CN117414351B - Traditional Chinese medicine patch for treating spleen-kidney yang deficiency constipation and preparation method and application thereof - Google Patents
Traditional Chinese medicine patch for treating spleen-kidney yang deficiency constipation and preparation method and application thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/04—Sulfur, selenium or tellurium; Compounds thereof
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- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
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Abstract
The invention provides a traditional Chinese medicine patch for treating constipation caused by spleen-kidney yang deficiency, and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine preparations. The traditional Chinese medicine patch is prepared by adding sulfur, red sage root and ligusticum wallichii on the basis of aconite and rheum officinale, wherein the compatibility of the aconite and the rheum officinale plays roles of warming yang, dispelling cold and purging and eliminating accumulation, and simultaneously can regulate yin-yang balance of a body, the red sage root is a static product in blood, the ligusticum wallichii is a dynamic product in blood, and the two are mutually matched, so that qi and blood of a human body are smooth in running, sulfur is hot, and the traditional Chinese medicine patch has the effects of tonifying fire, supporting yang and relaxing the bowels. Compared with the shitong capsules, the application of the traditional Chinese medicine patch (the paste for tonifying kidney and reducing turbid) for treating spleen-kidney yang deficiency constipation provided by the invention to the Shenque acupoint can obviously improve the average total spontaneous defecation times per week of patients with MHD and chronic constipation, improve constipation symptoms, and is effective and safe in use and worthy of popularization.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicine preparations, and in particular relates to a traditional Chinese medicine patch for treating constipation caused by spleen-kidney yang deficiency, and a preparation method and application thereof.
Background
Chronic kidney disease patients develop to the end stage and need to rely on maintenance hemodialysis (Maintenance hemodialysis, MHD) to sustain life, and patients have poor quality of life and many complications. Constipation is a common digestive tract symptom in MHD patients, and students have shown that the incidence of constipation in dialysis patients is 34.2% according to the study of Rome iii diagnostic criteria. Chronic constipation can cause symptoms such as anorexia, abdominal distention and the like of patients, thereby influencing the nutrition intake of the patients, easily causing malnutrition, having lower life quality and even endangering life.
The prevalence of chronic constipation increases with age, women have higher prevalence than men and have significantly lower quality of life than non-chronic constipation groups. Chronic constipation is one of the most frequent complications of dialysis patients. The incidence of chronic constipation in peritoneal dialysis patients is 17.9% -28.9%, while the incidence of chronic constipation in MHD patients is as high as 37.74%. Constipation in MHD patients is a result of multiple factors: mhd patients need long-term control of water, salt intake to reduce volume load, while reduction of water intake reduces intestinal lubrication; 1.MHD patients have low phosphorus and low potassium diet for a long time, and the ingestion of coarse grains, partial vegetables and fruits is limited, and the ingestion of vegetable fibers is insufficient; patients with MHD often have a plurality of complications, and the patients need to take medicines regularly for a long time, wherein the phosphorus binding agent and the iron agent can cause constipation; the physical activity level of patients with MHD is generally low, so that gastrointestinal peristalsis is slowed down, and chronic constipation is easy to cause. The treatment measures of clinical chronic constipation comprise increasing dietary fiber and water intake, increasing exercise and maintaining good defecation habit. In addition, the Chinese medicinal preparation can relieve the symptoms of patients with chronic constipation by adopting a volume purgative, an osmotic purgative, a stimulus purgative or Chinese medicinal herbs (Chinese patent medicinal preparation or decoction) and the like. But MHD patients often have multiple diseases, are greatly limited in increasing dietary fiber and water intake, and have heavy gastrointestinal burden and increased dependence due to long-term oral administration, thus being in a non-virtuous circle. It is clear that chronic constipation in MHD patients is very difficult to treat.
The constipation relieving capsule is quite convenient for treating constipation caused by deficiency of essence, blood, intestine dryness and spleen qi stagnation and heat retention, and is widely used for treating constipation clinically. In recent years, many studies on patients with MHD with chronic constipation have shown that the acupoint application can improve constipation symptoms of the patients (for example, journal paper: "traditional Chinese medicine acupoint application prevents 66 cases of constipation of patients with chronic heart failure", lin Weiwang Ping, zhejiang journal of Chinese medicine, 2015, 2; patent: CN 115957257A).
The acupoint application belongs to the category of external treatment methods of traditional Chinese medicine, and researches show that the therapy has a certain curative effect in improving constipation, insomnia and other complications of MHD patients, has no side effect, and is safe and easy to operate. The invention aims to provide a traditional Chinese medicine patch for treating spleen-kidney yang deficiency constipation, so as to more effectively improve constipation of MHD patients, and play an advantage in improving life quality of the patients and reducing medical burden.
Disclosure of Invention
Aiming at the problems existing in the prior art, the invention provides a traditional Chinese medicine patch for treating constipation caused by spleen-kidney yang deficiency, and a preparation method and application thereof. The traditional Chinese medicine patch is prepared by adding sulfur, red sage root and ligusticum wallichii on the basis of aconite and rheum officinale, wherein the compatibility of the aconite and the rheum officinale plays roles of warming yang, dispelling cold and purging and eliminating accumulation, and simultaneously can regulate yin-yang balance of a body, the red sage root is a static product in blood, the ligusticum wallichii is a dynamic product in blood, and the two are mutually matched, so that qi and blood of a human body are smooth in running, sulfur is hot, and the traditional Chinese medicine patch has the effects of tonifying fire, supporting yang and relaxing the bowels.
In order to achieve the above purpose, in a first aspect, the invention provides a traditional Chinese medicine patch for treating constipation caused by spleen-kidney yang deficiency, which comprises the following medicinal materials in parts by weight: 12-18 parts of aconite, 12-18 parts of rheum officinale, 8-12 parts of sulfur, 16-24 parts of radix salviae miltiorrhizae and 12-18 parts of ligusticum wallichii.
The end-stage kidney disease belongs to the categories of traditional Chinese medicine 'Guange' and 'kidney fatigue', and the main disease is located in spleen and kidney and involves multiple viscera. The end-stage kidney disease is marked by deficiency of the spleen and the kidney, and blood stasis is blocked in kidney collaterals, so that kidney body wilt loses the function. Constipation is caused by spleen-qi deficiency and kidney-yang deficiency. The failure of the intestines to moisten, dry stool, kidney yang deficiency, decline of the fire in the gate, lack of warmth, endogenous yin cold, congeal the intestines, cause yang qi obstruction, body fluids obstruction, and difficult intestinal tract transportation, which leads to constipation. One study of the secondary silence shows that the traditional Chinese medicine syndrome of the patients with the chronic constipation complicated with the MHD is most marked by the deficiency of the secret, wherein the deficiency of yang is most marked by the deficiency of the secret. In the early stage, the effects of the hemp seed intestine-moistening pills, lactulose and the like for treating the chronic constipation are not ideal, and the common pathogenesis of the disease is considered to be inconsistent. The capsule for treating constipation has the advantages of treating both essence and blood, regulating liver, spleen and kidney, and slightly better effect than other medicines after use, but the constipation is still poor in improvement and the recurrence rate is high. Therefore, yu Renhuan teaches that aiming at spleen-kidney yang deficiency common to clinical MHD patients with chronic constipation, a method of applying traditional Chinese medicine to Shenque acupoint is proposed for treatment, so that oral medicine of the patients is reduced, and gastrointestinal tract burden is relieved. The following are the following in the "reason text: the theory of external treatment is that of internal treatment, and the externally-treated herbs are that of internal treatment, and the different ones, although the recipe ear is treated externally, it is not treated internally. So it is parallel to internal treatment and can supplement the internal treatment. The acupoint application therapy is a traditional Chinese medicine external therapy method, takes theory of channels and collaterals and acupoints as the places where qi and blood of viscera are concentrated as theoretical basis, applies traditional Chinese medicines to the relevant acupoints, and the medicines are absorbed through skin to excite the menstrual qi so as to play a role in regulating the organism and achieve the effects of preventing and treating diseases. The Shenque acupoint is the umbilical region of the human body, which is the last part to be closed during the growth and development of the human body. The periphery is provided with a large quantity of neurons which are closely connected with the channels such as conception vessels, pulse vessels and the like, the internal part can be connected with the internal organs and six fu organs, the external part can reach the limbs and the bones, the skin is thinner, and the medicine is easy to absorb.
Yu Renhuan A Chinese medicinal patch (paste for protecting kidney and lowering turbid pathogen, applied on shenque acupoint) for treating constipation due to spleen-kidney yang deficiency is prepared from radix Aconiti lateralis Preparata, radix et rhizoma Rhei, sulfur, saviae Miltiorrhizae radix and rhizoma Ligustici Chuanxiong. Fu Zi is hot in nature, pungent in flavor, tonifying fire and supporting yang, and is called as a first medicine for restoring yang and rescuing collapse; rhubarb, radix et rhizoma Rhei, with cold nature and bitter taste, is a purgative herb. However, fuzi is explicitly listed as a lower traditional Chinese medicine in Shennong Ben Cao Jing, which is toxic and can not be taken for a long time; some of them are called "general" and they are also very bitter and cold in nature. The compatibility of the two drugs can restrict the disadvantage of cold and heat bias; is pungent and bitter in formula, and has the effects of opening the stomach, lowering the bitter, regulating qi movement and harmonizing spleen and stomach. The compatibility of the two herbs together has the effects of warming yang, dispelling cold, purging and eliminating accumulation, and can regulate yin and yang balance of the organism, and is mainly used for treating yang deficiency diseases, and has the effects of enhancing intestinal peristalsis and defecation (see journal literature on research progress of compatibility mechanism of aconite and rheum officinale for treating yang deficiency diseases, chen Guqi and the like, chinese herbal medicines, 2022, 53 (11): 3518-3530). The oral administration of the oral liquid has the effects of tonifying fire, supporting yang and relaxing bowels, and can be used for treating impotence, cold foot, asthma and cold asthma due to deficiency and constipation due to deficiency-cold. Modern pharmacological research shows that after sulfur is taken orally, potassium sulfide or hydrogen sulfide can be formed in the intestines, so that gastrointestinal mucous membrane is stimulated to promote intestinal peristalsis, and excrement is softened to relieve diarrhea. However, sulfur is a herb of Jinshi, which is toxic and can not be taken for a long time. Clinical MHD patients suffer from damaged gastrointestinal mucosa, and oral radix aconiti carmichaeli, rheum officinale and sulfur are less prone to abuse, and Yu Renhuan teaches that the three medicines are prepared into external application, so that the figure is slowly drawn. Danshen is bitter in flavor and slightly cold in nature, and has the effects of activating blood circulation to dissipate blood stasis, promoting blood circulation to relieve pain, removing blood stasis and promoting tissue regeneration. Chuan Xiong is pungent in flavor, warm in nature, spicy and fragrant in nature, and has the actions of activating blood and promoting qi circulation, dispelling wind and relieving pain. Danshen root is a static herb in blood, chuan Xiong is a moving herb in blood, and both are mutually compatible, so that qi and blood of the human body are smooth. On the whole, the paste applied on the Shenque acupoint has the efficacy of warming yang, purging, and adjusting qi, blood, yin and yang of the organism.
In a preferred embodiment, the traditional Chinese medicine patch for treating constipation due to spleen-kidney yang deficiency is prepared from the following medicinal materials in parts by weight: 15 parts of aconite, 15 parts of rheum officinale, 10 parts of sulfur, 20 parts of radix salviae miltiorrhizae and 15 parts of ligusticum wallichii.
In a preferred embodiment, the traditional Chinese medicine patch is an application.
In a second aspect, the invention provides a preparation method of the traditional Chinese medicine patch for treating constipation caused by spleen-kidney yang deficiency, the medicinal materials are weighed according to the formula, ground into fine powder, sieved, and mixed with an application medium to prepare the patch.
In a preferred embodiment, the application medium is selected from at least one of honey, vinegar, sesame oil, vaseline, paraffin oil, yellow wine, more preferably honey; the mass ratio of the fine powder to the application medium is 1:0.3-3, more preferably 1:1.
In a preferred embodiment, the medicinal material is ground to a fine powder and then sieved through a 50-200 mesh sieve, more preferably a 80 mesh sieve.
In a preferred embodiment, the patch is prepared by blending the patch medium into a paste, paste or pellet, and more preferably by rubbing the patch medium into a pellet.
In a preferred embodiment, the medicinal materials are ground into fine powder, sieved by a 80-mesh sieve, blended with honey according to the mass ratio of 1:1, rubbed into pills and made into the application.
In a third aspect, the invention provides application of the traditional Chinese medicine patch for treating constipation caused by spleen-kidney yang deficiency in a product for treating constipation caused by spleen-kidney yang deficiency.
Compared with the prior art, the invention has the beneficial effects that:
1. the traditional Chinese medicine patch (kidney-protecting turbidity-reducing patch) for treating spleen-kidney yang deficiency constipation provided by the invention is a patch empirical formula taught by Yu Renhuan, is applied clinically for a long time, and has good curative effects on improving constipation of chronic kidney patients and relieving edema.
2. Compared with the shitong capsules, the application of the traditional Chinese medicine patch (the paste for tonifying kidney and reducing turbid) for treating spleen-kidney yang deficiency constipation provided by the invention to the Shenque acupoint can obviously improve the average total spontaneous defecation times per week of patients with MHD and chronic constipation, improve constipation symptoms, and is effective and safe in use and worthy of popularization.
3. The traditional Chinese medicine patch (kidney-tonifying turbidity-reducing patch) for treating spleen-kidney yang deficiency constipation is applied to the shenque acupoint to treat spleen-kidney yang deficiency MHD with chronic constipation, so that the excrement characters of patients are obviously improved, the excrement laborious degree is reduced, the excrement frequency is increased, the excrement time is shortened, and the spontaneous excrement frequency is increased. Compared with the shitong capsules, the shenque acupoint plaster for tonifying kidney and descending turbid has certain advantages in the aspects of clinical curative effect, constipation symptom integration, spontaneous defecation frequency and the like. Therefore, the clinical treatment of the MHD patient with chronic constipation should analyze the traditional Chinese medicine syndrome type of the patient in detail, and the syndrome differentiation is that other diseases with spleen-kidney yang deficiency type constipation, such as chronic kidney disease complicated with chronic constipation, senile constipation and the like, can be treated by adopting the Chinese medicine patch (kidney tonifying and turbidity reducing patch) for treating the spleen-kidney yang deficiency type constipation by applying on the Shenque acupoint.
Detailed Description
It is worth to say that the medicinal materials used in the invention are all common commercial products, and the sources are not particularly limited.
Example 1
The traditional Chinese medicine is prepared from the following medicinal materials in parts by weight: 15 parts of aconite, 15 parts of rheum officinale, 30 parts of sulfur and 15 parts of ligusticum wallichii.
The preparation method comprises the following steps: weighing the above medicinal materials according to the formula, grinding into fine powder, sieving with 80 mesh sieve, mixing with Mel according to the mass ratio of fine powder to Mel of 1:1, and making into pill.
Example 2
The traditional Chinese medicine is prepared from the following medicinal materials in parts by weight: 15 parts of aconite, 15 parts of rheum officinale, 30 parts of radix salviae miltiorrhizae and 15 parts of ligusticum wallichii.
The preparation method comprises the following steps: weighing the above medicinal materials according to the formula, grinding into fine powder, sieving with 80 mesh sieve, mixing with Mel according to the mass ratio of fine powder to Mel of 1:1, and making into pill.
Example 3 Chinese medicinal Patch for treating constipation due to spleen-kidney yang deficiency
The traditional Chinese medicine is prepared from the following medicinal materials in parts by weight: 15 parts of aconite, 15 parts of rheum officinale, 10 parts of sulfur, 20 parts of radix salviae miltiorrhizae and 15 parts of ligusticum wallichii.
The preparation method comprises the following steps: weighing the above medicinal materials according to the formula, grinding into fine powder, sieving with 80 mesh sieve, mixing with Mel according to the mass ratio of fine powder to Mel of 1:1, and making into pill.
Example 4 Chinese medicinal Patch for treating constipation due to spleen-kidney yang deficiency
The traditional Chinese medicine is prepared from the following medicinal materials in parts by weight: 12 parts of aconite, 18 parts of rheum officinale, 10 parts of sulfur, 16 parts of radix salviae miltiorrhizae and 18 parts of ligusticum wallichii.
The preparation method comprises the following steps: weighing the above medicinal materials according to the formula, grinding into fine powder, sieving with 80 mesh sieve, mixing with Mel according to the mass ratio of fine powder to Mel of 1:1, and making into pill.
Example 5 Chinese medicinal Patch for treating constipation due to spleen-kidney yang deficiency
The traditional Chinese medicine is prepared from the following medicinal materials in parts by weight: 18 parts of aconite, 12 parts of rheum officinale, 11 parts of sulfur, 24 parts of radix salviae miltiorrhizae and 12 parts of ligusticum wallichii.
The preparation method comprises the following steps: weighing the above medicinal materials according to the formula, grinding into fine powder, sieving with 80 mesh sieve, mixing with Mel according to the mass ratio of fine powder to Mel of 1:1, and making into pill.
Test case clinical data
1.1 study design A prospective randomized controlled study was used to initially explore the effectiveness and safety of the traditional Chinese medicine patches (kidney-protecting turbidity-reducing patches) of examples 1-3 for treatment of patients with MHD with chronic constipation by applying to the Shenque acupoint. Grouping is performed by adopting a random number table method.
1.2 study object
A patient suffering from chronic constipation accompanied by hemodialysis performed in a dialysis center of a aster hospital of the Chinese academy of science of Chinese traditional medicine, 1 st year 2022 nd month 6 th year 2022, is selected as a study object.
1.1.1 Inclusion criteria (1) age: 18-65 years old; (2) regular hemodialysis treatment for more than 6 months; (3) is suitable for chronic constipation diagnosis; (4) the differentiation of the traditional Chinese medicine is spleen-kidney yang deficiency; (5) the life can be self-care; (6) voluntarily attending the study, and signing informed consent.
1.1.2 exclusion criteria: (1) diseases such as severe barycenter, brain, liver and hematopoietic system, or other serious diseases affecting their survival; (2) suffering from mental illness or being unable to cooperate with a researcher; (3) treating constipation with other cathartic drugs and/or non-drug therapies; (4) broken skin at acupoints and allergy to applied components.
1.1.3 diagnostic criteria chronic constipation diagnostic criteria: symptoms of difficult and/or reduced number of bowel movements (less than 3 times per week), dry and hard stools, and at least 6 months of disease. The number of bowel movements was counted using the average number of complete spontaneous bowel movements per week (SCBM) against roman iv standard.
The traditional Chinese medicine dialectical standard refers to the common knowledge of the medical specialist in constipation, and the main symptoms are spleen-kidney yang deficiency, and can combine with turbid toxin, blood stasis, damp-heat, blood deficiency and wind dryness. Constipation mainly caused by spleen-kidney yang deficiency: (1) dry or non-dry stool and difficult discharge; (2) aversion to cold and cold limbs. Secondary symptoms: (1) lumbago, tinnitus; (2) Soreness and coldness of the waist and knees, pale red tongue, swollen or pale tongue with teeth marks, thin and white coating and weak pulse.
1.3 Research method
1.3.1 The patients are treated by conventional hemodialysis for 3 times/week, and the control group is prepared into capsule for 3 capsules for 2 times/day. The just-through capsule is produced by the pharmaceutical industry of Wuhan Jianmen, 0.35g of which is 9 tablets/box. The Chinese medicinal patches (paste for protecting kidney and lowering turbidity) of examples 1 to 3 were applied to the Shenque acupoint. Acupoint selection and placement of shenque acupoint: the middle of the umbilicus, the center of the umbilicus. The application time is as follows: applied to SHENQUE acupoint 1 hr after hemodialysis is started, and removed 3 times per week after 6 hr. The observation time points are as follows: pre-treatment, 1 week post-treatment, and 2 weeks post-treatment.
1.3.2 personnel training the present study according to the "traditional Chinese medicine nursing routine technical operation rules" issued by the Chinese medical society, the nurses attending the application treatment are trained, and the training key points are the drug allocation, the application key points and the notification matters.
1.4 Observation index
1.4.1 evaluation of clinical efficacy according to the national traditional Chinese medicine administration diagnostic efficacy Standard of the disease of traditional Chinese medicine. And (3) curing: defecation is carried out for 1 time within 2 days, the stool is smooth, smooth in dissolving and free of recurrence in a short period; improvement: defecation is carried out within 3 days, the stool is smooth, and the defecation is unsmooth; the method is characterized in that: the symptoms are not improved. Total effective rate = (cure + improvement) number of cases/total number of cases 100%.
1.4.2 SCBM counts the number of spontaneous complete defecation of patients, and only the autonomous defecation of the complete emptying sensation considered by the patients is spontaneous complete defecation, and SCBM is considered to be normal defecation for more than or equal to 3 times.
1.4.3 score of constipation main symptom score according to scoring standard, including fecal character, referring to the consensus of constipation traditional Chinese medicine diagnosis and treatment expert; the defecation is laborious; defecation time; falling, inexhaustible and distending feeling; frequency of defecation and abdominal distension. Higher scores indicate more severe constipation symptoms.
1.4.4 Body mass growth index average data of patient mass growth weeks at each observation time point are retrieved from the Beyond hemodialysis system at the center of China for comparison.
1.5 Statistical method
Statistical analysis was performed using SPSS25.0 software, and data using mean.+ -. Standard deviation ±s) represents. The data are subjected to normalization and variance alignment tests, two independent data are compared by adopting an independent t test or a Mann-Whitney U test, and the data are compared before and after treatment by adopting a paired t test or a paired rank sum test. The test has statistical significance with P <0.05 and P < 0.01.
1.6 Results
1.6.1 General cases
The study was finally completed with 80 cases of MHD with chronic constipation, 20 cases of each of examples 1-3 and control, and 2 weeks of experimental observation was completed. Example 1 group: 10 men and 10 women; age 29-64 (51.15+ -8.53) years, dialysis age 15-106 (49.95+ -17.99) months; example 2 group: men 12 and women 8; age 32-67 (50.80 + -8.71) years, dialysis age 20-101 (49.70 + -16.80) months; example 3 group: men 9 and women 11; age 33-65 (56.10+ -9.41) years, dialysis age 13-128 (46.50 + -31.82) months; control group: men 12 and women 8; age 30-65 (51.40+ -9.90); dialysis age 9-98 (44.60 + -25.36) months. The differences in general data comparison between groups for gender, age and dialysis age were not statistically significant (P > 0.05).
1.6.2 Comparison of clinical efficacy
When the treatment is carried out for 1 week, the group 1 of the example cures 3 cases, improves 8 cases, does not cure 9 cases, and has the total effective rate of 55%; example 2 cures 2 cases, improves 8 cases, does not cure 10 cases, and has the total effective rate of 50%; example 3 cures 4 cases, improves 12 cases, does not cure 4 cases, and has the total effective rate of 80%; the control group heals 2 cases, improves 6 cases, does not heal 12 cases, and the total effective rate is 40%. The differences between the total effective rate of the group of example 3 and that of the control group and the group of examples 1-2 are statistically significant (P < 0.05). When the treatment is carried out for 2 weeks, the group of the embodiment 1 cures 3 cases, improves 8 cases, does not cure 9 cases, and has the total effective rate of 55 percent; example 2 cures 3 cases, improves 7 cases, does not cure 10 cases, and has the total effective rate of 50%; example 3 cure 6 cases, 11 cases are improved, 3 cases are not cured, and the total effective rate is 85%; the control group heals 3 cases, 7 cases are improved, 10 cases are not healed, and the total effective rate is 50%. The differences between the total effective rate of the group of example 3 and that of the control group and the group of examples 1-2 are statistically significant (P < 0.05). Details are shown in Table 1.
Table 1 comparison of two clinical efficacy
Note that: group-to-group comparison: delta is compared with the time point of the control group, and P is less than 0.05; * P <0.05 compared to example 3 group at the same time point.
As can be seen from the data in table 1, in the example 3, the total effective rate is significantly improved by using the combination of the red sage root and sulfur, compared with the example 1, and the example 2, the total effective rate is significantly improved by using the same amount of sulfur, and the effective rate is improved after 2 weeks of treatment compared with 1 week of treatment, which means that the combination of the red sage root and sulfur can synergistically improve the treatment effect.
1.6.3 average spontaneous complete bowel movement per week (SCBM) comparison
The differences in SCBM comparison for each group prior to treatment were not statistically significant (P > 0.05). After 1 week of treatment, the SCBM of example 3 was higher than that of the pre-treatment and control groups, examples 1-2 (P < 0.05), and the control groups were not significantly different from the examples 1-2 (P > 0.05) compared to the pre-treatment groups. After 2 weeks of treatment, each group SCBM was significantly higher than before treatment (P < 0.05); example 3 group SCBM was higher than control group and examples 1-2 group (P < 0.05); treatment for 2 weeks example 3 group SCBM was higher than treatment for 1 week (P < 0.05). Details are shown in Table 2.
Table 2 comparison of average spontaneous complete bowel movements per week (SCBM) for two groups
Note that: group-to-group comparison: delta is compared with the time point of the control group, and P is less than 0.05; * P <0.05 compared to example 3 group at the same time point; intra-group comparison: # compared to pre-treatment, P <0.05; p <0.05 compared to treatment for 1 week.
As can be seen from the data in table 1, in the example 3, the same amount of sulfur is used in combination with the root of red-rooted salvia, and in the example 2, the number of spontaneous and complete defecation per week is significantly increased compared with the example 1, which indicates that the root of red-rooted salvia and sulfur are used in combination, so that the synergistic effect can be achieved and the therapeutic effect can be improved.
1.6.4 Integral comparison of Constipation symptoms in two groups
The difference between the integral comparison of the constipation symptoms of the two groups before treatment is not statistically significant (P > 0.05). After 1 week of treatment, the integral of constipation symptoms was reduced in both groups compared to before treatment, and the difference was statistically significant (P < 0.05). After 2 weeks of treatment, the total integral, fecal character, fecal effort, fecal time and fecal frequency integral of example 3 group was reduced compared to pre-treatment, the total integral and fecal time integral of control group were reduced compared to pre-treatment, and the differences were statistically significant (P < 0.05). After 1 week and 2 weeks of treatment, the total score, stool character, effort, time and frequency of bowel movements were lower in the example 3 group than in the control group, and the differences were statistically significant (P < 0.05). Details are shown in Table 3.
Table 3 integral comparison of Constipation symptoms in two groups
Note that: group-to-group comparison: delta is compared with the time point of the control group, and P is less than 0.05; intra-group comparison: * P <0.05 for 1 week of treatment compared to pre-treatment; 2 weeks of # treatment compared to pre-treatment, P <0.05; p <0.05 for 1 week compared to 2 weeks of treatment.
1.6.5 comparison of mass gain of two groups
There was no significant difference in mass increase between the two groups before treatment, 1 week after treatment and 2 weeks after treatment (P > 0.05). Both groups of treatments had no effect on the physical gain of the patients (P > 0.05). Details are shown in Table 4.
Table 4 comparison of mass gain of two groups
1.6.6 Safety observation
The patients in each group have no adverse reaction, the patients in the example 1 group have 3 cases, the example 2 group has 2 cases, the patients in the example 3 group have 3 cases, and the skin of the application part is reddish, and other discomforts such as itching, stinging and the like are avoided, so that the normal response of the application is considered.
Finally, it should be noted that the above description is only for illustrating the technical solution of the present invention, and not for limiting the scope of the present invention, and that the simple modification and equivalent substitution of the technical solution of the present invention can be made by those skilled in the art without departing from the spirit and scope of the technical solution of the present invention.
Claims (9)
1. The traditional Chinese medicine patch for treating constipation due to spleen-kidney yang deficiency is characterized by comprising the following medicinal materials in parts by weight: 15 parts of aconite, 15 parts of rheum officinale, 10 parts of sulfur, 20 parts of radix salviae miltiorrhizae and 15 parts of ligusticum wallichii.
2. The traditional Chinese medicine patch according to claim 1, wherein the traditional Chinese medicine patch is an application.
3. The method for preparing a Chinese medicinal patch for treating constipation due to yang deficiency of spleen and kidney according to any one of claims 1-2, wherein the preparation method comprises weighing the medicinal materials according to the formula, grinding the medicinal materials into fine powder, sieving, adding the application medium, and concocting to obtain the patch.
4. The method according to claim 3, wherein the application medium is at least one selected from honey, vinegar, sesame oil, vaseline, paraffin oil, and yellow wine, and the mass ratio of the fine powder to the application medium is 1:0.3-3.
5. The method of claim 4, wherein the application medium is honey and the mass ratio of the fine powder to the application medium is 1:1.
6. The preparation method of claim 3, wherein the medicinal materials are ground into fine powder, sieved by a 50-200-mesh sieve, and mixed with a paste medium to form paste, paste or pill, and then the paste is prepared.
7. The preparation method according to claim 6, wherein the medicinal materials are ground into fine powder, sieved by a 80-mesh sieve, and rubbed into pills by adding an application medium to prepare the patch.
8. The preparation method of claim 3, wherein the medicinal materials are ground into fine powder, sieved by a 80-mesh sieve, blended with honey according to a mass ratio of 1:1, rubbed into pills and made into application.
9. The application of the traditional Chinese medicine patch for treating spleen-kidney yang deficiency constipation in preparing a product for treating spleen-kidney yang deficiency constipation is characterized in that the traditional Chinese medicine patch for treating spleen-kidney yang deficiency constipation is prepared by the traditional Chinese medicine patch according to any one of claims 1-2 or the preparation method according to any one of claims 3-8.
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