CN111000959B

CN111000959B - Chinese patent medicine for treating spleen deficiency syndrome postoperative fatigue syndrome and preparation method thereof

Info

Publication number: CN111000959B
Application number: CN201911237277.5A
Authority: CN
Inventors: 邬素珍; 吴声振; 朱巧玲; 曾志强; 许焕英
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: CN111000959A

Abstract

The invention provides a Chinese patent medicine for treating spleen deficiency syndrome postoperative fatigue syndrome and a preparation method thereof. The Chinese patent medicine comprises, by weight, 20-50 g of costustoot, 10-30 g of fructus amomi, 20-50 g of bighead atractylodes rhizome, 30-70 g of prepared fingered citron, 20-50 g of steamed tangerine peel, 20-50 g of cooked codonopsis pilosula, 20-50 g of poria cocos, 10-30 g of honey-fried licorice root, 10-30 g of ginger processed pinellia tuber, 20-50 g of salvia miltiorrhiza, 12-35 g of sun-dried ginseng, 30-70 g of coix seed, 30-70 g of suberect spatholobus stem, 30-70 g of Chinese date, 20-50 g of capillary wormwood herb, 20-50 g of chicken's gizzard-membrane and 20-50 g of teasel root. Clinical experiments prove that the Chinese patent medicine for treating the spleen deficiency syndrome postoperative fatigue syndrome can effectively improve the number of T lymphocytes of a patient, improve the postoperative fatigue degree and the spleen deficiency syndrome of the patient and improve the overall treatment effect of the disease.

Description

Chinese patent medicine for treating spleen deficiency syndrome postoperative fatigue 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 spleen deficiency syndrome postoperative fatigue syndrome and a preparation method thereof.

Background

At present, the traditional Chinese medicines commonly used for treating spleen deficiency syndrome postoperative fatigue syndrome mainly comprise Xiaoyao powder (main components comprise radix bupleuri, poria cocos, angelica sinensis, radix paeoniae alba, rhizoma atractylodis macrocephalae, mint, ginger, radix curcumae, szechwan chinaberry fruit, mangnolia officinalis, fructus aurantii, liquorice and the like), eight-treasure decoction plus or minus (main components comprise radix codonopsis pilosulae, poria cocos, rhizoma atractylodis macrocephalae, liquorice, rhizoma ligustici wallichii, angelica sinensis, radix paeoniae alba, rehmannia glutinosa and the like), and Yougui pill plus or minus (main components comprise radix rehmanniae preparata, radix aconiti lateralis preparata, cinnamon, yam, rhizoma atractylodis macrocephalae, dogwood, semen cuscutae, colla cornus cervi, fructus lycii, angelica sinensis, eucommia ulmoides, radix glycyrrhizae preparata and the like).

From clinical practices of the hospital for many years, the traditional Chinese medicine has a certain curative effect on the treatment of the spleen deficiency syndrome postoperative fatigue syndrome, but in general, the curative effect is not ideal. After the traditional Chinese medicine is not effective, a plurality of patients can use western medicines for calming nerves or receive other treatment means such as acupuncture and massage. However, for various postoperative fatigue syndrome patients including the postoperative fatigue syndrome of spleen deficiency syndrome, the western medicine for calming nerves cannot play a role in treating both symptoms and root causes. In addition, although acupuncture and tuina have some positive effects on the treatment of postoperative fatigue syndrome (including spleen deficiency syndrome), it is not enough to cure some postoperative fatigue syndrome (including spleen deficiency syndrome) by acupuncture and tuina alone.

Disclosure of Invention

The invention aims to actually improve the curative effect of the spleen deficiency syndrome postoperative fatigue syndrome, thereby overcoming the defects of the prior art. The purpose of the invention is realized by the following technical scheme:

a Chinese patent medicine for treating spleen deficiency syndrome postoperative fatigue syndrome is prepared from, per hundred grams, 20-50 grams of costustoot, 10-30 grams of fructus amomi, 20-50 grams of rhizoma atractylodis macrocephalae, 30-70 grams of prepared fingered citron, 20-50 grams of steamed tangerine peel, 20-50 grams of cooked codonopsis pilosula, 20-50 grams of poria cocos, 10-30 grams of honey-fried licorice root, 10-30 grams of ginger processed pinellia tuber, 20-50 grams of salvia miltiorrhiza, 12-35 grams of sun-dried ginseng, 30-70 grams of semen coicis, 30-70 grams of caulis spatholobi, 30-70 grams of Chinese date, 20-50 grams of oriental wormwood, 20-50 grams of endothelium corneum gigeriae galli and 20-50 grams of teasel root.

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:

33-34 g of costustoot, bighead atractylodes rhizome, steamed tangerine peel, cooked codonopsis pilosula, poria cocos, red sage root, capillary wormwood herb, endothelium corneum gigeriae galli and teasel root, 16-17 g of fructus amomi, honey-fried licorice root and ginger processed pinellia tuber, 49-51 g of prepared fingered citron, coix seed, suberect spatholobus stem and Chinese date and 19-21 g of sun-dried ginseng.

In order to make the Chinese patent medicine into the form of solid products 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 syndrome postoperative fatigue syndrome is prepared by fully mixing a paste formula and a proper amount of pharmaceutic adjuvant which plays a role of forming, wherein the medicinal materials required for preparing each hundred grams of the paste formula are 60 grams of costustoot, 48 grams of fructus amomi, 60 grams of rhizoma atractylodis macrocephalae, 84 grams of prepared fingered citron, 60 grams of steamed tangerine peel, 60 grams of cooked codonopsis pilosula, 60 grams of poria cocos, 48 grams of honey-fried licorice root, 48 grams of ginger processed pinellia tuber, 60 grams of salvia miltiorrhiza, 42 grams of sun-dried ginseng, 84 grams of semen coicis, 84 grams of caulis spatholobi, 84 grams of Chinese date, 84 grams of capillary wormwood herb, 60 grams of endothelium corneum gigeriae galli and 60 grams of teasel root.

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

step one, preparing materials, and accurately blending various required medicinal materials according to the prescription recorded in the technical scheme, wherein the costustoot, the fructus amomi and the steamed tangerine peel are packaged in another bag, the sun-dried ginseng is sliced and packaged in another bag, and other medicinal materials, namely general medicinal materials (the costustoot, the fructus amomi, the steamed tangerine peel and the sun-dried ginseng are other medicinal materials except for the medicinal materials, and in the invention, the medicinal materials are also called as general medicines) are weighed and mixed, and are filled into a non-woven bag for decocting;

step two, soaking: placing the medicinal materials in the non-woven fabric bag in a stainless steel medicine soaking barrel, adding 6-8 times of water (referring to drinkable water, the same below) by weight of the medicinal materials until the medicinal materials are completely immersed, and soaking in a shade place at 0-20 deg.C for 8-10 hr to allow water to fully permeate into medicinal material tissues, so as to facilitate the dissolution of effective components 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 pot 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 by 10-15cm, heating and boiling for more than 60 minutes, squeezing the residues to obtain juice, and preserving the first decocting medicinal juice 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) decoction of volatile component-containing herbs (also called volatile drugs): mixing radix aucklandiae, fructus Amomi 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) decocting precious and fine medicines: soaking sun-dried ginseng slices in 6 times of water for 60 min, heating and boiling in a mixed vacuum cooling device for 60 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 40 minutes, and preserving the second decoction in another container; adding water 3 times the weight of the medicinal materials into the medicinal residues, heating and boiling for 20 minutes, and preserving the third decoction in another container; adding the radix Ginseng residue after three times decoction into other common medicinal materials, and decocting;

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 for 6-8 hr.

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

(3) Mixing the three decocted sun-dried ginseng decoctions, filtering with 80 mesh sieve, boiling the filtrate for 10 min, spreading for cooling, and standing in 0-20 deg.C 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 and the sun-dried ginseng decoction which are 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 'dripping water into beads', the relative density is more than or equal to 1.35, and the water content is less than 35%, 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 the paste formula is 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, cooling, covering tightly, sticking a sealing strip and a label, and noting 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 Chinese patent medicine for treating the spleen deficiency syndrome postoperative fatigue syndrome can effectively improve the number of T lymphocytes of a patient, improve the postoperative fatigue degree and the spleen deficiency syndrome of the patient and improve the overall treatment effect of the disease. Particularly, compared with decoction with the same prescription (decoction obtained by decocting medicinal materials according to the prescription), the medicine is superior to the decoction in the aspect of improving the fatigue degree and the spleen deficiency of postoperative fatigue syndrome patients on the 30 th postoperative day, and is superior to the decoction in the aspect of improving the curative effect of CD3+, CD4+, CD4+/CD8+ of the patients, and the reason is that: compared with the traditional decoction method, the preparation method of the invention can better extract and reserve the medicinal components in the medicinal materials.

Drawings

Fig. 1 is a process flow chart of the preparation of the Chinese patent medicine in embodiment 5 of the invention.

Detailed Description

Example 1

A Chinese patent medicine for treating spleen deficiency syndrome postoperative fatigue syndrome is prepared from 20 g of costustoot, 10 g of fructus amomi, 20 g of bighead atractylodes rhizome, 30 g of prepared fingered citron, 20 g of steamed tangerine peel, 20 g of cooked codonopsis pilosula, 20 g of poria cocos, 10 g of honey-fried licorice root, 10 g of ginger processed pinellia tuber, 20 g of salvia miltiorrhiza, 12 g of sun-dried ginseng, 30 g of coix seed, 30 g of caulis spatholobi, 30 g of Chinese date, 20 g of capillary wormwood herb, 20 g of endothelium corneum gigeriae galli and 20 g of teasel root.

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 spleen deficiency syndrome postoperative fatigue syndrome is prepared from 50 g of costustoot, 30 g of fructus amomi, 50 g of rhizoma atractylodis macrocephalae, 70 g of prepared fingered citron, 50 g of steamed tangerine peel, 50 g of cooked codonopsis pilosula, 50 g of poria cocos, 30 g of honey-fried licorice root, 30 g of ginger processed pinellia tuber, 50 g of salvia miltiorrhiza, 35 g of sun-dried ginseng, 70 g of semen coicis, 70 g of caulis spatholobi, 70 g of Chinese date, 50 g of capillary wormwood herb, 50 g of endothelium corneum gigeriae galli and 50 g of teasel root.

Example 3

A Chinese patent medicine for treating spleen deficiency syndrome postoperative fatigue syndrome, wherein each hundred grams of the Chinese patent medicine is prepared from 33.5 grams of costustoot, 16.5 grams of fructus amomi, 33.5 grams of rhizoma atractylodis macrocephalae, 50 grams of prepared fingered citron, 33.5 grams of steamed tangerine peel, 33.5 grams of cooked codonopsis pilosula, 33.5 grams of poria cocos, 16.5 grams of honey-fried licorice root, 16.5 grams of ginger processed pinellia tuber, 33.5 grams of salvia miltiorrhiza, 20 grams of sun-dried ginseng, 50 grams of semen coicis, 50 grams of caulis spatholobi, 50 grams of Chinese date, 33.5 grams of capillary wormwood herb, 33.5 grams of endothelium corneum gigeriae galli and 33.5 grams of teasel root.

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 in the preparation method of the Chinese patent medicine for treating the spleen deficiency syndrome postoperative fatigue syndrome (in the embodiment, the Chinese patent medicine can be named as postoperative recovery paste) comprises two decocting normal-pressure decocting machines, a parallel traditional Chinese medicine 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 traditional Chinese medicine 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 preparation method comprises the following steps:

step one, preparing materials, and accurately blending various required medicinal materials according to the prescription recorded in the technical scheme, wherein the costustoot, the fructus amomi and the steamed tangerine peel are packaged in another bag, the sun-dried ginseng is sliced and packaged in another bag, and other medicinal materials, namely general medicinal materials (the costustoot, the fructus amomi, the steamed tangerine peel and the sun-dried ginseng are other medicinal materials except for the costustoot, the fructus amomi, the steamed tangerine peel and the sun-dried ginseng, and in the invention, the medicinal materials are also called general medicines) are weighed and mixed, and are filled into a non-woven bag for decocting.

Step two, soaking: placing the medicinal materials in the non-woven fabric bag in a stainless steel medicine soaking barrel, adding 6-8 times of water (referring to drinkable water, the same below) by weight of the medicinal materials until the medicinal materials are completely immersed, and soaking in a shade place at 0-20 deg.C for 8-10 hr to allow water to fully permeate into medicinal material tissue, so as to facilitate dissolution of effective components during decoction of the medicinal materials.

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

(3) decocting precious and fine medicines: soaking sun-dried ginseng slices in 6 times of water for 60 minutes, heating and boiling in a mixed vacuum cooling device for 60 minutes, and preserving a first decoction in another device; adding water 4 times the weight of the medicinal materials into the medicinal residues, heating and boiling for 40 minutes, and preserving the second decoction in another container; adding water 3 times the weight of the medicinal materials into the medicinal residues, heating and boiling for 20 minutes, and preserving the third decoction in another container; adding the radix Ginseng residue after three times decoction into other common medicinal materials, and decocting.

It is worth noting that 20-30% of decoction is left in the residue after traditional decoction method of traditional Chinese medicine, therefore, the dissolution rate of effective components of the medicine is generally 30% for the first decoction, 40-50% for the second decoction and 20-30% for 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 common method of decocting twice without pressing dry the dregs, the method greatly improves the decoction rate of the active ingredients of the medicine.

In the embodiment, the medicine costustoot, fructus amomi and steamed tangerine peel containing volatile components are extracted by adopting a hybrid vacuum cooling device independently developed by the institute, so that the volatilization and the loss of the effective components of the medicine are reduced.

In addition, the sun-dried ginseng is taken as a precious and fine medicinal material, and is taken into consideration to be decocted separately to obtain juice and then added into an ointment formula for use, so that the loss caused by the adsorption of active ingredients of the medicine by other medicines when the sun-dried ginseng is decocted together with other medicines is avoided.

In order to fully extract the effective components in the sun-dried ginseng, the sun-dried ginseng slices can be decocted in advance when the step is actually executed, so that the sun-dried ginseng dregs after three times of decoction can be added into other common medicinal materials for continuous decoction.

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

and 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 formula concentration preparation system.

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.

Step seven, collecting paste: adding the volatile medicinal decoction and the sun-dried ginseng decoction which are filtered in the fifth step into the common medicinal concentrated solution, continuously stirring and concentrating until the stirring rod is lifted to see a flag, or the water drops form beads, the relative density is more than or equal to 1.35, and the water content is less than 35%, extinguishing the fire and stopping the boiling to obtain a paste formula, namely the Chinese patent medicine (also called as the soft extract medicine) in the state of soft extract, and subpackaging the hot paste into containers which are cleaned and sterilized.

It is worth noting that, because the main components of the costustoot, the amomum villosum and the steamed tangerine peel are volatile components, if the costustoot, the amomum villosum and the steamed tangerine peel are decocted and concentrated with other medicinal materials, most of the active components are easy to volatilize and dissipate; when the sun-dried ginseng is decocted together with other medicinal materials, the effective ingredients of the medicinal materials can be adsorbed by other medicinal materials to cause loss, and the effective ingredients of the sun-dried ginseng can be completely utilized by adding the single decoction. 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.

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 kind of medicinal materials is larger (for example, the prescription provided in embodiment 2 or embodiment 4 is adopted, or even the prescription with larger dosage of medicinal materials is adopted), and after step eight is executed, the paste prescription is mixed with an appropriate 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: postoperative rehabilitation ointment.

Research data and methods

1. Research data sources

The cases come from 120 patients with spleen deficiency syndrome postoperative fatigue syndrome (POFS) who are operated in surgery and gynecology of our hospital in 2017 and 2019 and 5 months, and are randomly divided into decoction groups and ointment formula groups, wherein each group comprises 60 patients.

2. Diagnostic criteria

(1) Diagnostic criteria for western POFS: refer to the 1994 national center for disease control, Fukada et al, revised diagnostic criteria for chronic fatigue syndrome. After the operation of the patient, 4 or more than 4 symptoms are simultaneously obtained:

fatigue which is not easy to relieve due to overweight physical or psychological load;

② muscle weakness without clear cause;

thirdly, insomnia symptoms are ubiquitous, or dreaminess and early awakening are caused;

fourthly, head distension, dizziness or headache; attention is not focused, and memory is reduced;

sixthly, the appetite is not vibrating; shoulder discomfort, chest tightness, or low back pain, delocalized myalgia or arthralgia, without a clear history of rheumatism or trauma;

inhibition of interest, anxiety or stress, fear;

-interest has declined or lost; decreased sexual function;

ninthly, low fever, dry throat, pharyngalgia or tightness in the throat.

(2) The traditional Chinese medicine syndrome type standard of the spleen deficiency syndrome is as follows: refer to the "diagnosis standard of common traditional Chinese medicine syndrome" published by the clinical consultation of Chinese medicine and pharmacology in China in 2008. The failure of spleen qi to transport and transform results in the symptoms of weakness, poor appetite, abdominal distention and loose stool. The common symptoms and the measured value are no appetite for a long time or eating less for a long time = 4; after eating, distension and fullness = 2; abdominal distension = 3; abdominal pain = 2; dull pain = 2; diarrhea or loose stool = 4; listlessness = 2; burnout fatigue = 2; gas short = 2; lazy-to-speak = 2; lethargy = 2; often chills = 2; edema = 2; body wasting or body obesity = 2; pale complexion or white complexion or sallow complexion = 2; pale tongue or swollen tongue = 2; tongue edge tooth print = 2; thin and white tongue coating or white tongue coating = 2; slow or deficient 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.

3. Inclusion criteria

(1) The patient is 18-65 years old and receives benign disease of the general anesthesia operation treatment of the trachea cannula in surgery and gynecology of our hospital;

(2) before operation, the functions of heart, liver, lung and kidney are normal;

(3) the POFS standard for western diagnosis and Chinese syndrome diagnosis is met;

(4) voluntarily attend the study and sign informed consent.

4. Exclusion criteria

(1) Those with low culture degree or having no understanding of the meaning of the scale characters due to factors such as intelligence;

(2) the person with poor compliance refuses to participate in the tester;

(3) patients with mental diseases; severe visceral diseases.

(4) Patients with malignant tumors.

5. Treatment regimens

(1) The decoction group is as follows:

the prescription comprises 10 g of costustoot (added later), 5 g of fructus amomi (added later), 10 g of bighead atractylodes rhizome, 15 g of prepared fingered citron, 10 g of steamed tangerine peel, 10 g of cooked codonopsis pilosula, 10 g of poria cocos, 5 g of honey-fried licorice root, 5 g of ginger processed pinellia tuber, 10 g of salvia miltiorrhiza, 6 g of sun-dried ginseng (decocted additionally), 15 g of coix seed, 15 g of suberect spatholobus stem, 15 g of Chinese date, 10 g of capillary wormwood herb, 10 g of chicken's gizzard-membrane and 10 g of teasel root.

Decoction: the decoction is decocted in the decoction room of our hospital by using decoction machine produced by effective company of original medical equipment in Beijing Tohua, each dose is concentrated into 150ml per dose, and the decoction is packed into 1 packet in vacuum by a liquid medicine packing machine.

The taking method comprises the following steps: 1 dose per day, and is taken after half an hour after breakfast for 1 month continuously.

(2) The cream formula comprises the following components: see example 3.

Preparing the paste: see example 5.

The taking method of the ointment formula comprises the following steps: the preparation is taken during non-menstrual period, and is stopped taking during menstrual period, and is taken 1 time every day, 30ml each time, and is taken half an hour after breakfast for 1 month continuously.

In the experimental process, the hospital takes corresponding security measures for the invention.

6. Observation index

(1) VAS visual simulation fatigue degree, traditional Chinese medicine syndrome and marquisition integration: the patients were observed and recorded on day 1 post-surgery, day 14 post-surgery, and day 30 post-surgery.

(2) CD4, CD8, CD4+/CD8+ level detection: blood test was performed on day 1 after surgery, day 14 after surgery, and day 30 after surgery.

7. Clinical curative effect

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%.

Eight, 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 comparison

In total 120 patients in hospital are diagnosed as post-operative fatigue syndrome of spleen deficiency syndrome. 57 men and 63 women, 65 years old and 18 years old at minimum, wherein 70 abdominal operations and 50 mammary operations are randomly divided into 2 groups, 60 ointment groups and 60 decoction groups. No significant difference (P > 0.05) was observed between age, disease course and type of surgery in the two groups, indicating that the baseline data in the two groups were equally comparable.

2. Two groups of clinical curative effects

The total effective rate (95.00%) of the plaster formula group is higher than that of the decoction group (91.60%), and the difference has no statistical significance (P is more than 0.05), namely, the curative effects of the two groups are equivalent. See table 1.

TABLE 1 two clinical efficacy comparisons [ n (%) ]

3. VAS visual simulation fatigue degree score comparison before and after two groups of treatment

The VAS visual simulation fatigue degree scores of the two groups of cases on the 1 st day after operation (before treatment) are compared without significant difference (P is more than 0.05), namely the VAS visual simulation fatigue degree scores of the two groups before treatment are proved to be comparable. Compared between the two groups, the VAS visual simulation fatigue degree score on the 14 th day after operation has no significant difference (P is more than 0.05), while the VAS visual simulation fatigue degree score on the 30 th day after operation has the advantage that the paste formula group is significantly lower than the decoction group (P is less than 0.05). Compared with the prior and the post-treatment, the VAS visual simulation fatigue degree scores of the ointment formula group and the decoction group on the 14 th day and the 30 th day after the operation are obviously reduced (P is less than 0.05) compared with the score on the 1 st day after the operation; the VAS visual simulation fatigue degree scores of the ointment group and the decoction group at the 30 th day after the operation are obviously reduced compared with the scores at the 14 th day after the operation (P is less than 0.05). Namely, the two groups can improve the fatigue degree of the postoperative fatigue syndrome patients on the 14 th day after operation and the 30 th day after operation, the curative effect of improving the fatigue degree of the postoperative fatigue syndrome patients on the 14 th day after operation is equivalent, and the curative effect of improving the fatigue degree of the postoperative fatigue syndrome patients on the 30 th day after operation is superior to that of the decoction group. See table 2.

TABLE 2 comparison of VAS visual simulation fatigue degree scores (+ -s) before and after treatment in two groups

4. Comparison of Chinese medicine syndrome and marquis integral before and after two groups of treatment

The traditional Chinese medicine syndrome score (spleen deficiency syndrome) on the 1 st day (before treatment) after the operation of the two groups of cases has no significant difference (P is more than 0.05), which indicates that the traditional Chinese medicine syndrome score of the two groups before treatment has comparability. The comparison of the two groups shows that the traditional Chinese medicine syndrome score has no significant difference (P is more than 0.05) on the 14 th day after operation, while the traditional Chinese medicine syndrome score is more than the decoction group (P is less than 0.05) on the 30 th day after operation. Compared with the prior treatment and the subsequent treatment, the traditional Chinese medicine syndrome score of 14 days after the operation and the traditional Chinese medicine syndrome score of 30 days after the operation of the plaster formula group and the decoction group are both obviously reduced (P is less than 0.05) compared with 1 day after the operation; the Chinese medicine syndrome-hou score of the plaster formula group and the decoction group at the 30 th day after the operation is obviously reduced compared with the Chinese medicine syndrome-hou score of the plaster formula group and the decoction group at the 14 th day after the operation (P is less than 0.05). Namely, the two groups can improve the spleen deficiency syndrome of the postoperative fatigue syndrome patients on the 14 th day after operation and the 30 th day after operation, the curative effect of the two groups on the improvement of the spleen deficiency syndrome of the postoperative fatigue syndrome patients on the 14 th day after operation is equivalent, and the curative effect of the ointment formula group on the improvement of the spleen deficiency syndrome of the postoperative fatigue syndrome patients on the 30 th day after operation is superior to that of the decoction group. See table 3.

TABLE 3 two sets of Hou integration comparisons (± s) of Chinese medicine before and after treatment

5. Comparison of T lymphocytes before and after treatment in both groups

The levels of CD3+, CD4+, CD4+/CD8+ in the two groups were not significantly different (P > 0.05) on day 1 (before treatment) after the operation, which indicates that the T lymphocytes in the two groups before treatment are comparable. Compared between the two groups, the levels of CD3+, CD4+, CD4+/CD8+ on the 14 th day after operation are not significantly different (P is more than 0.05), and the plaster formula group is significantly higher than the decoction group (P is less than 0.05) on the 30 th day after operation. Compared with the ointment and the decoction before and after treatment, the levels of CD3+, CD4+, CD4+/CD8+ on the 14 th day and the 30 th day after the operation of the ointment and the decoction are obviously increased (P is less than 0.05) compared with the level on the 1 st day after the operation; the levels of CD3+, CD4+, CD4+/CD8+ on the 30 th day after operation of the ointment group and the decoction group are obviously increased compared with the level on the 14 th day after operation (P is less than 0.05). Namely, the water average of CD3+, CD4+, CD4+/CD8+ of the two groups is improved compared with that before the treatment on the 14 th day and the 30 th day after the operation, the curative effect of the two groups for improving the CD3+, CD4+, CD4+/CD8+ of the patients on the 14 th day is equivalent, and the curative effect of the ointment group for improving the CD3+, CD4+, CD4+/CD8+ of the patients on the 30 th day after the operation is superior to that of the decoction group. See tables 4-6.

TABLE 4 two sets of CD3+ (+ -s)

TABLE 5 two sets of CD4+ (+ -s)

Table 6 two sets of CD4+/CD8+ comparisons (± s)

(III) conclusion of the study

1. The total effective rate (95.00%) of the postoperative recovery ointment for treating the postoperative fatigue syndrome of the spleen deficiency syndrome is equivalent to the curative effect of the decoction group (91.6%), and the postoperative recovery ointment can improve the clinical symptoms of the postoperative fatigue syndrome of patients.

2. The postoperative recovery ointment and decoction can improve the fatigue degree and spleen deficiency syndrome of postoperative fatigue syndrome patients on the 14 th and 30 th days after operation, the curative effect of improving the fatigue degree and spleen deficiency syndrome of the postoperative fatigue syndrome patients on the 14 th day after operation is equivalent, and the curative effect of improving the fatigue degree and spleen deficiency syndrome of the postoperative fatigue syndrome patients on the 30 th day after operation is superior to that of the decoction.

3. The postoperative recovery ointment and decoction have higher water average before treatment on the 14 th day and the 30 th day after operation, the curative effect of improving the levels of CD3+, CD4+, CD4+/CD8+ of patients on the 14 th day is equivalent, and the curative effect of improving the levels of CD3+, CD4+, CD4+/CD8+ of patients on the 30 th day after operation is superior to that of the decoction.

In conclusion, the postoperative recovery ointment can be used for treating the spleen deficiency postoperative fatigue syndrome, effectively increasing the number of T lymphocytes of a patient, improving the postoperative fatigue degree and the spleen deficiency syndrome of the patient and improving the overall treatment effect of the disease.

Claims

1. A Chinese patent medicine for treating spleen deficiency syndrome postoperative fatigue syndrome is characterized in that: the Chinese patent medicine is prepared from 20-50 g of costustoot, 10-30 g of fructus amomi, 20-50 g of bighead atractylodes rhizome, 30-70 g of prepared fingered citron, 20-50 g of steamed tangerine peel, 20-50 g of cooked codonopsis pilosula, 20-50 g of poria cocos, 10-30 g of honey-fried licorice root, 10-30 g of ginger processed pinellia tuber, 20-50 g of salvia miltiorrhiza, 12-35 g of sun-dried ginseng, 30-70 g of coix seed, 30-70 g of suberect spatholobus stem, 30-70 g of Chinese date, 20-50 g of capillary wormwood herb, 20-50 g of chicken's gizzard-membrane and 20-50 g of teasel root.

2. The Chinese patent medicine of claim 1, wherein: 33-34 g of costustoot, bighead atractylodes rhizome, steamed tangerine peel, cooked codonopsis pilosula, poria cocos, red sage root, capillary wormwood herb, endothelium corneum gigeriae galli and teasel root, 16-17 g of fructus amomi, honey-fried licorice root and ginger processed pinellia tuber, 49-51 g of prepared fingered citron, coix seed, suberect spatholobus stem and Chinese date and 19-21 g of sun-dried ginseng.

3. A Chinese patent medicine for treating spleen deficiency syndrome postoperative fatigue syndrome is prepared by fully mixing a paste formula and a proper amount of pharmaceutic adjuvant which plays a role of forming, wherein the medicinal materials required for preparing each hundred grams of the paste formula are 60 grams of costustoot, 48 grams of fructus amomi, 60 grams of rhizoma atractylodis macrocephalae, 84 grams of prepared fingered citron, 60 grams of steamed tangerine peel, 60 grams of cooked codonopsis pilosula, 60 grams of poria cocos, 48 grams of honey-fried licorice root, 48 grams of ginger processed pinellia tuber, 60 grams of salvia miltiorrhiza, 42 grams of sun-dried ginseng, 84 grams of semen coicis, 84 grams of caulis spatholobi, 84 grams of Chinese date, 84 grams of capillary wormwood herb, 60 grams of endothelium corneum gigeriae galli and 60 grams of teasel root.

4. A preparation method of a Chinese patent medicine for treating spleen deficiency syndrome postoperative fatigue syndrome is characterized by comprising the following steps: the method comprises the following steps:

preparing materials, accurately blending various required medicinal materials according to the prescription recorded in any one of claims 1 to 3, wherein costustoot, fructus amomi and steamed tangerine peel are packaged in another bag, sun-dried ginseng slices are packaged in another bag, other medicinal materials, namely common medicinal materials, weighing and mixing the medicinal materials, and filling the medicinal materials into a non-woven bag for decocting;

step two, soaking: placing the medicinal materials in the non-woven fabric bag in a stainless steel medicine soaking barrel, adding water 6-8 times of the weight of the medicinal materials until the medicinal materials are completely immersed, and soaking in shade at 0-20 deg.C for 8-10 hr to allow water to fully permeate into medicinal material tissue, so as to facilitate dissolution of effective components during decoction of the medicinal materials;

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

(2) decocting medicinal materials containing volatile components: mixing radix aucklandiae, fructus Amomi 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;

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

step seven, collecting paste, namely adding the volatile medicine decoction and the sun-dried ginseng decoction which are filtered in the step five into common medicine concentrated solution, continuing stirring and concentrating until a stirring rod is lifted to see 'flag hanging' or 'dripping water into beads', the relative density is more than or equal to 1.35, and the water content is less than 35%, extinguishing and stopping boiling to obtain a paste formula, and subpackaging the paste formula into containers which are cleaned, sterilized and disinfected while the paste formula is hot;

5. The preparation method of the Chinese patent medicine for treating spleen deficiency syndrome postoperative fatigue syndrome according to claim 4, characterized by comprising the following steps: 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.