阅读说明：本技术 一种中药复方鼻炎栓剂及其制备方法 (Traditional Chinese medicine compound rhinitis suppository and preparation method thereof ) 是由 叶威良 李俊杰 曹琼 赵一浦 张菲玥 廖天添 赵宁宁 于 2021-08-26 设计创作，主要内容包括：本发明公开了一种中药复方鼻炎栓剂及其制备方法,克服了现行治疗鼻炎反复发作的缺陷及不良反应。其药物组份为篦麻子、细辛、乳香、没药、花蕊石、碘盐。本发明专利属纯中药复方栓剂,配伍巧妙,具有祛风清热化湿,消肿、解毒、排脓、消炎杀菌、通窍活血化瘀之功效,治疗急慢性、过敏性鼻炎、鼻窦炎,可使患者迅速减轻水肿、鼻塞、头痛、鼻涕、耳目发痒等病症。(The invention discloses a traditional Chinese medicine compound rhinitis suppository and a preparation method thereof, which overcome the defects and adverse reactions of repeated attack of rhinitis in the existing treatment. The medicine components are castor seed, asarum, frankincense, myrrh, ophicalcite and iodized salt. The invention belongs to a pure Chinese medicinal compound suppository, has ingenious compatibility of medicines, has the effects of dispelling wind, clearing heat, eliminating dampness, reducing swelling, detoxifying, expelling pus, diminishing inflammation, sterilizing, dredging orifices, promoting blood circulation and removing blood stasis, treats acute and chronic allergic rhinitis and nasosinusitis, and can quickly relieve symptoms of edema, nasal obstruction, headache, nasal discharge, ear and eye itching and the like of a patient.)

1. A traditional Chinese medicine compound rhinitis suppository is characterized by being prepared from the following medicine components in parts by weight: 25-35 parts of castor seed, 8-12 parts of asarum, 8-12 parts of frankincense, 8-12 parts of myrrh, 8-12 parts of ophicalcitum, 0.5-1.5 parts of iodized salt and 15.5-42.5 parts of glycerogelatin.

2. The traditional Chinese medicine compound rhinitis suppository as claimed in claim 1, which is characterized by being prepared from the following medicinal components in parts by weight: 28-32 parts of castor seed, 9-11 parts of asarum, 9-11 parts of frankincense, 9-11 parts of myrrh, 9-11 parts of ophicalcitum, 0.8-1.2 parts of iodized salt and 22.8-35.2 parts of glycerogelatin.

3. The traditional Chinese medicine compound rhinitis suppository as claimed in claim 2, which is characterized by being prepared from the following medicinal components in parts by weight: : 30 parts of castor seed, 10 parts of asarum, 10 parts of frankincense, 10 parts of myrrh, 10 parts of ophicalcitum, 1 part of iodized salt and 29 parts of glycerogelatin.

4. The preparation method of the traditional Chinese medicine compound rhinitis suppository as claimed in any one of claims 1 to 3, is characterized by comprising the following specific steps:

step 1, raw material pretreatment

Step 1.1, adopting a freezing and crushing process to the frankincense and the myrrh, putting the frankincense and the myrrh into a freezer for freezing, taking out the frankincense and the myrrh after 5 hours, and obtaining fine powder of the frankincense and the myrrh by adopting a method of quick crushing in times;

step 1.2, husking the castor seeds by using a husking machine, pouring the castor seeds into a double-shaft double-paddle reverse high-speed shearing, dispersing and stirring pulverizer, and stirring at a high speed to obtain a castor seed paste;

step 1.3, washing, drying, smashing into fragments, calcining until the fragments are red, taking out, adding clear water, infiltrating, immediately taking out, cooling, and crushing by using a high-speed shearing, dispersing, stirring and crushing machine to obtain ophicalcitum powder;

step 1.4, removing impurities from asarum, spraying clear water, wetting, cutting into sections, and drying in the shade. Crushing by a high-speed shearing, dispersing and stirring crusher to obtain asarum powder;

step 2, weighing, melting the matrix, adding the medicine and mixing uniformly

Weighing the medicines in the steps 1.1, 1.2, 1.3 and 1.4, uniformly mixing to form paste, placing glycerogelatin on a water bath to be heated to 80 ℃ for melting, then adding the paste and iodized salt, continuously stirring uniformly for 30min, then pouring the mixture into a nasal cavity suppository mold coated with a lubricant until the mixture overflows from a mold opening, cooling, scraping redundant suppository blocks after complete solidification, opening the mold and taking out to obtain the externally used traditional Chinese medicine compound rhinitis suppository.

Technical Field

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine compound rhinitis suppository prescription for treating rhinitis and a preparation method thereof.

Background

Rhinitis, including allergic rhinitis, chronic sinusitis, and the like, refers to inflammation that results from physical, chemical irritation or autoimmune changes to the nasal mucosa and submucosal tissues. Typical symptoms are usually manifested as nasal obstruction, watery nasal discharge, sneezing, rhinitis type headache, dizziness, etc.

Rhinitis belongs to the category of nasosinusitis in traditional Chinese medicine, and is mainly caused by wind-heat pathogen entering interior to transform heat, toxic heat and turbid nasal discharge and obstruction of nasal orifices. In chronic cases, the lung qi is deficient to defensive qi, which is apt to be attacked by exogenous pathogenic factors. Spleen deficiency failing to transport and transform, retention of phlegm-dampness, obstructing the nasal orifices and invading the mucosa of the nasal sinuses, resulting in nasosinusitis. Therefore, chronic rhinitis should clear lung-heat and benefit spleen, and can be fundamentally conditioned by using the formulas and the like. The traditional Chinese medicine has reliable curative effect on rhinitis, small toxic and side effect and wide prospect.

Modern medicine usually adopts intranasal glucocorticoid to administer, nasal cavity washing method, antihistamine, vasoconstrictor and some Chinese patent medicines to treat rhinitis patients, adopts operation treatment for serious patients, but the effect is not obvious, the treatment is not easy, side effects are easy to remain, drug rhinitis is formed or nasal mucosa damage is caused, even 'empty nose syndrome' is formed, and more pain is caused to the patients.

The suppository is solid preparation prepared from raw materials and proper matrix, and can be administered via nasal cavity. Its advantages include (1) the drug is not damaged by gastrointestinal pH or enzyme; (2) drugs with irritation to gastric mucosa can be prevented from being absorbed by the irritation (3) through nasal administration, and most of the drugs are not damaged by liver first-pass action; (4) nasal absorption is less than oral interference factors; (5) the method can be used for patients who cannot or do not want to swallow tablets, pills and capsules, especially infants and children; (6) is an effective way to treat patients with emesis; (7) it has topical effects in lubricating nasal cavity, resisting bacteria, relieving pain, and stopping oxygen. (8) Has quick action and high bioavailability. When the nasal spray is applied to the nasal cavity, the matrix is mild, so that the nasal spray has little irritation to the nasal cavity, and the drug effect is prolonged.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine compound rhinitis suppository and a preparation method thereof, and aims to solve the problems in the background technology.

In order to achieve the purpose, the invention provides the following technical scheme: a traditional Chinese medicine compound rhinitis suppository is characterized by being prepared from the following medicine components in parts by weight: 25-35 parts of castor seed, 8-12 parts of asarum, 8-12 parts of frankincense, 8-12 parts of myrrh, 8-12 parts of ophicalcitum, 0.5-1.5 parts of iodized salt and 15.5-42.5 parts of glycerogelatin.

Preferably, 28 to 32 parts of castor seed, 9 to 11 parts of asarum, 9 to 11 parts of frankincense, 9 to 11 parts of myrrh, 9 to 11 parts of ophicalcitum, 0.8 to 1.2 parts of iodized salt and 22.8 to 35.2 parts of glycerogelatin.

Preferably, 30 parts of castor seed, 10 parts of asarum, 10 parts of frankincense, 10 parts of myrrh, 10 parts of ophicalcitum, 1 part of iodized salt and 29 parts of glycerogelatin.

A preparation method of a traditional Chinese medicine compound rhinitis suppository is characterized by comprising the following specific steps:

step 1, raw material pretreatment

Step 1.1, adopting a freezing and crushing process, putting the frankincense and the myrrh into a freezer for freezing, taking out the frankincense and the myrrh after 5 hours, and adopting a method of quick crushing in times to obtain fine powder (No. eight sieve powder) of the frankincense and the myrrh.

And step 1.2, husking the castor seeds by using a husking machine, pouring the husked castor seeds into a double-shaft double-paddle reverse high-speed shearing, dispersing and stirring pulverizer, and stirring at a high speed to form a paste. Obtaining the castor bean paste.

Step 1.3, the ophicalcitum is cleaned, dried and smashed into fragments. Calcining until it is red, taking out, adding clear water, soaking, taking out, cooling, and pulverizing with high speed shearing dispersion stirring pulverizer to obtain Ophicalcitum powder (No. eight sieve powder).

Step 1.4, removing impurities from asarum, spraying clear water, wetting, cutting into sections, and drying in the shade. And (4) crushing by a high-speed shearing, dispersing, stirring and crushing machine to obtain asarum powder (No. eight sieve powder).

Step 2, weighing, melting the matrix, adding the medicine and mixing uniformly

Weighing the medicines in the step 1.1, the step 1.2, the step 1.3 and the step 1.4, uniformly mixing to form paste, placing glycerogelatin on a water bath, heating to 80 ℃ to melt, adding the paste and iodized salt, and continuously and uniformly stirring for 30 min; then pouring the mixture into a nasal cavity suppository mold coated with a lubricant until the mixture overflows out of a mold opening; cooling, completely solidifying, scraping off excessive suppository blocks, opening the mold, and taking out to obtain the traditional Chinese medicine compound rhinitis suppository.

The pharmacological effects of the raw materials of the invention are as follows:

castor seed, sweet and pungent in flavor, mild in nature; the main treatment is as follows: eliminating swelling and drawing out toxin; purgation and removing stagnation; dredging collaterals and benefiting orifices. Abscess, deep-rooted carbuncle and pyogenic infections; scrofula; acute mastitis; pharyngitis; scabies, tinea and sore; scalding; edema and fullness; dry stool; facial distortion; traumatic injury.

Asarum herb, pungent in flavor, warm in nature and with little toxicity; the main treatment is as follows: relieving exterior syndrome, dispelling cold, dispelling pathogenic wind, relieving pain, dredging orifices, warming lung, and eliminating phlegm. Wind-cold type common cold, headache, toothache, rheumatism, nasosinusitis, cough due to lung cold. Fragrant, pungent and warm in property, it is good at dispersing wind-cold-dampness, unblocking orifices and alleviating pain.

Frankincense, pungent and bitter in flavor and warm in nature; the main treatment is as follows: promote blood circulation, move qi and alleviate pain, resolve swelling and promote tissue regeneration. Can be used for treating thoracic obstruction, cardialgia, epigastralgia, dysmenorrhea, amenorrhea, puerperal blood stasis, abdominal pain, rheumatic arthralgia, spasm of muscles and tendons, traumatic injury, carbuncle, swelling, and pyocutaneous disease.

Myrrh, pungent and bitter in flavor, warm in nature and non-toxic; it is mainly used for dissipating blood stasis, relieving pain, eliminating swelling and promoting granulation. Can be used for treating thoracic obstruction, cardialgia, gastralgia, dysmenorrhea, amenorrhea, puerperal blood stasis, abdominal mass, rheumatic arthralgia, traumatic injury, carbuncle, swelling, and pyocutaneous disease.

Ophicalcitum is sour, astringent and neutral in flavor; is mainly used for removing blood stasis and stopping bleeding. Can be used for treating hemoptysis, hematemesis, traumatic hemorrhage, traumatic injury, and pain.

Iodized salt, preservative and antibacterial agent. The function is as follows: has permeability, can improve the absorption of the medicine by mucosa, and has the effects of disinfection, sterilization and antisepsis.

Compared with the prior art, the invention has the following characteristics: has the efficacy of treating various acute, chronic and allergic rhinitis, has remarkable treatment effect, no relapse after healing, can radically cure rhinitis for many years, and has high cure rate. The traditional Chinese medicine composition disclosed by the invention is an external preparation, is a pure traditional Chinese medicine compound preparation, has no toxic or side effect, has no drug dependence and does not cause drug-induced rhinitis. Meanwhile, the preparation process adopts a novel matrix, adopts the traditional concept technology and adopts the perfect presentation of the modern technology, and is simple, easy to implement, convenient for production, quality control, clinical popularization and the like.

Drawings

FIG. 1 is a process flow diagram of the preparation method of the present invention.

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 present invention and are not intended to limit the present invention.

Example 1

A traditional Chinese medicine compound rhinitis suppository comprises the following raw materials in parts by weight: 25 parts of castor seed, 8 parts of asarum, 8 parts of frankincense, 8 parts of myrrh, 8 parts of ophicalcitum, 0.5 part of iodized salt and 42.5 parts of glycerogelatin.

Example 2

A traditional Chinese medicine compound rhinitis suppository comprises the following raw materials in parts by weight: 28 parts of castor seed, 9 parts of asarum, 9 parts of frankincense, 9 parts of myrrh, 9 parts of ophicalcitum, 0.8 part of iodized salt and 32.5 parts of glycerogelatin.

Example 3

A traditional Chinese medicine compound rhinitis suppository comprises the following raw materials in parts by weight: 30 parts of castor seed, 10 parts of asarum, 10 parts of frankincense, 10 parts of myrrh, 10 parts of ophicalcitum, 1 part of iodized salt and 29 parts of glycerogelatin.

Example 4

A traditional Chinese medicine compound rhinitis suppository comprises the following raw materials in parts by weight: 32 parts of castor seed, 11 parts of asarum, 11 parts of frankincense, 11 parts of myrrh, 11 parts of ophicalcitum, 1.2 parts of iodized salt and 22.8 parts of glycerogelatin.

Example 5

A traditional Chinese medicine compound rhinitis suppository comprises the following raw materials in parts by weight: 35 parts of castor seed, 12 parts of asarum, 12 parts of frankincense, 12 parts of myrrh, 12 parts of ophicalcitum, 1.5 parts of iodized salt and 15.5 parts of glycerogelatin.

The raw materials in the above examples were prepared by the following steps:

1. pretreatment of raw materials

1.1, adopting a freezing and crushing process, putting the frankincense and the myrrh into a freezer for freezing, taking out the frankincense and the myrrh after 5 hours, and adopting a method of fractional quick crushing on the basis of the original low temperature (the problems of quality degradation and softening and bonding of medicinal materials caused by temperature rise are eliminated, so that the effective components of the medicine are fully released, the hygroscopicity, the fluidity and the filling property of the medicinal material fine powder after low-temperature treatment are enhanced, the required fine powder is obtained, the quality of finished products is stabilized), and the frankincense and the myrrh fine powder (No. eight sieve powder) is obtained.

1.2, peeling the castor seeds by using a peeling machine, pouring the peeled castor seeds into a double-shaft double-paddle reverse high-speed shearing, dispersing and stirring pulverizer, and stirring at a high speed to form a paste. Obtaining the castor bean paste.

1.3, washing, drying and smashing the ophicalcitum into fragments. Calcining until it is red, taking out, adding clear water, soaking, taking out, cooling, and pulverizing with high speed shearing dispersion stirring pulverizer to obtain Ophicalcitum powder (No. eight sieve powder).

1.4, removing impurities from asarum, spraying clear water, wetting, cutting into sections, and drying in the shade. And (4) crushing by a high-speed shearing, dispersing, stirring and crushing machine to obtain asarum powder (No. eight sieve powder).

2. Weighing, melting the matrix, adding the drug (mixing)

Weighing the above (1.1), (1.2), (1.3) and (1.4), mixing uniformly to obtain paste, and heating the glycerogelatin in water bath (80 deg.C) to melt. Adding the paste (1.1) and iodized salt, and stirring for 30 min.

3. Injection moulding, cooling, scraping, removing

3.1 injection moulding (pouring into a lubricated nasal cavity plug until the mould mouth overflows)

And 3.2, cooling, namely cooling until the materials are completely solidified.

3.3 scraping and taking out: scraping off excessive suppository blocks, opening the mold and taking out to obtain the traditional Chinese medicine compound rhinitis suppository for treating rhinitis for external use.

4. Encapsulating, externally packaging, inspecting and warehousing

4.1 the suppository taken out of the mould is encapsulated by a suppository encapsulating machine set. And during encapsulation, controlling the heat preservation temperature, the encapsulation speed and the working temperature of the sealing and cutting machine. The grain weight and weight difference were sampled every 30 minutes.

4.2 external packing: each inner box is filled with 8 shell bags (8 stpes), one bag of finger sleeves (8) and a specification, the inner boxes are filled into a middle box, and each large box is filled with 120 middle boxes and one packing sheet. The joint of the upper and lower sealing covers of the big box is firmly pasted by a box sealing adhesive tape. The accuracy of product batch number, production date and effective period printing is controlled, and the product cannot be filled in a medium box or a large box in a small quantity or neglected.

4.3, inspecting and warehousing (storing in a warehouse at 0-30 ℃). The traditional Chinese medicine compound rhinitis suppository for treating rhinitis is obtained.

5. Quality standard

5.1, appearance property: the product is dark brown, and can be made into bullet-shaped suppository by mixing the above materials with matrix. 5.2, character inspection: the appearance should be complete and smooth. And has a suitable hardness. The suppository should meet the requirements specified in the suppository entry in pharmacopoeia of the people's republic of China:

5.3, pH value: 1 suppository prepared in the embodiment 1-5 is taken out, 20 ml of distilled water is added, the mixture is heated and stirred to be dissolved, and the pH value is measured to be 5.5-7.0 after cooling, and all the requirements are met.

5.5, weight difference: the average of 10 examination results is 1.85 plus or minus 0.05 g, the weight difference limit is less than plus or minus 5 percent, and the requirements of pharmacopoeia of the people's republic of China are met.

5.6, fusion time limit: the suppositories prepared in examples 4 to 7 were each taken 3 times, left at room temperature for 1 hour, examined according to the method prescribed for the disintegration time of the tablet, and found to have a melting time of 60 minutes (water-soluble base) and to have no hard core when all of them are melted, softened or pressed against. Meets the requirements of pharmacopoeia of the people's republic of China.

5.7, stability observation: the suppository is stored at room temperature (25 s 3) deg.C and 4 deg.C, and periodically checked for appearance change, softening point range, main drug content and in vitro release.

Clinical observation data:

the traditional Chinese medicine compound rhinitis suppository prepared according to the mixture ratio of the embodiments 1, 2, 3, 4 and 5 is applied to 60 clinical cases for observation, and the trial shows that the traditional Chinese medicine compound rhinitis suppository has ideal treatment effect.

Administration dose:

control group: the medicine is orally taken by western medicines of rhinitis treating tablets, loratadine and chlorphenamine, and can be repeatedly administered once for 4 hours of patients with stuffy nose according to the conventional dose of 10mg per kilogram.

Treatment groups: the traditional Chinese medicine compound rhinitis suppository is used for 1 granule below 5 years old and 1-2 granules above 5 years old, and can be repeatedly administered once for a patient with stuffy nose and edema obstruction within 4 hours.

The main observation is as follows:

observing the change of nasal cavity and the general condition (observing the change of edema, nasal obstruction, headache, nasal discharge, ear and eye itching, etc.) for 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours and more than 24 hours after the medicine is applied respectively

The curative effect index is as follows:

the effect is shown: the nasal obstruction is normal within 4 hours, and the general symptoms are obviously improved within three days.

The method has the following advantages: those with nasal obstruction in 12 hours and those with general symptoms relieved in three days.

And (4) invalidation: the nasal obstruction is normal within more than 12 hours, and the general symptoms are unchanged within three days.

As a result:

compared with the effective rate of the control group, the statistical treatment that p is more than 0.03 proves that the treatment group has no obvious difference with the control group, and the total effective rates of the suppository prepared by the mixture ratios of the examples 1, 2, 3, 4, 5 and 6 are respectively 80%, 85.6%, 90.2%, 95% and 99%.

Typical cases

Case one: yang is in certain age, 40 years old, and mainly complains of nasal obstruction and sneezing for more than 5 years, which aggravates the disease for 15 days. The patients with the prior medical history sneeze, watery nasal discharge and nasal obstruction in the morning 5 years ago, have nasal itching, throat itching and ear itching, are ineffectively treated by oral anti-influenza drugs, and then are diagnosed as allergic rhinitis in XXXXXX hospitals, and are mild and heavy when taking anti-allergic drugs such as loratadine, chlorphenamine and the like, and are aggravated in autumn. The external traditional Chinese medicine compound rhinitis suppository is used for treating 3 granules of rhinitis, 3 times per day, and 1 day, and has good nasal obstruction symptom; the medicine is used for 2 days, and has good symptoms of nasal itching, throat itching and ear itching; the continuous use for 7 days has no symptoms. Half a year later, follow-up visit without relapse.

Case two: liu Zhi, male, 35 years old complained of nasal obstruction and sneezing for more than 7 years. The patient sneezes and has nasal obstruction in the morning 7 years ago, the patient has rhinocnesmus, the oral anti-influenza drug treatment is ineffective, and then the symptoms of the oral anti-allergic drugs such as allergic rhinitis and loratadine are diagnosed in a certain community hospital and are not obviously relieved. The external traditional Chinese medicine compound rhinitis suppository is used for treating rhinitis 2 granules for 2 times per day for 2 days, and sneezing and rhinocnesmus are gradually weakened; the symptoms are basically improved after the continuous use for 30 days. Half a year later, follow-up visit without relapse.

Case three: zhangyi, women, 48 years old complain of nasal obstruction and sneezing for more than 10 years, aggravate the existing medical history of 20 days, namely, the patient sneezes and has nasal obstruction in the morning before 10 years, the nasal itching is accompanied, the treatment of oral anti-cold drugs is ineffective, and then the symptoms of the oral anti-allergic drugs such as the allergic rhinitis and the oral loratadine are diagnosed in a community hospital and are not obviously relieved. The traditional Chinese medicine compound rhinitis suppository is externally used for treating 1 granule for 1 time per day for 1 day; after continuous use for 7 days, nasal obstruction, sneezing and nasal itching are weakened. Follow-up after 8 months without recurrence.

The foregoing is a more detailed description of the invention in connection with specific preferred embodiments and is not intended to limit the invention to the particular forms disclosed. For those skilled in the art to which the invention pertains, several simple deductions or substitutions can be made without departing from the spirit of the invention, and all shall be considered as belonging to the protection scope of the invention.