CN111000962B

CN111000962B - Chinese patent medicine for treating functional dyspepsia of spleen deficiency and damp stagnation syndrome and preparation method thereof

Info

Publication number: CN111000962B
Application number: CN201911237224.3A
Authority: CN
Inventors: 邬素珍; 黎家楼; 许焕英; 谢洪; 吴声振
Original assignee: Foshan Fuxing Chancheng Hospital Co Ltd
Current assignee: Foshan Fuxing Chancheng Hospital Co Ltd
Priority date: 2019-12-05
Filing date: 2019-12-05
Publication date: 2021-12-17
Anticipated expiration: 2039-12-05
Also published as: CN111000962A

Abstract

The invention provides a Chinese patent medicine for treating functional dyspepsia of spleen deficiency and damp stagnation syndrome and a preparation method thereof. The Chinese medicinal materials for preparing the Chinese patent medicine comprise cooked codonopsis pilosula, angelica sinensis, rhizoma cimicifugae, rhizoma atractylodis stir-fried with bran, lotus leaves, hawthorn, honey-fried licorice root, steamed dried orange peel, radix bupleuri, golden cypress, wild chrysanthemum, prepared fingered citron, endothelium corneum gigeriae galli, rhizoma atractylodis macrocephalae, astragalus mongholicus, poria with hostwood, eupatorium, radix curcumae, vinegar turtle shell, salvia miltiorrhiza, semen coicis, bitter apricot seeds, fried white hyacinth beans, medicated leaven and honey. The preparation method of the Chinese patent medicine comprises nine basic steps of material preparation, soaking, decoction (the decoction of common medicines, the decoction of medicines containing volatile components and the treatment of special medicines need to be distinguished), precipitation, filtration, concentration, paste collection, paste cooling, finished product packaging and the like. Clinical experiments prove that the traditional Chinese medicine composition can effectively improve clinical symptoms of postprandial satiety discomfort, early satiety, epigastric pain and upper abdominal burning sensation of patients, and improve the spleen deficiency and dampness encumbering symptoms of the patients, and has remarkable clinical treatment effect.

Description

Chinese patent medicine for treating functional dyspepsia of spleen deficiency and damp stagnation syndrome and preparation method thereof

Technical Field

The invention belongs to the field of Chinese patent medicines, and particularly relates to a Chinese patent medicine for treating functional dyspepsia of spleen deficiency and damp stagnation syndrome and a preparation method thereof.

Background

At present, the Chinese patent medicines for treating functional dyspepsia caused by spleen deficiency and damp stagnation mainly comprise ginseng, poria, bighead atractylodes rhizome powder, aucklandia root and rhizoma atractylodis pills, stomach invigorating and digestion promoting tablets, spleen invigorating pills and the like. The Chinese patent medicines have certain curative effect on patients with functional dyspepsia of spleen deficiency and damp stagnation, but have some defects. Taking the Shenling Baizhu powder as an example, the medicine has great side effect for patients with diarrhea accompanied with symptoms of constipation or anus falling feeling, or patients with hypertension, heart disease, kidney disease and diabetes, and patients in pregnancy.

Besides the Chinese patent medicines, western medicines such as domperidone tablets (morpholine), ranitidine, meweinin and the like are also commonly used for treating functional dyspepsia caused by spleen deficiency and dampness encumbering, and have certain curative effect. However, these western medicines also have some disadvantages. Taking domperidone tablet (moleplant), some patients may have drug allergy after taking the tablet, and in addition, some patients with mechanical intestinal obstruction, gastrointestinal bleeding, pheochromocytoma and other diseases or symptoms, or patients in pregnancy period should not take the tablet.

Disclosure of Invention

The object of the present invention is to overcome the drawbacks of the prior art described above, and is achieved by the following technical solution:

a Chinese patent medicine for treating functional dyspepsia caused by spleen deficiency and damp encumbering syndrome is prepared from the Chinese medicinal materials of 10-30 g of cooked codonopsis pilosula, 10-30 g of angelica sinensis, 10-30 g of rhizoma cimicifugae, 10-30 g of bran-fried rhizoma atractylodis, 10-30 g of lotus leaf, 10-30 g of hawthorn, 5-20 g of honey-fried licorice root, 10-30 g of steamed dried orange peel, 5-20 g of radix bupleuri, 15-40 g of golden cypress, 10-30 g of wild chrysanthemum flower, 15-40 g of prepared fingered citron, 15-40 g of endothelium corneum gigeriae galli, 10-30 g of bighead atractylodes rhizome, 60-100 g of astragalus mongholicus, 10-30 g of poria with hostwood, 10-30 g of eupatorium, 15-40 g of radix curcumae, 15-40 g of vinegar turtle shell, 15-40 g of salvia miltiorrhiza, 20-50 g of semen coicis, 10-30 g of bitter apricot kernel, and 15-40 g of fried white hyacinth bean, medicated leaven 10-30 g, honey 3-10 g.

On the basis of the technical scheme, the invention can be added with the following technical means for further limiting the dosage of various medicinal materials so as to better or more specifically realize the purpose of the invention:

the Chinese medicinal composition is prepared from the following raw materials, by weight, 16-17 g of cooked codonopsis pilosula, angelica sinensis, cimicifuga foetida, rhizoma atractylodis stir-fried with bran, lotus leaves, hawthorn, steamed tangerine peel, wild chrysanthemum, bighead atractylodes rhizome, poria with hostwood, eupatorium fortunei, bitter apricot seeds and medicated leaven (the dosage of each medicinal material is the same as the dosage of the following medicinal materials), 9-11 g of honey-fried licorice roots and radix bupleuri, 26-27 g of phellodendron amurense, prepared fingered citron, endothelium corneum gigeriae galli, radix curcumae, vinegar turtle shells, salvia miltiorrhiza and stir-fried white hyacinth beans, 83-84 g of astragalus mongholicus, 33-34 g of coix seeds and 6-7 g of honey.

In order to prepare the Chinese patent medicine into the product forms such as pills, tablets, capsules and the like which are more convenient for patients to carry, the invention takes the technical scheme as reference and further adopts the following technical scheme:

a Chinese patent medicine for treating spleen deficiency damp-encumbering syndrome functional dyspepsia is prepared by fully mixing a paste formula and a proper amount of medicinal auxiliary materials with a forming effect to form a solid state, and the medicinal materials required by preparing each hectic gram of the paste formula are 45 grams of cooked codonopsis pilosula, 45 grams of angelica, 45 grams of rhizoma cimicifugae, 45 grams of rhizoma atractylodis stir-fried with bran, 45 grams of lotus leaf, 45 grams of hawthorn, 30 grams of honey-fried licorice root, 45 grams of steamed tangerine peel, 30 grams of radix bupleuri, 60 grams of golden cypress, 45 grams of wild chrysanthemum, 60 grams of prepared fingered citron, 60 grams of endothelium corneum gigeriae galli, 45 grams of rhizoma atractylodis macrocephalae, 150 grams of astragalus, 45 grams of poria with hostwood, 45 grams of eupatorium, 60 grams of radix curcumae, 60 grams of vinegar turtle shell, 60 grams of salvia miltiorrhiza, 75 grams of semen coicis, 45 grams of bitter apricot kernel, 60 grams of fried white hyacinth bean, 45 grams of medicated leaven and 15 grams of honey.

The invention also provides a method for preparing the Chinese patent medicine, which comprises the following steps:

preparing materials, and accurately blending various medicinal materials according to the prescription recorded in the technical scheme, wherein wild chrysanthemum flower, eupatorium fortunei and steamed tangerine peel are packaged in another bag, honey is packaged in another bag, other medicinal materials, namely common medicinal materials, are weighed and mixed, and are packaged into a non-woven bag for decocting;

soaking, namely placing the medicinal materials in the non-woven fabric bag into a stainless steel medicine soaking barrel, adding water with the weight 6-8 times of that of the medicinal materials until the medicinal materials are completely soaked, and soaking the medicinal materials in a shade place at 0-20 ℃ for 8-10 hours to ensure that water fully permeates into medicinal material tissues so as to facilitate the dissolution of active ingredients during the decoction of the medicinal materials;

step three, decocting, which specifically comprises the following steps:

(1) decocting general medicinal materials, putting the soaked medicinal materials into a decocting tank of two decocting normal-pressure decocting machines, pouring the original soaking liquid, if the liquid can not soak 10-15cm of the medicinal surface, adding water until the liquid can soak 10-15cm of the medicinal surface, heating and boiling for 60 minutes, squeezing the dregs to obtain juice, and storing the first decocting liquid in another container; adding water into the residue until the residue is 10cm above the surface of the medicine, heating and boiling for 40 min, squeezing the residue to obtain a decoction, and storing the second decoction in another container; adding water into the residue until the residue is 5cm above the surface of the medicine, boiling for 30 min, squeezing the residue to obtain decoction, and storing the third decoction in another container;

(2) decocting medicinal materials containing volatile components, mixing flos Chrysanthemi Indici, herba Eupatorii and steamed pericarpium Citri Tangerinae, soaking in 6 times of water for 60 min, heating and boiling in a mixed vacuum cooling device for 20 min, and storing the first decoction in another container; adding water 4 times the weight of the medicinal materials into the medicinal residues, heating and boiling for 15 minutes, and preserving the second decoction in another container; adding water 3 times the weight of the medicinal materials into the residue, heating and boiling for 10 min, storing the third decoction in another container, and adding the residue into other common medicinal materials for further decocting;

(3) treatment of special drugs: sieving Mel with 100 mesh sieve, and heating in a container to refine Mel;

and step four, precipitating, which specifically comprises the following steps:

(1) mixing the decoctions, filtering with 80 mesh sieve, boiling the filtrate for 30 min, spreading for cooling, and standing in 0-20 deg.C shade region for 6-8 hr;

(2) mixing the volatile medicinal decoction obtained by decocting for three times, filtering with 80 mesh screen, boiling the filtrate for 10 min, spreading for cooling, and standing at 0-20 deg.C in shade for 6-8 hr;

filtering, namely taking supernatant after precipitation, and filtering by using a 100-mesh screen respectively;

step six, concentration, namely placing the filtered general medicine decoction in a plurality of small heat-preservation and heat-insulation tanks, and performing low-temperature closed concentration to be in a semifluid state by adopting a parallel traditional Chinese medicine paste concentration preparation system;

step seven, collecting paste, namely adding the volatile medicine decoction filtered in the step five into a common medicine concentrated solution, continuously stirring and concentrating until a stirring rod is lifted to see flag hanging or drop water to form beads, the relative density is more than or equal to 1.35, and the water content is less than 35%, adding refined honey, uniformly stirring, extinguishing and stopping boiling to obtain a paste formula (Chinese patent medicine in a paste state), and subpackaging the paste formula into containers which are cleaned and sterilized while hot;

step eight, cooling the paste, namely placing the subpackaged paste in a paste cooling area with the temperature of 0-20 ℃ and the humidity of 45-75%, spreading for cooling, and covering and sealing after completely cooling;

and step nine, packaging the finished product, spreading the paste formula for cooling, placing the paste formula in a medicine bottle, covering the medicine bottle tightly, attaching a sealing strip and a label, and indicating the production date and the production batch number.

Further, in the step one, various medicinal materials are accurately blended by adopting the large prescription scheme, after the step eight is executed, the obtained paste formula is mixed with a proper amount of pharmaceutic adjuvants which have a forming effect and then prepared into a solid medicine form, and the pharmaceutic adjuvants are mixed powder formed by mixing highland barley powder, sorghum flour and glutinous rice flour according to the ratio of 2: 1. By suitable amount is meant an amount of a pharmaceutical excipient sufficient to convert the cream formulation to a solid state similar to "dry dough".

Clinical experiments prove that the traditional Chinese medicine composition can effectively improve clinical symptoms of postprandial satiety discomfort, early satiety, epigastric pain and upper abdominal burning sensation of patients, and improve the spleen deficiency and dampness encumbering symptoms of the patients, and has remarkable clinical treatment effect.

Drawings

Fig. 1 is a flow chart of the preparation of the spleen-invigorating, dampness-resolving and stomach-harmonizing paste of the present invention.

Detailed Description

Example 1

A Chinese patent medicine for treating functional dyspepsia caused by spleen deficiency and damp encumbering is prepared from 10 g of cooked codonopsis pilosula, 10 g of angelica sinensis, 10 g of rhizoma cimicifugae, 10 g of rhizoma atractylodis fried with bran, 10 g of lotus leaf, 10 g of hawthorn, 5 g of honey-fried licorice root, 10 g of steamed tangerine peel, 5 g of radix bupleuri, 15 g of golden cypress, 10 g of wild chrysanthemum flower, 15 g of prepared fingered citron, 15 g of endothelium corneum gigeriae galli, 10 g of bighead atractylodes rhizome, 60 g of astragalus membranaceus, 10 g of poria with hostwood, 10 g of eupatorium, 15 g of radix curcumae, 15 g of vinegar turtle shell, 15 g of salvia miltiorrhiza, 20 g of semen coicis, 10 g of bitter almond, 15 g of fried white hyacinth bean, 10 g of medicated leaven and 3 g of honey.

In this and the following examples, the herbs refer to the raw materials of decoction pieces of Chinese herbs.

Example 2

A Chinese patent medicine for treating functional dyspepsia caused by spleen deficiency and damp stagnation is prepared from, by weight, 30 g of cooked codonopsis pilosula, 30 g of angelica sinensis, 30 g of rhizoma cimicifugae, 30 g of bran-fried rhizoma atractylodis, 30 g of lotus leaf, 30 g of hawthorn, 20 g of honey-fried licorice root, 30 g of steamed tangerine peel, 20 g of radix bupleuri, 40 g of golden cypress, 30 g of wild chrysanthemum flower, 40 g of prepared fingered citron, 40 g of endothelium corneum gigeriae galli, 30 g of rhizoma atractylodis macrocephalae, 100 g of astragalus membranaceus, 30 g of poria with hostwood, 30 g of eupatorium, 40 g of radix curcumae, 40 g of vinegar turtle shell, 40 g of salvia miltiorrhiza, 50 g of semen coicis, 30 g of bitter almond, 40 g of fried white hyacinth bean, 30 g of medicated leaven and 10 g of honey.

Example 3

A Chinese patent medicine for treating spleen deficiency damp-encumbered syndrome functional dyspepsia is prepared from, per hectic gram, 16.5 g of cooked radix codonopsis pilosulae, 16.5 g of angelica sinensis, 16.5 g of rhizoma cimicifugae, 16.5 g of rhizoma atractylodis stir-fried with bran, 16.5 g of lotus leaf, 16.5 g of hawthorn, 10 g of honey-fried licorice root, 16.5 g of steamed tangerine peel, 10 g of radix bupleuri, 26.5 g of golden cypress, 16.5 g of wild chrysanthemum flower, 26.5 g of prepared fingered citron, 26.5 g of endothelium corneum gigeriae galli, 16.5 g of bighead atractylodes rhizome, 83.5 g of astragalus root, 16.5 g of poria with hostwood, 16.5 g of eupatorium, 26.5 g of radix curcumae, 26.5 g of turtle shell with vinegar, 26.5 g of salvia miltiorrhiza, 33.5 g of semen coicis, 16.5 g of bitter apricot kernel, 26.5 g of stir-fried white hyacinth bean, 16.5 g of medicated leaven and 6.5 g of honey.

Example 4

Example 5

The preparation method adopted by the invention is further described below by combining the attached drawings.

As shown in figure 1, the production equipment adopted by the preparation method for the Chinese patent medicine for treating spleen deficiency and dampness encumbering syndrome functional dyspepsia comprises two decocting normal-pressure decocting machines, a parallel Chinese medicinal paste prescription concentration preparation system (independently developed in the institute, patent number: 201620659405.0), a hybrid vacuum cooling device (independently developed in the institute, patent number: 201620656314.1), an electric Chinese medicinal residue juicing machine (independently developed in the institute, patent number: 201620659402.7), a small-sized heat-preservation and heat-insulation tank (independently developed in the institute, patent number: 201620656341.9), a stainless steel medicine soaking barrel and a 100-mesh stainless steel sieve.

The method for preparing the spleen-invigorating, dampness-resolving and stomach-harmonizing paste comprises the following steps:

step one, preparing materials, and accurately blending the medicines according to the prescription composition, for example, but not limited to, accurately blending the medicines according to the prescriptions provided in examples 1 to 4, wherein the wild chrysanthemum flower, the eupatorium fortunei and the steamed tangerine peel containing volatile components are separately packaged and used as honey of special medicines, and other medicinal materials (hereinafter, referred to as general medicines) in the prescription are weighed and mixed and then are filled into a non-woven bag for decocting medicines.

Soaking, namely placing the group medicines in the non-woven fabric bag into a stainless steel medicine soaking barrel, adding water with the weight 6-8 times of that of the medicines until the medicines are completely soaked, and soaking the medicines in a shade place at 0-20 ℃ for 8-10 hours to ensure that water fully permeates into the tissues of the medicines so as to be beneficial to the dissolution of active ingredients during the decoction of the medicines.

It is worth noting that, because the paste formula medicine is soaked for a long time, when the temperature of a soaking area reaches above 28 ℃, the medicine in the soaking area is easy to grow microorganisms, and mildew or rancidity is caused.

The method regulates the temperature of the soaking area, can effectively inhibit the activity of microorganisms, and thus reduces the occurrence of mildew growth or deterioration of the medicinal materials in the long-time soaking process.

Step three, decocting, which specifically comprises the following steps:

(1) decocting general medicines, namely putting soaked medicines into a decocting tank of two decocting normal-pressure decocting machines, pouring original soaking liquid, adding water until the liquid is 10-15cm higher than the medicine surface if the liquid cannot be 10-15cm higher than the medicine surface, heating and boiling for 60 minutes, squeezing dregs to obtain decoction, and storing the first decocting liquid in another container; adding water into the residue until the residue is 10cm above the surface of the medicine, heating and boiling for 40 min, squeezing the residue to obtain a decoction, and storing the second decoction in another container; adding water into the residue until the residue is 5cm above the surface of the medicine, boiling for 30 min, squeezing the residue to obtain decoction, and storing the third decoction in another container.

(2) Decocting the medicines containing volatile components, mixing the three medicines of the wild chrysanthemum, the eupatorium and the steamed dried orange peel, adding water with the weight 6 times of that of the medicinal materials, soaking for 60 minutes, placing the mixture in a mixed vacuum cooling device, heating and boiling for 20 minutes, and preserving the first decoction in another container; adding water 4 times the weight of the medicinal materials into the medicinal residues, heating and boiling for 15 minutes, and preserving the second decoction in another container; adding water 3 times the weight of the medicinal materials into the residue, heating and boiling for 10 min, storing the third decoction in another container, and adding the residue into other common medicinal materials for further decocting.

(3) Treatment of special drugs: sieving Mel with 100 mesh sieve, and heating in a container to obtain Mel.

In addition, 20-30% of decoction is left in the decoction dregs after decoction according to the traditional Chinese medicine decoction method, so the dissolution rate of the effective components of the medicine is generally 30% of the first decoction, 40-50% of the second decoction and 20-30% of the third decoction. The medicines in the method are decocted for three times, and the decoction is carried out for the next time after the pressure equalization and dry decoction dregs are taken out after each time of decoction is finished. Compared with the operation method of decocting twice without pressing dry the medicine dregs, the invention greatly improves the decocting rate of the effective components of the medicine.

In the embodiment, the wild chrysanthemum, the eupatorium and the steamed tangerine peel containing volatile components are extracted by a hybrid vacuum cooling device independently developed by the institute, so that the volatilization and the loss of the active components of the medicines can be greatly reduced.

In addition, the honey is refined separately so as to remove impurities, kill microorganisms and improve the purity, thereby ensuring the quality of the finished product of the paste formula.

And step four, precipitating, which specifically comprises the following steps:

(2) mixing the volatile medicinal decoctions, filtering with 80 mesh screen, boiling the filtrate for 10 min, spreading for cooling, and standing at 0-20 deg.C in shade for 6-8 hr.

And step five, filtering, and filtering supernatant after precipitation by using a 100-mesh screen respectively.

And step six, concentration, namely placing the filtered general medicine decoction in a plurality of small heat-preservation and heat-insulation tanks, and carrying out low-temperature closed concentration to be in a semifluid state by adopting a parallel-type traditional Chinese medicine ointment formula concentration preparation system independently developed by the institute.

It should be noted that, in this embodiment, the small-sized heat-insulating tank is used as the concentrating container, so that the temperature of the tank body can be maintained for a long time, and the liquid medicine can be concentrated by using the parallel-type traditional Chinese medicine paste prescription concentrating preparation system, so that a low-temperature negative-pressure environment in a boiling state can be provided for tens of containers at the same time, the time for heating and concentrating the liquid medicine is reduced by more than 50% compared with the traditional open type, the concentration efficiency of the liquid medicine is greatly improved, and the manufacturing cost is reduced; meanwhile, the liquid medicine is concentrated in a low-temperature closed state, so that the oxidation and the loss of the active ingredients of the medicine are avoided to the maximum extent.

And step seven, collecting paste, namely adding the volatile medicine decoction filtered in the step five into a common medicine concentrated solution, continuously stirring and concentrating until a stirring rod is lifted to see flag hanging or drop-to-bead, the relative density is more than or equal to 1.35, and the water content is less than 35%, adding refined honey, uniformly stirring, extinguishing and stopping boiling to obtain the Chinese patent medicine in a paste state, and subpackaging the Chinese patent medicine in a container which is cleaned and sterilized while the Chinese patent medicine is hot.

In addition, as the main components such as the wild chrysanthemum flower, the eupatorium fortunei, the steamed tangerine peel and the like are volatile components, if the wild chrysanthemum flower, the eupatorium fortunei, the steamed tangerine peel and the like are decocted and concentrated with other medicinal materials, most of the active components are easy to volatilize and dissipate; if the honey is decocted with other medicines, the efficacy of the honey will be weakened. Therefore, the four medicaments are respectively processed and added before the paste collection, so that the extraction and utilization of the active ingredients of the medicaments can be furthest ensured.

And step eight, cooling the paste, namely placing the subpackaged paste in a paste cooling area with the temperature of 0-20 ℃ and the humidity of 45-75%, spreading for cooling, and covering and sealing after completely cooling.

Notably, if sealed prematurely, the water droplets on the top of the container fall back to the surface of the ointment, causing the surface concentration of the ointment to decrease and become moldy. In addition, the paste needs to be cooled open during paste cooling, the temperature of a paste cooling area should be controlled to be 0-20 ℃, the humidity is 45-75%, and the paste cooling area is dust-free and free of ants, flies, cockroaches, mice and the like.

Example 6

The basic steps of this embodiment are the same as those of steps one to eight of embodiment 5, except that in this embodiment, the dosage of each herb is larger (for example, the prescription provided in embodiment 4 is adopted, or even a prescription with a larger dosage is adopted), and after step eight is performed, the paste formulation is mixed with a proper amount of pharmaceutical excipients for forming and then made into solid medicine forms such as pills, tablets, capsules (referring to granular or powdery pharmaceutical ingredients in capsules) and the like, instead of bottling.

In this embodiment, the pharmaceutical excipients for molding are mixed powder of highland barley flour (preferably highland barley flour produced in high altitude areas such as Tibet), sorghum flour and glutinous rice flour. Mixing the highland barley flour, the sorghum flour and the glutinous rice flour in a ratio of 2: 1, adding into the paste formula, and continuously stirring until the Chinese patent medicine is converted from a paste state into a solid state similar to dry dough. Thereafter, the Chinese patent medicine can be further prepared into solid products such as pills, tablets or capsules. It should be noted that the amount of the mixed powder is different and proper according to the water content of the paste formula. By suitable amount is meant an amount of the mixed flour sufficient to convert the cream to a solid state similar to "dry dough". For example, when the water content of the cream formula is 20%, 100 g of the cream formula and 20 g of the mixed powder for forming are fully mixed and continuously stirred, and the Chinese patent medicine in a solid state similar to a dry dough can be prepared. Further processing to obtain solid medicine in the form of pill, tablet, capsule, etc.

It should be noted that, the highland barley powder, the sorghum powder and the glutinous rice powder are used as the pharmaceutic adjuvant, because the highland barley powder has strong adsorption capacity and can effectively adsorb and retain volatile components in the Chinese patent medicine, but the highland barley powder has poor adhesion (not beneficial to product forming), the glutinous rice powder has strong adhesion (beneficial to product forming) and poor adsorption capacity, and when the sorghum powder is used, because the sorghum powder has relatively slow rate of absorbing water, the pharmaceutic adjuvant contains the sorghum powder, which is beneficial to the sufficient and uniform mixing of the pharmaceutic adjuvant and the paste formula, therefore, the highland barley powder, the sorghum powder and the glutinous rice powder are mixed according to the ratio of 2: 1 to prepare the pharmaceutic adjuvant.

The technical scheme of the invention is described in detail through six embodiments, and the curative effect of the invention is further described below by combining clinical experimental data. In addition, in clinical experiments, the Chinese patent medicine for verifying the curative effect of the invention has been named as: ointment for strengthening spleen, eliminating dampness and harmonizing stomach.

Research data and methods

1. Source of case

120 cases of patients with dyspepsia (FD) of spleen deficiency and damp stagnation syndrome of 18-70 years old who come to the hospital for treatment from 5 months to 2019 months in 2017 are selected and randomly divided into a plaster formula group and a western medicine group, and each group comprises 60 cases.

Diagnostic criteria

(1) Diagnostic criteria for western FD: reference is made to the "Roman III" diagnostic criteria for functional gastrointestinal disorders. Must include 1 or more of the following: firstly, the patient feels full and uncomfortable after meals; early satiety; ③ epigastric pain; fourthly, burning sensation of the upper abdomen; and no evidence of organic disease (including gastroscopy) that could explain the symptoms; symptoms appear at least 6 months before diagnosis, and the above criteria are met in nearly 3 months.

(2) The traditional Chinese medicine diagnosis standard for spleen deficiency and dampness encumbrance syndrome is as follows: spleen qi deficiency, damp turbidity, retention in the interior, manifested as no appetite for a long time, abdominal distension, frequent diarrhea, weight, sleepiness, pale and swollen tongue, etc. The essential element is spleen dampness. Or with phlegm, qi stagnation, qi deficiency and yang deficiency. Common syndromes and the measured value are no appetite for long = 2; sticky and greasy in the mouth = 2; thirst = 1; nausea = 2; emesis = 2; abdominal pain = 2; abdominal distension = 2; diarrhea/loose stool = 2; stool mucus = 2; listlessness = 1; lethargy = 2; burnout fatigue = 2; dizziness = 1; head weight = 1; body acid weight = 2; eyelid edema/edema = 2; oliguria = 1; more and more leukorrhea = 2; obesity = 2; yellow-dark-on-face = 1; pale and swollen = 2; tongue edge tooth print = 2; white tongue coating = 1; greasy tongue coating = 2; tongue coating lubrication = 2; soft/slow pulse = 2.

When in use, the disease data of each symptom, sign and the like of a patient are weighted and summed according to the prompted syndrome type (the measurement of the mild symptom is that the main complaint or the severe symptom is heavy, the measurement value is multiplied by 1.5, the measurement value is moderate, the measurement value is multiplied by 1, and the measurement value is light, and the measurement value is multiplied by 0.7). Then a determination is made as to the pattern. The syndrome decision generally has 20 as a common threshold.

Incorporation criteria

(1) The FD Western diagnosis standard and the Chinese medicine diagnosis standard are met;

(2) the patient is conscious, has no aphasia and intelligent obstacle, and can understand the content of the scale and cooperate with treatment when the degree of culture is above the primary school;

(3) patients aged 18-70 years, agreed and signed an informed consent for entry into the study.

Exclusion criteria

(1) Those who do not meet inclusion diagnostic criteria.

(2) Combined with gastroduodenal ulcer and erosive property; history of abdominal surgery; the endoscopic examination shows severe dysplasia of gastric mucosa or malignant change suspected by pathological diagnosis.

(3) The upper gastrointestinal symptoms caused by the medicine, such as taking non-steroidal anti-inflammatory drugs, etc.

(4) Dyspepsia caused by liver, gallbladder, pancreas and spleen diseases, diabetes, connective tissue diseases, cardiac and renal insufficiency and other systemic diseases.

(5) Patients with undesirable mental and psychological disorders are participating in other trials or investigators, pregnant or lactating women.

(6) Allergic constitution or patients known to have allergy to the composition of the prescription in this test may be drug-dependent, alcoholic, or psychotic.

Methods of treatment

(1) Western medicine group: domperidone tablets (produced by Maruzin, Maruzu Lizhu pharmaceutical factory, specification: 10 mg/tablet) are orally taken at 10 mg/time and 3 times/day, and are taken with warm boiled water 30 minutes before meal for 1 month.

(2) Cream formula set

See example 3 for formulation. No prescription was published to the patient during the clinical trial.

Preparing the paste: see example 5.

The taking method comprises the following steps: the composition is administered for 1 time every day, 30ml each time, half an hour after breakfast, and 1 month continuously.

And observation index

Before and after 1 month of treatment, the observation of the classification chart of the main symptoms and the Chinese medicine syndrome-hou integration chart are respectively carried out.

(1) Chief complaint rating scale: the symptoms of the disease are recorded by referring to a symptom classification table in the dyspepsia traditional Chinese medicine diagnosis and treatment consensus opinion revised by the spleen and stomach disease division of the Chinese medical society in 2010, and the details are shown in an attached table 1.

(2) The traditional Chinese medicine syndrome score chart: the recording of the traditional Chinese medicine syndrome hou-ji score chart is carried out by referring to the 'diagnosis standard of common traditional Chinese medicine syndrome' revised by the medical consultation and diagnosis division in China in 2008, which is detailed in attached table 2.

And judgment of therapeutic efficacy

Grading symptoms and judging the curative effect of the traditional Chinese medicine syndrome: the therapeutic effect of the study is determined according to the therapeutic effect determination standard in the clinical research guiding principle of traditional Chinese medicine edited by ZhengXiao cornus in 2002.

The clinical cure is as follows: the clinical symptoms and physical signs are obviously improved, and the syndrome integral is reduced by more than or equal to 95 percent;

the effect is shown: the clinical symptoms and physical signs are obviously improved, and the syndrome integral is reduced by more than or equal to 70 percent;

the method has the following advantages: the clinical symptoms and physical signs are improved, and the syndrome integral is reduced by more than or equal to 30 percent;

and (4) invalidation: clinical symptoms and physical signs are not obviously improved or even aggravated, and the syndrome integral is reduced by less than 30%.

Efficacy index = (pre-treatment integral-post-treatment integral)/pre-treatment integral × 100%.

Statistical method

Data were analyzed by SPSS25.0, and data were measured (+ -s), with comparisons between groups using independent sample t-tests, comparisons within groups paired t-tests, counts n (%) for x 2 tests, and P < 0.05 for differences of statistical significance.

(II) results of the study

1. General data comparisons two groups of sex, age, disease course baseline data were compared in balance (P > 0.05), see Table 1.

TABLE 1 comparison of two general data sets

2. The total effective rate (88.34%) of the clinical curative effect plaster formula group is higher than that (56.66%) of the western medicine group, and the difference has statistical significance (P is less than 0.05). The clinical curative effect of the plaster formula group on treating patients with spleen deficiency and damp stagnation syndrome FD is better than that of the western medicine group. See table 2.

TABLE 2 two clinical efficacy comparisons [ n (%) ]

3. The comparison of the main symptoms before and after treatment in the two groups of cases shows that the scores of the main symptoms before treatment (postprandial fullness and discomfort, early satiety, epigastric pain and burning sensation of the upper abdomen) in the two groups of cases have no significant difference (P is more than 0.05), which indicates that the main symptoms before treatment in the two groups are comparable. The main symptom scores of the ointment formula group and the western medicine group after treatment are obviously reduced (P is less than 0.05) compared with the main symptom scores before treatment, the ointment formula group is superior to the western medicine group in the score of reducing early satiety and upper abdominal burning, and the score of reducing postprandial satiety and discomfort and upper abdominal pain is equivalent to the western medicine group. The ointment formula group and the western medicine group can obviously improve the main symptoms of patients with spleen deficiency and damp stagnation syndrome FD after 1 month of treatment, the ointment formula group is superior to western medicines in improving the symptoms of early satiety and upper abdominal burning, and the curative effect of the ointment formula group on improving the symptoms of postprandial satiety discomfort and upper abdominal pain is equivalent to that of the western medicine group. See table 3.

TABLE 3 comparison of the principal symptoms (+ -s) before and after treatment of two groups

4. The traditional Chinese medicine syndrome integral comparison before and after two groups of treatment has no significant difference (P is more than 0.05) in the traditional Chinese medicine syndrome integral comparison before two groups of treatment, namely, the traditional Chinese medicine syndrome integral comparison before two groups of treatment has comparability. The traditional Chinese medicine syndrome score after treatment of the ointment formula group is remarkably reduced (P is less than 0.05) compared with that before treatment, and is obvious (P is less than 0.05) compared with a western medicine group; the syndrome score of the traditional Chinese medicine after treatment of the western medicine group is not reduced significantly (P is more than 0.05) compared with that before treatment. The ointment formula can effectively improve the spleen deficiency and damp-encumbering syndrome of FD patients, and is superior to western medicine groups. See table 4.

TABLE 4 integral comparison of Chinese medicine syndrome before and after two groups of treatment (+ -s)

(III) conclusion of the study

1. The total effective rate of the spleen-invigorating, dampness-resolving and stomach-harmonizing ointment for treating functional dyspepsia caused by spleen deficiency and dampness stagnation is higher than that of western medicine.

2. After being treated for 1 month, the spleen-invigorating, dampness-resolving and stomach-harmonizing ointment and the western medicine group can obviously improve the symptoms of 'postprandial fullness and discomfort', 'early fullness feeling', 'epigastric burning feeling' of the FD patient with the spleen-deficiency and dampness-encumbering syndrome, the spleen-invigorating, dampness-resolving and stomach-harmonizing ointment is superior to the western medicine group in improving the symptoms of 'early fullness feeling', 'epigastric burning feeling', and the curative effects of the spleen-invigorating, dampness-resolving and stomach-harmonizing ointment and the western medicine group are equivalent to the curative effects of the western medicine group in improving the symptoms of 'postprandial fullness and discomfort', 'epigastric burning feeling'.

3. The spleen-invigorating, dampness-resolving and stomach-harmonizing ointment can effectively improve the spleen deficiency and dampness encumbrance syndrome of FD patients and is superior to western medicine groups.

In conclusion, the spleen-invigorating, dampness-resolving and stomach-harmonizing ointment for treating the spleen-deficiency and dampness-retention syndrome FD can effectively improve the clinical symptoms of the patient such as postprandial satiety discomfort, early satiety feeling, epigastric pain and epigastric burning feeling, and can improve the spleen-deficiency and dampness-retention syndrome of the patient, and has remarkable clinical curative effect.

Attached table 1 symptom grading table

Attached table 2 Chinese medicine syndrome Hou integration chart

Note: when in use, the disease data of each symptom, sign and the like of a patient are weighted and summed according to the prompted syndrome type (the measurement of the mild symptom is that the main complaint or the severe symptom is heavy, the measurement value is multiplied by 1.5, the measurement value is moderate, the measurement value is multiplied by 1, and the measurement value is light, and the measurement value is multiplied by 0.7).

Claims

1. A Chinese patent medicine for treating functional dyspepsia of spleen deficiency and damp stagnation syndrome is characterized in that: the Chinese patent medicine is prepared from the following raw materials, by weight, 10-30 g of cooked codonopsis pilosula, 10-30 g of angelica sinensis, 10-30 g of cimicifuga foetida, 10-30 g of bran-fried rhizoma atractylodis, 10-30 g of lotus leaves, 10-30 g of hawthorn, 5-20 g of honey-fried licorice root, 10-30 g of steamed tangerine peel, 5-20 g of radix bupleuri, 15-40 g of golden cypress, 10-30 g of wild chrysanthemum, 15-40 g of prepared fingered citron, 15-40 g of endothelium corneum gigeriae galli, 10-30 g of bighead atractylodes rhizome, 60-100 g of astragalus mongholicus, 10-30 g of poria with hostwood, 10-30 g of eupatorium, 15-40 g of radix curcumae, 15-40 g of vinegar-turtle shell, 15-40 g of salvia miltiorrhiza, 20-50 g of coix seeds, 10-30 g of bitter almonds, 15-40 g of fried white hyacinth beans, 10-30 g of medicated leaven and 3-10 g of honey.

2. The Chinese patent medicine of claim 1, wherein: the Chinese medicine composition is prepared from the following raw materials, by weight, 16-17 g of cooked codonopsis pilosula, angelica sinensis, cimicifuga foetida, rhizoma atractylodis stir-fried with bran, lotus leaves, hawthorn, steamed tangerine peel, wild chrysanthemum, bighead atractylodes rhizome, poria with hostwood, eupatorium fortunei, bitter apricot seeds and medicated leaven, 9-11 g of honey-fried licorice root and radix bupleuri, 26-27 g of phellodendron, prepared fingered citron, endothelium corneum gigeriae galli, radix curcumae, vinegar turtle shell, salvia miltiorrhiza and fried white hyacinth bean, 83-84 g of astragalus mongholicus, 33-34 g of coix seeds and 6-7 g of honey.

3. A Chinese patent medicine for treating spleen deficiency damp-encumbering syndrome functional dyspepsia is prepared by fully mixing a paste formula and a proper amount of medicinal auxiliary materials with a forming effect to form a solid state, and the medicinal materials required by preparing each hectic gram of the paste formula are 45 grams of cooked codonopsis pilosula, 45 grams of angelica, 45 grams of rhizoma cimicifugae, 45 grams of rhizoma atractylodis stir-fried with bran, 45 grams of lotus leaf, 45 grams of hawthorn, 30 grams of honey-fried licorice root, 45 grams of steamed tangerine peel, 30 grams of radix bupleuri, 60 grams of golden cypress, 45 grams of wild chrysanthemum, 60 grams of prepared fingered citron, 60 grams of endothelium corneum gigeriae galli, 45 grams of rhizoma atractylodis macrocephalae, 150 grams of astragalus, 45 grams of poria with hostwood, 45 grams of eupatorium, 60 grams of radix curcumae, 60 grams of vinegar turtle shell, 60 grams of salvia miltiorrhiza, 75 grams of semen coicis, 45 grams of bitter apricot kernel, 60 grams of fried white hyacinth bean, 45 grams of medicated leaven and 15 grams of honey.

4. A preparation method of a Chinese patent medicine for treating functional dyspepsia of spleen deficiency and damp stagnation syndrome is characterized by comprising the following steps: the method comprises the following steps:

preparing materials, accurately blending various medicinal materials according to a prescription recorded in any one of claims 1 to 3, wherein the wild chrysanthemum flower, the eupatorium and the steamed tangerine peel are separately packaged, the honey is separately packaged, other medicinal materials, namely general medicinal materials, are weighed and mixed, and are packaged into a non-woven bag for decocting;

step three, decocting, which specifically comprises the following steps:

(1) decocting general medicinal materials, putting the soaked medicinal materials into a decocting tank of two decocting normal-pressure decocting machines, pouring the original soaking medicinal liquid, if the medicinal liquid can not soak 10-15cm of the medicinal surface, adding water until the medicinal surface is soaked 10-15cm, heating and boiling for 60 min, squeezing the residues to obtain decoction, and storing the first decocting medicinal liquid in another container; adding water into the residue until the residue is 10cm above the surface of the medicine, heating and boiling for 40 min, squeezing the residue to obtain a decoction, and storing the second decoction in another container; adding water into the residue until the residue is 5cm above the surface of the medicine, boiling for 30 min, squeezing the residue to obtain decoction, and storing the third decoction in another container;

(2) decocting the medicines containing volatile components, mixing the three medicines of the wild chrysanthemum, the eupatorium and the steamed dried orange peel, adding water with the weight 6 times of that of the medicinal materials, soaking for 60 minutes, placing the mixture in a mixed vacuum cooling device, heating and boiling for 20 minutes, and preserving the first decoction in another container; adding water 4 times the weight of the medicinal materials into the medicinal residues, heating and boiling for 15 minutes, and preserving the second decoction in another container; adding water 3 times the weight of the medicinal materials into the residue, heating and boiling for 10 min, storing the third decoction in another container, and adding the residue into other common medicinal materials for further decocting;

and step four, precipitating, which specifically comprises the following steps:

step seven, collecting paste, namely adding the volatile medicine decoction filtered in the step five into common medicine concentrated solution, continuously stirring and concentrating until a stirring rod is lifted to see flag hanging or drop water to form beads, the relative density is more than or equal to 1.35, and the water content is less than 35%, adding refined honey, uniformly stirring, extinguishing and stopping boiling to obtain a paste formula, and subpackaging the paste formula into a container which is cleaned and sterilized while hot;

5. The method of claim 4, wherein: step one is executed, each medicinal material is accurately blended according to the prescription recorded in claim 3, and after step eight is executed, the paste formula is mixed with a proper amount of pharmaceutic adjuvants which have a forming effect and are prepared into a solid medicine form, wherein the pharmaceutic adjuvants are mixed powder formed by mixing highland barley powder, sorghum flour and glutinous rice flour according to a ratio of 2: 1.