阅读说明：本技术 一种治疗慢性溃疡性结肠炎中药制剂及其制备方法 (Traditional Chinese medicine preparation for treating chronic ulcerative colitis and preparation method thereof ) 是由 姜璐 赵启东 赵玉洁 于 2020-05-21 设计创作，主要内容包括：本发明属于药物制备技术领域,公开了一种治疗慢性溃疡性结肠炎中药制剂及其制备方法,治疗慢性溃疡性结肠炎中药制剂包括马齿苋、小叶三点金、金樱子、马兰、枇杷叶、藿香、水；制备方法包括将药材加水进行浸泡,煎煮,过滤；减压浓缩得到浸膏,经减压干燥、粉碎、过筛,得到药物粉末；在药物粉末中加入硬脂酸镁和蒸馏水,充分混合,压片得到片剂；将阻滞剂、致孔剂、增塑剂、抗粘剂溶解在水中,配制成混合液喷涂于片剂外层,制成缓释片剂。本发明能够实现清热解毒、止泻的效果,对肠道起到舒缓镇静效果,实现对慢性溃疡性结肠炎的治疗,无毒副作用；药物在肠道维持有效浓度时间长,能增强治疗效果。(The invention belongs to the technical field of medicine preparation, and discloses a traditional Chinese medicine preparation for treating chronic ulcerative colitis and a preparation method thereof, wherein the traditional Chinese medicine preparation for treating chronic ulcerative colitis comprises purslane, lobular trilobate gold, cherokee rose fruit, kalimeris indica, loquat leaf, wrinkled gianthyssop herb and water; the preparation method comprises soaking the above materials in water, decocting, and filtering; concentrating under reduced pressure to obtain extract, drying under reduced pressure, pulverizing, and sieving to obtain medicinal powder; adding magnesium stearate and distilled water into the medicinal powder, mixing, and tabletting to obtain tablet; dissolving retarder, pore-forming agent, plasticizer, and antisticking agent in water, and spraying the mixture on the outer layer of tablet to obtain sustained release tablet. The traditional Chinese medicine composition can realize the effects of clearing away heat and toxic materials and stopping diarrhea, has the effect of relieving and calming the intestinal tract, realizes the treatment of chronic ulcerative colitis, and has no toxic or side effect; the medicine can maintain effective concentration in intestinal tract for a long time, and can enhance therapeutic effect.)

1. A preparation method of a traditional Chinese medicine preparation for treating chronic ulcerative colitis is characterized in that the preparation method of the traditional Chinese medicine preparation for treating chronic ulcerative colitis comprises the following steps:

mixing purslane, lobular trilobate gold, cherokee rose fruit, kalimeris indica, loquat leaf and wrinkled gianthyssop herb, and cleaning the mixture for three times by using distilled water to remove surface impurities;

step two, adding water into the cleaned mixture for soaking, putting the soaked mixture into a decocting container of a decocting control system, and inputting the weight and the type of the related mixture;

step three, the decocting control system controller obtains the weight and type data of the input related mixture, judges and sets the water absorption coefficient, the heating temperature, the heating firepower and the total heating time of the traditional Chinese medicine, calculates the required water adding amount according to the corresponding water adding amount functional relation, and controls the water inlet pipe to add water according to the required water adding amount;

the function relationship of the water adding amount is that the water adding amount is (the water absorption coefficient of the weight of the traditional Chinese medicinal materials is ×, the required decoction amount is added, the total heating time is ×, the evaporation amount per unit time of slow fire is added)/(1, the boiling time coefficient is ×, and the evaporation amount per unit time of slow fire is added);

the required soup amount is a fixed value, the heat supply amount corresponding to the strong fire is a fixed value, the heat supply amount corresponding to the slow fire is a fixed value, the boiling time coefficient of the strong fire is the time required by each unit of water from the initial temperature to the boiling point temperature under the condition of heating by the strong fire, and the evaporation amount of the slow fire in unit time is the evaporation amount of water under the condition of heating by the slow fire in unit time;

step four, after the water is added, controlling the heater to heat, measuring the heating time by using a timer, and when the actual heating time reaches the required heating time, controlling the heater to stop heating by using the controller; meanwhile, the controller controls the filter to filter the liquid medicine to obtain a first filtrate;

step five, adding water into the residual medicine dregs filtered in the step four again, and carrying out secondary decoction and filtration by using a decoction control system to obtain a second filtrate;

step six, uniformly mixing the first filtrate obtained in the step four and the second filtrate obtained in the step five to obtain a mixed filtrate; adding the mixed filtrate into a reduced pressure concentration tank of a reduced pressure concentration device, and reducing the pressure of the reduced pressure concentration device to a negative pressure state and maintaining the negative pressure state;

step seven, starting a circulating pump of the decompression concentration device, introducing high-temperature steam into the decompression concentration tank, controlling a heater to heat, separating the steam generated in heating from the liquefied liquid part by using a gas-liquid separation device, cooling the steam by using a cooling device, and collecting the steam at the bottom of the cooling device; concentrating the liquid part again by using a reduced pressure concentration tank until an extract is obtained;

step eight, adding the extract obtained in the step seven into a decompression drying device, performing decompression drying on the extract by using the decompression drying device, simultaneously detecting the heating temperature of the extract in real time by using a temperature sensor, detecting the humidity of the extract by using a humidity sensor, and adjusting the heating temperature based on the detected humidity of the extract; when the detected humidity of the extract reaches a preset drying value, stopping heating, and crushing and sieving the dried extract by using an ultrasonic crusher to obtain medicine powder;

step nine, adding the medicine powder into a mixer, adding magnesium stearate and distilled water into the mixer, setting the mixing time to be 10-20 min, fully mixing, and tabletting by using a tabletting machine to obtain tablets;

dissolving the retarder, the pore-forming agent, the plasticizer and the anti-sticking agent in water to prepare a mixed solution, and spraying the mixed solution on the outer layer of the tablet to prepare the slow-release tablet.

2. The method for preparing a Chinese medicinal preparation for treating chronic ulcerative colitis according to claim 1, wherein in the second step, when the cleaned mixture is soaked in water, the water is over the medicinal materials.

3. The method for preparing a Chinese medicinal preparation for treating chronic ulcerative colitis according to claim 1, wherein in step three, the heating temperature and total heating time are as follows: the heating temperature is 90-110 ℃, and the heating time is 3-4 hours.

4. The method for preparing a traditional Chinese medicine preparation for treating chronic ulcerative colitis according to claim 1, wherein in step eight, the size of the screen used for sieving is 14-16 meshes.

5. The method for preparing a traditional Chinese medicine preparation for treating chronic ulcerative colitis according to claim 1, wherein in the tenth step, the mass ratio of the retarder, the pore-forming agent, the plasticizer and the anti-sticking agent is 4:3:2: 2.

6. The method for preparing a Chinese medicinal formulation for treating chronic ulcerative colitis of claim 1, wherein in step ten, the retardant is one or a combination of ethyl cellulose and alosetron.

7. The method for preparing a Chinese medicinal preparation for treating chronic ulcerative colitis according to claim 1, wherein in step ten, the pore-forming agent is a composition of one or more of polyethylene glycols, lactose, sucrose, hypromellose, polyvinylpyrrolidone, sodium lauryl sulfate, tween 80, talc, or silicon dioxide.

8. The method of claim 1, wherein in step ten, the plasticizer is one or more of triethyl citrate, tributyl citrate, dimethyl phthalate, diethyl phthalate, and dibutyl phthalate.

9. The method for preparing a Chinese medicinal preparation for treating chronic ulcerative colitis according to claim 1, wherein in step ten, the antisticking agent is a combination of one or more of talc and glycerol monostearate.

10. The traditional Chinese medicine preparation for treating chronic ulcerative colitis, which is prepared by the preparation method of the traditional Chinese medicine preparation for treating chronic ulcerative colitis according to the claims 1-9, is characterized by comprising the following components in parts by mass:

13-15 parts of purslane, 10-20 parts of trilobate chloranthus, 8-12 parts of cherokee rose fruit, 4-6 parts of Indian kalimeris herb, 3-9 parts of loquat leaf, 2-4 parts of wrinkled gianthyssop herb and 130 parts of water.

Technical Field

The invention belongs to the technical field of medicine preparation, and particularly relates to a traditional Chinese medicine preparation for treating chronic ulcerative colitis and a preparation method thereof.

Background

At present, chronic ulcerative colitis is a diffuse inflammation of colon and rectal mucosa, the symptoms are mainly diarrhea, stool containing blood, pus and mucus is discharged, paroxysmal spastic pain of colon is often accompanied, and the chronic ulcerative colitis is heavy after urgency and can be relieved after defecation. At present, the clinical treatment is mostly carried out by adopting amino salicylic acid and cortical solid acid medicines, but the defects of rebound after medicine withdrawal, unstable curative effect, large side effect after long-term medicine administration and the like exist; the surgery treatment excises the whole colon, has more complications and seriously influences the life quality of postoperative patients; the traditional Chinese medicine preparation has the problems of slow effect and poor treatment effect.

Through the above analysis, the problems and defects of the prior art are as follows: the adoption of aminosalicylic acid and cortical solid acid medicines in the treatment of chronic ulcerative colitis has the defects of rebound after medicine withdrawal, unstable curative effect, large side effect after long-term administration and the like; the complications of the operation treatment are more, and the life quality of the postoperative patient is seriously influenced; the traditional Chinese medicine preparation has slow effect and poor treatment effect.

Disclosure of Invention

Aiming at the problems in the prior art, the invention provides a traditional Chinese medicine preparation for treating chronic ulcerative colitis and a preparation method thereof.

The invention is realized in such a way that a preparation method of a traditional Chinese medicine preparation for treating chronic ulcerative colitis comprises the following steps:

mixing purslane, lobular trilobate gold, cherokee rose fruit, kalimeris indica, loquat leaf and wrinkled gianthyssop herb, and cleaning the mixture for three times by using distilled water to remove surface impurities;

step two, adding water into the cleaned mixture for soaking, putting the soaked mixture into a decocting container of a decocting control system, and inputting the weight and the type of the related mixture;

step three, the decocting control system controller obtains the weight and type data of the input related mixture, judges and sets the water absorption coefficient, the heating temperature, the heating firepower and the total heating time of the traditional Chinese medicine, calculates the required water adding amount according to the corresponding water adding amount functional relation, and controls the water inlet pipe to add water according to the required water adding amount;

the function relationship of the water adding amount is that the water adding amount is (the water absorption coefficient of the weight of the traditional Chinese medicinal materials is ×, the required decoction amount is added, the total heating time is ×, the evaporation amount per unit time of slow fire is added)/(1, the boiling time coefficient is ×, and the evaporation amount per unit time of slow fire is added);

the required soup amount is a fixed value, the heat supply amount corresponding to the strong fire is a fixed value, the heat supply amount corresponding to the slow fire is a fixed value, the boiling time coefficient of the strong fire is the time required by each unit of water from the initial temperature to the boiling point temperature under the condition of heating by the strong fire, and the evaporation amount of the slow fire in unit time is the evaporation amount of water under the condition of heating by the slow fire in unit time;

step four, after the water is added, controlling the heater to heat, measuring the heating time by using a timer, and when the actual heating time reaches the required heating time, controlling the heater to stop heating by using the controller; meanwhile, the controller controls the filter to filter the liquid medicine to obtain a first filtrate;

step five, adding water into the residual medicine dregs filtered in the step four again, and carrying out secondary decoction and filtration by using a decoction control system to obtain a second filtrate;

step six, uniformly mixing the first filtrate obtained in the step four and the second filtrate obtained in the step five to obtain a mixed filtrate; adding the mixed filtrate into a reduced pressure concentration tank of a reduced pressure concentration device, and reducing the pressure of the reduced pressure concentration device to a negative pressure state and maintaining the negative pressure state;

step seven, starting a circulating pump of the decompression concentration device, introducing high-temperature steam into the decompression concentration tank, controlling a heater to heat, separating the steam generated in heating from the liquefied liquid part by using a gas-liquid separation device, cooling the steam by using a cooling device, and collecting the steam at the bottom of the cooling device; concentrating the liquid part again by using a reduced pressure concentration tank; until obtaining extract;

step eight, adding the extract obtained in the step seven into a decompression drying device, performing decompression drying on the extract by using the decompression drying device, simultaneously detecting the heating temperature of the extract in real time by using a temperature sensor, detecting the humidity of the extract by using a humidity sensor, and adjusting the heating temperature based on the detected humidity of the extract; when the detected humidity of the extract reaches a preset drying value, stopping heating, and crushing and sieving the dried extract by using an ultrasonic crusher to obtain medicine powder;

step nine, adding the medicine powder into a mixer, adding magnesium stearate and distilled water, setting the mixing time to be 10-20 min, fully mixing, and tabletting by a tabletting machine to obtain tablets;

dissolving the retarder, the pore-forming agent, the plasticizer and the anti-sticking agent in water to prepare a mixed solution, and spraying the mixed solution on the outer layer of the tablet to prepare the slow-release tablet.

Further, in the second step, when the cleaned mixture is soaked in water, the water is over the medicinal materials.

Further, in the third step, the heating temperature and the total heating time are as follows: the heating temperature is 90-110 ℃, and the heating time is 3-4 hours.

Further, in the eighth step, the size of the screen used for sieving is 14-16 meshes.

Further, in the tenth step, the mass ratio of the retarder, the pore-forming agent, the plasticizer and the anti-sticking agent is 4:3:2: 2.

Further, in the tenth step, the retardant is one or a combination of two of ethyl cellulose and alosetron.

Further, in the tenth step, the pore-forming agent is a composition of one or more of polyethylene glycols, lactose, sucrose, hypromellose, polyvinylpyrrolidone, sodium dodecyl sulfate, tween 80, talc powder or silicon dioxide.

Further, in the tenth step, the plasticizer is one or more of triethyl citrate, tributyl citrate, dimethyl phthalate, diethyl phthalate and dibutyl phthalate.

Further, in the tenth step, the antisticking agent is a composition of one or more of talcum powder and glyceryl monostearate.

The invention also aims to provide a traditional Chinese medicine preparation for treating chronic ulcerative colitis, which is prepared by the preparation method of the traditional Chinese medicine preparation for treating chronic ulcerative colitis, and the traditional Chinese medicine preparation for treating chronic ulcerative colitis comprises the following components in parts by mass:

13-15 parts of purslane, 10-20 parts of trilobate chloranthus, 8-12 parts of cherokee rose fruit, 4-6 parts of Indian kalimeris herb, 3-9 parts of loquat leaf, 2-4 parts of wrinkled gianthyssop herb and 130 parts of water.

By combining all the technical schemes, the invention has the advantages and positive effects that: herba Portulacae is a plant used as both medicine and food, and has effects of clearing heat, promoting diuresis, removing toxic substance, relieving swelling, eliminating inflammation, quenching thirst, and promoting urination. Acid in nature and cold in nature. It enters liver and large intestine meridians. Clear heat and remove toxicity, cool blood and stop bleeding, stop dysentery. It can be used for treating toxic heat, dysentery with blood, carbuncle, furuncle, eczema, hematochezia, hemorrhoid, metrorrhagia, and metrostaxis. The herba Dictyotae Repentis is (radix Dictyotae Repentis) of Desmodium of Leguminosae, and is used as medicine by root and whole herb. Sweet in nature and mild in nature. Mainly used for strengthening spleen and promoting diuresis, relieving cough and asthma, and detoxifying and reducing swelling. Can be used for treating dysentery, cough, asthma, and bronchitis. Fructus Rosae Laevigatae is dried mature fruit of fructus Rosae Laevigatae of Rosaceae. Has the effects of securing essence and reducing urination, securing metrorrhagia and leukorrhagia, and relieving diarrhea with astringents. It is commonly used for seminal emission, spermatorrhea, enuresis, frequent urination, metrorrhagia, leukorrhagia, chronic diarrhea and dysentery. Herba Kalimeridis is dried whole plant or root of Kalimerian of Compositae, collected in summer and autumn, and used fresh or sun-dried. It is pungent in flavor and cool in nature. Has the effects of cooling blood, stopping bleeding, clearing heat, promoting diuresis, removing toxic substances and relieving swelling. Can be used for treating hematemesis, epistaxis, bloody dysentery, metrorrhagia, traumatic hemorrhage, jaundice, edema, stranguria with turbid urine, common cold, cough, pharyngalgia, pharyngitis, hemorrhoid, carbuncle, erysipelas, and infantile malnutrition. The folium Eriobotryae is leaf of Eriobotrya japonica of Rosaceae. Has effects in clearing away lung heat, relieving cough, regulating stomach function, promoting urination, and quenching thirst. Has effects of treating lung heat phlegm cough, hemoptysis, epistaxis, and stomach heat emesis. Huoxiang pungent, slightly warm. It enters spleen, stomach and lung meridians. Fragrant, resolving turbidity, regulating the middle warmer, arresting vomiting, relieving exterior syndrome and clearing summer-heat. Can be used for treating damp obstruction in middle warmer, abdominal distention, emesis, summer-heat dampness exterior syndrome, early stage of damp-warm syndrome, fever, listlessness, chest distress, cold-dampness, summer-heat, abdominal pain, emesis, diarrhea, nasosinusitis, and headache.

According to the invention, by adding the purslane, the herba saururi chinensis, the cherokee rose fruit, the kalimeris indica, the loquat leaves and the agastache rugosus, the effects of clearing away heat and toxic materials, stopping diarrhea, promoting qi circulation and relieving pain can be realized, the effect of relieving and calming the intestinal tract is realized, the treatment of the chronic ulcerative colitis is realized, and no toxic or side effect is caused. The slow release of the medicine ensures that the medicine can maintain the effective concentration in the intestinal tract for a long time, and can enhance the treatment effect.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed to be used in the embodiments of the present application will be briefly described below, and it is obvious that the drawings described below are only some embodiments of the present application, and it is obvious for those skilled in the art that other drawings can be obtained from the drawings without creative efforts.

Fig. 1 is a flow chart of a method for preparing a traditional Chinese medicine preparation for treating chronic ulcerative colitis according to an embodiment of the present invention.

Fig. 2 is a graph of the effects of sustained release provided by embodiments of the present invention.

FIG. 3 is a graph showing the relationship between the time and the release concentration of the sustained-release tablet when the coating amount of the sustained-release drug provided by the embodiment of the present invention is 5.0.

FIG. 4 is a graph showing the relationship between the time and the release concentration of the sustained-release tablet when the coating amount of the sustained-release drug provided by the embodiment of the present invention is 6.0.

FIG. 5 is a graph showing the relationship between the time and the release concentration of the sustained-release tablet when the coating amount of the sustained-release drug provided by the embodiment of the present invention is 7.0.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

Aiming at the problems in the prior art, the invention provides a traditional Chinese medicine preparation for treating chronic ulcerative colitis and a preparation method thereof, and the invention is described in detail with reference to the accompanying drawings.

As shown in fig. 1, the preparation method of the traditional Chinese medicine preparation for treating chronic ulcerative colitis provided by the embodiment of the present invention includes the following steps:

s101, mixing purslane, lobular trilobate gold, cherokee rose fruit, kalimeris indica, loquat leaf and wrinkled gianthyssop herb, and cleaning the mixture for three times by using distilled water to remove surface impurities;

s102, soaking the cleaned mixture in water, decocting for 3-4 hours at 90-110 ℃ by using a decoction control system, filtering to obtain filtrate, repeatedly adding water, decocting and filtering once, and combining the two filtrates;

s103, carrying out reduced pressure concentration on the filtrate by using a reduced pressure concentration device to obtain an extract, and carrying out reduced pressure drying, crushing and sieving on the extract by using a reduced pressure drying device to obtain medicine powder;

s104, adding the medicine powder into a mixer, adding magnesium stearate and distilled water, setting the mixing time to be 10-20 min, fully mixing, and tabletting by a tabletting machine to obtain tablets;

and S105, dissolving the retarder, the pore-forming agent, the plasticizer and the anti-sticking agent in water to prepare a mixed solution, and spraying the mixed solution on the outer layer of the tablet to prepare the slow-release tablet.

The traditional Chinese medicine preparation for treating chronic ulcerative colitis provided by the embodiment of the invention comprises the following components in parts by mass:

13-15 parts of purslane, 10-20 parts of trilobate chloranthus, 8-12 parts of cherokee rose fruit, 4-6 parts of Indian kalimeris herb, 3-9 parts of loquat leaf, 2-4 parts of wrinkled gianthyssop herb and 130 parts of water.

In step S102, a decocting control method of a decocting control system provided in the embodiment of the present invention includes:

(1) putting the soaked mixture into a decocting container, and inputting the weight and type of the related mixture;

(2) the decocting control system controller obtains the input weight and type data of the related mixture, judges and sets the water absorption coefficient, the heating temperature, the heating firepower and the total heating time of the traditional Chinese medicine, calculates the required water adding amount according to the corresponding water adding amount functional relation, and controls the water inlet pipe to add water according to the required water adding amount;

the function relationship of the water adding amount is that the water adding amount is (the water absorption coefficient of the weight of the traditional Chinese medicinal materials is ×, the required decoction amount is added, the total heating time is ×, the evaporation amount per unit time of slow fire is added)/(1, the boiling time coefficient is ×, and the evaporation amount per unit time of slow fire is added);

the required soup amount is a fixed value, the heat supply amount corresponding to the strong fire is a fixed value, the heat supply amount corresponding to the slow fire is a fixed value, the boiling time coefficient of the strong fire is the time required by each unit of water from the initial temperature to the boiling point temperature under the condition of heating by the strong fire, and the evaporation amount of the slow fire in unit time is the evaporation amount of water under the condition of heating by the slow fire in unit time;

(3) after the water is added, controlling the heater to heat, measuring the heating time by using a timer, and when the actual heating time reaches the required heating time, controlling the heater to stop heating by using the controller; meanwhile, the controller controls the filter to filter the liquid medicine to obtain a first filtrate;

(4) adding water again to the residue filtered in the step (3), and performing secondary decoction and filtration by using a decoction control system to obtain a second filtrate; and uniformly mixing the obtained first filtrate and the obtained second filtrate to obtain mixed filtrate.

In step S103, the reduced-pressure concentration method provided in the embodiment of the present invention includes:

adding the mixed filtrate into a reduced pressure concentration tank of a reduced pressure concentration device, and reducing the pressure of the reduced pressure concentration device to a negative pressure state and maintaining the negative pressure state; starting a circulating pump of the decompression concentration device, introducing high-temperature steam into the decompression concentration tank, controlling a heater to heat, separating the steam generated in heating from the liquefied liquid part by using a gas-liquid separation device, cooling the steam by using a cooling device, and collecting the steam at the bottom of the cooling device; and concentrating the liquid part again by using a reduced pressure concentration tank until an extract is obtained.

In step S103, the reduced-pressure drying method provided in the embodiment of the present invention includes:

adding the obtained extract into a decompression drying device, performing decompression drying on the extract by using the decompression drying device, simultaneously detecting the heating temperature of the extract in real time by using a temperature sensor, detecting the humidity of the extract by using a humidity sensor, and adjusting the heating temperature based on the detected humidity of the extract; and when the detected moisture of the extract reaches a preset drying value, stopping heating.

The mass ratio of the retarder, the pore-forming agent, the plasticizer and the anti-sticking agent provided by the embodiment of the invention is 4:3:2: 2.

The retarder provided by the embodiment of the invention is one or a composition of two of ethyl cellulose and alosetron.

The pore-foaming agent provided by the embodiment of the invention is one or a composition of polyethylene glycol, lactose, sucrose, hydroxypropyl methylcellulose, polyvinylpyrrolidone, sodium dodecyl sulfate, tween 80, talcum powder or silicon dioxide.

The plasticizer provided by the embodiment of the invention is one or a combination of triethyl citrate, tributyl citrate, dimethyl phthalate, diethyl phthalate and dibutyl phthalate.

The antisticking agent provided by the embodiment of the invention is a composition of one or more of talcum powder and glyceryl monostearate.

The technical solution of the present invention is further described with reference to the following specific examples.