CN111544550B - Traditional Chinese medicine formula flora capsule, preparation method and application in preparation of medicine for treating type 2 diabetes - Google Patents
Traditional Chinese medicine formula flora capsule, preparation method and application in preparation of medicine for treating type 2 diabetes Download PDFInfo
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Abstract
The invention belongs to the field of medicines, and particularly relates to a flora capsule in a traditional Chinese medicine formula, which is prepared by matching freeze-dried powder obtained by separating fecal bacteria with traditional Chinese medicine extraction effective components and crushing the obtained powder to obtain traditional Chinese medicine extraction powder. The invention combines the traditional Chinese medicine extraction method, deeply fuses the traditional Chinese medicine extraction method and the fecal bacteria separation process to prepare the flora capsule with the traditional Chinese medicine formula, greatly improves the treatment effect while changing the administration method, and realizes an efficient and comfortable treatment approach.
Description
Technical Field
The invention belongs to the technical field of medicines, particularly relates to the technical field of coprophilous fungi transplantation, and more particularly relates to a coprophilous fungi capsule with a traditional Chinese medicine formula, a preparation method thereof, and application thereof in preparing medicines for treating type 2 diabetes.
Background
The structural and functional change of intestinal flora can cause a series of metabolic diseases such as obesity, type 2 diabetes mellitus and the like, and researches in recent years suggest that the coprophilous fungi transplantation treatment can improve the blood sugar control level of the type 2 diabetes mellitus, improve metabolism and improve insulin sensitivity.
"Fecal transplantation" (FMT), which is defined as the transplantation of functional flora in the feces of healthy people into the gastrointestinal tract of patients by nasogastric or duodenal tubes, gastroscope or colonoscope, rectal catheter enema, etc., reestablishing the balance of intestinal flora, repairing the barrier of intestinal mucosa, and realizing the treatment of specific intestinal and parenteral diseases.
However, although the above administration method can achieve the purpose of intestinal bacteria transplantation, it needs to infuse the bacteria liquid into the intestinal tract of a patient for treatment in a tubular state or under an endoscope, and the patient has limited physiological and psychological acceptance, thereby limiting the clinical popularization and application of the treatment technology. For example, 15 clinical efficacy analyses of chronic transmission constipation by flora capsule treatment are reported in Tianhongliang et al (15 clinical efficacy analyses of chronic transmission constipation by flora capsule treatment, No. 36, No. 4 of 2016 in China's journal of practical surgery), but the research result is a preliminary attempt, and the study result is not included in a control group, so that the defect of fecal flora transplantation is still insufficient. Particularly, the content of the flora capsule in the article is single bacterial liquid, and the content of the bacterial liquid can be reduced by adding conventional auxiliary materials, so that further research and development are needed, and the coprophilous fungi transplantation is better applied to treatment of diseases.
Disclosure of Invention
In view of the above problems, the inventor of the present invention combines the traditional administration method with the traditional Chinese medicine extraction method to deeply fuse the two processes to prepare the capsule of the flora in the formula of the traditional Chinese medicine, so as to greatly improve the treatment effect and realize an efficient and comfortable treatment approach.
The technical scheme provided by the invention is as follows:
on one hand, the invention provides a traditional Chinese medicine formula flora capsule which is characterized by being prepared by matching traditional Chinese medicine extract powder obtained by crushing freeze-dried powder after separation of fecal bacteria and traditional Chinese medicine extract effective components.
In one embodiment, the fecal bacteria is isolated by a device for isolating microorganisms from the contents of the lumen, more specifically by the device described in the' 201410606325.4 patent.
More specifically, the preparation method of the freeze-dried powder after the separation of the coprophilous fungi comprises the following steps:
(1) collecting feces samples of healthy donors by using an aseptic sampling bottle, sealing and conveying the feces samples to an aseptic operation room, matching with a filter bottle, an AB bottle, a deodorization bottle, a buffer bottle and a bacteria liquid bottle in an aseptic disposable consumable material, connecting in series, and placing in an intelligent feces and bacteria separation system for flora collection;
(2) the physiological saline is filled into the sampling bottle through the liquid adding driving device to soak the excrement sample;
(3) opening an air pump II to collect the mixed bacteria liquid in the sampling bottle into a buffer bottle sequentially through filter screens with different filtering values, then filling the bacteria liquid in the buffer bottle into the bacteria liquid bottle through a bacteria liquid driving device, centrifuging, removing supernatant after centrifugation, and keeping precipitate, wherein the precipitate is the bacteria liquid precipitate after separation and purification;
(4) adding glycerol into each centrifugal tube, uniformly mixing by using an oscillator, pre-freezing the centrifugal tubes, quickly freezing and drying the pre-frozen samples after pre-freezing is finished, and dehydrating the freeze-dried bacteria liquid to obtain freeze-dried powder.
Further preferably, a stirring rod is arranged in the sampling bottle, and in the step (2), the stirring rod in the sampling bottle stirs the fecal sample to be fully homogenized.
In a preferred embodiment, the volume ratio of the flora freeze-dried powder to the traditional Chinese medicine extraction powder is 0.5-2: 1, more preferably 1: 1. the preparation method specifically comprises the steps of mixing the two materials, stirring and uniformly mixing the two materials by a miniature stirrer, and further filling acid-resistant hydroxypropyl methylcellulose capsules.
In a more preferred embodiment, the Chinese medicinal extract powder is prepared by pulverizing effective components extracted from Chinese medicinal formula of radix Panacis Quinquefolii, rhizoma Polygonati, Massa Medicata Fermentata, cortex Lycii, and Curcumae rhizoma. More preferably, the weight ratio of the American ginseng to the western ginseng, the rhizoma polygonati, the medicated leaven, the cortex lycii radicis and the curcuma zedoary in the traditional Chinese medicine formula is 8-12:12-18:12-18:8-12:8-12, and preferably 10:15:15:10: 10.
The extraction of the effective components of the traditional Chinese medicine can be carried out according to the conventional method, in a specific embodiment, the preparation method of the traditional Chinese medicine extraction powder is as follows,
(1) cutting or pulverizing the above herbs at a certain proportion, and placing in a decocting container;
(2) soaking in water;
(3) heating to boil, leaching, separating decoction, decocting the residue for 2-3 times, and collecting decoction;
(4) extracting the decoction with alcohol, preferably ethanol;
(5) drying the alcoholic extractive filtrate, and pulverizing with micronizer, preferably micropowder less than 10 μm.
The invention also provides application of the traditional Chinese medicine formula flora capsule in preparing a medicine for treating type 2 diabetes.
The invention also provides a preparation method of the flora capsule with the traditional Chinese medicine formula, which comprises the step of crushing and uniformly mixing the freeze-dried powder obtained after the separation of the coprophilous fungi and the effective components extracted from the traditional Chinese medicines, wherein the freeze-dried powder and the effective components are uniformly mixed and stirred by a miniature stirrer to prepare the bacterium capsule, and the bacterium capsule is further filled with the acid-resistant hydroxypropyl methylcellulose capsule.
The invention further provides a traditional Chinese medicine composition of a medicine for treating type 2 diabetes, which comprises American ginseng, rhizoma polygonati, medicated leaven, cortex lycii radicis and curcuma zedoary, wherein the weight ratio of the American ginseng, the rhizoma polygonati, the medicated leaven, the cortex lycii radicis and the curcuma zedoary is 8-12:12-18:12-18:8-12:8-12, and preferably 10:15:15:10: 10.
The treatment mechanism of the invention is based on the clinical characteristics of diabetes, and the invention belongs to the category of diabetes in traditional Chinese medicine. The traditional Chinese medicine considers that the main pathogenesis of diabetes is 'yin deficiency as the main symptom and dryness-heat as the secondary symptom'. The traditional Chinese medicine considers that the heat of diabetes is classified into dry heat, damp heat and stagnant heat, and the pathogenic of stagnant heat is difficult to remove and the most variable syndrome is among the three types of heat, so that the heat is the main pathological factor for generating various chronic diseases after the diabetes is long. And the qi can promote the production of body fluid, nourish yin and moisten dryness, and simultaneously, the qi-tonifying medicine can play a better role in tonifying yin. Aiming at the pathogenesis characteristics of diabetes with yin deficiency as the basis and heat stasis complicated, the invention proposes a treatment method for tonifying qi and yin, clearing heat and activating blood, the inventor extracts effective components from American ginseng, rhizoma polygonati, medicated leaven, cortex lycii radicis and rhizoma zedoariae, and prepares capsules after smashing the extracted effective components of the traditional Chinese medicines and skillfully combining with coprinus comatus freeze-dried powder, thereby exploring the curative effect of the capsule on type 2 diabetes. In the invention, the American ginseng is a monarch drug, and has the effects of tonifying qi, promoting the production of body fluid, nourishing yin, moistening dryness and clearing heat, and treating diabetes with yin deficiency. Rhizoma polygonati, cortex lycii radicis and rhizoma zedoariae are ministerial drugs, wherein the rhizoma polygonati is neutral in nature, and has the effects of tonifying qi and yin, moistening lung and tonifying kidney, and assisting the American ginseng to tonify qi and promote the production of body fluid; cortex Lycii has effects of clearing heat and cooling blood, and Curcumae rhizoma has effects of promoting qi circulation and removing blood stasis, and invigorating spleen, and can be used for clearing heat and cooling blood and removing blood stasis to treat syndrome of blood stasis and heat. Medicated leaven has the functions of strengthening spleen and stomach, promoting digestion and relieving stasis, and has the functions of dispelling heat accumulation in stomach and intestine and promoting the smooth movement of qi. The traditional Chinese medicine has the advantages of special efficacy, multiple effects, strict compatibility and accordance with pathogenesis. Meanwhile, the modern pharmacology proves that the medicine has the effects of regulating blood sugar, reducing blood fat or improving the hemodynamics, and the medicated leaven can also improve the imbalance of intestinal flora, is through in the middle and the west and has strong persuasion.
The invention has the following beneficial effects: the invention combines the traditional Chinese medicine extraction method, deeply fuses the traditional Chinese medicine extraction method and the fecal bacteria separation process to prepare the flora capsule with the traditional Chinese medicine formula, greatly improves the treatment effect while changing the administration method, and realizes an efficient and comfortable treatment approach. Clinical verification shows that the traditional Chinese medicine formula flora capsule prepared by combining the traditional Chinese medicine formula and the intestinal flora has an obvious treatment effect, the combination of the traditional Chinese medicine formula and the intestinal flora has a complementary effect, the defects of inconvenience in decoction and taking of traditional Chinese medicine are overcome, the pain of patients caused by enteroscopy assistance in the course of flora infusion is overcome, and the treatment effect is obviously improved. Not only meets the requirements of people on applicability, safety and effectiveness, but also realizes the desires of people on environmental protection, humanization and convenience.
Drawings
FIG. 1 is a schematic view of the structure of an intelligent fecal bacteria separation system (i.e., FIG. 1 in the 201410606325.4 patent)
Fig. 2 is a schematic structural view of the sterile disposable consumable of the present invention.
FIG. 3 is a schematic flow chart of the extraction process of Chinese herbs.
FIG. 4 is a schematic structural diagram of a stainless steel filter screen in the intelligent fecal bacteria separation system of the present invention. Wherein the A grade is 1.0mm, the B grade is 600 μm, the C grade is 500 μm, the D grade is 350 μm, the E grade is 250 μm, the F grade is 200 μm, the G grade is 150 μm, the H grade is 100 μm, the I grade is 70 μm, the J grade is 60 μm, and the K grade is 40 μm.
FIG. 5 is a schematic view of the process flow of the flora of the present invention.
FIG. 6 shows the effect of the bacteria capsule preparation on fasting plasma glucose of type 2 diabetes model rats.
FIG. 7 shows the effect of the bacterial capsule preparation of the traditional Chinese medicine formula on the serum insulin of type 2 diabetes model rats.
Fig. 8 is a comparison of FBG before and after two groups of treatments.
FIG. 9 is a comparison of PBG before and after treatment in two groups.
FIG. 10 is a comparison of HbA1c before and after treatment in two groups.
Detailed Description
The invention is further illustrated by the following detailed description of specific embodiments, which are not intended to be limiting but are merely exemplary.
Example 1: extracting flora
The invention uses an intelligent fecal bacteria separating system matched with a disposable consumable component for automatic separation and extraction, wherein the intelligent fecal bacteria separating system is a device for separating microorganisms in cavity contents, and the patent numbers are as follows: ZL201410606325.4, or fecal pretreatment analyzer, model: FMT-5A-50/FMT-6A-50. The disposable consumables comprise a filter flask 3, a separator tank 4, a split charging bottle 5, a deodorizing device 8, a liquid absorption and deodorization buffer bottle 11, a bacteria liquid pipeline 22 and the like.
The method for extracting the flora comprises the following main steps:
200g of excrement sample of a healthy donor is collected by a sterile original material tank (a sterile disposable consumable material with the structure shown in figure 2), the excrement sample is hermetically conveyed to a sterile operation room, and the excrement sample is placed in an intelligent excrement and bacteria separation system together with a filter flask 3, a separation material tank 4, a split charging bottle 5, a deodorizing device 8, a liquid absorption and deodorization buffer bottle 11, a bacteria liquid pipeline 22 and the like to collect flora.
1000ml of physiological saline is filled into the sampling bottle through the liquid adding driving device 7 to soak the excrement sample, and the excrement sample is stirred through the stirring device to be fully homogenized.
And opening the second air pump 31 to collect the mixed bacteria liquid in the sampling bottle into the split bottle 5 sequentially through A, B, C, D, E, F, J, H, I, J, K (detailed values are shown in figure 4) and filter bottles 3 with different filter values. Centrifuging at 5 deg.C, removing supernatant, and retaining precipitate, which is the precipitate of the separated and purified bacteria solution, and has a total weight of about 100 g.
About 10ml (12.6g) of glycerol was added to each of the divided bottles 5, mixed well with a shaker, and pre-frozen in a freezer at-80 ℃ for one hour. After the pre-freezing is finished, the pre-frozen sample is quickly transferred into a bacterial liquid preparation freeze dryer (for example, the product name is the freeze dryer, the production enterprise: Ningbo New Ganoderma lucidum Biotech Co., Ltd., model: scientz-18N) for freeze drying under the pressure of 0.006Pa for not less than 10 hours, and the bacterial liquid after freeze drying is dehydrated to obtain the flora freeze-dried powder.
Example 2: extraction of Chinese medicine
The traditional concentration extraction method is used for extracting effective components of the traditional Chinese medicine (please refer to the process flow of the traditional Chinese medicine extraction in figure 3), and the specific method is as follows:
the medicinal materials of American ginseng, rhizoma polygonati, medicated leaven, cortex lycii radicis and rhizoma zedoariae are taken according to the weight ratio of 10:15:15:10:10, and are cut or crushed properly and placed in a decocting container.
Adding appropriate amount of water to immerse the medicinal materials for appropriate time.
Heating to boil, leaching for a certain time, separating decoction, decocting the residue for 2-3 times, and collecting decoction.
Evaporating the water decoction until the specific gravity is 1:1, adding 2 times of ethanol after cooling, fully mixing, standing overnight for precipitation, filtering the clear solution the next day, cleaning the precipitate with a small amount of 60% ethanol, mixing the cleaning solution and the filtrate, recovering ethanol under reduced pressure, concentrating to 1g/ml, moving to a cooling place (or adding a certain amount of water for mixing), standing for a certain time to complete precipitation, and filtering.
Drying the filtrate with vacuum dryer, pulverizing with superfine pulverizer to obtain 10 μm superfine powder.
Example 3: preparing traditional Chinese medicine formula flora capsule
The technological process of the flora in the traditional Chinese medicine formula is shown in figure 5, the freeze-dried flora powder in the example 1 and the traditional Chinese medicine extract powder extracted in the example 2 are mixed according to the volume ratio of 1:1, then the mixture is stirred and uniformly mixed by a miniature stirrer to prepare the flora in the traditional Chinese medicine formula, acid-resistant hydroxypropyl methylcellulose capsules are used for filling, each capsule contains 1.5 g of traditional Chinese medicine powder and 1.5 g of bacterial powder, and the capsules are packaged by a sealed packaging bag and then stored in a refrigerator at the temperature of minus 20 ℃.
Example 4: therapeutic effect of traditional Chinese medicine formula flora capsule on type 2 diabetes model rats
Through experimental research, the influence of the traditional Chinese medicine formula flora capsule on glycolipid metabolism and insulin resistance of rats of type 2 diabetes models is discussed.
1 materials of the experiment
1.1 Experimental animals
SPF grade SD male rats 40, body weight 200 + -20 g, 8 weeks old. Each cage is 5 cages for raising. Humidity is 40-60%, and room temperature is 16-26 ℃. Feeding with common feed, freely taking water, and feeding before dark. Rats were observed dynamically for food intake and water intake and weighed once a week. Cage padding was changed once a day.
1.2 drugs and reagents
The concentration of the traditional Chinese medicine formula flora capsule prepared in the embodiment 3 is 2.1g/ml when in use, and the traditional Chinese medicine formula flora capsule is the maximum concentration liquid medicine capable of passing through a rat gavage device.
Pioglitazone (Ritong, 15 mg/tablet, Hengrui medicine of Jiangsu, national Standard: H20040631).
Streptozotocin (STZ) (Sigma Co., USA). Glucose assay kit (Shanghai Rongsheng biopharmaceutical Co., Ltd.), insulin ELISA kit (R & G Co., Ltd., Shanghai Yuan Xiang medical instruments Co., Ltd.). Trisodium citrate, citric acid and sodium pentobarbital.
1.3 high-sugar and high-fat feed formula
Cholesterol, lard, sucrose, egg yolk powder and common feed.
1.4 Main instruments and Equipment
Glucometer and blood glucose test paper (Qiangsheng medical equipment company), full-automatic immunoturbidimeter. A table centrifuge, a plurality of syringes, a plurality of test tubes, beakers and measuring cylinders, a precision electronic balance, an electronic scale, tin foil paper and the like.
2 method of experiment
2.1 modeling
After adaptive feeding for 1 week, the rats are randomly divided into a normal control group (10) and a model building group (30), the normal control group is fed with common feed, after the model building group is fed with high-sugar high-fat feed for 6 weeks, the rats of the model building group are injected with streptozotocin (STZ, 30mg/kg) in the abdominal cavity once, the normal control group (A group) is injected with equivalent citric acid buffer solution once, blood is collected after 72 hours, the whole blood sugar is measured by a SureStepPlus glucometer of Qiangsheng company, and the rat model of type 2 diabetes is determined as the blood sugar of which is more than or equal to 16.7 mmol/L.
2.2 animal grouping and administration
After molding, the molded rats were randomly divided into 10 groups of model control group (group B), pioglitazone group (group C) and traditional Chinese medicine formula bacteria group (group D). In addition, 10 normal control groups (group A) were provided. Performing intragastric administration on the group C with 2.5 g/kg.d pioglitazone, and performing intragastric administration on the group D with 12 g/kg.d of traditional Chinese medicine formula flora capsule preparation; the groups A and B were administered with the same amount of physiological saline for intragastric administration. The administration volume was 10ml/kg body weight, 1 time per day, and the administration was continued for 8 weeks at fixed time intervals.
During the experiment, the food and water intake is not limited, and insulin and other hypoglycemic drugs are not used.
2.3 blood sample Collection
The rats were sacrificed before the model creation and on the 8 weekend days after the gavage, fasted for 12 hours before sacrifice, and body weight, body length and tail length were measured; the eye socket blood sampling specimen is used for detecting insulin, blood sugar and other biochemical indexes.
2.4 detection of Biochemical and immunological indices
Blood sugar is detected by a full-automatic biochemical analyzer. All assay items were handled strictly according to the kit instructions.
2.5 statistical treatment
Observation ofAnd comparing the change conditions of the observation indexes in different time periods of each group, and performing hypothesis test and correlation analysis by using SPSS for Windows 22.0 statistical software. All data measured as mean. + -. standard deviation
The results were analyzed by t-test and by variance analysis (Oneway-ANOVA) between two groups and before and after the group. P<A difference of 0.05 is statistically significant.
Results of the experiment
1 influence of traditional Chinese medicine formula flora capsule preparation liquid on fasting blood glucose of model rat
After treatment, the fasting blood glucose of the traditional Chinese medicine formula bacteria group and the pioglitazone group have significant difference (p is less than 0.01) compared with that before treatment, and after treatment, the fasting blood glucose of the traditional Chinese medicine formula bacteria group and the pioglitazone group have significant difference (p is less than 0.01) compared with that of the model group. The results are shown in Table 1 and FIG. 6.
Table 1: influence of traditional Chinese medicine formula flora capsule preparation liquid on fasting plasma glucose of type 2 diabetes model rats
Note: comparison in the anterior and posterior group ═ P < 0.01; Δ P <0.01 compared to the model set.
2 Effect of traditional Chinese medicine formula flora capsule preparation liquid on fasting insulin of model rat serum
After treatment, the fasting insulin levels of the blood serum of rats in the traditional Chinese medicine formula bacterium group and the pioglitazone group are obviously increased compared with those before treatment, and the two groups have statistical significance (P <0.01), and have significant difference (P <0.01) compared with the type 2 diabetes model group. The results are shown in Table 2 and FIG. 7.
Table 2:influence of traditional Chinese medicine formula flora capsule preparation liquid on fasting insulin of 2-type diabetes model rat serum
Note: comparison in the anterior and posterior group ═ P < 0.01; Δ P <0.01 compared to the model set.
And (3) analyzing an experimental result: animal experiments show that the fasting blood glucose of the traditional Chinese medicine formula bacterium group after treatment has significant difference (p is less than 0.01) compared with that before treatment, and has significant difference (p is less than 0.01) compared with a model group. The traditional Chinese medicine formula flora capsule is prompted to have the function of reducing blood sugar.
After treatment, the fasting serum insulin level of the rats in the traditional Chinese medicine formula bacterium group is increased compared with that before treatment, has statistical significance (P <0.01) and has significant difference (P <0.01) compared with a model group. The traditional Chinese medicine formula flora capsule is prompted to have the effects of promoting insulin secretion and improving fasting insulin level, and the traditional Chinese medicine formula flora capsule can achieve the result of reducing blood sugar through the effect.
Example 5: clinical curative effect observation of traditional Chinese medicine formula flora capsule on type 2 diabetes
In order to verify the effect of the traditional Chinese medicine formula flora capsule on treating type 2 diabetes, 60 patients were selected to be subjected to the traditional Chinese medicine formula flora capsule (the traditional Chinese medicine formula flora capsule prepared in example 3) (clinical observation on treating type 2 diabetes, all patients were randomly divided into two groups, wherein 30 patients were treated, 30 patients were compared, and the two groups of patients before treatment had no significant difference in terms of sex, age, course of disease, body mass index and the like through statistical analysis and were comparable.
1. Treatment regimens
Both groups of patients underwent routine basic treatment including health education, diet control, and regular exercise.
Control group: basic treatment and conventional western medicines (according to Chinese guide for prevention and treatment of type 2 diabetes (2010 version)).
Treatment groups: basic treatment, treatment with conventional western medicines (according to Chinese type 2 diabetes prevention and treatment guidelines (2010 version)), and capsule with flora in traditional Chinese medicine formula, 2 times daily, 20 capsules each time.
Both groups were treated for 1 treatment period of 4 weeks, and 3 treatment periods were observed.
2. Western diagnostic criteria:
(1) diabetes [ according to diabetes diagnostic criteria established by the World Health Organization (WHO) 1999 ].
Firstly, obvious DM symptoms such as more than three, one less, and the like exist, and random blood sugar is more than or equal to 11.1mmol/L (200 mg/dl);
② the fasting venous plasma sugar is more than or equal to 7.0mmol/L (126 mg/dl);
③ OGTT (oral administration 75g glucose) PG is more than or equal to 11.1mmol/L (200mg/dl) for 2 hours
The three methods, which are individually in line with one, can be used as diagnosis bases and standards, but the diagnosis can be established when the rechecking result at intervals still meets the diagnosis standards.
(2) Diagnostic criteria for type 2 diabetes
Referring to the diagnostic criteria for Diabetes published in journal Diabetes Care, 7.1997, the results of the insulin release test are one of the following criteria, i.e. type 2 Diabetes.
Firstly, insulin resistance is mainly accompanied by relative insulin deficiency.
② insulin is obviously deficient with insulin resistance.
3. Inclusion criteria
(1) The age is between eighteen years and sixty-five years;
(2) informed consent;
(3) meets the diagnosis standard of type 2 diabetes;
(4) the nature is not limited.
4. Exclusion criteria
(1) T1DM, pregnancy, and blood sugar rise caused by drugs;
(2) if the medicine is not taken according to the prescription, the curative effect or the data are not complete and the like which affect the judgment of the curative effect cannot be judged;
(3) patients who are participating in clinical studies with other drugs.
5. Changes of blood sugar and glycosylated hemoglobin in the front and back groups
Compared with the blood sugar and the glycosylated hemoglobin of the two groups before treatment, the blood sugar and the glycosylated hemoglobin have no obvious difference (P is more than 0.05) and are comparable. After treatment, the fasting blood sugar and the postprandial blood sugar of the patients in the treatment group and the control group are obviously reduced, and have obvious difference (P <0.01) compared with the patients before treatment; the fasting blood glucose improvement of the treatment group is obviously different (P <0.01) compared with the control group, the postprandial blood glucose improvement of the treatment group is different (P <0.05) compared with the control group, and the glycosylated hemoglobin improvement of the treatment group is different (P <0.05) compared with the control group. See table 3, fig. 8, fig. 9, fig. 10.
Table 3: comparison of FBG, PBG, HbA1c before and after treatment of both groups
Note: major anterior and posterior aspect of the treatment is ═ P <0.05, ═ P < 0.01; between-bay comparison Δ P <0.05, Δ P <0.01
6. Analysis of results
After treatment, fasting blood sugar, postprandial blood sugar and glycosylated hemoglobin of patients in the treatment group and the control group are obviously reduced, and have difference (P is less than 0.05 or P is less than 0.01) compared with the control group, which shows that the improvement effect of the conventional western medicine and traditional Chinese medicine formula flora capsule on the blood sugar of type 2 diabetes is better than the effect of controlling the blood sugar by singly using the conventional western medicine.
Example 6: clinical cases
Typical cases in clinical efficacy observations according to example 5 are provided below. I.e. the treatment regimen of the cases was: 20 granules are taken every time, 2 times a day; every 4 weeks for 1 course of treatment; three courses of treatment.
Case 1:
a patient is a male, is 72 years old, has the history of type 2 diabetes for more than 30 years, is orally taken for controlling blood sugar and poor blood sugar by 'gliclazide 30mgqd and acarbose 50mg tid', and then 'saxagliptin 5mg qd', the fasting blood sugar is controlled to be 8.5-9.5mmol/l, the postprandial blood sugar is 10-12mmol/l, and the glycosylated hemoglobin is 7-7.5%. Dry mouth with profuse fluid, fat, dry stool, fatigue, bitter taste, red tongue with yellow coating, and wiry and thready pulse. After the traditional Chinese medicine formula flora capsule is taken, three treatment courses are achieved, dry mouth and bitter taste and fatigue and weakness are obviously improved, and excrement is taken once a day. The fasting blood sugar is controlled to be about 7mmol/l, the postprandial blood sugar is about 8mmol/l, and the glycosylated hemoglobin is 6.8 percent.
Case 2:
a patient king a certain woman in the age of 69 and having a history of type 2 diabetes for 18 years is orally administered with metformin 500mgtid to control blood sugar, and then the symptoms of digestive tracts are obvious, the patients are changed to saxagliptin 5mg qd and repaglinide 1mg tid, fasting blood sugar is controlled to be 9-10mmol/l, postprandial blood sugar is 9-12mmol/l, glycosylated hemoglobin is about 8.5%, blood sugar fluctuation is large, a hypoglycemic reaction occurs once, and then excessive diet control is not needed. Polyphagia, easy hunger, abdominal distension, loose stool, fatigue, dry mouth, red tongue with little coating and thready and rapid pulse. After the traditional Chinese medicine formula flora capsule is taken for three treatment courses, hunger sensation is obviously relieved, abdominal distension and stool conditions are obviously improved, fasting blood sugar is controlled to be 6-9mmol/l, postprandial blood sugar is about 10mmol/l, and glycosylated hemoglobin is 7.8%.
Case 3:
a patient is a male in Luzhi province, the history of type 2 diabetes is 10 years old in 56 years old, the blood sugar is controlled by orally taking metformin and saxagliptin, the fasting blood sugar is controlled at 8-10mmol/l, the postprandial blood sugar is 9-11mmol/l, the glycosylated hemoglobin is 7.7%, the mouth is dry and polydipsia is prone to abdominal distension, and the loose stool is easy. After the traditional Chinese medicine formula flora capsule is taken for three treatment courses, the dry mouth, abdominal distension and stool conditions are obviously improved, metformin is stopped, fasting blood sugar is controlled to be 6-7mmol/l, postprandial blood sugar is about 9mmol/l, and glycosylated hemoglobin is 7.1%.
Case 4:
a patient named Jinzhi, male, 81 years old, has a history of type 2 diabetes for more than 30 years, is orally taken with various hypoglycemic drugs for controlling blood sugar, but the control is poor, the patient is controlled by combining 'Noohalin 30R, 26u early and 12u late' with 'sitagliptin 100mg qd' 5 years ago to control the blood sugar, the fasting blood sugar is controlled at 7-10mmol/l, the postprandial blood sugar is 8-14mmol/l, the glycosylated hemoglobin is about 7.5%, the blood sugar fluctuation is large, the diet control is poor, the patient is easy to anxiety, has little exercise, abdominal distension, defecate is carried out for 2-3 days, the tongue is red, the tongue is yellow, and the pulse is wiry. After the traditional Chinese medicine formula flora capsule is taken for three treatment courses, the symptoms are obviously improved, the fasting blood sugar is controlled to be 6-9mmol/l, the postprandial blood sugar is controlled to be about 9-10mmol/l, and the glycosylated hemoglobin is 6.4%. The daily dosage of insulin is reduced by 4 u.
Case 5:
a patient has some plum, male and 43 years old, and has a history of type 2 diabetes for 3 years, the patient orally takes metformin 1000 mg/day to control blood sugar, fasting blood sugar is good, and glycosylated hemoglobin is 6.5%, but digestive tract symptoms are obvious, abdominal distension is caused, loose stool is easy, the tongue is pale red, teeth marks are formed, and the tongue coating is white and greasy. Because the blood sugar is controlled satisfactorily, the replacement of the hypoglycemic agent is not wanted temporarily, and the capsule with the traditional Chinese medicine formula flora is taken for three treatment courses, abdominal distension and loose stool are improved, metformin is not used, and 6.0% of glycosylated hemoglobin is used.
Case 6:
the patient in forest, male, 76 years old, and the history of type 2 diabetes is 20 years old, the blood sugar is controlled by using 'insulin glargine hypodermic injection 18 u/day' + 'acarbose oral administration 150 mg/day' at ordinary times, the fasting blood sugar is controlled at 6-8mmol/l, the postprandial blood sugar is 8-12mmol/l, the blood sugar is about 11mmol/l after breakfast for 2 hours, the blood sugar is controlled at the rest time period, the glycosylated hemoglobin is 7.2%, the mouth is dry and polydipsia, the stool is dry and irregular, the stool is sticky, the tongue is red and has little coating, and the pulse is thready and wiry. After the traditional Chinese medicine formula flora capsule is taken, three treatment courses are achieved, the dry mouth and excrement conditions are obviously improved, the body is complained of ease, the blood sugar is 7-10mmol/l after breakfast, and the glycosylated hemoglobin is 7%.
Case 7:
the patient Li Yi, Man and 51 years old is diagnosed with the type 2 diabetes for 1 month, the blood sugar is found to be increased during physical examination, the fasting state reaches 12mmol/l, the patient is examined by a hospital system, the type 2 diabetes is diagnosed, the glycosylated hemoglobin is 9.8 percent, the thirst is obvious, the patient is given the subcutaneous injection of 30 u in the morning and 22u in the evening of Nonhui and 10u in the evening to combine with the saxagliptin for 5 mg/day to control the blood sugar, and the capsule is matched with the traditional Chinese medicine formula flora capsule to treat three courses of treatment, the blood sugar control is better, the three courses of treatment are carried out, the thirst is obviously improved, and the glycosylated hemoglobin is 6.4 percent.
Case 8:
a patient is Zhangzhi, a woman is 70 years old, 8 years old for diagnosing type 2 diabetes mellitus, normally, repaglinide 1mg tid + saxagliptin 5mg qd are used for controlling blood sugar, fasting blood sugar is controlled to be 7-8mmol/l, postprandial blood sugar is 8-11mmol/l, glycosylated hemoglobin is 7.3%, dry mouth and polydipsia, dry and irregular stool, red tongue with little coating and fine and wiry pulse. By taking the traditional Chinese medicine formula flora capsule cooperatively, the dry mouth and stool conditions are obviously improved in three treatment courses, the fasting blood sugar is 6-8mmol/l, the postprandial blood sugar is 7-9mmol/l, and the glycosylated hemoglobin is 6.4%.
Case 9:
a patient is young and a woman is 81 years old, the 2-type diabetes mellitus is diagnosed for nearly 40 years, the patient usually uses 'Nohejia 30 u 26u early and 14u late' subcutaneous injection to control blood sugar, but diet is irregular, the patient is fond of eating snacks, so the blood sugar is not well controlled, fluctuation is large, the blood sugar is 7-16mmol/l, diet control is difficult, glycosylated hemoglobin is 8.4%, diabetic retinopathy and peripheral neuropathy complications exist, dry mouth and polydipsia are prone to abdominal distension, numbness of hands and feet, unclear vision, skin itch, memory decline, oral ulcer easily, constipation, red tongue with thin and yellow coating and wiry pulse. The standard use of insulin is guided, the injection dosage is adjusted when more food is eaten or the blood sugar is higher, and the capsule of the traditional Chinese medicine formula flora is taken in a matched manner to treat three courses of treatment, dry mouth, blurred vision, pruritus cutanea, clear stool, difficult change of eating habits, 7-11mmol/l of blood sugar and 7% of glycosylated hemoglobin.
Case 10:
a patient in south China is a male or a 50-year old, is diagnosed with the type 2 diabetes for 12 years, usually uses 'insulin glargine 20 u/day subcutaneous injection' + '1 mg oral administration before three meals of noh and long' to control blood sugar, has 'dyspepsia' and is easy to have abdominal distension, the possibility of 'gastroparesis' is considered before 2 years, the blood sugar fluctuation is between 6 and 13mmol/l, more indigestible food is eaten, abdominal distension, even vomiting, irregular defecate is eaten for one line in 1 to 4 days, the time is dry, the tongue is reddish, the tooth marks are formed, the tongue is white and greasy, and the pulse is weak. Regular diet is guided, and the traditional Chinese medicine formula flora capsules are taken in a matched manner, so that three treatment courses are achieved, abdominal distension is obviously improved, vomiting is avoided, excrement is obviously improved, blood sugar is 6-11mmol/l, and glycosylated hemoglobin is 7.5%.
Case 11:
a patient aged for a certain time, female and 67 years old, diagnosed with the type 2 diabetes mellitus for nearly 20 years, is treated by oral hypoglycemic drugs once, and then is poor in blood sugar control, the patient uses 14 u/day subcutaneous injection of insulin glargine plus 50mg before acarbose three meals to control blood sugar, and the dosage of insulin glargine is reduced to 10 u/day, 7mmol/l of fasting blood sugar, 9-10mmol/l of postprandial blood sugar and 8% of glycosylated hemoglobin are matched to take the traditional Chinese medicine formula flora capsule, so that three treatment courses are achieved, the mood anxiety is improved, the dosage of insulin glargine is reduced to 10 u/day, 7mmol/l of fasting blood sugar, 7-9mmol/l of postprandial blood sugar and 7.5% of glycosylated hemoglobin.
Case 12:
after a certain patient is born by 37 years old and male, the blood sugar is increased by physical examination, then 2-type diabetes mellitus is diagnosed, spatiotemporal abdominal blood sugar is found to be 7.2mmol/l, postprandial blood sugar is 10.0mmol/l, glycosylated hemoglobin is 7.8%, polyphagia and bulimia are caused, dry mouth is guided to control diet and exercise in proper amount, and after the traditional Chinese medicine formula flora capsule is taken, three treatment courses are treated, polyphagia and bulimia are caused, dry mouth is improved, fasting blood sugar is about 6.5mmol/l, postprandial blood sugar is about 8.0mmol/l, and glycosylated hemoglobin is 7.3%.
Claims (10)
1. A traditional Chinese medicine formula flora capsule is characterized in that the traditional Chinese medicine formula flora capsule is prepared by crushing freeze-dried powder after separation of fecal bacteria and traditional Chinese medicine extraction effective components to obtain traditional Chinese medicine extraction powder;
the preparation method of the freeze-dried powder after the coprophilous fungi separation comprises the following steps:
(1) collecting feces samples of healthy donors by using an aseptic sampling bottle, sealing and conveying the feces samples to an aseptic operation room, matching with a filter bottle, an AB bottle, a deodorization bottle, a buffer bottle and a bacteria liquid bottle in an aseptic disposable consumable material, connecting in series, and placing in an intelligent feces and bacteria separation system for flora collection;
(2) the liquid adding driving device is used for automatically adding liquid to fill the physiological saline into the sampling bottle to soak the fecal sample;
(3) opening an air pump to collect the mixed bacteria liquid in the sampling bottle into a buffer bottle sequentially through filter screens with different filtering values, then filling the bacteria liquid in the buffer bottle into the bacteria liquid bottle through a bacteria liquid driving device, centrifuging, removing supernatant after centrifugation, and keeping precipitate, wherein the precipitate is the separated and purified bacteria liquid precipitate;
(4) adding glycerol into each centrifugal tube, uniformly mixing the glycerol with an oscillator, pre-freezing the glycerol, quickly freezing and drying a pre-frozen sample after the pre-freezing is finished, and dehydrating the freeze-dried bacterial liquid to obtain freeze-dried powder;
the Chinese medicine extract powder is prepared by crushing effective components extracted from a Chinese medicine formula consisting of American ginseng, rhizoma polygonati, medicated leaven, cortex lycii radicis and curcuma zedoary.
2. The traditional Chinese medicine formula flora capsule according to claim 1, wherein a stirring rod is arranged in the sampling bottle, and in the step (2), the stirring rod in the sampling bottle stirs the fecal sample to be fully homogenized.
3. The traditional Chinese medicine formulation flora capsule of claim 1 or 2, wherein: the volume ratio of the freeze-dried powder separated from the coprophilous fungi to the traditional Chinese medicine extraction powder is 0.5-2: 1; wherein the freeze-dried powder separated from the fecal bacteria and the traditional Chinese medicine extract powder are uniformly mixed by a micro-mixer after the two are mixed.
4. The traditional Chinese medicine formula flora capsule of claim 3, wherein: the volume ratio of the freeze-dried powder separated from the coprophilous fungi to the traditional Chinese medicine extraction powder is 1: 1.
5. the traditional Chinese medicine formula flora capsule of claim 3, wherein: further filling with acid-resistant hypromellose capsule to obtain traditional Chinese medicine flora capsule.
6. The traditional Chinese medicine formula flora capsule of claim 4, wherein: further filling with acid-resistant hypromellose capsule to obtain traditional Chinese medicine flora capsule.
7. The traditional Chinese medicine formula flora capsule of claim 1, wherein: the weight ratio of the American ginseng to the western ginseng, the sealwort, the medicated leaven, the cortex lycii radicis and the curcuma zedoary in the traditional Chinese medicine formula is 8-12:12-18:12-18:8-12: 8-12.
8. The traditional Chinese medicine formula flora capsule of claim 7, wherein: the weight ratio of the American ginseng to the western ginseng, the sealwort, the medicated leaven, the cortex lycii radicis and the curcuma zedoary in the traditional Chinese medicine formula is 10:15:15:10: 10.
9. The traditional Chinese medicine formula flora capsule according to claim 7 or 8, wherein: the preparation method of the traditional Chinese medicine extraction powder comprises the following steps,
(1) cutting or pulverizing the above herbs at a certain proportion, and placing in a decocting container;
(2) soaking in water;
(3) heating to boil, leaching, separating decoction, decocting the residue for 2-3 times, and collecting decoction;
(4) extracting the decoction with ethanol;
(5) drying the filtrate extracted by ethanol, and then pulverizing the dried filtrate by using a superfine pulverizer to obtain superfine powder with the particle size of less than 10 mu m.
10. Use of a traditional Chinese formulation flora capsule according to any of claims 1 to 9 in the manufacture of a medicament for the treatment of type 2 diabetes.
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| CN115989798A (en) * | 2022-09-21 | 2023-04-21 | 中国人民解放军联勤保障部队第九〇〇医院 | IgA vasculitis humanized flora mouse model and construction method |
| CN115969034B (en) * | 2022-11-01 | 2023-12-22 | 嫦娥创新（武汉）生物科技有限公司 | Oral freeze-dried powder for diabetics and preparation method thereof |
| CN115887604A (en) * | 2023-01-06 | 2023-04-04 | 杭州络通生物科技有限公司 | Research on drug for treating type II diabetes by using citrus reticulata blanco and liquorice extracts |
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| CN104922158A (en) * | 2015-06-05 | 2015-09-23 | 中国人民解放军第三军医大学第三附属医院 | Fecal microbiota capsule, as well as preparation method and application thereof |
| CN105624024A (en) * | 2014-10-31 | 2016-06-01 | 南京法迈特科技发展有限公司 | Separation device of microorganisms in gastrointestinal tract contents |
| CN110638782A (en) * | 2019-09-16 | 2020-01-03 | 广东南芯医疗科技有限公司 | Method for preparing capsule |
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| SG187713A1 (en) * | 2010-08-04 | 2013-03-28 | Borody Thomas J | Compositions for fecal floral transplantation and methods for making and using them and devices for delivering them |
| BR112015012123A8 (en) * | 2012-11-26 | 2018-01-23 | Borody Thomas J | compositions for the recovery of a fecal microbiota and methods for producing and using them. |
| CN105749064A (en) * | 2016-05-09 | 2016-07-13 | 林荣波 | Traditional Chinese medicine composition with blood glucose reduction function |
| CN106492117A (en) * | 2016-11-30 | 2017-03-15 | 王江波 | A kind of Chinese medicine composition for treating diabetes |
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