WO2017101210A1 - Gastritis treating traditional chinese medicine composition preparation method and preparation - Google Patents

Abstract

Provided are a method for preparing a traditional Chinese medicine composition for treating gastritis and a pharmaceutical preparation prepared by the same. The method comprises the following steps: grinding lily bulb, sanqi, inner membrane of chicken gizzard, cattail pollen, yanhusuo and rhizoma anemones altaicae into powder of 80-200 meshes; taking tuckahoe, figwort root, Sichuan lovage rhizome, lindera aggregata, oriental waterplantain rhizome, dwarf lilyturf tuber, largehead atractylodes rhizome, Chinese angelica, virgate wormwood herb, garden burnet root, ebark peony root and dendrobium for decocting in water, merging, filtering and concentrating the liquid medicine to get an extract with a relative density of 1.10-1.50; mixing the powder and the extract to get a drug active substance and to produce a pharmaceutical preparation composition. Products produced by this method have the characteristics of good stability and remarkable therapeutic effect etc.

Description

Preparation method and preparation of traditional Chinese medicine composition for treating gastritis Field of invention

The invention relates to a preparation method of a traditional Chinese medicine composition, in particular to a preparation method of a traditional Chinese medicine composition for treating gastritis and a pharmaceutical preparation prepared by the method.

Background technique

Morodan is a drug that reduces the stomach, reduces spleen and swells, and relieves pain. For chronic atrophic gastritis and stomach pain, fullness, nausea, poor appetite, belching, heartburn and other symptoms. Dosage, oral, honey pill once 9 ~ 18g, 3 times a day, with rice soup or warm water before meals, or as directed. It is prepared from 18 kinds of traditional Chinese medicines such as Lily, Ophiopogon japonicus, Dendrobium, Poria, Atractylodes Rhizome, Brassica oleracea L., Radix Paeoniae Alba, Radix Notoginseng, Yanhusuo (Vinegar), Chicken Inner Gold (Sautéed), Scrophulariaceae and Angelica. Cheng, pharmacological effects are as follows

1 Function: Angelica has inhibitory effects on dysentery bacillus, Vibrio cholerae, Proteus and Escherichia coli. Panax notoginseng saponins have strong inhibitory effects on certain fungi.

2 gastric mucosa: This side has a repair effect on gastric mucosal damage.

3 Pharmacological studies Uygur medicine has two-way regulation of excitability and inhibition of gastrointestinal smooth muscle, promoting the secretion of digestive juice; chicken gold increases gastric secretion, acidity and digestion.

4 Immune function: According to the pharmacological experiment, Atractylodes can effectively improve the humoral immune function in addition to the spleen.

5 Pharmacology found that the party's Sanqi, Angelica, sputum, etc. have liver protection, relieve alcoholic liver poisoning, and promote the function of seroconversion in the liver.

The Chinese patent discloses the following formulation of the formulation of Morodan

The atractylodes are fried with bran, the eucalyptus is treated with vinegar, and the chicken is made of fried chicken.

And preparation method:

The above eighteen flavors, add water 1-3 times, each time 1.5-3 hours, combine the decoction, filter, the filtrate is concentrated to the appropriate amount, add ethanol, so that the alcohol content reaches 60-80%, let stand, filter The ethanol is recovered, the filtrate is concentrated, refrigerated with water, filtered, and finally a clinically acceptable dosage form is prepared by a conventional procedure directly or by adding a pharmaceutically acceptable excipient.

Chinese patent 200710120838.4 discloses the following method for determining the content of Morodan.

The content is determined as follows:

Determined by high performance liquid chromatography;

Chromatographic conditions and system suitability test: using octadecylsilane bonded silica as a filler; 15-60:40-85 acetonitrile-water as mobile phase; detection wavelength is 230nm, theoretical plate number calculated according to paeoniflorin peak Should not be less than 1000 ~ 5000;

Preparation of reference solution: accurately weigh the appropriate amount of paeoniflorin reference substance, add methanol, ethanol, n-butanol, water, chloroform or ethyl acetate to make a solution containing 30-50μg per 1ml, that is;

Preparation of the test solution: Take the Morodan Xiaomi Pill or the big honey pill under the weight difference, and cut it. Weigh accurately 1 ~ 10g, add diatomaceous earth 1 ~ 10g, ground well, placed in a conical flask, precision added solvent methanol, ethanol, n-butanol, water, chloroform or ethyl acetate 15-25ml, Concealed, weighed, sonicated or hot reflux or cold soaked for 30 minutes, taken out and placed at room temperature, weighed, made up with solvent methanol, ethanol, n-butanol, water, chloroform or ethyl acetate to 15-25ml Shake well, filter, precision draw 4-6ml of the filtrate, put it in a 10ml volumetric flask, dilute to the mark with methanol, ethanol, n-butanol, water, chloroform or ethyl acetate, shake well, then get;

Determination method: respectively, accurately draw the reference solution and the test solution 20μl each, inject into the liquid chromatograph, determine, that is; Morotan per 1g containing white peony with paeoniflorin C ₂₃ H ₂₈ O ₁₁ , not less than 0.8 Mg.

The present inventors have found in clinical and production practice that the prior art needs to be improved in terms of efficacy, stability, and raw material saving, in order to improve the action of the drug, prolong the storage period, reduce the amount of the drug, and improve the adaptability of the drug. To this end, the inventors have improved the prior art to complete the present invention.

Summary of the invention:

In order to improve the defects of the prior art, the present invention provides a novel preparation method of Morodan, which is prepared as follows:

The preparation method is as follows:

Lily, Sanqi, Jiujinjin, Puhuang, Yanhusuo, Jiujiao Liupu six kinds of medicines are crushed into 80-200 mesh powder; the remaining medicine flavor is boiled 2-4 times with water, 0.5-3 hours each time, combined with liquid filtration and concentration The extract to a relative density of 1.10 to 1.50; the powder is mixed with the extract to obtain a pharmaceutically active substance, and a pharmaceutical preparation composition is prepared by a formulation method.

Preferably, the preparation method of the present invention is as follows:

Lily, Sanqi, Jiujinjin, Puhuang, Yanhusuo, Jiujiu Liupu six kinds of medicine pulverized into 100 mesh powder; the remaining medicinal taste and water decocted 3 times, each time for 2 hours, the combined drug solution was filtered and concentrated to a relative density of 1.10-1.50 The extract is mixed with the extract to obtain a pharmaceutically active substance, which is prepared into a pharmaceutical preparation composition by a formulation method.

A preferred preparation of the present invention is a concentrated pellet prepared by the following steps: taking a pharmaceutically active ingredient mixed with a powder and an extract, and adding 0.6-1.5 parts by weight of refined honey to 1 part by weight of the pulverized powder to prepare a concentrated honey pellet.

Compared with the prior art, the method of the invention obviously increases the main active ingredient, the drug effect is obviously improved, and the stability of the preparation is obviously improved.

The beneficial effects of the present invention are illustrated below by experimental data:

Experimental content:

Comparative experiment between the present invention and prior art

Experiment 1, the effect of acid ethanol on acute gastric mucosal injury in rats

Animals were administered in groups. On the 7th day after administration, the animals in each group were fasted for 48 hours. Before the test, the animals in each group were re-administered (water) once. After 2 hours, each rat was given acid ethanol. 2ml (150mmol/L hydrochloric acid and 60% ethanol mixed in a ratio of 1:1). After 1h, the rats were anesthetized with an excess of ether, and the rats were sacrificed. The stomach was removed by abdomen. The cardia was clamped with a clip, and 5 ml of 1% formaldehyde solution was injected from the pylorus. Close the pylorus, put the whole stomach in 1% formaldehyde solution for 10min, cut it along the big curve of the stomach, turn the stomach out, gently wash the contents with water, spread the stomach on the glass plate, measure with precision caliper The length of gastric mucosal injury was calculated as the gastric mucosal injury index by the sum of the length of the injury (the doubling of the lesion width was greater than 1 mm), and the inhibition rate was calculated.

The experimental results are as follows:

It can be seen from the results that the gastric mucosa of each group had different degrees of damage. The present invention group and the prior art group were lighter than the model control group, and the injury index was significantly decreased (P<0.05).

Comparison of rat regenerative mucosal thickness

Group	Number of animals (only)	Regenerated mucosal thickness (μm)
Control group	10	420
Model group	10	100
Group of the invention	10	345
Existing technology group	10	300

Comparison of thickness of granulation scar layer in ulcerated stove

Group	Number of animals (only)	Granulation scar thickness (μm)
Control group	10	0
Model group	10	0.6
Group of the invention	10	0.16
Existing technology group	10	0.24

Experiment 2, the effect on gastric juice secretion in rats

Animals were administered in groups of 10 rats. After the last administration, the animals in each group were fasted for 24 hours, anesthetized with ether, cut a small mouth along the midline of the abdomen, gently pulled out the stomach, ligated the pylorus, and then 12 The intestinal administration was performed once, and the abdominal wall incision was sutured. After 6 hours, the incision was opened and the cardia was ligated, the whole stomach was removed, the blood was removed by filter paper, the stomach wall was cut along the stomach, and the stomach contents were decanted and collected in a graduated centrifuge tube. Centrifuge at 1500r/min for 10min, accurately record the amount of gastric juice, determine the total acidity of gastric juice with phenol red as indicator, and measure the activity of pepsin by Mettle capillary method.

The experimental results are as follows:

As can be seen from the results, both the present invention group and the prior art group can reduce the total acidity of the gastric juice and the pepsin activity.

Experiment 3, in vivo antibacterial test:

Both the present invention group and the prior art group can reduce the number of deaths of S. aureus infected mice and prolong the survival days of infected mice;

The experimental results are as follows:

Group	Number of animals (only)	Number of deaths (only)	Survival rate%
Normal control group	20	0	100
Model group	20	12	40

Group of the invention	20	6	70
Existing technology group	20	9	55

Experiment 4. Anti-inflammatory test results:

Both the present invention group and the prior art group can reduce the degree of swelling of the auricle caused by xylene in mice.

Effect on delayed type hypersensitivity in mice (ankle thickening method)

Dose group	Number of animals (only)	Swelling degree of foot (24 mm) after injection
Negative control group	10	0.215
Group of the invention	10	0.465
Existing technology group	10	0.346

Experiment 5, accelerated stability experiment

Place the sample in a constant temperature and humidity chamber under the condition of 40 °C ± 2 °C and relative humidity of 75% ± 5%. Sampling at the set time, the content of the relevant components is determined, and the preliminary stability test results after the test are as follows

Preliminary stability test results after test of the sample of the present invention

Preliminary stability test results after testing of prior art samples

The advantages of the present invention are mainly manifested in:

By improving the preparation method, the following technical effects have been obtained: the dosage of the drug is lowered, the content of the active ingredient is increased, the stability of the preparation is improved, and the therapeutic effect of the drug is improved.

detailed description:

The invention is further illustrated by the following examples without intending to limit the invention.

Example 1

The preparation method is as follows:

Lily, Sanqi, Jiujinjin, Puhuang, Yanhusuo, Jiujiu Liupu six kinds of medicine pulverized into 100 mesh powder; the remaining medicinal taste and water decocted 3 times, each time for 2 hours, the combined drug solution was filtered and concentrated to a relative density of 1.10-1.50 The extract is mixed with the extract to obtain a pharmaceutically active substance, which is pelletized and dried to prepare a concentrated pellet; or the powder is mixed with the extract, granulated, and dried to form a capsule or tablet;

Example 2

The preparation method is as follows:

Lily, Sanqi, Jiujinjin, Puhuang, Yanhusuo, Jiujie Zhangpu six-flavored medicine is pulverized into 80-200 mesh powder; the remaining medicinal taste is boiled twice with water for 0.5 hour, and the combined drug solution is filtered and concentrated to a relative density of 1.10. - 1.50 extract; the powder is mixed with the extract to obtain a pharmaceutically active substance, Pilling and drying to form a concentrated pill; or mixing the powder with the extract, granulating, and drying to form a capsule or tablet;

Example 3

The preparation method is as follows:

Lily, notoginseng, chicken inner gold, puhuang, yanhusuo, nine-section calamus pulverized into 80-200 mesh powder; the remaining medicinal taste was boiled 4 times for 3 hours, and the combined drug solution was filtered and concentrated to a relative density of 1.10. - 1.50 of the extract; the powder is mixed with the extract, pelletized, and dried to prepare a concentrated pellet; the powder is mixed with the extract to obtain a pharmaceutically active substance, which is pelletized and dried to prepare a concentrated pellet; or the powder is mixed with the extract, granulated, Dry to make a capsule or tablet;

The sample prepared by the method of the above examples was determined by a content measurement method: not less than 1.4 mg per 1 g of sputum containing paeoniflorin C ₂₃ H ₂₈ O ₁₁ .

Claims (7)

1. A preparation method of a traditional Chinese medicine composition for treating gastritis, wherein the traditional Chinese medicine composition is prepared from the following weight ratio traditional Chinese medicine raw material medicine,

   

   It is characterized in that the steps of the preparation method are as follows:

   Lily, Sanqi, Jiujinjin, Puhuang, Yanhusuo, Jiujiao Liupu six kinds of medicines are crushed into 80-200 mesh powder; the remaining medicine flavor is boiled 2-4 times with water, 0.5-3 hours each time, combined with liquid filtration and concentration The extract to a relative density of 1.10 to 1.50; the powder is mixed with the extract to obtain a pharmaceutically active substance, and a pharmaceutical preparation composition is prepared by a formulation method.
2. The preparation method according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following weight ratio of traditional Chinese medicine raw materials.

   

   

   It is characterized in that the steps of the preparation method are as follows:

   Lily, Sanqi, Jiujinjin, Puhuang, Yanhusuo, Jiujiao Liupu six kinds of medicines are crushed into 80-200 mesh powder; the remaining medicine flavor is boiled 2-4 times with water, 0.5-3 hours each time, combined with liquid filtration and concentration The extract to a relative density of 1.10 to 1.50; the powder is mixed with the extract to obtain a pharmaceutically active substance, and a pharmaceutical preparation composition is prepared by a formulation method.
3. The preparation method according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following weight ratio of traditional Chinese medicine raw materials.

   

   It is characterized in that the steps of the preparation method are as follows:

   Lily, Sanqi, Jiujinjin, Puhuang, Yanhusuo, Jiujiu Liupu six kinds of medicine pulverized into 100 mesh powder; the remaining medicinal taste and water decocted 3 times, each time for 2 hours, the combined drug solution was filtered and concentrated to a relative density of 1.10-1.50 The extract is mixed with the extract to obtain a pharmaceutically active substance, which is prepared into a pharmaceutical preparation composition by a formulation method.
4. The preparation method according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following weight ratio of traditional Chinese medicine raw materials.

   

   

   It is characterized in that the steps of the preparation method are as follows:

   Lily, Sanqi, Jiujinjin, Puhuang, Yanhusuo, Jiujiu Liupu six kinds of medicine pulverized into 100 mesh powder; the remaining medicinal taste and water decocted 3 times, each time for 2 hours, the combined drug solution was filtered and concentrated to a relative density of 1.10-1.50 The extract is mixed with the extract to obtain a pharmaceutically active substance, which is pelletized and dried to prepare a concentrated pellet; or the powder is mixed with the extract, granulated, and dried to form a capsule or tablet.
5. The preparation method according to claim 1, wherein the traditional Chinese medicine composition is a concentrated pill comprising concentrated water pill, concentrated pill, and concentrated water pill.
6. The preparation method according to claim 1, wherein the traditional Chinese medicine composition is a capsule.
7. The preparation method according to claim 1, wherein the traditional Chinese medicine composition is a tablet.