Preparation method and application of fructus cannabis honey decoction guide

Abstract

The invention relates to a preparation method and application of fructus cannabis decocted with honey, and belongs to the technical field of traditional Chinese medicines and natural medicines. On the basis of traditional honey decoction, the fructus cannabis which is a medicine and food homologous crop is added, so that synergistic interaction is achieved, and bowel relaxing is achieved; the suppository is manufactured by using a high-temperature-resistant food-grade silica gel model which is consistent in size and model, so that the safety of personnel and the attractive appearance and specification consistency of the suppository are ensured; edible glutinous rice paper is adopted for packaging, so that the suppository is prevented from being mutually bonded and bonded with a medicine bag during preservation, and meanwhile, moisture is prevented; when the suppository is used, tea oil is used as a lubricating medium, the success rate of entering the anus is improved, and patients are free of pain and exclusion.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine and natural medicine, and particularly relates to a preparation method and application of hemp seed honey enema. Background Art

[0002] With the acceleration of people's living rhythm and the change of diet structure, the prevalence rate of constipation has been increasing year by year. Constipation can not only cause anorectal diseases such as anal fissure and hemorrhoids, but also lead to problems such as blood vessel rupture in elderly patients with cardiovascular and cerebrovascular diseases and angina pectoris in elderly patients with coronary heart disease. Western medicine often uses laxatives to treat constipation, but long-term use is likely to cause iatrogenic habitual constipation and even adverse reactions. At the same time, oral laxatives are subject to the first-pass effect of the liver, with a slow onset time and poor patient acceptance. Traditional Chinese medicine has a long history of clinical use in treating constipation, and its toxic and side effects are within a reasonable dosage range. Hemp seed has the characteristics of "lubricating the lower part without damaging qi and relieving constipation gently without damaging body fluid", and honey enema, as the earliest anal suppository, is simple and effective. The combination of the two has a better effect. Summary of the Invention

[0003] The object of the present invention is achieved by the following technical solutions: A preparation method of hemp seed honey enema, comprising the following steps:

[0004] (1) Refining honey: Placing honey in a constant-temperature stirring kettle and concentrating it under reduced pressure at 60 - 70 °C until the water content ≤ 18%;

[0005] (2) Mixing powder: After cooling to 37 ± 1 °C, adding 80-mesh ultrafine hemp seed powder, with the mass ratio of honey to ultrafine hemp seed powder being 5:1 - 10:1, and continuing to heat and stir until a uniform caramel-colored semi-solid is formed;

[0006] (3) Injecting into mold: Injecting the mixed material into a silicone mold pre-coated with camellia oil and quickly cooling and solidifying it in a water bath at 0 - 4 °C;

[0007] (4) Packaging: After demolding, wrapping it with a single grain of rice paper and sealing it with an aluminum-plastic composite film, and storing it refrigerated at 2 - 8 °C.

[0008] Preferably, the refractive index of the honey after reduced-pressure concentration in step (1) is ≥ 1.490.

[0009] Preferably, the mass ratio of honey to ultrafine hemp seed powder in step (2) is 10:1.

[0010] Preferably, the heating temperature in step (2) is 60 - 70 °C and the time is 15 min.

[0011] Preferably, the stirring speed in step (2) is 300 rpm.

[0012] Preferably, the length of the silicone mold in step (3) is 25 mm and the diameter is 12 mm.

[0013] Preferably, the water bath cooling time in step (3) is 10 min.

[0014] Preferably, the application of the prepared Cannabis sativa honey suppository as a drug for treating chronic constipation is provided.

[0015] Compared with the prior art, the advantages of the present invention are as follows:

[0016] 1. The present invention uses honey and Cannabis sativa, both of which are both food and medicine, as the formula, and takes advantage of the characteristics of Cannabis sativa that "lubricating the lower energizer does not damage qi, and slow purgation does not damage body fluid", and is applied to the elderly and infirm patients with chronic constipation to achieve the effects of moistening the intestines and relieving constipation, and invigorating the middle qi and replenishing qi.

[0017] 2. The traditional honey suppository is hand-rolled into a suppository shape after the honey coagulates like maltose, which has the risk of scalding and is not aesthetically pleasing. This patent uses a high-temperature-resistant and edible silicone mold with consistent size and model (length 25 mm, diameter 12 mm) to make suppositories, ensuring the safety of personnel and the aesthetics and specification consistency of the suppositories.

[0018] 3. After the suppositories of the present invention are made, they are packaged with edible rice paper, which can prevent the suppositories from sticking to each other during storage, prevent the suppositories from sticking to the medicine bag, and also has the function of moisture-proof.

[0019] 4. When using the Cannabis sativa honey suppository of the present invention, tea oil is used as the lubricating medium, which improves the success rate of entering the anus and ensures that the patient has no pain and does not reject it. Detailed implementation mode

[0020] The content of the present invention will be described in detail below in conjunction with embodiments:

[0021] Example 1: Verification of formula optimization

[0022] Experimental design: Prepare 3 groups of suppositories with different ratios

[0023] Group 1: Honey:Cannabis sativa = 5:1

[0024] (1) Refining honey: Place the honey in a constant-temperature stirring kettle and concentrate it under reduced pressure at 60-70 °C until the water content ≤ 18%, and measure the refractive index ≥ 1.490;

[0025] (2) Mixing powder: After cooling to 37 ± 1 °C, add 80-mesh Cannabis sativa ultrafine powder. The mass ratio of honey to Cannabis sativa ultrafine powder is 5:1, and continue to heat and stir until a uniform caramel-colored semi-solid is formed. The heating temperature is 60-70 °C, the time is 15 min, and the stirring speed is 300 rpm;

[0026] (3) Injecting into the mold: Inject the mixed material into a silicone mold pre-coated with tea oil. The length of the silicone mold is 25 mm and the diameter is 12 mm, and quickly cool and solidify in a water bath at 0-4 °C. The water bath cooling time is 10 min;

[0027] (4) Packaging: After demolding, it is wrapped individually with rice paper and then sealed with an aluminum-plastic composite film, and stored refrigerated at 2 - 8°C.

[0028] Group 2: Honey: Hemp seed = 7:1

[0029] (1) Honey refining: Place the honey in a constant-temperature stirring kettle and concentrate it under reduced pressure at 60 - 70°C until the water content ≤ 18%, and the measured refractive index ≥ 1.490;

[0030] (2) Powder mixing: After cooling to 37 ± 1°C, add 80-mesh ultrafine hemp seed powder. The mass ratio of honey to ultrafine hemp seed powder is 7:1. Continue to heat and stir until a uniform caramel-colored semi-solid is formed. The heating temperature is 60 - 70°C, the time is 15 min, and the stirring speed is 300 rpm;

[0031] (3) Molding: Inject the mixed material into a silicone mold pre-coated with tea oil. The length of the silicone mold is 25 mm and the diameter is 12 mm. Rapidly cool and solidify it in a water bath at 0 - 4°C. The water bath cooling time is 10 min;

[0032] (4) Packaging: After demolding, it is wrapped individually with rice paper and then sealed with an aluminum-plastic composite film, and stored refrigerated at 2 - 8°C.

[0033] Group 3: Honey: Hemp seed = 10:1 (preferred scheme)

[0034] (1) Honey refining: Place the honey in a constant-temperature stirring kettle and concentrate it under reduced pressure at 60 - 70°C until the water content ≤ 18%, and the measured refractive index ≥ 1.490;

[0035] (2) Powder mixing: After cooling to 37 ± 1°C, add 80-mesh ultrafine hemp seed powder. The mass ratio of honey to ultrafine hemp seed powder is 10:1. Continue to heat and stir until a uniform caramel-colored semi-solid is formed. The heating temperature is 60 - 70°C, the time is 15 min, and the stirring speed is 300 rpm;

[0036] (3) Molding: Inject the mixed material into a silicone mold pre-coated with tea oil. The length of the silicone mold is 25 mm and the diameter is 12 mm. Rapidly cool and solidify it in a water bath at 0 - 4°C. The water bath cooling time is 10 min;

[0037] (4) Packaging: After demolding, it is wrapped individually with rice paper and then sealed with an aluminum-plastic composite film, and stored refrigerated at 2 - 8°C.

[0038] Control group: Pure honey suppository

[0039] Pharmacodynamic experiment (mouse constipation model)

[0040]

[0041] Data analysis

[0042] Group 3 (10:1) was significantly superior to other groups in core indicators such as defecation time and fecal water content (P<0.01), proving that there is an optimal ratio for the synergistic effect of honey and hemp seed.

[0043] Example 2: Comparison of molding processes

[0044] Experimental design

[0045] Compare the quality of suppositories of traditional manual molding (control group) and silicone mold molding (experimental group):

[0046]

[0047] Conclusion: The mold molding process reduces the weight difference of the product by 68.4%, fully meeting the pharmacopoeia standards and solving the dose error problem of the traditional process.

[0048] Example 3: Storage stability test

[0049] Accelerated test (40°C / RH75%, 6 months)

[0050]

[0051] Conclusion: The combination of rice paper packaging and refrigeration improves the stability of the product by 4.75 times in the accelerated test, meeting the requirement of a 12-month shelf life.

[0052] Example 4: Clinical application effect

[0053] Clinical trial (elderly patients with constipation, n = 120)

[0054]

[0055] The onset time of the suppository of the present invention is shortened by 56.3% compared with the commercially available product, and the pain score is reduced by 67.6% (P<0.001), proving that the lubrication of tea oil and the dosage form improvement significantly improve the clinical applicability.

[0056] Although the present invention has been described in detail above with general descriptions and specific embodiments, based on the present invention, some modifications or improvements can be made, which are obvious to those skilled in the art. Therefore, these modifications or improvements made without departing from the spirit of the present invention all fall within the scope of protection required by the present invention.

Claims

1. A preparation method of Cannabis sativa semen honey enema, characterized in that, It includes the following steps: (1) Refining honey: Place the honey in a constant-temperature stirring kettle and concentrate it under reduced pressure at 60 - 70°C until the water content ≤ 18%; (2) Mixing powder: After cooling to 37 ± 1°C, add 80-mesh ultra-fine powder of Cannabis sativa seeds. The mass ratio of honey to ultra-fine powder of Cannabis sativa seeds is 5:1 - 10:

1. Continue heating and stirring until a uniform caramel-colored semi-solid is formed; (3) Injecting into molds: Inject the mixed material into a silicone mold pre-coated with tea oil and quickly cool and solidify it in a 0 - 4°C water bath; (4) Packaging: After demolding, wrap each one with rice paper and seal it with an aluminum-plastic composite film, and store it refrigerated at 2 - 8°C.

2. The preparation method of the Cannabis sativa seed honey enema according to claim 1, wherein, In step (1), the refractive index of the honey after concentration under reduced pressure is measured to be ≥ 1.

490.

3. The preparation method of a hemp seed honey enema according to claim 1, characterized in that, In step (2), the mass ratio of honey to ultra-fine powder of Cannabis sativa seeds is 10:

1.

4. The preparation method of a cannabis seed honey enema according to claim 1, characterized in that, In step (2), the heating temperature is 60 - 70°C and the time is 15 min.

5. The preparation method of hemp seed honey clyster according to claim 1, characterized in that, In step (2), the stirring speed is 300 rpm.

6. The preparation method of a Cannabis sativa seed honey enema according to claim 1, characterized in that, In step (3), the length of the silicone mold is 25 mm and the diameter is 12 mm.

7. The preparation method of the Cannabis sativa seed honey enema according to claim 1, characterized in that, In step (3), the water bath cooling time is 10 min.

8. Use of the Cannabis sativa seed honey enema prepared by the preparation method according to any one of claims 1 to 7 as a drug for treating chronic constipation.

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