Improved laxative capsule as well as preparation method and application thereof

Abstract

The invention discloses an improved laxative capsule as well as a preparation method and application thereof, the improved laxative capsule is prepared by extracting the following traditional Chinese medicine decoction pieces in parts by weight: 10-20 parts of cistanche, 10-20 parts of eucommia ulmoides, 15-25 parts of semen cuscutae, 20-30 parts of Chinese yam and the like, and the invention discloses the preparation method of the improved laxative capsule. Pharmacodynamic experiments prove that the improved laxative capsule has a good effect on treating spleen-kidney yang deficiency type constipation.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to an improved Tongbianling capsule and a preparation method and application thereof. Background Art

[0002] Tongbianling Capsule is a product listed in the seventh volume of the original standard Chinese medicine formula preparation issued by the Ministry. It can relieve heat and stagnation, moisten the intestines and relieve constipation. It is used for constipation caused by heat accumulation, constipation caused by long-term bed rest, temporary abdominal distension and constipation, and habitual constipation in the elderly. The prescription and process are as follows: Prescription: 1200g senna leaves, 150g angelica, 150g Cistanche deserticola; Process: Take 75g angelica and grind it into fine powder, add water to the remaining angelica and senna leaves, boil for 1.5 hours, filter, concentrate the filtrate into a thick paste, add angelica powder, mix well, dry at low temperature, crush, sieve, mix well, and put it into capsules.

[0003] Analyzing the habitual constipation of the elderly, traditional Chinese medicine believes that it is mainly due to the following reasons: First, the gastrointestinal motility is reduced, which easily leads to feces being retained in the intestines and unable to be excreted. Second, the abdominal muscle tension is reduced, resulting in weak defecation, making it difficult to excrete feces. Third, the amount of activity is relatively small, and the gastrointestinal motility is slowed down. Fourth, due to tooth loss, the elderly’s diet is too refined, and there is less dietary fiber in the food, which easily leads to difficulty in defecation and causes habitual constipation in the elderly. In clinical practice, it is found that as the elderly age, their organs gradually weaken, and sometimes they suffer from yang deficiency. Common symptoms include cold limbs, frequent urination, sore waist and knees, etc. They are diagnosed as spleen and kidney yang deficiency: congenital yang deficiency, or after illness, childbirth, old age, yin and kidney yang deficiency, insufficient yang, yin and cold condensation, difficult intestinal transmission, resulting in difficult bowel movements, difficulty in excretion, clear and long urine, fear of cold and preference for warmth, cold pain in the abdomen, etc. Since Tongbianling Capsule is used for constipation caused by heat, if it is not differentiated, the elderly using Tongbianling Capsule are prone to consume their vital energy, and get half the result with twice the effort. After long-term research, the applicant has improved Tongbianling Capsule. Summary of the invention

[0004] The purpose of the present invention is to provide an improved Tongbianling capsule and a preparation method thereof, and use of the improved Tongbianling capsule in the preparation of a medicine for treating spleen and kidney yang deficiency type constipation. The improved Tongbianling capsule further adds traditional Chinese medicine with the effects of tonifying the kidney and strengthening yang, tonifying qi and strengthening the spleen, and adjusts the appropriate drug ratio, which significantly improves the drug efficacy. At the same time, the preparation method is simple, there is no complicated extraction process, and it is convenient to prepare.

[0005] To achieve the above-mentioned purpose of the invention, the technical solution of the present invention is as follows:

[0006] The invention discloses an improved Tongbianling capsule, which is prepared by extracting the following Chinese medicinal pieces in parts by weight: 10-20 parts of Cistanche deserticola, 10-20 parts of Eucommia ulmoides, 15-25 parts of Cuscuta australis, 20-30 parts of Dioscorea opposita, 15-25 parts of Astragalus, 10-20 parts of Ginseng, 20-30 parts of Aster, 5-15 parts of Perilla seed, 10-20 parts of Loquat leaf, 20-30 parts of Angelica sinensis, 15-25 parts of Rehmannia root, 8-12 parts of White Peony Root, 5-15 parts of Cannabis seed, 10-20 parts of Platycladus orientalis seed, 10-20 parts of Pine Nut seed, 15-25 parts of Tangerine peel, 8-12 parts of Costusroot, and 12-18 parts of Magnolia officinalis.

[0007] The improved Tongbianling capsule is prepared by extracting the following Chinese medicinal pieces in parts by weight: 15 parts of Cistanche deserticola, 15 parts of Eucommia ulmoides, 20 parts of Cuscuta australis, 25 parts of Dioscorea opposita, 20 parts of Astragalus, 15 parts of Ginseng, 25 parts of Aster, 10 parts of Perilla seed, 15 parts of Loquat leaf, 25 parts of Angelica sinensis, 20 parts of Rehmannia root, 10 parts of White Peony Root, 10 parts of Cannabis seed, 15 parts of Platycladus orientalis seed, 15 parts of Pine Nut seed, 20 parts of Tangerine peel, 10 parts of Costus root, and 15 parts of Magnolia officinalis.

[0008] The improved Tongbianling capsule is prepared by extracting the following Chinese medicinal pieces in parts by weight: 10-20 parts of Cistanche deserticola, 10-20 parts of Eucommia ulmoides, 15-25 parts of Cuscuta australis, 20-30 parts of Dioscorea opposita, 15-25 parts of Astragalus, 10-20 parts of Ginseng, 20-30 parts of Aster, 5-15 parts of Perilla seed, 10-20 parts of Loquat leaf, 20-30 parts of Angelica sinensis, 15-25 parts of Rehmannia root, 8-12 parts of White Peony Root, 5-15 parts of Cannabis seed, 10-20 parts of Platycladus cypress seed, 10-20 parts of Pine Nut seed, 15-25 parts of Tangerine peel, 8-12 parts of Costus root, and 12-18 parts of Magnolia officinalis.

[0009] The improved Tongbianling capsule is prepared by extracting the following Chinese medicinal pieces in parts by weight: 15 parts of Cistanche deserticola, 15 parts of Eucommia ulmoides, 20 parts of Cuscuta australis, 25 parts of Dioscorea opposita, 20 parts of Astragalus, 15 parts of Ginseng, 25 parts of Aster, 10 parts of Perilla seed, 15 parts of Loquat leaf, 25 parts of Angelica sinensis, 20 parts of Rehmannia root, 10 parts of White Peony Root, 10 parts of Cannabis seed, 15 parts of Platycladus orientalis seed, 15 parts of Pine Nut seed, 20 parts of Tangerine peel, 10 parts of Costus root, and 15 parts of Magnolia officinalis.

[0010] The preparation method of the improved Tongbianling capsule comprises the following steps:

[0011] (1) Grinding the Chinese herbal medicine pieces by weight into coarse powder, adding 10-15 times the weight of the Chinese herbal medicine pieces of water and decocting twice, each decocting for 2-4 hours, combining the decoctions, filtering, and concentrating to a clear paste with a relative density of 1.15-1.25;

[0012] (2) Add 95% ethanol to the paste obtained in step (1) until the ethanol concentration in the paste is 65%, precipitate with alcohol for 24 hours, take the supernatant, recover the ethanol until there is no alcohol taste, concentrate it into a thick paste with a relative density of 1.25-1.35, dry it, grind it into a fine powder of 100-120 mesh, add an appropriate amount of lubricant, and fill it into capsules.

[0013] In the step (1) of the preparation method of the improved Tongbianling capsule, water is added in an amount of 12 times the weight of the Chinese herbal medicine.

[0014] In step (2) of the preparation method of the improved Tongbianling Capsule, the mixture is concentrated into a thick paste with a relative density of 1.3.

[0015] The improved Tongbianling capsule is used in preparing a medicine for treating spleen-kidney yang deficiency type constipation.

[0016] The above-mentioned Chinese herbal medicines all meet the pharmacopoeia standards.

[0017] The symptoms of constipation due to spleen and kidney yang deficiency include dry stool, difficulty in defecation, long and clear urine, abdominal distension, and soreness of waist and knees. "Medical Biography·Consumption Conclusion" says: "The reason is that they are all excessive sexual intercourse, irregular diet, or excessive drinking of alcohol, excessive spicy and hot food. The fire of food and drink starts from the spleen and stomach, and the fire of lust starts from the gate of life, resulting in excessive fire and insufficient water, and the lack of body fluids, so the transmission is abnormal, and gradually forms the syndrome of dryness." It clearly points out some of the causes of this disease. "Miscellaneous Diseases Origin and Flow Xizhu·Origin and Flow of Constipation" in the Qing Dynasty emphasizes that "constipation is also a kidney disease." As the kidney controls the five liquids and opens the orifices to the two yin, it is believed that constipation should be treated from the kidney. "Jingyue Complete Book·Miscellaneous Symptoms·Consumption" says: If the yang of the lower jiao is deficient, the yang qi will not work. If the yang qi does not work, it cannot be transmitted and the yin will condense below. This is yang deficiency and yin stagnation. Therefore, Cistanche, Eucommia and Cuscuta australis are used to nourish the kidney and strengthen yang, while yam, astragalus and ginseng are used to nourish qi and strengthen the spleen, and they are all the main medicines; The Secret Records of the Stone Chamber in the Qing Dynasty said: "People think that constipation is caused by dryness of the large intestine, but who knows that it is caused by dryness of the lungs? When the lungs are dry, the clear and sour qi cannot descend to the large intestine." At the same time, spleen and kidney yang deficiency leads to obstruction of the transportation and distribution of qi, blood, body fluids, and spleen and kidney yang deficiency may lead to insufficient qi and blood, and the waist and knees lose sufficient nourishment, resulting in symptoms of sore waist and knees. Symptoms of this type of patients may include long-term low back pain, knee pain and discomfort, so Aster, Perilla, Loquat Leaf are used to descend the lung qi, and Angelica, Rehmannia glutinosa, and White Peony Root are used to nourish blood and moisten dryness. According to TCM theory, the lungs give birth to the kidneys, which means that metal gives birth to water. For example, the essence of the lungs descends to nourish the kidney essence, and the lung qi descends to help the kidney absorb qi. Aster, Perilla, Loquat Leaf, Angelica, Rehmannia glutinosa, and White Peony Root are all ministerial drugs, which can achieve the effect of nourishing the kidney by descending the lung qi. The Treatise on Consequences states: "Dryness belongs to the Shaoyin meridian, and insufficient body fluids are used to moisten it. Constipation belongs to the Taiyin meridian, and dry stools are used to purge it with bitter herbs." It also states that "worm accumulation", "seven emotions and qi blockage", "phlegm stagnation", "medicine and stone poison", "organ cold", "blood dryness" and other factors can all cause constipation, and uses hemp seeds, cypress seeds and pine seeds to warm and relieve constipation as adjuvants; when the spleen and kidney yang are deficient, the spleen cannot normally transport and transform the essence of water and grain, causing food to remain in the stomach, resulting in food accumulation and gas, which in turn causes abdominal distension. Abdominal distension often occurs in the upper abdomen, and may be accompanied by symptoms such as belching and hiccups. At the same time, spleen and kidney yang deficiency can lead to decreased organ function, which affects the transportation and lifting functions of the spleen and stomach, making it impossible to digest and absorb food in time, which in turn causes difficulty in defecation. Such patients usually feel a feeling of falling in the anus, accompanied by a strong desire to defecate, but the actual amount of defecation is very small. Tangerine peel, costus root, and magnolia bark can be used to relieve qi and remove stagnation. The whole prescription is composed of Cistanche deserticola, Eucommia ulmoides, Cuscuta australis, yam, Astragalus, ginseng, Aster, Perilla seed, loquat leaf, Angelica sinensis, Rehmannia root, white peony root, hemp seed, cypress seed, pine nut seed, tangerine peel, costus root, and magnolia bark. It is used to treat spleen and kidney yang deficiency type constipation, especially habitual spleen and kidney yang deficiency type constipation in the elderly. DETAILED DESCRIPTION

[0018] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content of the present invention, those skilled in the art can make various changes or modifications to the present invention, but these equivalent forms fall within the scope limited by the appended claims of the application equally.

[0019] Embodiment 1:

[0020] Take 150g of Cistanche deserticola, 150g of Eucommia ulmoides, 200g of Cuscuta australis, 250g of Dioscorea opposita, 200g of Astragalus, 150g of Ginseng, 250g of Aster, 100g of Perilla seed, 150g of Loquat leaf, 250g of Angelica sinensis, 200g of Rehmannia root, 100g of White Peony, 100g of Cannabis seed, 150g of Platycladus seed, 150g of Pine nut seed, 200g of Tangerine peel, 100g of Aucklandia lappa, and 150g of Magnolia officinalis. The preparation method comprises the following steps:

[0021] (1) Grind the Chinese herbal medicine pieces by weight into coarse powder, add 12 times the weight of the Chinese herbal medicine pieces of water and boil twice, each time for 3 hours, combine the decoctions, filter, and concentrate to a clear paste with a relative density of 1.2;

[0022] (2) Add 95% ethanol to the paste obtained in step (1) until the ethanol concentration in the paste is 65%, and precipitate for 24 hours. Take the supernatant, recover the ethanol until there is no alcohol taste, and concentrate it into a thick paste with a relative density of 1.3. Dry it, grind it into a fine powder of 110 mesh, add an appropriate amount of lubricant, and fill it into capsules.

[0023] Embodiment 2:

[0024] Take 100g of Cistanche deserticola, 200g of Eucommia ulmoides, 150g of Cuscuta australis, 300g of yam, 150g of Astragalus, 200g of ginseng, 200g of Aster, 150g of Perilla seed, 100g of loquat leaf, 300g of Angelica sinensis, 150g of Rehmannia root, 120g of White Peony, 50g of Cannabis seed, 200g of Platycladus orientalis seed, 100g of Pine nut seed, 250g of Tangerine peel, 80g of Aucklandia lappa, and 180g of Magnolia officinalis. The preparation method comprises the following steps:

[0025] (1) Grinding the Chinese herbal medicine pieces by weight into coarse powder, adding 10 times the weight of the Chinese herbal medicine pieces of water and decocting twice, each time for 4 hours, combining the decoctions, filtering, and concentrating to a clear paste with a relative density of 1.15;

[0026] (2) Add 95% ethanol to the paste obtained in step (1) until the ethanol concentration in the paste is 65%, and precipitate for 24 hours. Take the supernatant, recover the ethanol until there is no alcohol taste, and concentrate it into a thick paste with a relative density of 1.3. Dry it, grind it into a fine powder of 100 mesh, add an appropriate amount of lubricant, and fill it into capsules.

[0027] Embodiment 3:

[0028] Take 200g of Cistanche deserticola, 100g of Eucommia ulmoides, 250g of Cuscuta australis, 200g of yam, 250g of Astragalus, 100g of ginseng, 300g of Aster, 50g of Perilla seed, 200g of loquat leaf, 200g of Angelica sinensis, 250g of Rehmannia root, 80g of White Peony Root, 150g of Cannabis seed, 100g of Platycladus orientalis seed, 200g of Pine Nut seed, 150g of Tangerine peel, 120g of Aucklandia lappa, and 120g of Magnolia officinalis. The preparation method comprises the following steps:

[0029] (1) Grind the Chinese herbal medicine pieces by weight into coarse powder, add 15 times the weight of the Chinese herbal medicine pieces of water and boil twice, each time for 2 hours, combine the decoctions, filter, and concentrate to a clear paste with a relative density of 1.25;

[0030] (2) Add 95% ethanol to the paste obtained in step (1) until the ethanol concentration in the paste is 65%, and precipitate with alcohol for 24 hours. Take the supernatant, recover the ethanol until there is no alcohol taste, and concentrate it into a thick paste with a relative density of 1.25. Dry it, grind it into a fine powder of 120 mesh, add an appropriate amount of lubricant, and fill it into capsules.

[0031] Example 4: Pharmacodynamics Experiment

[0032] Establishment of the constipation model of spleen and kidney yang deficiency: According to the preparation method of the yang deficiency constipation model in the reference, 60 rats were randomly divided into a blank control group, a model group, a positive drug control group, and a group 1 of the present invention, each with 15 rats. The rats in the model group, the positive drug control group, and the group 1 of the present invention were given 3.0 mg / kg body weight of loperamide suspension (loperamide dissolved in distilled water) by gavage for 21 consecutive days, and hydrocortisone injection 25 mg / (kg·d) was given to the hind limbs intramuscularly every day, and fed with ordinary feed; the blank control group was given an equal volume of distilled water by gavage. After the modeling was completed, the rats were fasted but not watered for 24 hours, and activated carbon was gavaged, and the gavage time of each rat was recorded, and then the time when the rat discharged the first black stool was observed and recorded, and the difference between the two was recorded as the gastrointestinal transit time of the rat. The mean of the time when the blank control group rats discharged the first black stool was recorded as the standard for judging whether the modeling was successful, that is, if the time when the rats discharged black stools was greater than the mean of the normal group, the modeling was deemed to be successful, and if the time when the rats discharged black stools was less than the mean of the normal group, the modeling was deemed to be unsuccessful. The model group, the positive drug control group, and the embodiment of the present invention group 1 rats were all successfully modeled. Then the model group rats were given water gavage, 1 time / d, for 21 consecutive days. The positive drug control group group was given Tongbianling Capsules (Tonghua Jinma Pharmaceutical Group Co., Ltd., National Medicine Standard Z20063182) 2g / kg body weight gavage, 1 time / d, for 21 consecutive days. The embodiment of the present invention group 1 was given the improved Tongbianling Capsules prepared by the embodiment of the present invention group 1 2g / kg body weight gavage, 1 time / d, for 21 consecutive days.

[0033] Detection of small intestinal propulsion rate of rats in each group: 21 days after administration, rats were fasted for 18 hours and given 2.0mL semisolid nutrient paste (consisting of 4.0mL red ink, 2.0g sodium carboxymethyl cellulose, 1.6g starch, 3.2g milk powder, 1.6g sugar, and 50.0mL water) by gavage, and rats were killed by dislocation of the neck 30 minutes later. The abdominal cavity of the rats was opened, the mesentery was separated, and the intestinal tube from the upper end to the pylorus and the lower end to the ileocecal part was cut, and the intestinal tube was straightened and laid on white paper, and the propulsion length of the nutrient paste (red line) and the total length of the small intestine were measured, and the small intestinal propulsion rate was calculated, and the small intestinal propulsion rate (%) = the propulsion length of the nutrient paste (red line) / the total length of the small intestine × 100%.

[0034] Results: See Table 1.

[0035] Table 1 Comparison of small intestinal propulsion rate of rats in each group after 21 days of administration (%, x±s)

[0036] Group Small intestinal propulsion rate Blank control group 74.56±5.43 Model Group <![CDATA[42.98±3.72 ### ]]> Positive drug control group 65.03±5.12* Embodiment 1 of the present invention 81.64±5.63**

[0037] Compared with the blank control group, ###P<0.001, compared with the model group *P<0.05, **P<0.01

[0038] Compared with the blank control group, the small intestinal propulsion rate of the model group was significantly improved after 21 days of administration, indicating that the spleen-kidney yang deficiency type constipation model was successfully established. After 21 days of administration, the small intestinal propulsion rates of rats in the Example 1 group of the present invention and the positive drug control group were improved compared with the model group (P<0.05 or P<0.01); the small intestinal propulsion rate effect of the Example 1 group of the present invention was better than that of the positive drug control group, indicating that the improved Tongbianling Capsule has a good effect on spleen-kidney yang deficiency type constipation.

[0039] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. An improved Tongbianling capsule, characterized in that: The improved Tongbianling capsule is prepared by extracting the following Chinese medicinal pieces in parts by weight: 10-20 parts of Cistanche deserticola, 10-20 parts of Eucommia ulmoides, 15-25 parts of Cuscuta australis, 20-30 parts of Dioscorea opposita, 15-25 parts of Astragalus, 10-20 parts of Ginseng, 20-30 parts of Aster, 5-15 parts of Perilla seed, 10-20 parts of Loquat leaf, 20-30 parts of Angelica sinensis, 15-25 parts of Rehmannia root, 8-12 parts of White Peony Root, 5-15 parts of Cannabis seed, 10-20 parts of Platycladus orientalis seed, 10-20 parts of Pine Nut seed, 15-25 parts of Tangerine peel, 8-12 parts of Costus root, and 12-18 parts of Magnolia officinalis.

2. The improved Tongbianling capsule according to claim 1, characterized in that: The improved Tongbianling capsule is prepared by extracting the following Chinese herbal medicine pieces in parts by weight: 15 parts of Cistanche deserticola, 15 parts of Eucommia ulmoides, 20 parts of Cuscuta australis, 25 parts of Dioscorea opposita, 20 parts of Astragalus membranaceus, 15 parts of Ginseng, 25 parts of Aster tataricus, 10 parts of Perilla seed, 15 parts of Loquat leaf, 25 parts of Angelica sinensis, 20 parts of Rehmannia root, 10 parts of White Peony Root, 10 parts of Cannabis seed, 15 parts of Platycladus orientalis seed, 15 parts of Pine Nut seed, 20 parts of Tangerine peel, 10 parts of Costus root, and 15 parts of Magnolia officinalis.

3. The improved Tongbianling capsule according to claim 1, characterized in that: The improved Tongbianling capsule is prepared by extracting the following Chinese medicinal pieces in parts by weight: 10-20 parts of Cistanche deserticola, 10-20 parts of Eucommia ulmoides, 15-25 parts of Cuscuta australis, 20-30 parts of Dioscorea opposita, 15-25 parts of Astragalus, 10-20 parts of Ginseng, 20-30 parts of Aster, 5-15 parts of Perilla seed, 10-20 parts of Loquat leaf, 20-30 parts of Angelica sinensis, 15-25 parts of Rehmannia root, 8-12 parts of White Peony Root, 5-15 parts of Cannabis seed, 10-20 parts of Platycladus orientalis seed, 10-20 parts of Pine Nut seed, 15-25 parts of Tangerine peel, 8-12 parts of Costus root, and 12-18 parts of Magnolia officinalis.

4. The improved Tongbianling capsule according to claim 1, characterized in that: The improved Tongbianling capsule is prepared by extracting the following Chinese herbal medicine pieces in parts by weight: 15 parts of Cistanche deserticola, 15 parts of Eucommia ulmoides, 20 parts of Cuscuta australis, 25 parts of Dioscorea opposita, 20 parts of Astragalus membranaceus, 15 parts of Ginseng, 25 parts of Aster tataricus, 10 parts of Perilla seed, 15 parts of Loquat leaf, 25 parts of Angelica sinensis, 20 parts of Rehmannia root, 10 parts of White Peony Root, 10 parts of Cannabis seed, 15 parts of Platycladus orientalis seed, 15 parts of Pine Nut seed, 20 parts of Tangerine peel, 10 parts of Costus root, and 15 parts of Magnolia officinalis.

5. The improved Tongbianling capsule according to claim 1, characterized in that: The preparation method of the improved Tongbianling capsule comprises the following steps: (1) Grinding the Chinese herbal medicine pieces by weight into coarse powder, adding 10-15 times the weight of the Chinese herbal medicine pieces of water and decocting twice, each decocting for 2-4 hours, combining the decoctions, filtering, and concentrating to a clear paste with a relative density of 1.15-1.25; (2) Add 95% ethanol to the paste obtained in step (1) until the ethanol concentration in the paste is 65%, precipitate with alcohol for 24 hours, take the supernatant, recover the ethanol until there is no alcohol taste, concentrate it into a thick paste with a relative density of 1.25-1.35, dry it, grind it into a fine powder of 100-120 mesh, add an appropriate amount of lubricant, and fill it into capsules.

6. The improved Tongbianling capsule according to claim 5, characterized in that: In the step (1) of the preparation method of the improved Tongbianling capsule, water is added in an amount of 12 times the weight of the Chinese herbal medicine.

7. The improved Tongbianling capsule according to claim 5, characterized in that: In the preparation method of the improved Tongbianling capsule, the step (2) is concentrated into a thick paste with a relative density of 1.

3.

8. Use of the improved Tongbianling capsule as claimed in claim 1 in the preparation of a medicine for treating constipation of spleen-kidney yang deficiency type.