CN114344422B - Traditional Chinese medicine composition for preventing and treating postoperative constipation caused by qi and blood deficiency and intestinal dryness and application thereof - Google Patents
Traditional Chinese medicine composition for preventing and treating postoperative constipation caused by qi and blood deficiency and intestinal dryness and application thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for preventing and treating postoperative constipation caused by qi and blood deficiency and intestinal dryness and application thereof, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 15-30 parts of raw astragalus membranaceus, 10-15 parts of angelica sinensis, 6-9 parts of raw rhubarb, 10-15 parts of immature bitter orange, 10-15 parts of mangnolia officinalis, 10-15 parts of rhizoma cyperi, 10-15 parts of achyranthes bidentata, 10-15 parts of semen plantaginis, 10-15 parts of fructus cannabis, 15-20 parts of rice sprout, 15-20 parts of malt and 5-10 parts of liquorice. The traditional Chinese medicine composition is used for treating the pathogenesis of constipation, qi deficiency, blood stasis and blood-less intestinal dryness after the operation in the middle of surgery, and has the effects of tonifying qi, nourishing blood, removing blood stasis, clearing hollow viscera, moistening dryness and regulating qi. Animal experiments prove that the animal model can obviously improve constipation symptoms of a blood deficiency constipation animal model and decrease red blood cells and hemoglobin; clinical experiments prove that the traditional Chinese medicine composition can obviously reduce postoperative constipation symptoms, relieve gastrointestinal discomfort, improve postoperative life quality, is safe and effective in use in the perioperative period, and can improve the satisfaction degree and comfort degree of patients.
Description
Technical Field
The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for preventing and treating postoperative constipation caused by qi and blood deficiency and intestinal dryness and application thereof.
Background
Clinically patients are prone to constipation after surgery because surgery results in slow bowel movements. Research shows that constipation can obviously produce anxiety, depression and other bad emotions besides symptoms such as abdominal distension, abdominal pain, appetite reduction and the like, and seriously affect postoperative rehabilitation. Clinically, constipation is treated by adopting symptomatic treatment methods such as laxatives and the like, adverse reactions such as diarrhea, vomiting and the like are easily caused by excessive cathartics and excessive use, and the risk of electrolyte disorder is generated after operation, so serious people can endanger life. At present, the safety of the traditional Chinese medicine in perioperative period is approved.
Journal literature (Zhang Heyan, wu Bo. Postoperative No. 1 prescription combined rehabilitation exercise promotes postoperative functional rehabilitation of osteoarthritis total knee joint replacement random parallel control research [ J ] practical internal medicine journal of traditional Chinese medicine, 2016,30 (9): 23-25.) discloses that postoperative No. 1 prescription combined rehabilitation exercise can promote postoperative functional rehabilitation of osteoarthritis total knee joint replacement, the curative effect is satisfactory, no serious adverse reaction occurs, and postoperative No. 1 prescription consists of: rhizoma anemarrhenae, radix rehmanniae Preparata, rhizoma Ligustici Chuanxiong, radix Paeoniae alba, atractylodis rhizoma, cortex et radix Polygalae, semen Platycladi, ginseng radix, etc. Journal literature (Chen Huiping. Self-planned postoperative prescription 1 promotes the recovery of the gastrointestinal function after hysterectomy in 54 cases [ J ]. Zhejiang chinese medicine journal 2010 (6): 1.) discloses that postoperative prescription 1 has remarkable curative effect on promoting the early recovery of the gastrointestinal function after hysterectomy, and the prescription medicine comprises the following components: bupleurum, angelica, peach kernel, trichosanthes root each 9g, safflower, pangolin scales, raw licorice, prepared rhubarb each 6g, magnolia officinalis, bitter orange each 10g, and mirabilitum sulfate 3g. Journal literature (Chen Lingzhen. Prescription 1 after combined acupoint massage to promote gastrointestinal function recovery after abdominal gynecology surgery 58 cases [ J ]. Zhejiang traditional Chinese medicine journal, 2013 (4): 1.) discloses a treatment method of oral administration of prescription 1 after combined acupoint massage to promote gastrointestinal function recovery of patients after abdominal gynecology surgery to obtain satisfactory curative effect, and the prescription 1 after surgery comprises the following medicinal components: 10g of magnolia bark and bitter orange respectively, 9g of bupleurum root, angelica, peach kernel and trichosanthes root respectively, 6g of safflower, stir-baked squama manitis, prepared rhubarb and raw liquorice respectively, and 3g of glauber salt. Patent document CN108853457a discloses a traditional Chinese medicine composition for improving postoperative gastrointestinal discomfort symptoms of thyroid cancer patients, which comprises the following components: 12-20g of pinellia ternate, 12-20g of dried orange peel, 10-20g of immature bitter orange, 10-20g of mangnolia officinalis, 10-20g of bamboo shavings, 12-20g of poria cocos, 12-20g of bighead atractylodes rhizome, 15-25g of Chinese yam, 20-30g of coix seed, 5-12g of rheum officinale, 5-12g of coptis chinensis, 3-6g of fructus amomi, 20-30g of endothelium corneum gigeriae galli, 20-30g of hawthorn, 20-30g of medicated leaven, 20-30g of malt, 10-30g of astragalus membranaceus, 10-25g of angelica sinensis, 10-25g of radix paeoniae alba, 12-20g of radix curcumae, 12-20g of rhizoma cyperi, 12-20g of radix bupleuri, 12-20g of cortex moutan, 12-20g of cape jasmine, 15-25g of selfheal, 10-15g of dried ginger and 10-20g of liquorice.
However, the traditional Chinese medicine composition with remarkable curative effect on constipation caused by postoperative qi and blood deficiency and intestinal dryness has not been reported yet.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for preventing and treating postoperative constipation caused by qi and blood deficiency and intestinal dryness, aiming at the defects in the prior art.
The invention further aims to provide application of the traditional Chinese medicine composition.
In order to realize the first purpose, the invention adopts the technical scheme that:
a traditional Chinese medicine composition for preventing and treating constipation caused by postoperative qi and blood deficiency and intestinal dryness is prepared from the following raw material medicines in parts by weight: 15-30 parts of raw astragalus membranaceus, 10-15 parts of angelica sinensis, 6-9 parts of raw rhubarb, 10-15 parts of immature bitter orange, 10-15 parts of mangnolia officinalis, 10-15 parts of rhizoma cyperi, 10-15 parts of achyranthes bidentata, 10-15 parts of semen plantaginis, 10-15 parts of fructus cannabis, 15-20 parts of rice sprout, 15-20 parts of malt and 5-10 parts of liquorice.
As a preferred example of the invention, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 15-20 parts of raw astragalus membranaceus, 11-13 parts of angelica sinensis, 6-7 parts of raw rhubarb, 11-13 parts of immature bitter orange, 11-13 parts of mangnolia officinalis, 11-13 parts of rhizoma cyperi, 11-13 parts of radix achyranthis bidentatae, 11-13 parts of semen plantaginis, 11-13 parts of fructus cannabis, 15-16 parts of rice sprout, 15-16 parts of malt and 5-7 parts of liquorice.
More preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 18 parts of raw astragalus root, 12 parts of angelica, 6 parts of raw rhubarb, 12 parts of immature bitter orange, 12 parts of officinal magnolia bark, 12 parts of nutgrass galingale rhizome, 12 parts of twotooth achyranthes root, 12 parts of plantain seed, 12 parts of hemp seed, 15 parts of rice sprout, 15 parts of malt and 6 parts of liquorice.
As another preferred example of the present invention, the Chinese medicinal composition further comprises a pharmaceutically conventional carrier.
More preferably, the pharmaceutically conventional carriers include emulsifiers, fillers, binders, humectants, disintegrants, absorption enhancers, flavoring agents, coloring agents, co-solvents.
As another preferable example of the present invention, the formulation of the Chinese medicinal composition is decoction, pill, tablet, mixture, capsule, granule, powder, paste or wine.
In order to achieve the second object, the invention adopts the technical scheme that:
the application of the traditional Chinese medicine composition in preparing a medicine for preventing and treating postoperative constipation.
As a preferred example of the invention, the postoperative constipation is constipation caused by deficiency of qi and blood and intestinal dryness after operation.
The invention has the advantages that:
the traditional Chinese medicine composition is a clinical proved formula, and raw astragalus and angelica in the formula have the effects of tonifying qi, activating blood and nourishing blood; radix et rhizoma Rhei and fructus Aurantii Immaturus for removing blood stasis and clearing hollow viscera, and guiding downward to remove food stagnation; cyperus rotundus and magnolia officinalis move qi and stagnation; semen plantaginis can induce diuresis and drain dampness; fructus Cannabis has effects of moistening dryness, relaxing bowels, and tonifying deficiency; the rice sprout and the malt have the functions of tonifying spleen and promoting appetite; achyranthes root, radix achyranthis bidentatae dispels stasis and promotes menstruation, draws blood downward, is tangential to the pathogenesis of constipation, qi deficiency, blood stasis and blood deficiency and intestinal dryness after middle-jiao operation, and liquorice coordinates the various drugs to play a role in tonifying qi, nourishing blood, removing stasis, clearing hollow viscera, moistening dryness and regulating qi. Animal experiments prove that the traditional Chinese medicine composition can obviously improve the constipation symptom of a blood deficiency constipation animal model and the reduction of red blood cells and hemoglobin. Clinical experiments prove that the traditional Chinese medicine composition can obviously reduce postoperative constipation symptoms, relieve gastrointestinal discomfort, improve postoperative life quality, is safe and effective in perioperative use, and can improve the satisfaction degree and comfort degree of patients.
Drawings
FIG. 1 is a schematic study flow chart of the clinical trial of example 19.
Detailed Description
The following detailed description of the present invention will be made with reference to the accompanying drawings.
Example 1 preparation of decoction of the Chinese medicinal composition of the present invention
Weighing the following raw material medicines in parts by weight: 15 parts of raw astragalus root, 10 parts of angelica, 9 parts of raw rhubarb, 15 parts of immature bitter orange, 10 parts of officinal magnolia bark, 10 parts of nutgrass galingale rhizome, 15 parts of twotooth achyranthes root, 15 parts of plantain seed, 10 parts of fructus cannabis, 15 parts of rice sprout, 20 parts of malt and 10 parts of liquorice, crushing, adding a proper amount of water, and decocting by a conventional method.
Example 2 preparation of decoction of the Chinese medicinal composition of the present invention
Weighing the following raw material medicines in parts by weight: 30 parts of raw astragalus, 10 parts of angelica, 6 parts of raw rhubarb, 10 parts of immature bitter orange, 15 parts of magnolia officinalis, 15 parts of rhizoma cyperi, 15 parts of achyranthes root, 10 parts of plantain seed, 10 parts of fructus cannabis, 15 parts of rice sprout, 20 parts of malt and 10 parts of liquorice, crushing, adding a proper amount of water, and decocting by a conventional method.
Example 3 preparation of decoction of the Chinese medicinal composition of the present invention (III)
Weighing the following raw material medicines in parts by weight: 30 parts of raw astragalus root, 10 parts of angelica, 9 parts of raw rhubarb, 10 parts of immature bitter orange, 15 parts of officinal magnolia bark, 10 parts of nutgrass galingale rhizome, 15 parts of twotooth achyranthes root, 10 parts of plantain seed, 15 parts of hemp seed, 15 parts of rice sprout, 20 parts of malt and 5 parts of liquoric root, crushing, adding a proper amount of water, and decocting by a conventional method.
Example 4 preparation of decoction of the Chinese medicinal composition of the present Invention (IV)
Weighing the following raw material medicines in parts by weight: 30 parts of raw astragalus root, 15 parts of angelica, 9 parts of raw rhubarb, 10 parts of immature bitter orange, 10 parts of officinal magnolia bark, 10 parts of nutgrass galingale rhizome, 15 parts of twotooth achyranthes root, 15 parts of plantain seed, 15 parts of hemp seed, 15 parts of rice sprout, 15 parts of malt and 5 parts of liquoric root, crushing, adding a proper amount of water, and decocting by a conventional method.
Example 5 preparation of decoction of the Chinese medicinal composition of the present invention (V)
Weighing the following raw material medicines in parts by weight: 15 parts of raw astragalus root, 15 parts of angelica, 6 parts of raw rhubarb, 15 parts of immature bitter orange, 10 parts of officinal magnolia bark, 15 parts of nutgrass galingale rhizome, 10 parts of twotooth achyranthes root, 15 parts of plantain seed, 10 parts of hemp seed, 20 parts of rice sprout, 15 parts of malt and 10 parts of liquoric root, crushing, adding a proper amount of water, and decocting by a conventional method.
Example 6 preparation of decoction of the Chinese medicinal composition of the present invention (six)
Weighing the following raw material medicines in parts by weight: 30 parts of raw astragalus, 15 parts of angelica, 6 parts of raw rhubarb, 10 parts of immature bitter orange, 15 parts of officinal magnolia bark, 15 parts of nutgrass galingale rhizome, 10 parts of twotooth achyranthes root, 15 parts of plantain seed, 10 parts of hemp seed, 20 parts of rice sprout, 15 parts of malt and 10 parts of liquorice, crushing, adding a proper amount of water, and decocting by a conventional method.
Example 7 preparation of decoction of the Chinese medicinal composition of the present invention (seven)
Weighing the following raw material medicines in parts by weight: 30 parts of raw astragalus root, 15 parts of angelica, 6 parts of raw rhubarb, 10 parts of immature bitter orange, 15 parts of officinal magnolia bark, 15 parts of nutgrass galingale rhizome, 10 parts of twotooth achyranthes root, 10 parts of plantain seed, 15 parts of fructus cannabis, 20 parts of rice sprout, 15 parts of malt and 5 parts of liquoric root, crushing, adding a proper amount of water, and decocting by a conventional method.
Example 8 preparation of decoction of the Chinese medicinal composition of the present invention (eight)
Weighing the following raw material medicines in parts by weight: 18 parts of raw astragalus root, 12 parts of angelica, 6 parts of raw rhubarb, 12 parts of immature bitter orange, 12 parts of officinal magnolia bark, 12 parts of nutgrass galingale rhizome, 12 parts of twotooth achyranthes root, 12 parts of plantain seed, 12 parts of hemp seed, 15 parts of rice sprout, 15 parts of malt and 6 parts of liquoric root, crushing, adding a proper amount of water, and decocting by a conventional method.
Example 9 preparation of decoction of the Chinese medicinal composition of the present invention (nine)
Weighing the following raw material medicines in parts by weight: 20 parts of raw astragalus, 13 parts of angelica, 6 parts of raw rhubarb, 11 parts of immature bitter orange, 13 parts of officinal magnolia bark, 13 parts of nutgrass galingale rhizome, 11 parts of twotooth achyranthes root, 11 parts of plantain seed, 13 parts of hemp seed, 16 parts of rice sprout, 15 parts of malt and 5 parts of liquoric root, crushing, adding a proper amount of water, and decocting by a conventional method.
Example 10 preparation of decoction of the Chinese medicinal composition of the present invention (ten)
Weighing the following raw material medicines in parts by weight: 15 parts of raw astragalus root, 13 parts of angelica, 6 parts of raw rhubarb, 13 parts of immature bitter orange, 11 parts of officinal magnolia bark, 13 parts of nutgrass galingale rhizome, 11 parts of twotooth achyranthes root, 13 parts of plantain seed, 11 parts of hemp seed, 16 parts of rice sprout, 15 parts of malt and 7 parts of liquoric root, crushing, adding a proper amount of water, and decocting by a conventional method.
Example 11 preparation of decoction of the Chinese medicinal composition of the present invention (eleven)
Weighing the following raw material medicines in parts by weight: 20 parts of raw astragalus, 13 parts of angelica, 7 parts of raw rhubarb, 11 parts of immature bitter orange, 11 parts of officinal magnolia bark, 11 parts of nutgrass galingale rhizome, 11 parts of twotooth achyranthes root, 11 parts of plantain seed, 13 parts of hemp seed, 16 parts of rice sprout, 16 parts of malt and 5 parts of liquoric root, crushing, adding a proper amount of water, and decocting by a conventional method.
Example 12 preparation of decoction of the Chinese medicinal composition of the present invention (twelve)
Weighing the following raw material medicines in parts by weight: 20 parts of raw astragalus root, 13 parts of angelica, 7 parts of raw rhubarb, 11 parts of immature bitter orange, 11 parts of officinal magnolia bark, 11 parts of nutgrass galingale rhizome, 11 parts of twotooth achyranthes root, 13 parts of plantain seed, 11 parts of hemp seed, 16 parts of rice sprout, 15 parts of malt and 7 parts of liquoric root, crushing, adding a proper amount of water, and decocting by a conventional method.
EXAMPLE 13 preparation of the Chinese medicinal composition of the present invention
Weighing the raw materials according to the weight part ratio of any one of embodiments 1-12, mixing, crushing, adding 8 times and 10 times of water, decocting twice for 1 hour each time, filtering respectively, combining the filtrates, concentrating to a relative density of 1.20 (80-85 ℃), cooling, adding 3 times of ethanol, stirring, standing, filtering the supernatant, steaming the filtrate without alcohol smell, standing, and concentrating the supernatant; adding appropriate pharmaceutical adjuvants (white sugar, mel, benzyl propionic acid or ethylparaben, etc.), and making into mixture.
EXAMPLE 14 preparation of pellets of the Chinese medicinal composition of the present invention
Weighing the raw materials according to the weight part ratio of any one of the embodiments 1 to 12, crushing the raw materials into fine powder, and sieving the fine powder with a 80-mesh sieve for later use; weighing a certain amount of honey, heating the honey in an evaporation pan until the honey is boiled (if impurities exist, filtering the honey), continuously refining the honey to obtain refined honey, and fishing out floating foams; mixing refined honey and medicinal powder at a ratio of 1:1, and mixing thoroughly; placing the well-mixed dough-like soft material for a certain time; the pills are manually made into smooth and spherical pills and are wrapped by wax paper.
EXAMPLE 15 preparation of the powder of the Chinese medicinal composition of the present invention
Weighing the raw materials according to the weight part ratio of any one of embodiments 1-12, mixing, crushing into fine powder, sieving with a 80-mesh sieve, and packaging with wax paper.
EXAMPLE 16 preparation of the paste of the Chinese medicinal composition of the present invention
Weighing the raw materials according to the weight part ratio of any one of embodiments 1-12, mixing, crushing, adding 8 times and 10 times of water, decocting twice for 1 hour each time, filtering respectively, combining the filtrates, concentrating to a relative density of 1.20 (80-85 ℃), cooling, adding 3 times of ethanol, stirring, standing, filtering the supernatant, steaming the filtrate without alcohol smell, standing, concentrating the supernatant under reduced pressure to obtain an extract, dripping the extract on mulberry paper without water seepage, and sealing in a sterile bottle.
EXAMPLE 17 preparation of the Chinese medicinal composition of the present invention
Weighing the raw materials according to the weight part ratio of any one of embodiments 1-12, mixing, crushing, putting the raw materials and 8 times of white spirit in a closed container, soaking at room temperature, stirring regularly, soaking for 15 days, taking supernatant, squeezing dregs of a decoction, mixing squeezed liquid and the supernatant, stirring uniformly, standing for settling for 12 days, filtering, filling the filtrate in a dry and clean container, and sealing to obtain the traditional Chinese medicine composition.
EXAMPLE 18 animal testing of the Chinese medicinal composition of the present invention
1 materials and methods
1.1 animals
SPF-level Kunming mice, with a body mass of 30 + -2 g and half female and half male, were purchased from Shanghai Si Laike laboratory animals, inc. Animals were acclimatized for 1 week prior to the experiment.
1.2 drugs
The traditional Chinese medicine composition comprises the following components: weighing 18 parts of raw astragalus root, 12 parts of angelica, 6 parts of raw rhubarb, 12 parts of immature bitter orange, 12 parts of officinal magnolia bark, 12 parts of nutgrass galingale rhizome, 12 parts of twotooth achyranthes root, 12 parts of plantain seed, 12 parts of fructus cannabis, 15 parts of rice sprout, 15 parts of malt and 6 parts of liquorice according to the parts by weight, crushing, adding 10 times of water for decocting for 2 times, each time for 1 hour, combining the filtrates and concentrating.
Postoperative side 1: weighing 9 parts of radix bupleuri, angelica sinensis, peach kernel and radix trichosanthis, 6 parts of safflower, stir-baked squama manitis, raw liquorice and prepared rhubarb, 10 parts of magnolia officinalis and bitter orange respectively according to the parts by weight, adding 10 times of water, decocting for 2 times, 1 hour each time, merging filtrate, adding 3 parts of glauber salt, mixing uniformly and concentrating.
The contrast traditional Chinese medicine composition I: weighing 18 parts of raw astragalus root, 12 parts of angelica, 6 parts of raw rhubarb, 12 parts of immature bitter orange, 12 parts of magnolia officinalis, 12 parts of nutgrass galingale rhizome, 12 parts of twotooth achyranthes root, 12 parts of plantain seed, 12 parts of fructus cannabis, 15 parts of malt and 6 parts of liquorice according to the parts by weight, crushing, adding 10 times of water, decocting for 2 times, each time for 1 hour, combining filtrates, and concentrating.
A control traditional Chinese medicine composition II: weighing 20 parts of raw astragalus root, 20 parts of angelica, 6 parts of raw rhubarb, 12 parts of immature bitter orange, 12 parts of magnolia officinalis, 12 parts of nutgrass galingale rhizome, 12 parts of twotooth achyranthes root, 12 parts of plantain seed, 12 parts of fructus cannabis, 10 parts of rice sprout, 10 parts of malt and 6 parts of liquorice according to the parts by weight, crushing, adding 10 times of water, decocting for 2 times, each time for 1 hour, combining the filtrates, and concentrating.
1.3 Main instruments
Mythic22 full-automatic blood cell analyzer, sartorius BL310 electronic balance, DZLW-s-b constant temperature water bath.
1.4 grouping, molding and administration
Mice were randomly divided into 6 groups, including a normal control group, a model control group, a treatment group with the traditional Chinese medicine of the present invention, a treatment group with the postoperative formula No. 1, a treatment group with the control traditional Chinese medicine one, and a treatment group with the control traditional Chinese medicine two, each group containing 10 mice. Except for the normal control group, the other groups were subjected to blood deficiency constipation model mouse modeling. Adopting tail-breaking bloodletting method in the first 2 weeks, disinfecting the tail tip part of the mouse with 75% alcohol, cutting off 2mm tail tip, and immersing in 38 deg.C constant temperature water bath for bloodletting for 3min. Starting at week 3, orbital sinus phlebotomy was performed by bleeding about 0.6mL with 20. Mu.l capillary pipette each time, 1 time per week, and gavage with loperamide hydrochloride at a dose of 3.0mg/kg, l times per day for 4 weeks based on the exsanguination. After the modeling is finished, the mice of each administration group are respectively administered with corresponding drugs for intragastric administration, the dose is 1g crude drug/kg, and the normal control group and the model control group are infused with equal volume of distilled water. Daily for 2 weeks 1 time.
1.5 Observation index
The stool character, hair color, lip color, mental state and the like of each group of mice are observed during the experiment period, after the last administration for 60min, each group of mice are fasted for 12h, and are perfused with 10% carbon powder suspension, after 20min, each group of mice orbit veins Dou Caixie are subjected to erythrocyte count (RBC) and Hemoglobin (HGB) content measurement, then the mice are killed by dislocation of cervical vertebrae, intestinal canals from pylorus to ileocecal region are picked, the carbon powder propelling distance is measured, and the small intestine propelling rate is calculated.
1.6 statistical methods
The data was processed using SPSS 25.0 statistical software to
Showing that the comparison among a plurality of groups adopts one-factor variance analysis, and the subsequent two-by-two comparison of variance adopts an LSD method, P<0.05 indicates that the difference is statistically significant.
2 results
2.1 general conditions in mice
Normal control mice had ruddy lips and paws and normal defecation. The lips and the claws of the mice of the other groups are whitish after the model is made, the defecation amount is reduced compared with that of a normal control group, the stool quality is hard, the lips and the claws of the mice of each administration group are improved after the administration is finished compared with those of the mice of the model group before the administration, and the stool amount and the stool quality are also improved.
2.2 groups of mice RBC and HGB comparison
The results are shown in table 1, and it can be seen that RBC and HGB of the model group mice are significantly reduced (P < 0.01) compared to the normal control group mice, indicating that the model group mice have blood deficiency syndrome. Compared with the model group, the RBC and HGB of the mice in each administration group are obviously increased (P is less than 0.05 or P is less than 0.01), and the mice have obvious effect on improving blood deficiency syndrome, wherein the RBC and HGB of the mice in the traditional Chinese medicine treatment group are obviously higher than those of the other administration groups (P is less than 0.05 or P is less than 0.01), and reach the level of the mice in the normal model group (P is more than 0.05).
TABLE 1 comparison of RBC and HGB in groups of mice: (
n＝10)/>
Compared with the normal control group, * P＜0.05， ** p is less than 0.01; in comparison with the set of models, # P＜0.05， ## p is less than 0.01; compared with the traditional Chinese medicine treatment group of the invention, △ P＜0.05， △△ P＜0.01。
2.3 Effect of the rate of intestinal Propulsion in groups of mice
As a result, as shown in Table 2, it was found that the intestinal transit rate was significantly decreased in the model group mice as compared with that in the normal group mice (P < 0.01), indicating the occurrence of constipation. The intestinal propulsion rate of mice in each administration group is improved compared with that in the model group, and the intestinal propulsion rate of the mice in other administration groups except the postoperative No. 1 square group has statistical significance (P is less than 0.01) compared with that in the model group. Wherein, the intestinal propulsion rate of the mice in the traditional Chinese medicine treatment group is obviously higher than that of the other administration groups (P is less than 0.01).
TABLE 2 comparison of Small intestine Processingefficiencies in groups: (
n＝10)
Compared with the normal control group, ** p is less than 0.01; in comparison with the set of models, ## p is less than 0.01; compared with the traditional Chinese medicine treatment group of the invention, △△ P＜0.01。
EXAMPLE 19 clinical trials of the Chinese medicinal composition of the present invention
1 materials and methods
1.1 study objects and groups
According to the clinical observation of the constipation rate after hip and knee joint replacement is about 50%, taking alpha =0.05,1-beta =0.8 and the threshold value = -0.15, and performing bilateral test, calculating the sample size to be n =100 (Power = 0.8038) by using Pearson chi-square test. 120 patients with hip walking and constipation after knee replacement in joint orthopedic surgery of Guanghua Hospital, shanghai university of medicine, 1 month to 2021 month, 8 months are selected, the patients are randomly divided into a traditional Chinese medicine group (n = 60) and a control group (n = 60) by an SPSS software random number generator, and a research scheme is designed according to random, single-blind and parallel controls (figure 1). The study was terminated early due to temporary discharge, non-scheduled medication, rejection of traditional Chinese medicines, etc., 3 patients (2 traditional Chinese medicines, 1 control group) were dropped, and a total of 117 patients finally completed the study, the traditional Chinese medicine group (n = 58) and the control group (n = 59).
1.2 inclusion, exclusion, termination criteria (Table 3)
TABLE 3. Inclusion, exclusion, termination criteria
1.3 diagnostic criteria
Western diagnostic standard according to Roman IV diagnostic standard [1] (hard feces or dry feces, which makes defecation hard, makes defecation endless, makes anus and rectum block during defecation, and needs manipulation assistance), two or more items can be diagnosed. The standard for diagnosing the syndrome of traditional Chinese medicine refers to the "guiding principles of clinical research on new Chinese medicines [2] The principal symptoms are dry stool, difficult defecation and abdominal distension, and the secondary symptoms are inappetence, soreness and weakness of waist and knees, dizziness, dry throat, pale or reddish tongue, and deep, wiry or weak pulse. The main symptoms are necessary, the secondary symptoms are two, and the diagnosis can be carried out when the score value is more than 6.
1.4 treatment regimens
Planning before operation: according to the perioperative period scheme of the joint orthopedic surgery in our hospital, all patients are taught before the operation, so that the mood is kept smooth, and the states of tension and anxiety are reduced. The diet after operation is uniformly distributed by the nutrition department with high fiber diet, and each person drinks 1.5-2.0L of water every day. The operation mode and the medication plan are executed by the same group of doctors and teams according to the same standard, the blind method is mainly used for blinding the patients, and the traditional Chinese medicine and the western medicine are not informed to have the function of relaxing the bowels when being used. All patients in the group are integrally evaluated before operation, and the diet and the defecation condition of the patient are collected at the 2d after operation and are included into the tested patient according to the inclusion standard.
Intervention scheme: the traditional Chinese medicine is the traditional Chinese medicine composition of the invention, which is prepared by the traditional Chinese medicine preparation department of Guanghua Hospital affiliated to Shanghai Chinese medicine university: 18g of raw astragalus root, 12g of angelica, 6g of raw rhubarb, 12g of immature bitter orange, 12g of officinal magnolia bark, 12g of nutgrass galingale rhizome, 12g of twotooth achyranthes root, 12g of plantain seed, 12g of hemp seed, 15g of rice sprout, 15g of malt and 6g of liquorice, wherein each bag is 200ml and is used for 2 times a day. The control group was given 15ml of lactulose oral liquid (Abbott Biologicals B.V, lot No.: 363066) three times daily. The study was approved by the ethical committee of the Guanghua Hospital, university of medicine, shanghai, and registered in the Chinese clinical laboratory registry (ChiCTR 2100051629).
1.5 Observation index
The main observation indexes are as follows: evaluation of patient Constipation Primary symptom score criteria after operation 2, 9d [3] (Table 4) including Bristol Stool Scale (BSFS) Stool classification, defecation time, defecation frequency, abdominal distension, defecation difficulty and sense of anal plumpness, average number of spontaneous complete defecations per week (SCBM), and the number of SCBM > 3 is currently considered as normal defecation.
Secondary indexes are as follows: a Constipation Patient symptom self-rating scale (PAC-SYM) is a living quality condition score and comprises stool traits (2 items), rectal Symptoms (7 items) and abdominal Symptoms (3 items), 5 severity grades are divided by 0-4 according to a Likert grade 5 scoring method, and the higher the score is, the poorer the quality of life is indicated. Chinese medicine syndrome score quoted' guiding principle of clinical research of new Chinese medicine [3] The entry is made into a qi and blood deficiency and intestine dryness syndrome scale which comprises 4 grades (0, 2, 4 and 6 grades) of main symptoms (dry stool, difficult defecation, abdominal distension and inappetence); secondary symptoms (dizziness, shortness of breath, no speaking, dry throat), no, light, medium and heavy at 4 (0, 1, 2, 3 points); tongue pulse (pale or light red tongue, deep and thready or weak pulse, thin or pale tongue coating),with or without (0 min, 1 min).
The safety index is as follows: the basic vital signs, liver and kidney functions (AST, ALT and Cr), the routine hematuria and fecal history and adverse reactions (vomiting, diarrhea and the like) of the testee before and after intervention are recorded. After the occurrence of the drug-related adverse reaction, the termination criteria were followed.
TABLE 4 Constipation chief symptom score criteria
1.6 therapeutic efficacy criteria
The main curative effect indexes are as follows: the treatment effect of the patient is divided into clinical healing (symptom disappears), obvious effect (> 2 level), effective (> 1 level), ineffective (no improvement in level) 4 and the like according to the symptom improvement level. And statistically analyzing the scores according to the defecation situation of the patients in the research period.
Secondary efficacy index: the traditional Chinese medicine syndrome scoring adopts a nimodipine method [1] And calculating the ratio of the integral difference before and after traditional Chinese medicine intervention to the integral before intervention, and dividing the ratio into 4 grades of clinical recovery (more than or equal to 95%), obvious effect (70% -94%), effective effect (30% -69%) and ineffective effect (less than 30%).
1.7 statistical analysis
Data were collected and collated by the subjects groups without participation in the experimenters, and data analysis was performed using the IBM SPSS Statistics 25. The composition ratio between the two groups is compared by Pearson X2 test, the measurement data conforming to normal distribution is tested by t test, the measurement data not conforming to normal distribution is tested by nonparametric test (Wilcoxon-Mann-Whitney U test), and the measurement data is tested by mean plus standard deviation
It is shown that the grade data are tested by rank sum test (Kruskal-Wallis H test), and that P values less than 0.05 are statistically significant.
2 results
2.1 Baseline data
The baseline data of the traditional Chinese medicine and the control group, such as general conditions, operation modes, perioperative medication and the like, are not different and have comparability (Table 5).
Table 5. Baseline data (e.g.,
)/>
note: a, t testing; b, pearson χ 2 Checking; c, fisher exact probability method; * P is less than 0.05;
2.2 Observation and safety indices
Compared with a control group, the average degree of defecation after the treatment of the patient is 0.38, the average degree of anal pendant expansion is 0.33, the average degree of defecation time is 0.23, and the average score is 0.92; PAC-SYM reduces stool symptom by 1.23 points averagely, rectum symptom by 4.6 points averagely, abdomen symptom by 7.11 points averagely, and average score by 7.11 points; SCBM increased 1.85 times on average, chinese medicine syndrome score decreased 6.82 points on average, and the above two groups scored before and after treatment with statistical difference (95% CI, P < 0.05); there were no statistical differences in the major indices of liver and kidney function (table 6, table 7). After the grade curative effect evaluation of the main symptoms of constipation, the total effective rate of the traditional Chinese medicine is 86.1 percent, the control group is 78.2 percent, and the difference has statistical significance (x 2=15.736, 95 percent CI, P < 0.001); each individual index was compared between the two groups by U-test and was statistically different (95% CI, P < 0.05) (Table 8).
TABLE 6 Primary symptom score (
95％CI)
Note: a, comparing the average scores of two groups before treatment by a t test; b, comparing the average scores of the two groups after treatment by a t test; p < 0.05;
TABLE 7 Secondary symptom score (C) ((C))
95％CI)
Note: a, comparing the average scores of two groups before treatment by a t test; b, comparing the average scores of the two groups after treatment by a t test; p < 0.05;
TABLE 8 Primary symptom treatment Rate (example,%)
Note: a, through pearsonX 2 Checking, comparing between two groups, wherein p is less than 0.001; h test shows that the comparison P between two groups is less than 0.05;
discussion of 3
The whole-course painless perioperative period of hip and knee joint replacement is an important part in the field of rapid rehabilitation [4] . Tan and other researches show that postoperative pain can not be effectively controlled, postoperative rehabilitation is obviously influenced, postoperative complications and chronic pain risks are obviously increased, and life quality and psychological health are also greatly influenced [5] . The analgesic regimen has a greater impact on postoperative constipation. Advanced analgesia is adopted, fasting before general anesthesia operation, combined use of a plurality of anesthetic drugs in the operation, local injection of cocktail, and whole-course analgesia within 48 hours after operation (especially a self-control analgesia pump which takes a drug of a class A as a main drug) [6] ) This is an important factor for the occurrence of constipation after operation [7] . Research shows that the opioid drug can act on opioid receptors of the intestinal nervous system and block the neuron-mediated intestinal tract function [8] Inhibiting gastrointestinal tract normal rhythmic activity and glandular secretion [9][10] . The postoperative gastrointestinal peristalsis is reduced, the intestinal emptying time is prolonged, the functional recovery is retarded, the absorption of intestinal fluid is reduced, the appetite is often reduced, the nutritional state is poor, the postoperative recovery is seriously influenced, and the health is prolongedThe recurrent period obviously increases the perioperative complication risk of the elderly patients [11] . And the physiological stimulation of the gastrointestinal tract is reduced because the wound of the postoperative patient is not healed and the patient lacks the activity under the bed, which is also the cause of the postoperative constipation. Under the guidance of the rapid rehabilitation theory, although the time for a patient to lie in bed can be obviously reduced and the time for the patient to go to the ground for movement can be accelerated, the occurrence of postoperative constipation can not be effectively prevented [12] Clinically, constipation is resolved only by means of AGA/EAPC recommendation [13] There are many potential risks, and the treatment scheme is not good in curative effect and safety [14] 。
Based on the differential treatment and clinical experience of the traditional Chinese medicine, the doctor of the Chinese zodiac ripple owner of the inventor summarizes the No. 1 prescription after the traditional Chinese medicine operation. Raw astragalus and angelica in the formula have the effects of tonifying qi, activating blood and nourishing blood; radix et rhizoma Rhei and fructus Aurantii Immaturus for removing blood stasis and clearing hollow viscera, and guiding downward to remove food stagnation; cyperus rotundus and magnolia officinalis move qi and stagnation; the plantain seeds induce diuresis and drain dampness; fructus Cannabis has effects of moistening dryness, relaxing bowels, and tonifying deficiency; the rice sprouts and the malt have the functions of tonifying spleen and promoting appetite; achyranthes root, radix achyranthis bidentatae dispels stasis and promotes menstruation, draws blood downward, is tangential to the pathogenesis of constipation, qi deficiency, blood stasis and blood deficiency and intestinal dryness after middle-jiao operation, and liquorice coordinates the various drugs to play a role in tonifying qi, nourishing blood, removing stasis, clearing hollow viscera, moistening dryness and regulating qi.
The research adopts a random, single-blind and parallel comparison method, uses indexes such as BSFS, defecation time, defecation frequency, abdominal distension, defecation labor waste and anus plumpness, SCBM, PAC-SYM, traditional Chinese medicine syndrome score and the like, quantifies the defecation difficulty of the constipation patients after the operation from the main symptoms, the secondary symptoms, the life quality, the functional recovery and other multi-degrees of the constipation, and combines the pathogenesis of qi deficiency and blood stasis after the operation and the blood deficiency and intestinal dryness as well as the overall view and the diagnosis and treatment thought of the traditional Chinese medicine. The results show that compared with the control group, the traditional Chinese medicine group patients have obvious improvement on defecation difficulty, anus plumpness and defecation time. PAC-SYM is a scale developed by Mapi Research Trust to assess symptoms and severity in constipation patients [15] The mean reduction of PAC-SYM after 7 days of treatment was 7.11 points, the differences being statistically significant (P)<0.05 Shows that the traditional Chinese medicine can obviously relieve the constipation symptom, improve the life quality and is superior to a control group. The average increase of SCBM after treatment is 1.85 times, the ratio of more than or equal to 3 times is 86.1 percent and is obviously higher than that of a control group (P)<0.05). The average score of the traditional Chinese medicine syndrome is reduced by 6.82 points,the clinical cure rate is 43.9 percent and is superior to the control group by 32.2 percent (P)<0.05 Indicating that the recovery of the general symptoms of the postoperative patients is better than that of the control group. The safety indexes show no statistical difference and are all in a normal range, which indicates that the traditional Chinese medicine has no obvious influence on the functions of liver and kidney.
After the medicine is used, the daily defecation frequency of a patient has no statistical difference compared with the prior defecation frequency, and a symptom self-rating scale (PAC-SYM) of a constipation patient is combined, so that the traditional Chinese medicine composition is not only similar to the effect of a cathartic and is simple and mechanical to increase the defecation frequency, but also improves the gastrointestinal tract function of the patient on the whole, which is the embodiment of the whole observation of the traditional Chinese medicine, and the specific mechanism for correcting the whole postoperative state and improving the constipation symptom still needs to be further researched.
In conclusion, the traditional Chinese medicine composition can obviously reduce postoperative constipation symptoms, relieve gastrointestinal discomfort and improve postoperative life quality, and is safe and effective in perioperative use. The traditional Chinese medicine intervened in the perioperative period of the orthopaedics is an innovation point of a traditional Chinese and western medicine combined rapid rehabilitation theory, the characteristics of traditional Chinese medicine symptoms in the perioperative period of the orthopaedics are fully excavated, treatment is carried out based on syndrome differentiation, and the satisfaction degree and the comfort degree of a patient can be improved.
Reference documents:
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[2] zheng Xiaoyu, ed, new edition of guidelines for clinical research of new drugs in Chinese medicine [ M ], published by Chinese medicine science and technology, 2002, 5.
[3] The Chinese medical society of traditional Chinese medicine, spleen and stomach diseases, constipation, and the consensus of traditional Chinese medicine diagnosis and treatment experts (2017) [ J ]. J: 2017, 58 (15): 1348.
[4]Husted H,Jensen CM,Solgaard S,et al.Reduced length of stay following hip and knee arthroplasty in Denmark 2000-2009:from research to implementation.Arch Orthop Trauma Surg,2012,132(1):101-104.
[5]Tan M,Law LS,Gan TJ.Optimizing pain management to facilitate enhanced recoery after surgery pathways[J]Can J Anaesth,2015,62(2):203-218.
[6] zhang Xuezhe, wang Wenping, wang Ning clinical study of the paste, TONGBIANYI, for the treatment of opioid-related constipation [ J ]. Chinese journal of pharmacy, 2021,39 (06): 179-183.
[7]Blot Ella,Raz Merlita,Withall Jennifer,Link Lauren,Rich Ellen.The Effectiveness of a Senokot Cocktail for Postoperative Constipation.[J].Orthopedic nursing,2021,40(3).
[8]FARMER A D,HOLT C B,DOWNES T J,et al.Pathophysiology,diagnosis,and management of opioid-induced constipation[J].Lancet Gastroenterol Hepatol,2018,3(3):203-212.
[9] Cui Shiyun. Experts in adverse drug reactions to analgesia, consensus [ J ]. J. Electronic journal of tumor metabolism and nutrition, 2021,8 (02): 139-143.
[10]GY AW ALI B,HAY ASHI N,TSUKUURA H,et al.Opioid-induced constipation[J].Scand J Gastroenterol,2015,50(11):1331-1338.
[11]Ross-Adjie GM,Monterosso L,Bulsara M.Bowel management post major joint arthroplasty:results from a randomised controlled trial.Int J Orthop Trauma Nurs,2015,19(2):92-101.
[12]Marciniak CM,Toledo S,Lee J,et al.Lubiprostone vs Senna in postoperative orthopedic surgery patients with opioid-induced constipation:a double-blind,active-comparator trial.World J Gastroenterol,2014,20(43):16323-16333.
[13]Use of opioid analgesics in the treatment of cancer pain:evidence-based recommendations from the EAPC.Caraceni A,Hanks G,Kaasa S,et al.Lancet Oncol.2012；13:0–68.
[14] Li Xiaofeng, wang Yongjun, mo Wen, hu Zhijun, qiu Dehua, shi Qi, pingchun Jieshi spring and autumn Shi Qi teaching and Dan Xiaoshan traumatology experience inherit innovation [ J ] Shanghai pharmaceutical journal 2017,51 (01): 1-4.
[15]The PAC-SYM questionnaire for chronic constipation:defining the minimal important difference.Yiannakou Y,Tack J,Piessevaux H,et al.Aliment Pharmacol Ther.2017；46:1103–1111.
The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and additions can be made without departing from the method of the present invention, and these modifications and additions should also be regarded as the protection scope of the present invention.
Claims (8)
1. The traditional Chinese medicine composition for preventing and treating constipation caused by postoperative qi and blood deficiency and intestinal dryness is characterized by being prepared from the following raw material medicines in parts by weight: 15-30 parts of raw astragalus membranaceus, 10-15 parts of angelica sinensis, 6-9 parts of raw rhubarb, 10-15 parts of immature bitter orange, 10-15 parts of mangnolia officinalis, 10-15 parts of rhizoma cyperi, 10-15 parts of achyranthes bidentata, 10-15 parts of semen plantaginis, 10-15 parts of fructus cannabis, 15-20 parts of rice sprout, 15-20 parts of malt and 5-10 parts of liquorice.
2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 15-20 parts of raw astragalus membranaceus, 11-13 parts of angelica sinensis, 6-7 parts of raw rhubarb, 11-13 parts of immature bitter orange, 11-13 parts of mangnolia officinalis, 11-13 parts of rhizoma cyperi, 11-13 parts of radix achyranthis bidentatae, 11-13 parts of semen plantaginis, 11-13 parts of fructus cannabis, 15-16 parts of rice sprout, 15-16 parts of malt and 5-7 parts of liquorice.
3. The traditional Chinese medicine composition according to claim 2, which is prepared from the following raw materials in parts by weight: 18 parts of raw astragalus root, 12 parts of angelica, 6 parts of raw rhubarb, 12 parts of immature bitter orange, 12 parts of officinal magnolia bark, 12 parts of nutgrass galingale rhizome, 12 parts of twotooth achyranthes root, 12 parts of plantain seed, 12 parts of hemp seed, 15 parts of rice sprout, 15 parts of malt and 6 parts of liquorice.
4. The Chinese medicinal composition of claim 1, wherein the Chinese medicinal composition further comprises a pharmaceutically conventional carrier.
5. The composition of claim 4, wherein the pharmaceutically acceptable carrier comprises an emulsifier, a filler, a binder, a humectant, a disintegrant, an absorption enhancer, a flavoring agent, a coloring agent, and a solubilizing agent.
6. The traditional Chinese medicine composition of claim 1, wherein the traditional Chinese medicine composition is in the form of decoction, pill, tablet, mixture, capsule, granule, powder, paste or wine.
7. Use of the Chinese medicinal composition of any one of claims 1-6 in the preparation of a medicament for preventing and treating postoperative constipation.
8. The use of claim 7, wherein the post-operative constipation is post-operative constipation due to deficiency of both qi and blood and intestinal dryness.
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