Disclosure of Invention
The invention provides a traditional Chinese medicine composition for treating atrophic gastritis and a preparation method thereof, and the traditional Chinese medicine composition can be used for better treating atrophic gastritis, and has the advantages of remarkable effect, safety and reliability.
In order to achieve the above purpose, the technical scheme of the invention is as follows:
the traditional Chinese medicine composition for treating atrophic gastritis is prepared from the following raw materials in parts by weight:
3-10 parts of angelica sinensis, 3-10 parts of ligusticum wallichii, 10-30 parts of white paeony root, 10-40 parts of dandelion, 10-30 parts of eclipta alba, 5-20 parts of barbed skullcap herb, 5-20 parts of lychee seed, 5-20 parts of fructus aurantii, 10-30 parts of lily, 5-20 parts of magnolia officinalis, 5-20 parts of radix trichosanthis, 10-30 parts of capillary artemisia, 3-10 parts of endothelium corneum gigeriae galli, 10-30 parts of oldenlandia diffusa, 10-30 parts of honeysuckle and 2-10 parts of liquorice.
Preferably, the feed is prepared from the following raw materials in parts by weight:
4-8 parts of Chinese angelica, 4-8 parts of szechuan lovage rhizome, 15-25 parts of white paeony root, 10-30 parts of dandelion, 10-20 parts of common flowery knotweed herb, 8-16 parts of barbed skullcap herb, 5-15 parts of lychee seed, 8-16 parts of bitter orange, 20-30 parts of lily, 5-15 parts of magnolia officinalis, 8-16 parts of mongolian snakegourd root, 8-16 parts of virgate wormwood herb, 4-8 parts of chicken's gizzard-skin, 15-25 parts of oldenlandia diffusa, 10-20 parts of honeysuckle and 4-8 parts of liquorice.
Preferably, the active ingredient is prepared by water extraction or ethanol extraction with the volume percentage concentration of 40-80%.
Preferably, the preparation method of the active ingredient comprises the following steps:
adding water 8-12 times of the total weight of all the medicinal materials, decocting for 1-3 times, each for 1-2 hr, mixing the extractive solutions, filtering, and concentrating under reduced pressure to obtain soft extract.
Preferably, the preparation method of the active ingredient comprises the following steps:
Mixing all the above materials, reflux-extracting with 40-80% ethanol for 2-3 times, each time with ethanol amount of 4-10 times of total amount of the materials for 1-3 hr, mixing extractive solutions, filtering, and concentrating the filtrate into soft extract to obtain active ingredient.
Preferably, the preparation method of the concentrated pill comprises the following steps:
drying the active ingredients at 60-80deg.C, pulverizing into fine powder with 80-120 mesh sieve, adding Mel and water, making into 2-3mm pill, and drying at 60-80deg.C.
The invention also provides a traditional Chinese medicine preparation for treating atrophic gastritis, which is applied to the traditional Chinese medicine composition for treating atrophic gastritis and a pharmaceutically acceptable carrier.
Pharmaceutically acceptable carriers of the invention include, but are not limited to, the following:
diluents such as zinc oxide, calamine, starch, powdered sugar, lactose, dextrin, microcrystalline cellulose, inorganic salts, sugar alcohols, etc.
The binder is gelatin, polyethylene glycol, cellulose derivative, adeps ragmitis, vaseline, silicone oil, lanoline, cellulose, gum, raw rubber, lead soap, lanoline, etc.
Organic solvents such as boric acid, lead acetate, copper sulfate, zinc sulfate, aluminum acetate, rivanol, furacilin, neomycin, potassium permanganate, diethyl ether, ethanol, acetone, etc.
Disintegrating agents such as starch, sodium carboxymethyl starch, cellulose derivatives, crospovidone, etc.
The lubricant comprises magnesium stearate, silica gel micropowder, talcum powder, polyethylene glycol, triethanolamine, sodium laurylsulfate, stearic acid, cetyl alcohol, polyethylene glycol, monoglyceride, span, tween, etc.
Emulsifying agent such as adeps ragmitis, vaseline, silicone oil, lanoline, polyethylene glycol, cellulose, etc.
Cosolvent such as water, ethanol, glycerol, propylene glycol, liquid paraffin, vegetable oil, dimethyl sulfoxide, azelastone, etc.
Flavoring agent such as sucrose, monosaccharide, and aromatic.
Preservative such as benzoic acid, sorbic acid, methyl ester, ethyl ester, propyl ester, etc.
The preparation method of each traditional Chinese medicine preparation formulation comprises the following steps:
1. Powder:
the active ingredients of the traditional Chinese medicine composition for treating atrophic gastritis are dried and crushed to obtain powder;
2. tablet:
the active ingredients of the traditional Chinese medicine composition for treating atrophic gastritis are dried, crushed and pressed into tablets.
3. The capsule comprises the following components:
The active ingredients of the traditional Chinese medicine composition for treating atrophic gastritis are dried, crushed and then filled into hollow capsules or sealed into elastic soft capsules to obtain capsules, wherein the materials for forming the hollow hard capsule shell or the elastic soft capsule shell are gelatin, glycerol, water and other medicinal materials.
4. The granule comprises the following components:
the active ingredients of the traditional Chinese medicine composition for treating atrophic gastritis are dried, crushed, mixed with proper auxiliary materials and granulated to obtain granules, wherein the auxiliary materials comprise diluents, absorbents, wetting agents, adhesives, flavoring agents and effervescent auxiliary materials.
5. Solutions or suspensions:
The active ingredients of the traditional Chinese medicine composition for treating atrophic gastritis are dissolved in water, vegetable oil or other medicinal liquid solvents to obtain a solution or a suspension.
The prescription of the invention is as follows, and the pathogenesis of atrophic gastritis is considered to be caused by liver and spleen imbalance, damp-heat toxin entering collaterals to damage stomach yin, and qi and blood stasis. Herba Artemisiae Scopariae, radix Paeoniae alba, radix Angelicae sinensis, rhizoma Ligustici Chuanxiong with effects of promoting blood circulation, softening liver and removing blood stasis as monarch, fructus Aurantii, cortex Magnolia officinalis, semen litchi, endothelium corneum Gigeriae Galli with effects of regulating qi-flowing, invigorating spleen, eliminating turbid pathogen as ministerial drugs, herba Taraxaci, herba Hedyotidis Diffusae, herba Scutellariae Barbatae with effects of clearing heat, detoxicating and resisting cancer as adjuvant drugs, bulbus Lilii, glycyrrhrizae radix with effects of regulating qi and blood, tranquilizing mind, regulating stomach, moistening dryness of Trichosanthis radix, preventing intestinal epithelium, nourishing yin and clearing heat as messenger drugs. The medicines are combined, so that the gastric mucosa gland atrophy and intestinal epithelial metaplasia can be reversed, and the tumor is resisted.
The traditional Chinese medicine composition is summarized on the basis of a large number of clinical experimental researches, accords with the traditional Chinese medicine theory and the modern medical theory, has no toxic or side effect, complements each other among the traditional Chinese medicines, and has good curative effect on atrophic gastritis.
Detailed Description
The present invention will be described in detail with reference to the following examples.
Example 1
The traditional Chinese medicine composition for treating atrophic gastritis is prepared from the following raw materials in parts by weight:
3kg of angelica sinensis, 3kg of ligusticum wallichii, 10kg of white paeony root, 10kg of dandelion, 10kg of common flowery knotweed herb, 5kg of barbed skullcap herb, 5kg of lychee seed, 5kg of fructus aurantii, 10kg of lily, 5kg of magnolia officinalis, 5kg of radix trichosanthis, 10kg of capillary artemisia, 3kg of chicken's gizzard-membrane, 10kg of oldenlandia diffusa, 10kg of honeysuckle and 2kg of liquorice.
The preparation method of the active ingredients comprises the following steps:
Adding water 8 times of the total weight of all the medicinal materials, decocting for 1 time and 1 hr each time, mixing the extractive solutions, filtering, and concentrating under reduced pressure to obtain soft extract with relative density of 1.20 at 80deg.C.
The preparation method of the concentrated pill comprises the following steps:
Drying the active ingredients at 60deg.C, pulverizing into fine powder, sieving with 80 mesh sieve, adding refined Mel and water, making into pill, making into 2mm pill, and drying at 60-deg.C.
Example 2
The traditional Chinese medicine composition for treating atrophic gastritis is prepared from the following raw materials in parts by weight:
10kg of angelica sinensis, 10kg of ligusticum wallichii, 30kg of white paeony root, 40kg of dandelion, 30kg of common flowery knotweed herb, 20kg of barbed skullcap herb, 20kg of lychee seed, 20kg of fructus aurantii, 30kg of lily, 20kg of magnolia officinalis, 20kg of radix trichosanthis, 30kg of capillary artemisia, 10kg of chicken's gizzard-membrane, 30kg of oldenlandia diffusa, 30kg of honeysuckle and 10kg of liquorice.
The preparation method of the active ingredients comprises the following steps:
Adding water 12 times of the total weight of all the medicinal materials, decocting for 3 times and 2 hours each time, mixing the extractive solutions, filtering, concentrating under reduced pressure to obtain soft extract with relative density of 1.30 at 80deg.C, and obtaining the active ingredient.
The preparation method of the concentrated pill comprises the following steps:
Drying the active ingredients at 80deg.C, pulverizing into fine powder, sieving with 120 mesh sieve, adding Mel and water, making into pill, and drying at 80deg.C.
Example 3
The traditional Chinese medicine composition for treating atrophic gastritis is prepared from the following raw materials in parts by weight:
6kg of angelica sinensis, 6kg of ligusticum wallichii, 15kg of white paeony root, 18kg of dandelion, 15kg of common flowery knotweed herb, 12kg of barbed skullcap herb, 12kg of lychee seed, 12kg of fructus aurantii, 25kg of lily, 10kg of magnolia officinalis, 12kg of radix trichosanthis, 12kg of capillary artemisia, 6kg of chicken's gizzard-membrane, 18kg of oldenlandia diffusa, 12kg of honeysuckle and 6kg of liquorice.
The preparation method of the active ingredient comprises the following steps:
Adding water 10 times of the total weight of all the medicinal materials, decocting for 2 times and 1.5 hr each time, mixing extractive solutions, filtering, and concentrating under reduced pressure to obtain soft extract.
The preparation method of the concentrated pill comprises the following steps:
Drying the active ingredients at 70deg.C, pulverizing into fine powder, sieving with 100 mesh sieve, adding Mel and water, making into pill, making into 2.5mm pill, and drying at 70deg.C.
Example 4
The traditional Chinese medicine composition for treating atrophic gastritis is prepared from the following raw materials in parts by weight:
4kg of angelica sinensis, 4kg of ligusticum wallichii, 15kg of white paeony root, 15kg of dandelion, 10kg of common flowery knotweed herb, 8kg of barbed skullcap herb, 5kg of lychee seed, 5kg of fructus aurantii, 10kg of lily, 5kg of magnolia officinalis, 8kg of radix trichosanthis, 10kg of capillary artemisia, 4kg of chicken's gizzard-membrane, 15kg of oldenlandia diffusa, 10kg of honeysuckle and 4kg of liquorice.
The preparation method of the active ingredient comprises the following steps:
mixing all the medicinal materials, reflux-extracting with 45% ethanol for 2 times, wherein the ethanol consumption is 6 times of the total amount of the medicinal materials, extracting for 2 hr, mixing the extractive solutions, filtering, and concentrating under reduced pressure to obtain soft extract with relative density of 1.23 at 80deg.C to obtain active ingredient.
The traditional Chinese medicine composition of the embodiment is prepared into tablets, and the preparation method comprises the following steps:
And (3) drying the active ingredients, crushing, mixing with a proper amount of starch and dextrin, sieving with a 100-mesh sieve, and tabletting to obtain the tablet.
Example 5
The traditional Chinese medicine composition for treating atrophic gastritis is prepared from the following raw materials in parts by weight:
8kg of angelica sinensis, 8kg of ligusticum wallichii, 25kg of white paeony root, 15kg of dandelion, 20kg of common flowery knotweed herb, 16kg of barbed skullcap herb, 15kg of lychee seed, 15kg of fructus aurantii, 20kg of lily, 15kg of magnolia officinalis, 16kg of radix trichosanthis, 20kg of capillary artemisia, 8kg of chicken's gizzard-membrane, 25kg of oldenlandia diffusa, 13kg of honeysuckle and 7kg of liquorice.
The preparation method of the active ingredient comprises the following steps:
adding water 9 times of the total weight of all the medicinal materials, decocting for 2 times each for 1.3 hr, mixing extractive solutions, filtering, and concentrating under reduced pressure to obtain soft extract with relative density of 1.26 at 80deg.C.
The traditional Chinese medicine composition of the embodiment is prepared into capsules, and the preparation method comprises the following steps:
and (3) drying the active ingredients, crushing, sieving with an 80-mesh sieve, and filling into hollow capsules to obtain capsules.
Example 6
The traditional Chinese medicine composition for treating atrophic gastritis is prepared from the following raw materials in parts by weight:
6kg of angelica sinensis, 7kg of ligusticum wallichii, 16kg of white paeony root, 28kg of dandelion, 12kg of common flowery knotweed herb, 12kg of barbed skullcap herb, 11kg of lychee seed, 16kg of fructus aurantii, 16kg of lily, 8kg of magnolia officinalis, 8kg of radix trichosanthis, 18kg of capillary artemisia, 7kg of chicken's gizzard-membrane, 22kg of oldenlandia diffusa, 18kg of honeysuckle and 4kg of liquorice.
The preparation method of the active ingredient comprises the following steps:
Adding water 11 times of the total weight of all the medicinal materials, decocting for 2 times each for 1.6 hr, mixing extractive solutions, filtering, and concentrating under reduced pressure to obtain soft extract with relative density of 1.24 at 80deg.C.
The traditional Chinese medicine composition of the embodiment is prepared into granules, and the preparation method comprises the following steps:
mixing the active ingredients with proper amount of starch and sugar powder, granulating, and drying to obtain granule.
Experimental example 1 summary of clinical trials
1. The case selection is to take 100 cases of chronic atrophic gastritis patients, namely, patients treated by department of medical inpatient in third people's hospital in Hubei province in 2021, 3 months and 2023 months. All cases were randomized into 2 groups at a 1:1 ratio, 50 observations, ages 39-66, mean 56.16 + -7.35, 50 controls, ages 41-65, mean 55.78 + -8.17. No other major systemic diseases are found in the examination, and the two groups of ages, pathogenesis reasons, physical conditions and the like have no significant difference (P > 0.05) and are comparable.
2. Diagnostic criteria:
Reference is made to "chinese chronic gastritis consensus" (2017 edition )[Jiang J X,Liu Q,Mao X Y,et al.Downward trend in the prevalence of Helicobacter pyloriinfections and corresponding frequent upper gastrointestinal diseases profile changes in Southeastern China between 2003and 2012[J].Springerplus,2016,5(1):1601.] is in compliance with the diagnostic criteria for chronic atrophic gastritis:
the endoscope diagnosis standard is that the white and red phases of mucous membrane are seen under the endoscope, the white phases are mainly used, folds flatten or even disappear, mucous membrane blood vessels are exposed, and mucous membrane particles or nodules and the like are basically expressed.
Pathological histological diagnosis standard, that is, the pathological biopsy shows the inherent gland atrophy, namely, the atrophic gastritis can be diagnosed.
3. Criteria for Chinese medical symptoms:
referring to "chronic atrophic gastritis Combined diagnosis and treatment consensus opinion" [ Li Junxiang, chen, lv Bin, wang Yangang. Chronic atrophic gastritis combined diagnosis and treatment consensus opinion (2017) [ J ]. Chinese, western and Chinese combined journal of digestion, 2018,26 (02): 121-131 ] ], new Chinese medicine clinical study guidelines [ Zhengyu ]. New Chinese medicine clinical study guidelines [ M ]. Beijing: chinese medical science and technology publishing, 2002:125-128 ],
The main symptoms are epigastric pain and epigastric fullness and oppression.
The secondary symptoms include anorexia, (2) belching, singultus, (3) acid regurgitation or heartburn, (4) chest distress, chest pain, (5) loose stool, and (6) listlessness.
4. Symptom score:
The main symptoms include gastric fullness and gastralgia, each of which is not obvious according to subjective severity, 0 point in the product, 2 points in the product, obvious symptoms but not affecting life and work, 4 points in the product, heavy symptoms, the need of medicine control, 6 points in the product, and 0-7 points in the product according to days of attack per week.
The secondary syndrome is that each term has no integral of 0 point and some integral of 2 points.
The total is divided into the sum of the principal syndrome score and the secondary syndrome score.
5. Treatment effect score for syndromes:
calculated by nimodipine scoring method, therapeutic index (%) = (integral before treatment-
Post-treatment integral)/pre-treatment integral x 100%.
① Healing, wherein the curative effect index is more than or equal to 95%;
② The obvious effect is that the curative effect index is less than or equal to 70 percent and less than 95 percent;
③ The effective rate is 30 percent or less, and the curative effect index is less than 70 percent;
④ The efficacy index is less than 30%.
6. Treatment group:
The Chinese medicinal composition comprises 6g of Chinese angelica, 6g of szechuan lovage rhizome, 15g of white paeony root, 18g of dandelion, 15g of common flowery knotweed herb, 12g of barbed skullcap herb, 12g of lychee seed, 12g of bitter orange, 25g of lily, 10g of magnolia bark, 12g of mongolian snakegourd root, 12g of virgate wormwood herb, 6g of chicken's gizzard-skin, 18g of oldenlandia diffusa, 12g of honeysuckle flower and 6g of liquorice. Decocting with water twice, mixing decoctions, concentrating to 300ml, and taking twice daily in the morning and evening for 4 weeks as a treatment course, and evaluating the curative effect after administration.
7. Control group:
The Moruodan is orally taken 1 bag at a time and 3 times a day. The specification was 1.84 g/bag. According to the guidelines of clinical research of new Chinese medicine, the common consensus opinion of the Chinese medical science and medical expert of chronic gastritis (2017 edition) [ Zhang Shengsheng, tang Xudong, huang Suiping, liqun ], the common consensus opinion of the Chinese medical science and medical expert of chronic gastritis (2017) [ J ]. J.Chinese medicine, 2017,32 (07): 3060-3064 ], the treatment course is 4 weeks, and the curative effect is evaluated after the administration is finished.
8. Experimental conditions:
1. Chinese medicine symptom integral comparison before and after two groups of treatments
The main symptoms are that the degree, frequency and total integral are significantly reduced (P < 0.05) after 1 week of administration of the observation group and the treatment group compared with the prior administration. The observed and treated groups were significantly reduced in degree, frequency and total integral after 4 weeks of dosing compared to 1 week of dosing (P < 0.05), and there was no statistical difference in degree, frequency and total integral of the main symptoms after 4 weeks of dosing (P > 0.05) between the observed and treated groups prior to 1 week of dosing. See table 1.
TABLE 1 integral of primary symptoms before and after administration for each group of patients
Note that ΔP <0.05 compared to pre-dose and bar P <0.05 compared to 1 week of dose
2. Integration of symptoms before and after administration for each group of patients
The secondary symptoms are that the secondary symptoms have no obvious difference (P > 0.05) in the integral of the secondary symptoms after the administration of the observation group and the control group for 1 week compared with the administration before the administration, and the integral of the secondary symptoms has obviously decreased (P < 0.05) in the observation group and the secondary symptoms after the administration for 4 weeks compared with the administration for 1 week. The group comparison, the observation group and the treatment group have no obvious difference (P > 0.05) between the integral and the total integral of each secondary symptoms before administration, and the observation group has better total integral than the control group (P < 0.05) and no obvious difference (P > 0.05) after administration for 1 week compared with the control group. After 4 weeks of administration, the observed group had belch, acid regurgitation and heartburn, chest distress and chest pain integral and the total integral of secondary symptoms were superior to the control group (P < 0.05) with no obvious difference (P > 0.05) compared with the control group. See table 2.
TABLE 2 integration of symptoms before and after administration for each group of patients
Note that Δp <0.05 compared to pre-dose in this group and P <0.05 compared to control group
3. Total score before and after dosing for each group of patients:
The total integral of the observed group and the control group was not significantly different (P > 0.05) before the administration for 1 week compared with the group, and significantly decreased (P < 0.05) after the administration for 4 weeks compared with the control group. See table 3.
TABLE 3 total integral of symptoms before and after administration for each group of patients
Note that compared to the control group, P <0.05
4. Comparison of clinical efficacy of two groups of treatments
The nimodipine method calculates the curative effect index to evaluate the total integral, the observed group is higher than the control group in cure rate, the obvious effect is equivalent to that of the control group, and the observed group is better than the control group (P < 0.05) in the overall syndrome evaluation. See table 4.
Table 4 evaluation of the efficacy index of each group of patients (%, n)
While the invention has been described in detail in the foregoing general description, embodiments and experiments, it will be apparent to those skilled in the art that modifications and improvements can be made thereto. Accordingly, such modifications or improvements may be made without departing from the spirit of the invention and are intended to be within the scope of the invention as claimed.