Membrane-nourishing pregnancy-assisting bag and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine preparation, in particular to a film-nourishing pregnancy-assisting bag and a preparation method thereof.The preparation method comprises the steps that 1, raw materials are prepared, specifically, traditional Chinese medicine clean material decoction pieces of mulberries, lycium ruthenicum, human placenta and dendrobium officinale are weighed; and the site cleaning work is completed after weighing. 2, crushing and sieving: mixing the weighed clean material decoction pieces, and carrying out coarse crushing; and performing fine crushing after coarse crushing. Step 3, drying and sterilizing: spreading the sieved medicinal powder in a tray filling device respectively; and drying and sterilizing. And step 4, mixing and sieving: mixing the sterilized medicinal powder again. 5, medicine split charging, wherein the medicine powder mixed again is split charged in a sterile workshop. And step 6, labeling and warehousing: after sub-packaging, carrying out label printing and outer packaging labeling. According to the invention, the safety of the product is ensured through efficient crushing and uniform mixing and by adopting a drying and sterilizing mode for treatment.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine preparation, and specifically relates to a membrane-nourishing and pregnancy-assisting package and a preparation method thereof. Background Art

[0002] Thin endometrium refers to the endometrial thickness below the threshold thickness capable of achieving pregnancy. Currently, most scholars believe that in assisted reproductive technology (ART), on the day of hCG or the day of luteal support, when the endometrial thickness measured by transvaginal ultrasound is <7 mm, it is thin endometrium, which can lead to infertility. The main high-risk factors for thin endometrium are: advanced age, infection, intrauterine operation, drugs, and a part of idiopathic thin endometrium.

[0003] In the prior art, through individualized treatment, although there is a certain curative effect, there are also some problems. For example, the decocting process of some formulas is complex and the convenience is poor. It is necessary to accurately master the compatibility ratio, decocting time and heat of the medicinal materials. Its medication cycle is long, there is a first-pass effect in the liver, and the local drug concentration is low, which is not conducive to popularization.

[0004] In summary, how to solve the problems of complex decocting process, poor convenience, first-pass effect in the liver, and low local drug concentration in the prior art has become a difficult problem that needs to be solved urgently in the current field. Therefore, it is necessary to propose a membrane-nourishing and pregnancy-assisting package and a preparation method thereof. Summary of the Invention

[0005] To solve the above problems, the present invention provides a membrane-nourishing and pregnancy-assisting package and a preparation method thereof. Through efficient pulverization and uniform mixing, and by adopting a method of drying and sterilization for treatment, the safety of the product is ensured. The finished product has simple operation steps, strong convenience and practicability, can avoid the first-pass effect in the liver, and increase the local drug concentration.

[0006] To achieve the above object, the technical solution of the present invention is as follows: A membrane-nourishing and pregnancy-assisting package includes mulberry, black wolfberry, placenta hominis, and dendrobium officinale with a mass ratio of 3:1:1:1.

[0007] Further, a preparation method of a membrane-nourishing and pregnancy-assisting package includes the following steps:

[0008] Step 1, raw material preparation: Use a calibrated electronic scale to accurately weigh the net material slices of traditional Chinese medicinal materials of mulberry, black wolfberry, placenta hominis, and dendrobium officinale according to the proportion; after weighing, complete the site cleaning work.

[0009] Step 2, pulverization and sieving: Mix the weighed net material slices for coarse pulverization; after coarse pulverization, conduct fine pulverization, and after fine pulverization, sieve through a 100-200 mesh sieve to obtain medicinal powder; after sieving, conduct site cleaning, and calculate the yield and material balance rate.

[0010] Step 3, drying and sterilization: spread the sieved powders in a tray with a thickness of ≤2.0 cm; and dry and sterilize.

[0011] Step 4, mixing and sieving: Mix the sterilized powder again, with the mixing time ≥30min; after mixing, sieve through a 100-200 mesh sieve again; after sieving again, clean the area and calculate the yield and material balance rate.

[0012] Step 5: Drug repackaging: repack the remixed drug powder in the sterile workshop, and check the packaging volume and sealing degree from time to time during the repackaging.

[0013] Step 6: Labeling and warehousing: After packaging, label printing and outer packaging labeling are carried out; after labeling is completed, the finished product can be put into storage for use after passing the inspection.

[0014] Furthermore, in step 2, during the crushing and screening process, the ingredients are weighed and prepared according to the batch preparation instructions, and two people are combined; the coarse crushing is carried out using a graded continuous feeding crusher; and the fine crushing is carried out using a vibrating pharmaceutical ultrafine crusher.

[0015] Furthermore, in step 2, the yields of coarse crushing, fine crushing and screening are all 90% to 100%.

[0016] Further, in step 2, the material balance rate calculation formula is as follows:

[0017] W = (finished product weight + waste weight + return weight) / received weight × 100%

[0018] Wherein, W is the material balance rate, which ranges from 97% to 103%.

[0019] Furthermore, in step three, the drying and sterilization method is to use a hot air sterilization box, set the drying temperature to 50-65° C., set the drying and sterilization time to 12-15 hours, and the yield is 85%-100%.

[0020] Furthermore, in step 4, the mixing is performed again according to the mixing station operation procedures, the yield of mixed screening is 90% to 100%, and the material balance rate is 97% to 103%.

[0021] Furthermore, in step five, the drugs are packaged in medicinal polyethylene bags, with each bag containing 60 to 100 g; irregular inspections are conducted 3 to 5 times per batch and records are kept.

[0022] Further, in step six, labeling and warehousing includes the following steps:

[0023] S1. Label printing: Collect the labels for this batch of products according to the batch packaging instructions; and check the appearance inspection report or certificate of conformity for product name, specification, quantity, text, pattern, color, material and size.

[0024] S2. Adjust the printing equipment according to the product batch number, production date and expiration date of this batch. After adjustment, perform printing.

[0025] S3. According to the batch packaging instruction, obtain the product labels of this batch that have passed the printing inspection, and check the appearance of the product name, quantity, color, specification and material. Place them in the outer packaging room for outer packaging labeling.

[0026] S4. The finished products after labeling are transported to the waiting inspection area of the finished product warehouse through a turnover basket, and are stored in the warehouse for use after passing the finished product inspection.

[0027] Furthermore, in step one, auxiliary decoction pieces are added during raw material preparation. The auxiliary decoction pieces are selected from one or more of wild jujube seeds, polygala roots and polygonum multiflorum thunb. The mass ratio of the net decoction pieces of traditional Chinese medicine to the auxiliary decoction pieces is 4:1.

[0028] Adopting the above scheme has the following beneficial effects:

[0029] 1. By accurately weighing the raw materials, combining coarse crushing and fine crushing, and using the treatment method of sieving multiple times, the particle size of the medicinal powder is uniform, which is beneficial to the full release of drug components and the absorption and utilization by the human body, thus improving the medicinal effect; through the implementation of the drying and sterilization steps, the moisture and microorganisms in the medicinal powder are effectively removed, ensuring the sterile state of the product, extending the shelf life of the product, and ensuring the safety of the product.

[0030] Through the step of re - mixing, it is ensured that the components in the medicinal powder are evenly distributed, avoiding the difference in medicinal effects caused by uneven component distribution, further ensuring the uniformity and fineness of the medicinal powder, and improving the overall quality of the product. And calculate the yield and material balance rate after each operation is completed to ensure that the material loss in the production process is within the controllable range, improving production efficiency and cost control.

[0031] 2. After each operation step of the present invention is completed, the site is cleared to ensure that there is no residue of raw materials and auxiliary materials on the site, no various waste materials, ensuring that the production environment is clean and tidy, avoiding cross - contamination, ensuring the cleanliness of the preparation environment, and further improving the product quality. And the product is sub - packed in an aseptic workshop to ensure the aseptic state of the product during the sub - packing process, avoiding secondary contamination; during sub - packing, the sub - packing quantity and sealing degree are checked irregularly to ensure the accuracy and integrity of each bag of product, which is convenient for patients to use and store.

[0032] 3. By conducting irregular inspections on the sub-packaged products, the present invention ensures the stability and controllability of product quality during the sub-packaging process, promptly discovers and solves possible problems. After sub-packaging, the products are labeled with outer packaging to avoid the problems of label confusion or mislabeling with the products, ensuring the appearance quality and packaging standardization of the products. After labeling, they are transported to the awaiting inspection area of the finished product warehouse and stored for use after passing the finished product inspection; it is ensured that all products have undergone strict quality inspections before labeling and warehousing, and only qualified products can be warehoused for use, thus guaranteeing the safety and quality of the products.

[0033] 4. In the process of raw material treatment, the present invention adds adjuvant Chinese herbal pieces. The selected adjuvants have the functions of calming the nerves and sedation, helping to improve sleep quality, relieve anxiety and stress, maintain the balance of hormone levels, regulate endocrine, and enhance immunity and resistance. Compared with the possible side effects of Western medicine in treating infertility, the use of traditional Chinese medicine adjuvants is gentler and can reduce the occurrence of adverse reactions. The prepared finished products have simple operation steps, strong convenience and practicability, and are suitable for the needs of most families; they can avoid the first-pass effect of the liver and increase the local drug concentration.

[0034] Additional aspects and advantages of the present invention will be partially given in the following description, partially will become apparent from the following description, or be understood through the practice of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 It is a schematic flow chart of the preparation method of the endometrium-nourishing pregnancy-assisting package in the embodiment of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0036] The following is further detailed through specific embodiments:

[0037] Example 1:

[0038] As shown in the Figure 1 drawing: An endometrium-nourishing pregnancy-assisting package includes mulberries, black goji berries, placenta hominis, and dendrobium officinale with a mass ratio of 3:1:1:1.

[0039] A preparation method of an endometrium-nourishing pregnancy-assisting package includes the following steps:

[0040] Step 1, raw material preparation: Use a calibrated YH-T1 type electronic scale to accurately weigh the net Chinese herbal pieces of mulberries, black goji berries, placenta hominis, and dendrobium officinale, with a mass of 300 g, 100 g, 100 g, and 100 g respectively; ensure the accuracy and consistency of the raw materials. After weighing, complete the site cleaning work; ensure that there is no residue of raw materials and auxiliary materials on the site, no various waste materials, and ensure that the production environment is clean and tidy.

[0041] Step 2, crushing and screening: weigh the ingredients according to the batch preparation instructions, and two people compound; mix the weighed clean ingredients and use the LG-150 graded continuous feeding crusher for coarse crushing; after coarse crushing, use the WZJ-12B vibrating drug ultrafine crusher for fine crushing, and pass through a 100-mesh sieve to obtain the drug powder; make the drug powder particle size uniform, which is conducive to the full release of drug ingredients and absorption and utilization by the human body, thereby improving the efficacy. After screening, the site is cleared, with a yield rate of 90% and a material balance rate of 97%, ensuring full utilization of raw materials and reducing waste, and also helping to monitor the stability and reliability of the preparation process.

[0042] Among them, the calculation formula of material balance rate W is as follows:

[0043] W = (finished product weight + waste weight + return weight) / received weight × 100%

[0044] Step 3, drying and sterilization: the sieved powder is spread flat in the tray with a thickness of 2.0 cm to ensure that the powder is evenly heated during the drying and sterilization process, thereby improving the sterilization effect; the HGRF-9203 hot air sterilizer is used, the drying temperature is set to 65°C, and the drying and sterilization time is set to 15h for drying and sterilization, with a yield of 85%, which effectively removes moisture and microorganisms in the powder, ensures the sterility of the product, and reduces the risk of infection during use.

[0045] Step 4, mixing and sieving: the sterilized powder is mixed again according to the mixing post operating procedures, and the mixing time is 30 minutes; after mixing, it is sieved through a 100-mesh sieve again to further ensure the uniformity and fineness of the powder and improve the overall quality of the product; after sieving again, the site is cleared, and the recovery rate is 90% and the material balance rate is 97%.

[0046] Step 5, drug packaging: In the sterile workshop, the remixed drug powder is packaged in pharmaceutical polyethylene bags, with 100g in each bag; ensure the sterility of the product during the packaging process to avoid secondary contamination. During packaging, check the packaging volume and sealing degree from time to time, record three times for each batch, ensure the accuracy and integrity of each bag of product, and facilitate patient use and storage.

[0047] Step six, labeling and warehousing: After packaging, label printing and outer packaging labeling are carried out; after labeling is completed, the finished product can be put into storage for use after passing the inspection, so as to further ensure the safety of patients' medication.

[0048] Specifically, labeling and warehousing include the following steps:

[0049] S1. Label printing: Collect the labels for this batch of products according to the batch packaging instructions; and check the appearance inspection report or certificate of conformity for product name, specification, quantity, text, pattern, color, material and size.

[0050] S2. Adjust the printing equipment according to the product batch number, production date and expiration date of this batch, and use the MY380F labeling machine for printing.

[0051] S3. Receive the product labels of this batch that have passed the printing inspection according to the batch packaging instructions, check the appearance of the product name, quantity, color, specification and material, and place them in the outer packaging room for outer packaging labeling.

[0052] S4. The finished products after labeling are transported to the waiting inspection area of the finished product warehouse through a turnover basket, and are stored in the warehouse for use after passing the finished product inspection.

[0053] Example 2:

[0054] The difference from the above example is that the present invention also provides an adjuvant decoction piece, which is processed together with the purified Chinese medicinal material decoction pieces during the preparation of the raw materials. The adjuvant decoction piece is selected from one or more of wild jujube seeds, polygala roots and polygonum multiflorum thunb. In this example, the adjuvant decoction piece is selected as wild jujube seeds, and the masses of the purified Chinese medicinal material decoction pieces and the adjuvant decoction pieces are 400 g and 100 g respectively.

[0055] The specific implementation process is as follows: By adding the adjuvant decoction piece, which has the effects of calming the nerves and sedation, it helps to improve the sleep quality, relieve anxiety and stress, maintain the balance of hormone levels, regulate the endocrine and enhance the immunity and resistance. Compared with the possible side effects of Western medicine treatment for infertility, the use of traditional Chinese medicine adjuvants is more gentle and can reduce the occurrence of adverse reactions.

[0056] Tests and Verifications

[0057] 1. Method

[0058] Select 72 patients undergoing artificial insemination, and divide them into an experimental group and a control group with 36 cases in each group on average. During the ovulation induction cycle, the experimental group was treated with the Yangmo Zhuyun Package combined with estradiol gel. Usage of the Yangmo Zhuyun Package: The patient prepares 2 abalones weighing about 50 g each (if dried, soak them in water until soft first), cut them open with the shells, take 100 ml of water, add the Zhuyun Package, stew the abalones and the Zhuyun Package together, bring to a boil over high heat and then simmer over low heat for 40 minutes, add 2 slices of ginger and 1 tael of rice wine, and take the decoction and abalones warm.

[0059] The control group was treated with estradiol gel, and parameters such as the endometrial thickness, endometrial morphology, uterine artery blood flow parameters, traditional Chinese medicine syndrome scores, and clinical pregnancy rate of the two groups were observed.

[0060] 2. Results

[0061] After the treatment, a total of 170 effective IUI (intrauterine insemination) cycles were obtained in the two groups. Among them, there were 84 cycles in the experimental group and 86 cycles in the control group. After the treatment, the endometrial thickness of the experimental group was higher than that of the control group. The endometrial thicknesses of the two groups were compared by the rank sum test, and the difference was statistically significant (P<0.05).

[0062] After treatment, the number of type A endometrium in the experimental group increased compared with that in the control group. The endometrial morphology of the two groups was compared by chi-square test, and the difference was statistically significant (P<0.05). After treatment, both the pulsatility index (PI) and resistance index (RI) of uterine artery blood flow in the experimental group were lower than those in the control group. The uterine artery blood flow parameters of the two groups were compared by rank sum test, and the differences were statistically significant (P<0.05). See Table 1.

[0063] Table 1 Comparison of endometrial thickness, morphology, and uterine artery blood flow parameters between the two groups after treatment (x±s / n / M(P25-P75))

[0064]

[0065] Note a: Compared with the control group: *Z=-2.486, P=0.013<0.05

[0066] Note b: Comparison of endometrial morphology between the two groups: χ 2 =18.114, P=0.000<0.05

[0067] Note c: Compared with the control group: #Z=2.534, P=0.011<0.05

[0068] Note d: Compared with the control group: ￥Z=2.251, P=0.024<0.05

[0069] After treatment, the TCM syndrome score in the experimental group was lower than that in the control group. The difference was statistically significant by rank sum test (P<0.05). After treatment, the TCM syndrome scores of both groups decreased compared with those before treatment, and the differences were statistically significant within each group (P<0.05). See Table 2.

[0070] Table 2 Comparison of TCM syndrome scores between the two groups before and after treatment (M(P25-P75))

[0071]

[0072] Note a: Compared with the control group: *Z=2.033, r=0.042<0.05

[0073] Note b: Compared with before treatment: #Z=-5.108, r=0.000<0.05

[0074] Note c: Compared with before treatment: ￥Z=-5.021, r=0.000<0.05

[0075] After treatment, there were 16 clinical pregnancies in 16 cycles in the experimental group, with a pregnancy rate of 19.04%; there were 11 clinical pregnancies in 11 cycles in the control group, with a pregnancy rate of 12.79%. The clinical pregnancy rate in the experimental group was slightly higher than that in the control group. The difference was not statistically significant by chi-square test (P>0.05). See Table 3.

[0076] Table 3 Comparison of clinical pregnancy rates between the two groups after treatment (n, %)

[0077]

[0078] Note a: Comparison of clinical pregnancy rates: χ 2 = 1.245, r = 0.264 > 0.05

[0079] Obviously, the above embodiments are merely examples given for clear illustration and are not limitations on the implementation manners. For those of ordinary skill in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to enumerate all the implementation manners here. And the obvious changes or modifications derived therefrom still fall within the protection scope of the present invention.

Claims

1. A membrane nourishing and fertility-aiding package, characterized in that: It includes mulberry, black wolfberry, placenta and dendrobium officinale in a mass ratio of 3:1:1:

1.

2. A method for preparing a membrane-nourishing pregnancy-aiding package, based on the membrane-nourishing pregnancy-aiding package in claim 1, characterized in that: The following steps are involved: Step 1, raw material preparation: Use a calibrated electronic scale to accurately weigh the pure Chinese medicinal material pieces of mulberry, black wolfberry, placenta and dendrobium according to the proportion; after weighing, complete the cleaning work; Step 2, crushing and sieving: the weighed clean material pieces are mixed and coarsely crushed; the coarse crushing is then finely crushed, and the fine crushing is passed through a 100-200 mesh sieve to obtain the medicinal powder; after sieving, the site is cleared and the yield and material balance rate are calculated; Step 3, drying and sterilization: Spread the sieved powders in a tray with a thickness of ≤2.0 cm; and dry and sterilize; Step 4, mixing and sieving: the sterilized powder is mixed again, and the mixing time is ≥30min; after mixing, it is sieved again with a 100-200 mesh sieve; after sieving again, the site is cleaned, and the yield and material balance rate are calculated; Step 5: Drug packaging: The remixed drug powder is packaged in the sterile workshop, and the packaging volume and sealing degree are checked from time to time during packaging; Step 6: Labeling and warehousing: After packaging, label printing and outer packaging labeling are carried out; after labeling is completed, the finished product can be put into storage for use after passing the inspection.

3. The method for preparing the membrane nourishing and pregnancy-assisting bag according to claim 2, characterized in that: In step 2, during the crushing and screening process, the ingredients are weighed and mixed according to the batch preparation instructions, and two people are combined; the coarse crushing is carried out using a graded continuous feeding crusher; the fine crushing is carried out using a vibrating pharmaceutical ultrafine crusher.

4. The method for preparing the membrane nourishing and pregnancy-assisting bag according to claim 3, characterized in that: In step 2, the yields of coarse crushing, fine crushing and screening are all 90% to 100%.

5. The method for preparing the membrane nourishing and pregnancy-assisting bag according to claim 4, characterized in that: In step 2, the material balance rate calculation formula is as follows: W = (finished product weight + waste weight + return weight) / received weight × 100% Wherein, W is the material balance rate, which ranges from 97% to 103%.

6. The method for preparing the membrane nourishing and fertility-aiding bag according to claim 5, characterized in that: In step three, the drying and sterilization method is to use a hot air disinfection box, set the drying temperature to 50-65°C, set the drying and sterilization time to 12-15h, and the yield is 85%-100%.

7. The method for preparing the membrane nourishing and fertility-aiding bag according to claim 6, characterized in that: In step 4, the mixing is performed again according to the mixing station operation procedures, the mixed screening yield is 90% to 100%, and the material balance rate is 97% to 103%.

8. The method for preparing the membrane nourishing and fertility-aiding bag according to claim 7, characterized in that: In step five, the drugs are packaged in medicinal polyethylene bags, with each bag containing 60 to 100 grams; irregular inspections are conducted 3 to 5 times per batch and records are kept.

9. The method for preparing the membrane nourishing and fertility-aiding bag according to claim 8, characterized in that: In step six, labeling and warehousing includes the following steps: S1. Label printing: Collect the labels of this batch of products according to the batch packaging instructions; and check the appearance inspection report or certificate of conformity for product name, specification, quantity, text, pattern, color, material and size; S2. Adjust the printing equipment according to the batch number, production date and expiration date of the product, and then print; S3. According to the batch packaging instructions, collect the qualified printed labels of this batch of products, check the product name, quantity, color, specification and material appearance, and put them in the outsourcing room for outer packaging labeling; S4. After labeling, the finished products are transported to the inspection area of ​​the finished product warehouse via turnover baskets, and are put into storage for use after passing the finished product inspection.

10. The method for preparing the membrane nourishing and fertility-aiding bag according to claim 9, characterized in that: In step one, auxiliary medicinal slices are added during raw material preparation, and the auxiliary medicinal slices are selected from one or more of Semen Ziziphi Spinosae, Tenuifolia Root and Caulis Polygoni Multiflori; the mass ratio of pure Chinese medicinal material medicinal slices to auxiliary medicinal slices is 4:1.

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