Paederia scandens suppository and preparation method thereof

Abstract

The invention discloses a paederia scandens suppository and a preparation method thereof. The paederia scandens suppository comprises the following raw materials in parts by weight: 4-5 parts of mixed fatty glyceride and 1 part of paederia scandens powder, the preparation method specifically comprises the following steps: (1) weighing the raw materials; uniformly mixing the mixed fatty glyceride and the paederia scandens powder, and stirring in a water bath until the mixture is molten; and (3) pouring into a suppository mold coated with glycerol in advance, oscillating, wiping off the overflowed mixed solution, freezing, and taking out to obtain the suppository. The suppository is prepared from the mixed fatty glyceride and the paederia scandens powder, is administrated through an anal plug, has the effects of clearing away heat and toxic materials, eliminating dampness, relieving swelling and pain, stopping bleeding and the like, has the modern medical effects of resisting inflammation, easing pain and the like, is homologous in medicine and food and is non-toxic, so that the purpose of effectively treating mixed hemorrhoids is achieved; the composition has the advantages of unique formula, low cost, safety, reliability, remarkable curative effect and the like.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine suppositories, and more particularly to a Cistanche deserticola suppository and a preparation method thereof. Background Art

[0002] Mixed hemorrhoids, in Chinese medicine, are called hemorrhoids. They are hemorrhoid diseases characterized by varicose veins forming masses above and below the dentate line in the same position as the anus, with no obvious boundary between the inside and outside. Clinical manifestations include blood in the stool and swelling in the anus, and there may be swelling, foreign body sensation or pain in the anus, accompanied by local secretions or itching. It has the same name as the disease in Western medicine. If the disease is treated early, the prognosis is generally good. However, some patients also develop complications such as anemia during the course of the disease.

[0003] Traditional Chinese medicine external treatment for mixed hemorrhoids has many methods, definite efficacy, simple and easy to use, and is widely used in clinical practice, with certain characteristics and advantages. At present, there are many types of external dosage forms for the treatment of mixed hemorrhoids in clinical practice, among which suppositories have the advantages of faster absorption and onset of action, higher drug concentration at the local medication site, and more significant efficacy; and for patients with difficulty in oral medication, it is convenient to administer the drug through the cavity.

[0004] Damp-heat mixed hemorrhoids are the most common syndrome differentiation of mixed hemorrhoids in clinical practice. In clinical practice, Chinese medicine suppositories have achieved certain results in the treatment of damp-heat mixed hemorrhoids. In order to better play the advantages and characteristics of TCM external treatment, clinically looking for drugs with obvious efficacy, good safety and suitable for promotion to treat damp-heat mixed hemorrhoids, it is necessary to use modern pharmaceutical chemistry analysis methods, continuously explore the mechanism of action of Chinese medicine suppositories in the treatment of damp-heat mixed hemorrhoids, establish appropriate evaluation indicators, and further conduct in-depth research.

[0005] As a common folk medicine, Cistanche deserticola is a medicine and food of the same origin, with a sweet taste and a neutral nature. It enters the spleen, stomach, liver, and gallbladder meridians; it is mostly used in single prescriptions and folk prescriptions. "Essentials of the Nature of Raw Herbs" records: Its head treats new internal injuries, ... washes sores and relieves pain, eliminates heat and disperses toxins. Its leaves are pounded with rice and eaten with sugar, and can stop diarrhea. It has the effects of clearing away heat and detoxifying, removing dampness and swelling, relieving pain, and stopping bleeding. Modern pharmacological studies have found that the whole plant contains Cistanche deserticola glycosides, Cistanche deserticola subglycosides and alkaloids, which have anti-inflammatory and analgesic effects and are non-toxic. However, Cistanche deserticola currently has the problems of low resource utilization and lack of related product development. It is necessary to strengthen systematic pharmaceutical and quality control research, and promote the development and utilization of its products in combination with the existing application basis.

[0006] Therefore, how to develop a Cistanche suppository for treating mixed hemorrhoids is a problem that those skilled in the art need to solve urgently. Summary of the invention

[0007] In view of this, the object of the present invention is to provide a Cistanche deserticola suppository and a preparation method thereof to solve the deficiencies in the prior art.

[0008] In order to achieve the above object, the present invention adopts the following technical solution:

[0009] A Cistanche suppository comprises the following raw materials in parts by weight: 4-5 parts of mixed fatty acid glyceride and 1 part of Cistanche powder.

[0010] Furthermore, the above-mentioned Cistanche deserticola suppository comprises the following raw materials in parts by weight: 4 parts of mixed fatty acid glycerides and 1 part of Cistanche deserticola powder.

[0011] Furthermore, the above-mentioned Cistanche deserticola suppository comprises the following raw materials in parts by weight: 5 parts of mixed fatty acid glycerides and 1 part of Cistanche deserticola powder.

[0012] A method for preparing a Cistanche deserticola suppository comprises the following steps:

[0013] (1) Weighing the raw materials according to the weight of the above-mentioned Cistanche deserticola suppository;

[0014] (3) mixing the mixed fatty acid glyceride and the Cistanche deserticola powder, stirring in a water bath until dissolved, to obtain a mixed solution;

[0015] (3) Pour the mixture into a suppository mold that has been pre-coated with glycerin, shake it, wipe off the overflowed mixture, freeze it, and take it out to obtain the Cistanche deserticola suppository.

[0016] Furthermore, in the above step (2), the temperature of the water bath is 80°C.

[0017] Furthermore, in the above step (3), the freezing time is 10 minutes.

[0018] It can be seen from the above technical solution that compared with the prior art, the beneficial effects of the present invention are as follows:

[0019] 1. The present invention uses mixed fatty acid glyceride and millet vine powder to make suppositories, which are administered through anal plugs. They have the effects of clearing away heat and detoxifying, removing dampness, reducing swelling and relieving pain, and stopping bleeding, as well as modern medical effects such as anti-inflammatory and analgesia. Moreover, the medicine and food are of the same origin and are non-toxic, thereby achieving the purpose of effectively treating mixed hemorrhoids. The invention has the advantages of unique formula, low cost, safety and reliability, and significant efficacy.

[0020] 2. Use the Cistanche suppository of the present invention to treat patients with mixed hemorrhoids. Use disposable gloves to place the Cistanche suppository of the present invention in the anus, and rest in bed for 5-10 minutes so that the drug can be fully absorbed. One week is a course of treatment. Clinical observations have shown that the Cistanche suppository of the present invention has the characteristics of fast effect, short course of treatment, high efficiency, no "rebound" after drug withdrawal, non-toxicity, safety and reliability, etc., and has abundant raw material sources, simple preparation method and low cost. It is the first choice for treating mixed hemorrhoids of damp-heat type.

[0021] 3. The Cnidium monnieri suppository of the present invention has a unique recipe, a rigorous formula, and refined drug selection. Through local administration, the local drug concentration is increased, the drug can directly reach the lesion, avoiding the volatilization of some active ingredients of the drug, promoting wound healing, and having a definite therapeutic effect.

[0022] 4. The present invention further verifies the clinical efficacy of Millettia repens suppository in treating mixed hemorrhoids of damp-heat type, explores its theoretical mechanism, forms a new drug treatment program for mixed hemorrhoids of damp-heat type, and provides a reliable basis for the development of new drugs. DETAILED DESCRIPTION

[0023] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0024] In the following examples, mixed fatty acid glycerides (type 36), product batch number: YZ20240710, net weight: 1 kg, validity period: 24 months, implementation standard: "Chinese Pharmacopoeia" 2020 edition Part IV, manufacturer: Shandong Ruisheng Pharmaceutical Excipients Co., Ltd.

[0025] Millettia repens, manufacturer: Bozhou Bozhoutang Biological Co., Ltd., type: powder grinding on behalf of customers, product type: agricultural and sideline products, packaging: bulk, implementation standard: Q / BYJ0001S.

[0026] Glycerin (medical), manufacturer: Dezhou Wuyue Washing and Disinfection Products Co., Ltd., specification: 500g / bottle, implementation standard: Q / 371402DWY035, product batch number: 240816, seller: Qingdao Schultz Biotechnology Co., Ltd.

[0027] Example 1

[0028] The Cistanche suppository comprises the following raw materials by weight: 4 g of mixed fatty acid glyceride and 1 g of Cistanche powder.

[0029] The preparation method of the above-mentioned Cnidium monnieri suppository specifically comprises the following steps:

[0030] (1) Weighing the raw materials according to the weight of the above-mentioned Cistanche deserticola suppository;

[0031] (4) mixing the mixed fatty acid glyceride and the smilax china powder, stirring in a water bath at 80° C. until dissolved, to obtain a mixed solution;

[0032] (3) Pour the mixture into a suppository mold that has been pre-coated with glycerin, shake it and wipe off the overflowed mixture, freeze it for 10 minutes, and take it out to obtain the Cistanche deserticola suppository.

[0033] Example 2

[0034] The Cistanche suppository comprises the following raw materials by weight: 5 g of mixed fatty acid glyceride and 1 g of Cistanche powder.

[0035] The preparation method of the above-mentioned Cnidium monnieri suppository specifically comprises the following steps:

[0036] (1) Weighing the raw materials according to the weight of the above-mentioned Cistanche deserticola suppository;

[0037] (5) mixing the mixed fatty acid glyceride and the smilax china powder, stirring in a water bath at 80° C. until dissolved, to obtain a mixed solution;

[0038] (3) Pour the mixture into a suppository mold that has been pre-coated with glycerin, shake it and wipe off the overflowed mixture, freeze it for 10 minutes, and take it out to obtain the Cistanche deserticola suppository.

[0039] Performance Testing

[0040] 1. Selection of Cistanche deserticola suppositories

[0041] Same as Example 1.

[0042] 2. Inclusion criteria of cases

[0043] 1. Aged between 18 and 65, regardless of gender;

[0044] 2. No history of anorectal disease surgery, anal malformation or dysfunction;

[0045] 3. Those who have no serious diseases of the respiratory system, digestive system, circulatory system, or blood system, and no obvious abnormalities in liver and kidney function;

[0046] 4. No symptoms of anal incontinence in the past and no related medications;

[0047] 5. There are 3-5 hemorrhoids, and the internal hemorrhoids are of grade I to III;

[0048] 6. Receive treatment with Cistanche deserticola suppository;

[0049] 7.The patient signs the informed consent form.

[0050] 3. Exclusion criteria for cases

[0051] 1. Patients with other anorectal diseases such as rectal polyps, anal fissures, perianal abscesses, and anal fistulas;

[0052] 2. Patients with gastrointestinal diseases such as chronic diarrhea, chronic constipation, and inflammatory bowel disease;

[0053] 3. Those with urinary tract infection or obstruction caused by prostatic hypertrophy, tumor, stones, etc.;

[0054] 4. Patients with severe heart, liver, kidney and blood system diseases and mental illnesses;

[0055] 5. Patients with infectious diseases such as tuberculosis, hepatitis B, sexually transmitted diseases, etc.

[0056] 6. Patients with metabolic diseases such as diabetes that affect wound healing;

[0057] 7. Perioperative treatment does not meet the requirements, the efficacy cannot be judged or the data are incomplete, which affects the judgment of the efficacy;

[0058] 8. Pregnant and lactating women;

[0059] 9. Allergic constitution;

[0060] 10. People with mental disorders.

[0061] IV. Case Selection

[0062] A randomized controlled trial was used to design a trial. 120 subjects who met the criteria were randomly assigned to a treatment group (Ciliata serrata suppository) and a control group (Mayinglong Musk Hemorrhoids Suppository) in a 1:1 ratio, with 60 cases in each group. There were no significant differences in age, condition, and gender between the two groups.

[0063] 5. Treatment Methods

[0064] 1. Choose the drug

[0065] Treatment group: Cnidium monnieri suppository (same as Example 1)

[0066] Control group: Mayinglong Musk Hemorrhoid Suppositories (musk ketone, artificial bezoar, pearl, borneol, notoginseng, gallnut, calamine, belladonna fluid extract) (Mayinglong Pharmaceutical Group Co., Ltd., approval number: National Medicine Standard Z42021461)

[0067] 2. Method of administration

[0068] Treatment group: Millettia reticulata suppository, anal plug, 1 capsule / time, 1 time / day, external application before bedtime or after defecation, continuous medication for 1 week, record symptom changes, and record symptom changes after 1 week of discontinuation.

[0069] Control group: Mayinglong Musk Hemorrhoid Suppository, anal plug, 1 capsule / time, 1 time / day, external use before bedtime or after defecation, continuous medication for 1 week, record symptom changes, and record symptom changes after 1 week of discontinuation.

[0070] When using, first put the provided fingertip on the index finger, tear open the suppository package, take out the suppository, and gently insert it into the anus about 2 cm.

[0071] 3. Main efficacy indicators

[0072] According to the efficacy scoring standard, the degree of internal hemorrhoid prolapse, blood in stool, anal burning pain, and stool conditions were observed and scored before and one week after treatment in the two groups of patients. Urine conditions were also recorded; tongue coating and pulse were not scored.

[0073] In addition, patients in both groups underwent blood cell analysis, urine analysis, stool routine + occult blood, liver function and kidney function tests before treatment and one week after treatment.

[0074] VI. Efficacy evaluation criteria The efficacy evaluation criteria for clinical symptoms refer to the efficacy scoring criteria of the "Guiding Principles for Clinical Research of New Chinese Medicines" and the efficacy is evaluated according to the following formula:

[0075] The symptom score was calculated using the nimodipine method: therapeutic index = (score before treatment - score after treatment) / score before treatment × 100%.

[0076] Clinical recovery: symptoms disappear or almost disappear, and symptom score decreases by ≥95%;

[0077] Markedly effective: symptoms were significantly improved, 95%>symptom score decreased ≥70%;

[0078] Effective: All symptoms improved, 70%>symptom score decreased ≥30%;

[0079] Ineffective: There is no significant improvement in symptoms, and some symptoms may even be aggravated; the symptom score is reduced by <30%.

[0080] Significant efficacy = (number of cured patients + number of effective patients) / total number of patients × 100%.

[0081] Total effective rate = (number of cured patients + number of markedly effective patients + number of effective patients) / total number of patients × 100%.

[0082] VII. Treatment Outcomes

[0083] The treatment results of the two groups of patients after 1 week of medication were observed, and the score data of the main efficacy indicators of the two groups were input into SPSS21.0 statistical software, and the rank sum test, two independent sample test, and Mann-Whitney U test were used. The results of efficacy comparison are shown in Table 1.

[0084] Table 1 Comparison of therapeutic effects between the treatment group and the control group

[0085] Group Recovered / person Significant effect / person Effective / person Invalid / person Efficiency / % Total effective rate / % Treatment Group 11 16 26 7 45.0 88.3 Control group 10 14 30 6 40.0 90.0

[0086] As shown in Table 1, there was no significant statistical difference between the treatment group and the control group in terms of clinical efficacy (P=0.086>0.05).

[0087] In addition, no obvious abnormalities were found in blood cell analysis, urine analysis, stool routine + occult blood, liver function and kidney function of the two groups of patients.

[0088] 8. Conclusion

[0089] The present invention selects Mayinglong Musk Hemorrhoid Suppositories as a control group to compare the clinical efficacy and safety of Jishiteng Suppositories. The results show that the marked efficacy of the treatment group is 45%, and the total effective rate is 88.3%, while the marked efficacy of the control group is 40%, and the total effective rate is 90%. The two groups of data are compared statistically, and the difference is not statistically significant.

[0090] Conclusion: In terms of the efficacy of treating mixed hemorrhoids of damp-heat type, Jishiteng suppository and Mayinglong Musk hemorrhoid suppository are equivalent and equally safe.

[0091] The above description of the disclosed embodiments enables one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A Herba Cistanches Linn., characterized in that: The method comprises the following raw materials in parts by weight: 4-5 parts of mixed fatty acid glyceride and 1 part of Cnidium officinale powder.

2. The Herba Cistanches Linn. suppository according to claim 1, characterized in that: The method comprises the following raw materials in parts by weight: 4 parts of mixed fatty acid glyceride and 1 part of Cnidium officinale powder.

3. The Herba Cistanches Linn. suppository according to claim 1, characterized in that: The method comprises the following raw materials in parts by weight: 5 parts of mixed fatty acid glyceride and 1 part of Cnidium officinale powder.

4. A method for preparing a Cistanche deserticola suppository, characterized in that: The specific steps include: (1) Weighing the raw materials according to the weight proportion of the Cnidium monnieri suppository according to any one of claims 1 to 3; (2) mixing the mixed fatty acid glyceride and the Cistanche deserticola powder, stirring in a water bath until dissolved, to obtain a mixed solution; (3) Pour the mixed solution into a suppository mold pre-coated with glycerin, shake it and wipe off the overflowed mixed solution, freeze it, and take it out to obtain the Cistanche deserticola suppository.

5. The method for preparing the Cnidium monnieri suppository according to claim 4, characterized in that: In step (2), the temperature of the water bath is 80°C.

6. The method for preparing the Cnidium monnieri suppository according to claim 4, characterized in that: In step (3), the freezing time is 10 minutes.