill product in a medicament for preventing or treating helicobacter pylori; the product of the xianglian pill comprises at least one of a xianglian pill, a concentrated xianglian pill, a xianglian capsule and a new xianglian capsule.

Further, the Xinxianglian capsule is prepared by the following method: weighing 4 parts of golden thread and 1 part of costus root, and mixing; crushing a sample; reflux-extracting with 5 times of 30-80% ethanol for 1-3 times; mixing extractive solutions, recovering solvent to obtain extract, drying, pulverizing, and making into capsule.

Furthermore, the content of the coptis total alkaloids of the Xinxianglian capsule is 38 to 38.4 percent.

Furthermore, the coptis total alkaloid contains 22.3-22.5% of berberine, 6.1-6.2% of palmatine, 6.4-6.5% of coptisine and 3.1-3.2% of epiberberine.

The invention also provides a new application of the xianglian pill product in medicaments for preventing or treating digestive tract tumors; the product of the xianglian pill comprises at least one of a xianglian pill, a concentrated xianglian pill, a xianglian capsule and a new xianglian capsule.

Further, the Xinxianglian capsule can be prepared according to the following method: weighing 4 parts of golden thread and 1 part of costus root, and mixing; crushing a sample; reflux-extracting with 5 times of 30-80% ethanol for 1-3 times; mixing extractive solutions, recovering solvent to obtain extract, drying, pulverizing, and making into capsule.

Further, the tumor of the digestive tract includes gastric cancer or colon cancer.

The invention also provides a new application of the xianglian pill product in preventing or treating atrophic gastritis; the product of the xianglian pill comprises at least one of a xianglian pill, a concentrated xianglian pill, a xianglian capsule and a new xianglian capsule.

Further, the Xinxianglian capsule can be prepared according to the following method: weighing 4 parts of golden thread and 1 part of costus root, and mixing; crushing a sample; reflux-extracting with 5 times of 30-80% ethanol for 1-3 times; mixing extractive solutions, recovering solvent to obtain extract, drying, pulverizing, and making into capsule.

The invention also provides a new application of the product of the xianglian pill in preparing medicaments for preventing or treating cardiovascular and cerebrovascular diseases; the product of the xianglian pill comprises at least one of a xianglian pill, a concentrated xianglian pill, a xianglian capsule and a new xianglian capsule.

Further, the Xinxianglian capsule can be prepared according to the following method: weighing 4 parts of golden thread and 1 part of costus root, and mixing; crushing a sample; reflux-extracting with 5 times of 30-80% ethanol for 1-3 times; mixing extractive solutions, recovering solvent to obtain extract, drying, pulverizing, and making into capsule.

Further, the cardiovascular and cerebrovascular diseases comprise atherosclerosis.

The invention has the beneficial effects that:

the invention discloses a new application of a xianglian pill product in the aspects of preventing or treating helicobacter pylori, digestive tract tumor, atrophic gastritis, cardiovascular and cerebrovascular diseases and the like; solves the problem that the therapeutic action of the xianglian pill is always limited to 'treating dysentery caused by damp-heat in large intestine with symptoms of purulent blood in stool, tenesmus, fever and abdominal pain, enteritis and bacillary dysentery with the symptoms' and the new therapeutic action is not developed all the time; the product of the xianglian pill has the function of resisting helicobacter pylori Hp, and the safety of the xianglian pill is higher than that of the coptis chinensis and the coptis chinensis extract; the product of the xianglian pill can also be used for treating digestive tract cancer; in addition, the product of the xianglian pill also has the effect of preventing cardiovascular and cerebrovascular diseases including atherosclerosis.

Drawings

FIG. 1 is a diagram of the inner wall of blood vessels of experimental animals of various groups of atherosclerosis according to the seventh embodiment of the present invention;

FIG. 2 is a bar graph of the thickness of the inner wall of experimental animals of each group of atherosclerosis according to the seventh embodiment of the present invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following detailed description and accompanying drawings. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

In addition, unless otherwise specifically indicated, various starting materials, reagents, instruments and equipment used in the present invention may be commercially available or prepared by existing methods.

Example 1:

weighing 80g of coptis chinensis tablet and 20g of fructus evodiae, performing reflux extraction for 3 times by using 30% ethanol in an amount which is 5 times that of the coptis chinensis tablet and the fructus evodiae, combining extracting solutions, filtering and recovering a solvent, concentrating the extracting solution into thick paste, drying, crushing, and encapsulating to obtain the Xinxianglian capsule. HPLC (High Performance Liquid Chromatography) content analysis shows that the Xinxianglian capsule contains 22.5% of berberine, 6.2% of palmatine, 6.5% of coptisine and 3.2% of epiberberine. The product has smaller volume than the concentrated xianglian pill and the original xianglian capsule, is easier to granulate and is more formulated for oral administration; and has effects in resisting helicobacter pylori (Hp), preventing digestive tract tumor such as gastric cancer and colon cancer, lowering blood sugar, preventing diabetic complication, reducing blood lipid, preventing atherosclerosis, preventing fatty liver, and reducing weight.

Example 2:

weighing 80g of coptis chinensis tablet and 20g of fructus evodiae, performing reflux extraction for 1 time by using 80% ethanol in an amount which is 5 times that of the coptis chinensis tablet and 20g of fructus evodiae, combining extracting solutions, filtering and recovering a solvent, concentrating the extracting solution into thick paste, drying, crushing, and encapsulating to obtain the Xinxianglian capsule. HPLC content analysis shows that the Xinxianglian capsule contains 22.3% of berberine, 6.1% of palmatine, 6.5% of coptisine and 3.1% of epiberberine. The product has smaller volume than the concentrated xianglian pill and the original xianglian capsule, is easier to granulate and is more formulated for oral administration; and has effects in resisting helicobacter pylori (Hp), preventing digestive tract tumor such as gastric cancer and colon cancer, lowering blood sugar, preventing diabetic complication, reducing blood lipid, preventing atherosclerosis, preventing fatty liver, and reducing weight.

Example 3:

weighing 80g of coptis chinensis tablet and 20g of fructus evodiae, performing reflux extraction for 2 times by using 50% ethanol in an amount which is 5 times that of the coptis chinensis tablet and the fructus evodiae, combining extracting solutions, filtering and recovering a solvent, concentrating the extracting solution into thick paste, drying, crushing, and encapsulating to obtain the Xinxianglian capsule. HPLC content analysis shows that the Xinxianglian capsule contains 22.4% of berberine, 6.2% of palmatine, 6.4% of coptisine and 3.1% of epiberberine. The product has smaller volume than the concentrated xianglian pill and the original xianglian capsule, is easier to granulate and is more formulated for oral administration; and has effects in resisting helicobacter pylori (Hp), preventing digestive tract tumor such as gastric cancer and colon cancer, lowering blood sugar, preventing diabetic complication, reducing blood lipid, preventing atherosclerosis, preventing fatty liver, and reducing weight.

Example 4: in vitro Helicobacter Pylori (HP) killing effect

Control drug 1 (berberine): weighing 1kg of berberine monomer, adding starch, and making into capsule with berberine content of 38%.

Control drug 2: weighing 1kg coptisine monomer, adding starch, and making into capsule with coptisine content of 38%.

Control drug 3: weighing 1kg of palmatine monomer, adding starch, and preparing into capsule, wherein the content of palmatine is controlled to be 38%.

Control drug 4: weighing 1kg of epiberberine monomer, adding starch, and making into capsule with the content of epiberberine controlled at 38%.

Control drug 5: weighing 1kg of jatrorrhizine monomer, adding starch, and making into capsule with jatrorrhizine content of 38%.

Control drug 6 (total alkaloids of coptis): weighing Coptidis rhizoma total alkaloids, adding starch, and making into capsule, wherein the Coptidis rhizoma total alkaloids are controlled to be 38% (berberine 22.4%, palmatine 6.0%, berberine 6.4%, and epiberberine 3.2%).

Control drug 7 (xianglian pill): 4 parts of golden thread and 1 part of costus root. Pulverizing, mixing, and making into watered pill (2015 edition of Chinese pharmacopoeia). HPLC analysis shows that the content of total alkaloids is 7.52% (berberine 4.4%, palmatine 1.2%, coptisine 1.28%, epiberberine 0.64%).

Control drug 8 (concentrated xianglian pill): 4 parts of golden thread and 1 part of costus root. The concentrated xianglian pills are produced according to the process of processing the concentrated xianglian pills in the 'Chinese pharmacopoeia' 2015 edition. HPLC analysis shows that the content of total alkaloids is 14.04% (berberine 8.8%, palmatine 2.4%, coptisine 1.56%, epiberberine 1.28%).

Control drug 9 (xianglian capsule): 4 parts of golden thread and 1 part of costus root. Processing "xianglian capsule" according to the ministerial standard (WS3-146(Z-136) -2004 (Z)): extracting volatile oil from radix aucklandiae by steam distillation, and collecting volatile oil; filtering the water solution after extracting volatile oil, concentrating the filtrate to appropriate amount, drying, and pulverizing into fine powder; reflux-extracting Coptidis rhizoma with 70% ethanol at 75-80 deg.C for three times, the first time for 2 hr, and the second and third times for 1 hr, mixing extractive solutions, filtering, recovering ethanol from filtrate, concentrating to appropriate amount, drying, pulverizing into fine powder, adding above fine powder and appropriate amount of adjuvants, mixing, granulating, drying, spraying radix aucklandiae volatile oil, mixing, and making into capsule of 1000 granules. HPLC analysis shows that the content of total alkaloids is 28.03% (berberine 17.6%, palmatine 4.8%, coptisine 3.12%, epiberberine 2.51%).

Control drug 10: pulverizing radix aucklandiae into powder.

New xianglian capsule: prepared according to example 3. HPLC analysis shows that the content of total alkaloids is 38.1% (berberine 22.4%, palmatine 6.2%, coptisine 6.4%, and epiberberine 3.1%).

The experimental method comprises the following steps: the antibacterial experiment of Hp is carried out according to the research guiding principle of natural medicine (traditional Chinese medicine) new medicine; the experimental strain is NCTC 11637; MIC (minimum inhibitory concentration) of related drugs was determined according to the sesquidilution method (Chinese journal of basic medicine, 2017,23(03): 405-.

TABLE 1 MIC of drug vs Hp (NCTC 11637)

Medicine	MIC(mg/L)
		Medicine group (Xinxianglian capsule)	10.2
Control drug 1	65
		Control drug 2	130
Control drug 3	260
		Control drug 4	260
Control drug 5	260
		Control drug 6	32.5
Control drug 7	81.2
		Control drug 8	40.6
Control drug 9	20.5
		Control drug 10	1040

Since coptis contains alkaloids such as berberine, coptisine, palmatine, epiberberine and jateorhizine, the study also detects the activity of the coptis in inhibiting Hp. As can be seen from Table 1, each drug group had a good effect of inhibiting Hp. In the coptis alkaloid monomer, the berberine has the strongest activity of inhibiting Hp; the effect of the coptis total alkaloid on inhibiting Hp is found to be superior to that of berberine by deducting different factors of the concentration of each medicament; the Hp inhibiting activity of the xianglian pill series is higher than that of the coptis total alkaloids; the activity of the novel xianglian capsule for inhibiting Hp produced by the process is superior to that of a concentrated xianglian pill and a xianglian capsule. The inhibition effect of the costustoot on Hp is very weak (compared with the drug 10), and after being compounded with the coptis chinensis, the effect of improving the antibacterial activity of the coptis chinensis is achieved, which shows that the costustoot has a synergistic Hp-resistant effect.

Example 5: preventing colon cancer and gastric cancer, and resisting colon cancer and gastric cancer

Control drug 1: weighing 1kg of berberine monomer, adding starch, and making into capsule with berberine content of 38%.

Control drug 2: weighing 1kg coptisine monomer, adding starch, and making into capsule with coptisine content of 38%.

Control drug 3: weighing 1kg of palmatine monomer, adding starch, and preparing into capsule, wherein the content of palmatine is controlled to be 38%.

Control drug 4: weighing 1kg of epiberberine monomer, adding starch, and making into capsule with the content of epiberberine controlled at 38%.

Control drug 5: weighing 1kg of jatrorrhizine monomer, adding starch, and making into capsule with jatrorrhizine content of 38%.

Control drug 6: weighing Coptidis rhizoma total alkaloids, adding starch, and making into capsule, wherein the Coptidis rhizoma total alkaloids are controlled to be 38% (berberine 22.4%, palmatine 6.0%, berberine 6.4%, and epiberberine 3.2%).

Control drug 7: 4 parts of golden thread and 1 part of costus root. Pulverizing, mixing, and making into watered pill (2015 edition of Chinese pharmacopoeia). HPLC analysis shows that the content of total alkaloids is 7.52% (berberine 4.4%, palmatine 1.2%, coptisine 1.28%, epiberberine 0.64%).

Control drug 8: 4 parts of golden thread and 1 part of costus root. The concentrated xianglian pills are produced according to the process of processing the concentrated xianglian pills in the 'Chinese pharmacopoeia' 2015 edition. HPLC analysis shows that the content of total alkaloids is 14.04% (berberine 8.8%, palmatine 2.4%, coptisine 1.56%, epiberberine 1.28%).

Control drug 9: 4 parts of golden thread and 1 part of costus root. Processing "xianglian capsule" according to the ministerial standard (WS3-146(Z-136) -2004 (Z)): extracting volatile oil from radix aucklandiae by steam distillation, and collecting volatile oil; filtering the water solution after extracting volatile oil, concentrating the filtrate to appropriate amount, drying, and pulverizing into fine powder; reflux-extracting Coptidis rhizoma with 70% ethanol at 75-80 deg.C for three times, the first time for 2 hr, and the second and third times for 1 hr, mixing extractive solutions, filtering, recovering ethanol from filtrate, concentrating to appropriate amount, drying, pulverizing into fine powder, adding above fine powder and appropriate amount of adjuvants, mixing, granulating, drying, spraying radix aucklandiae volatile oil, mixing, and making into capsule of 1000 granules. HPLC analysis shows that the content of total alkaloids is 28.08% (berberine 17.6%, palmatine 4.8%, coptisine 3.12%, epiberberine 2.56%).

Control drug 10: pulverizing radix aucklandiae into powder.

New xianglian capsule: prepared according to example 3. HPLC analysis shows that the content of total alkaloids is 38.1% (berberine 22.4%, palmatine 6.2%, coptisine 6.4%, and epiberberine 3.1%).

150 BALB/c-nu nude mice with 4 weeks old are fed in a single cage, a barrier isolation system is balanced for 3-5 days, and sterile feed and water are sufficient. Nude mice were randomly divided into 15 groups of 10 mice each, each group of nude mice was inoculated with gastric cancer tumor cells (BGC-823) (0.1 mL/mouse) and colon cancer cells (HCT-116) (0.1 mL/mouse) except for a negative control group, and were fed with experimental drugs at controlled doses: the dose of berberine group is 100mg/Kg, the dose of total alkaloids (berberine, palmatine, coptisine and epiberberine) of other drug groups is 100mg/Kg, and the dose of radix aucklandiae is 1329 mg/Kg; after 30 days, the mice were sacrificed, the tumor mass was removed, weighed, and analyzed to compare the average weight of tumor tissue per group and the incidence of tumors. The results are shown in Table 2.

TABLE 2 antitumor and antitumor Effect test

Note: compared to the positive control:^*P<0.05，^**P<0.01; compared with the total alkaloid group:^ΔP<0.05。

the test results show that compared with the positive control group, the drug group and the control drug group have obvious anti-gastric cancer and anti-colon cancer effects (P)<0.05); the effect of the coptis alkaloid monomer (berberine, coptisine, palmatine, epiberberine, jateorhizine and the like) on resisting gastric cancer and colon cancer reaches a remarkable level (p)<0.05), the effect of the rhizoma coptidis total alkaloids and the xianglian pill series products on resisting gastric cancer and colon cancer reaches extremely obvious level (p)<0.01); the effect of the coptis total alkaloids on resisting gastric cancer and colon cancer is obviously better than that of berberine. Compared with total alkaloids of rhizoma Coptidis, XIANGLIAN pill series has significant effect in resisting gastric cancer and colon cancer^Δp<0.05), which shows that the effect of the xianglian pill series products on resisting gastric cancer and colon cancer is superior to that of the coptis total alkaloids. The costustoot has no inhibition effect on the gastric cancer and the gastric cancer (the contrast medicament 10), and after being compounded with the coptis, the effect of the coptis on resisting the gastric cancer and the colon cancer can be obviously improved, which shows that the costustoot has good synergistic effect on resisting the gastric cancer and the colon cancer^Δp<0.05)。

Example 6 comparison of Effect on prevention of atrophic gastritis

Control drug 1: weighing 1kg of berberine monomer, adding starch, and making into capsule with berberine content of 38%.

Control drug 2: weighing 1kg coptisine monomer, adding starch, and making into capsule with coptisine content of 38%.

Control drug 3: weighing 1kg of palmatine monomer, adding starch, and preparing into capsule, wherein the content of palmatine is controlled to be 38%.

Control drug 4: weighing 1kg of epiberberine monomer, adding starch, and making into capsule with the content of epiberberine controlled at 38%.

Control drug 5: weighing 1kg of jatrorrhizine monomer, adding starch, and making into capsule with jatrorrhizine content of 38%.

Control drug 6: weighing Coptidis rhizoma total alkaloids, adding starch, and making into capsule, wherein the Coptidis rhizoma total alkaloids are controlled to be 38% (berberine 22.4%, palmatine 6.0%, berberine 6.4%, and epiberberine 3.2%).

Control drug 7: 4 parts of golden thread and 1 part of costus root. Pulverizing, mixing, and making into watered pill (2015 edition of Chinese pharmacopoeia). HPLC analysis shows that the content of total alkaloids is 7.52% (berberine 4.4%, palmatine 1.2%, coptisine 1.28%, epiberberine 0.64%).

Control drug 8: 4 parts of golden thread and 1 part of costus root. The concentrated xianglian pills are produced according to the process of processing the concentrated xianglian pills in the 'Chinese pharmacopoeia' 2015 edition. HPLC analysis shows that the content of total alkaloids is 14.04% (berberine 8.8%, palmatine 2.4%, coptisine 1.56%, epiberberine 1.28%).

Control drug 9: 4 parts of golden thread and 1 part of costus root. Processing "xianglian capsule" according to the ministerial standard (WS3-146(Z-136) -2004 (Z)): extracting volatile oil from radix aucklandiae by steam distillation, and collecting volatile oil; filtering the water solution after extracting volatile oil, concentrating the filtrate to appropriate amount, drying, and pulverizing into fine powder; reflux-extracting Coptidis rhizoma with 70% ethanol at 75-80 deg.C for three times, the first time for 2 hr, and the second and third times for 1 hr, mixing extractive solutions, filtering, recovering ethanol from filtrate, concentrating to appropriate amount, drying, pulverizing into fine powder, adding above fine powder and appropriate amount of adjuvants, mixing, granulating, drying, spraying radix aucklandiae volatile oil, mixing, and making into capsule of 1000 granules. HPLC analysis shows that the content of total alkaloids is 28.08% (berberine 17.6%, palmatine 4.8%, coptisine 3.12%, epiberberine 2.56%).

Control drug 10: pulverizing radix aucklandiae into powder.

Medicine group (Xinxianglian capsule): prepared according to example 3. HPLC analysis shows that the content of total alkaloids is 38.1% (containing berberine 22.4%, palmatine 6.2%, berberine 6.4%, and epiberberine 3.1%).

The research method for preventing atrophic gastritis is disclosed in the literature (Wangwen, summer, Zhang Zhonghai. stomach-benefiting granule has reversion effect on chronic atrophic gastritis and gastric precancerous lesion of rat. world China J.Eigestion, 1999; 7(6): 541): 120 rats are divided into 12 groups, each group comprises 10 rats, a normal group (N groups) is not molded, and the normal group is infused with normal saline 12.5 mL/kg; after model recovery group (group M) model 90d, each rat was drenched with physiological saline 2M L, 50d daily; after 90 days of drug modeling, each rat drenches the drug every day, and the dosage is controlled as follows: the dosage of Coptidis rhizoma alkaloid monomer group is 100mg/Kg, the dosage of total alkaloids (berberine, palmatine, coptisine, and epiberberine) of the other medicinal groups is 100mg/Kg, and the dosage of radix aucklandiae is 1329mg/Kg for 50 days. Then, measuring the gastric mucosa transmembrane potential difference; 1mL of gastric lavage fluid is extracted from the gastric cavity washing fluid, the activity of pepsin is measured by adopting a Mett method, and the pH value of gastric juice is measured by using a digital acidimeter for the rest gastric juice. The results are shown in Table 3.

TABLE 3 experiment of the effect of atrophic gastritis resistance

Note: compared to the positive control:^*P<0.05，^**P<0.01; compared with the total alkaloid group:^ΔP<0.05。

test results show that compared with a positive control group, the drug group and the control drug group have obvious effect of resisting atrophic gastritis, and the effect of the coptis alkaloid monomer (berberine, coptisine, palmatine, epiberberine, jateorhizine and the like) on resisting atrophic gastritis reaches a remarkable level (p)<0.05), while the rhizoma coptidis total alkaloids and the xianglian pill series products have extremely obvious level (p) of atrophic gastritis resistance<0.01); the effect of the rhizoma coptidis total alkaloids on resisting atrophic gastritis is obviously better than that of berberine. Compared with total alkaloids of rhizoma Coptidis, XIANGLIAN pill series has remarkable anti-atrophic gastritis effect^Δp<0.05), indicating fragranceThe pill series products have obvious effect of resisting atrophic gastritis. The atrophic gastritis develops into early pathological changes of gastric cancer, and the coptis alkaloid and xianglian pill series products have good effect of resisting the atrophic gastritis, thereby further showing that the coptis alkaloid and xianglian pill series products have good effect of preventing the gastric cancer. The costustoot has almost no therapeutic effect on the atrophic gastritis (the contrast medicament 10), and after being compounded with the coptis chinensis, the effect of the coptis chinensis on treating the atrophic gastritis can be obviously improved, which shows that the costustoot has good synergistic effect.

Example 7: experiment for preventing atherosclerosis

Control drug 1: weighing 1kg of berberine monomer, adding starch, and making into capsule with berberine content of 38%.

Control drug 2: weighing Coptidis rhizoma total alkaloids, adding starch, and making into capsule, wherein the Coptidis rhizoma total alkaloids are controlled to be 38% (berberine 22.4%, palmatine 6.0%, berberine 6.4%, and epiberberine 3.2%).

Control drug 3: 4 parts of golden thread and 1 part of costus root. Pulverizing, mixing, and making into watered pill (2015 edition of Chinese pharmacopoeia). HPLC analysis shows that the content of total alkaloids is 7.52% (berberine 4.4%, palmatine 1.2%, coptisine 1.28%, epiberberine 0.64%).

Control drug 4: 4 parts of golden thread and 1 part of costus root. The concentrated xianglian pills are produced according to the process of processing the concentrated xianglian pills in the 'Chinese pharmacopoeia' 2015 edition. HPLC analysis shows that the content of total alkaloids is 14.04% (berberine 8.8%, palmatine 2.4%, coptisine 1.56%, epiberberine 1.28%).

Control drug 5: 4 parts of golden thread and 1 part of costus root. Processing "xianglian capsule" according to the ministerial standard (WS3-146(Z-136) -2004 (Z)): extracting volatile oil from radix aucklandiae by steam distillation, and collecting volatile oil; filtering the water solution after extracting volatile oil, concentrating the filtrate to appropriate amount, drying, and pulverizing into fine powder; reflux-extracting Coptidis rhizoma with 70% ethanol at 75-80 deg.C for three times, the first time for 2 hr, and the second and third times for 1 hr, mixing extractive solutions, filtering, recovering ethanol from filtrate, concentrating to appropriate amount, drying, pulverizing into fine powder, adding above fine powder and appropriate amount of adjuvants, mixing, granulating, drying, spraying radix aucklandiae volatile oil, mixing, and making into capsule of 1000 granules. HPLC analysis shows that the content of total alkaloids is 28.08% (berberine 17.6%, palmatine 4.8%, coptisine 3.12%, epiberberine 2.56%).

New xianglian capsule: prepared according to example 3. HPLC analysis shows that the content of total alkaloids is 38.1% (berberine 22.4%, palmatine 6.2%, coptisine 6.4%, and epiberberine 3.1%).

The blood fat reducing experimental method is carried out according to the research guiding principle of natural medicines (traditional Chinese medicines) new medicines: the Apoe mice were divided into 7 groups, and the blank group (10) was given normal diet and the high fat group (60) was given high fat diet; after 4 weeks, detecting blood lipid indexes, and dividing the golden yellow hamster successfully molded in the high-fat group into 6 groups (8-10 mice in each group); each group continued to be given high fat diet; the dose of berberine group is 100mg/Kg, the dose of total alkaloids (berberine, palmatine, coptisine and epiberberine) of other drug groups is 100mg/Kg, and the dose of radix aucklandiae is 1329 mg/Kg; the normal group and the model group were given the same volume of physiological saline, respectively; continuously feeding for 12 weeks. Mice were sacrificed, cardiovascular vessels were harvested, sections stained, and vessel wall thickness was measured. See fig. 1-2.

Referring to fig. 1-2, wherein fig. 1 is a diagram of the inner wall of the blood vessel of each group of experimental animals, and fig. 2 is a histogram of the thickness of the inner wall of each group of experimental animals; as can be seen from the figure, the medicament can reduce the thickness of the inner wall of the blood vessel of the hyperlipemia experimental animal, thereby having the function of preventing atherosclerosis; the prevention effect of the total alkaloids is better than that of berberine, the prevention effect of the rhizoma coptidis pill series is better than that of the rhizoma coptidis total alkaloids, and the effect of the new rhizoma coptidis capsule is better than that of the rhizoma coptidis pill series under the same alkaloid concentration.

Example 8: safety test of drugs

The experimental method comprises the following steps: and balancing 70 Km mice with the age of 4 weeks for 3-5 days by using a barrier isolation system, wherein the sterile feed and the water are sufficient. Mice were randomly divided into 7 groups of 10 mice each; the solution of the invention in example 3 and each drug component are prepared into 20 percent solution, except for a negative control group, each drug experiment component is separately gavage 0.6mL, gavage is carried out once in 8 hours, and gavage is carried out continuously for three times (the total dose is 18 g/kg). Then, the mice were allowed to feed freely, the body weight was measured 3 days later, and after 15 days, the mortality of each group was counted, and the results are shown in Table 4.

Control drug 1: weighing 1kg of berberine monomer, adding starch, and making into capsule with berberine content of 38%.

Control drug 2: weighing 1kg coptisine monomer, adding starch, and making into capsule with coptisine content of 38%.

Control drug 3: weighing 1kg of palmatine monomer, adding starch, and preparing into capsule, wherein the content of palmatine is controlled to be 38%.

Control drug 4: weighing 1kg of epiberberine monomer, adding starch, and making into capsule with the content of epiberberine controlled at 38%.

Control drug 5: weighing 1kg of jatrorrhizine monomer, adding starch, and making into capsule with jatrorrhizine content of 38%.

Control drug 6: weighing Coptidis rhizoma total alkaloids, adding starch, and making into capsule, wherein the Coptidis rhizoma total alkaloids are controlled to be 38% (berberine 22.4%, palmatine 6.0%, berberine 6.4%, and epiberberine 3.2%).

Control drug 7: 4 parts of golden thread and 1 part of costus root. Pulverizing, mixing, and making into watered pill (2015 edition of Chinese pharmacopoeia). HPLC analysis shows that the content of total alkaloids is 7.52% (berberine 4.4%, palmatine 1.2%, coptisine 1.28%, epiberberine 0.64%).

Control drug 8: 4 parts of golden thread and 1 part of costus root. The concentrated xianglian pills are produced according to the process of processing the concentrated xianglian pills in the 'Chinese pharmacopoeia' 2015 edition. HPLC analysis shows that the content of total alkaloids is 14.04% (berberine 8.8%, palmatine 2.4%, coptisine 1.56%, epiberberine 1.28%).

Control drug 9: 4 parts of golden thread and 1 part of costus root. Processing "xianglian capsule" according to the ministerial standard (WS3-146(Z-136) -2004 (Z)): extracting volatile oil from radix aucklandiae by steam distillation, and collecting volatile oil; filtering the water solution after extracting volatile oil, concentrating the filtrate to appropriate amount, drying, and pulverizing into fine powder; reflux-extracting Coptidis rhizoma with 70% ethanol at 75-80 deg.C for three times, the first time for 2 hr, and the second and third times for 1 hr, mixing extractive solutions, filtering, recovering ethanol from filtrate, concentrating to appropriate amount, drying, pulverizing into fine powder, adding above fine powder and appropriate amount of adjuvants, mixing, granulating, drying, spraying radix aucklandiae volatile oil, mixing, and making into capsule of 1000 granules. HPLC analysis shows that the content of total alkaloids is 28.08% (berberine 17.6%, palmatine 4.8%, coptisine 3.12%, epiberberine 2.56%).

Control drug 10: pulverizing radix aucklandiae into powder.

New xianglian capsule: prepared according to example 3. HPLC analysis shows that the content of total alkaloids is 38.1% (berberine 22.4%, palmatine 6.2%, coptisine 6.4%, and epiberberine 3.1%).

The test method comprises the following steps: the drug was formulated as a 20% solution, 1mL of the solution was gavaged per mouse, and then the mice were observed for weight change and counted for death within 15 days. The results are shown in Table 4 below.

Table 4 safety evaluation test results

Note: compared to the normal group:^*P<0.05，^**P<0.01。

as can be seen from Table 4, the coptis alkaloid monomer has high safety; the coptis total alkaloid contains impurities, so the safety is lower than that of a monomer; the xianglian pill (contrast medicine 7) is directly used after being pulverized by coptis chinensis, so that the safety is poorer, and the weight loss of mice is obvious (^*P<0.05), even one mouse died; the safety of the extracted concentrated xianglian pills is greatly improved, and the safety of further concentrated xianglian capsules and new xianglian capsules is higher; this may be related to the fact that the bulk drug contains more impurities and the safety is reduced.

The foregoing is a more detailed description of the present invention that is presented in conjunction with specific embodiments, and the practice of the invention is not to be considered limited to those descriptions. For those skilled in the art to which the invention pertains, several simple deductions or substitutions can be made without departing from the spirit of the invention, and all shall be considered as belonging to the protection scope of the invention.